81 FR 54822 - Lawrence E. Stewart, M.D.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 159 (August 17, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 159 (August 17, 2016)
| Page Range | 54822-54848 | |
| FR Document | 2016-19595 |
[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)] [Notices] [Pages 54822-54848] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19595] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 16-14] Lawrence E. Stewart, M.D.; Decision and Order On June 1, 2016, Administrative Law Judge (ALJ) Charles Wm. Dorman issued the attached Recommended Decision. Therein, the ALJ found that on multiple occasions, Respondent issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for schedule II controlled substances such as Norco 10/ 325mg (hydrocodone/acetaminophen) and Hycodan (hydrocodone/homatropine cough syrup),\1\ the schedule III controlled substance phentermine, and the schedule IV controlled substance alprazolam, in violation of 21 CFR 1306.04(a). See R.D. at 34-60.\2\ --------------------------------------------------------------------------- \1\ Effective October 6, 2014, combination hydrocodone products including both Norco and Hycodan were transferred from schedule III to schedule II of the Controlled Substances Act. See Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II, 79 FR 49661. Thus, at the time Respondent issued some of the Norco and Hycodan prescriptions, the drug was a schedule III controlled substance. This, however, has no consequence for my decision. \2\ All citations to the Recommended Decision are to the slip opinion as issued by the ALJ. --------------------------------------------------------------------------- More specifically, the evidence showed that Respondent prescribed the controlled substances to his girlfriend knowing that she was seeking the drugs to abuse them. The evidence also showed that while some of the prescriptions were issued in the name of Respondent's girlfriend, in multiple instances, Respondent issued prescriptions, including multiple prescriptions for Hycodan, listing his girlfriend's two children, who were then three and five years old respectively, as the patients, and that Respondent did so knowing that his girlfriend intended to use the cough syrup because she enjoyed drinking it. The evidence further showed that on multiple occasions, Respondent issued prescriptions for Norco \3\ to undercover agents who posed as acquaintances of his girlfriend, knowing that the drugs would then be provided to his girlfriend and that Respondent further instructed his girlfriend as to how her purported acquaintances should present as having headaches so that he could document a reason in the their charts for having issued the prescriptions. --------------------------------------------------------------------------- \3\ The evidence also showed that at one of the undercover agent's visits, Respondent also gave her a prescription for Hycodan cough syrup. --------------------------------------------------------------------------- The ALJ also found that on multiple occasions, Respondent violated Rule 1.4 of the Mississippi State Board of Medical Licensure's Rules by failing to document in his girlfriend's chart the diagnosis or justification for issuing the prescription, as well as required information including the drug's name, the dose, strength and quantity. R.D. at 37-39 (citing Miss. Code R. Sec. 30-17-2640:1.4; also citing id. Sec. 30-17-2640:1.16; Miss. Code Sec. Sec. 73-25-29(3) and (13)). The ALJ also made a similar finding with respect to four hydrocodone cough syrup prescriptions Respondent issued in the names of his girlfriend's children. R.D. at 46-47 (Rx's issued on 6/17/14, 7/23/14, 11/19/14); id. at 49 (Rx 11/3/14). With respect to the phentermine prescriptions Respondent issued to his girlfriend, the ALJ found that he ``completely failed to comply'' with the Board's Rule 1.5 because he did not prescribe ``adjunctively with caloric restriction,'' ``never conducted and recorded an initial comprehensive evaluation'' including ``a thorough patient history or physical examination,'' and never recorded required histories, nor her height, weight, BMI, body measurements, and vital signs. R.D. 43. The ALJ also found that Respondent did not conduct a re-evaluation of his girlfriend every 30 days as required by Rule 1.5. Id. Finally, noting that Rule 1.5 generally requires that the patient have a BMI greater than 30 in order to justify prescribing phentermine, the ALJ observed that Respondent's girlfriend testified that she had gone from 135 to 121 pounds and that she presented at the hearing ``with a slender body type.'' Id. The ALJ thus explained that ``[a]fter observing [her] appearance,'' he found ``it difficult to comprehend . . . how Respondent could have possibly believed that [she] has a high enough BMI to justify'' prescribing weight-loss medication. Id. The ALJ thus found that Respondent violated 21 CFR 1306.04(a), the Board's Rule 1.5, and Mississippi Code sections 73-25-29(3) and (13) when he prescribed phentermine to his girlfriend. Id. at 44. Based on these findings, the ALJ concluded that Respondent had engaged in ``an egregious level of intentional diversion'' and that the Government had satisfied its prima facie burden of showing that ``Respondent's continued registration would be inconsistent with the public interest.'' R.D. at 61. Because ``Respondent offered no evidence that he accepted responsibility for his misconduct or reformed his ways,'' the ALJ found that he ``failed to rebut the Government's prima facie case.'' Id. The ALJ thus recommended that I revoke Respondent's registration and deny any application to renew or modify his registration. Id. Respondent filed Exceptions to the ALJ's Recommended Decision. Thereafter, the ALJ forwarded the record to me for Final Agency Action. Having considered the record in its entirety, including Respondent's Exceptions, I have decided to adopt the ALJ findings of fact, conclusions of law, and recommended Order. However, before I address Respondent's Exceptions, I deem it necessary to address the ALJ's ruling on the admissibility of the FDA package insert for Hycodan (GX 4). On motion of Respondent's counsel, the ALJ ruled inadmissible Government Exhibit 4, which the Government represented was the FDA package insert for Hycodan.\4\ Tr. 422, 427. The basis of Respondent's objection was that the exhibit contains ``little more than generalizations and medical opinions'' and that the ALJ's prehearing statement required the parties to disclose ``the names and credentials and opinions of medical experts . . . who would be offering medical opinions in this case.'' Id. at 420. Respondent's counsel further argued that ``[t]he government did not identify any expert capable of being cross-examined on any of these opinions'' and that ``[t]here is no reason to believe that [the Exhibit was] authored by a physician, much less do we know whether the author had credentials to offer these opinions.'' Id. --------------------------------------------------------------------------- \4\ There is no dispute that the Exhibit was what the Government represented it to be--a copy of the package insert. Nor is there any dispute as to how the document was obtained. --------------------------------------------------------------------------- After the Government argued that the document was the FDA package insert, which is included ``with every drug purchased or sold,'' id. at 422, Respondent argued that the copyright of the document was the manufacturer and that ``we don't know who authored it, or what their credentials were, but it's a self-interested marketing pharmaceutical company'' that is ``trying to sell their [sic] medicine'' and while the company has a ``self-interest[] to comply with a federal regulation . . . ``[i]t doesn't mean that the content is government-sanctioned.'' Id. at 422-23. Respondent thus asserted that the [[Page 54823]] document was ``just not reliable enough.'' Id. at 426. The ALJ sustained the objection but provided no explanation as to his reason for doing so. I conclude, however, that the Exhibit was admissible. As the FDA has explained, the package insert ``is part of the FDA-approved labeling,'' and ``[t]he FDA approved label is the official description of a drug product, which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnant women, children, and other populations; and safety information for the patient.'' See U.S. Food and Drug Administration, Drugs@FDA Instructions: Health Information, available at www.fda.gov/Drugs/InformationOnDrugs/ucm079450.htm (accessed August 4, 2016). The FDA's approval of a drug label follows extensive clinical trials, including trials which examine the safety and effectiveness of a drug and are part of the process for approving the drug for marketing. See Food and Drug Administration, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 FR 3922 (2006) (Final Rule) (``A prescription drug product's FDA-approved labeling (also known as `professional labeling,' `package insert,' `direction circular,' or `package circular') is a compilation of information about the product, approved by FDA, based on the agency's thorough analysis of the new drug application (NDA) . . . submitted by the applicant. This labeling contains information necessary for safe and effective use.''). Under the Food, Drug and Cosmetic Act, a drug ``shall be deemed to be misbranded . . . [u]nless its labeling bears . . . such adequate warning against use . . . by children where its use may be dangerous to health.'' 21 U.S.C. 352(f). Moreover, introducing a misbranded drug into interstate commerce is a violation of 21 U.S.C. 331(a). Thus, there are ample incentives for drug manufacturers to provide reliable information in the package insert. Based on the foregoing, I find that there are sufficient indicia of reliability to support the admission of the document into evidence and make it a part of the record.\5\ I further find that this evidence is probative on the issue of whether the Hycodan prescriptions issued by Respondent in the name of his girlfriend's children were for a legitimate medical purpose. See, e.g., Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409, 413 (6th Cir. 2008) (holding that dispensing contraindicated controlled substance is evidence of 21 CFR 1306.04(a) violation). --------------------------------------------------------------------------- \5\ Hearsay evidence is admissible in administrative proceedings, provided it is relevant and material and supported by sufficient indicia of reliability. See, e.g., Mireille Lalanne, 78 FR 47750 (2013). As further noted above, in opposing the admission of the package insert, Respondent represented that it contained expert opinions from unidentified persons whom he could not cross-examine and thus was being offered in violation of the ALJ's Prehearing Order. However, in its pre-hearing statement, the Government provided notice that it intended to offer the Exhibit and pursuant to the ALJ's Prehearing Ruling, the Government was required to provide the document to Respondent by 2 p.m. on February 12, 2016. ALJ Ex. 9, at 2. No claim is made that the Government failed to comply with the ALJ's ruling. While Respondent asserts that he was unable to cross-examine the persons who wrote the package insert, he made no attempt to subpoena either an FDA official involved in reviewing the document or an employee from the manufacturer who was involved in preparing it. Moreover, Respondent could have sought to challenge the reliability of the document by producing evidence (whether through expert testimony or studies) disputing the package insert's statement regarding the risks of prescribing the drug to children less than six years of age. Respondent, however, produced no evidence which calls into question the reliability of the statements contained in the insert. --------------------------------------------------------------------------- Notably, the Hycodan package insert's safety information includes the following warning: ``The use of HYCODAN is not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression.'' GX 4, at 2. Notably, Respondent's girlfriend's daughter was not even five years old when he wrote the first Hycodan prescription in her name. GE 55, at 1-2. Respondent also wrote Hycodan prescriptions in the name of his girlfriend's son who was then three years old. Id. at 3-4; 11-12. In short, neither of the children who were listed as the patients on the Hycodan prescriptions was six years of age when Respondent wrote the prescriptions. Thus, I consider this as additional evidence which supports the conclusion that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he issued the Hycodan prescriptions in the names of his girlfriend's children. 21 CFR 1306.04(a). I now turn to Respondent's Exceptions. Exception I--The Government Failed ``to Prove Violations of State or Local Laws Sufficient to Demonstrate Danger to the Public Interest.'' Respondent argues that the ALJ failed to give proper weight to the decision of Dr. Craig, the Medical Board's Executive Director, to close the Board's investigation of his prescribing practices without recommending the initiation of a formal action against his medical license. Exceptions, at 1-2. According to Respondent, the Board reviewed ``all such clinical and prescription records'' for his girlfriend and her children, and it ``decided that there was no evidence of any breach of any medical standard of care sufficient to bring any administrative charge against [him] related to any such prescription.'' Id. at 2. He also asserts that Dr. Craig ``determined that there was not even sufficient professional reason to issue [him] an informal warning as to any such prescription for pain medication.'' Id. Respondent then argues that ``[r]ather than . . . defer[] to the professional judgments made by [Dr. Craig as to] whether State laws were violated by [him], the ALJ['s] Recommendation proceeds to interpret and apply those State laws without the benefit of any medical evidence, or any medical opinion in any form, anywhere in the record of this case.'' Id. And noting the ALJ's discussion that ```DEA has not required expert testimony to establish a violation of 21 CFR 1306.04(a) in cases where a prescriber engaged in drug deals, where there were notable differences between patients' medical records and diagnoses, and where a prescriber falsified patients' charts,' '' Respondent contends that the Government did not allege that he engaged in any such conduct. Id. at n.1. I reject the Exception. As for the contention that Dr. Craig reviewed the medical records and prescriptions and did not find the evidence sufficient to initiate a proceeding against his license, Respondent ignores the credited testimony that the Board terminated its investigation upon the request of the Mississippi Bureau of Narcotics (MBN) after the latter informed the Board that it was conducting a criminal investigation. Tr. 60 (testimony of MBN agent); GE 3, at 2 (Board Complaint form entry dated ``3-20-15'' stating ``MBN has asked that we hold off on doing anything to this doctor because they are working a criminal case on him'').\6\ A Board investigator also testified that ``it's customary for [the Board] to back off [of an investigation] and let a criminal agency pursue their [sic] case'' and that Dr. Craig was aware of the criminal investigation. Tr. 210. --------------------------------------------------------------------------- \6\ The Board's investigation involved interviewing Respondent, as well as reviewing his girlfriend's patient file and a PMP report of her controlled substance prescriptions. GE 3, at 4-6. Notably, the Board's investigator testified that the Board did not interview Respondent's girlfriend. Tr. 196. --------------------------------------------------------------------------- Moreover, even then the Board's letter cautioned Respondent ``that authorizing [[Page 54824]] refills for Phentermine/Adipex without the benefit of a medical examination is strictly prohibited by the Board's Rules and Regulations'' and specifically quoted the Board's Rule 1.5(E), which states that: ``[a] patient continued on a controlled substance in schedule III, IV, V for the purpose of weight reduction or the treatment of obesity should undergo an in-person re-evaluation once every 30 days.'' GE 3, at 1. Finally, as the evidence shows, subsequent to the Board's closing of its investigation, Respondent again issued multiple controlled substance prescriptions to purported acquaintances of his girlfriend knowing that the drugs would subsequently be provided to his girlfriend. Accordingly, I reject Respondent's contention that the Board's closing of its investigation reflects its ``professional judgments'' that Respondent acted within the bounds of accepted professional practice when he prescribed to Respondent and the undercover officers. Under both this and his subsequent exception, Respondent argues that the ALJ's decision is unprecedented because the Government put forward no expert testimony to support the conclusion that he violated 21 CFR 1306.04(a) in issuing the various prescriptions. However, contrary to Respondent's understanding, numerous decisions of both the federal courts in criminal cases and this Agency have held that expert testimony is not necessarily required to prove that a physician acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing a controlled substance prescription. See United States v. Pellman, 668 F.3d 918, 924 (7th Cir. 2012) (quoting United States v. Armstrong, 550 F.3d 382, 388-89 (5th Cir. 2008) (``While expert testimony may be both permissible and useful, a jury can reasonably find that a doctor prescribed controlled substances not in the usual course of professional practice or for other than a legitimate medical purpose from adequate lay witness evidence surrounding the facts and circumstances of the prescriptions.'')); Armstrong, 550 F.3d at 389 (``Jurors have had a wide variety of their own experiences in doctors' care over their lives, thus and expert testimony is not necessarily required for jurors to rationally conclude that seeing patients for as little as two or three minutes before prescribing powerful narcotics is not in the usual course of professional conduct.'').\7\ See also T.J. McNichol, 77 FR 57133, 57147-49 (2012), pet. for rev. denied, 537 Fed. Appx. 905 (11th Cir. 2013); Morris W. Cochran, 77 FR 17505, 17519-20 (2011) (holding, without expert testimony, that prescriptions lacked a legitimate medical purpose where physician noted in patient medical records that patients had no pain, did not document any findings to support a diagnosis, and yet diagnosed patients as having chronic pain); Robert F. Hunt, 75 FR 49995, 50003 (2010) (holding, without expert testimony, that physician lacked a legitimate medical purpose based on statements made during undercover visits and falsification of chart). See also Jack A. Danton, 76 FR 60900, 60904 (2011). --------------------------------------------------------------------------- \7\ See also United States v. Word, 806 F.2d 658, 663 (6th Cir. 1986); United States v. Larson, 507 F.2d 385, 387 (9th Cir. 1974); United States v. Bartee, 479 F.2d 484, 488-89 (10th Cir. 1973); State v. Moody, 393 So.2d 1212, 1215 (La. 1981). --------------------------------------------------------------------------- Thus, while expert testimony is typically necessary to establish a violation of 21 CFR 1306.04(a) `` `where a physician ma[kes] some attempt to comply with various state medical practice standards and the adequacy of those efforts is at issue,' . . . the facts and circumstances surrounding the issuance of the prescription may nonetheless establish a violation even without expert testimony.'' McNichol, 77 FR 57147-48 (quoting Danton, 76 FR at 60904 & n.13). Accordingly, in McNichol, the Agency found a violation proved, notwithstanding that the ALJ had rejected the testimony of the Government's Expert, because while the physician had gone through the motions of a physical exam, the physician's ``comments manifest[ed] that he knew that [the patient] was an abuser of controlled substances.'' Id. at 57148. See also Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (``[T]he prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.'') (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). Here, as the ALJ found, Respondent issued multiple prescriptions to his girlfriend while failing to document the performance of a physical exam, as well as findings and diagnoses that would support the issuance of the prescriptions. Moreover, with respect to the hydrocodone cough syrup prescriptions Respondent issued to his girlfriend which listed her children as the patients, the ALJ credited her testimony that she told Respondent that she wanted the big bottle of hydrocodone cough syrup and he ``knew I would drink it too.'' R.D. 7; 11 (citing Tr. 216, 251-52, 268, 273); see also Tr. 298 (girlfriend's testimony that the Norco prescriptions were ``not for a headache'' but were ``[j]ust for fun''). Likewise, with respect to the prescriptions Respondent provided in March and April 2015 to his girlfriend's purported acquaintances, the undercover recordings clearly establish that Respondent knew that the acquaintances were not seeking the prescriptions to treat legitimate medical conditions but to provide the drugs to his girlfriend. Given the evidence that clearly shows that Respondent issued the prescriptions to support his girlfriend's abuse of controlled substances, the Government was not required to put forward expert testimony to prove its case. Exception II--The Government ``Fail[ed] to Prove `Past Experience in the Distribution of Controlled Substances.' '' Respondent further argues that the ALJ erred when he refused ``to allow Respondent to seek clinical evidence about [his girlfriend's] medical history through third-party document subpoenas.'' Exceptions, at 2. Prior to the hearing, Respondent requested that the ALJ issue eight subpoenas to health care providers for their medical records ``which reflect, relate to, or explain the clinical or medical basis for prescribing'' controlled substances (primarily hydrocodone with acetaminophen) to his girlfriend. See, e.g., ALJ Ex. 13, at 6. In seeking the subpoenas, Respondent maintained that ``[i]n order for the truth about [his girlfriend's] medical condition and needs to be revealed . . . the clinical findings and judgment of all such health care providers should be available to the Court in order to allow a comparison between Dr. Stewart's judgment and the judgments of a substantial number of other health care professionals in the same community.'' ALJ Ex. 13, at 3. On the various subpoenas, Respondent explained that because one of the Government's Exhibits (the PMP report, GE 49) shows that the other health care providers had also issued hydrocodone prescriptions to his girlfriend, ``[t]he presumed legitimacy of the particular clinical findings which caused [the] other health care professionals in the same community to prescribe the same medication to [her] could be strongly probative of the medical inaccuracy of the . . . core allegations against'' him. See, e.g., GE 13, at 6. The Government opposed the issuance of the subpoenas. It argued that [[Page 54825]] the information Respondent sought was irrelevant because the only allegations it raised as to the unlawful prescribing of hydrocodone with acetaminophen to his girlfriend involved the four Norco prescriptions which were identified in paragraph 4 of the Show Cause Order.\8\ ALJ Ex. 14, at 2-3. The Government also argued that ``[i]n each of those instances,'' it was ``alleg[ing] that Respondent prescribed to [her] either without conducting any examination of her or without noting those prescriptions in her chart.'' Id. at 3. And it further argued that none of the records would address the ``actual charges against'' Respondent. Id. --------------------------------------------------------------------------- \8\ The Show Cause Order alleged that the prescriptions were issued on May 22, June 17, September 11, and October 29, 2014. ALJ Ex. 1, at 2. --------------------------------------------------------------------------- The ALJ agreed with the Government and denied Respondent's request. ALJ Ex. 16. The ALJ explained that having reviewed the allegations of the Show Cause Order, he agreed with ``the Government's assessment that the question of whether [Respondent' girlfriend] needed a particular medication is not an issue before me.'' Id. at 1. And noting that ``Respondent has not produced a summary of [his] expected testimony,'' the ALJ then reasoned that ``there is no information in the record that the Respondent based his decision to prescribe a particular medication to [his girlfriend] based upon his knowledge of what some other treating physician had prescribed for'' her. Id. at 1-2. Concluding that the information sought by Respondent was irrelevant, the ALJ denied the request. Id. at 2. I conclude that the ALJ properly denied Respondent's request. I do not, however, read the Government's Opposition as expressing the position that his girlfriend's need for the Norco prescriptions was not at issue. While the Government alleged that these particular prescriptions were unlawful because: (1) Respondent did not ``conduct[] an examination of'' of his girlfriend or ``document[] such in her file,'' or (2) Respondent did not note the prescriptions in her chart and thus violated the Board's Rules 1.4, 1.11(b) and 1.16, the Government also cited 21 CFR 1306.04(a)). Because ``[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose,'' 21 CFR 1306.04(a), a patient's need for the drug is invariably at issue when a violation of this provision is alleged. See also Miss. Code R. Sec. 30-17-2640:1.4 (``No physician shall prescribe, administer or dispense any controlled substance . . . without a good faith prior examination and medical indication therefore.''). Indeed, assessing whether a patient needs a controlled substance to treat a medical condition is the reason why the usual course of professional practice generally requires that a physician take a detailed history and conduct an appropriate examination of the patient to make a proper diagnosis and treatment plan.\9\ See id. --------------------------------------------------------------------------- \9\ As Rule 1.4 further states: Standards of proper medical practice require that, upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) Take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results. The observance of these principles as a function of the ``course of legitimate professional practice'' is particularly of importance in cases in which controlled substances are to play a part in the course of treatment. It is the responsibility of the physician to dispense, prescribe or administer such drugs with proper regard for the actual and potential dangers. Miss. Code R. Sec. 30-17-2640:1.4. --------------------------------------------------------------------------- I nonetheless agree with the ALJ's conclusion that the information sought by the subpoenas was irrelevant. Notably, Respondent made no proffer that he had obtained and reviewed the records maintained by these other providers and had based his decisions to prescribe hydrocodone to his girlfriend on those records. Nor did Respondent proffer that he was acting as a covering physician for any of these other physicians (or any other authorized prescriber) when he prescribed the hydrocodone to his girlfriend. Respondent further contends that the prescriptions issued by the other providers ``strongly support a conclusion that [his] own prescriptions for [h]ydrocodone for use by [his girlfriend] were within the bounds of the medical standard of care practiced in that community.'' Exceptions, at 4. However, were it the case that Respondent's prescribing of hydrocodone was within the bounds of professional practice, he could have put on an expert to testify as such.\10\ Yet Respondent chose not do so. --------------------------------------------------------------------------- \10\ Respondent initially proposed to call a physician and professor from the University of Mississippi Medical Center who would testify that the prescriptions he issued ``were for legitimate medical purposes'' and ``were in the usual course of and consistent with [his] own standard professional practices [and] were consistent with the standard of care in the medical community in which they lived.'' ALJ Ex. 17, at 2-3. While the Government moved to exclude the proffered testimony, the ALJ denied the Government's motion and specifically ruled that the expert could testify to the above subjects. ALJ Ex. 28, 3-4. Respondent did not, however, call this witness. Of further note, even if Respondent had put on testimony that the prescriptions were ``consistent with [his] own standard professional practices,'' that testimony would have been unavailing because the standard of professional practice is not defined by a physician's subjective belief as to the propriety of his practices but on the application of the standards of practice in the State where he practices. United States v. Tobin, 676 F.3d 1264, 1290 (11th Cir. 2012). For similar reasons, evidence as to the standard of care in the medical community in which Respondent lived would also be unavailing. --------------------------------------------------------------------------- Respondent also contends that the evidence is insufficient to show that the hydrocodone prescriptions lacked a legitimate medical purpose because ``it is clear that during the months relevant to this case [his girlfriend] was in fact suffering from a chronic migraine condition and associated headache pain, and that [he] was treating her for that condition.'' Exceptions, at 3. Respondent points to the testimony of his girlfriend that she was hospitalized for migraines ``[t]hree times prior to the beginning of his treatment of her in February 2014, and a fourth time during that treatment in August of 2014.'' Id. He further maintains that his charts ``specified that she complained of, and in fact suffered from, a chronic migraine condition.'' Id. It is true that in two of the visit notes for his girlfriend (April 21 and Sept. 2, 2014), Respondent listed Maxalt, a non-controlled drug, and Norco (hydrocodone with acetaminophen), as the drugs he prescribed to her for this condition. GE 2, at 12. Yet prior to Respondent's issuance of the first Norco prescription to her, she had ``asked him to write the big bottle'' of hydrocodone cough syrup ``so that [she] could have some too'' and ``told him I like to drink it'' because she ``like[d] the way it made [her] feel.'' Tr. 251-52; 273. Thus, Respondent already knew that his girlfriend was a drug abuser.\11\ --------------------------------------------------------------------------- \11\ Respondent points to the testimony of his girlfriend that she never told him that she was addicted to hydrocodone, dependent on the drug, or taking it ``for no reason.'' Exceptions, at 3. As discussed above, Respondent's girlfriend subsequently clarified that she took the Norco ``just for fun.'' Tr. 298. To the extent Respondent believes that his misconduct in writing the Norco prescriptions should be excused because his girlfriend did not tell him why she was taking the Norco, the evidence is clear that she had previously asked him to prescribe the big bottle of cough syrup so that she ``could have some too'' and had told him that she ``like[d] to drink it'' because of ``the way it made [her] feel.'' Thus, Respondent clearly knew that his girlfriend was a drug abuser at the time he wrote her the first Norco prescription. --------------------------------------------------------------------------- The evidence also shows that Respondent told his girlfriend that taking hydrocodone could itself ``cause migraines.'' Id. at 283; see also id. at 299. Respondent's girlfriend testified that he told her that taking hydrocodone ``would not help'' her migraines. Id. at 300. She further testified that ``[t]he hydrocodone was not for a headache,'' but for ``[e]xtracurricular activities,'' i.e., [[Page 54826]] ``just for fun.'' Id. at 298. Moreover, Respondent issued the first of the Norco prescriptions to her without even taking a history and conducting a physical examination of her. GE 2, at 12; see Miss. Code R. Sec. 30-17-2640:1.4. He also failed to document several of the hydrocodone prescriptions in his girlfriend's chart.\12\ Compare GE 2, at 12, with GE 3, at 9-10. Thus, the evidence strongly supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed Norco to his girlfriend. 21 CFR 1306.04(a). --------------------------------------------------------------------------- \12\ Indeed, Respondent wrote the first Norco prescription for her on February 21, 2014. The note in her patient file simply states: ``2-21-14 Hc 7.5/325 (#40, 1)--may be picked up at desk.'' GE 2, at 12. Thus, Respondent issued the prescription without taking a history of his girlfriend's migraines and without conducting a physical exam. --------------------------------------------------------------------------- Respondent also appears to argue that the alprazolam prescription he issued to his girlfriend was not unlawful because she suffered from anxiety and he referred her to a psychiatrist who had prescribed the drug to her. Exceptions, at 4. While Respondent acknowledges that he did not ``diagnose [her] himself as to anxiety,'' he argues that he issued the prescription ``in reliance on that psychiatrist's independent clinical judgment'' and gave her a refill so that she could ``avoid[] further one-hour trips to the psychiatrist to obtain a refill.'' Id. I am not persuaded. Notably, the psychiatrist prescribed only a seven-day supply of alprazolam extended release in the .5 mg dosage. GE 49, at 1. Respondent, however, prescribed a stronger dosage of alprazolam and greater quantity, providing her with a prescription for 40 tablets of the 1mg immediate release dosage form, with a refill for an additional 40 tablets. Id. This was not a refill of the psychiatrist's prescription at all, but a substantially different and stronger prescription. Yet the medical record contains no evidence that Respondent coordinated his prescribing with the psychiatrist. As for Respondent's explanation that he wrote the prescription so that his girlfriend would not have to make the one-hour trip to obtain a refill, this begs the question as to why the psychiatrist would not be willing to call in a refill. I thus reject Respondent's Exception to the extent it challenges the ALJ's findings as to the alprazolam prescription. As for the phentermine prescriptions, Respondent again invokes Dr. Craig's letter in which he stated that the Board was closing its investigation while cautioning Respondent about the need to conduct an in-person re-evaluation every 30 days. Exceptions, at 4. Respondent revisits his argument that Dr. Craig ``determined that there was no sufficient medical basis for alleging any violation . . . of any medical standard in Mississippi.'' Id. However, as previously explained, the Board terminated its investigation because Respondent was the subject of a criminal investigation. Moreover, the ALJ thoroughly explained the basis for his conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued the phentermine prescriptions to his girlfriend.\13\ --------------------------------------------------------------------------- \13\ Respondent points to the evidence that on March 27, 2015, he declined to prescribe weight loss medication to one of the undercover agents. Exceptions, at 4 (citing GE 10, at 1-2). However, several weeks earlier, Respondent had been visited by a State Board Investigator who had told him that his documentation for the phentermine prescriptions that he issued to his girlfriend was inadequate and he may have already received the letter from Dr. Craig by the date of the first undercover visit. In any event, while Respondent may have taken to heart the warning he received from Dr. Craig regarding the prescribing of weight loss medications, this obviously had no impact on his prescribing of narcotics, as evidenced by his prescribing of Norco and Hycodan to the undercover agents. --------------------------------------------------------------------------- Finally, Respondent argues that ``[t]he DEA, through the CI [his girlfriend], effectively caused [him] to engage in conduct, which, according to the record . . . he apparently had never engaged in on any other occasion.'' Exceptions, at 5. Continuing, Respondent argues that his ``conduct, in issuing prescriptions for pain medications to third parties in an effort to provide the CI with continuing relief from her migraine conditions, arose from the peculiar combination of his personal relationship and familiarity with the CI and the CI's insistence that her `friends' were seeking medication for'' her use. Id. Respondent thus maintains that this ``peculiar circumstance . . . provides no significant medical or other evidence sufficient to justify any conclusion that [his] conduct . . . poses, or is likely to pose in the future, any danger to the public health or safety.'' Id. I disagree. To the extent Respondent's argument sounds in the entrapment defense, I reject it as there is ample evidence that he was predisposed to issue the unlawful prescriptions given the multiple unlawful prescriptions he wrote for his girlfriend in 2014, prior to the involvement of the MBN and DEA. See United States v. Sumlin, 271 F.3d 274 (D.C. Cir. 2001). As for the assertion that he wrote the prescriptions to the undercover agents to provide his girlfriend ``with continuing relief from her migraine conditions,'' this is simply counterfactual as the record abounds with evidence that Respondent knew she was seeking the drugs to abuse them. Tr. 345; GE15; 16; GE 17, at 2-4, 6-8; GE 18, at 3. I therefore reject Respondent's contention that there is no ``significant medical or other evidence'' to support the conclusion that he poses a danger to public health and safety.\14\ Exceptions, at 5. To the contrary, the evidence shows that on multiple occasions, Respondent issued prescriptions outside of the usual course of professional practices and which lacked a legitimate medical purpose to feed his girlfriend's abuse of controlled substances. This conduct amply supports the conclusion that he has committed such as acts as to render his registration ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). --------------------------------------------------------------------------- \14\ In arguing that he does not ``pose . . . any danger to public health or safety,'' Respondent cites 21 U.S.C. 823(e), the provision which governs the registration of distributors of schedule III through V controlled substances and not practitioners, who are registered under section 823(f). However, to the extent Respondent argues that the Government is required to put forward such proof in seeking the revocation of his registration, the Government is not required to do so even though one of the section 823(f) factors is ``such other conduct which may threaten the public health and safety.'' 21 U.S.C. 823(f). While this factor encompasses conduct which is not otherwise embraced by the other section 823(f) factors, it is indisputable that issuing prescriptions to feed a person's drug abuse is conduct which threatens public health and safety. --------------------------------------------------------------------------- Exception III--The ALJ Violated Respondent's Fifth Amendment Rights When He Denied His Request To Delay the Hearing Until the End of His Criminal Trial Respondent's final contention is that the ALJ violated his Fifth Amendment privilege against self-incrimination when he denied his request to reschedule the hearing until after his criminal trial concluded. Exceptions, at 5-6. Notably, the Government did not call Respondent to testify and the ALJ declined to draw an adverse inference from his failure to testify on his own behalf even though doing so would have been warranted. See Keating v. Office of Thrift Supervision, 45 F.3d 322, 326 (9th Cir. 1995) (``Not only is it permissible to conduct a civil proceeding at the same time as a related criminal proceeding, even if that necessitates invocation of the Fifth Amendment privilege, but it is even permissible for the trier of fact to draw adverse inferences from the invocation of the Fifth Amendment in a civil proceeding.'') (citing Baxter v. Palmigiano, 425 U.S. 308, 318 (1976)). ` Here, Respondent does not contend that the need to preserve his Fifth Amendment privilege prevented him [[Page 54827]] from providing testimony refuting the allegations that he unlawfully prescribed various controlled substances to his girlfriend and the undercover officers. Rather, he argues that ``[b]ecause he desired understandably to preserve and not to waive his Fifth Amendment privileges with respect to his criminal trial, [he] was prohibited from `rebutting' any prima facie Government case through his own hearing testimony, which was the only practical way he had to `accept responsibility'' or to affirm that he `will not engage in future misconduct.''' Id. at 6. I reject Respondent's contention. See Grider Drug 1 & 2, 77 FR 44069, 44104 (2012). In Grider, the respondents argued that the Agency should reject an ALJ's conclusions that the pharmacies had failed to rebut the Government's prima facie case because their owner, who was under indictment in two state criminal cases, did not testify and thus offered no evidence to show that he had accepted responsibility and implemented corrective measures. Invoking SEC v. Dresser Industries, Inc., 628 F.2d 1368, 1375-76 (D.C. Cir.1980), the Grider respondents further argued that because their owner was under indictment, the ALJ should have stayed the proceeding until the state criminal cases were concluded so as not to ``undermine the party's Fifth Amendment privilege against self-incrimination.'' 77 FR at 44104. The Agency rejected Grider's arguments. As the Agency explained, ```as a general matter, due process is not infringed merely because an accused person is subjected, without his consent, to an administrative hearing concerning matters involved in a pending criminal proceeding.''' Id. (quoting 628 F.2d at 1376 n.21). As Dresser Industries noted, ``[t]he civil and regulatory laws of the United States frequently overlap with the criminal laws creating the possibility of parallel [administrative] and criminal proceedings, either successive or simultaneous'' and that ``[i]n the absence of substantial prejudice to the rights of the parties involved, such parallel proceedings are unobjectionable.'' 628 F.2d at 1374. Thus, in Dresser Industries, the D.C. Circuit observed that ``[t]he Constitution . . . does not ordinarily require a stay of civil proceedings pending the outcome of criminal proceedings.'' Id. at 1375. To be sure, in Dresser Industries, the D.C Circuit further explained that ``the strongest case for deferring civil proceedings is where a party under indictment for a serious offense is required to defend a civil or administrative action involving the same matter.'' Id. However, the court further explained that the potential harm to a party's Fifth Amendment privilege is just one of the factors to be considered in determining whether to stay the noncriminal proceeding. Id. at 1376. Continuing, the court explained that ``[i]f delay of the noncriminal proceedings would not seriously injure the public interest, a court may be justified in deferring it.'' Id. (emphasis added). That decision is, however, committed to the discretion of the trial court. See, e.g., Keating, 45 F.3d at 325 (setting forth multiple factors). Here, I find no reason to conclude that the ALJ abused his discretion when he declined to continue the proceeding until the conclusion of Respondent's criminal trial. Notably, in his request for a continuance, Respondent provided no information to the ALJ as to when that trial would commence.\15\ That trial--and a subsequent appeal were Respondent convicted of the charges--could go on for several years. The ALJ was not required to withhold conducting the hearing while Respondent litigates in other forums. See 45 F.3d at 325 (noting that ``convenience of the court in the management of its cases'' is a factor). So too, the Government has a strong interest in proceeding expeditiously with this litigation, and indeed, under the Constitution, the Agency has an obligation to provide prompt post-deprivation process where the Government immediately suspends a registration. Id.; see also Barry v. Barchi, 443 U.S. 56, 64 (1979). --------------------------------------------------------------------------- \15\ In opposing the request, the Government noted that Respondent had also sought a continuance of the criminal case. ALJ Ex. 6, at 1 n.1. --------------------------------------------------------------------------- As for the burden on Respondent, it is true that courts have held that the prejudice to a respondent's Fifth Amendment privilege may be substantial where there are parallel administrative and criminal proceedings. Keating, 45 F.3d at 326. However, while ``the extent to which the defendant's Fifth Amendment rights are implicated is a significant factor . . . to consider . . . it is only one consideration to be weighed against others.'' Id. (citation omitted). Notably, Respondent was not otherwise foreclosed from putting on a defense. Indeed, in its pre-hearing statement, Respondent proposed to call an expert witness who would testify that the prescriptions were lawfully issued but ultimately chose not to call this witness. Notably, in his Exceptions, Respondent does not maintain that because he invoked the privilege, he was precluded from refuting the factual basis of the allegations. Instead, Respondent now contends that my consideration of the ALJ's recommendation ``should await the disposition of the criminal case . . . following which he should be given an opportunity promptly and succinctly to tell his side of the story and express his complete remorse.'' Exceptions, at 6. However, as discussed above, in his Exceptions, Respondent continues to dispute the allegations (as well as the ALJ's factual findings and legal conclusions) that he issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for each of the different drugs (i.e., the hydrocodone cough syrup, the Norco tablets, the alprazolam, and the phentermine). Thus, his argument begs the question of which allegations he now would admit to. The Fifth Amendment privilege is not ``a sword whereby a claimant asserting the privilege [is] freed from adducing proof in support of a burden which would otherwise have been his.'' United States v. Rylander, 460 U.S. 752, 758 (1983). See also MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (quoting Keating v. Office of Thrift Supervision, 45 F.3d 322, 326 (9th Cir. 1995)). Indeed, the misconduct established on this record is so egregious and occurred over such a lengthy period, that even were I to remand to allow Respondent to express his ``complete remorse'' and the ALJ was to find this credible, I would still find his registration to be inconsistent with the public interest. See Hatem M. Attaya, 81 FR 8221, 8244 (2016); Fred Samimi, 79 FR 18698, 18714 (2014) (denying applications noting that notwithstanding ALJ's finding that physician ``credibly accept responsibility for his misconduct, this is a case where actions speak louder than words''). Thus, I find that Respondent has failed to establish that the ALJ abused his discretion when he denied Respondent's request to continue the proceeding until his criminal trial concluded.\16\ --------------------------------------------------------------------------- \16\ It is, of course, commonplace that matters involving DEA registrants will lead to both a revocation proceeding and a criminal investigation and subsequent charges at either the federal or state level. However, the very purpose of a proceeding brought under 21 U.S.C. 823(f) and 824(a)(4) is to protect the public interest, and, in the Controlled Substances Act, Congress directed that these ``proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter.'' Thus, I conclude that the fifth Keating factor (``the interest of the public in the pending . . . litigation'') also supports the ALJ's denial of Respondent's stay request. As for the fourth Keating factor, ``the interests of persons not parties to the [administrative] litigation,'' 45 F.3d at 326, Respondent puts forward no argument as to why this factor supports the requested stay or a remand at this juncture. --------------------------------------------------------------------------- [[Page 54828]] Accordingly, I reject Respondent's third exception and will adopt the ALJ's recommended sanction of revocation. ORDER Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration AS2286311 issued to Lawrence E. Stewart, M.D., be, and it hereby is, revoked. I further order that any application of Lawrence E. Stewart, M.D., to renew or modify the above registration, or for any additional registration be, and it hereby is, denied. This Order is effectively immediately.\17\ --------------------------------------------------------------------------- \17\ For the same reasons that led me to immediately suspend Respondent's registration, I find that the public interest necessitates that this Order be effective immediately. See 21 CFR 1316.67. Dated: August 9, 2016. Chuck Rosenberg, Acting Administrator. Paul A. Dean, Esq. for the Government. J. Brad Pigott, Esq. for the Respondent. RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION Administrative Law Judge Charles Wm. Dorman. On December 9, 2015, the Drug Enforcement Administration (``DEA'' or ``Government'') served Lawrence E. Stewart, M.D. (``Respondent''), with an Order to Show Cause and Immediate Suspension of Registration (``OSC/ISO''), which immediately suspended the Respondent's DEA Certificate of Registration (``COR''), Number AS2286311. Administrative Law Judge Exhibit (``ALJ- '') 1-2. The Respondent's COR has remained suspended throughout these proceedings. In response to the OSC/ISO, the Respondent requested a hearing before an Administrative Law Judge. ALJ-3. That hearing was held in New Orleans, Louisiana on March 22 and 23, 2016. The issue currently before the Administrator is whether the Respondent's COR should be revoked, and applications for renewal or modification denied, because continued registration would be inconsistent with the public interest under 21 U.S.C. 823(f) and 824(a)(4). The following recommendations are based on my consideration of the entire administrative record, including all of the testimony, admitted exhibits, and the oral and written arguments of counsel. ALLEGATIONS 1. From February 2014 to May 2015, the Respondent prescribed controlled substances, including hydrocodone and alprazolam, to a confidential informant (``CI'') \1\ without conducting and/or documenting a physical examination, and without recording the controlled substance prescriptions in CI's chart, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rules 1.4, 1.11(b), and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a). ALJ-1, at 2. --------------------------------------------------------------------------- \1\ The Prehearing Ruling and Protective Order directed that the confidential informant would be referred to as ``CI.'' ALJ-9, at 5. Accordingly, in this Recommended Decision, the confidential informant will be referred to as ``CI.'' --------------------------------------------------------------------------- 2. On four occasions, the Respondent prescribed phentermine to CI without adequate documentation, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rule 1.5, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a). ALJ- 1, at 3. 3. From February 7, 2014 to November 19, 2014, the Respondent prescribed hydrocodone products to CI's children \2\ without conducting examinations of them, and for CI's personal use, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rules 1.4, 1.10, 1.11(b), and 1.16, and Mississippi Code Sec. Sec. 73- 25-29(3) and (13), and 21 CFR Sec. 1306.04(a) and 1306.05(a). ALJ-1, at 2-3. The Respondent prescribed hydrocodone-homatropine syrup to these children, who were under the age of six. ALJ-1, at 3. Hydrocodone-homatropine syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Respondent also prescribed adult dosages of hydrocodone-homatropine to these children, even though the recommended dosage for children ages six to eleven is half of the adult dosage. ALJ-1, at 2-3. --------------------------------------------------------------------------- \2\ The Prehearing Ruling and Protective Order directed that CI's children would be referred to as ``Kid 1'' and ``Kid 2.'' ALJ- 9, at 5. Accordingly, in this Recommended Decision, CI's son will be referred to as ``Kid 1,'' and CI's daughter will be referred to as ``Kid 2.'' --------------------------------------------------------------------------- 4. On five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents' prescription requests were fraudulent, in violation of 21 U.S.C. 841(a) and 842(a), and 21 CFR Sec. 1306.04(a). ALJ-1, at 3. In total, the Respondent wrote seven prescriptions on five occasions to undercover agents, for a total of 190 dosage units of hydrocodone tablets and 72 dosage units of hydrocodone syrup. ALJ-1, at 11. On at least four of those occasions, the Respondent knew that CI would receive a portion of the prescribed controlled substances. ALJ-1, at 3-4. The Respondent also knew that CI had attempted to commit suicide using controlled substances that the Respondent had prescribed to her. ALJ-1, at 3-4. 5. From February 2014 to October 2015, the Respondent unlawfully prescribed controlled substances in violation of 21 U.S.C. 841(a) and 842(a). ALJ-1, at 2. Specifically, the Respondent prescribed controlled substances when he knew or should have known that the prescriptions were not for legitimate medical purposes and were not made in the usual course of professional practice, in violation of 21 CFR Sec. 1306.04(a) and Mississippi Code Sec. Sec. 41-29-137(a)(1) and 41-29- 141(1). ALJ-1, at 2. 6. On September 2, 2014, the Respondent prescribed meperidine to CI. ALJ-1, at 3. The Respondent was the only practitioner to prescribe meperidine to CI. ALJ-1, at 3. CI used meperidine to attempt to commit suicide in December 2014. ALJ-1, at 3. STIPULATIONS OF FACT \3\ --------------------------------------------------------------------------- \3\ See ALJ-9, 20; Tr. 9. --------------------------------------------------------------------------- The Government and the Respondent stipulated to the following facts: 1. Respondent is registered with the DEA as a practitioner to handle controlled substances in Schedules II-V under DEA COR AS2286311 at 405 Marion Avenue, P.O. Box 666, McComb, Mississippi 39648-2709. 2. DEA COR AS2286311 will expire by its terms on February 28, 2018. 3. Respondent is presently licensed in Mississippi as a medical doctor (M.D.) with Medical License 11503. 4. CI is the mother of Kid 1 and Kid 2. 5. Hydrocodone-Acetaminophen 10-325 (Norco), Hydrocodone- Acetaminophen 7.5-325 (Norco), Hydrocodone-Acetaminophen 5-325 (Norco), and Hydrocodone-Homatropine Syrup (Hycodan) are all classified as Hydrocodone Combination Products. 6. Hydrocodone Combination Products are classified by DEA as Schedule II Controlled Substances and have been so classified since October 6, 2014. Before October 6, 2014, Hydrocodone Combination Products were classified by DEA as Schedule III Controlled Substances. 7. Alprazolam is classified by DEA as a Schedule IV Controlled Substance. [[Page 54829]] 8. Phentermine (Adipex) is classified by DEA as a Schedule IV Controlled Substance. 9. Meperidine (Demerol) is classified by DEA as a Schedule II Controlled Substance. WITNESSES The Government presented its case through the testimony of nine \4\ witnesses. First, the Government called Kendrick Lewis (``Lewis''). Tr. 24. Lewis is an employee of the Mississippi Bureau of Narcotics (``MBN''). Tr. 25. Lewis received a complaint against the Respondent on January 18, 2015. Tr. 25. Lewis spoke with CI and her husband, who had made the complaint together. Tr. 25, 29-31. Other than this conversation, Lewis had no further contact with CI. Tr. 28. Based on the nature of the complaint, Lewis contacted MBN's diversion unit, which began investigating the Respondent. Tr. 26-27, 31. During 2015, Lewis participated in the investigation by assisting with surveillance on March 27, April 8, April 29, and October 16. Tr. 27. Lewis's testimony was thorough, detailed, and internally consistent. Therefore, I merit it as credible in this Recommended Decision. --------------------------------------------------------------------------- \4\ Although the Government also called Antoine Battle to the stand, the Government did not elicit any testimony from Mr. Battle, and he was excused without testifying. Tr. 155-58. --------------------------------------------------------------------------- Second, the Government called Mary Flinchum (``Flinchum''). Tr. 33. Flinchum is a lieutenant for the MBN and a task force officer for the DEA's Tactical Diversion Squad. Tr. 33-34. Flinchum received an intelligence report about the Respondent from MBN. Tr. 35. Flinchum interviewed CI and her husband, separately and together, about their complaint to MBN. Tr. 36, 82. Flinchum helped decide that MBN should investigate the Respondent. Tr. 36-37. Flinchum also communicated with the Mississippi State Board of Medical Licensure (``Mississippi Board''), which was conducting an independent investigation concerning the Respondent. Tr. 58-59. Flinchum was familiar with an undercover investigation of the Respondent during March, April, and October of 2015. Tr. 77-81. Later, Flinchum was recalled to offer further testimony concerning the October 2015 undercover operation. Tr. 449-50. Through Flinchum's testimony, the Government authenticated and successfully offered into evidence Government Exhibits (``GE-'') 13 through 21, 27 through 29, 38 through 40, and 53. Tr. 38-57. I find all of these exhibits to be accurate, authentic, and meriting credibility. On cross-examination, the Respondent authenticated and successfully offered into evidence GE-2. Tr. 62-63. I find that Flinchum's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Third, the Government called Undercover Agent #1 \5\ (``Agent 1''). Tr. 89. Agent 1 is a female DEA task force officer and former MBN Agent. Tr. 89-90. Agent 1 participated in an undercover investigation of the Respondent. Tr. 90-91. Agent 1 attended undercover medical appointments with the Respondent on four occasions in 2015: March 27, April 8, April 29, and October 16. Tr. 91, 102, 111, 119. Agent 1 also accompanied CI to a rendezvous with the Respondent at a Walmart before the second undercover appointment on April 8, 2015. Tr. 128-29. Through Agent 1's testimony, the Government authenticated and successfully offered into evidence GE-9 through 12, 24 through 26, 30 through 33, 42 through 47, and 54. Tr. 91-128. I find all of these exhibits to be accurate, authentic, and meriting credibility. I also find that Agent 1's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. --------------------------------------------------------------------------- \5\ Pursuant to the Prehearing Ruling and Protective Order, the identities of the undercover agents are not disclosed in this Recommended Decision. ALJ-9. --------------------------------------------------------------------------- Fourth, the Government called Undercover Agent #2 (``Agent 2''). Tr. 141. Agent 2 is a female MBN agent. Tr. 141. Agent 2 participated in the undercover investigation of the Respondent. Tr. 142. Agent 2 attended an undercover medical appointment with the Respondent on April 29, 2015. Tr. 143. Through Agent 2's testimony, the Government authenticated and successfully offered into evidence GE-34 through 37. Tr. 143-51. I find these exhibits to be accurate, authentic, and meriting full credibility. I also find that Agent 2's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Fifth, the Government called MBN Agent Charles Causey (``Causey''). Tr. 159. In 2015, Causey assisted with audiovisual surveillance for the DEA and MBN's undercover investigation of the Respondent on March 27, April 8, April 29, and October 16. Tr. 162-63. Causey testified that the video recordings of these undercover operations may contain incorrect internal date/time stamps, and that the dates and times on the video recordings do not necessarily correspond to the actual dates and times on which the video recordings were made. Tr. 165-66. I find that Causey's testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision. Sixth, the Government called Leslie Ross (``Ross''). Tr. 168. Ross is an investigations supervisor for the Mississippi Board and a task force officer for the DEA's Tactical Diversion Squad. Tr. 168-69. The Mississippi Board reviews and issues medical licenses, promulgates rules and regulations for the practice of medicine in Mississippi, investigates complaints about Mississippi licensees, and imposes disciplinary action when necessary. Tr. 170. Several days before the Mississippi Board closed its investigation concerning the Respondent, Ross received a call from Agent Flinchum, advising Ross that the DEA and the MBN were investigating the Respondent. Tr. 194-95, 210. Ross explained that the phone call influenced the Mississippi Board's decision to close its case because it was the Mississippi Board's custom ``to back off and let a criminal agency pursue their case.'' Tr. 210. Without interviewing CI, the Mississippi Board closed its investigation. Tr. 196. Ross also helped author part of Mississippi Administrative Rule 1.5, which regulates diet medication prescriptions in Mississippi. Tr. 172. Ross established the foundation for the Court to take official notice of Mississippi Administrative Rules 1.1, 1.2, 1.4, 1.10, and 1.16. Tr. 188-93. Additionally, while Ross did not conduct the Mississippi Board's investigation of the Respondent, she supervised Todd Pohnert, who conducted the investigation. Tr. 170, 173. Ross served administrative subpoenas for information about the Respondent to two Mississippi pharmacies, one in McComb and one in Brookhaven. Tr. 185. I find that Ross' testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Through Ross' testimony, the Government authenticated and successfully offered into evidence GE-3 and 8. Tr. 171-78. I find these exhibits to be accurate, authentic, and meriting credibility. Furthermore, through Ross' testimony, the Government established some foundation for GE-7 and 55. Tr. 185-88. Seventh, the Government called CI. Tr. 212. CI testified about her relationship with the Respondent and [[Page 54830]] how and why she obtained controlled substance prescriptions from him. Tr. 212-31.\6\ Through CI's testimony, the Respondent admitted GE-49, 56, and 57. Tr. 284, 300-03, 335-38. I find these exhibits to be generally accurate, authentic, and meriting credibility. I also find that CI's testimony was generally forthright, internally consistent, and generally merited credibility \7\ in this Recommended Decision. --------------------------------------------------------------------------- \6\ The Respondent asked CI extensively about an exhibit, pre- marked for identification as Respondent's Exhibit (``RE-'') 1. See generally Tr. 231-73. However, the Respondent never offered RE-1 into evidence. Therefore, the contents of RE-1 are not considered in this Recommended Decision. \7\ There were some inconsistencies in CI's lengthy testimony. First, when asked if she paid cash for prescriptions from the Respondent, CI answered that she believed she always used insurance. Tr. 360. However, CI's Prescription Monitoring Program report shows that, in 2014, CI paid for prescriptions from the Respondent with cash 15 times, and used her insurance only 5 times. See GE-49, at 1- 3. Second, CI suggested that it was the Respondent's idea for CI to send a friend into his office to get prescriptions for her. Tr. 345- 47. However, audio recordings of the Respondent's telephone calls with CI suggest that it was CI's idea for her to send a friend into the Respondent's office to get prescriptions for CI. See GE-16, file 2015-03-16_18-51-48_EDT, at 20-21; GE-16, file 2015-03-18_11-03- 33_EDT, at 2. Third, CI testified that the Respondent only conducted a physical examination of her one time. Tr. 322. The Respondent's patient file for CI seems to indicate, however, that the Respondent gave CI some sort of examination on both April 21 and September 2 of 2014. GE-2, at 12. In these three instances, I do not find CI's testimony credible. --------------------------------------------------------------------------- Eighth, the Government called James Pacheco (``Pacheco''). Tr. 385. Pacheco is an agent for the MBN and a task force officer for the DEA's Tactical Diversion Squad. Tr. 386. Pacheco participated in the undercover investigation of the Respondent by coordinating the surveillance aspect of the investigation. Tr. 388. Pacheco assisted with physical surveillance of the Respondent and CI during an undercover operation at a Walmart on April 8, 2015. Tr. 388-89. Pacheco personally observed most of the operation at Walmart. Tr. 389. Pacheco also testified that he listened to the undercover operation conducted at the Respondent's clinic in October 2015. Tr. 406-07. Through Pacheco's testimony, the Government authenticated and successfully offered into evidence GE-22 and 23. Tr. 387-93. I find these exhibits to be accurate, authentic, and meriting credibility. I also find that Pacheco's testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision. The Government's ninth witness was Maria Gilbert (``Gilbert''). Tr. 409. Gilbert is a DEA diversion investigator, and was a case agent in the investigation of the Respondent. Tr. 409-10. Gilbert helped submit the evidence acquired by the undercover agents into a DEA evidence locker. Tr. 440. Gilbert also directed DEA personnel to obtain Prescription Monitoring Program (``PMP'') reports during the investigation. Tr. 438. Gilbert created the administrative subpoenas issued to pharmacies to obtain information about the Respondent. Tr. 412. Gilbert helped conduct an administrative search of the Respondent's office. Tr. 427-28. Through Gilbert's testimony, the Government authenticated and successfully offered into evidence GE-7, 41, 48, 50 through 52, 55, and 58 through 60. Tr. 411-18, 427-39. I find these exhibits to be accurate, uncontested, and meriting credibility. I also find that Gilbert's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. The Respondent did not call any witnesses or offer any of his proposed exhibits into evidence. Tr. 458. The factual findings below are based on a preponderance of the evidence, including the detailed, credible, and competent testimony of the aforementioned witnesses, the exhibits entered into evidence, and the record before me. FACTUAL FINDINGS 1. The Respondent has not previously been convicted of any crime related to controlled substances. GE-1, at 1. The Respondent has never had his state medical license revoked, suspended, denied, restricted, or placed on probation. GE-1, at 1. The Respondent's Relationship with CI 2. The Respondent and CI became Facebook friends and began talking with each other in January 2014. Tr. 213, 237. CI asked the Respondent questions about the health of Kid 1.\8\ Tr. 213-14, 246-47, 261-62. The Respondent performed a tonsillectomy on Kid 1 and placed tubes in his ears on January 30, 2014. GE-57, at 13, 19-20; Tr. 219, 235, 285. Following Kid 1's tonsillectomy, CI asked the Respondent for medication for Kid 1's medical condition; the Respondent was willing to write prescriptions for Kid 1. GE-57, at 5-6; Tr. 246-47, 249. Around that time, CI and the Respondent became friends and began texting and talking on the phone. Tr. 213-14, 240. --------------------------------------------------------------------------- \8\ See Stipulation (``Stip.'') 4; see also ALJ-9, at 5. --------------------------------------------------------------------------- 3. In the spring of 2014, CI and the Respondent began to have a consensual sexual relationship. Tr. 213, 218-19, 290-92, 296, 359. During the summer of 2014, CI and the Respondent saw each other very often. Tr. 324. CI and the Respondent communicated frequently by texting and calling each other on their cell phones. Tr. 355-56. 4. CI engaged in a sexual affair with the Respondent because she was infatuated with him and because she wanted to obtain controlled substances for her recreational use. Tr. 291-92. The controlled substances, however, were not a prerequisite for sexual relations. Tr. 289. 5. The sexual relationship between CI and the Respondent ended in November 2014. Tr. 219. A. The Respondent's Medical Treatment of CI and Her Children 6. The Respondent provided medical treatment to CI several times, beginning in 2010. GE-2, at 12-13; Tr. 215, 277. Specifically, the Respondent treated CI for a sinus infection, vertigo, and migraines. GE-2, at 12-13; Tr. 215, 277-78, 287, 321. CI had a serious migraine condition that caused her to seek treatment in emergency rooms on four occasions. Tr. 278-80, 347. CI discussed her migraines and hospitalizations with the Respondent, who gave her information about migraines. Tr. 282, 287. The Respondent prescribed Maxalt \9\ to CI to treat her migraines. GE-2, at 12; Tr. 215-16, 283. --------------------------------------------------------------------------- \9\ Maxalt, or rizatriptan benzoate, is not a federally controlled substance. See generally 21 CFR Sec. Sec. 1308.11- 1308.15 (2015). --------------------------------------------------------------------------- 7. The Respondent had a patient file for CI and wrote notes therein about her treatment. See GE-2, at 12-13. The Respondent conducted two physical examinations of CI, once when he was treating her for a sinus infection, and again when he was treating her for a migraine headache.\10\ GE-2, at 12-13; Tr. 322. The Respondent also requested a CT \11\ sinus scan for CI in 2014. GE-2, at 12, 14. A CT scan showed that CI's sinuses were ``clear [and] scant thickening in LNF duct.'' GE-2, at 14. --------------------------------------------------------------------------- \10\ See supra note 7. \11\ Computerized tomography. --------------------------------------------------------------------------- 8. CI took Kid 1 and Kid 2 to appointments with the Respondent. Tr. 219, 261-62, 285-86, 335-36, 338; see, e.g., GE-56, at 3-4; GE-57, at 6, 9-10. The Respondent conducted legitimate medical procedures on both children and saw the children for follow-up appointments. GE-56, at 3- 4; GE-57, at 5-6; Tr. 219, 261-62. 9. CI sent the Respondent at least one message via social media requesting his medical advice about Kid 1's condition. Tr. 262-63. CI communicated with the Respondent about the physical [[Page 54831]] condition of her children to get his medical advice. Tr. 263-65. 10. Near a date stamp reading ``February 4, 2014,'' the Respondent recorded in Kid 1's medical file that CI had migraines, that she may call in for a prescription if needed, and that he discussed phentermine \12\ with her. GE-57, at 6; see Tr. 286. The Respondent's patient file for CI also contains a telephone request form, dated July 18, 2014, and signed by the Respondent, which states that CI requested a phentermine refill. GE-2, at 15. CI's patient file, however, does not note any reasons that the Respondent prescribed phentermine to CI. See GE-2, at 12-13. --------------------------------------------------------------------------- \12\ CI denied asking the Respondent for phentermine in February 2014. Tr. 286-88. Phentermine is another name for Adipex. See Stip. 8; Tr. 288. --------------------------------------------------------------------------- B. CI's Drug Use 11. Prior to her relationship with the Respondent, CI took controlled substances, including hydrocodone, which were prescribed by numerous other doctors to help treat pain resulting from four lithotripsies, kidney stones, a broken tailbone, a root canal, and TMJ \13\. GE-49, at 2; Tr. 214, 275-76, 304-09. CI told the Respondent about these prescriptions. Tr. 309. --------------------------------------------------------------------------- \13\ Temporomandibular joint dysfunction, or lockjaw. --------------------------------------------------------------------------- 12. CI occasionally used Adderall for nonmedicinal purposes. Tr. 215. CI had not used cough syrup for nonmedicinal purposes prior to her relationship with the Respondent. Tr. 215. 13. After Kid 1 had his tonsils removed on January 30, 2014, CI took some of Kid 1's pain medication. Tr. 273-74, 276. As a result of the tonsillectomy, the Respondent prescribed two different forms of hydrocodone for Kid 1. GE-51, at 1; GE-57, at 6, 14, 22. 14. The Respondent first prescribed cough syrup for Kid 2 on January 24, 2014. GE-50, at 1; GE-56, at 4. The Respondent again prescribed cough syrup for Kid 2 in February 2014. Tr. 216, 258-59; GE- 50, at 1; GE-56, at 4. The Respondent did not examine Kid 2 before he prescribed cough syrup for her. Tr. 217, 251; see GE-56, at 4. 15. CI talked with the Respondent about prescribing a ``big bottle'' of cough syrup so that CI could drink it. Tr. 216, 251-52, 268, 273. CI thought that the Respondent knew she did not have a cough. Tr. 216, 251-52, 268. In February 2014, CI asked the Respondent to prescribe \14\ a ``big bottle'' of hydrocodone cough syrup for Kid 2. Tr. 216-17, 250, 252-53, 259. At that time, CI told the Respondent that Kid 2 had a cough. Tr. 250-51, 253-55. On February 7, 2014, the Respondent doubled the size of Kid 2's prescription for cough syrup. GE-50, at 1; GE-55, at 1-2. --------------------------------------------------------------------------- \14\ CI later testified that this was a refill of a prescription written by the Respondent. Tr. 272-73. --------------------------------------------------------------------------- 16. CI told the Respondent when Kid 1 or Kid 2 had a cough. Tr. 250. CI, however, did not bring her children to see the Respondent regarding a cough; she requested cough syrup from the Respondent because she liked drinking it. Tr. 220, 273; see generally GE-56, at 3- 4; GE-57, at 5-6. 17. The Respondent prescribed Norco, Xanax, and Adipex to CI on multiple occasions. Tr. 26; GE-49. The Respondent prescribed Norco \15\ to CI, which she took daily instead of as needed. Tr. 297. CI took hydrocodone ``[j]ust for fun.'' Tr. 298. CI would tell the Respondent when she ran low on a prescription, and he would give her another prescription.\16\ Tr. 298-99. He advised her that hydrocodone could cause migraines. Tr. 298-99. --------------------------------------------------------------------------- \15\ Norco is a hydrocodone combination product. See Stip. 5. \16\ Specifically, CI testified that when she ran low on a prescription, the Respondent would refill it. Tr. 298-99. Refills are not authorized for hydrocodone combination products, such as Norco. Compare 21 U.S.C. Sec. 829(a), with Stip. 6. The record does not contain any evidence that the Respondent attempted to give CI a refill on a hydrocodone combination product. Therefore, I interpret CI's statement as meaning that whenever she ran low on a prescription, she would tell the Respondent, and he would issue another prescription to her. --------------------------------------------------------------------------- 18. On several occasions, the Respondent provided prescriptions to CI while he was at CI's house. Tr. 217-18; see Tr. 26. On those occasions, the Respondent did not communicate a diagnosis to CI or perform a physical examination of CI. Tr. 218. Sometimes, CI took her children to appointments with the Respondent as an excuse to see the Respondent, who would then occasionally give prescriptions to CI. Tr. 219-20. On one occasion, the Respondent met CI in the garden section of a Walmart, where he gave her prescriptions for cough syrup and pain medication. Tr. 218. 19. At times, CI told the Respondent about her children's pain or physical conditions to get prescriptions for her own personal use. Tr. 267. CI would occasionally administer the prescribed medication to her children. Tr. 270-72. 20. CI requested that the Respondent write a prescription for Adderall for her, but he declined to do so. Tr. 223. In the spring of 2014, CI asked the Respondent to write her a prescription for Adipex, a weight loss drug. Tr. 223-24, 288-89. The Respondent wrote prescriptions and refills for Adipex to CI. GE-49, at 1-2; Tr. 223-24. CI used Adipex for approximately three months. Tr. 224. The Respondent did not conduct a physical examination of CI focused on weight issues at any point before or while CI took Adipex, and the Respondent did not discuss alternative weight loss treatments with CI. Tr. 224-25; see GE- 2, at 12-13. 21. CI had anxiety, which she discussed with the Respondent. Tr. 322. The Respondent told her to visit a certain psychiatrist. Tr. 225, 295. CI visited that psychiatrist twice. Tr. 225. The psychiatrist prescribed a low dosage of time-release Xanax \17\. Tr. 225, 295, 304; see GE-49, at 1. The Respondent then prescribed \18\ a stronger dosage of Xanax to CI. Tr. 226; see GE-49, at 1. --------------------------------------------------------------------------- \17\ Xanax is a brand name for alprazolam, which is a benzodiazepine and a Schedule IV controlled substance. Stip. 7; see 21 CFR Sec. 1308.14(c)(2); Tr. 304. \18\ CI testified that this prescription was a refill prescription, but that it was for a different dosage. Tr. 295-96. --------------------------------------------------------------------------- 22. The Respondent wrote nine prescriptions \19\ to CI, contained in GE-7 and 41, which are not documented in the Respondent's patient file for CI. Compare GE-2, at 12-13 (containing the Respondent's patient file for CI), with GE-7, at 1-2 (containing a prescription written by the Respondent to CI), and GE-41 (containing prescriptions written by the Respondent and filled by CI), and GE-49 (containing CI's PMP report); see Tr. 364-77. The Respondent's patient file for CI does not include any notes from any examinations on the dates on which the Respondent wrote these nine prescriptions. GE-2, at 12-13. CI did not have a physical examination or receive counseling before the Respondent gave her any of these prescriptions. Tr. 384; see GE-2, at 12-13.\20\ --------------------------------------------------------------------------- \19\ Seven of these prescriptions, written to CI in 2014, were as follows: May 19 for Adipex; May 22 for Norco; June 17 for Norco; July 24 for Adipex; September 8 for Adipex; September 11 for Norco; and October 6 for Xanax. Compare GE-2, at 12-13, with GE-41, at 1-7, 12-13, and 18-23, and GE-49. The Respondent wrote another prescription for Adipex to CI on April 9, 2014. Compare GE-2, at 12- 13, with GE-7, at 1-2, and GE-49. The Respondent also wrote a prescription for Hycodan to CI, dated December 3, 2014, but CI's PMP report said that the prescription was written on December 4, 2014. Compare GE-41, at 28-29, with GE-49. Regardless of when this prescription was actually written, it was not documented in CI's patient file. See GE-2, at 12-13. \20\ CI testified about a prescription that is not in GE-41. Tr. 364, 369-70. The prescription allegedly was written in her name by the Respondent. Tr. 369-70. The prescription allegedly was dated October 29, 2014. Tr. 369-70. The Respondent's PMP report likewise lists a prescription for hydrocodone-acetaminophen (Norco) prescribed by the Respondent on October 29, 2014. GE-49, at 1. However, neither of the two copies of GE-41 submitted to me includes this prescription. Examination of both submitted copies of GE-41 reveals that no pages of GE-41 are missing. At the hearing, however, Government counsel provided CI with an excerpt of what he said was ``part of Exhibit 41,'' and he provided the Respondent and the ALJ with a copy of what was handed to the witness. Tr. 364. That excerpt has now been included in the administrative record as ALJ-29. Comparing ALJ-29 with GE-41, I have determined that the witness did, in fact, examine a prescription dated October 29, 2014. That prescription, however, was never offered into evidence. Furthermore, the witness was never asked if the prescription, dated October 29, 2014, refreshed her memory of having received the prescription. Accordingly, I decline to find that the Government presented sufficient evidence to establish that the Respondent wrote a prescription to CI on October 29, 2014. Following the hearing, the parties were provided with copies of ALJ-29. --------------------------------------------------------------------------- [[Page 54832]] 23. Two prescriptions written by the Respondent to Kid 1 are not documented in Kid 1's medical chart. Compare GE-51 (containing Kid 1's PMP report and listing prescriptions from June 17 and November 19 of 2014), and GE-55, at 3-4, 11-12 (containing prescriptions from June 17 and November 19 of 2014), with GE-57 (containing Kid 1's medical file, which does not include any examination or prescription notes for June 17 or November 19 of 2014); see also Tr. 377-81. Likewise, a prescription written by the Respondent to Kid 2 is not documented in Kid 2's medical chart. Compare GE-50 (containing Kid 2's PMP report and listing a prescription written on July 23, 2014), and GE-55, at 5-6 (containing a prescription dated July 23, 2014), with GE-56 (containing Kid 2's medical file, which does not include any examination notes or prescription notes for July 23, 2013). 24. On one occasion in early fall of 2014, following CI's complaint of a severe migraine, the Respondent prescribed Demerol to CI. Tr. 222, 296-97, 317-18, 382. Next to the date ``September 2, 2014'' in CI's medical chart, the Respondent wrote that he refilled her prescription of phentermine, looked at her ears and nose, and counselled her. GE-2, at 12; Tr. 323. He also wrote that he prescribed Demerol and Xanax to CI. GE-2, at 12. CI did not ask the Respondent for Demerol. Tr. 296, 318. 25. CI's husband discovered that CI was having an affair with the Respondent. Tr. 26, 320. Sometime after the discovery, in December 2014, CI attempted suicide using the Demerol the Respondent prescribed to her. Tr. 222, 314-17. CI went to a mental institution for a week following her suicide attempt. Tr. 227, 309. In January 2015, CI told the Respondent that she had tried to kill herself. Tr. 226-27, 309-11. C. The MBN Complaint 26. After CI's husband discovered the affair and CI attempted to commit suicide, CI and her husband made a complaint against the Respondent to the MBN. Tr. 25, 29-31, 71, 228-29, 339-40. CI told MBN investigators that she got medications from the Respondent for nonmedicinal purposes because she enjoyed using them. Tr. 84. D. The Anonymous Letter 27. The Mississippi Board received an unsigned letter, allegedly from CI's husband, which complained about the extramarital affair between CI and the Respondent. GE-3, at 3; Tr. 58, 66. The Mississippi Board and MBN both received a copy of the letter. Tr. 66-67, 70-71, 398-99. Several witnesses testified that CI's husband was not the author of this letter. Tr. 67-70, 326, 394, 396. The author of the letter is unknown. Tr. 67-70, 201, 326, 394-95. 28. The letter was written in the first person, and CI's husband's name was typewritten on the bottom of the letter, along with CI's date of birth and social security number. GE-3, at 3. The letter said that the author's wife, CI, had an affair with the Respondent for over a year, and that the author did not know about it until he found a box of empty pill bottles that the Respondent had prescribed to CI, even though CI was not his patient. GE-3, at 3. The letter was stamped as received by the Mississippi Board on February 19, 2015. GE-3, at 3. 29. By the time the MBN received a copy of the letter, it had already begun its investigation of the Respondent because of the complaint made by CI and her husband. Tr. 71, 74-76. After receiving a copy of the letter, the Mississippi Board began conducting an independent investigation of the Respondent. Tr. 58, 61, 203. E. The Mississippi Board Investigation 30. A Mississippi Board investigator met with the Respondent regarding the anonymous letter. GE-3, at 4-6. At that time, the Mississippi Board was unaware that the DEA was conducting a simultaneous investigation of the Respondent. Tr. 180. 31. In response to the investigator's inquiry, the Respondent said that he only saw CI when she or her children had appointments, and had not seen CI outside of his office. GE-3, at 5; Tr. 179, 202. The Respondent suggested that he had not engaged in sexual misconduct with CI. GE-3, at 5; Tr. 180, 207. The Respondent also suggested that he was not aware that CI had attempted to commit suicide or had been committed to a mental hospital. GE-3, at 5, 7. 32. The investigator made copies of CI's patient charts and found several shortcomings with CI's medical records. GE-3, at 4-5; Tr. 180, 197. First, the investigator found seven prescriptions in CI's PMP report that were not documented in the Respondent's patient file for CI. GE-3, at 5. The Respondent explained that he might have documented the missing prescriptions in his patient files for CI's children instead. GE-3, at 5. 33. Second, the investigator found that CI's patient file did not include any notes about CI's vitals, height/weight, BMI, or alternative weight control treatment plans, and did not indicate that CI received any counseling about other weight loss options. GE-3, at 5; Tr. 180. 34. Following the investigator's visit, the Mississippi Board sent the Respondent a copy of the anonymous letter purportedly from CI's husband.\21\ See GE-2, at 6-8. The investigator told the Respondent that he should send a letter to the Mississippi Board as a follow-up from the investigator's visit. GE-3, at 5; Tr. 179. --------------------------------------------------------------------------- \21\ The handwritten notation on the bottom of the letter was likely added by a Mississippi Board investigator. Tr. 87; see GE-2, at 6. --------------------------------------------------------------------------- 35. The Respondent sent a letter to the Mississippi Board. GE-3, at 7-8; Tr. 179-80. Therein, the Respondent denied knowing that CI had overdosed.\22\ GE-3, at 7; Tr. 180. The Respondent stated that he was ``appalled, outraged, and disgusted'' by the anonymous letter's allegations. GE-3, at 7; Tr. 208. The Respondent wrote that the medications CI used to overdose ``were legitimately prescribed for valid medical problems.'' GE-3, at 7. The Respondent wrote that he was unaware that CI had received controlled substances from other prescribers and that CI did not show ``any hint of drug-seeking behavior.'' GE-3, at 7. The Respondent acknowledged that he should not refill medications for a parent during a child's visit without pulling the parent's chart, and said that he would not do so in the future. GE- 3, at 7. The Respondent stated that he would not refill diet drugs for patients in the future without completing the appropriate documentation. GE-3, at 7. --------------------------------------------------------------------------- \22\ Specifically, the Respondent wrote that he was ``sorry to learn that [CI] may have deliberately taken an overdose.'' GE-3, at 7. --------------------------------------------------------------------------- 36. The Mississippi Board contemplated closing its investigation of the Respondent because it did not have enough evidence supporting the allegations of the Respondent's sexual misconduct. Tr. 181, 184, 194- 95, 197, 209-10. Throughout the course of its investigation, however, the Mississippi Board never interviewed CI. Tr. 196. 37. On March 20, 2015, while the Mississippi Board was contemplating closing its investigation, Flinchum [[Page 54833]] contacted the Mississippi Board and requested, on the DEA's behalf, that the Mississippi Board discontinue its investigation of, and communication with, the Respondent. GE-3, at 2; Tr. 60-61, 181, 209. The Mississippi Board customarily will discontinue an investigation to allow a criminal agency to pursue a case. Tr. 210. 38. The Mississippi Board closed its investigation of the Respondent on March 23, 2015. GE-3, at 1; Tr. 181. A letter from the Mississippi Board to the Respondent terminated the Board's investigation. GE-3 at 1; Tr. 183. The letter stated that the Mississippi Board concluded its investigation and that, after a thorough review of the information and facts from the investigation, it decided not to recommend any formal action. GE-3, at 1. This letter was a truthful and accurate reflection of the Board's reasons for terminating the investigation. Tr. 64-65, 86, 195-97. 39. The letter also cautioned the Respondent against ``authorizing refills for Phentermine/Adipex without benefit of a medical examination.'' GE-3, at 1 (discussing Mississippi Administrative Rule 1.5(E)). 40. The letter told the Respondent that the Mississippi Board had found some deficiencies with his medical records. Tr. 181, 183-84, 203. The letter did not exonerate the Respondent, but warned him about his inadequate documentation of weight loss prescriptions. Tr. 184, 203. F. DEA Undercover Operations 41. The DEA began undercover operations concerning the Respondent in March 2015. Tr. 77-78. 42. CI was told that if she cooperated with law enforcement, she would not be in any trouble. Tr. 342-43. CI signed a confidential informant agreement with the DEA. Tr. 343-44, 394. 43. The DEA instructed CI not to have any contact \23\ with the Respondent unless the DEA supervised the contact. Tr. 350. CI did not comply with this instruction and met the Respondent one time without DEA's supervision. Tr. 353, 358. --------------------------------------------------------------------------- \23\ The DEA did not ask CI to attend an undercover appointment with the Respondent because CI had a physical relationship with the Respondent, and because CI said that she was addicted to cough syrup. Tr. 400. --------------------------------------------------------------------------- 44. With CI's consent, the DEA gave CI a telephone number that recorded all calls and text messages exchanged between CI and the Respondent. Tr. 37-38, 84-85, 230. This telephone number operated through an application that the DEA installed on CI's cellular phone. Tr. 382. This application automatically recorded all calls, conversations, and multimedia messages exchanged between CI and the Respondent. Tr. 37-38, 85-86. 45. CI called and texted the Respondent outside of the presence of MBN and DEA agents. Tr. 85-86. The DEA did not tell CI what to say to the Respondent. Tr. 85-86. i. Interactions Between the Respondent and CI Before the First Undercover Appointment 46. The DEA agents asked CI to contact the Respondent by phone or by text message and ask him for Norco and cough syrup. Tr. 346, 348-49. 47. On March 16, 2015, at approximately 6:51 p.m., the Respondent and CI spoke on the phone. GE-15-16. CI asked the Respondent to meet her at Walmart and give her a prescription for something. GE-16, file 2015-03-16_18-51-48_EDT, at 19; see Tr. 345. The Respondent said he could not do that because the Mississippi Board was watching him and he could go to jail or lose his license. GE-16, file 2015-03-16_18-51- 48_EDT, at 19-20; see Tr. 230, 345-47. He said that everything he had prescribed to CI was legitimate and written in her chart. GE-16, file 2015-03-16_18-51-48_EDT, at 20. After CI again asked the Respondent several times to give her a prescription, CI asked him instead to write a prescription for someone else.\24\ Id. The Respondent said he could prescribe to anyone who came into his office, and what they did with their prescriptions was ``their business,'' but that it had ``to be a legitimate thing.'' Id. at 21. CI asked him multiple times to write prescriptions for her, but in different names, and the Respondent said he could not do so without someone coming for a visit and having a chart. Id. The Respondent said he could ``probably pilfer'' some medication from his wife for CI. Id. at 22. CI repeatedly asked the Respondent to get her some controlled substances, and the Respondent repeatedly said he would see what he could do. Id. at 24-26. --------------------------------------------------------------------------- \24\ Contra Tr. 346; see supra note 7. --------------------------------------------------------------------------- 48. On March 17, 2015, at approximately 1:07 p.m., the Respondent and CI spoke on the phone. GE-15-16. CI asked the Respondent to slip ``a couple Lorcets'' into her mailbox. GE-16, file 2015-03-17_13-07- 36_EDT, at 4. The Respondent joked, ``I need to learn to play the guitar so you could be getting sex, drugs and rock and roll, you know.'' Id. CI asked the Respondent to ``sneak [her] some meds.'' Id. at 7. The Respondent said, ``I've got your request and I'm telling you that is highly, highly dangerous for me.'' Id. 49. On March 18, 2015, at approximately 11:03 a.m., the Respondent and CI spoke on the phone. GE-15-16. CI suggested that the Respondent could write a prescription in Kid 1's name. GE-16, file 2015-03-18_11- 03-33_EDT, at 1. The Respondent responded sarcastically and attempted to change the subject. Id. at 1-2. CI said that she really needed him to find a way to write her a prescription. Id. at 2. The Respondent said he did not know how to do that. Id. CI suggested that he could write a prescription in someone else's name. Id. The Respondent said he would ``have to have somebody that's legitimate'' and ``what they did with the medicine[,] that was up to them . . . somebody that's trustworthy.'' Id. at 3. The Respondent indicated that it was like a ``federal crime when you write medicine to--that are diverted to somebody else.'' Id. CI said that the Respondent used to write her prescriptions ``all the time.'' Id. The Respondent said, ``Yeah, but I wrote it for you.'' Id. CI recalled that the Respondent ``used to bring [his] prescription pad over and a bottle of vodka,'' and that she ``miss[ed] those days.'' Id. The Respondent replied, ``I know, me too.'' Id. The Respondent joked with CI that it was good to have a boyfriend with a prescription pad. Id. at 4. 50. On March 25, 2015, at approximately 10:36 a.m., the Respondent and CI spoke on the phone. GE-17, at 1-5.\25\ CI asked the Respondent if he would write a prescription to another person. GE-17, at 2. The Respondent remarked that it was dangerous and it would have to be to an established patient; he suggested that she get another doctor to write a prescription for her. GE-17, at 2. CI insisted, and the Respondent said ``it has to be legitimate'' and for a ``legitimate patient'' because the Mississippi Board was watching him. GE-17, at 2. The Respondent said he could treat a patient for CI if the patient had headaches and anxiety. GE-17, at 3. The Respondent said, ``what he does with 'em is his business.'' GE-17, at 3. CI asked the Respondent if he would write something to her friend who came in with a headache; the Respondent said, ``Yeah, I could write him something.'' GE-17, at 3. CI clarified that the prescription would really be for her, and requested that he prescribe ``Lorcet or something;'' the Respondent said, ``Yeah, I could write him some-- [[Page 54834]] yeah, some stuff like that.'' GE-17, at 3. The Respondent cautioned CI that taking too many Lorcet or Demerol would be harmful and painful to her. GE-17, at 4. CI said she just wanted ``some pain pills from [her] boyfriend.'' GE-17, at 4. --------------------------------------------------------------------------- \25\ See GE-16, file 2015-03-25_10-36-40_EDT. --------------------------------------------------------------------------- 51. On March 25, 2015, at approximately 11:43 a.m., the Respondent texted CI, ``I won't be in the office tomorrow. I could see her Friday.'' GE-53, file 2015-03-25_11-43-42_EDT. CI texted back, ``Ok:) she is a real cool girl. I use [sic] to party with her.'' GE-53, file 2015-03-25_11-47-23_EDT; see Tr. 349. 52. On March 25, 2015, at approximately 2:36 p.m., the Respondent and CI spoke on the phone. GE-17, at 6-8.\26\ The Respondent asked CI for her friend's name. GE-17, at 6-8. CI told the Respondent the alias first name of Agent 1. GE-17, at 6-7. The Respondent said, ``If she's coming in for what I think she's coming in, tell her not to tell me that. That needs to be your secret. I don't wanna know that. She needs to have a headache and I will treat her for a headache, and so [I] don't mind giving her prescriptions to treat a headache.'' GE-17, at 7. The Respondent discussed the medications he could prescribe to Agent 1 and told CI that they ``would be perfectly appropriate for you to take.'' GE-17, at 7; see Tr. 349 (noting that the Respondent knew that Agent 1 was not a real patient and that medication prescribed to Agent 1 would be given to CI). --------------------------------------------------------------------------- \26\ See GE-16, file 2015-03-25_14-36-02_EDT. --------------------------------------------------------------------------- 53. On March 26, 2015, at approximately 11:18 a.m., the Respondent and CI spoke on the phone. GE-18.\27\ CI told the Respondent that Agent 1 had an appointment with him ``tomorrow at 2:00--2:10, I think.'' GE- 18, at 3. The Respondent replied, ``Okay. We'll see if we can't get my girlfriend fixed up.'' GE-18, at 3. The Respondent said CI should remind Agent 1 to ``play it straight'' and tell the Respondent what he to needed to write on a chart to ``keep the medical examiners at bay . . . .'' GE-18, at 3. CI asked him if he would prescribe Norco to Agent 1. GE-18, at 3. The Respondent said, ``Yeah, I'll write her Norco and some more Maxalt, and then you can have some Maxalt also. Just remember to hide it.'' GE-18, at 3. --------------------------------------------------------------------------- \27\ See GE-16, file 2015-03-26_11-18-28_EDT. --------------------------------------------------------------------------- 54. Based on Findings of Fact 47 through 53 and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on March 27, 2015, the Respondent knew that Agent 1 was not a legitimate patient and that any medication he prescribed to her at that appointment would be given to and used by CI. ii. Undercover Appointment #1: March 27, 2015 55. Agent 1's first appointment with the Respondent was on March 27, 2015. GE-10; Tr. 91. Upon arriving at the Respondent's clinic, Agent 1 signed in, completed paperwork, and waited in the Respondent's waiting room. GE-9; Tr. 92. The Respondent's nurse called Agent 1 back into an examination room and spoke briefly with her. GE-9; Tr. 92, 94. 56. Agent 1 met with the Respondent. GE-9-10; Tr. 91; see GE-59 (containing the Respondent's patient file for Agent 1). The appointment lasted approximately seven minutes. GE-9. When the Respondent asked Agent 1 what her problem was, she told him, ``Just kind of a whole head thang [sic].'' GE-10, at 1; Tr. 94. The Respondent asked Agent 1 how long her head had been bothering her, and she indicated just a few days. GE-9-10. The Respondent quickly looked into Agent 1's ears, nose, and throat. GE-9-10; Tr. 94, 132. The Respondent asked her if she was dizzy, nauseous, or taking other medication. GE-9-10. He advised her that Maxalt works well for sinus headaches and gave her instructions for taking her prescriptions. GE-9-10. The Respondent did not communicate any diagnosis to Agent 1, nor did he record a diagnosis in her patient file.\28\ GE-9-10; GE-59, at 4. --------------------------------------------------------------------------- \28\ The Respondent's March 27, 2015 notes in Agent 1's patient file mention photophobia. GE-59, at 4. The transcript and recording of the office visit, however, contain no mention of photophobia or any discussion of the symptoms of photophobia. GE-9-10. --------------------------------------------------------------------------- 57. Agent 1 asked the Respondent if he could help her with her weight loss. GE-9-10. The Respondent declined to prescribe anything for weight loss to Agent 1; he said that it was not his area of expertise and it was heavily regulated by the Mississippi Board. GE-10, at 2. He recommended that she could go to a licensed diet center for assistance. GE-10, at 3. 58. The Respondent wrote two prescriptions for Agent 1: one non- refillable prescription for Norco, and one refillable prescription for Maxalt. GE-11-12; Tr. 95. The Respondent told Agent 1 that he would give her ``lots of refills'' on the Maxalt. GE-10, at 1. 59. That same day, CI and the Respondent had a phone conversation about the Respondent's meeting with CI's ``friend,'' Agent 1. GE-13-14; GE-20, file Post Buy CI Call With STEWART 3-27-2015. The Respondent said he enjoyed meeting Agent 1 and that he was ``hopeful that that helps'' CI. GE-14, at 1. CI said that she could get through because the Respondent ``hooked'' her up. GE-14, at 1. The Respondent responded, ``absolutely that needs to be about as discreet as [unintelligible].'' GE-14, at 1. The Respondent told CI to ``not take that other stuff but one at a time.'' GE-14, at 1. He said that, during Agent 1's appointment, he ``talked about headaches and pretty much left it exactly at that.'' GE-14, at 1. The Respondent told CI, ``[s]o um you got refills on that Maxalt. Um she does,'' and noted that he could not give refills ``on the other one . . ..'' GE-14, at 2. iii. Interactions Between the Respondent and CI Between the First and Second Undercover Appointments 60. On April 1, 2015, at approximately 8:28 p.m., the Respondent and CI spoke on the phone. GE-19.\29\ CI said that she spent time with Agent 1. GE-19, at 1. The Respondent asked her, ``So that all went smooth with getting your medicine and all that?'' GE-19, at 1; see Tr. 230-31. CI said she might need some more. GE-19, at 1. The Respondent said he was glad he could help and that it was ``just because of'' the Mississippi Board complaint that ``it just has to be straight up and clean.'' GE-19, at 1. --------------------------------------------------------------------------- \29\ See GE-16, file 2015-04-01_20-28-54_EDT. --------------------------------------------------------------------------- 61. On April 2, 2015, at approximately 2:15 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-02_14-15-50_EDT. CI told the Respondent that Agent 1 would come back and that she ``took all'' after CI ``halved some with her.'' Id. CI asked the Respondent if he could ``give her a little bit more if she'd come back in.'' Id. at 1. The Respondent replied, ``I can do that.'' Id. at 2. The Respondent asked if ``she'' really had migraines. Id. CI said ``no'' and laughed. Id. The Respondent laughed too and said he was just wondering because there were a lot of refills. Id. The Respondent said, ``[l]ong as we don't get outta hand. Just be sure to keep 'em really hidden.'' Id. 62. On April 2, 2015, at approximately 3:04 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-02_15-04-43_EDT. CI asked the Respondent whether he could write her ``80'' if someone came in to see him. Id. at 1. The Respondent said he could not because it would be a red flag, and that ``40 is a pretty substantial number.'' Id. at 1-2. The Respondent joked that CI should tell her husband that he messed up CI's ``drug [[Page 54835]] connection'' when he filed the complaint. Id. at 2. 63. On April 6, 2015, at approximately 8:59 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-06_20-59-35_EDT. CI told the Respondent that she had talked to Agent 1, who was coming on Wednesday. Id. at 2. The Respondent said, ``I'm glad to help her and take care of her.'' Id. He commented that he had to follow the rules when taking care of her. Id. CI asked the Respondent to help her out when he saw Agent 1. Id. at 3. The Respondent said he would take care of Agent 1's headaches ``like any other patient'' and that he had to follow the rules, treating her ``like anybody else.'' Id. 64. On April 7, 2015, at approximately 1:29 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-07_13-29-34_EDT. CI asked the Respondent if she could attend Agent 1's appointment. Id. at 2. The Respondent said it was ``a little bit on the risky side.'' Id. 65. On April 7, 2015, at approximately 6:28 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-07_18-28-45_EDT. CI asked the Respondent if he wanted her to come with Agent 1 to her appointment the next day. Id. at 7. The Respondent said that he was nervous about it and had to treat Agent 1 the way he treated everyone else. Id. CI thanked the Respondent and said she knew he was seeing Agent 1 for her. Id. at 8. The Respondent said that he was treating her as a patient, and that it was dangerous. Id. 66. On April 7, 2015, at approximately 7:04 p.m., CI texted the Respondent and asked if he would meet her at Walmart the next day around lunch. GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04- 01_TO_2015-04-30_ALL.\30\ --------------------------------------------------------------------------- \30\ Contra Tr. 129. --------------------------------------------------------------------------- 67. On April 8, 2015, at approximately 8:59 a.m., CI again texted the Respondent and asked him to go to Walmart on his lunch break so that she could ``run into'' him. GE-21, at 3. CI texted the Respondent that Agent 1 would be there and that Agent 1 knew about their relationship, but was ``cool'' and would ``cover'' for CI. GE-21, at 5- 6. 68. On April 8, 2015, at approximately 10:16 a.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-08_10-16-03_EDT. The Respondent said he would love to see CI at Walmart at noon that day. Id. at 1. CI again said Agent 1 knew that the Respondent was CI's boyfriend. Id. CI said she was fat because she was not taking Adipex anymore. Id. at 3. The Respondent said that she worried too much and that she was beautiful. Id.\31\ The Respondent and CI agreed to meet in Walmart that day. Id. at 7-8. --------------------------------------------------------------------------- \31\ See GE-27, at 1; contra Tr. 225. --------------------------------------------------------------------------- 69. On April 8, 2015, at approximately 12:31 p.m., CI texted the Respondent and said, if he wanted to save Agent 1 some money, he could bring a prescription for her with him to Walmart. GE-21, at 8. At 12:37 p.m., the Respondent replied that he ``MUST see her in the office. You know why.'' GE-21, at 9. iv. Undercover Operation at Walmart: April 8, 2015 70. On April 8, 2015, Agent 1 accompanied CI to Walmart at approximately 12:45 p.m. GE-22-23; Tr. 128-29, 133-34. The Respondent met CI in the home furnishings department. GE-22; Tr. 389. CI wore a video and audio recording device. Tr. 347-48, 389; see GE-22. The Respondent spoke with CI. Tr. 129; see GE-22. The video recording did not capture an image of the Respondent's face, and much of the recording is inaudible. GE-22. 71. The Respondent told CI to tell Agent 1 to space out her appointments more. Tr. 129-30. The Respondent said, ``[w]e will be good now, so but you can't come back like every week for a prescription cause they keep up, it's like every 4 weeks.'' GE-23. CI asked the Respondent how she was ``supposed to last that long.'' GE-23. The Respondent told her to ``go buy a bottle of Vodka . . . .'' GE-23. 72. At approximately 3:29 p.m., CI texted the Respondent that she really felt fat and asked him to write Agent 1 ``something for that too.'' GE-21, at 13. 73. Based on Findings of Fact 47 through 53, Findings of Fact 56 through 72, and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on April 8, 2015, the Respondent knew that Agent 1 was not a legitimate patient and that at least some of the medication he prescribed at that appointment would be given to and used by CI. v. Undercover Appointment #2: April 8, 2015 74. Agent 1 had a second appointment with the Respondent that took place on April 8, 2015. GE-24-25; Tr. 102. The Respondent's nurse asked Agent 1 why she was back so soon after her first visit and if she was taking her medication correctly. GE-24; GE-25, at 1; Tr. 103. Agent 1 said she just ``ran out'' of medication and was taking it twice a day. GE-25, at 1. The nurse told her that she did not need to take pain medication ``every day all year long.'' GE-25, at 1. 75. The Respondent met with Agent 1 and asked her what she had going on. GE-25, at 1. Agent 1 said, ``Same thing. Same stuff.'' GE-25, at 1. The Respondent asked if the medicine had helped. GE-25, at 1. Agent 1 said it helped ``a little bit.'' GE-25, at 1. The Respondent began writing almost immediately after he entered the room without conducting any sort of examination of Agent 1. GE-24-25; Tr. 103-04, 132. The appointment lasted approximately seven minutes. GE-24. 76. The Respondent and Agent 1 talked casually about boating and skiing. GE-25, at 2-3. The Respondent took out his prescription pad and wrote prescriptions for Agent 1. GE-25, at 3. The Respondent said, ``[w]e need to kinda stretch this out [to] make it last a month.'' GE- 25, at 3. 77. The Respondent wrote two prescriptions \32\ to Agent 1: one for 40 Norco, and one for Maxalt. GE-24-26; Tr. 104. The Respondent told Agent 1 that he gave her refills for Maxalt but could not for ``the other.'' GE-25, at 1. The Respondent again told her to ``spread it out a little bit longer.'' GE-25, at 2. He said that ``the other ones are not really intended for . . . daily use,'' but that he would ``go ahead and give [her] a refill.'' GE-25, at 2. --------------------------------------------------------------------------- \32\ In GE-26, the Government only provided a copy of the prescription for Norco. However, the Respondent's discussion of Maxalt, preserved in GE-24 and 25, indicates that the Respondent also prescribed Maxalt to Agent 1. Additionally, Agent 1's testimony that she received two prescriptions at this appointment was credible and uncontested. Tr. 104. --------------------------------------------------------------------------- vi. Interactions Between the Respondent and CI Between the Second and Third Undercover Appointments 78. On April 8, 2015, at approximately 5:01 p.m., CI texted the Respondent and said ``[t]hank u sweetheart for hooking me up again :).'' GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04- 01_TO_2015-04-30_ALL. 79. On April 8, 2015, at approximately 6:15 p.m., the Respondent and CI spoke on the phone. GE-27.\33\ CI asked how things went with Agent 1. GE-27, at 1. The Respondent said he thought they went okay. GE-27, at 1. The Respondent and CI discussed their encounter in Walmart. GE-27, at 3. The Respondent asked CI what Agent 1 said to CI, and she told him that Agent 1 said that they had talked about the [[Page 54836]] Respondent's boat. GE-27, at 5. The Respondent said that he talked with Agent 1 about a boat because ``we had to be in there more than ten seconds'' so that his ``nosy nurse'' would not think, ``[d]ang, why is this appointment over with in ten seconds?'' GE-27, at 5. --------------------------------------------------------------------------- \33\ See GE-16, file 2015-04-08_18-15-44_EDT. --------------------------------------------------------------------------- 80. On April 14, 2015, at approximately 3:48 p.m., CI texted the Respondent and asked him how many friends she could ``send in ur office for `headaches' lol?'' GE-20, file 2015-04-14_15-48-52_EDT. 81. On April 14, 2015, at approximately 6:47 p.m., the Respondent and CI spoke on the phone. GE-38.\34\ CI again asked the Respondent how many friends she could send to him with a headache. GE-38, at 2. The Respondent said they had to be really careful about it. Id. The Respondent told CI that if she had a friend who was ``willing to help'' her, she should not tell him about it and should just ask the friend to come by and ``mention that they've got headaches.'' GE-38, at 2. The Respondent said he was nervous about it because he knew he was being watched. GE-38, at 2. The Respondent said that, but for CI's husband, CI could ``have all the sex, drugs, and rock and roll'' that she needed. GE-38, at 2. CI told the Respondent that she was ``running low'' and needed ``some more pills or something.'' GE-38, at 3. The Respondent suggested she drink vodka. GE-38, at 3. CI asked if he would treat Agent 1 for a cough if Agent 1 came in for a cough, and if he would give Agent 1 cough medicine. GE-38, at 3. The Respondent said he could give her cough medicine for something legitimate, and warned CI that the state monitors drug-seeking behavior. GE-38, at 3-4. CI asked the Respondent to prescribe her a ``big bottle,'' like he used to prescribe to her. GE-38, at 4. The Respondent said he could give her about eight ounces. GE-38, at 4. The Respondent told CI that he could not prescribe Adipex to her and explained why. GE-38, at 6. The Respondent told CI that he could help her feel happier if he did not get ``busted by the . . . drug police.'' GE-38, at 8. --------------------------------------------------------------------------- \34\ See GE-20, file 2015-04-14_18-47-34_EDT; GE-28, file 2015- 04-14_18-47-34_EDT. --------------------------------------------------------------------------- 82. On April 14, 2015, at approximately 7:02 p.m., CI texted the Respondent and asked if he had any Adipex left over from a prescription to his wife. GE-20. 83. On April 15, 2015, at approximately 9:30 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI talked about being severely depressed. GE-28, file 2015-04-15_21-30-59_EDT, at 9. The Respondent talked about how CI's husband would not let her ``have drugs.'' Id. at 10. 84. On April 22, 2015, at approximately 10:28 a.m., the Respondent and CI spoke on the phone. GE-20, 28. CI told the Respondent that Agent 1 and some of her friends were coming next week to see the Respondent. GE-28, file 2015-04-22_10-28-41_EDT, at 3. The Respondent warned CI that he had to be careful because it was ``super serious.'' Id. CI laughed and said that they had headaches. Id. The Respondent told CI that prescribing frequently to people from out of town was a ``big'' red flag. Id. The Respondent said he could not ``do it on any kind of regular basis.'' Id. at 4. 85. On April 22, 2015, at approximately 12:10 p.m., the Respondent texted CI that he ``CANNOT do anything other than legitimate medical stuff'' because it was risky and CI's husband had everyone ``on high alert.'' GE-20. CI texted back and asked if he would see Agent 1 next week, and that Agent 1 and her friends would not ``tell.'' GE-20. CI asked him to ``write in their chart it's for migraines like u always do.'' GE-20. The Respondent texted back that he would see Agent 1 and treat her in a medically appropriate way. GE-20. The Respondent also texted that his usual prescription for Lorcet (40) ``should last more than a month.'' GE-20. The Respondent texted that his feelings for CI needed to be ``totally separate from [his] medical practice.'' GE-20. 86. On April 22, 2015, at approximately 1:03 p.m., the Respondent and CI spoke on the phone. GE-20, 28. The Respondent said that they had to be really careful because the Mississippi Board was watching him. GE-28, file 2015-04-22_13-03-23_EDT, at 1-2. He compared their situation to going to ``buy drugs at a crack house.'' Id. at 2. The Respondent said everything needed to be ``straight'' and ``above the board.'' Id. The Respondent said that his normal prescription dosage of headache medicine should last more than 30 days, and that it would raise alarm if he saw people more than once a month or every other month for headaches. Id. CI said that it had been a month since he saw Agent 1; the Respondent said he did not remember. Id. CI asked him how he got ``away with it'' when he was seeing her; he replied that ``they weren't watching nearly as close'' and that CI had legitimate headaches and he ``was writing it down every time.'' Id. at 3. The Respondent said he was not giving her prescriptions ``super often.'' Id. The Respondent discussed headaches, Maxalt, and Lorcet with CI. Id. at 3-4. CI asked the Respondent if he would see ``them'' next week. Id. at 4. The Respondent said that he would see anybody that came in to his office. Id. CI asked him to ``write 'em Lorcet.'' Id. The Respondent said that ``[i]t would even be better if I don't even know who they are'' and instructed CI to not tell him their names. Id. The Respondent said that he treats everyone the same. Id. at 5. The Respondent said that he liked to be nice to Agent 1, who he identified as CI's friend. Id. 87. On April 22, 2015, at approximately 2:32 p.m., CI texted the Respondent, ``[w]hat I wouldn't do for an aipex [sic] right now ! Omg :/.'' GE-20, file 2015-04-22_14-32-41_EDT. 88. On April 27, 2015, at approximately 2:45 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI said she spoke to Agent 1, who was going to see the Respondent that Wednesday. GE-20, file 2015-04- 27_14-45-16_EDT. The Respondent said he would be glad to see her. Id. CI said that Agent 1 would give CI all of Agent 1's prescriptions. Id. CI said Agent 1 and Agent 2 would split Agent 2's prescriptions. GE-28, file 2015-04-27_14-45-16_EDT, at 1. The Respondent said he did not ``know anything about that and [did not] want to know anything about that.'' Id. CI discussed previously taking ``like 20'' of the Demerol that the Respondent prescribed to her. Id. at 7. 89. On April 28, 2015, at approximately 8:23 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI told the Respondent to not forget that Agent 1 and Agent 2 were coming tomorrow. GE-28, file 2015- 04-28_20-23-38_EDT, at 1. The Respondent acknowledged that he knew they were coming and said he would see them then. Id. CI told the Respondent to ``[h]ook her up good. Give her some cough medicine.'' Id. 90. On April 29, 2015, at approximately 9:38 a.m., the Respondent and CI spoke on the phone. GE-20, 28, 29. CI told the Respondent not to forget that Agent 1 was coming that day. GE-29, at 7. The Respondent replied that he would not forget and would ``take care of her.'' GE-29, at 7. CI told him to give her cough medicine. GE-29, at 7. The Respondent said he would see what he could do, but that CI was ``really pushing [his] envelope.'' GE-29, at 7. 91. On April 29, 2015, at approximately 3:40 p.m., CI texted the Respondent that Agent 1 said that Agent 2 `` `has a cough too' if u could hook her up with some cough med . . . Please :) .'' GE-39, at 5. [[Page 54837]] 92. Based on Findings of Fact 47 through 53, 56 through 72, and 75 through 91, and the transcript at pages 91, 136, 230, and 349, I find that, by the time the Respondent met with Agents 1 and 2 on April 29, 2015, the Respondent knew that Agent 1 and Agent 2 were not legitimate patients and that at least some of the medications that he prescribed to them during their appointments that day would be given to and used by CI and/or shared by the Agents. vii. Undercover Appointment #3: April 29, 2015, with Agent 1 93. Agent 1 had a third appointment with the Respondent, which occurred on April 29, 2015. GE-30-31; Tr. 111. 94. The Respondent met with Agent 1 and asked her, ``Headaches for you?'' GE-31, at 1. Agent 1 responded, ``Yep.'' GE-31, at 1. The Respondent performed a brief examination of Agent 1, checking her ears and nose. GE-30-31; Tr. 112, 132. The Respondent observed that Agent 1 still had ``refills on the other.'' GE-31, at 1. 95. Agent 1 told the Respondent that she talked on the phone with a friend of hers, who told her that she was coughing a lot and needed to get something for her cough; Agent 1 also told the Respondent that she had not paid it much attention to it. GE-31, at 1; Tr. 133, 138-39. The Respondent immediately told Agent 1 that he would give her some cough syrup. GE-30; Tr. 133, 139-40. Agent 1 was not coughing during the appointment. GE-30; Tr. 138. Agent 1 did not tell the Respondent that she had a cough. GE-30-31; Tr. 113, 132. Agent 1 did not directly request cough syrup from the Respondent. GE-30-31; Tr. 113. 96. The Respondent wrote two prescriptions to Agent 1: one for 40 Norco 10/325, and one for eight ounces of Hycodan. GE-32-33; Tr. 113. viii. Undercover Appointment #4: April 29, 2015, with Agent 2 97. Agent 2 also had an appointment with the Respondent on April 29, 2015. GE-34-35; Tr. 143. 98. The Respondent met with Agent 2. GE-34-35; Tr. 144; see also GE-58 (containing the Respondent's patient file for Agent 2). The Respondent asked her what he could do for her. Agent 2 she said she had ``a little headache,'' but noted that it had not been going on for a long time. GE-35, at 1; Tr. 144. The Respondent briefly looked into Agent 2's ears, nose, and mouth. GE-34-35; Tr. 144. The Respondent asked her a few questions about allergies, blood pressure, and smoking. GE-35, at 2. The Respondent then wrote prescriptions to Agent 2. GE-34. Meanwhile, the Respondent talked casually with Agent 2 about sports, Birmingham, and restaurants. GE-35, at 2-3. 99. The Respondent wrote two prescriptions for Agent 2: one for 40 Norco 10/325, and one for Maxalt with unlimited refills. GE-35, at 3; GE-36-37; Tr. 144. ix. Interactions Between the Respondent and CI Between the Fourth and Fifth Undercover Appointments 100. On April 29, 2015, at approximately 1:48 p.m., the Respondent and CI spoke on the phone. GE-29, at 9. CI asked the Respondent if he had seen Agent 1. GE-29, at 9. The Respondent said he had. GE-29, at 9. CI asked him what he gave her. GE-29, at 9. The Respondent said, ``appropriate medicine,'' and laughed. GE-29, at 9. He said that he gave her something for her headache and cough. GE-29, at 9. CI thanked the Respondent. GE-29, at 9. 101. On April 30, 2015, at approximately 9:19 a.m., the Respondent and CI spoke on the phone. GE-40; see GE-20, 28. CI told the Respondent that she got her medication. GE-40, at 1. The Respondent said he was ``glad all that worked out.'' GE-40, at 1; see Tr. 230-31. The Respondent asked CI who Agent 2 was and if she was Agent 1's friend. GE-40, at 1. CI told the Respondent that Agent 1 gave all of hers to CI, and that Agent 1 and Agent 2 split Agent 2's prescription. GE-40, at 2. The Respondent said he was glad he could help, and that both agents were ``very appropriate'' because they went ``through the motions.'' GE-40, at 2. The Respondent said that during the appointment with Agent 2, he was thinking, ``I'm not mentioning [CI] and I'm not mentioning [Agent 1].'' GE-40, at 2. 102. The DEA's investigation was suspended while the Respondent campaigned for political office. Tr. 78. The DEA contacted CI in October 2015 and asked her to talk to the Respondent again to try to get him to write another prescription. Tr. 358. CI said no. Tr. 358. x. Undercover Appointment #5: October 16, 2015 103. Agent 1 had a fourth appointment with the Respondent, which took place on October 16, 2015. Tr. 78, 119. The purpose of this appointment was to refresh the investigation concerning the Respondent. Tr. 78. Upon arriving at the Respondent's clinic, the Respondent's receptionist told Agent 1 that her chart had been misplaced,\35\ so Agent 1 filled out new paperwork and sat in the Respondent's waiting room. GE-42-43; Tr. 119-20, 137. --------------------------------------------------------------------------- \35\ After the Respondent was arrested, Agent 1's original file, GE-59, was found in the Respondent's desk, along with the files for CI and CI's children. Tr. 428. --------------------------------------------------------------------------- Agent 1 waited for about an hour and twenty minutes before she was called into an exam room. GE-42; Tr. 406. 104. Agent 1 met with the Respondent. GE-42; see GE-60 (containing Agent 1's October 16, 2015 patient file). The Respondent examined Agent 1's ears, nose, and throat. GE-60, at 4; Tr. 120, 132.\36\ The Respondent asked Agent 1 what her symptoms were and what he had treated her for in the past. GE-43, at 2; Tr. 135. Agent 1 thought the Respondent was acting as though he did not know who she was. Tr. 120, 135, 452; see GE-42-43. --------------------------------------------------------------------------- \36\ The audiovisual recording of Agent 1's appointment did not record any physical examination by the Respondent during this appointment. See GE-42. However, because the audiovisual recording was incomplete, and because Agent 1 testified that the Respondent examined her ears, nose, and throat, I find as a matter of fact that the Respondent conducted a physical examination of Agent 1 at this appointment. --------------------------------------------------------------------------- 105. The Respondent discussed the most effective medication for Agent 1 to take for headaches. GE-43, at 2-3. Agent 1 asked the Respondent if he remembered Agent 2. GE-43, at 3. The Respondent stopped, thought about it, and said he did not. GE-42, 43. 106. Agent 1's recording device partially failed and did not record the last few minutes of Agent 1's appointment with the Respondent. Tr. 79, 451. 107. While the Respondent was writing prescriptions for Agent 1, she asked the Respondent if he had spoken with CI lately. Tr. 122, 135, 452-53. The Respondent paused and looked surprised, then continued writing the prescriptions and stated that he had not heard from CI lately. Tr. 122-23. 108. The Respondent wrote Agent 1 prescriptions for 30 Norco 5/325, four ounces of Hycodan, Maxalt, Zyrtec, and dexamethasone. GE-44-47, 54; Tr. 120, 126-27, 452. The Respondent discussed these prescriptions with Agent 1 during the appointment. Tr. 452-53, 455-56. 109. During this visit, Agent 1 did not say that she had a cough. GE-42-43; Tr. 126, 138-39, 454. Agent 1 only stated at the outset of the appointment that she needed the ``same as before,'' and did not tell the Respondent that she had any specific complaints. GE-42-43; Tr. 454. The Respondent nonetheless prescribed cough syrup to Agent 1. GE- 45; Tr. 139. [[Page 54838]] G. Search of the Respondent's Office 110. The Respondent was arrested on December 9, 2015. Tr. 427, 432. That same day, the DEA searched the Respondent's office and examined his records and patient files. Tr. 427, 432. The Respondent's office kept patient files in a general population of files. Tr. 433. 111. The DEA unlocked the Respondent's desk drawer and discovered several patient files that had not been kept in the general population of patient files. Tr. 428, 432. In the Respondent's desk, the DEA found one patient file for Agent 1, one file for CI, one file for Kid 1, and one file for Kid 2. Tr. 428; see GE-2, 56-57, 59. 112. The DEA found a second patient file for Agent 1 within the general population of the Respondent's patient files. Tr. 433; see GE- 60. The DEA also found a patient file for Agent 2 in the general population of the Respondent's patient files. Tr. 434; see GE-58. Additional facts required to resolve the issues in this case are included below in the Analysis section of this Recommended Decision. ANALYSIS To revoke a respondent's registration, the Government must prove, by a preponderance of the evidence, that the regulatory requirements for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100-02 (1981); 21 CFR Sec. 1301.44(e) (2015). Under 21 U.S.C. Sec. 824(a)(4), the DEA may revoke a registrant's COR if the registrant acted in a way that renders continued registration ``inconsistent with the public interest.'' The DEA considers the following five factors to determine whether continued registration is in the public interest: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The [registrant's] experience in dispensing, or conducting research with respect to controlled substances. (3) The [registrant's] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. 21 U.S.C. 823(f) (2012). These public interest factors are considered separately. See Robert A. Leslie, M.D., 68 Fed. Reg. 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D., 58 Fed. Reg. 37507, 37508 (1993). Thus, there is no need to enter findings on each of the factors. Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Further, there is no requirement to consider a factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76-77 (4th Cir. 1988). When deciding whether registration is in the public interest, the totality of the circumstances must be considered. See generally Joseph Gaudio, M.D., 74 Fed. Reg. 10083, 10094-95 (2009). The Government bears the initial burden of proof, and must justify revocation by a preponderance of the evidence. Steadman, 450 U.S. at 100-03. If the Government makes a prima facie case for revocation, the burden of proof shifts to the registrant to show that revocation would be inappropriate. Med. Shoppe-Jonesborough, 73 Fed. Reg. 364, 387 (2008). A registrant may prevail by successfully attacking the veracity of the Government's allegations or evidence. Alternatively, a registrant may rebut the Government's prima facie case for revocation by accepting responsibility for wrongful behavior and by taking remedial measures to ``prevent the re-occurrence of similar acts.'' Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8236 (2010). In addition, when assessing the appropriateness and extent of sanctioning, the DEA considers the egregiousness of the offenses and the DEA's interest in specific and general deterrence. David A. Ruben, M.D., 78 Fed. Reg. 38363, 38385 (2013). Factor One: The Recommendation of the Appropriate State Licensing Board or Professional Disciplinary Authority Neither party directly advanced an argument under Factor One. However, a substantial portion of the Respondent's post-hearing brief (``ALJ-34'') argues that the DEA should give significant deference to the Mississippi Board's termination of its investigation against the Respondent. ALJ-34, at 3-6. Therefore, by inference, the Respondent advanced a theory under Factor One that his license should not be revoked because the Mississippi Board declined to take formal disciplinary action against him. Although the Mississippi Board did not make a formal recommendation to the DEA in this matter, the DEA interprets a state licensing board's ``recommendation'' broadly. See Kenneth Harold Bull, M.D., 78 Fed. Reg. 62666, 62672 (2013) (considering disciplinary actions taken by a state board under Factor One).\37\ A state board's disciplinary actions can provide evidence of what a state licensing board would recommend. Id. For example, when a state board puts a registrant on probation, the DEA views the probation as a recommendation from the state board. E.g., Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (2013). --------------------------------------------------------------------------- \37\ But see George R. Smith, M.D., 78 FR 44972, 44979 (2013) (finding that the absence of a state licensing board's direct recommendation weighs neither for nor against a respondent); Paul Weir Battershell, N.P., 76 FR 44359, 44365-66 (2011) (same); Gilbert Eugene Johnson, M.D., 75 FR 65663, 65666 n.3 (2010) (same). --------------------------------------------------------------------------- Here, the Mississippi Board has not revoked, suspended, or restricted the Respondent's license. GE-1, at 1; GE-3, at 1. The Mississippi Board investigated the Respondent in March 2015. See GE-3. This investigation was limited to reviewing an anonymous letter, interviewing the Respondent, and visiting the Respondent's office. See GE-3, at 1-2, 4-6. The Mississippi Board neither exonerated the Respondent nor took any formal action against him. GE-3; Tr. 184, 203. The Mississippi Board only issued a warning letter to the Respondent to conclude its investigation. GE-3, at 1. Consistent with the findings of Investigator Pohnert, the Mississippi Board warned the Respondent that doctors are only permitted to refill phentermine prescriptions if they first conduct and document medical examinations. GE-3, at 1, 5. The fact ``that a state has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.'' Carlos Gonzalez, M.D., 76 Fed. Reg. 63118, 63140 (2011) (citing Patrick W. Stodola, M.D., 74 Fed. Reg. 20727, 20730 (2009); Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 461 (2009)). Rather, the DEA, apart from the Mississippi Board, has its own independent responsibility to determine whether the Respondent's continued registration is in the public interest. See Edmund Chein, M.D., 72 Fed. Reg. 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008). Accordingly, the Mississippi Board's warning letter does not weigh either for or against the Respondent under Factor One. Factors Two and Four: The Respondent's Experience in Dispensing Controlled Substances and Compliance with Applicable State, Federal, or Local Laws Relating to Controlled Substances Allegations 1 through 5 all claim that the Respondent illegitimately prescribed controlled substances outside the course of his professional practice. See supra pp. 2-3. Regarding these allegations, the [[Page 54839]] Government endeavored to show that the Respondent knowingly diverted, or attempted to divert, controlled substances. This evidence is properly analyzed under Factors Two and Four because ``[p]roof that a physician knowingly diverted controlled substances is the best evidence for assessing his experience in dispensing controlled substances, although it is also relevant in assessing his compliance with applicable laws related to controlled substances.'' Syed Jawed Akhtar- Zaidi, M.D., 80 Fed. Reg. 42961, 42968 n.17 (2015). Under the Controlled Substances Act (``CSA''), it is unlawful for a person to distribute controlled substances, except as authorized under the CSA. 21 U.S.C. 841(a)(1). To combat drug abuse and trafficking of controlled substances, ``Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.'' Gonzales v. Raich, 545 U.S. 1, 13 (2005). To maintain this closed regulatory system, controlled substances may only be prescribed if a DEA registrant writes a valid prescription. Gonzalez, 76 FR at 63141. As the Supreme Court explained, ``the prescription requirement . . . ensures that patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). A controlled substance prescription is not valid unless it is ``issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.'' 21 CFR Sec. 1306.04(a). Federal regulations further provide that ``[a]n order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. Sec. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of [controlled substance laws].'' Id.; see 21 U.S.C. Sec. 842(a)(1) (establishing that, under the CSA, it is illegal for a person to distribute or dispense controlled substances without a prescription, as is required under 21 U.S.C. Sec. 829). Much like the federal regulations, the Mississippi Code provides that it is illegal to dispense Schedule II \38\ controlled substances except upon a valid prescription written by a practitioner. Miss. Code Sec. Sec. 41-29-137(a)(1), 41-29-141(1). The Mississippi Code further provides that a registrant's license may be revoked if the registrant prescribes narcotics outside of the course of legitimate professional practice, id. Sec. 73-25-29(3), or if the registrant violates the Mississippi Board's administrative rules, id. Sec. 73-25-29(13). --------------------------------------------------------------------------- \38\ These sections of the Mississippi Code only apply to the Respondent's Schedule II controlled substance prescriptions. Notably, hydrocodone combination products, such as Norco and Hycodan, were re-classified by the federal government as Schedule II controlled substances on October 6, 2014. See Stip. 5-6. The parties made no argument, and presented no evidence, regarding the classification of hydrocodone combination products in the state of Mississippi. --------------------------------------------------------------------------- The DEA recognizes several methods to show that a registrant wrote prescriptions without a legitimate medical purpose and outside of the usual course of professional practice. See Jack A. Danton, D.O., 76 FR 60900, 60901 (2011). The Respondent, however, incorrectly suggests that the Government must provide ``medical literature'' or a ``medical opinion'' in order to establish that a registrant acted outside the usual course of professional practice and lacked a legitimate medical purpose. ALJ-34, at 5. Typically, the Government uses expert testimony to establish a violation of 21 CFR 1306.04(a). T.J. McNichol, M.D., 77 FR 57133, 57147-48 (2012). However, ``whether expert testimony is needed is necessarily dependent on the nature of the allegations and the other evidence in the case.'' Beau Boshers, M.D., 76 FR 19401, 19402 n.4 (2011). Numerous state and federal courts have found in criminal cases, which require a higher standard of proof than is required in these proceedings, that expert testimony is not required to establish a violation of 21 U.S.C. Sec. 841 or 21 CFR Sec. 1306.04(a). McNichol, 77 FR at 57147.\39\ For example, the DEA has not required expert testimony to establish a violation of 21 CFR Sec. 1306.04(a) in cases where a prescriber engaged in drug deals,\40\ where there were notable differences between patients' medical records and diagnoses,\41\ and where a prescriber falsified patients' charts.\42\ Simply put, whether the Government must present expert testimony is dependent on the facts of each case. McNichol, 77 FR at 57147-48. --------------------------------------------------------------------------- \39\ E.g., United States v. Pellman, 668 F.3d 918, 924 (7th Cir. 2012); United States v. Armstrong, 550 F.3d 382, 389 (5th Cir. 2008); United States v. Word, 806 F.2d 658, 663 (6th Cir. 1986); United States v. Larson, 507 F.2d 385, 387 (9th Cir. 1974); United States v. Bartee, 479 F.2d 484, 488-89 (10th Cir. 1973); State v. Moody, 393 So.2d 1212, 1215 (La. 1981). \40\ Boshers, 76 Fed. Reg. at 19402 n.4. \41\ Morris W. Cochran, M.D., 77 Fed. Reg. 17505, 17519-20 (2011). \42\ Robert F. Hunt, D.O., 75 Fed. Reg. 49995, 50003 (2010). --------------------------------------------------------------------------- In the Government's post-hearing brief (``ALJ-35''), it advanced two theories regarding how the Respondent violated 21 CFR Sec. 1306.04(a): (1) the Respondent knowingly diverted controlled substances to CI, and (2) the Respondent violated state medical practice standards. ALJ-35, at 18-24. The Government can prove that a registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose by ``providing evidence showing that [the registrant] knowingly diverted drugs.'' Danton, 76 Fed. Reg. at 60901. Additionally, the Government can prove that a registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose by providing evidence showing that the registrant violated a state medical practice standard ``which has a substantial relationship to the CSA's purpose of preventing substance abuse and diversion.'' Id. Neither of these methods of proof requires the presentation of expert testimony. Id. Allegation 1: Hydrocodone and Alprazolam Prescriptions to CI In Allegation 1, the Government claimed that the Respondent prescribed hydrocodone and alprazolam to CI from February 2014 to May 2015 \43\ without conducting and/or documenting a physical examination, and without recording the prescriptions in CI's patient file, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, (``Mississippi Administrative Rules'') 1.4, 1.11(b),\44\ and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a). ALJ-1, at 2. Specifically, the Government alleged that the Respondent issued improper [[Page 54840]] prescriptions to CI: (a) on May 22, 2014, for 40 units of a hydrocodone combination product; (b) on June 17, 2014, for 40 units of a hydrocodone combination product; (c) on September 11, 2014, for 40 units of a hydrocodone combination product; (d) on October 6, 2014, for 40 units of alprazolam with one refill for 40 units; (e) on October 29, 2014, for 40 units of a hydrocodone combination product; and (f) on December 4, 2014, for 180 units of a hydrocodone combination product. ALJ-1, at 2. --------------------------------------------------------------------------- \43\ The record does not contain any evidence that the Respondent prescribed controlled substances directly to CI in 2015. The 2015 prescriptions that the Government alluded to under Allegation 1 were the Respondent's 2015 prescriptions to Agent 1 and Agent 2. Those prescriptions are discussed at length under Allegation 4, infra pp. 50-58. \44\ Rule 1.11(b) requires that ``[e]very written prescription delivered to a patient, or delivered to any other person on behalf of a patient, must be manually signed on the date of issuance by the physician.'' Miss. Code R. Sec. 30-17-2640:1.11(b). Although the Government alleged a violation of this provision in its OSC/ISO, the Government did not advance a theory or offer evidence to establish a violation of this specific rule. I therefore find that the Government's allegation that the Respondent violated Rule 1.11(b) is NOT SUSTAINED. --------------------------------------------------------------------------- Under the Mississippi Administrative Code, the Mississippi Board requires that a prescribing physician must: maintain a complete record of his or her examination, evaluation and treatment of the patient which must include documentation of the diagnosis and reason for prescribing, dispensing or administering any controlled substance; the name, dose, strength, quantity of the controlled substance and the date that the controlled substance was prescribed, dispensed or administered. Miss. Code R. Sec. 30-17-2640:1.4.\45\ This record must ``be maintained in the patient's medical records.'' Id. --------------------------------------------------------------------------- \45\ I find that the documentation requirements of Mississippi Administrative Rule 1.4 share a substantial relationship with the CSA's purpose of preventing drug abuse and diversion. --------------------------------------------------------------------------- Further, the Mississippi Board requires that a physician cannot prescribe a controlled substance ``without a good faith prior examination and medical indication therefore.'' Id. This obligation is a continuing one; ``upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results.'' Id. (emphasis added). A physician's failure to complete these three steps is conduct outside the ``course of legitimate professional practice.'' Id. In fact, any violation of these rules is considered conduct outside of the course of legitimate professional practice, in violation of Section 73-25-29(3) of the Mississippi Code. Miss. Code R. Sec. 30-17-2640:1.16. The evidence establishes that, on four occasions, the Respondent prescribed controlled substances to CI without writing any notes about any prescriptions or examinations in CI's patient file. On May 22, 2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE-41, at 4; GE-49, at 2. On June 17, 2014, the Respondent prescribed 40 units of Norco 7.5/325 \46\ to CI. GE-41, at 6; GE-49, at 2. On September 11, 2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE-41, at 20; GE-49, at 2. On December 4, 2014, the Respondent prescribed 180 units, or six ounces, of Hycodan to CI.\47\ GE-41, at 28; GE-49, at 1. None of these four prescriptions were recorded in CI's medical file. See GE-2, at 12-13. The Respondent did not document a diagnosis or reason for prescribing to CI on any of these dates. The Respondent did not write the names, doses, strengths, or quantities of these prescriptions to CI in CI's medical record. The Respondent did not record the dates of these prescriptions in CI's medical record. The Respondent did not record any notes in CI's medical record about any physical examinations on these dates. --------------------------------------------------------------------------- \46\ Originally, the Government alleged that the Respondent prescribed Norco 10/325 on June 17, 2014. See ALJ-1, at 2. However, as the Government correctly noted in its post-hearing brief, the Respondent prescribed Norco 7.5/325 on June 17, 2014. ALJ-35, at 6 n.1; see GE-41, at 6. \47\ The record reflects some confusion concerning the date of this prescription. GE-41, at 21, indicates it was written on December 3, 2014, while GE-49, at 1, indicates it was written on December 4, 2014. See supra note 19. Regardless of the one day variance, the analysis is the same. --------------------------------------------------------------------------- Because of the complete absence of this required information in CI's patient file, the prescriptions that the Respondent wrote to CI on these four dates were improper under Mississippi Administrative Rule 1.4. The Government's allegations that these four prescriptions to CI violated Mississippi Administrative Rule 1.4 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Because these prescriptions violated Mississippi Administrative Rule 1.4, these prescriptions were issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Further, there is no evidence that the Respondent even saw CI on May 22, June 17, September 11, or December 4 of 2014. Even absent expert testimony, the DEA has held that a prescriber does not act in the usual course of professional practice if the prescriber writes prescriptions to a patient without first seeing the patient. Armando B. Figueroa, M.D., 73 Fed. Reg. 40380, 40381-82 (2008). Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) on these four occasions are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. On October 6, 2014, the Respondent prescribed 40 units of alprazolam 1 mg, with one refill, to CI. GE-41, at 22; GE-49, at 1. In CI's medical file, near a date stamp reading September 2, 2014, the Respondent noted ``Xanax 1mg (#40, 1),'' but did not write any justification for this prescription, as is required by Mississippi Administrative Rule 1.4. See GE-2, at 12-13. The Respondent did not write any notes anywhere in CI's patient file about a diagnosis of anxiety or any of CI's alleged symptoms. See GE-2, at 12-13. Additionally, CI's testimony and her PMP report indicate that, although CI's psychiatrist prescribed a smaller dosage of alprazolam to her, the Respondent increased CI's dosage without any noted justification. GE- 49, at 1; Tr. 225-26, 295, 304; see GE-2 (failing to justify an increased dosage of alprazolam); see also GE-2, at 21 (documenting that another registrant prescribed 7 units of alprazolam ER 0.5 mg to CI on September 30, 2014, and that the Respondent then prescribed 40 units of alprazolam 1 mg on October 6, 2014). Because the Respondent never documented a reason for prescribing alprazolam to CI in her patient file, the Government's allegation that the October 6, 2014 prescription violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, this prescription was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) by issuing the October 6, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Government also alleged that the Respondent prescribed 40 units of a hydrocodone product to CI on October 29, 2014. ALJ-1, at 2. Although this alleged prescription is noted on CI's PMP report, see GE- 49, as Government counsel stated, ``PMPs are not without their flaws'' and are not ``necessarily accurate.'' Tr. 302-03. The Government offered testimony from CI related to this alleged prescription. Tr. 369-70. CI was presented with a copy of this alleged prescription, which she reviewed. Tr. 369-70. At the hearing, CI did not testify about the prescription from her [[Page 54841]] personal recollection; she only looked at and read off of the copy of the prescription presented to her. Tr. 369-70. I do not find that CI's testimony proved the existence of the October 29 prescription. This copy of the prescription was not offered into evidence.\48\ In sum, the Government failed to offer substantial evidence that the Respondent did, in fact, prescribe hydrocodone to CI on October 29, 2014 outside of the course of his professional practice. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) by issuing an October 29, 2014 prescription are NOT SUSTAINED. --------------------------------------------------------------------------- \48\ See supra note 20. --------------------------------------------------------------------------- Beyond the above-mentioned specific prescribing events, the Government provided ample evidence that, throughout 2014, the Respondent prescribed controlled substances to CI outside of the usual course of his professional practice and without a legitimate medical purpose. The DEA has held, even without the benefit of expert testimony, that a controlled substance prescription based on a patient's request ``rather than the result of the application of the physician's medical judgment'' lacks a medical purpose. Robert M. Golden, M.D., 61 Fed. Reg. 24808, 24812 (1996) (citing Robert L. Dougherty, Jr., M.D., 60 Fed. Reg. 55047 (1995); Harland J. Borcherding, D.O., 60 Fed. Reg. 28796 (1995)). Likewise, the Mississippi Administrative Rules state that a prescriber lacks good faith when he ``permit[s] the patient to name the drug desired'' or ``dispens[es] drugs to patients having no medical need, when the physician knew or should have known that the patients were addicts.'' Miss. Code R. Sec. 30-17-2640:1.4. It is true that, at times, the Respondent intended to treat CI's medical conditions. GE-2, at 12-13; Tr. 215, 277-78, 287, 321. However, even if the Respondent subjectively intended to provide legitimate medical treatment to CI, ``[t]he appropriate focus is not on the subjective intent of the doctor, but rather . . . whether the physician prescribe[d] medicine `in accordance with [the accepted] standard of medical practice.' '' United States v. Merrill, 513 F.3d 1293, 1306 (11th Cir. 2008) (quoting United States v. Moore, 423 U.S. 122, 139 (1975)). The Respondent's failure to perform and document physical examinations of CI, and his failure to document his prescriptions to CI, constitutes a significant failure to comply with Mississippi medical standards, regardless of the Respondent's subjective intent. Here, CI took Norco daily and recreationally, and the Respondent gave prescriptions to CI upon her request. Tr. 297-99. The Respondent gave prescriptions to CI at her house, at her children's appointments, and in the garden section of Walmart. Tr. 26, 217-20. The Respondent did not provide CI with a diagnosis or perform physical examinations before giving these prescriptions to CI. See Tr. 217-18; see also GE-2, at 12-13. Importantly, the Respondent only made three entries in CI's patient file in 2014, on February 21, April 21, and September 2, and he made no entries in CI's patient chart in 2015. See GE-2, at 12-13. Neither party presented any standard to evaluate the adequacy of the patient file entries.\49\ Assuming that the file entries on those dates are adequate, under Mississippi Administrative Rule 1.4, any prescriptions that the Respondent issued to CI in 2014, other than on February 21, April 21, and September 2, were issued outside of the Respondent's professional practice. CI's PMP report indicates that CI may have filled prescriptions written by the Respondent on 13 dates in 2014.\50\ I do not find that the PMP report, standing alone, constitutes substantial evidence that these prescriptions existed, as discussed supra. However, CI's credible, confident, and uncontested testimony that she simply requested prescriptions from the Respondent ``for fun,'' and that he would give them to her, considered in conjunction with the PMP report, constitutes substantial evidence that the Respondent prescribed controlled substances to CI in 2014 based on CI's request rather than in the proper exercise of sound medical judgment. On these grounds, the Government's allegations that the Respondent violated Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. --------------------------------------------------------------------------- \49\ CI's patient file is not entirely legible. See GE-2, at 12- 13. The February 21, 2014 entry reads: ``HC 7.5/325 (#40, 1)--may be picked up at desk.'' GE-2, at 12. The April 21, 2014 entry reads: ``Headaches ? `Sinuses' Motion sickness Occasional vertigo Ears clear OC/OP clear Nose mildly inflamed CT [rarr] clear and thickening in L NF duct Rx Maxalt (one given) HC 10/325 (#40) (refill).'' GE-2, at 12. The September 2, 2014 entry reads: ``Lexapro Maxalt prn has anxiety c migraines Migraine--usually responsive to Maxalt, now c brea[illegible] Ears clean; [illegible] in [supreg] EAC @[illegible] Nose clear OC/OP clear Counseled [illegible] Rx Zofran Demerol 50 (#30) HC 10/325 (#40, 1) Phentermine (refilled) Xanax 1mg (#40, 1).'' GE-2, at 12. These three notations are the only entries in the Respondent's patient file for CI during 2014. \50\ Specifically, these dates are as follows: February 21, April 9, May 19, May 22, June 17, July 19, July 24, September 2, September 8, September 11, October 6, October 29, and December 4. See GE-2, at 21-23; GE-49, at 1-3. --------------------------------------------------------------------------- Allegation 2: Phentermine Prescriptions to CI In Allegation 2, Government claimed that the Respondent prescribed phentermine \51\ to CI without adequate documentation, in violation of Mississippi Administrative Rule 1.5, Mississippi Code Sec. Sec. 73-25- 29(3) and (13), and 21 CFR Sec. 1306.04(a). ALJ-1, at 3. The Government specifically alleged that this inappropriate prescribing occurred on four occasions in 2014: April 9, for 30 dosage units; May 19, for 30 dosage units with one refill; July 24, for 30 dosage units; and September 8, for 30 dosage units with two refills. ALJ-1, at 3. --------------------------------------------------------------------------- \51\ Phentermine, or Adipex, is a Schedule IV controlled substance. See Stip. 8. --------------------------------------------------------------------------- The administration of weight loss medication is regulated by state medical standards. See generally Wesley G. Harline, M.D., 65 Fed. Reg. 5665 (2000) (discussing, at length, general practice and state medical standards for legitimately prescribing controlled substances for weight loss). The Mississippi Board has a special standard of care for practitioners who prescribe diet medication. See Miss. Code R. Sec. 30-17-2640:1.5; see also GE-8; Tr. 171-72. Specifically, Rule 1.5 requires a doctor prescribing weight loss drugs to: (1) only prescribe adjunctively with caloric restriction; (2) conduct and thoroughly record an initial comprehensive evaluation; (3) record a thorough patient history and physical exam; (4) conduct an in-person re- evaluation of the patient once every 30 days, recording the patient's weight, BMI, blood pressure, pulse, and the results of all tests to monitor adverse effects of the medication; and (5) maintain records about the patient's weight loss efforts, dedication, responses, contraindications, and adverse effects during treatment. Miss. Code R. Sec. 30-17-2640:1.5. The patient's history and physical exam must, at a minimum, document: 1. Past medical history, past surgical history, social history, family history, weight history, dietary history, gynecological (GYN) history if female, review of systems, allergies and medications. 2. Height, weight, Body Mass Index (BMI), blood pressure, pulse, % body fat or waist circumference/weight hip ratio, HEENT, chest, heart, abdomen, extremities. [[Page 54842]] 3. Appropriate testing related to medical weight loss . . . . Id. The Government presented evidence that the Respondent wrote four prescriptions for phentermine to CI. On April 9, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE-7, at 1-2; GE-49, at 2. On May 19, 2014, the Respondent prescribed 30 units of Adipex 37.5, with one refill to CI. GE-7, at 3-4; GE-41, at 2-3; GE-49, at 2. On July 24, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE-7, at 5-6; GE-41, at 12-13; GE-49, at 2. On September 8, 2014, the Respondent prescribed 30 units of phentermine 37.5 with two refills to CI. GE-7, at 7-8; GE-41, at 18-19; GE-49, at 2. During 2014, CI filled these prescriptions seven times. GE-49, at 1-2. In the administrative record, there are only four notations in the Respondent's files related to phentermine, Adipex, or weight loss prescriptions. The first mention of phentermine is in the Respondent's patient file for Kid 1 near a date stamp reading February 4, 2014. GE- 57, at 6; Tr. 286. That note reads, ``Mother has migraines ? in children May call in Rx if needed. Discussed phentermine c mother May consider this as well.'' GE-57, at 6. The second time phentermine was mentioned was in a March 19, 2014 entry in Kid 1's patient file. That note reads, ``Discussed [illegible] medications c mother Rx [illegible] Phentermine 37.5.'' GE-57, at 5; Tr. 286. The third mention of phentermine, and the first in the Respondent's patient file for CI, is dated July 18, 2014. GE-2, at 15. This third mention is on a patient telephone request form, which indicated that CI called the Respondent to ask about a refill of ``phentermine 37.5 (#30, 2)'' for her to ``pick up at front.'' GE-2, at 15. The final mention of phentermine, and the only one contained in the Respondent's treatment notes of CI, is dated September 2, 2014. GE-2, at 12. This last entry simply reads, ``Phentermine (refilled).'' GE-2, at 12. Accordingly, while prescribing phentermine to CI on April 9, May 19, July 24, and September 8, the Respondent completely failed to comply with the requirements of Mississippi Administrative Rule 1.5. The Respondent never prescribed phentermine adjunctively with caloric restriction. He never conducted and recorded an initial comprehensive evaluation. He never recorded a thorough patient history or physical examination. He never conducted an in-person re-evaluation of CI once every 30 days. He never recorded CI's, BMI, blood pressure, pulse, past medical history, social history, family history, dietary history, gynecological history, height, weight, or body measurements. He did not document CI's efforts to lose weight or note her response to treatment. A prescriber lacks good faith if he prescribes controlled substances to a patient who the prescriber knew or should have known had no legitimate medical need for the controlled substances prescribed. Miss. Code R. Sec. 30-17-2640:1.4. It is concerning that the Respondent wholly failed to document any justification whatsoever for CI's supposed need for weight loss medication. During 2014, CI went from 135 pounds down to 121 pounds. Tr. 224. At the hearing, CI presented with a slender body type. After observing CI's appearance, I find it difficult to comprehend, from even a layman's perspective, how the Respondent could have possibly believed that CI had a high enough BMI \52\ to justify the administration of weight loss medication. --------------------------------------------------------------------------- \52\ See Miss. Code R. Sec. 30-17-2640:1.5(A)(4) (requiring generally a BMI of greater than 30.0 in a normal, otherwise healthy patient to justify prescribing weight loss drugs); see also Minnix v. Colvin, No. 2:12CV00038, 2014 WL 618688, at *3 n.3 (W.D. Va. Feb. 18, 2014) (defining a BMI of 30 or higher as obesity) (citing Nat'l Inst. of Health, Calculate Your Body Mass Index, http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm (last visited May 18, 2016)). --------------------------------------------------------------------------- The Respondent displayed a complete disregard for Mississippi's weight loss prescription requirements. He prescribed weight loss drugs to CI without any documented medical justification. GE-2, at 12-13. ``[W]here a medical record contains no findings that support a diagnosis, . . . expert testimony is not necessary to conclude that a prescription lacked a legitimate medical purpose.'' McNichol, 77 Fed. Reg. at 57151 (citations omitted). Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.5, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a), by prescribing phentermine to CI on April 9, May 19, July 24, and September 8 of 2014 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Respondent argued in his post-hearing brief that, after receiving the Mississippi Board's warning letter, he refused to prescribe weight loss medication to an undercover agent. ALJ-34, at 6. The Respondent argued that this refusal showed that he ``came promptly into conformity'' with Mississippi's weight loss medication prescribing standards. ALJ-34, at 6. However, even if the Respondent took remedial measures, those measures, standing alone, cannot rebut the Government's prima facie case for revocation unless the Respondent also accepted responsibility for his actions. See Michael S. Moore, M.D., 76 Fed. Reg. 45867, 45868 (2011); Hassman, 75 Fed. Reg. at 8236. The Respondent did not testify and did not accept responsibility. Accordingly, the Respondent failed to rebut the Government's prima facie case for revocation based upon his violation of state regulations that detail the requirements for prescribing weight loss medication. Allegation 3: Prescribing to CI's Children: Physical Examinations, Propriety of Prescriptions, and True Intended Recipient In Allegation 3, the Government claimed that, from February 7 to November 19 of 2014, the Respondent prescribed hydrocodone products to CI's children without conducting examinations, and that the prescriptions were for CI's personal use, in violation of Mississippi Administrative Rules 1.4, 1.10, 1.11(b),\53\ and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) and 1306.05(a). ALJ-1, at 2-3. Mississippi Administrative Rule 1.10 requires that a prescription for a controlled substance contain ``the complete name and address of the patient to whom the physician is prescribing the controlled substance.'' Miss. Code R. Sec. 30-17- 2640:1.10. Likewise, 21 CFR Sec. 1306.05(a) requires that a controlled substance prescription must ``bear the full name and address of the patient.'' --------------------------------------------------------------------------- \53\ For the reasons previously discussed, supra note 44, the Government's allegation that the Respondent violated Mississippi Administrative Rule 1.11(b) is NOT SUSTAINED. --------------------------------------------------------------------------- Additionally, the Government alleged that the Respondent prescribed hydrocodone-homatropine (``cough'') syrup, or Hycodan, to CI's children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Government alleged that the Respondent prescribed adult dosages of this cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ-1, at 2-3. The Government further alleged that the Respondent issued the following improper prescriptions for hydrocodone combination products to CI's children in [[Page 54843]] 2014: (a) to Kid 2 on February 7, for 150 dosage units, with one refill; (b) to Kid 1 on June 17, for 180 dosage units, with one refill; (c) to Kid 2 on July 23, for 480 dosage units; (d) to Kid 2 on September 2, for 120 dosage units; (e) to Kid 2 on November 3, for 180 dosage units; and (f) to Kid 1 on November 19, for 115 dosage units. ALJ-1, at 2-3. A. The February 7 Prescription On February 7, 2014, the Respondent wrote a prescription for 240 units of Hycodan to Kid 2. GE-50, at 1; GE-55, at 1-2. The Respondent's medical file for Kid 2 appeared to contain a notation from 2014, possibly from February 7, documenting a Hycodan prescription. See GE- 56, at 4. The copy of the medical file partially cut off this notation because it was at the bottom of a copied page. See GE-56, at 4. The only legible part of the notation appears to read, ``Hycodan (8 oz, 2 refills) to Brookhaven Walmart.'' See GE-56 at 4. CI testified that the Respondent did not examine Kid 2 before prescribing cough syrup to her in February. Tr. 217, 251. The Respondent's patient file for Kid 2 does not include any notes about any physical examination on that date. The Respondent did not document a diagnosis for Kid 2 on that date. Because this required information was not recorded prior to prescribing controlled substances to Kid 2, the Government's allegation that the Respondent violated Mississippi Administrative Rule 1.4 by failing to conduct a physical examination of Kid 2 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code Sec. Sec. 73- 25-29(3) and (13), and 21 CFR Sec. 1306.04(a) on February 7, 2014, are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Just 15 days before the February 7, 2014 prescription, the Respondent prescribed 120 units (or 24 days' worth) of Hycodan syrup to Kid 2. See GE-50, at 1; GE-56, at 4. Thus, Kid 2 still should have had approximately nine days of Hycodan syrup remaining from her last prescription and should not have needed additional Hycodan syrup on February 7, much less double the original dosage. See GE-50, at 1 (showing that the January 24, 2014 prescription was a 24-day supply). CI discussed the real reason that the Respondent wrote this prescription. CI testified that, in February 2014, the Respondent prescribed a big bottle of cough syrup to Kid 2 so that CI could drink it as well, even though the Respondent knew that CI did not have a cough. Tr. 216-17, 250-53, 259, 268, 273. While Kid 2 did have a cough at that time, Tr. 250-51, 253-55, I give full credit to CI's testimony that the Respondent knew that CI intended to consume some of Kid 2's Hycodan prescription. Considering the timing of the February 7 prescription and its large dosage, I find, based on a totality of the circumstances, that a preponderance of evidence supports the conclusion that the Respondent knew that CI would consume at least part of Kid 2's February 7, 2014 prescription. It is a violation of 21 CFR Sec. 1306.05 for a registrant to prescribe controlled substances to a patient knowing that someone other than the patient named on the prescription would receive the medication. Golden, 61 FR at 24811. Therefore, the Government's allegations that the February 7, 2014 prescription violated Mississippi Administrative Rule 1.10 and 21 CFR Sec. 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. B. The June 17, July 23, and November 19 Prescriptions The Respondent wrote three prescriptions to CI's children without recording the prescriptions in the children's medical records. First, on June 17, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan syrup to Kid 1. GE-51, at 1; GE-55, at 3-4. The Respondent's patient file for Kid 1 does not contain any notes dated on or about \54\ June 17, 2014. See GE-57. The Respondent did not document a diagnosis for Kid 1 at this time. Then, on July 23, 2014, the Respondent wrote a prescription for 16 ounces (or 480 units) of Hycet liquid to Kid 2. GE-50, at 1; GE-55, at 5-6. The Respondent's patient file for Kid 2 does not contain any notes dated on or about July 23, 2014. See GE-56. Finally, on November 19, 2014, the Respondent wrote a prescription for eight ounces (or 115 units) of Hycodan for Kid 1. GE-51, at 1; GE-55, at 11. The Respondent's patient file for Kid 1 does not contain any notes on or about November 19, 2014. See GE-56. --------------------------------------------------------------------------- \54\ Although the Respondent's patient file for Kid 1 includes notes from examinations on March 19, 2014, and June 9, 2014, the notes next to these dates do not contain any notations about a Hycodan prescription. See GE-57. --------------------------------------------------------------------------- The Respondent did not write the name, dose, strength, or quantity of any of these prescriptions in the medical records of CI's children. The Respondent did not record the dates of the prescriptions or the reasons for the prescriptions. The Respondent did not record any notes about any physical examinations on these dates. There is no evidence in the record before me indicating that the Respondent ever saw CI's children on the dates that he wrote these prescriptions to them. Even absent any expert testimony, failure to see a patient before prescribing medications to the patient is outside of the legitimate practice of medicine. Figueroa, 73 FR at 40381. Therefore, the Government's allegations that the June 17, 2014, and November 19, 2014 prescriptions to Kid 1, and July 23, 2014 prescription to Kid 2, violated Mississippi Administrative Rule 1.4 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Because these prescriptions violated Mississippi Administrative Rule 1.4, they were issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) by issuing the June 17, July 23, and November 19 prescriptions are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Government further alleged that these prescriptions were issued for CI's personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI's children on June 17, July 23, and November 19. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough; (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 265-66, 273. In addition, the administrative record supports CI's testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE- [[Page 54844]] 56, at 2-4; GE-57, at 5-6. I find that CI's testimony, when considered cumulatively and in conjunction with other evidence of record, establishes that, at the time the Respondent wrote the June 17, July 23, and November 19 prescriptions, he knew that CI would drink at least some of the cough syrup, though there was no medical reason for her to do so. Therefore, the Government's allegations that these three prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR Sec. 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. C. The September 2 and November 3 Prescriptions On September 2, 2014, the Respondent wrote a prescription for four ounces (or 120 units) of Hycodan for Kid 2. GE-50, at 1; GE-55, at 7-8. The Respondent's patient file for Kid 2 included some notes dated September 2, 2014. GE-56, at 3. These notes stated, ``URI Ears clear Nose, OC/OP mildly inflamed Lungs clear Rx [illegible] 15 Hycodan.'' GE-56, at 3. Because these notes indicate that the Respondent examined Kid 2, and because the Government did not enter any evidence contesting the accuracy of these notes, I find that the Government failed to show by substantial evidence that the Respondent did not conduct a physical examination of Kid 2 on September 2, and the Government's allegation to that effect is NOT SUSTAINED. However, Kid 2's medical record did not include any diagnosis or reason for prescribing Hycodan to Kid 2, as required by Mississippi Administrative Rule 1.4. Additionally, the medical record did not clearly include the dose, strength, or quantity of Hycodan prescribed to Kid 2, as required by Mississippi Administrative Rule 1.4. Because the medical record did not contain this information, the Government's allegation that the September 2, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) by issuing the September 2, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Similarly, on November 3, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan for Kid 2. GE-50, at 1; GE-55, at 9-10. The Respondent wrote a note near a date stamp reading November 4, 2014, in Kid 2's file. GE-56, at 2. This note said, ``[illegible] 5 problems Rx Hycodan (6 oz) (requested).'' GE-56, at 2. The medical record did not include documentation of a diagnosis and reason for prescribing controlled substances, other than the fact that it was ``requested.'' Moreover, the medical record did not include the dosage or strength of the Hycodan prescribed, as is required by Mississippi Administrative Rule 1.4. Further, the notes near the November 3, 2014 date stamp did not indicate that the Respondent conducted any examination prior to prescribing Hycodan to Kid 2, as is required by Mississippi Administrative Rule 1.4. Therefore, the Government's allegation that the November 3, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) by issuing the November 3, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Government also alleged that the September 2 and November 3 prescriptions were issued for CI's personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI's children on September 2 and November 3. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough: (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 266, 273. In addition, the administrative record supports CI's testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE-56, at 2-4; GE-57, at 5-6. I find that CI's testimony, when considered cumulatively and in conjunction with other evidence of record, establishes that, at the time the Respondent wrote the September 2 and November 3 prescriptions, he knew that CI would drink at least some of the cough syrup, though there was no medical reason for her to do so. Therefore, the Government's allegations that these two prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. D. Dangerous Prescriptions The Government alleged that the Respondent prescribed cough syrup to CI's children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Government also alleged that the Respondent prescribed adult dosages of cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ-1, at 2-3. There is no evidence on the record before me \55\ that indicates that it is improper to prescribe cough syrup to children. There is no evidence on the record before me that indicates that the dosages of cough syrup that the Respondent prescribed to CI's children were improper dosages. The Government did not offer an authentic, well- founded medical opinion that the quantities and types of prescriptions to CI's children were improper. The Government had the burden of proving that the prescriptions were unlawful. See Ruben, 78 FR at 38384. The Government failed to meet this burden. Accordingly, the Government's allegations regarding the propriety of the Respondent's prescriptions to CI's children are NOT SUSTAINED. --------------------------------------------------------------------------- \55\ The Government offered into evidence three printouts from Web sites, allegedly obtained from the FDA's Web site, WebMD, and Drugs.com. See Gov't Proposed Exs. 4-6. Upon the Respondent's timely objection, I rejected these three exhibits because they were improper opinion testimony, lacked adequate foundation, and were not properly authenticated. See Tr. 418-26. --------------------------------------------------------------------------- [[Page 54845]] Allegation 4: Fraudulent Prescriptions for CI through Undercover Agents \56\ --------------------------------------------------------------------------- \56\ In its post-hearing brief, the Government argued that this conduct should be analyzed under Factor Five. ALJ-35, at 21-24. However, in the Government's OSC/ISO and its presentation of evidence at the hearing, the Government made a strong argument that the Respondent's prescriptions to the undercover agents violated state and federal laws, and were acts of knowing diversion which reflected poorly on the Respondent's experience in dispensing controlled substances. Therefore, analysis of this conduct under Factors Two and Four is appropriate. --------------------------------------------------------------------------- In Allegation 4, the Government claimed that, on five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents' prescription requests were fraudulent, in violation of 21 U.S.C. Sec. Sec. 841(a) and 842(a) and 21 CFR Sec. 1306.04(a). ALJ-1, at 3. The Government alleged that the Respondent wrote seven hydrocodone prescriptions on five occasions to undercover agents, for 190 total dosage units of hydrocodone tablets and 72 total dosage units of hydrocodone syrup. ALJ-1, at 11. The Government alleged that, on four of those occasions, the Respondent knew that CI would receive a portion of the prescribed medications. ALJ-1, at 3-4. A. Undercover Appointments 1 through 4 The evidence against the Respondent regarding the first four undercover appointments is significant, conclusive, and uncontested. The Respondent compared his diversion of drugs to CI with going to ``buy drugs at a crack house.'' GE-28, file 2015-04-22_13-03-23_EDT, at 2. In some sense, this was an apt description. Whenever CI asked the Respondent for drugs, he would attempt to convey them to her. Prior to each of the first four undercover appointments, CI clearly and repeatedly asked the Respondent for controlled substances.\57\ CI specifically named certain controlled substances that she wanted the Respondent to prescribe to Agent 1 and Agent 2 to divert to her.\58\ Although the Respondent wanted to be ignorant about the identities of CI's ``friends,'' \59\ the Respondent knew that Agent 1 and Agent 2 were ``friends'' of CI \60\ and that they would give CI at least some of the drugs he prescribed to them.\61\ The Respondent had reason to know that Agent 1 and Agent 2 did not legitimately need medication for themselves.\62\ The Respondent had reason to know that Agent 1, Agent 2, and CI were splitting their prescriptions.\63\ Therefore, based on the communications exchanged between the Respondent and CI, I find that the Respondent knew that Agent 1 and Agent 2 were ``not seeking treatment for a legitimate medical condition but [were] engaged in . . . diversion.'' See McNichol, 77 FR at 57148. Despite circumstances that plainly and unambiguously indicated diversion, the Respondent nonetheless prescribed drugs to Agent 1 and Agent 2 during the first four undercover appointments. --------------------------------------------------------------------------- \57\ GE-16, file 2015-03-16_18-51-48_EDT, at 20-21, 24-26 (expressing that CI was seeking drugs before the first undercover appointment); GE-16, file 2015-03-18_11-03-33_EDT, at 2 (same); GE- 17, at 4 (same); see GE-16, file 2015-04-02_14-15-50_EDT, at 1 (expressing that CI was seeking drugs before the second undercover appointment, and indicating that she had taken all of the drugs from the first appointment too quickly); see also GE-28, file 2015-04- 13_20-26-31_EDT, at 7 (expressing that CI was seeking more drugs before the third and fourth undercover appointments); GE-28, file 2015-04-28_20-23-38_EDT, at 1 (same); GE-38, at 2-3 (same). \58\ GE-16, file 2015-03-17_13-07-36_EDT, at 4 (asking for Lorcet/Norco before the first undercover appointment); GE-17, at 3 (same); GE-18, at 3 (asking for Norco before the first undercover appointment); see GE-16, file 2015-04-02_15-04-43_EDT, at 1-2 (asking for a double dosage, presumably of Norco, before the second undercover appointment); see also GE-28, file 2015-04-28_20-23- 38_EDT, at 1 (asking for cough medicine before the third and fourth undercover appointments); GE-29, at 7 (same); GE-38, at 3-4 (asking for a ``big bottle'' of cough syrup before the third and fourth undercover appointments); GE-39, at 5 (asking for cough medicine before the third and fourth undercover appointments). \59\ GE-28, file 2015-04-22_13-03-23_EDT, at 4-5 (expressing his desire to remain ignorant before the third and fourth undercover appointments); GE-28, file 2015-04-27_14-45-16_EDT, at 1 (same); GE- 38, at 2 (same). The Respondent even stated at one point, ``if [Agent 1 is] coming in for what I think she's coming in, tell her not to tell me that. That needs to be your secret. I don't wanna know that. She needs to have a headache and I will treat her for a headache, and so don't mind giving her prescriptions to treat a headache.'' GE-17, at 7. \60\ GE-16, file 2015-04-07_13-29-34_EDT, at 2 (discussing CI accompanying Agent 1 to her appointment); GE-16, file 2015-04-07_18- 28-45_EDT, at 7-8 (same); GE-16, file 2015-04-08_10-16-03_EDT, at 1 (saying that Agent 1 knew about their relationship); GE-17, at 6-7 (identifying Agent 1 before the first undercover appointment); GE- 21, at 5-6 (identifying Agent 1 before the second undercover appointment); see GE-21, at 8 (asking the Respondent to bring Agent 1's prescriptions to his rendezvous with CI at Walmart to save her money); see also GE-28, file 2015-04-22_13-03-23_EDT, at 4-5 (recognizing Agent 1 as CI's friend before the third and fourth undercover appointments); GE-28, file 2015-04-28_20-23-38_EDT, at 1 (identifying Agent 1 and Agent 2 as CI's friends before the third and fourth undercover appointments); GE-40, at 2 (recognizing that, at the time of Agent 2's appointment, the Respondent knew that Agent 2 was affiliated with CI and Agent 1). \61\ GE-16, file 2015-03-18_11-03-33_EDT, at 2-4 (suggesting that CI could send a friend in to get prescriptions before the first undercover appointment); GE-17, at 3 (same, and acknowledging, before the first undercover appointment, that any prescriptions to CI's friends would be diverted to CI); GE-17, at 7 (advising that the prescriptions he gave to Agent 1 would be fine for CI to take); GE-18, at 3 (stating, before the first undercover appointment, that the Respondent would write prescriptions for Agent 1 so CI could have the medication); see GE-14, at 1 (identifying Agent 1 as CI's friend, and discussing how the Respondent ``hooked [CI] up,'' before the second undercover appointment); GE-16, file 2015-04-02_14-15- 50_EDT, at 1-2 (same); GE-21, at 13 (thanking the Respondent for ``hooking'' her up before the second undercover appointment); GE-28, file 2015-04-28_20-23-38_EDT, at 1 (asking the Respondent to ``[h]ook'' up CI's friend before the third and fourth undercover appointments). \62\ E.g., GE-16, file 2015-04-02_14-15-50_EDT, at 2; GE-16, file 2015-04-02_15-04-43_EDT, at 1-2. \63\ GE-28, file 2015-04-27_14-45-16_EDT, at 1. --------------------------------------------------------------------------- Even beyond this, the Respondent took extra efforts to facilitate the diversion of drugs to CI. The Respondent discussed the scheduling of Agent 1 and Agent 2's appointments with CI, and CI reminded him about the timing of those appointments.\64\ The Respondent asked CI to tell her friends to pretend they had headaches and act like legitimate patients.\65\ After the third and fourth undercover appointments, the Respondent praised Agent 1 and Agent 2 for acting very appropriately by going ``through the motions.'' GE-40, at 2. After each of the first four appointments, CI told the Respondent that she had received the drugs prescribed to Agent 1 and Agent 2; in response, the Respondent stated that he was happy to help get drugs to CI.\66\ --------------------------------------------------------------------------- \64\ GE-18, at 3 (discussing the first undercover appointment); GE-23 (discussing, before the second undercover appointment, the need to space out the appointments more); see GE-16, file 2015-04- 06_20-59-35_EDT, at 2 (discussing the second undercover appointment); see also GE-28, file 2015-04-22_10-28-41_EDT, at 3-4 (discussing the third and fourth undercover appointments); GE-28, file 2015-04-22_13-03-23_EDT, at 4 (same); GE-28, file 2015-04- 28_20-23-38_EDT, at 1 (same); GE-29, at 7 (same). \65\ GE-18, at 3 (instructing CI to tell Agent 1 to ``play it straight'' and tell him what he needed to write in his chart at the first undercover appointment). \66\ GE-14, at 1 (telling CI, after the first undercover appointment, that he was happy to meet Agent 1 and hoped it helped, and receiving thanks from CI for ``hooking'' her up); GE-14, at 2 (acknowledging that the prescriptions that he gave to Agent 1 went to CI); GE-19, at 1 (asking CI if everything ``went smooth with getting your medication'' and expressing that he was happy to help); GE-40, at 1-2 (asking CI if she got the medication and expressing that he was ``glad all that worked out''). --------------------------------------------------------------------------- It is true that the Respondent conducted appointments with Agents 1 and 2, and wrote notes in their medical files. In that aspect, this case is similar to Robert F. Hunt, D.O., 75 FR 49995 (2010). Dr. Hunt had said that he wrote information on a patient's chart ``just to cover [his] ass.'' Id. at 50003. The DEA held that this statement made it ``clear that [Dr. Hunt] knew that he lacked a legitimate medical purpose for prescribing'' controlled substances. Id. Similarly, although the Respondent [[Page 54846]] conducted appointments with Agents 1 and 2 and wrote notes in their medical files, the Respondent's statements to CI before and after each of the first four appointments made it clear that the Respondent was unquestionably prescribing controlled substances to Agents 1 and 2 to intentionally divert drugs to CI. His statements also make clear that the records he was keeping concerning Agents 1 and 2 were merely to keep the Mississippi Board investigators at bay. E.g., GE-18, at 3. Moreover, the fact that a registrant conducted a medical appointment before prescribing controlled substances does not, standing by itself, validate the prescriptions issued; rather, an appointment may be used by a prescriber as ``a sham justification to support an unlawful prescription.'' McNichol, 77 Fed. Reg. at 57148. An appointment can constitute a perfunctory, sham examination if the registrant ``already agreed to issue'' certain prescriptions to a patient. Darryl J. Mohr, M.D., 77 Fed. Reg. 34998, 35000 (2012). This is precisely what happened here. Before each of the first four undercover appointments, the record unambiguously shows that the Respondent knew exactly what he would prescribe to Agents 1 and 2 before they ever walked through his door, because he knew what drugs CI had requested. For example, the Respondent prescribed Hycodan to Agent 1, even though she was not coughing during her appointment, because he had told CI that he would get eight ounces of cough syrup to her. GE- 33, at 1; GE-38, at 3-4, 8; Tr. 113. Following the second appointment, the Respondent himself acknowledged the sham nature of the appointment; he stated that he had made small talk with Agent 1 because ``we had to be in there more than ten seconds'' so that his ``nosy nurse'' would not think, ``[d]ang, why is this appointment over with in ten seconds?'' GE-27, at 1, 5. It is not surprising that, during Agent 1's second appointment, the Respondent did not bother to conduct even a sham physical examination. See GE-24-25; Tr. 103-04, 132. The facts of this case present an appalling and flagrant disregard of a registrant's duty to prescribe controlled substances only to legitimate patients. While the Respondent told CI that his feelings for her needed to be ``totally separate from [his] medical practice,'' GE- 20, he was unable to follow his own internal guidance. In fact, the size of the Respondent's diversion was significant: during the first four undercover appointments, the Respondent prescribed a total of 160 units of Norco and eight ounces of Hycodan to the undercover agents, who he believed would divert those drugs to CI.\67\ The Respondent repeatedly joked about providing CI access to all the drugs that she wanted.\68\ Even though the Respondent did not take his responsibilities as a registrant seriously, he did understand the potential legal consequences of his actions. The Respondent repeatedly expressed a fear of getting in trouble for diverting drugs to CI.\69\ This reflects that the Respondent undoubtedly knew that his actions were wrong.\70\ --------------------------------------------------------------------------- \67\ GE-11, at 1 (prescribing 40 units of Norco 10/325 to Agent 1 at the first undercover appointment); GE-26, at 1 (prescribing 40 units of Norco 10/325 to Agent 1 at the second undercover appointment); GE-32 (prescribing 40 units of Norco 10/325 to Agent 1 at the third undercover appointment); GE-33, at 1 (prescribing eight ounces of Hycodan to Agent 1 at the third undercover appointment); GE-36, at 1 (prescribing 40 units of Norco 10/325 to Agent 2 at the fourth undercover appointment). \68\ GE-16, file 2015-03-17_13-07-36_EDT, at 7 (joking before the first undercover appointment); GE-16, file 2015-03-18_11-03- 33_EDT, at 4 (same); GE-16, file 2015-04-02_15-04-43_EDT, at 1-2 (joking before the second undercover appointment); GE-29, at 9 (joking after the third and fourth undercover appointments); GE-38, at 2 (joking before the third and fourth undercover appointments). \69\ GE-16, file 2015-03-17_13-07-36_EDT, at 7 (admitting fear before the first undercover appointment); GE-16, file 2015-04-02_14- 15-50_EDT, at 2 (instructing CI to keep things hidden); GE-17, at 2 (expressing fear before the first undercover appointment); see GE- 14, at 1 (expressing fear after the first undercover appointment); GE-16, file 2015-04-02_15-04-43_EDT, at 2 (discussing avoiding detection before the second undercover appointment); GE-16, file 2015-04-07_13-29-34_EDT, at 2 (same); GE-16, file 2015-04-07_18-28- 45_EDT, at 7-8 (same); see also GE-28, file 2015-04-22_10-28-41_EDT, at 3-4 (expressing concern about getting caught before the third and fourth undercover appointments); GE-28, file 2015-04-22_13-03- 23_EDT, at 4 (same); GE-38, at 2 (same). \70\ See GE-16, file 2015-03-18_11-03-33_EDT, at 2-3 (reflecting his knowledge that his actions were wrongful before the first undercover appointment); GE-38, at 8 (expressing his fear that he might be ``busted'' by the ``drug police''). --------------------------------------------------------------------------- I find that, during the first four undercover appointments, the Respondent knew that Agent 1 and Agent 2 were not real patients and that at least some of the medications he prescribed to them would be given to CI. I find that the Respondent prescribed medications to Agent 1 and Agent 2 upon CI's request for those medications. I further find that, when the Respondent wrote prescriptions to Agent 1 and Agent 2 during those four appointments, the Respondent intended to divert drugs to CI. Thus, by ``providing evidence showing that [the Respondent] knowingly diverted drugs,'' the Government proved that the Respondent acted outside of the usual course of his professional practice and lacked a legitimate medical purpose. See Danton, 76 Fed. Reg. at 60901. Therefore, the Government's allegations that the first four undercover appointments violated 21 U.S.C. Sec. Sec. 841(a) and 842(a), and 21 CFR Sec. 1306.04(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. To the extent that the Respondent's actions are interpreted as prescribing controlled substances to CI indirectly,\71\ his prescriptions are grave violations of 21 CFR 1306.04(a). On this point, this case bears a striking similarity to Annicol Marrocco, M.D., 80 FR 28695 (2015). In that case, Dr. Marrocco prescribed controlled substances to her lover, but did not physically see her lover for three to six months while he was using those prescriptions. Id. at 28703. The DEA found that Dr. Marrocco lacked a legitimate purpose for her prescriptions because she was unable to supervise her lover's use of his medication, which reflected ``a stunning disregard for [Dr. Marrocco's] obligations as a prescriber of controlled substances.'' Id.; see Figueroa, 73 FR at 40381 (noting that failure to see a patient before prescribing medication deviates from the legitimate practice of medicine). Similarly, other than two brief interactions in public places, the Respondent never saw CI while he was prescribing controlled substances to Agent 1 and Agent 2 to divert to CI. Therefore, the Respondent could not monitor CI's use of controlled substances. --------------------------------------------------------------------------- \71\ See supra note 43. --------------------------------------------------------------------------- Additionally, prescribing controlled substances based on a patient's request, ``rather than the result of the application of the physician's medical judgment,'' lacks a legitimate medical purpose. Golden, 61 FR at 24812 (citing Dougherty, 60 FR 55047; Borcherding, 60 FR 28796). The Respondent's prescriptions to Agent 1 and Agent 2 were based only on CI's request for certain controlled substances, not on any physical examination or medical evaluation. Under Mississippi Administrative Rule 1.4(a), such prescribing establishes that the Respondent lacked good faith in issuing these prescriptions. For these reasons, to the extent that the Respondent's 2015 prescriptions to Agent 1 and Agent 2 are perceived as indirect prescriptions to CI, they clearly violate Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR 1306.04(a), and the Government's allegations to that effect are [[Page 54847]] SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. In addition, the Respondent diverted controlled substances to CI through the undercover agents after he knew that CI attempted to commit suicide. Such actions reflect an astonishing level of irresponsibility in the Respondent's prescribing activity. In McNichol, the DEA held under Factors Two and Four that a prescriber's statement, which reflected concern about putting a patient potentially ``in jeopardy of overdose,'' made it ``clear that [the prescriber] believed that [the patient] was a drug abuser.'' 77 FR at 57149. Similarly, in Jayam Krishna-Iyer, the DEA held that ``[a] practitioner who ignores the warning signs that [his] patients are either personally abusing or diverting controlled substances commits `acts inconsistent with the public interest,' 21 U.S.C. 824(a)(4), even if [he] is merely gullible or na[iuml]ve.'' 74 FR at 460 n.3. Additionally, it is ``relevant that [a registrant], knowing that the CI had been treated for drug abuse, facilitated her access to controlled substances.'' Golden, 61 FR at 24812. Here, the facts indicate that the Respondent knew his prescribing actions put CI's health in danger. The Respondent knew that CI previously had attempted to commit suicide using drugs he prescribed to her. He knew she was still depressed. GE-28, file 2015-04-15_21-30- 59_EDT, at 9. He expressed fear and concern that she would take too many pills, resulting in ``unfixably bad'' damage and a ``long, agonizing, painful way to go.'' GE-14, at 1; GE-17, at 4. In spite of all of this, the Respondent continued to divert controlled substances to CI and said he was ``glad'' to do so. GE-19, at 1; GE-40, at 1; Tr. 230-31. Under these circumstances, the Respondent's continued prescribing controlled of substances to CI reflects negatively on the Respondent's experience in dispensing controlled substances. B. Undercover Appointment #5 Although the Government did not allege that the Respondent's prescriptions to Agent 1 during the fifth undercover appointment were knowing attempts to divert drugs to CI, the Government alleged that the October 2015 prescriptions violated 21 U.S.C. 841(a) and 842(a) and 21 CFR 1306.04(a) because the Respondent knew or should have known that Agent 1's prescription requests were fraudulent. See ALJ-1, at 3-4. The Government presented no evidence of any communications between the Respondent and CI or Agent 1 immediately preceding Agent 1's October 2015 appointment. At the appointment, Agent 1 met with the Respondent, who examined her ears, nose, and throat. Tr. 120, 132. The Respondent appeared to not remember Agent 1. Tr. 120, 135, 452; see GE- 42-43. Only the first portion of the appointment was recorded, and no witnesses were able to confidently recall the whole conversation between Agent 1 and the Respondent. In response to Agent 1's inquiry, the Respondent indicated during the appointment that he did not remember Agent 2. GE-42-43. When Agent 1 asked the Respondent if he had heard from CI lately, the Respondent paused, and looked surprised, before saying that he had not. Tr. 122-23, 135, 452-53. Agent 1 said that she needed the ``same as before,'' but did not tell the Respondent that she had any specific complaints. GE-42-43; Tr. 454. The Respondent discussed the efficacy of medication with Agent 1. GE-43, at 2-3. Agent 1 never said she had a cough. GE-42-43; Tr. 126, 454. Nonetheless, the Respondent prescribed cough syrup, among other things, to Agent 1. GE- 45; Tr. 139. The Respondent's medical file for Agent 1 indicated that Agent 1 had ``migraine headaches, as before Weather changes may make it worse Maxalt helps most of the time Norco works okay as a backup Dry [illegible] cough; no [illegible] to be allergy related Allergy symptoms Ears clear OC/OP clear Nose c somewhat [illegible] Lungs clear.'' GE-60, at 4. The Respondent also recorded that he wrote five prescriptions to CI, including 30 units of Norco 5/325 and four ounces of Hycodan. GE-60, at 4. These facts summarize the totality of the evidence before me concerning the October 2015 undercover appointment. Based on these facts, I find that there is not substantial evidence that the Respondent knew or should have known that Agent 1's prescription requests were fraudulent. The recordings and testimony do not clearly indicate that Agent 1 was presenting sham symptoms to the Respondent. Agent 1's patient file indicated that the Respondent examined Agent 1, recorded her complaints, and recorded the prescriptions he gave to her. Importantly, the Government did not allege that the Respondent's medical record for Agent 1 from the October appointment was deficient; it only alleged that he knew or should have known that Agent 1's prescription requests were fraudulent. The Government bears the burden of proof on this point. ``[U]nder the substantial evidence test, the evidence must `do more than create a suspicion of the existence of the fact to be established.''' Alvin Darby, M.D., 75 FR 26993, 26999 n.31 (2010) (citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S. 292, 300 (1939)). The Government failed to meet this burden. The Government offered insufficient evidence to support a conclusion that the Respondent knew or should have known that, five and a half months after last seeing Agent 1, and while reviewing a new medical chart, her requests during the October 2015 appointment were fraudulent. Therefore, the Government's allegations that the fifth undercover appointment violated 21 U.S.C. 841(a) and 842(a), and 21 CFR 1306.04(a), because the Respondent knew or should have known that Agent 1's prescription requests were fraudulent are NOT SUSTAINED. Allegation 5: Prescriptions Issued in 2014 and 2015 The Government alleged that, from February 2014 to October 2015, the Respondent unlawfully prescribed controlled substances in violation of 21 U.S.C. 841(a) and 842(a). ALJ-1, at 2. Specifically, the Government alleged that the Respondent prescribed controlled substances when he knew or should have known that they were not prescribed for legitimate medical purposes, and were not written in the usual course of professional practice, in violation of 21 CFR 1306.04(a) and Mississippi Code Sec. Sec. 41-29-137(a)(1) and 41-29-141(1). ALJ-1, at 2. Those sections of the Mississippi Code provide that it is illegal for practitioners to dispense Schedule II controlled substances without a valid written prescription. Miss. Code Sec. Sec. 41-29-137(a)(1), 41-29-141(1). Under Allegation 1, I sustained the Government's allegations that the Respondent's 2014 prescriptions to CI on May 22, June 17, September 11, October 6, and December 4 were outside the usual course of his professional practice and were illegitimate prescriptions that violated 21 CFR 1306.04(a). Under Allegation 2, I sustained the Government's allegations that the Respondent's 2014 prescriptions to CI on April 9, May 19, July 24, and September 8 were outside the usual course of his professional practice and were illegitimate prescriptions that violated 21 CFR 1306.04(a). Under Allegation 3, I sustained the Government's allegations that the Respondent's 2014 prescriptions to Kid 2 on February 7, July 23, September 2, and November 3, and the Respondent's prescriptions to [[Page 54848]] Kid 1 on June 17 and November 19, were outside the usual course of his professional practice and were illegitimate prescriptions that violated 21 CFR 1306.04(a). Finally, under Allegation 4, I sustained the Government's allegations that the Respondent's prescriptions written during the first four undercover appointments in 2015 were fraudulent and violated 21 CFR 1306.04(a). I have held that all of these prescriptions were issued outside of the Respondent's usual course of professional practice and were not issued for legitimate medical purposes. Therefore, the Government's allegation that the Respondent violated 21 CFR 1306.04(a) is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. The Government also established that some prescriptions were invalid because CI, rather than the named patient, was the actual intended recipient of several prescriptions. The Government's allegations that the Respondent's six prescriptions to CI's children, identified supra, and 2015 hydrocodone combination product prescriptions to the undercover agents at the first four undercover appointments violated Mississippi Code Sec. Sec. 41-29- 137(a)(1) and 41-29-141(1) are SUSTAINED.\72\ Because the Respondent issued illegitimate prescriptions, the Government's allegations that the Respondent violated 21 U.S.C. 841(a) and 842(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. --------------------------------------------------------------------------- \72\ Hydrocodone combination products were reclassified by the federal government as Schedule II controlled substances as of October 6, 2014. Stip. 6. The Government has not shown how hydrocodone combination products are scheduled in the state of Mississippi. The Government's allegations that the Respondent's prescriptions predating October 6, 2014, violated Mississippi Code Sec. Sec. 41-29-137(a)(1) and 41-29-141(1), which only address Schedule II controlled substances, are NOT SUSTAINED. --------------------------------------------------------------------------- Allegation 6: Meperidine Used in Suicide Attempt The Government alleged that the Respondent prescribed 30 dosage units of meperidine 50 mg to CI, which she used to try to kill herself. ALJ-1, at 3. The evidence shows that the Respondent prescribed Demerol to CI on September 2, 2014. GE-2, at 12; GE-49, at 2; Tr. 222, 296-97, 317-18, 382. The Respondent appears to have been the only person to prescribe Demerol to CI. See GE-49. CI used the Demerol to attempt to commit suicide in December 2014. Tr. 222, 315-17. The Government, however, did not specify or argue why this Demerol prescription was improper. The Government did not allege or argue that the Respondent failed to conduct a physical examination of CI, or failed to maintain proper medical charts, when he prescribed Demerol to CI. The Government did not allege or argue that the Respondent knew or anticipated that CI would attempt to commit suicide using the Demerol he prescribed to her. The Government did not even allege or argue that the Respondent possessed anything other than a legitimate intent to treat CI's physical symptoms when he prescribed Demerol to her. Therefore, to the extent that the Government alleged that the Respondent's Demerol prescription to CI merits revocation of his COR, the Government's allegation is NOT SUSTAINED. Under Factors Two and Four,\73\ the Respondent's prescribing conduct indicates that his continued registration is not in the public interest. Therefore, Factors Two and Four militate strongly in favor of revocation of the Respondent's COR. --------------------------------------------------------------------------- \73\ Both parties specifically discussed Factor Five in their post-hearing briefs. Factor Five considers conduct not otherwise addressed under Factors One through Four. 21 U.S.C. 823(f)(5). As discussed supra, the Respondent's actions in this case are most appropriately analyzed under Factors Two and Four. Therefore, consideration of this conduct under Factor Five, the ``catch-all'' factor, is inappropriate. --------------------------------------------------------------------------- RECOMMENDATION Even if the Respondent had knowingly attempted to divert controlled substances to CI only one time, that alone would have been sufficient to make a prima facie case for revocation of the Respondent's license. See MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011). ``[P]roof of a single act of intentional or knowing diversion is sufficient to satisfy the Government's prima facie burden of showing that a practitioner's continued registration is inconsistent with the public interest, and if unrebutted by a showing that the practitioner accepts responsibility for his misconduct and will not engage in future misconduct, warrants the revocation of a registration.'' McNichol, 77 FR at 57145 (internal citations omitted); see also Krishna-Iyer, 74 FR at 462-64; Alan H. Olefsky, 57 FR 928, 928-29 (1992). In cases of knowing diversion, ``the [DEA] has an interest in deterring [the Respondent] and others from engaging in similar egregious behavior.'' Michael A. White, M.D., 79 FR 62957, 62967 (2014). Here, the Government has proven far more than one act of knowing diversion. The Government has proven that the Respondent repeatedly and continually issued illegitimate prescriptions to CI and others for multiple types of drugs based solely on CI's request. The Government has proven that, on multiple occasions, the Respondent knowingly issued fraudulent prescriptions with the intent to divert drugs to CI. The Respondent's improper prescribing constituted an egregious level of intentional diversion. Accordingly, Factors Two and Four weigh heavily against the Respondent, and the Government has established a prima facie case supporting revocation of the Respondent's registration. Further, after evaluating all of the above established facts, I find that considerations of both specific and general deterrence also weigh in favor of revocation in this case. Because the Government has made a prima facie case that the Respondent's continued registration would be inconsistent with the public interest, the Respondent had the burden of production to ``present[] sufficient mitigating evidence'' to show why he can be entrusted with a registration. See Med. Shoppe--Jonesborough, 73 FR at 387 (quoting Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). Specifically, to rebut the Government's prima facie case, the Respondent must have both accepted responsibility for his actions and demonstrated that he would not engage in future misconduct. Stodola, 74 FR at 20734-35. However, the Respondent offered no evidence \74\ that he accepted responsibility for his misconduct or reformed his ways. Therefore, the Respondent failed to rebut the Government's prima facie case. --------------------------------------------------------------------------- \74\ The Government requested that I draw an adverse inference against the Respondent because of his failure to testify at the hearing. ALJ-35, at 27-28. However, I decline to do so because an adverse inference is unnecessary in light of the overwhelming evidence against the Respondent. --------------------------------------------------------------------------- Because the Government proved that the Respondent's registration is inconsistent with the public interest, and because the Respondent failed to rebut the Government's prima facie case, I RECOMMEND that the Respondent's DEA Certificate of Registration be REVOKED and any applications for renewal or modification of his license be DENIED. Dated: June 1, 2016 s/Charles Wm. Dorman Administrative Law Judge [FR Doc. 2016-19595 Filed 8-16-16; 8:45 am] BILLING CODE 4410-09-P
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By order of the Commission. his girlfriend, knowing that the drugs showing that ‘‘Respondent’s continued
Issued: August 10, 2016. would then be provided to his girlfriend registration would be inconsistent with
Lisa R. Barton, and that Respondent further instructed the public interest.’’ R.D. at 61. Because
Secretary to the Commission. his girlfriend as to how her purported ‘‘Respondent offered no evidence that
[FR Doc. 2016–19560 Filed 8–16–16; 8:45 am] acquaintances should present as having he accepted responsibility for his
BILLING CODE 7020–02–P
headaches so that he could document a misconduct or reformed his ways,’’ the
reason in the their charts for having ALJ found that he ‘‘failed to rebut the
issued the prescriptions. Government’s prima facie case.’’ Id. The
The ALJ also found that on multiple ALJ thus recommended that I revoke
DEPARTMENT OF JUSTICE occasions, Respondent violated Rule 1.4 Respondent’s registration and deny any
of the Mississippi State Board of application to renew or modify his
Drug Enforcement Administration
Medical Licensure’s Rules by failing to registration. Id.
[Docket No. 16–14] document in his girlfriend’s chart the Respondent filed Exceptions to the
diagnosis or justification for issuing the ALJ’s Recommended Decision.
Lawrence E. Stewart, M.D.; Decision prescription, as well as required Thereafter, the ALJ forwarded the record
and Order information including the drug’s name, to me for Final Agency Action.
On June 1, 2016, Administrative Law the dose, strength and quantity. R.D. at Having considered the record in its
Judge (ALJ) Charles Wm. Dorman issued 37–39 (citing Miss. Code R. § 30–17– entirety, including Respondent’s
the attached Recommended Decision. 2640:1.4; also citing id. § 30–17– Exceptions, I have decided to adopt the
Therein, the ALJ found that on multiple 2640:1.16; Miss. Code §§ 73–25–29(3) ALJ findings of fact, conclusions of law,
occasions, Respondent issued and (13)). The ALJ also made a similar and recommended Order. However,
prescriptions outside of the usual course finding with respect to four before I address Respondent’s
of professional practice and which hydrocodone cough syrup prescriptions Exceptions, I deem it necessary to
lacked a legitimate medical purpose for Respondent issued in the names of his address the ALJ’s ruling on the
schedule II controlled substances such girlfriend’s children. R.D. at 46–47 (Rx’s admissibility of the FDA package insert
as Norco 10/325mg (hydrocodone/ issued on 6/17/14, 7/23/14, 11/19/14); for Hycodan (GX 4).
acetaminophen) and Hycodan id. at 49 (Rx 11/3/14). On motion of Respondent’s counsel,
With respect to the phentermine the ALJ ruled inadmissible Government
(hydrocodone/homatropine cough
prescriptions Respondent issued to his Exhibit 4, which the Government
syrup),1 the schedule III controlled
girlfriend, the ALJ found that he represented was the FDA package insert
substance phentermine, and the
‘‘completely failed to comply’’ with the for Hycodan.4 Tr. 422, 427. The basis of
schedule IV controlled substance
Board’s Rule 1.5 because he did not Respondent’s objection was that the
alprazolam, in violation of 21 CFR
prescribe ‘‘adjunctively with caloric exhibit contains ‘‘little more than
1306.04(a). See R.D. at 34–60.2 restriction,’’ ‘‘never conducted and
More specifically, the evidence generalizations and medical opinions’’
recorded an initial comprehensive and that the ALJ’s prehearing statement
showed that Respondent prescribed the
evaluation’’ including ‘‘a thorough required the parties to disclose ‘‘the
controlled substances to his girlfriend patient history or physical
knowing that she was seeking the drugs names and credentials and opinions of
examination,’’ and never recorded medical experts . . . who would be
to abuse them. The evidence also required histories, nor her height,
showed that while some of the offering medical opinions in this case.’’
weight, BMI, body measurements, and Id. at 420. Respondent’s counsel further
prescriptions were issued in the name of vital signs. R.D. 43. The ALJ also found
Respondent’s girlfriend, in multiple argued that ‘‘[t]he government did not
that Respondent did not conduct a re- identify any expert capable of being
instances, Respondent issued evaluation of his girlfriend every 30
prescriptions, including multiple cross-examined on any of these
days as required by Rule 1.5. Id. Finally, opinions’’ and that ‘‘[t]here is no reason
prescriptions for Hycodan, listing his noting that Rule 1.5 generally requires
girlfriend’s two children, who were then to believe that [the Exhibit was]
that the patient have a BMI greater than
three and five years old respectively, as authored by a physician, much less do
30 in order to justify prescribing
the patients, and that Respondent did so we know whether the author had
phentermine, the ALJ observed that
knowing that his girlfriend intended to credentials to offer these opinions.’’ Id.
Respondent’s girlfriend testified that she
use the cough syrup because she After the Government argued that the
had gone from 135 to 121 pounds and
enjoyed drinking it. The evidence document was the FDA package insert,
that she presented at the hearing ‘‘with
further showed that on multiple which is included ‘‘with every drug
a slender body type.’’ Id. The ALJ thus
occasions, Respondent issued purchased or sold,’’ id. at 422,
explained that ‘‘[a]fter observing [her]
prescriptions for Norco 3 to undercover Respondent argued that the copyright of
appearance,’’ he found ‘‘it difficult to
agents who posed as acquaintances of the document was the manufacturer and
comprehend . . . how Respondent
that ‘‘we don’t know who authored it, or
could have possibly believed that [she]
1 Effective October 6, 2014, combination what their credentials were, but it’s a
has a high enough BMI to justify’’
hydrocodone products including both Norco and
prescribing weight-loss medication. Id. self-interested marketing
Hycodan were transferred from schedule III to pharmaceutical company’’ that is
schedule II of the Controlled Substances Act. See The ALJ thus found that Respondent
Schedules of Controlled Substances: Rescheduling violated 21 CFR 1306.04(a), the Board’s ‘‘trying to sell their [sic] medicine’’ and
of Hydrocodone Combination Products from Rule 1.5, and Mississippi Code sections while the company has a ‘‘self-interest[]
Schedule III to Schedule II, 79 FR 49661. Thus, at
73–25–29(3) and (13) when he to comply with a federal regulation . . .
mstockstill on DSK3G9T082PROD with NOTICES
the time Respondent issued some of the Norco and ‘‘[i]t doesn’t mean that the content is
Hycodan prescriptions, the drug was a schedule III prescribed phentermine to his
controlled substance. This, however, has no girlfriend. Id. at 44. government-sanctioned.’’ Id. at 422–23.
consequence for my decision. Based on these findings, the ALJ Respondent thus asserted that the
2 All citations to the Recommended Decision are
concluded that Respondent had engaged
to the slip opinion as issued by the ALJ. 4 There is no dispute that the Exhibit was what
3 The evidence also showed that at one of the in ‘‘an egregious level of intentional the Government represented it to be—a copy of the
undercover agent’s visits, Respondent also gave her diversion’’ and that the Government had package insert. Nor is there any dispute as to how
a prescription for Hycodan cough syrup. satisfied its prima facie burden of the document was obtained.
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![Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 54823
document was ‘‘just not reliable this evidence is probative on the issue without recommending the initiation of
enough.’’ Id. at 426. of whether the Hycodan prescriptions a formal action against his medical
The ALJ sustained the objection but issued by Respondent in the name of his license. Exceptions, at 1–2. According to
provided no explanation as to his reason girlfriend’s children were for a Respondent, the Board reviewed ‘‘all
for doing so. I conclude, however, that legitimate medical purpose. See, e.g., such clinical and prescription records’’
the Exhibit was admissible. As the FDA Medicine Shoppe-Jonesborough v. DEA, for his girlfriend and her children, and
has explained, the package insert ‘‘is 300 Fed. Appx. 409, 413 (6th Cir. 2008) it ‘‘decided that there was no evidence
part of the FDA-approved labeling,’’ and (holding that dispensing of any breach of any medical standard
‘‘[t]he FDA approved label is the official contraindicated controlled substance is of care sufficient to bring any
description of a drug product, which evidence of 21 CFR 1306.04(a) administrative charge against [him]
includes indication (what the drug is violation). related to any such prescription.’’ Id. at
used for); who should take it; adverse Notably, the Hycodan package insert’s 2. He also asserts that Dr. Craig
events (side effects); instructions for safety information includes the ‘‘determined that there was not even
uses in pregnant women, children, and following warning: ‘‘The use of sufficient professional reason to issue
other populations; and safety HYCODAN is not recommended for use [him] an informal warning as to any
information for the patient.’’ See U.S. in children less than 6 years of age such prescription for pain medication.’’
Food and Drug Administration, Drugs@ because of the risk of fatal respiratory Id.
FDA Instructions: Health Information, depression.’’ GX 4, at 2. Notably, Respondent then argues that ‘‘[r]ather
available at www.fda.gov/Drugs/ Respondent’s girlfriend’s daughter was than . . . defer[] to the professional
InformationOnDrugs/ucm079450.htm not even five years old when he wrote judgments made by [Dr. Craig as to]
(accessed August 4, 2016). The FDA’s the first Hycodan prescription in her whether State laws were violated by
approval of a drug label follows name. GE 55, at 1–2. Respondent also [him], the ALJ[’s] Recommendation
extensive clinical trials, including trials wrote Hycodan prescriptions in the proceeds to interpret and apply those
which examine the safety and name of his girlfriend’s son who was State laws without the benefit of any
effectiveness of a drug and are part of then three years old. Id. at 3–4; 11–12. medical evidence, or any medical
the process for approving the drug for In short, neither of the children who opinion in any form, anywhere in the
marketing. See Food and Drug were listed as the patients on the record of this case.’’ Id. And noting the
Administration, Requirements on Hycodan prescriptions was six years of ALJ’s discussion that ‘‘‘DEA has not
Content and Format of Labeling for age when Respondent wrote the required expert testimony to establish a
Human Prescription Drug and prescriptions. Thus, I consider this as violation of 21 CFR 1306.04(a) in cases
Biological Products, 71 FR 3922 (2006) additional evidence which supports the where a prescriber engaged in drug
(Final Rule) (‘‘A prescription drug conclusion that Respondent lacked a deals, where there were notable
product’s FDA-approved labeling (also legitimate medical purpose and acted differences between patients’ medical
known as ‘professional labeling,’ outside of the usual course of records and diagnoses, and where a
‘package insert,’ ‘direction circular,’ or professional practice when he issued prescriber falsified patients’ charts,’ ’’
‘package circular’) is a compilation of the Hycodan prescriptions in the names Respondent contends that the
information about the product, of his girlfriend’s children. 21 CFR Government did not allege that he
approved by FDA, based on the agency’s 1306.04(a). I now turn to Respondent’s engaged in any such conduct. Id. at n.1.
thorough analysis of the new drug Exceptions. I reject the Exception. As for the
application (NDA) . . . submitted by the contention that Dr. Craig reviewed the
Exception I—The Government Failed medical records and prescriptions and
applicant. This labeling contains ‘‘to Prove Violations of State or Local
information necessary for safe and did not find the evidence sufficient to
Laws Sufficient to Demonstrate Danger initiate a proceeding against his license,
effective use.’’). to the Public Interest.’’
Under the Food, Drug and Cosmetic Respondent ignores the credited
Act, a drug ‘‘shall be deemed to be Respondent argues that the ALJ failed testimony that the Board terminated its
misbranded . . . [u]nless its labeling to give proper weight to the decision of investigation upon the request of the
bears . . . such adequate warning Dr. Craig, the Medical Board’s Executive Mississippi Bureau of Narcotics (MBN)
against use . . . by children where its Director, to close the Board’s after the latter informed the Board that
use may be dangerous to health.’’ 21 investigation of his prescribing practices it was conducting a criminal
U.S.C. 352(f). Moreover, introducing a investigation. Tr. 60 (testimony of MBN
misbranded drug into interstate examine and thus was being offered in violation of agent); GE 3, at 2 (Board Complaint form
commerce is a violation of 21 U.S.C.
the ALJ’s Prehearing Order. However, in its pre- entry dated ‘‘3–20–15’’ stating ‘‘MBN
hearing statement, the Government provided notice has asked that we hold off on doing
331(a). Thus, there are ample incentives that it intended to offer the Exhibit and pursuant
anything to this doctor because they are
for drug manufacturers to provide to the ALJ’s Prehearing Ruling, the Government was
required to provide the document to Respondent by working a criminal case on him’’).6 A
reliable information in the package
2 p.m. on February 12, 2016. ALJ Ex. 9, at 2. No Board investigator also testified that
insert. Based on the foregoing, I find claim is made that the Government failed to comply ‘‘it’s customary for [the Board] to back
that there are sufficient indicia of with the ALJ’s ruling.
off [of an investigation] and let a
reliability to support the admission of While Respondent asserts that he was unable to
cross-examine the persons who wrote the package criminal agency pursue their [sic] case’’
the document into evidence and make it
insert, he made no attempt to subpoena either an and that Dr. Craig was aware of the
a part of the record.5 I further find that FDA official involved in reviewing the document or criminal investigation. Tr. 210.
an employee from the manufacturer who was Moreover, even then the Board’s letter
mstockstill on DSK3G9T082PROD with NOTICES
5 Hearsay evidence is admissible in
involved in preparing it. Moreover, Respondent
administrative proceedings, provided it is relevant could have sought to challenge the reliability of the cautioned Respondent ‘‘that authorizing
and material and supported by sufficient indicia of document by producing evidence (whether through
reliability. See, e.g., Mireille Lalanne, 78 FR 47750 expert testimony or studies) disputing the package 6 The Board’s investigation involved interviewing
(2013). insert’s statement regarding the risks of prescribing Respondent, as well as reviewing his girlfriend’s
As further noted above, in opposing the the drug to children less than six years of age. patient file and a PMP report of her controlled
admission of the package insert, Respondent Respondent, however, produced no evidence which substance prescriptions. GE 3, at 4–6. Notably, the
represented that it contained expert opinions from calls into question the reliability of the statements Board’s investigator testified that the Board did not
unidentified persons whom he could not cross- contained in the insert. interview Respondent’s girlfriend. Tr. 196.
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refills for Phentermine/Adipex without FR 57133, 57147–49 (2012), pet. for rev. ‘‘knew I would drink it too.’’ R.D. 7; 11
the benefit of a medical examination is denied, 537 Fed. Appx. 905 (11th Cir. (citing Tr. 216, 251–52, 268, 273); see
strictly prohibited by the Board’s Rules 2013); Morris W. Cochran, 77 FR 17505, also Tr. 298 (girlfriend’s testimony that
and Regulations’’ and specifically 17519–20 (2011) (holding, without the Norco prescriptions were ‘‘not for a
quoted the Board’s Rule 1.5(E), which expert testimony, that prescriptions headache’’ but were ‘‘[j]ust for fun’’).
states that: ‘‘[a] patient continued on a lacked a legitimate medical purpose Likewise, with respect to the
controlled substance in schedule III, IV, where physician noted in patient prescriptions Respondent provided in
V for the purpose of weight reduction or medical records that patients had no March and April 2015 to his girlfriend’s
the treatment of obesity should undergo pain, did not document any findings to purported acquaintances, the
an in-person re-evaluation once every support a diagnosis, and yet diagnosed undercover recordings clearly establish
30 days.’’ GE 3, at 1. Finally, as the patients as having chronic pain); Robert that Respondent knew that the
evidence shows, subsequent to the F. Hunt, 75 FR 49995, 50003 (2010) acquaintances were not seeking the
Board’s closing of its investigation, (holding, without expert testimony, that prescriptions to treat legitimate medical
Respondent again issued multiple physician lacked a legitimate medical conditions but to provide the drugs to
controlled substance prescriptions to purpose based on statements made his girlfriend. Given the evidence that
purported acquaintances of his during undercover visits and clearly shows that Respondent issued
girlfriend knowing that the drugs would falsification of chart). See also Jack A. the prescriptions to support his
subsequently be provided to his Danton, 76 FR 60900, 60904 (2011). girlfriend’s abuse of controlled
girlfriend. Accordingly, I reject Thus, while expert testimony is substances, the Government was not
Respondent’s contention that the typically necessary to establish a required to put forward expert
Board’s closing of its investigation violation of 21 CFR 1306.04(a) ‘‘ ‘where testimony to prove its case.
reflects its ‘‘professional judgments’’ a physician ma[kes] some attempt to
Exception II—The Government
that Respondent acted within the comply with various state medical
‘‘Fail[ed] to Prove ‘Past Experience in
bounds of accepted professional practice standards and the adequacy of
the Distribution of Controlled
practice when he prescribed to those efforts is at issue,’ . . . the facts
Substances.’ ’’
Respondent and the undercover officers. and circumstances surrounding the
Under both this and his subsequent issuance of the prescription may Respondent further argues that the
exception, Respondent argues that the nonetheless establish a violation even ALJ erred when he refused ‘‘to allow
ALJ’s decision is unprecedented without expert testimony.’’ McNichol, Respondent to seek clinical evidence
because the Government put forward no 77 FR 57147–48 (quoting Danton, 76 FR about [his girlfriend’s] medical history
expert testimony to support the at 60904 & n.13). Accordingly, in through third-party document
conclusion that he violated 21 CFR McNichol, the Agency found a violation subpoenas.’’ Exceptions, at 2. Prior to
1306.04(a) in issuing the various proved, notwithstanding that the ALJ the hearing, Respondent requested that
prescriptions. However, contrary to had rejected the testimony of the the ALJ issue eight subpoenas to health
Respondent’s understanding, numerous Government’s Expert, because while the care providers for their medical records
decisions of both the federal courts in physician had gone through the motions ‘‘which reflect, relate to, or explain the
criminal cases and this Agency have of a physical exam, the physician’s clinical or medical basis for
held that expert testimony is not ‘‘comments manifest[ed] that he knew prescribing’’ controlled substances
necessarily required to prove that a that [the patient] was an abuser of (primarily hydrocodone with
physician acted outside of the usual controlled substances.’’ Id. at 57148. See acetaminophen) to his girlfriend. See,
course of professional practice and also Gonzales v. Oregon, 546 U.S. 243, e.g., ALJ Ex. 13, at 6.
lacked a legitimate medical purpose in 274 (2006) (‘‘[T]he prescription In seeking the subpoenas, Respondent
issuing a controlled substance requirement . . . ensures patients use maintained that ‘‘[i]n order for the truth
prescription. See United States v. controlled substances under the about [his girlfriend’s] medical
Pellman, 668 F.3d 918, 924 (7th Cir. supervision of a doctor so as to prevent condition and needs to be revealed . . .
2012) (quoting United States v. addiction and recreational abuse. As a the clinical findings and judgment of all
Armstrong, 550 F.3d 382, 388–89 (5th corollary, [it] also bars doctors from such health care providers should be
Cir. 2008) (‘‘While expert testimony may peddling to patients who crave the available to the Court in order to allow
be both permissible and useful, a jury a comparison between Dr. Stewart’s
drugs for those prohibited uses.’’) (citing
can reasonably find that a doctor judgment and the judgments of a
United States v. Moore, 423 U.S. 122,
prescribed controlled substances not in substantial number of other health care
135, 143 (1975)).
the usual course of professional practice Here, as the ALJ found, Respondent professionals in the same community.’’
or for other than a legitimate medical issued multiple prescriptions to his ALJ Ex. 13, at 3. On the various
purpose from adequate lay witness girlfriend while failing to document the subpoenas, Respondent explained that
evidence surrounding the facts and performance of a physical exam, as well because one of the Government’s
circumstances of the prescriptions.’’)); as findings and diagnoses that would Exhibits (the PMP report, GE 49) shows
Armstrong, 550 F.3d at 389 (‘‘Jurors support the issuance of the that the other health care providers had
have had a wide variety of their own prescriptions. Moreover, with respect to also issued hydrocodone prescriptions
experiences in doctors’ care over their the hydrocodone cough syrup to his girlfriend, ‘‘[t]he presumed
lives, thus and expert testimony is not prescriptions Respondent issued to his legitimacy of the particular clinical
necessarily required for jurors to girlfriend which listed her children as findings which caused [the] other health
care professionals in the same
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rationally conclude that seeing patients the patients, the ALJ credited her
for as little as two or three minutes testimony that she told Respondent that community to prescribe the same
before prescribing powerful narcotics is she wanted the big bottle of medication to [her] could be strongly
not in the usual course of professional hydrocodone cough syrup and he probative of the medical inaccuracy of
conduct.’’).7 See also T.J. McNichol, 77 the . . . core allegations against’’ him.
F.2d 385, 387 (9th Cir. 1974); United States v. See, e.g., GE 13, at 6.
7 See also United States v. Word, 806 F.2d 658, Bartee, 479 F.2d 484, 488–89 (10th Cir. 1973); State The Government opposed the
663 (6th Cir. 1986); United States v. Larson, 507 v. Moody, 393 So.2d 1212, 1215 (La. 1981). issuance of the subpoenas. It argued that
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the information Respondent sought was without a good faith prior examination Respondent also contends that the
irrelevant because the only allegations it and medical indication therefore.’’). evidence is insufficient to show that the
raised as to the unlawful prescribing of Indeed, assessing whether a patient hydrocodone prescriptions lacked a
hydrocodone with acetaminophen to his needs a controlled substance to treat a legitimate medical purpose because ‘‘it
girlfriend involved the four Norco medical condition is the reason why the is clear that during the months relevant
prescriptions which were identified in usual course of professional practice to this case [his girlfriend] was in fact
paragraph 4 of the Show Cause Order.8 generally requires that a physician take suffering from a chronic migraine
ALJ Ex. 14, at 2–3. The Government also a detailed history and conduct an condition and associated headache pain,
argued that ‘‘[i]n each of those appropriate examination of the patient and that [he] was treating her for that
instances,’’ it was ‘‘alleg[ing] that to make a proper diagnosis and condition.’’ Exceptions, at 3.
Respondent prescribed to [her] either treatment plan.9 See id. Respondent points to the testimony of
without conducting any examination of I nonetheless agree with the ALJ’s his girlfriend that she was hospitalized
her or without noting those conclusion that the information sought for migraines ‘‘[t]hree times prior to the
prescriptions in her chart.’’ Id. at 3. And by the subpoenas was irrelevant. beginning of his treatment of her in
it further argued that none of the records Notably, Respondent made no proffer February 2014, and a fourth time during
would address the ‘‘actual charges that he had obtained and reviewed the that treatment in August of 2014.’’ Id.
against’’ Respondent. Id. records maintained by these other He further maintains that his charts
The ALJ agreed with the Government providers and had based his decisions ‘‘specified that she complained of, and
and denied Respondent’s request. ALJ to prescribe hydrocodone to his in fact suffered from, a chronic migraine
Ex. 16. The ALJ explained that having girlfriend on those records. Nor did condition.’’ Id.
reviewed the allegations of the Show Respondent proffer that he was acting as It is true that in two of the visit notes
Cause Order, he agreed with ‘‘the a covering physician for any of these for his girlfriend (April 21 and Sept. 2,
Government’s assessment that the other physicians (or any other 2014), Respondent listed Maxalt, a non-
question of whether [Respondent’ authorized prescriber) when he controlled drug, and Norco
girlfriend] needed a particular prescribed the hydrocodone to his (hydrocodone with acetaminophen), as
medication is not an issue before me.’’ girlfriend. the drugs he prescribed to her for this
Id. at 1. And noting that ‘‘Respondent Respondent further contends that the condition. GE 2, at 12. Yet prior to
has not produced a summary of [his] prescriptions issued by the other Respondent’s issuance of the first Norco
expected testimony,’’ the ALJ then providers ‘‘strongly support a prescription to her, she had ‘‘asked him
reasoned that ‘‘there is no information conclusion that [his] own prescriptions to write the big bottle’’ of hydrocodone
in the record that the Respondent based for [h]ydrocodone for use by [his cough syrup ‘‘so that [she] could have
his decision to prescribe a particular girlfriend] were within the bounds of some too’’ and ‘‘told him I like to drink
medication to [his girlfriend] based the medical standard of care practiced it’’ because she ‘‘like[d] the way it made
upon his knowledge of what some other in that community.’’ Exceptions, at 4. [her] feel.’’ Tr. 251–52; 273. Thus,
treating physician had prescribed for’’ However, were it the case that Respondent already knew that his
her. Id. at 1–2. Concluding that the Respondent’s prescribing of girlfriend was a drug abuser.11
information sought by Respondent was hydrocodone was within the bounds of The evidence also shows that
professional practice, he could have put Respondent told his girlfriend that
irrelevant, the ALJ denied the request.
on an expert to testify as such.10 Yet taking hydrocodone could itself ‘‘cause
Id. at 2.
I conclude that the ALJ properly Respondent chose not do so. migraines.’’ Id. at 283; see also id. at
denied Respondent’s request. I do not, 299. Respondent’s girlfriend testified
however, read the Government’s
9 As Rule 1.4 further states: that he told her that taking hydrocodone
Standards of proper medical practice require that, ‘‘would not help’’ her migraines. Id. at
Opposition as expressing the position upon any encounter with a patient, in order to 300. She further testified that ‘‘[t]he
that his girlfriend’s need for the Norco establish proper diagnosis and regimen of
treatment, a physician must take three steps: (a) hydrocodone was not for a headache,’’
prescriptions was not at issue.
While the Government alleged that Take and record an appropriate medical history, (b) but for ‘‘[e]xtracurricular activities,’’ i.e.,
carry out an appropriate physical examination, and
these particular prescriptions were (c) record the results. The observance of these the standard of professional practice is not defined
unlawful because: (1) Respondent did principles as a function of the ‘‘course of legitimate by a physician’s subjective belief as to the propriety
not ‘‘conduct[] an examination of’’ of his professional practice’’ is particularly of importance of his practices but on the application of the
in cases in which controlled substances are to play
girlfriend or ‘‘document[] such in her a part in the course of treatment. It is the
standards of practice in the State where he
file,’’ or (2) Respondent did not note the practices. United States v. Tobin, 676 F.3d 1264,
responsibility of the physician to dispense, 1290 (11th Cir. 2012). For similar reasons, evidence
prescriptions in her chart and thus prescribe or administer such drugs with proper as to the standard of care in the medical community
violated the Board’s Rules 1.4, 1.11(b) regard for the actual and potential dangers. in which Respondent lived would also be
and 1.16, the Government also cited 21 Miss. Code R. § 30–17–2640:1.4. unavailing.
10 Respondent initially proposed to call a 11 Respondent points to the testimony of his
CFR 1306.04(a)). Because ‘‘[a] physician and professor from the University of girlfriend that she never told him that she was
prescription for a controlled substance Mississippi Medical Center who would testify that addicted to hydrocodone, dependent on the drug,
to be effective must be issued for a the prescriptions he issued ‘‘were for legitimate or taking it ‘‘for no reason.’’ Exceptions, at 3. As
legitimate medical purpose,’’ 21 CFR medical purposes’’ and ‘‘were in the usual course discussed above, Respondent’s girlfriend
of and consistent with [his] own standard subsequently clarified that she took the Norco ‘‘just
1306.04(a), a patient’s need for the drug professional practices [and] were consistent with for fun.’’ Tr. 298.
is invariably at issue when a violation the standard of care in the medical community in To the extent Respondent believes that his
of this provision is alleged. See also which they lived.’’ ALJ Ex. 17, at 2–3. While the misconduct in writing the Norco prescriptions
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Miss. Code R. § 30–17–2640:1.4 (‘‘No Government moved to exclude the proffered should be excused because his girlfriend did not
testimony, the ALJ denied the Government’s motion tell him why she was taking the Norco, the
physician shall prescribe, administer or and specifically ruled that the expert could testify evidence is clear that she had previously asked him
dispense any controlled substance . . . to the above subjects. ALJ Ex. 28, 3–4. Respondent to prescribe the big bottle of cough syrup so that
did not, however, call this witness. she ‘‘could have some too’’ and had told him that
8 The Show Cause Order alleged that the Of further note, even if Respondent had put on she ‘‘like[d] to drink it’’ because of ‘‘the way it
prescriptions were issued on May 22, June 17, testimony that the prescriptions were ‘‘consistent made [her] feel.’’ Thus, Respondent clearly knew
September 11, and October 29, 2014. ALJ Ex. 1, at with [his] own standard professional practices,’’ that his girlfriend was a drug abuser at the time he
2. that testimony would have been unavailing because wrote her the first Norco prescription.
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‘‘just for fun.’’ Id. at 298. Moreover, to conduct an in-person re-evaluation her migraine conditions,’’ this is simply
Respondent issued the first of the Norco every 30 days. Exceptions, at 4. counterfactual as the record abounds
prescriptions to her without even taking Respondent revisits his argument that with evidence that Respondent knew
a history and conducting a physical Dr. Craig ‘‘determined that there was no she was seeking the drugs to abuse
examination of her. GE 2, at 12; see sufficient medical basis for alleging any them. Tr. 345; GE15; 16; GE 17, at 2–4,
Miss. Code R. § 30–17–2640:1.4. He also violation . . . of any medical standard 6–8; GE 18, at 3. I therefore reject
failed to document several of the in Mississippi.’’ Id. However, as Respondent’s contention that there is no
hydrocodone prescriptions in his previously explained, the Board ‘‘significant medical or other evidence’’
girlfriend’s chart.12 Compare GE 2, at 12, terminated its investigation because to support the conclusion that he poses
with GE 3, at 9–10. Thus, the evidence Respondent was the subject of a a danger to public health and safety.14
strongly supports the conclusion that criminal investigation. Moreover, the Exceptions, at 5. To the contrary, the
Respondent acted outside of the usual ALJ thoroughly explained the basis for evidence shows that on multiple
course of professional practice and his conclusion that Respondent acted occasions, Respondent issued
lacked a legitimate medical purpose outside of the usual course of prescriptions outside of the usual course
when he prescribed Norco to his professional practice and lacked a of professional practices and which
girlfriend. 21 CFR 1306.04(a). legitimate medical purpose when he lacked a legitimate medical purpose to
Respondent also appears to argue that issued the phentermine prescriptions to feed his girlfriend’s abuse of controlled
the alprazolam prescription he issued to his girlfriend.13 substances. This conduct amply
his girlfriend was not unlawful because Finally, Respondent argues that ‘‘[t]he supports the conclusion that he has
she suffered from anxiety and he DEA, through the CI [his girlfriend], committed such as acts as to render his
referred her to a psychiatrist who had effectively caused [him] to engage in registration ‘‘inconsistent with the
prescribed the drug to her. Exceptions, conduct, which, according to the record public interest.’’ 21 U.S.C. 824(a)(4).
at 4. While Respondent acknowledges . . . he apparently had never engaged in
that he did not ‘‘diagnose [her] himself on any other occasion.’’ Exceptions, at Exception III—The ALJ Violated
as to anxiety,’’ he argues that he issued 5. Continuing, Respondent argues that Respondent’s Fifth Amendment Rights
the prescription ‘‘in reliance on that his ‘‘conduct, in issuing prescriptions When He Denied His Request To Delay
psychiatrist’s independent clinical for pain medications to third parties in the Hearing Until the End of His
judgment’’ and gave her a refill so that an effort to provide the CI with Criminal Trial
she could ‘‘avoid[] further one-hour continuing relief from her migraine Respondent’s final contention is that
trips to the psychiatrist to obtain a conditions, arose from the peculiar the ALJ violated his Fifth Amendment
refill.’’ Id. combination of his personal relationship privilege against self-incrimination
I am not persuaded. Notably, the and familiarity with the CI and the CI’s when he denied his request to
psychiatrist prescribed only a seven-day insistence that her ‘friends’ were reschedule the hearing until after his
supply of alprazolam extended release seeking medication for’’ her use. Id. criminal trial concluded. Exceptions, at
in the .5 mg dosage. GE 49, at 1. Respondent thus maintains that this 5–6. Notably, the Government did not
Respondent, however, prescribed a ‘‘peculiar circumstance . . . provides no call Respondent to testify and the ALJ
stronger dosage of alprazolam and significant medical or other evidence declined to draw an adverse inference
greater quantity, providing her with a sufficient to justify any conclusion that from his failure to testify on his own
prescription for 40 tablets of the 1mg [his] conduct . . . poses, or is likely to behalf even though doing so would have
immediate release dosage form, with a pose in the future, any danger to the been warranted. See Keating v. Office of
refill for an additional 40 tablets. Id. public health or safety.’’ Id. Thrift Supervision, 45 F.3d 322, 326 (9th
This was not a refill of the psychiatrist’s I disagree. To the extent Respondent’s Cir. 1995) (‘‘Not only is it permissible to
prescription at all, but a substantially argument sounds in the entrapment conduct a civil proceeding at the same
different and stronger prescription. Yet defense, I reject it as there is ample time as a related criminal proceeding,
the medical record contains no evidence evidence that he was predisposed to even if that necessitates invocation of
that Respondent coordinated his issue the unlawful prescriptions given the Fifth Amendment privilege, but it is
prescribing with the psychiatrist. As for the multiple unlawful prescriptions he even permissible for the trier of fact to
Respondent’s explanation that he wrote wrote for his girlfriend in 2014, prior to draw adverse inferences from the
the prescription so that his girlfriend the involvement of the MBN and DEA. invocation of the Fifth Amendment in a
would not have to make the one-hour See United States v. Sumlin, 271 F.3d civil proceeding.’’) (citing Baxter v.
trip to obtain a refill, this begs the 274 (D.C. Cir. 2001). As for the assertion Palmigiano, 425 U.S. 308, 318 (1976)).
question as to why the psychiatrist that he wrote the prescriptions to the ‘ Here, Respondent does not contend
would not be willing to call in a refill. undercover agents to provide his that the need to preserve his Fifth
I thus reject Respondent’s Exception to girlfriend ‘‘with continuing relief from Amendment privilege prevented him
the extent it challenges the ALJ’s
findings as to the alprazolam 13 Respondent points to the evidence that on 14 In arguing that he does not ‘‘pose . . . any
prescription. March 27, 2015, he declined to prescribe weight danger to public health or safety,’’ Respondent cites
loss medication to one of the undercover agents. 21 U.S.C. 823(e), the provision which governs the
As for the phentermine prescriptions, Exceptions, at 4 (citing GE 10, at 1–2). However, registration of distributors of schedule III through
Respondent again invokes Dr. Craig’s several weeks earlier, Respondent had been visited V controlled substances and not practitioners, who
letter in which he stated that the Board by a State Board Investigator who had told him that are registered under section 823(f). However, to the
was closing its investigation while his documentation for the phentermine extent Respondent argues that the Government is
prescriptions that he issued to his girlfriend was required to put forward such proof in seeking the
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cautioning Respondent about the need inadequate and he may have already received the revocation of his registration, the Government is not
letter from Dr. Craig by the date of the first required to do so even though one of the section
12 Indeed, Respondent wrote the first Norco undercover visit. In any event, while Respondent 823(f) factors is ‘‘such other conduct which may
prescription for her on February 21, 2014. The note may have taken to heart the warning he received threaten the public health and safety.’’ 21 U.S.C.
in her patient file simply states: ‘‘2–21–14 Hc 7.5/ from Dr. Craig regarding the prescribing of weight 823(f). While this factor encompasses conduct
325 (#40, 1)—may be picked up at desk.’’ GE 2, at loss medications, this obviously had no impact on which is not otherwise embraced by the other
12. Thus, Respondent issued the prescription his prescribing of narcotics, as evidenced by his section 823(f) factors, it is indisputable that issuing
without taking a history of his girlfriend’s migraines prescribing of Norco and Hycodan to the prescriptions to feed a person’s drug abuse is
and without conducting a physical exam. undercover agents. conduct which threatens public health and safety.
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from providing testimony refuting the required to defend a civil or because he invoked the privilege, he
allegations that he unlawfully administrative action involving the was precluded from refuting the factual
prescribed various controlled same matter.’’ Id. However, the court basis of the allegations.
substances to his girlfriend and the further explained that the potential Instead, Respondent now contends
undercover officers. Rather, he argues harm to a party’s Fifth Amendment that my consideration of the ALJ’s
that ‘‘[b]ecause he desired privilege is just one of the factors to be recommendation ‘‘should await the
understandably to preserve and not to considered in determining whether to disposition of the criminal case . . .
waive his Fifth Amendment privileges stay the noncriminal proceeding. Id. at following which he should be given an
with respect to his criminal trial, [he] 1376. Continuing, the court explained opportunity promptly and succinctly to
was prohibited from ‘rebutting’ any that ‘‘[i]f delay of the noncriminal tell his side of the story and express his
prima facie Government case through proceedings would not seriously injure complete remorse.’’ Exceptions, at 6.
his own hearing testimony, which was the public interest, a court may be However, as discussed above, in his
the only practical way he had to ‘accept justified in deferring it.’’ Id. (emphasis Exceptions, Respondent continues to
responsibility’’ or to affirm that he ‘will added). That decision is, however, dispute the allegations (as well as the
not engage in future misconduct.’’’ Id. at committed to the discretion of the trial ALJ’s factual findings and legal
6. court. See, e.g., Keating, 45 F.3d at 325 conclusions) that he issued
I reject Respondent’s contention. See (setting forth multiple factors). prescriptions outside of the usual course
Grider Drug 1 & 2, 77 FR 44069, 44104 Here, I find no reason to conclude that of professional practice and which
(2012). In Grider, the respondents the ALJ abused his discretion when he lacked a legitimate medical purpose for
argued that the Agency should reject an declined to continue the proceeding each of the different drugs (i.e., the
ALJ’s conclusions that the pharmacies until the conclusion of Respondent’s hydrocodone cough syrup, the Norco
had failed to rebut the Government’s criminal trial. Notably, in his request for tablets, the alprazolam, and the
prima facie case because their owner, a continuance, Respondent provided no phentermine). Thus, his argument begs
who was under indictment in two state information to the ALJ as to when that the question of which allegations he
criminal cases, did not testify and thus trial would commence.15 That trial— now would admit to.
offered no evidence to show that he had and a subsequent appeal were The Fifth Amendment privilege is not
accepted responsibility and Respondent convicted of the charges— ‘‘a sword whereby a claimant asserting
implemented corrective measures. could go on for several years. The ALJ the privilege [is] freed from adducing
Invoking SEC v. Dresser Industries, Inc., was not required to withhold proof in support of a burden which
628 F.2d 1368, 1375–76 (D.C. Cir.1980), conducting the hearing while would otherwise have been his.’’ United
the Grider respondents further argued Respondent litigates in other forums. States v. Rylander, 460 U.S. 752, 758
that because their owner was under See 45 F.3d at 325 (noting that (1983). See also MacKay v. DEA, 664
indictment, the ALJ should have stayed ‘‘convenience of the court in the F.3d 808, 820 (10th Cir. 2011) (quoting
the proceeding until the state criminal management of its cases’’ is a factor). So Keating v. Office of Thrift Supervision,
cases were concluded so as not to too, the Government has a strong 45 F.3d 322, 326 (9th Cir. 1995)).
‘‘undermine the party’s Fifth interest in proceeding expeditiously Indeed, the misconduct established on
Amendment privilege against self- with this litigation, and indeed, under this record is so egregious and occurred
incrimination.’’ 77 FR at 44104. the Constitution, the Agency has an over such a lengthy period, that even
The Agency rejected Grider’s obligation to provide prompt post- were I to remand to allow Respondent
arguments. As the Agency explained, deprivation process where the to express his ‘‘complete remorse’’ and
‘‘‘as a general matter, due process is not Government immediately suspends a the ALJ was to find this credible, I
infringed merely because an accused registration. Id.; see also Barry v. Barchi, would still find his registration to be
person is subjected, without his 443 U.S. 56, 64 (1979). inconsistent with the public interest.
consent, to an administrative hearing As for the burden on Respondent, it See Hatem M. Attaya, 81 FR 8221, 8244
concerning matters involved in a is true that courts have held that the (2016); Fred Samimi, 79 FR 18698,
pending criminal proceeding.’’’ Id. prejudice to a respondent’s Fifth 18714 (2014) (denying applications
(quoting 628 F.2d at 1376 n.21). As Amendment privilege may be noting that notwithstanding ALJ’s
Dresser Industries noted, ‘‘[t]he civil substantial where there are parallel finding that physician ‘‘credibly accept
and regulatory laws of the United States administrative and criminal responsibility for his misconduct, this is
frequently overlap with the criminal proceedings. Keating, 45 F.3d at 326. a case where actions speak louder than
laws creating the possibility of parallel However, while ‘‘the extent to which words’’). Thus, I find that Respondent
[administrative] and criminal the defendant’s Fifth Amendment rights has failed to establish that the ALJ
proceedings, either successive or are implicated is a significant factor . . . abused his discretion when he denied
simultaneous’’ and that ‘‘[i]n the to consider . . . it is only one Respondent’s request to continue the
absence of substantial prejudice to the consideration to be weighed against proceeding until his criminal trial
rights of the parties involved, such others.’’ Id. (citation omitted). concluded.16
parallel proceedings are Notably, Respondent was not
unobjectionable.’’ 628 F.2d at 1374. otherwise foreclosed from putting on a
16 It is, of course, commonplace that matters
Thus, in Dresser Industries, the D.C. involving DEA registrants will lead to both a
defense. Indeed, in its pre-hearing revocation proceeding and a criminal investigation
Circuit observed that ‘‘[t]he Constitution statement, Respondent proposed to call and subsequent charges at either the federal or state
. . . does not ordinarily require a stay an expert witness who would testify level. However, the very purpose of a proceeding
of civil proceedings pending the
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brought under 21 U.S.C. 823(f) and 824(a)(4) is to
that the prescriptions were lawfully protect the public interest, and, in the Controlled
outcome of criminal proceedings.’’ Id. at issued but ultimately chose not to call Substances Act, Congress directed that these
1375. this witness. Notably, in his Exceptions, ‘‘proceedings shall be independent of, and not in
To be sure, in Dresser Industries, the Respondent does not maintain that lieu of, criminal prosecutions or other proceedings
D.C Circuit further explained that ‘‘the under this subchapter.’’ Thus, I conclude that the
fifth Keating factor (‘‘the interest of the public in the
strongest case for deferring civil 15 In opposing the request, the Government noted pending . . . litigation’’) also supports the ALJ’s
proceedings is where a party under that Respondent had also sought a continuance of denial of Respondent’s stay request.
indictment for a serious offense is the criminal case. ALJ Ex. 6, at 1 n.1. Continued
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Accordingly, I reject Respondent’s ALLEGATIONS dosage units of hydrocodone tablets and
third exception and will adopt the ALJ’s 1. From February 2014 to May 2015, 72 dosage units of hydrocodone syrup.
recommended sanction of revocation. the Respondent prescribed controlled ALJ–1, at 11. On at least four of those
substances, including hydrocodone and occasions, the Respondent knew that CI
ORDER
alprazolam, to a confidential informant would receive a portion of the
Pursuant to the authority vested in me prescribed controlled substances. ALJ–
by 21 U.S.C. 824(a) and 823(f), as well (‘‘CI’’) 1 without conducting and/or
documenting a physical examination, 1, at 3–4. The Respondent also knew
as 28 CFR 0.100(b), I order that DEA that CI had attempted to commit suicide
Certificate of Registration AS2286311 and without recording the controlled
substance prescriptions in CI’s chart, in using controlled substances that the
issued to Lawrence E. Stewart, M.D., be, Respondent had prescribed to her. ALJ–
and it hereby is, revoked. I further order violation of Mississippi Medical Board
Administrative Rules Part 2640, Chapter 1, at 3–4.
that any application of Lawrence E. 5. From February 2014 to October
Stewart, M.D., to renew or modify the 1, Rules 1.4, 1.11(b), and 1.16,
Mississippi Code §§ 73–25–29(3) and 2015, the Respondent unlawfully
above registration, or for any additional prescribed controlled substances in
registration be, and it hereby is, denied. (13), and 21 CFR § 1306.04(a). ALJ–1, at
2. violation of 21 U.S.C. 841(a) and 842(a).
This Order is effectively immediately.17 ALJ–1, at 2. Specifically, the
2. On four occasions, the Respondent
Dated: August 9, 2016. prescribed phentermine to CI without Respondent prescribed controlled
Chuck Rosenberg, adequate documentation, in violation of substances when he knew or should
Acting Administrator. Mississippi Medical Board have known that the prescriptions were
Paul A. Dean, Esq. for the Government. Administrative Rules Part 2640, Chapter not for legitimate medical purposes and
J. Brad Pigott, Esq. for the Respondent. 1, Rule 1.5, Mississippi Code §§ 73–25– were not made in the usual course of
29(3) and (13), and 21 CFR § 1306.04(a). professional practice, in violation of 21
RECOMMENDED RULINGS, FINDINGS ALJ–1, at 3. CFR § 1306.04(a) and Mississippi Code
OF FACT, CONCLUSIONS OF LAW, 3. From February 7, 2014 to §§ 41–29–137(a)(1) and 41–29–141(1).
AND DECISION November 19, 2014, the Respondent ALJ–1, at 2.
Administrative Law Judge Charles prescribed hydrocodone products to CI’s 6. On September 2, 2014, the
Wm. Dorman. On December 9, 2015, the children 2 without conducting Respondent prescribed meperidine to
Drug Enforcement Administration examinations of them, and for CI’s CI. ALJ–1, at 3. The Respondent was the
(‘‘DEA’’ or ‘‘Government’’) served personal use, in violation of Mississippi only practitioner to prescribe
Lawrence E. Stewart, M.D. Medical Board Administrative Rules meperidine to CI. ALJ–1, at 3. CI used
(‘‘Respondent’’), with an Order to Show Part 2640, Chapter 1, Rules 1.4, 1.10, meperidine to attempt to commit
Cause and Immediate Suspension of 1.11(b), and 1.16, and Mississippi Code suicide in December 2014. ALJ–1, at 3.
Registration (‘‘OSC/ISO’’), which §§ 73–25–29(3) and (13), and 21 CFR STIPULATIONS OF FACT 3
immediately suspended the § 1306.04(a) and 1306.05(a). ALJ–1, at
Respondent’s DEA Certificate of 2–3. The Respondent prescribed The Government and the Respondent
Registration (‘‘COR’’), Number hydrocodone-homatropine syrup to stipulated to the following facts:
AS2286311. Administrative Law Judge these children, who were under the age 1. Respondent is registered with the
Exhibit (‘‘ALJ-’’) 1–2. The Respondent’s of six. ALJ–1, at 3. Hydrocodone- DEA as a practitioner to handle
COR has remained suspended homatropine syrup is not recommended controlled substances in Schedules II–V
throughout these proceedings. In for children under the age of six because under DEA COR AS2286311 at 405
response to the OSC/ISO, the of a risk of death. ALJ–1, at 3. The Marion Avenue, P.O. Box 666, McComb,
Respondent requested a hearing before Respondent also prescribed adult Mississippi 39648–2709.
an Administrative Law Judge. ALJ–3. dosages of hydrocodone-homatropine to 2. DEA COR AS2286311 will expire
That hearing was held in New Orleans, these children, even though the by its terms on February 28, 2018.
Louisiana on March 22 and 23, 2016. recommended dosage for children ages 3. Respondent is presently licensed in
The issue currently before the six to eleven is half of the adult dosage. Mississippi as a medical doctor (M.D.)
Administrator is whether the ALJ–1, at 2–3. with Medical License 11503.
Respondent’s COR should be revoked, 4. On five occasions between March 4. CI is the mother of Kid 1 and Kid
and applications for renewal or and October 2015, the Respondent 2.
modification denied, because continued prescribed controlled substances to 5. Hydrocodone-Acetaminophen 10–
registration would be inconsistent with undercover agents when he knew or 325 (Norco), Hydrocodone-
the public interest under 21 U.S.C. should have known that the agents’ Acetaminophen 7.5–325 (Norco),
823(f) and 824(a)(4). The following prescription requests were fraudulent, Hydrocodone-Acetaminophen 5–325
recommendations are based on my in violation of 21 U.S.C. 841(a) and (Norco), and Hydrocodone-Homatropine
consideration of the entire 842(a), and 21 CFR § 1306.04(a). ALJ–1, Syrup (Hycodan) are all classified as
administrative record, including all of at 3. In total, the Respondent wrote Hydrocodone Combination Products.
the testimony, admitted exhibits, and seven prescriptions on five occasions to 6. Hydrocodone Combination
the oral and written arguments of undercover agents, for a total of 190 Products are classified by DEA as
counsel. Schedule II Controlled Substances and
1 The Prehearing Ruling and Protective Order have been so classified since October 6,
As for the fourth Keating factor, ‘‘the interests of directed that the confidential informant would be 2014. Before October 6, 2014,
mstockstill on DSK3G9T082PROD with NOTICES
persons not parties to the [administrative] referred to as ‘‘CI.’’ ALJ–9, at 5. Accordingly, in this
litigation,’’ 45 F.3d at 326, Respondent puts forward Recommended Decision, the confidential informant
Hydrocodone Combination Products
no argument as to why this factor supports the will be referred to as ‘‘CI.’’ were classified by DEA as Schedule III
requested stay or a remand at this juncture. 2 The Prehearing Ruling and Protective Order Controlled Substances.
17 For the same reasons that led me to directed that CI’s children would be referred to as 7. Alprazolam is classified by DEA as
immediately suspend Respondent’s registration, I ‘‘Kid 1’’ and ‘‘Kid 2.’’ ALJ–9, at 5. Accordingly, in a Schedule IV Controlled Substance.
find that the public interest necessitates that this this Recommended Decision, CI’s son will be
Order be effective immediately. See 21 CFR referred to as ‘‘Kid 1,’’ and CI’s daughter will be
1316.67. referred to as ‘‘Kid 2.’’ 3 See ALJ–9, 20; Tr. 9.
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how and why she obtained controlled of the Respondent. Tr. 409–10. Gilbert 290–92, 296, 359. During the summer of
substance prescriptions from him. Tr. helped submit the evidence acquired by 2014, CI and the Respondent saw each
212–31.6 Through CI’s testimony, the the undercover agents into a DEA other very often. Tr. 324. CI and the
Respondent admitted GE–49, 56, and evidence locker. Tr. 440. Gilbert also Respondent communicated frequently
57. Tr. 284, 300–03, 335–38. I find these directed DEA personnel to obtain by texting and calling each other on
exhibits to be generally accurate, Prescription Monitoring Program their cell phones. Tr. 355–56.
authentic, and meriting credibility. I (‘‘PMP’’) reports during the 4. CI engaged in a sexual affair with
also find that CI’s testimony was investigation. Tr. 438. Gilbert created the Respondent because she was
generally forthright, internally the administrative subpoenas issued to infatuated with him and because she
consistent, and generally merited pharmacies to obtain information about wanted to obtain controlled substances
credibility 7 in this Recommended the Respondent. Tr. 412. Gilbert helped for her recreational use. Tr. 291–92. The
Decision. conduct an administrative search of the controlled substances, however, were
Eighth, the Government called James Respondent’s office. Tr. 427–28. not a prerequisite for sexual relations.
Pacheco (‘‘Pacheco’’). Tr. 385. Pacheco Through Gilbert’s testimony, the Tr. 289.
is an agent for the MBN and a task force Government authenticated and 5. The sexual relationship between CI
officer for the DEA’s Tactical Diversion successfully offered into evidence GE–7, and the Respondent ended in November
Squad. Tr. 386. Pacheco participated in 41, 48, 50 through 52, 55, and 58 2014. Tr. 219.
the undercover investigation of the through 60. Tr. 411–18, 427–39. I find
Respondent by coordinating the these exhibits to be accurate, A. The Respondent’s Medical Treatment
surveillance aspect of the investigation. uncontested, and meriting credibility. I of CI and Her Children
Tr. 388. Pacheco assisted with physical also find that Gilbert’s testimony was 6. The Respondent provided medical
surveillance of the Respondent and CI thorough, detailed, and internally treatment to CI several times, beginning
during an undercover operation at a consistent. Therefore, I merit her in 2010. GE–2, at 12–13; Tr. 215, 277.
Walmart on April 8, 2015. Tr. 388–89. testimony as credible in this Specifically, the Respondent treated CI
Pacheco personally observed most of the Recommended Decision. for a sinus infection, vertigo, and
operation at Walmart. Tr. 389. Pacheco The Respondent did not call any migraines. GE–2, at 12–13; Tr. 215, 277–
also testified that he listened to the witnesses or offer any of his proposed 78, 287, 321. CI had a serious migraine
undercover operation conducted at the exhibits into evidence. Tr. 458. condition that caused her to seek
Respondent’s clinic in October 2015. Tr. The factual findings below are based treatment in emergency rooms on four
406–07. Through Pacheco’s testimony, on a preponderance of the evidence, occasions. Tr. 278–80, 347. CI discussed
the Government authenticated and including the detailed, credible, and her migraines and hospitalizations with
successfully offered into evidence GE– competent testimony of the the Respondent, who gave her
22 and 23. Tr. 387–93. I find these aforementioned witnesses, the exhibits information about migraines. Tr. 282,
exhibits to be accurate, authentic, and entered into evidence, and the record 287. The Respondent prescribed
meriting credibility. I also find that before me. Maxalt 9 to CI to treat her migraines.
Pacheco’s testimony was thorough, GE–2, at 12; Tr. 215–16, 283.
detailed, and internally consistent. FACTUAL FINDINGS
7. The Respondent had a patient file
Therefore, I merit his testimony as 1. The Respondent has not previously for CI and wrote notes therein about her
credible in this Recommended Decision. been convicted of any crime related to treatment. See GE–2, at 12–13. The
The Government’s ninth witness was controlled substances. GE–1, at 1. The Respondent conducted two physical
Maria Gilbert (‘‘Gilbert’’). Tr. 409. Respondent has never had his state examinations of CI, once when he was
Gilbert is a DEA diversion investigator, medical license revoked, suspended, treating her for a sinus infection, and
and was a case agent in the investigation denied, restricted, or placed on again when he was treating her for a
probation. GE–1, at 1. migraine headache.10 GE–2, at 12–13;
6 The Respondent asked CI extensively about an
exhibit, pre-marked for identification as The Respondent’s Relationship with CI Tr. 322. The Respondent also requested
Respondent’s Exhibit (‘‘RE-’’) 1. See generally Tr.
2. The Respondent and CI became a CT 11 sinus scan for CI in 2014. GE–
231–73. However, the Respondent never offered 2, at 12, 14. A CT scan showed that CI’s
RE–1 into evidence. Therefore, the contents of RE– Facebook friends and began talking with
1 are not considered in this Recommended each other in January 2014. Tr. 213, 237. sinuses were ‘‘clear [and] scant
Decision. CI asked the Respondent questions thickening in LNF duct.’’ GE–2, at 14.
7 There were some inconsistencies in CI’s lengthy
about the health of Kid 1.8 Tr. 213–14, 8. CI took Kid 1 and Kid 2 to
testimony. First, when asked if she paid cash for
246–47, 261–62. The Respondent appointments with the Respondent. Tr.
prescriptions from the Respondent, CI answered 219, 261–62, 285–86, 335–36, 338; see,
that she believed she always used insurance. Tr. performed a tonsillectomy on Kid 1 and
360. However, CI’s Prescription Monitoring placed tubes in his ears on January 30, e.g., GE–56, at 3–4; GE–57, at 6, 9–10.
Program report shows that, in 2014, CI paid for
2014. GE–57, at 13, 19–20; Tr. 219, 235, The Respondent conducted legitimate
prescriptions from the Respondent with cash 15
285. Following Kid 1’s tonsillectomy, CI medical procedures on both children
times, and used her insurance only 5 times. See
GE–49, at 1–3. Second, CI suggested that it was the asked the Respondent for medication for and saw the children for follow-up
Respondent’s idea for CI to send a friend into his Kid 1’s medical condition; the appointments. GE–56, at 3–4; GE–57, at
office to get prescriptions for her. Tr. 345–47.
Respondent was willing to write 5–6; Tr. 219, 261–62.
However, audio recordings of the Respondent’s 9. CI sent the Respondent at least one
telephone calls with CI suggest that it was CI’s idea prescriptions for Kid 1. GE–57, at 5–6;
for her to send a friend into the Respondent’s office Tr. 246–47, 249. Around that time, CI message via social media requesting his
to get prescriptions for CI. See GE–16, file 2015–03– medical advice about Kid 1’s condition.
mstockstill on DSK3G9T082PROD with NOTICES
and the Respondent became friends and
16_18–51–48_EDT, at 20–21; GE–16, file 2015–03–
began texting and talking on the phone. Tr. 262–63. CI communicated with the
18_11–03–33_EDT, at 2. Third, CI testified that the Respondent about the physical
Respondent only conducted a physical examination Tr. 213–14, 240.
of her one time. Tr. 322. The Respondent’s patient 3. In the spring of 2014, CI and the 9 Maxalt, or rizatriptan benzoate, is not a federally
file for CI seems to indicate, however, that the Respondent began to have a consensual
Respondent gave CI some sort of examination on controlled substance. See generally 21 CFR
both April 21 and September 2 of 2014. GE–2, at
sexual relationship. Tr. 213, 218–19, §§ 1308.11–1308.15 (2015).
10 See supra note 7.
12. In these three instances, I do not find CI’s
testimony credible. 8 See Stipulation (‘‘Stip.’’) 4; see also ALJ–9, at 5. 11 Computerized tomography.
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![Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 54831
condition of her children to get his CI told the Respondent that Kid 2 had approximately three months. Tr. 224.
medical advice. Tr. 263–65. a cough. Tr. 250–51, 253–55. On The Respondent did not conduct a
10. Near a date stamp reading February 7, 2014, the Respondent physical examination of CI focused on
‘‘February 4, 2014,’’ the Respondent doubled the size of Kid 2’s prescription weight issues at any point before or
recorded in Kid 1’s medical file that CI for cough syrup. GE–50, at 1; GE–55, at while CI took Adipex, and the
had migraines, that she may call in for 1–2. Respondent did not discuss alternative
a prescription if needed, and that he 16. CI told the Respondent when Kid weight loss treatments with CI. Tr. 224–
discussed phentermine 12 with her. GE– 1 or Kid 2 had a cough. Tr. 250. CI, 25; see GE–2, at 12–13.
57, at 6; see Tr. 286. The Respondent’s however, did not bring her children to 21. CI had anxiety, which she
patient file for CI also contains a see the Respondent regarding a cough; discussed with the Respondent. Tr. 322.
telephone request form, dated July 18, she requested cough syrup from the The Respondent told her to visit a
2014, and signed by the Respondent, Respondent because she liked drinking certain psychiatrist. Tr. 225, 295. CI
which states that CI requested a it. Tr. 220, 273; see generally GE–56, at visited that psychiatrist twice. Tr. 225.
phentermine refill. GE–2, at 15. CI’s 3–4; GE–57, at 5–6. The psychiatrist prescribed a low
patient file, however, does not note any 17. The Respondent prescribed Norco, dosage of time-release Xanax 17. Tr. 225,
reasons that the Respondent prescribed Xanax, and Adipex to CI on multiple 295, 304; see GE–49, at 1. The
phentermine to CI. See GE–2, at 12–13. occasions. Tr. 26; GE–49. The Respondent then prescribed 18 a
Respondent prescribed Norco 15 to CI, stronger dosage of Xanax to CI. Tr. 226;
B. CI’s Drug Use which she took daily instead of as see GE–49, at 1.
11. Prior to her relationship with the needed. Tr. 297. CI took hydrocodone 22. The Respondent wrote nine
Respondent, CI took controlled ‘‘[j]ust for fun.’’ Tr. 298. CI would tell prescriptions 19 to CI, contained in GE–
substances, including hydrocodone, the Respondent when she ran low on a 7 and 41, which are not documented in
which were prescribed by numerous prescription, and he would give her the Respondent’s patient file for CI.
other doctors to help treat pain resulting another prescription.16 Tr. 298–99. He Compare GE–2, at 12–13 (containing the
from four lithotripsies, kidney stones, a advised her that hydrocodone could Respondent’s patient file for CI), with
broken tailbone, a root canal, and cause migraines. Tr. 298–99. GE–7, at 1–2 (containing a prescription
TMJ 13. GE–49, at 2; Tr. 214, 275–76, 18. On several occasions, the written by the Respondent to CI), and
304–09. CI told the Respondent about Respondent provided prescriptions to CI GE–41 (containing prescriptions written
these prescriptions. Tr. 309. while he was at CI’s house. Tr. 217–18; by the Respondent and filled by CI), and
12. CI occasionally used Adderall for see Tr. 26. On those occasions, the GE–49 (containing CI’s PMP report); see
nonmedicinal purposes. Tr. 215. CI had Respondent did not communicate a Tr. 364–77. The Respondent’s patient
not used cough syrup for nonmedicinal diagnosis to CI or perform a physical file for CI does not include any notes
purposes prior to her relationship with examination of CI. Tr. 218. Sometimes, from any examinations on the dates on
the Respondent. Tr. 215. CI took her children to appointments which the Respondent wrote these nine
13. After Kid 1 had his tonsils with the Respondent as an excuse to see prescriptions. GE–2, at 12–13. CI did not
removed on January 30, 2014, CI took the Respondent, who would then have a physical examination or receive
some of Kid 1’s pain medication. Tr. occasionally give prescriptions to CI. Tr. counseling before the Respondent gave
273–74, 276. As a result of the 219–20. On one occasion, the her any of these prescriptions. Tr. 384;
tonsillectomy, the Respondent Respondent met CI in the garden section see GE–2, at 12–13.20
prescribed two different forms of of a Walmart, where he gave her
hydrocodone for Kid 1. GE–51, at 1; GE– prescriptions for cough syrup and pain 17 Xanax is a brand name for alprazolam, which
57, at 6, 14, 22. medication. Tr. 218. is a benzodiazepine and a Schedule IV controlled
14. The Respondent first prescribed 19. At times, CI told the Respondent substance. Stip. 7; see 21 CFR § 1308.14(c)(2); Tr.
304.
cough syrup for Kid 2 on January 24, about her children’s pain or physical 18 CI testified that this prescription was a refill
2014. GE–50, at 1; GE–56, at 4. The conditions to get prescriptions for her prescription, but that it was for a different dosage.
Respondent again prescribed cough own personal use. Tr. 267. CI would Tr. 295–96.
syrup for Kid 2 in February 2014. Tr. occasionally administer the prescribed 19 Seven of these prescriptions, written to CI in
216, 258–59; GE–50, at 1; GE–56, at 4. medication to her children. Tr. 270–72. 2014, were as follows: May 19 for Adipex; May 22
for Norco; June 17 for Norco; July 24 for Adipex;
The Respondent did not examine Kid 2 20. CI requested that the Respondent September 8 for Adipex; September 11 for Norco;
before he prescribed cough syrup for write a prescription for Adderall for her, and October 6 for Xanax. Compare GE–2, at 12–13,
her. Tr. 217, 251; see GE–56, at 4. but he declined to do so. Tr. 223. In the with GE–41, at 1–7, 12–13, and 18–23, and GE–49.
15. CI talked with the Respondent spring of 2014, CI asked the Respondent The Respondent wrote another prescription for
Adipex to CI on April 9, 2014. Compare GE–2, at
about prescribing a ‘‘big bottle’’ of cough to write her a prescription for Adipex, 12–13, with GE–7, at 1–2, and GE–49. The
syrup so that CI could drink it. Tr. 216, a weight loss drug. Tr. 223–24, 288–89. Respondent also wrote a prescription for Hycodan
251–52, 268, 273. CI thought that the The Respondent wrote prescriptions to CI, dated December 3, 2014, but CI’s PMP report
Respondent knew she did not have a and refills for Adipex to CI. GE–49, at said that the prescription was written on December
4, 2014. Compare GE–41, at 28–29, with GE–49.
cough. Tr. 216, 251–52, 268. In February 1–2; Tr. 223–24. CI used Adipex for Regardless of when this prescription was actually
2014, CI asked the Respondent to written, it was not documented in CI’s patient file.
prescribe 14 a ‘‘big bottle’’ of 15 Norco is a hydrocodone combination product. See GE–2, at 12–13.
hydrocodone cough syrup for Kid 2. Tr. See Stip. 5. 20 CI testified about a prescription that is not in
16 Specifically, CI testified that when she ran low GE–41. Tr. 364, 369–70. The prescription allegedly
216–17, 250, 252–53, 259. At that time,
on a prescription, the Respondent would refill it. was written in her name by the Respondent. Tr.
mstockstill on DSK3G9T082PROD with NOTICES
Tr. 298–99. Refills are not authorized for 369–70. The prescription allegedly was dated
12 CI denied asking the Respondent for
hydrocodone combination products, such as Norco. October 29, 2014. Tr. 369–70. The Respondent’s
phentermine in February 2014. Tr. 286–88. Compare 21 U.S.C. § 829(a), with Stip. 6. The record PMP report likewise lists a prescription for
Phentermine is another name for Adipex. See Stip. does not contain any evidence that the Respondent hydrocodone-acetaminophen (Norco) prescribed by
8; Tr. 288. attempted to give CI a refill on a hydrocodone the Respondent on October 29, 2014. GE–49, at 1.
13 Temporomandibular joint dysfunction, or
combination product. Therefore, I interpret CI’s However, neither of the two copies of GE–41
lockjaw. statement as meaning that whenever she ran low on submitted to me includes this prescription.
14 CI later testified that this was a refill of a a prescription, she would tell the Respondent, and Examination of both submitted copies of GE–41
prescription written by the Respondent. Tr. 272–73. he would issue another prescription to her. Continued
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23. Two prescriptions written by the suicide, CI and her husband made a investigator found seven prescriptions
Respondent to Kid 1 are not complaint against the Respondent to the in CI’s PMP report that were not
documented in Kid 1’s medical chart. MBN. Tr. 25, 29–31, 71, 228–29, 339– documented in the Respondent’s patient
Compare GE–51 (containing Kid 1’s 40. CI told MBN investigators that she file for CI. GE–3, at 5. The Respondent
PMP report and listing prescriptions got medications from the Respondent explained that he might have
from June 17 and November 19 of 2014), for nonmedicinal purposes because she documented the missing prescriptions
and GE–55, at 3–4, 11–12 (containing enjoyed using them. Tr. 84. in his patient files for CI’s children
prescriptions from June 17 and instead. GE–3, at 5.
D. The Anonymous Letter 33. Second, the investigator found
November 19 of 2014), with GE–57
(containing Kid 1’s medical file, which 27. The Mississippi Board received an that CI’s patient file did not include any
does not include any examination or unsigned letter, allegedly from CI’s notes about CI’s vitals, height/weight,
prescription notes for June 17 or husband, which complained about the BMI, or alternative weight control
November 19 of 2014); see also Tr. 377– extramarital affair between CI and the treatment plans, and did not indicate
81. Likewise, a prescription written by Respondent. GE–3, at 3; Tr. 58, 66. The that CI received any counseling about
the Respondent to Kid 2 is not Mississippi Board and MBN both other weight loss options. GE–3, at 5; Tr.
documented in Kid 2’s medical chart. received a copy of the letter. Tr. 66–67, 180.
Compare GE–50 (containing Kid 2’s 70–71, 398–99. Several witnesses 34. Following the investigator’s visit,
PMP report and listing a prescription testified that CI’s husband was not the the Mississippi Board sent the
written on July 23, 2014), and GE–55, at author of this letter. Tr. 67–70, 326, 394, Respondent a copy of the anonymous
5–6 (containing a prescription dated 396. The author of the letter is letter purportedly from CI’s
July 23, 2014), with GE–56 (containing unknown. Tr. 67–70, 201, 326, 394–95. husband.21 See GE–2, at 6–8. The
Kid 2’s medical file, which does not 28. The letter was written in the first investigator told the Respondent that he
include any examination notes or person, and CI’s husband’s name was should send a letter to the Mississippi
prescription notes for July 23, 2013). typewritten on the bottom of the letter, Board as a follow-up from the
24. On one occasion in early fall of along with CI’s date of birth and social investigator’s visit. GE–3, at 5; Tr. 179.
2014, following CI’s complaint of a security number. GE–3, at 3. The letter 35. The Respondent sent a letter to the
severe migraine, the Respondent said that the author’s wife, CI, had an Mississippi Board. GE–3, at 7–8; Tr.
prescribed Demerol to CI. Tr. 222, 296– affair with the Respondent for over a 179–80. Therein, the Respondent denied
97, 317–18, 382. Next to the date year, and that the author did not know knowing that CI had overdosed.22 GE–
‘‘September 2, 2014’’ in CI’s medical about it until he found a box of empty 3, at 7; Tr. 180. The Respondent stated
chart, the Respondent wrote that he pill bottles that the Respondent had that he was ‘‘appalled, outraged, and
refilled her prescription of phentermine, prescribed to CI, even though CI was not disgusted’’ by the anonymous letter’s
looked at her ears and nose, and his patient. GE–3, at 3. The letter was allegations. GE–3, at 7; Tr. 208. The
stamped as received by the Mississippi Respondent wrote that the medications
counselled her. GE–2, at 12; Tr. 323. He
Board on February 19, 2015. GE–3, at 3. CI used to overdose ‘‘were legitimately
also wrote that he prescribed Demerol
29. By the time the MBN received a prescribed for valid medical problems.’’
and Xanax to CI. GE–2, at 12. CI did not
copy of the letter, it had already begun GE–3, at 7. The Respondent wrote that
ask the Respondent for Demerol. Tr.
its investigation of the Respondent he was unaware that CI had received
296, 318.
25. CI’s husband discovered that CI because of the complaint made by CI controlled substances from other
was having an affair with the and her husband. Tr. 71, 74–76. After prescribers and that CI did not show
Respondent. Tr. 26, 320. Sometime after receiving a copy of the letter, the ‘‘any hint of drug-seeking behavior.’’
Mississippi Board began conducting an GE–3, at 7. The Respondent
the discovery, in December 2014, CI
independent investigation of the acknowledged that he should not refill
attempted suicide using the Demerol the
Respondent. Tr. 58, 61, 203. medications for a parent during a child’s
Respondent prescribed to her. Tr. 222,
visit without pulling the parent’s chart,
314–17. CI went to a mental institution E. The Mississippi Board Investigation and said that he would not do so in the
for a week following her suicide
30. A Mississippi Board investigator future. GE–3, at 7. The Respondent
attempt. Tr. 227, 309. In January 2015,
met with the Respondent regarding the stated that he would not refill diet drugs
CI told the Respondent that she had
anonymous letter. GE–3, at 4–6. At that for patients in the future without
tried to kill herself. Tr. 226–27, 309–11.
time, the Mississippi Board was completing the appropriate
C. The MBN Complaint unaware that the DEA was conducting documentation. GE–3, at 7.
26. After CI’s husband discovered the a simultaneous investigation of the 36. The Mississippi Board
affair and CI attempted to commit Respondent. Tr. 180. contemplated closing its investigation of
31. In response to the investigator’s the Respondent because it did not have
reveals that no pages of GE–41 are missing. At the inquiry, the Respondent said that he enough evidence supporting the
hearing, however, Government counsel provided CI only saw CI when she or her children allegations of the Respondent’s sexual
with an excerpt of what he said was ‘‘part of Exhibit had appointments, and had not seen CI misconduct. Tr. 181, 184, 194–95, 197,
41,’’ and he provided the Respondent and the ALJ outside of his office. GE–3, at 5; Tr. 179, 209–10. Throughout the course of its
with a copy of what was handed to the witness. Tr.
364. That excerpt has now been included in the 202. The Respondent suggested that he investigation, however, the Mississippi
administrative record as ALJ–29. Comparing ALJ– had not engaged in sexual misconduct Board never interviewed CI. Tr. 196.
29 with GE–41, I have determined that the witness with CI. GE–3, at 5; Tr. 180, 207. The 37. On March 20, 2015, while the
did, in fact, examine a prescription dated October Respondent also suggested that he was Mississippi Board was contemplating
mstockstill on DSK3G9T082PROD with NOTICES
29, 2014. That prescription, however, was never
offered into evidence. Furthermore, the witness was not aware that CI had attempted to closing its investigation, Flinchum
never asked if the prescription, dated October 29, commit suicide or had been committed
21 The handwritten notation on the bottom of the
2014, refreshed her memory of having received the to a mental hospital. GE–3, at 5, 7.
prescription. Accordingly, I decline to find that the 32. The investigator made copies of letter was likely added by a Mississippi Board
Government presented sufficient evidence to investigator. Tr. 87; see GE–2, at 6.
establish that the Respondent wrote a prescription
CI’s patient charts and found several 22 Specifically, the Respondent wrote that he was
to CI on October 29, 2014. Following the hearing, shortcomings with CI’s medical records. ‘‘sorry to learn that [CI] may have deliberately taken
the parties were provided with copies of ALJ–29. GE–3, at 4–5; Tr. 180, 197. First, the an overdose.’’ GE–3, at 7.
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contacted the Mississippi Board and recorded all calls, conversations, and ‘‘I’ve got your request and I’m telling
requested, on the DEA’s behalf, that the multimedia messages exchanged you that is highly, highly dangerous for
Mississippi Board discontinue its between CI and the Respondent. Tr. 37– me.’’ Id.
investigation of, and communication 38, 85–86. 49. On March 18, 2015, at
with, the Respondent. GE–3, at 2; Tr. 45. CI called and texted the approximately 11:03 a.m., the
60–61, 181, 209. The Mississippi Board Respondent outside of the presence of Respondent and CI spoke on the phone.
customarily will discontinue an MBN and DEA agents. Tr. 85–86. The GE–15–16. CI suggested that the
investigation to allow a criminal agency DEA did not tell CI what to say to the Respondent could write a prescription
to pursue a case. Tr. 210. Respondent. Tr. 85–86. in Kid 1’s name. GE–16, file 2015–03–
38. The Mississippi Board closed its 18_11–03–33_EDT, at 1. The
investigation of the Respondent on i. Interactions Between the Respondent Respondent responded sarcastically and
March 23, 2015. GE–3, at 1; Tr. 181. A and CI Before the attempted to change the subject. Id. at
letter from the Mississippi Board to the First Undercover Appointment 1–2. CI said that she really needed him
Respondent terminated the Board’s to find a way to write her a prescription.
46. The DEA agents asked CI to
investigation. GE–3 at 1; Tr. 183. The Id. at 2. The Respondent said he did not
contact the Respondent by phone or by
letter stated that the Mississippi Board know how to do that. Id. CI suggested
text message and ask him for Norco and
concluded its investigation and that, that he could write a prescription in
cough syrup. Tr. 346, 348–49.
after a thorough review of the someone else’s name. Id. The
47. On March 16, 2015, at Respondent said he would ‘‘have to
information and facts from the
investigation, it decided not to approximately 6:51 p.m., the have somebody that’s legitimate’’ and
recommend any formal action. GE–3, at Respondent and CI spoke on the phone. ‘‘what they did with the medicine[,] that
1. This letter was a truthful and accurate GE–15–16. CI asked the Respondent to was up to them . . . somebody that’s
reflection of the Board’s reasons for meet her at Walmart and give her a trustworthy.’’ Id. at 3. The Respondent
terminating the investigation. Tr. 64–65, prescription for something. GE–16, file indicated that it was like a ‘‘federal
86, 195–97. 2015–03–16_18–51–48_EDT, at 19; see crime when you write medicine to—that
39. The letter also cautioned the Tr. 345. The Respondent said he could are diverted to somebody else.’’ Id. CI
Respondent against ‘‘authorizing refills not do that because the Mississippi said that the Respondent used to write
for Phentermine/Adipex without benefit Board was watching him and he could her prescriptions ‘‘all the time.’’ Id. The
of a medical examination.’’ GE–3, at 1 go to jail or lose his license. GE–16, file Respondent said, ‘‘Yeah, but I wrote it
(discussing Mississippi Administrative 2015–03–16_18–51–48_EDT, at 19–20; for you.’’ Id. CI recalled that the
Rule 1.5(E)). see Tr. 230, 345–47. He said that Respondent ‘‘used to bring [his]
40. The letter told the Respondent everything he had prescribed to CI was prescription pad over and a bottle of
that the Mississippi Board had found legitimate and written in her chart. GE– vodka,’’ and that she ‘‘miss[ed] those
some deficiencies with his medical 16, file 2015–03–16_18–51–48_EDT, at days.’’ Id. The Respondent replied, ‘‘I
records. Tr. 181, 183–84, 203. The letter 20. After CI again asked the Respondent know, me too.’’ Id. The Respondent
did not exonerate the Respondent, but several times to give her a prescription, joked with CI that it was good to have
warned him about his inadequate CI asked him instead to write a a boyfriend with a prescription pad. Id.
documentation of weight loss prescription for someone else.24 Id. The at 4.
prescriptions. Tr. 184, 203. Respondent said he could prescribe to 50. On March 25, 2015, at
anyone who came into his office, and approximately 10:36 a.m., the
F. DEA Undercover Operations what they did with their prescriptions Respondent and CI spoke on the phone.
41. The DEA began undercover was ‘‘their business,’’ but that it had ‘‘to GE–17, at 1–5.25 CI asked the
operations concerning the Respondent be a legitimate thing.’’ Id. at 21. CI asked Respondent if he would write a
in March 2015. Tr. 77–78. him multiple times to write prescription to another person. GE–17,
42. CI was told that if she cooperated prescriptions for her, but in different at 2. The Respondent remarked that it
with law enforcement, she would not be names, and the Respondent said he was dangerous and it would have to be
in any trouble. Tr. 342–43. CI signed a could not do so without someone to an established patient; he suggested
confidential informant agreement with coming for a visit and having a chart. Id. that she get another doctor to write a
the DEA. Tr. 343–44, 394. The Respondent said he could prescription for her. GE–17, at 2. CI
43. The DEA instructed CI not to have ‘‘probably pilfer’’ some medication from insisted, and the Respondent said ‘‘it
any contact 23 with the Respondent his wife for CI. Id. at 22. CI repeatedly has to be legitimate’’ and for a
unless the DEA supervised the contact. asked the Respondent to get her some ‘‘legitimate patient’’ because the
Tr. 350. CI did not comply with this controlled substances, and the Mississippi Board was watching him.
instruction and met the Respondent one Respondent repeatedly said he would GE–17, at 2. The Respondent said he
time without DEA’s supervision. Tr. see what he could do. Id. at 24–26. could treat a patient for CI if the patient
353, 358. 48. On March 17, 2015, at had headaches and anxiety. GE–17, at 3.
44. With CI’s consent, the DEA gave approximately 1:07 p.m., the The Respondent said, ‘‘what he does
CI a telephone number that recorded all Respondent and CI spoke on the phone. with ’em is his business.’’ GE–17, at 3.
calls and text messages exchanged GE–15–16. CI asked the Respondent to CI asked the Respondent if he would
between CI and the Respondent. Tr. 37– slip ‘‘a couple Lorcets’’ into her write something to her friend who came
38, 84–85, 230. This telephone number mailbox. GE–16, file 2015–03–17_13– in with a headache; the Respondent
operated through an application that the said, ‘‘Yeah, I could write him
mstockstill on DSK3G9T082PROD with NOTICES
07–36_EDT, at 4. The Respondent joked,
DEA installed on CI’s cellular phone. Tr. ‘‘I need to learn to play the guitar so you something.’’ GE–17, at 3. CI clarified
382. This application automatically could be getting sex, drugs and rock and that the prescription would really be for
roll, you know.’’ Id. CI asked the her, and requested that he prescribe
23 The DEA did not ask CI to attend an
Respondent to ‘‘sneak [her] some ‘‘Lorcet or something;’’ the Respondent
undercover appointment with the Respondent
because CI had a physical relationship with the meds.’’ Id. at 7. The Respondent said, said, ‘‘Yeah, I could write him some—
Respondent, and because CI said that she was
addicted to cough syrup. Tr. 400. 24 Contra Tr. 346; see supra note 7. 25 See GE–16, file 2015–03–25_10–36–40_EDT.
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yeah, some stuff like that.’’ GE–17, at 3. and that any medication he prescribed said he enjoyed meeting Agent 1 and
The Respondent cautioned CI that to her at that appointment would be that he was ‘‘hopeful that that helps’’ CI.
taking too many Lorcet or Demerol given to and used by CI. GE–14, at 1. CI said that she could get
would be harmful and painful to her. through because the Respondent
ii. Undercover Appointment #1: March
GE–17, at 4. CI said she just wanted ‘‘hooked’’ her up. GE–14, at 1. The
27, 2015
‘‘some pain pills from [her] boyfriend.’’ Respondent responded, ‘‘absolutely that
GE–17, at 4. 55. Agent 1’s first appointment with needs to be about as discreet as
51. On March 25, 2015, at the Respondent was on March 27, 2015. [unintelligible].’’ GE–14, at 1. The
approximately 11:43 a.m., the GE–10; Tr. 91. Upon arriving at the Respondent told CI to ‘‘not take that
Respondent texted CI, ‘‘I won’t be in the Respondent’s clinic, Agent 1 signed in, other stuff but one at a time.’’ GE–14, at
office tomorrow. I could see her completed paperwork, and waited in the 1. He said that, during Agent 1’s
Friday.’’ GE–53, file 2015–03–25_11– Respondent’s waiting room. GE–9; Tr. appointment, he ‘‘talked about
43–42_EDT. CI texted back, ‘‘Ok:) she is 92. The Respondent’s nurse called headaches and pretty much left it
a real cool girl. I use [sic] to party with Agent 1 back into an examination room exactly at that.’’ GE–14, at 1. The
her.’’ GE–53, file 2015–03–25_11–47– and spoke briefly with her. GE–9; Tr. 92, Respondent told CI, ‘‘[s]o um you got
23_EDT; see Tr. 349. 94. refills on that Maxalt. Um she does,’’
52. On March 25, 2015, at 56. Agent 1 met with the Respondent. and noted that he could not give refills
approximately 2:36 p.m., the GE–9–10; Tr. 91; see GE–59 (containing ‘‘on the other one . . ..’’ GE–14, at 2.
Respondent and CI spoke on the phone. the Respondent’s patient file for Agent
GE–17, at 6–8.26 The Respondent asked 1). The appointment lasted iii. Interactions Between the Respondent
CI for her friend’s name. GE–17, at 6– approximately seven minutes. GE–9. and CI Between the First and Second
8. CI told the Respondent the alias first When the Respondent asked Agent 1 Undercover Appointments
name of Agent 1. GE–17, at 6–7. The what her problem was, she told him, 60. On April 1, 2015, at
Respondent said, ‘‘If she’s coming in for ‘‘Just kind of a whole head thang [sic].’’ approximately 8:28 p.m., the
what I think she’s coming in, tell her not GE–10, at 1; Tr. 94. The Respondent Respondent and CI spoke on the phone.
to tell me that. That needs to be your asked Agent 1 how long her head had GE–19.29 CI said that she spent time
secret. I don’t wanna know that. She been bothering her, and she indicated with Agent 1. GE–19, at 1. The
needs to have a headache and I will just a few days. GE–9–10. The Respondent asked her, ‘‘So that all went
treat her for a headache, and so [I] don’t Respondent quickly looked into Agent smooth with getting your medicine and
mind giving her prescriptions to treat a 1’s ears, nose, and throat. GE–9–10; Tr. all that?’’ GE–19, at 1; see Tr. 230–31.
headache.’’ GE–17, at 7. The 94, 132. The Respondent asked her if CI said she might need some more. GE–
Respondent discussed the medications she was dizzy, nauseous, or taking other 19, at 1. The Respondent said he was
he could prescribe to Agent 1 and told medication. GE–9–10. He advised her glad he could help and that it was ‘‘just
CI that they ‘‘would be perfectly that Maxalt works well for sinus because of’’ the Mississippi Board
appropriate for you to take.’’ GE–17, at headaches and gave her instructions for complaint that ‘‘it just has to be straight
7; see Tr. 349 (noting that the taking her prescriptions. GE–9–10. The up and clean.’’ GE–19, at 1.
Respondent knew that Agent 1 was not Respondent did not communicate any 61. On April 2, 2015, at
a real patient and that medication diagnosis to Agent 1, nor did he record approximately 2:15 p.m., the
prescribed to Agent 1 would be given to a diagnosis in her patient file.28 GE–9– Respondent and CI spoke on the phone.
CI). 10; GE–59, at 4. GE–16, file 2015–04–02_14–15–50_EDT.
53. On March 26, 2015, at 57. Agent 1 asked the Respondent if CI told the Respondent that Agent 1
approximately 11:18 a.m., the he could help her with her weight loss. would come back and that she ‘‘took
Respondent and CI spoke on the phone. GE–9–10. The Respondent declined to all’’ after CI ‘‘halved some with her.’’ Id.
GE–18.27 CI told the Respondent that prescribe anything for weight loss to CI asked the Respondent if he could
Agent 1 had an appointment with him Agent 1; he said that it was not his area ‘‘give her a little bit more if she’d come
‘‘tomorrow at 2:00—2:10, I think.’’ GE– of expertise and it was heavily regulated back in.’’ Id. at 1. The Respondent
18, at 3. The Respondent replied, by the Mississippi Board. GE–10, at 2. replied, ‘‘I can do that.’’ Id. at 2. The
‘‘Okay. We’ll see if we can’t get my He recommended that she could go to Respondent asked if ‘‘she’’ really had
girlfriend fixed up.’’ GE–18, at 3. The a licensed diet center for assistance. GE– migraines. Id. CI said ‘‘no’’ and laughed.
Respondent said CI should remind 10, at 3. Id. The Respondent laughed too and
Agent 1 to ‘‘play it straight’’ and tell the 58. The Respondent wrote two said he was just wondering because
Respondent what he to needed to write prescriptions for Agent 1: one non- there were a lot of refills. Id. The
on a chart to ‘‘keep the medical refillable prescription for Norco, and Respondent said, ‘‘[l]ong as we don’t get
examiners at bay . . . .’’ GE–18, at 3. CI one refillable prescription for Maxalt. outta hand. Just be sure to keep ’em
asked him if he would prescribe Norco GE–11–12; Tr. 95. The Respondent told really hidden.’’ Id.
to Agent 1. GE–18, at 3. The Respondent Agent 1 that he would give her ‘‘lots of 62. On April 2, 2015, at
said, ‘‘Yeah, I’ll write her Norco and refills’’ on the Maxalt. GE–10, at 1. approximately 3:04 p.m., the
some more Maxalt, and then you can 59. That same day, CI and the Respondent and CI spoke on the phone.
have some Maxalt also. Just remember Respondent had a phone conversation GE–16, file 2015–04–02_15–04–43_EDT.
to hide it.’’ GE–18, at 3. about the Respondent’s meeting with CI asked the Respondent whether he
54. Based on Findings of Fact 47 CI’s ‘‘friend,’’ Agent 1. GE–13–14; GE– could write her ‘‘80’’ if someone came
20, file Post Buy CI Call With in to see him. Id. at 1. The Respondent
mstockstill on DSK3G9T082PROD with NOTICES
through 53 and the transcript at pages
91, 230, and 349, I find that, by the time STEWART 3–27–2015. The Respondent said he could not because it would be
the Respondent met with Agent 1 on a red flag, and that ‘‘40 is a pretty
March 27, 2015, the Respondent knew 28 The Respondent’s March 27, 2015 notes in
substantial number.’’ Id. at 1–2. The
Agent 1’s patient file mention photophobia. GE–59, Respondent joked that CI should tell her
that Agent 1 was not a legitimate patient at 4. The transcript and recording of the office visit,
however, contain no mention of photophobia or any husband that he messed up CI’s ‘‘drug
26 See GE–16, file 2015–03–25_14–36–02_EDT. discussion of the symptoms of photophobia. GE–9–
27 See GE–16, file 2015–03–26_11–18–28_EDT. 10. 29 See GE–16, file 2015–04–01_20–28–54_EDT.
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connection’’ when he filed the Respondent was CI’s boyfriend. Id. CI medication and was taking it twice a
complaint. Id. at 2. said she was fat because she was not day. GE–25, at 1.
63. On April 6, 2015, at taking Adipex anymore. Id. at 3. The The nurse told her that she did not
approximately 8:59 p.m., the Respondent said that she worried too need to take pain medication ‘‘every day
Respondent and CI spoke on the phone. much and that she was beautiful. Id.31 all year long.’’ GE–25, at 1.
GE–16, file 2015–04–06_20–59–35_EDT. The Respondent and CI agreed to meet 75. The Respondent met with Agent 1
CI told the Respondent that she had in Walmart that day. Id. at 7–8. and asked her what she had going on.
talked to Agent 1, who was coming on 69. On April 8, 2015, at GE–25, at 1. Agent 1 said, ‘‘Same thing.
Wednesday. Id. at 2. The Respondent approximately 12:31 p.m., CI texted the Same stuff.’’ GE–25, at 1. The
said, ‘‘I’m glad to help her and take care Respondent and said, if he wanted to Respondent asked if the medicine had
of her.’’ Id. He commented that he had save Agent 1 some money, he could helped. GE–25, at 1. Agent 1 said it
to follow the rules when taking care of bring a prescription for her with him to helped ‘‘a little bit.’’ GE–25, at 1. The
her. Id. CI asked the Respondent to help Walmart. GE–21, at 8. At 12:37 p.m., the Respondent began writing almost
her out when he saw Agent 1. Id. at 3. Respondent replied that he ‘‘MUST see immediately after he entered the room
The Respondent said he would take care her in the office. You know why.’’ GE– without conducting any sort of
of Agent 1’s headaches ‘‘like any other 21, at 9. examination of Agent 1. GE–24–25; Tr.
patient’’ and that he had to follow the 103–04, 132. The appointment lasted
rules, treating her ‘‘like anybody else.’’ iv. Undercover Operation at Walmart:
April 8, 2015 approximately seven minutes. GE–24.
Id. 76. The Respondent and Agent 1
64. On April 7, 2015, at 70. On April 8, 2015, Agent 1 talked casually about boating and
approximately 1:29 p.m., the accompanied CI to Walmart at skiing. GE–25, at 2–3. The Respondent
Respondent and CI spoke on the phone. approximately 12:45 p.m. GE–22–23; Tr. took out his prescription pad and wrote
GE–16, file 2015–04–07_13–29–34_EDT. 128–29, 133–34. The Respondent met CI prescriptions for Agent 1. GE–25, at 3.
CI asked the Respondent if she could in the home furnishings department. The Respondent said, ‘‘[w]e need to
attend Agent 1’s appointment. Id. at 2. GE–22; Tr. 389. CI wore a video and kinda stretch this out [to] make it last a
The Respondent said it was ‘‘a little bit audio recording device. Tr. 347–48, 389; month.’’ GE–25, at 3.
on the risky side.’’ Id. see GE–22. The Respondent spoke with 77. The Respondent wrote two
65. On April 7, 2015, at CI. Tr. 129; see GE–22. The video prescriptions 32 to Agent 1: one for 40
approximately 6:28 p.m., the recording did not capture an image of Norco, and one for Maxalt. GE–24–26;
Respondent and CI spoke on the phone. the Respondent’s face, and much of the Tr. 104. The Respondent told Agent 1
GE–16, file 2015–04–07_18–28–45_EDT. recording is inaudible. GE–22. that he gave her refills for Maxalt but
CI asked the Respondent if he wanted 71. The Respondent told CI to tell could not for ‘‘the other.’’ GE–25, at 1.
her to come with Agent 1 to her Agent 1 to space out her appointments The Respondent again told her to
appointment the next day. Id. at 7. The more. Tr. 129–30. The Respondent said, ‘‘spread it out a little bit longer.’’ GE–
Respondent said that he was nervous ‘‘[w]e will be good now, so but you can’t 25, at 2. He said that ‘‘the other ones are
about it and had to treat Agent 1 the come back like every week for a not really intended for . . . daily use,’’
way he treated everyone else. Id. CI prescription cause they keep up, it’s like but that he would ‘‘go ahead and give
thanked the Respondent and said she every 4 weeks.’’ GE–23. CI asked the [her] a refill.’’ GE–25, at 2.
knew he was seeing Agent 1 for her. Id. Respondent how she was ‘‘supposed to
at 8. The Respondent said that he was last that long.’’ GE–23. The Respondent vi. Interactions Between the Respondent
treating her as a patient, and that it was told her to ‘‘go buy a bottle of Vodka . and CI Between the Second and Third
dangerous. Id. . . .’’ GE–23. Undercover Appointments
66. On April 7, 2015, at 72. At approximately 3:29 p.m., CI 78. On April 8, 2015, at
approximately 7:04 p.m., CI texted the texted the Respondent that she really approximately 5:01 p.m., CI texted the
Respondent and asked if he would meet felt fat and asked him to write Agent 1 Respondent and said ‘‘[t]hank u
her at Walmart the next day around ‘‘something for that too.’’ GE–21, at 13. sweetheart for hooking me up again :).’’
lunch. GE–20, file 2015–05– 73. Based on Findings of Fact 47 GE–20, file 2015–05–06_141328_601–
06_141328_601–904– through 53, Findings of Fact 56 through 904–1188_FROM_2015–04–
1188_FROM_2015–04–01_TO_2015– 72, and the transcript at pages 91, 230, 01_TO_2015–04–30_ALL.
04–30_ALL.30 and 349, I find that, by the time the 79. On April 8, 2015, at
67. On April 8, 2015, at Respondent met with Agent 1 on April approximately 6:15 p.m., the
approximately 8:59 a.m., CI again texted 8, 2015, the Respondent knew that Respondent and CI spoke on the phone.
the Respondent and asked him to go to Agent 1 was not a legitimate patient and GE–27.33 CI asked how things went with
Walmart on his lunch break so that she that at least some of the medication he Agent 1. GE–27, at 1. The Respondent
could ‘‘run into’’ him. GE–21, at 3. CI prescribed at that appointment would said he thought they went okay. GE–27,
texted the Respondent that Agent 1 be given to and used by CI. at 1. The Respondent and CI discussed
would be there and that Agent 1 knew their encounter in Walmart. GE–27, at 3.
about their relationship, but was ‘‘cool’’ v. Undercover Appointment #2: April 8,
2015 The Respondent asked CI what Agent 1
and would ‘‘cover’’ for CI. GE–21, at 5– said to CI, and she told him that Agent
6. 74. Agent 1 had a second appointment
1 said that they had talked about the
68. On April 8, 2015, at with the Respondent that took place on
approximately 10:16 a.m., the April 8, 2015. GE–24–25; Tr. 102. The
mstockstill on DSK3G9T082PROD with NOTICES
32 In GE–26, the Government only provided a
Respondent and CI spoke on the phone. Respondent’s nurse asked Agent 1 why copy of the prescription for Norco. However, the
GE–16, file 2015–04–08_10–16–03_EDT. she was back so soon after her first visit Respondent’s discussion of Maxalt, preserved in
The Respondent said he would love to and if she was taking her medication GE–24 and 25, indicates that the Respondent also
prescribed Maxalt to Agent 1. Additionally, Agent
see CI at Walmart at noon that day. Id. correctly. GE–24; GE–25, at 1; Tr. 103. 1’s testimony that she received two prescriptions at
at 1. CI again said Agent 1 knew that the Agent 1 said she just ‘‘ran out’’ of this appointment was credible and uncontested. Tr.
104.
30 Contra Tr. 129. 31 See GE–27, at 1; contra Tr. 225. 33 See GE–16, file 2015–04–08_18–15–44_EDT.
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Respondent’s boat. GE–27, at 5. The Respondent talked about how CI’s Maxalt, and Lorcet with CI. Id. at 3–4.
Respondent said that he talked with husband would not let her ‘‘have CI asked the Respondent if he would see
Agent 1 about a boat because ‘‘we had drugs.’’ Id. at 10. ‘‘them’’ next week. Id. at 4. The
to be in there more than ten seconds’’ 84. On April 22, 2015, at Respondent said that he would see
so that his ‘‘nosy nurse’’ would not approximately 10:28 a.m., the anybody that came in to his office. Id.
think, ‘‘[d]ang, why is this appointment Respondent and CI spoke on the phone. CI asked him to ‘‘write ’em Lorcet.’’ Id.
over with in ten seconds?’’ GE–27, at 5. GE–20, 28. CI told the Respondent that The Respondent said that ‘‘[i]t would
80. On April 14, 2015, at Agent 1 and some of her friends were even be better if I don’t even know who
approximately 3:48 p.m., CI texted the coming next week to see the they are’’ and instructed CI to not tell
Respondent and asked him how many Respondent. GE–28, file 2015–04– him their names. Id. The Respondent
friends she could ‘‘send in ur office for 22_10–28–41_EDT, at 3. The said that he treats everyone the same. Id.
‘headaches’ lol?’’ GE–20, file 2015–04– Respondent warned CI that he had to be at 5. The Respondent said that he liked
14_15–48–52_EDT. careful because it was ‘‘super serious.’’ to be nice to Agent 1, who he identified
81. On April 14, 2015, at Id. CI laughed and said that they had as CI’s friend. Id.
approximately 6:47 p.m., the headaches. Id. The Respondent told CI 87. On April 22, 2015, at
Respondent and CI spoke on the phone. that prescribing frequently to people approximately 2:32 p.m., CI texted the
GE–38.34 CI again asked the Respondent from out of town was a ‘‘big’’ red flag. Respondent, ‘‘[w]hat I wouldn’t do for
how many friends she could send to Id. The Respondent said he could not an aipex [sic] right now ! Omg :/.’’ GE–
him with a headache. GE–38, at 2. The ‘‘do it on any kind of regular basis.’’ Id. 20, file 2015–04–22_14–32–41_EDT.
Respondent said they had to be really at 4. 88. On April 27, 2015, at
careful about it. Id. The Respondent told 85. On April 22, 2015, at approximately 2:45 p.m., the
CI that if she had a friend who was approximately 12:10 p.m., the Respondent and CI spoke on the phone.
‘‘willing to help’’ her, she should not Respondent texted CI that he ‘‘CANNOT GE–20, 28. CI said she spoke to Agent
tell him about it and should just ask the do anything other than legitimate 1, who was going to see the Respondent
friend to come by and ‘‘mention that medical stuff’’ because it was risky and that Wednesday. GE–20, file 2015–04–
they’ve got headaches.’’ GE–38, at 2. CI’s husband had everyone ‘‘on high 27_14–45–16_EDT. The Respondent
The Respondent said he was nervous alert.’’ GE–20. CI texted back and asked said he would be glad to see her. Id. CI
about it because he knew he was being if he would see Agent 1 next week, and said that Agent 1 would give CI all of
watched. GE–38, at 2. The Respondent that Agent 1 and her friends would not Agent 1’s prescriptions. Id. CI said
said that, but for CI’s husband, CI could ‘‘tell.’’ GE–20. CI asked him to ‘‘write in Agent 1 and Agent 2 would split Agent
‘‘have all the sex, drugs, and rock and their chart it’s for migraines like u 2’s prescriptions. GE–28, file 2015–04–
roll’’ that she needed. GE–38, at 2. CI always do.’’ GE–20. The Respondent 27_14–45–16_EDT, at 1. The
told the Respondent that she was texted back that he would see Agent 1 Respondent said he did not ‘‘know
‘‘running low’’ and needed ‘‘some more and treat her in a medically appropriate anything about that and [did not] want
pills or something.’’ GE–38, at 3. The way. GE–20. The Respondent also to know anything about that.’’ Id. CI
Respondent suggested she drink vodka. texted that his usual prescription for discussed previously taking ‘‘like 20’’ of
GE–38, at 3. CI asked if he would treat Lorcet (40) ‘‘should last more than a the Demerol that the Respondent
Agent 1 for a cough if Agent 1 came in month.’’ GE–20. The Respondent texted prescribed to her. Id. at 7.
for a cough, and if he would give Agent that his feelings for CI needed to be 89. On April 28, 2015, at
1 cough medicine. GE–38, at 3. The ‘‘totally separate from [his] medical approximately 8:23 p.m., the
Respondent said he could give her practice.’’ GE–20. Respondent and CI spoke on the phone.
cough medicine for something 86. On April 22, 2015, at GE–20, 28. CI told the Respondent to
legitimate, and warned CI that the state approximately 1:03 p.m., the not forget that Agent 1 and Agent 2 were
monitors drug-seeking behavior. GE–38, Respondent and CI spoke on the phone. coming tomorrow. GE–28, file 2015–04–
at 3–4. CI asked the Respondent to GE–20, 28. The Respondent said that 28_20–23–38_EDT, at 1. The
prescribe her a ‘‘big bottle,’’ like he used they had to be really careful because the Respondent acknowledged that he knew
to prescribe to her. GE–38, at 4. The Mississippi Board was watching him. they were coming and said he would see
Respondent said he could give her about GE–28, file 2015–04–22_13–03–23_EDT, them then. Id. CI told the Respondent to
eight ounces. GE–38, at 4. The at 1–2. He compared their situation to ‘‘[h]ook her up good. Give her some
Respondent told CI that he could not going to ‘‘buy drugs at a crack house.’’ cough medicine.’’ Id.
prescribe Adipex to her and explained Id. at 2. The Respondent said everything 90. On April 29, 2015, at
why. GE–38, at 6. The Respondent told needed to be ‘‘straight’’ and ‘‘above the approximately 9:38 a.m., the
CI that he could help her feel happier board.’’ Id. The Respondent said that his Respondent and CI spoke on the phone.
if he did not get ‘‘busted by the . . . drug normal prescription dosage of headache GE–20, 28, 29. CI told the Respondent
police.’’ GE–38, at 8. medicine should last more than 30 days, not to forget that Agent 1 was coming
82. On April 14, 2015, at and that it would raise alarm if he saw that day. GE–29, at 7. The Respondent
approximately 7:02 p.m., CI texted the people more than once a month or every replied that he would not forget and
Respondent and asked if he had any other month for headaches. Id. CI said would ‘‘take care of her.’’ GE–29, at 7.
Adipex left over from a prescription to that it had been a month since he saw CI told him to give her cough medicine.
his wife. GE–20. Agent 1; the Respondent said he did not GE–29, at 7. The Respondent said he
83. On April 15, 2015, at remember. Id. CI asked him how he got would see what he could do, but that CI
‘‘away with it’’ when he was seeing her; was ‘‘really pushing [his] envelope.’’
mstockstill on DSK3G9T082PROD with NOTICES
approximately 9:30 p.m., the
Respondent and CI spoke on the phone. he replied that ‘‘they weren’t watching GE–29, at 7.
GE–20, 28. CI talked about being nearly as close’’ and that CI had 91. On April 29, 2015, at
severely depressed. GE–28, file 2015– legitimate headaches and he ‘‘was approximately 3:40 p.m., CI texted the
04–15_21–30–59_EDT, at 9. The writing it down every time.’’ Id. at 3. Respondent that Agent 1 said that Agent
The Respondent said he was not giving 2 ‘‘ ‘has a cough too’ if u could hook her
34 See GE–20, file 2015–04–14_18–47–34_EDT; her prescriptions ‘‘super often.’’ Id. The up with some cough med . . . Please :)
GE–28, file 2015–04–14_18–47–34_EDT. Respondent discussed headaches, .’’ GE–39, at 5.
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92. Based on Findings of Fact 47 Agent 2. GE–34. Meanwhile, the had been misplaced,35 so Agent 1 filled
through 53, 56 through 72, and 75 Respondent talked casually with Agent out new paperwork and sat in the
through 91, and the transcript at pages 2 about sports, Birmingham, and Respondent’s waiting room. GE–42–43;
91, 136, 230, and 349, I find that, by the restaurants. GE–35, at 2–3. Tr. 119–20, 137.
time the Respondent met with Agents 1 99. The Respondent wrote two Agent 1 waited for about an hour and
and 2 on April 29, 2015, the Respondent prescriptions for Agent 2: one for 40 twenty minutes before she was called
knew that Agent 1 and Agent 2 were not Norco 10/325, and one for Maxalt with into an exam room. GE–42; Tr. 406.
legitimate patients and that at least unlimited refills. GE–35, at 3; GE–36– 104. Agent 1 met with the
some of the medications that he 37; Tr. 144. Respondent. GE–42; see GE–60
prescribed to them during their
ix. Interactions Between the Respondent (containing Agent 1’s October 16, 2015
appointments that day would be given
and CI Between the Fourth and Fifth patient file). The Respondent examined
to and used by CI and/or shared by the
Undercover Appointments Agent 1’s ears, nose, and throat. GE–60,
Agents.
at 4; Tr. 120, 132.36 The Respondent
vii. Undercover Appointment #3: April 100. On April 29, 2015, at asked Agent 1 what her symptoms were
29, 2015, with Agent 1 approximately 1:48 p.m., the and what he had treated her for in the
93. Agent 1 had a third appointment Respondent and CI spoke on the phone. past. GE–43, at 2; Tr. 135. Agent 1
with the Respondent, which occurred GE–29, at 9. CI asked the Respondent if thought the Respondent was acting as
on April 29, 2015. GE–30–31; Tr. 111. he had seen Agent 1. GE–29, at 9. The though he did not know who she was.
94. The Respondent met with Agent 1 Respondent said he had. GE–29, at 9. CI Tr. 120, 135, 452; see GE–42–43.
and asked her, ‘‘Headaches for you?’’ asked him what he gave her. GE–29, at 105. The Respondent discussed the
GE–31, at 1. Agent 1 responded, ‘‘Yep.’’ 9. The Respondent said, ‘‘appropriate most effective medication for Agent 1 to
GE–31, at 1. The Respondent performed medicine,’’ and laughed. GE–29, at 9. He take for headaches. GE–43, at 2–3. Agent
a brief examination of Agent 1, checking said that he gave her something for her 1 asked the Respondent if he
her ears and nose. GE–30–31; Tr. 112, headache and cough. GE–29, at 9. CI remembered Agent 2. GE–43, at 3. The
132. The Respondent observed that thanked the Respondent. GE–29, at 9. Respondent stopped, thought about it,
Agent 1 still had ‘‘refills on the other.’’ 101. On April 30, 2015, at and said he did not. GE–42, 43.
GE–31, at 1. approximately 9:19 a.m., the 106. Agent 1’s recording device
95. Agent 1 told the Respondent that Respondent and CI spoke on the phone. partially failed and did not record the
she talked on the phone with a friend GE–40; see GE–20, 28. CI told the last few minutes of Agent 1’s
of hers, who told her that she was Respondent that she got her medication. appointment with the Respondent. Tr.
coughing a lot and needed to get GE–40, at 1. The Respondent said he 79, 451.
something for her cough; Agent 1 also was ‘‘glad all that worked out.’’ GE–40, 107. While the Respondent was
told the Respondent that she had not at 1; see Tr. 230–31. The Respondent writing prescriptions for Agent 1, she
paid it much attention to it. GE–31, at asked CI who Agent 2 was and if she asked the Respondent if he had spoken
1; Tr. 133, 138–39. The Respondent was Agent 1’s friend. GE–40, at 1. CI with CI lately. Tr. 122, 135, 452–53. The
immediately told Agent 1 that he would told the Respondent that Agent 1 gave Respondent paused and looked
give her some cough syrup. GE–30; Tr. all of hers to CI, and that Agent 1 and surprised, then continued writing the
133, 139–40. Agent 1 was not coughing Agent 2 split Agent 2’s prescription. prescriptions and stated that he had not
during the appointment. GE–30; Tr. 138. GE–40, at 2. The Respondent said he heard from CI lately. Tr. 122–23.
Agent 1 did not tell the Respondent that was glad he could help, and that both
she had a cough. GE–30–31; Tr. 113, agents were ‘‘very appropriate’’ because 108. The Respondent wrote Agent 1
132. Agent 1 did not directly request they went ‘‘through the motions.’’ GE– prescriptions for 30 Norco 5/325, four
cough syrup from the Respondent. GE– 40, at 2. The Respondent said that ounces of Hycodan, Maxalt, Zyrtec, and
30–31; Tr. 113. during the appointment with Agent 2, dexamethasone. GE–44–47, 54; Tr. 120,
96. The Respondent wrote two he was thinking, ‘‘I’m not mentioning 126–27, 452. The Respondent discussed
prescriptions to Agent 1: one for 40 [CI] and I’m not mentioning [Agent 1].’’ these prescriptions with Agent 1 during
Norco 10/325, and one for eight ounces GE–40, at 2. the appointment. Tr. 452–53, 455–56.
of Hycodan. GE–32–33; Tr. 113. 109. During this visit, Agent 1 did not
102. The DEA’s investigation was
say that she had a cough. GE–42–43; Tr.
viii. Undercover Appointment #4: April suspended while the Respondent
126, 138–39, 454. Agent 1 only stated at
29, 2015, with Agent 2 campaigned for political office. Tr. 78.
the outset of the appointment that she
97. Agent 2 also had an appointment The DEA contacted CI in October 2015
needed the ‘‘same as before,’’ and did
with the Respondent on April 29, 2015. and asked her to talk to the Respondent
not tell the Respondent that she had any
GE–34–35; Tr. 143. again to try to get him to write another
specific complaints. GE–42–43; Tr. 454.
98. The Respondent met with Agent 2. prescription. Tr. 358. CI said no. Tr.
The Respondent nonetheless prescribed
GE–34–35; Tr. 144; see also GE–58 358.
cough syrup to Agent 1. GE–45; Tr. 139.
(containing the Respondent’s patient file x. Undercover Appointment #5: October
for Agent 2). The Respondent asked her 16, 2015 35 After the Respondent was arrested, Agent 1’s
what he could do for her. Agent 2 she original file, GE–59, was found in the Respondent’s
said she had ‘‘a little headache,’’ but 103. Agent 1 had a fourth desk, along with the files for CI and CI’s children.
noted that it had not been going on for appointment with the Respondent, Tr. 428.
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36 The audiovisual recording of Agent 1’s
a long time. GE–35, at 1; Tr. 144. The which took place on October 16, 2015.
appointment did not record any physical
Respondent briefly looked into Agent Tr. 78, 119. The purpose of this examination by the Respondent during this
2’s ears, nose, and mouth. GE–34–35; appointment was to refresh the appointment. See GE–42. However, because the
Tr. 144. The Respondent asked her a investigation concerning the audiovisual recording was incomplete, and because
Respondent. Tr. 78. Upon arriving at the Agent 1 testified that the Respondent examined her
few questions about allergies, blood ears, nose, and throat, I find as a matter of fact that
pressure, and smoking. GE–35, at 2. The Respondent’s clinic, the Respondent’s the Respondent conducted a physical examination
Respondent then wrote prescriptions to receptionist told Agent 1 that her chart of Agent 1 at this appointment.
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G. Search of the Respondent’s Office decisive. David H. Gillis, M.D., 58 Fed. board’s disciplinary actions can provide
110. The Respondent was arrested on Reg. 37507, 37508 (1993). Thus, there is evidence of what a state licensing board
December 9, 2015. Tr. 427, 432. That no need to enter findings on each of the would recommend. Id. For example,
same day, the DEA searched the factors. Hoxie v. DEA, 419 F.3d 477, 482 when a state board puts a registrant on
Respondent’s office and examined his (6th Cir. 2005). Further, there is no probation, the DEA views the probation
records and patient files. Tr. 427, 432. requirement to consider a factor in any as a recommendation from the state
The Respondent’s office kept patient given level of detail. Trawick v. DEA, board. E.g., Tyson D. Quy, M.D., 78 Fed.
files in a general population of files. Tr. 861 F.2d 72, 76–77 (4th Cir. 1988). Reg. 47412, 47417 (2013).
When deciding whether registration is Here, the Mississippi Board has not
433.
in the public interest, the totality of the revoked, suspended, or restricted the
111. The DEA unlocked the
circumstances must be considered. See Respondent’s license. GE–1, at 1; GE–3,
Respondent’s desk drawer and
generally Joseph Gaudio, M.D., 74 Fed. at 1. The Mississippi Board investigated
discovered several patient files that had
Reg. 10083, 10094–95 (2009). the Respondent in March 2015. See GE–
not been kept in the general population
The Government bears the initial 3. This investigation was limited to
of patient files. Tr. 428, 432. In the
burden of proof, and must justify reviewing an anonymous letter,
Respondent’s desk, the DEA found one
revocation by a preponderance of the interviewing the Respondent, and
patient file for Agent 1, one file for CI,
evidence. Steadman, 450 U.S. at 100– visiting the Respondent’s office. See
one file for Kid 1, and one file for Kid
03. If the Government makes a prima GE–3, at 1–2, 4–6. The Mississippi
2. Tr. 428; see GE–2, 56–57, 59.
facie case for revocation, the burden of Board neither exonerated the
112. The DEA found a second patient
proof shifts to the registrant to show that Respondent nor took any formal action
file for Agent 1 within the general
revocation would be inappropriate. against him. GE–3; Tr. 184, 203. The
population of the Respondent’s patient
Med. Shoppe–Jonesborough, 73 Fed. Mississippi Board only issued a warning
files. Tr. 433; see GE–60. The DEA also
Reg. 364, 387 (2008). A registrant may letter to the Respondent to conclude its
found a patient file for Agent 2 in the investigation. GE–3, at 1. Consistent
prevail by successfully attacking the
general population of the Respondent’s with the findings of Investigator
veracity of the Government’s allegations
patient files. Tr. 434; see GE–58. Pohnert, the Mississippi Board warned
Additional facts required to resolve or evidence. Alternatively, a registrant
may rebut the Government’s prima facie the Respondent that doctors are only
the issues in this case are included permitted to refill phentermine
below in the Analysis section of this case for revocation by accepting
responsibility for wrongful behavior and prescriptions if they first conduct and
Recommended Decision. document medical examinations. GE–3,
by taking remedial measures to ‘‘prevent
ANALYSIS the re-occurrence of similar acts.’’ Jeri at 1, 5.
Hassman, M.D., 75 Fed. Reg. 8194, 8236 The fact ‘‘that a state has not acted
To revoke a respondent’s registration,
(2010). In addition, when assessing the against a registrant’s medical license is
the Government must prove, by a
appropriateness and extent of not dispositive in this administrative
preponderance of the evidence, that the determination as to whether
regulatory requirements for revocation sanctioning, the DEA considers the
egregiousness of the offenses and the continuation of a registration is
are satisfied. Steadman v. SEC, 450 U.S. consistent with the public interest.’’
91, 100–02 (1981); 21 CFR § 1301.44(e) DEA’s interest in specific and general
deterrence. David A. Ruben, M.D., 78 Carlos Gonzalez, M.D., 76 Fed. Reg.
(2015). Under 21 U.S.C. § 824(a)(4), the 63118, 63140 (2011) (citing Patrick W.
DEA may revoke a registrant’s COR if Fed. Reg. 38363, 38385 (2013).
Stodola, M.D., 74 Fed. Reg. 20727,
the registrant acted in a way that Factor One: The Recommendation of 20730 (2009); Jayam Krishna-Iyer, M.D.,
renders continued registration the Appropriate State Licensing Board 74 Fed. Reg. 459, 461 (2009)). Rather,
‘‘inconsistent with the public interest.’’ or Professional Disciplinary Authority the DEA, apart from the Mississippi
The DEA considers the following five Board, has its own independent
Neither party directly advanced an
factors to determine whether continued responsibility to determine whether the
argument under Factor One. However, a
registration is in the public interest: Respondent’s continued registration is
substantial portion of the Respondent’s
(1) The recommendation of the in the public interest. See Edmund
post-hearing brief (‘‘ALJ–34’’) argues
appropriate State licensing board or Chein, M.D., 72 Fed. Reg. 6580, 6590
that the DEA should give significant
professional disciplinary authority. (2007), aff’d, Chein v. DEA, 533 F.3d
(2) The [registrant’s] experience in deference to the Mississippi Board’s
termination of its investigation against 828 (D.C. Cir. 2008). Accordingly, the
dispensing, or conducting research with Mississippi Board’s warning letter does
respect to controlled substances. the Respondent. ALJ–34, at 3–6.
Therefore, by inference, the Respondent not weigh either for or against the
(3) The [registrant’s] conviction record Respondent under Factor One.
under Federal or State laws relating to advanced a theory under Factor One
the manufacture, distribution, or that his license should not be revoked Factors Two and Four: The
dispensing of controlled substances. because the Mississippi Board declined Respondent’s Experience in Dispensing
(4) Compliance with applicable State, to take formal disciplinary action Controlled Substances and Compliance
Federal, or local laws relating to against him. with Applicable State, Federal, or Local
controlled substances. Although the Mississippi Board did Laws Relating to Controlled Substances
(5) Such other conduct which may not make a formal recommendation to
the DEA in this matter, the DEA Allegations 1 through 5 all claim that
threaten the public health and safety. the Respondent illegitimately prescribed
interprets a state licensing board’s
21 U.S.C. 823(f) (2012). controlled substances outside the course
mstockstill on DSK3G9T082PROD with NOTICES
‘‘recommendation’’ broadly. See
These public interest factors are Kenneth Harold Bull, M.D., 78 Fed. Reg. of his professional practice. See supra
considered separately. See Robert A. 62666, 62672 (2013) (considering pp. 2–3. Regarding these allegations, the
Leslie, M.D., 68 Fed. Reg. 15227, 15230 disciplinary actions taken by a state
(2003). Each factor is weighed on a case- licensing board’s direct recommendation weighs
board under Factor One).37 A state neither for nor against a respondent); Paul Weir
by-case basis. Morall v. DEA, 412 F.3d Battershell, N.P., 76 FR 44359, 44365–66 (2011)
165, 173–74 (D.C. Cir. 2005). Any one 37 But see George R. Smith, M.D., 78 FR 44972, (same); Gilbert Eugene Johnson, M.D., 75 FR 65663,
factor, or combination of factors, may be 44979 (2013) (finding that the absence of a state 65666 n.3 (2010) (same).
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Government endeavored to show that controlled substances except upon a falsified patients’ charts.42 Simply put,
the Respondent knowingly diverted, or valid prescription written by a whether the Government must present
attempted to divert, controlled practitioner. Miss. Code §§ 41–29– expert testimony is dependent on the
substances. This evidence is properly 137(a)(1), 41–29–141(1). The facts of each case. McNichol, 77 FR at
analyzed under Factors Two and Four Mississippi Code further provides that a 57147–48.
because ‘‘[p]roof that a physician registrant’s license may be revoked if In the Government’s post-hearing
knowingly diverted controlled the registrant prescribes narcotics brief (‘‘ALJ–35’’), it advanced two
substances is the best evidence for outside of the course of legitimate theories regarding how the Respondent
assessing his experience in dispensing professional practice, id. § 73–25–29(3), violated 21 CFR § 1306.04(a): (1) the
controlled substances, although it is also or if the registrant violates the Respondent knowingly diverted
relevant in assessing his compliance Mississippi Board’s administrative controlled substances to CI, and (2) the
with applicable laws related to rules, id. § 73–25–29(13). Respondent violated state medical
controlled substances.’’ Syed Jawed practice standards. ALJ–35, at 18–24.
Akhtar-Zaidi, M.D., 80 Fed. Reg. 42961, The DEA recognizes several methods
The Government can prove that a
42968 n.17 (2015). to show that a registrant wrote registrant acted outside of the usual
Under the Controlled Substances Act prescriptions without a legitimate course of professional practice and
(‘‘CSA’’), it is unlawful for a person to medical purpose and outside of the lacked a legitimate medical purpose by
distribute controlled substances, except usual course of professional practice. ‘‘providing evidence showing that [the
as authorized under the CSA. 21 U.S.C. See Jack A. Danton, D.O., 76 FR 60900, registrant] knowingly diverted drugs.’’
841(a)(1). To combat drug abuse and 60901 (2011). The Respondent, Danton, 76 Fed. Reg. at 60901.
trafficking of controlled substances, however, incorrectly suggests that the Additionally, the Government can prove
‘‘Congress devised a closed regulatory Government must provide ‘‘medical that a registrant acted outside of the
system making it unlawful to literature’’ or a ‘‘medical opinion’’ in usual course of professional practice
manufacture, distribute, dispense, or order to establish that a registrant acted and lacked a legitimate medical purpose
possess any controlled substance except outside the usual course of professional by providing evidence showing that the
in a manner authorized by the CSA.’’ practice and lacked a legitimate medical registrant violated a state medical
Gonzales v. Raich, 545 U.S. 1, 13 (2005). purpose. ALJ–34, at 5. practice standard ‘‘which has a
To maintain this closed regulatory substantial relationship to the CSA’s
Typically, the Government uses
system, controlled substances may only purpose of preventing substance abuse
expert testimony to establish a violation
be prescribed if a DEA registrant writes and diversion.’’ Id. Neither of these
of 21 CFR 1306.04(a). T.J. McNichol,
a valid prescription. Gonzalez, 76 FR at methods of proof requires the
M.D., 77 FR 57133, 57147–48 (2012).
63141. As the Supreme Court explained, presentation of expert testimony. Id.
However, ‘‘whether expert testimony is
‘‘the prescription requirement . . .
ensures that patients use controlled needed is necessarily dependent on the Allegation 1: Hydrocodone and
substances under the supervision of a nature of the allegations and the other Alprazolam Prescriptions to CI
doctor so as to prevent addiction and evidence in the case.’’ Beau Boshers,
M.D., 76 FR 19401, 19402 n.4 (2011). In Allegation 1, the Government
recreational abuse. As a corollary, [it] claimed that the Respondent prescribed
also bars doctors from peddling to Numerous state and federal courts have
found in criminal cases, which require hydrocodone and alprazolam to CI from
patients who crave the drugs for those February 2014 to May 2015 43 without
prohibited uses.’’ Gonzales v. Oregon, a higher standard of proof than is
required in these proceedings, that conducting and/or documenting a
546 U.S. 243, 274 (2006) (citing United physical examination, and without
States v. Moore, 423 U.S. 122, 135, 143 expert testimony is not required to
establish a violation of 21 U.S.C. § 841 recording the prescriptions in CI’s
(1975)). patient file, in violation of Mississippi
A controlled substance prescription is or 21 CFR § 1306.04(a). McNichol, 77 FR
at 57147.39 For example, the DEA has Medical Board Administrative Rules
not valid unless it is ‘‘issued for a Part 2640, Chapter 1, (‘‘Mississippi
legitimate medical purpose by an not required expert testimony to
Administrative Rules’’) 1.4, 1.11(b),44
individual practitioner acting in the establish a violation of 21 CFR
and 1.16, Mississippi Code §§ 73–25–
usual course of his professional § 1306.04(a) in cases where a prescriber
29(3) and (13), and 21 CFR § 1306.04(a).
practice.’’ 21 CFR § 1306.04(a). Federal engaged in drug deals,40 where there
ALJ–1, at 2. Specifically, the
regulations further provide that ‘‘[a]n were notable differences between
Government alleged that the
order purporting to be a prescription patients’ medical records and
Respondent issued improper
issued not in the usual course of diagnoses,41 and where a prescriber
professional treatment . . . is not a 42 Robert F. Hunt, D.O., 75 Fed. Reg. 49995, 50003
prescription within the meaning and substance prescriptions. Notably, hydrocodone (2010).
intent of [21 U.S.C. § 829] and . . . the combination products, such as Norco and Hycodan, 43 The record does not contain any evidence that
were re-classified by the federal government as the Respondent prescribed controlled substances
person issuing it, shall be subject to the Schedule II controlled substances on October 6, directly to CI in 2015. The 2015 prescriptions that
penalties provided for violations of 2014. See Stip. 5–6. The parties made no argument, the Government alluded to under Allegation 1 were
[controlled substance laws].’’ Id.; see 21 and presented no evidence, regarding the the Respondent’s 2015 prescriptions to Agent 1 and
U.S.C. § 842(a)(1) (establishing that, classification of hydrocodone combination products Agent 2. Those prescriptions are discussed at length
in the state of Mississippi. under Allegation 4, infra pp. 50–58.
under the CSA, it is illegal for a person 39 E.g., United States v. Pellman, 668 F.3d 918, 44 Rule 1.11(b) requires that ‘‘[e]very written
to distribute or dispense controlled 924 (7th Cir. 2012); United States v. Armstrong, 550 prescription delivered to a patient, or delivered to
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substances without a prescription, as is F.3d 382, 389 (5th Cir. 2008); United States v. Word, any other person on behalf of a patient, must be
required under 21 U.S.C. § 829). 806 F.2d 658, 663 (6th Cir. 1986); United States v. manually signed on the date of issuance by the
Much like the federal regulations, the Larson, 507 F.2d 385, 387 (9th Cir. 1974); United physician.’’ Miss. Code R. § 30–17–2640:1.11(b).
States v. Bartee, 479 F.2d 484, 488–89 (10th Cir. Although the Government alleged a violation of this
Mississippi Code provides that it is 1973); State v. Moody, 393 So.2d 1212, 1215 (La. provision in its OSC/ISO, the Government did not
illegal to dispense Schedule II 38 1981). advance a theory or offer evidence to establish a
40 Boshers, 76 Fed. Reg. at 19402 n.4.
violation of this specific rule. I therefore find that
38 These sections of the Mississippi Code only 41 Morris W. Cochran, M.D., 77 Fed. Reg. 17505, the Government’s allegation that the Respondent
apply to the Respondent’s Schedule II controlled 17519–20 (2011). violated Rule 1.11(b) is NOT SUSTAINED.
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personal recollection; she only looked at standards, regardless of the 29(3) and (13), and 21 CFR § 1306.04(a)
and read off of the copy of the Respondent’s subjective intent. are also SUSTAINED by a
prescription presented to her. Tr. 369– Here, CI took Norco daily and preponderance of the evidence, and
70. I do not find that CI’s testimony recreationally, and the Respondent gave weigh in favor of the revocation sought
proved the existence of the October 29 prescriptions to CI upon her request. Tr. by the Government.
prescription. This copy of the 297–99. The Respondent gave
prescriptions to CI at her house, at her Allegation 2: Phentermine Prescriptions
prescription was not offered into
children’s appointments, and in the to CI
evidence.48 In sum, the Government
failed to offer substantial evidence that garden section of Walmart. Tr. 26, 217– In Allegation 2, Government claimed
the Respondent did, in fact, prescribe 20. The Respondent did not provide CI that the Respondent prescribed
hydrocodone to CI on October 29, 2014 with a diagnosis or perform physical phentermine 51 to CI without adequate
outside of the course of his professional examinations before giving these documentation, in violation of
practice. Therefore, the Government’s prescriptions to CI. See Tr. 217–18; see Mississippi Administrative Rule 1.5,
allegations that the Respondent violated also GE–2, at 12–13. Mississippi Code §§ 73–25–29(3) and
Mississippi Administrative Rules 1.4 Importantly, the Respondent only (13), and 21 CFR § 1306.04(a). ALJ–1, at
and 1.16, Mississippi Code §§ 73–25– made three entries in CI’s patient file in 3. The Government specifically alleged
29(3) and (13), and 21 CFR § 1306.04(a) 2014, on February 21, April 21, and that this inappropriate prescribing
by issuing an October 29, 2014 September 2, and he made no entries in occurred on four occasions in 2014:
prescription are NOT SUSTAINED. CI’s patient chart in 2015. See GE–2, at April 9, for 30 dosage units; May 19, for
Beyond the above-mentioned specific 12–13. Neither party presented any 30 dosage units with one refill; July 24,
prescribing events, the Government standard to evaluate the adequacy of the for 30 dosage units; and September 8,
provided ample evidence that, patient file entries.49 Assuming that the for 30 dosage units with two refills.
throughout 2014, the Respondent file entries on those dates are adequate, ALJ–1, at 3.
prescribed controlled substances to CI under Mississippi Administrative Rule The administration of weight loss
outside of the usual course of his 1.4, any prescriptions that the medication is regulated by state medical
professional practice and without a Respondent issued to CI in 2014, other standards. See generally Wesley G.
legitimate medical purpose. The DEA than on February 21, April 21, and Harline, M.D., 65 Fed. Reg. 5665 (2000)
has held, even without the benefit of September 2, were issued outside of the (discussing, at length, general practice
expert testimony, that a controlled Respondent’s professional practice. CI’s and state medical standards for
substance prescription based on a PMP report indicates that CI may have legitimately prescribing controlled
patient’s request ‘‘rather than the result filled prescriptions written by the substances for weight loss). The
of the application of the physician’s Respondent on 13 dates in 2014.50 I do Mississippi Board has a special standard
medical judgment’’ lacks a medical not find that the PMP report, standing of care for practitioners who prescribe
purpose. Robert M. Golden, M.D., 61 alone, constitutes substantial evidence diet medication. See Miss. Code R. § 30–
Fed. Reg. 24808, 24812 (1996) (citing that these prescriptions existed, as 17–2640:1.5; see also GE–8; Tr. 171–72.
Robert L. Dougherty, Jr., M.D., 60 Fed. discussed supra. However, CI’s credible, Specifically, Rule 1.5 requires a doctor
Reg. 55047 (1995); Harland J. confident, and uncontested testimony prescribing weight loss drugs to: (1)
Borcherding, D.O., 60 Fed. Reg. 28796 that she simply requested prescriptions only prescribe adjunctively with caloric
(1995)). Likewise, the Mississippi from the Respondent ‘‘for fun,’’ and that restriction; (2) conduct and thoroughly
Administrative Rules state that a he would give them to her, considered record an initial comprehensive
prescriber lacks good faith when he in conjunction with the PMP report, evaluation; (3) record a thorough patient
‘‘permit[s] the patient to name the drug constitutes substantial evidence that the history and physical exam; (4) conduct
desired’’ or ‘‘dispens[es] drugs to Respondent prescribed controlled an in-person re-evaluation of the patient
patients having no medical need, when substances to CI in 2014 based on CI’s once every 30 days, recording the
the physician knew or should have request rather than in the proper patient’s weight, BMI, blood pressure,
known that the patients were addicts.’’ exercise of sound medical judgment. On pulse, and the results of all tests to
Miss. Code R. § 30–17–2640:1.4. these grounds, the Government’s monitor adverse effects of the
It is true that, at times, the allegations that the Respondent violated medication; and (5) maintain records
Respondent intended to treat CI’s Mississippi Administrative Rules 1.4 about the patient’s weight loss efforts,
medical conditions. GE–2, at 12–13; Tr. and 1.16, Mississippi Code §§ 73–25– dedication, responses,
215, 277–78, 287, 321. However, even if contraindications, and adverse effects
the Respondent subjectively intended to 49 CI’s patient file is not entirely legible. See GE–
during treatment. Miss. Code R. § 30–
provide legitimate medical treatment to 2, at 12–13. The February 21, 2014 entry reads: ‘‘HC
7.5/325 (#40, 1)—may be picked up at desk.’’ GE– 17–2640:1.5. The patient’s history and
CI, ‘‘[t]he appropriate focus is not on the 2, at 12. The April 21, 2014 entry reads: ‘‘Headaches physical exam must, at a minimum,
subjective intent of the doctor, but ? ‘Sinuses’ Motion sickness Occasional vertigo Ears document:
rather . . . whether the physician clear OC/OP clear Nose mildly inflamed CT → clear 1. Past medical history, past surgical
prescribe[d] medicine ‘in accordance and thickening in L NF duct Rx Maxalt (one given)
HC 10/325 (#40) (refill).’’ GE–2, at 12. The
history, social history, family history,
with [the accepted] standard of medical September 2, 2014 entry reads: ‘‘Lexapro Maxalt weight history, dietary history,
practice.’ ’’ United States v. Merrill, 513 prn has anxiety c̄ migraines Migraine—usually gynecological (GYN) history if female,
F.3d 1293, 1306 (11th Cir. 2008) responsive to Maxalt, now c̄ brea[illegible] Ears review of systems, allergies and
(quoting United States v. Moore, 423 clean; [illegible] in ® EAC @[illegible] Nose clear
OC/OP clear Counseled [illegible] Rx Zofran
medications.
U.S. 122, 139 (1975)). The Respondent’s
mstockstill on DSK3G9T082PROD with NOTICES
Demerol 50 (#30) HC 10/325 (#40, 1) Phentermine 2. Height, weight, Body Mass Index
failure to perform and document (refilled) Xanax 1mg (#40, 1).’’ GE–2, at 12. These (BMI), blood pressure, pulse, % body fat
physical examinations of CI, and his three notations are the only entries in the or waist circumference/weight hip ratio,
failure to document his prescriptions to Respondent’s patient file for CI during 2014.
50 Specifically, these dates are as follows:
HEENT, chest, heart, abdomen,
CI, constitutes a significant failure to extremities.
February 21, April 9, May 19, May 22, June 17, July
comply with Mississippi medical 19, July 24, September 2, September 8, September
11, October 6, October 29, and December 4. See GE– 51 Phentermine, or Adipex, is a Schedule IV
48 See supra note 20. 2, at 21–23; GE–49, at 1–3. controlled substance. See Stip. 8.
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3. Appropriate testing related to days. He never recorded CI’s, BMI, Mississippi’s weight loss medication
medical weight loss . . . . blood pressure, pulse, past medical prescribing standards. ALJ–34, at 6.
Id. history, social history, family history, However, even if the Respondent took
The Government presented evidence dietary history, gynecological history, remedial measures, those measures,
that the Respondent wrote four height, weight, or body measurements. standing alone, cannot rebut the
prescriptions for phentermine to CI. On He did not document CI’s efforts to lose Government’s prima facie case for
April 9, 2014, the Respondent weight or note her response to revocation unless the Respondent also
prescribed 30 units of Adipex 37.5 to CI. treatment. accepted responsibility for his actions.
A prescriber lacks good faith if he See Michael S. Moore, M.D., 76 Fed.
GE–7, at 1–2; GE–49, at 2. On May 19,
prescribes controlled substances to a Reg. 45867, 45868 (2011); Hassman, 75
2014, the Respondent prescribed 30
patient who the prescriber knew or Fed. Reg. at 8236. The Respondent did
units of Adipex 37.5, with one refill to
should have known had no legitimate not testify and did not accept
CI. GE–7, at 3–4; GE–41, at 2–3; GE–49,
medical need for the controlled responsibility. Accordingly, the
at 2. On July 24, 2014, the Respondent
substances prescribed. Miss. Code R. Respondent failed to rebut the
prescribed 30 units of Adipex 37.5 to CI.
§ 30–17–2640:1.4. It is concerning that Government’s prima facie case for
GE–7, at 5–6; GE–41, at 12–13; GE–49,
the Respondent wholly failed to revocation based upon his violation of
at 2. On September 8, 2014, the
document any justification whatsoever state regulations that detail the
Respondent prescribed 30 units of
for CI’s supposed need for weight loss requirements for prescribing weight loss
phentermine 37.5 with two refills to CI. medication. During 2014, CI went from
GE–7, at 7–8; GE–41, at 18–19; GE–49, medication.
135 pounds down to 121 pounds. Tr.
at 2. During 2014, CI filled these 224. At the hearing, CI presented with Allegation 3: Prescribing to CI’s
prescriptions seven times. GE–49, at 1– a slender body type. After observing CI’s Children: Physical Examinations,
2. appearance, I find it difficult to Propriety of Prescriptions, and True
In the administrative record, there are comprehend, from even a layman’s Intended Recipient
only four notations in the Respondent’s perspective, how the Respondent could
files related to phentermine, Adipex, or In Allegation 3, the Government
have possibly believed that CI had a claimed that, from February 7 to
weight loss prescriptions. The first high enough BMI 52 to justify the
mention of phentermine is in the November 19 of 2014, the Respondent
administration of weight loss prescribed hydrocodone products to CI’s
Respondent’s patient file for Kid 1 near medication.
a date stamp reading February 4, 2014. children without conducting
The Respondent displayed a complete examinations, and that the prescriptions
GE–57, at 6; Tr. 286. That note reads, disregard for Mississippi’s weight loss
‘‘Mother has migraines ? in children were for CI’s personal use, in violation
prescription requirements. He of Mississippi Administrative Rules 1.4,
May call in Rx if needed. Discussed prescribed weight loss drugs to CI
phentermine c̄ mother May consider 1.10, 1.11(b),53 and 1.16, Mississippi
without any documented medical Code §§ 73–25–29(3) and (13), and 21
this as well.’’ GE–57, at 6. The second justification. GE–2, at 12–13. ‘‘[W]here a
time phentermine was mentioned was CFR § 1306.04(a) and 1306.05(a). ALJ–1,
medical record contains no findings that at 2–3. Mississippi Administrative Rule
in a March 19, 2014 entry in Kid 1’s support a diagnosis, . . . expert
patient file. That note reads, ‘‘Discussed 1.10 requires that a prescription for a
testimony is not necessary to conclude controlled substance contain ‘‘the
[illegible] medications c̄ mother Rx that a prescription lacked a legitimate
[illegible] Phentermine 37.5.’’ GE–57, at complete name and address of the
medical purpose.’’ McNichol, 77 Fed. patient to whom the physician is
5; Tr. 286. The third mention of Reg. at 57151 (citations omitted).
phentermine, and the first in the prescribing the controlled substance.’’
Therefore, the Government’s allegations Miss. Code R. § 30–17–2640:1.10.
Respondent’s patient file for CI, is dated that the Respondent violated
July 18, 2014. GE–2, at 15. This third Likewise, 21 CFR § 1306.05(a) requires
Mississippi Administrative Rule 1.5,
mention is on a patient telephone that a controlled substance prescription
Mississippi Code §§ 73–25–29(3) and
request form, which indicated that CI must ‘‘bear the full name and address of
(13), and 21 CFR § 1306.04(a), by
called the Respondent to ask about a the patient.’’
prescribing phentermine to CI on April
refill of ‘‘phentermine 37.5 (#30, 2)’’ for Additionally, the Government alleged
9, May 19, July 24, and September 8 of
her to ‘‘pick up at front.’’ GE–2, at 15. that the Respondent prescribed
2014 are SUSTAINED by a
The final mention of phentermine, and hydrocodone-homatropine (‘‘cough’’)
preponderance of the evidence, and
the only one contained in the syrup, or Hycodan, to CI’s children, who
weigh in favor of the revocation sought
Respondent’s treatment notes of CI, is were under the age of six, even though
by the Government.
dated September 2, 2014. GE–2, at 12. The Respondent argued in his post- cough syrup is not recommended for
This last entry simply reads, hearing brief that, after receiving the children under the age of six because of
‘‘Phentermine (refilled).’’ GE–2, at 12. Mississippi Board’s warning letter, he a risk of death. ALJ–1, at 3. The
Accordingly, while prescribing refused to prescribe weight loss Government alleged that the
phentermine to CI on April 9, May 19, medication to an undercover agent. Respondent prescribed adult dosages of
July 24, and September 8, the ALJ–34, at 6. The Respondent argued this cough syrup to these children, even
Respondent completely failed to comply that this refusal showed that he ‘‘came though the recommended dosage for
with the requirements of Mississippi promptly into conformity’’ with children aged six to eleven is half of the
Administrative Rule 1.5. The adult dosage. ALJ–1, at 2–3.
Respondent never prescribed The Government further alleged that
mstockstill on DSK3G9T082PROD with NOTICES
52 See Miss. Code R. § 30–17–2640:1.5(A)(4)
phentermine adjunctively with caloric (requiring generally a BMI of greater than 30.0 in the Respondent issued the following
a normal, otherwise healthy patient to justify improper prescriptions for hydrocodone
restriction. He never conducted and prescribing weight loss drugs); see also Minnix v.
recorded an initial comprehensive Colvin, No. 2:12CV00038, 2014 WL 618688, at *3
combination products to CI’s children in
evaluation. He never recorded a n.3 (W.D. Va. Feb. 18, 2014) (defining a BMI of 30
or higher as obesity) (citing Nat’l Inst. of Health, 53 For the reasons previously discussed, supra
thorough patient history or physical Calculate Your Body Mass Index, http:// note 44, the Government’s allegation that the
examination. He never conducted an in- www.nhlbi.nih.gov/guidelines/obesity/BMI/ Respondent violated Mississippi Administrative
person re-evaluation of CI once every 30 bmicalc.htm (last visited May 18, 2016)). Rule 1.11(b) is NOT SUSTAINED.
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56, at 2–4; GE–57, at 5–6. I find that CI’s SUSTAINED by a preponderance of the drinking it; and (4) she would request a
testimony, when considered evidence, and weigh in favor of the big bottle of cough syrup. Tr. 220, 266,
cumulatively and in conjunction with revocation sought by the Government. 273. In addition, the administrative
other evidence of record, establishes Similarly, on November 3, 2014, the record supports CI’s testimony that she
that, at the time the Respondent wrote Respondent wrote a prescription for six did not bring her children to see the
the June 17, July 23, and November 19 ounces (or 180 units) of Hycodan for Respondent regarding a cough, as
prescriptions, he knew that CI would Kid 2. GE–50, at 1; GE–55, at 9–10. The evidenced by their medical charts. GE–
drink at least some of the cough syrup, Respondent wrote a note near a date 56, at 2–4; GE–57, at 5–6. I find that CI’s
though there was no medical reason for stamp reading November 4, 2014, in Kid
testimony, when considered
her to do so. Therefore, the 2’s file. GE–56, at 2. This note said,
cumulatively and in conjunction with
Government’s allegations that these ‘‘[illegible] 5 problems Rx Hycodan (6
oz) (requested).’’ GE–56, at 2. The other evidence of record, establishes
three prescriptions violated Mississippi
Administrative Rule 1.10 and 21 CFR medical record did not include that, at the time the Respondent wrote
§ 1306.05(a) are SUSTAINED by a documentation of a diagnosis and the September 2 and November 3
preponderance of the evidence, and reason for prescribing controlled prescriptions, he knew that CI would
weigh in favor of the revocation sought substances, other than the fact that it drink at least some of the cough syrup,
by the Government. was ‘‘requested.’’ Moreover, the medical though there was no medical reason for
record did not include the dosage or her to do so. Therefore, the
C. The September 2 and November 3 strength of the Hycodan prescribed, as Government’s allegations that these two
Prescriptions is required by Mississippi prescriptions violated Mississippi
On September 2, 2014, the Administrative Rule 1.4. Further, the Administrative Rule 1.10 and 21 CFR
Respondent wrote a prescription for notes near the November 3, 2014 date 1306.05(a) are SUSTAINED by a
four ounces (or 120 units) of Hycodan stamp did not indicate that the preponderance of the evidence, and
for Kid 2. GE–50, at 1; GE–55, at 7–8. Respondent conducted any examination weigh in favor of the revocation sought
The Respondent’s patient file for Kid 2 prior to prescribing Hycodan to Kid 2, by the Government.
included some notes dated September 2, as is required by Mississippi
2014. GE–56, at 3. These notes stated, Administrative Rule 1.4. Therefore, the D. Dangerous Prescriptions
‘‘URI Ears clear Nose, OC/OP mildly Government’s allegation that the
inflamed Lungs clear Rx [illegible] 15 November 3, 2014 prescription to Kid 2 The Government alleged that the
Hycodan.’’ GE–56, at 3. Because these violated Mississippi Administrative Respondent prescribed cough syrup to
notes indicate that the Respondent Rule 1.4 is SUSTAINED by a CI’s children, who were under the age
examined Kid 2, and because the preponderance of the evidence, and of six, even though cough syrup is not
Government did not enter any evidence weighs in favor of the revocation sought recommended for children under the
contesting the accuracy of these notes, by the Government. Because this age of six because of a risk of death.
I find that the Government failed to prescription violated Mississippi ALJ–1, at 3. The Government also
show by substantial evidence that the Administrative Rule 1.4, it was issued alleged that the Respondent prescribed
Respondent did not conduct a physical outside of the course of the adult dosages of cough syrup to these
examination of Kid 2 on September 2, Respondent’s legitimate professional children, even though the recommended
and the Government’s allegation to that practice under Mississippi dosage for children aged six to eleven is
effect is NOT SUSTAINED. However, Administrative Rule 1.16. Therefore, the half of the adult dosage. ALJ–1, at 2–3.
Kid 2’s medical record did not include Government’s allegations that the There is no evidence on the record
any diagnosis or reason for prescribing Respondent violated Mississippi
Hycodan to Kid 2, as required by before me 55 that indicates that it is
Administrative Rule 1.16, Mississippi
Mississippi Administrative Rule 1.4. improper to prescribe cough syrup to
Code §§ 73–25–29(3) and (13), and 21
Additionally, the medical record did not children. There is no evidence on the
CFR § 1306.04(a) by issuing the
clearly include the dose, strength, or November 3, 2014 prescription are also record before me that indicates that the
quantity of Hycodan prescribed to Kid SUSTAINED by a preponderance of the dosages of cough syrup that the
2, as required by Mississippi evidence, and weigh in favor of the Respondent prescribed to CI’s children
Administrative Rule 1.4. Because the revocation sought by the Government. were improper dosages. The
medical record did not contain this The Government also alleged that the Government did not offer an authentic,
information, the Government’s September 2 and November 3 well-founded medical opinion that the
allegation that the September 2, 2014 prescriptions were issued for CI’s quantities and types of prescriptions to
prescription to Kid 2 violated personal use. The Government bears the CI’s children were improper. The
Mississippi Administrative Rule 1.4 is burden of proof on this point. The Government had the burden of proving
SUSTAINED by a preponderance of the administrative record in this case that the prescriptions were unlawful.
evidence, and weighs in favor of the supports the conclusion that the See Ruben, 78 FR at 38384. The
revocation sought by the Government. Government established, by a Government failed to meet this burden.
Because this prescription violated preponderance of the evidence, that the Accordingly, the Government’s
Mississippi Administrative Rule 1.4, it Respondent knew that CI would allegations regarding the propriety of
was issued outside of the course of the consume at least part of the cough syrup the Respondent’s prescriptions to CI’s
Respondent’s legitimate professional he prescribed to CI’s children on children are NOT SUSTAINED.
practice under Mississippi September 2 and November 3. In this
mstockstill on DSK3G9T082PROD with NOTICES
Administrative Rule 1.16. Therefore, the regard, CI testified that: (1) she would 55 The Government offered into evidence three
Government’s allegations that the tell the Respondent when her child printouts from Web sites, allegedly obtained from
Respondent violated Mississippi would have a cough: (2) she never the FDA’s Web site, WebMD, and Drugs.com. See
Administrative Rule 1.16, Mississippi brought her children to see the Gov’t Proposed Exs. 4–6. Upon the Respondent’s
timely objection, I rejected these three exhibits
Code §§ 73–25–29(3) and (13), and 21 Respondent regarding a cough; (3) she because they were improper opinion testimony,
CFR § 1306.04(a) by issuing the requested cough syrup from the lacked adequate foundation, and were not properly
September 2, 2014 prescription are also Respondent because she enjoyed authenticated. See Tr. 418–26.
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Allegation 4: Fraudulent Prescriptions Respondent wanted to be ignorant about prescriptions.63 Therefore, based on the
for CI through Undercover Agents 56 the identities of CI’s ‘‘friends,’’ 59 the communications exchanged between the
In Allegation 4, the Government Respondent knew that Agent 1 and Respondent and CI, I find that the
claimed that, on five occasions between Agent 2 were ‘‘friends’’ of CI 60 and that Respondent knew that Agent 1 and
March and October 2015, the they would give CI at least some of the Agent 2 were ‘‘not seeking treatment for
Respondent prescribed controlled drugs he prescribed to them.61 The a legitimate medical condition but
substances to undercover agents when Respondent had reason to know that [were] engaged in . . . diversion.’’ See
he knew or should have known that the Agent 1 and Agent 2 did not McNichol, 77 FR at 57148. Despite
agents’ prescription requests were legitimately need medication for circumstances that plainly and
fraudulent, in violation of 21 U.S.C. themselves.62 The Respondent had unambiguously indicated diversion, the
§§ 841(a) and 842(a) and 21 CFR reason to know that Agent 1, Agent 2, Respondent nonetheless prescribed
§ 1306.04(a). ALJ–1, at 3. The and CI were splitting their drugs to Agent 1 and Agent 2 during the
Government alleged that the first four undercover appointments.
Respondent wrote seven hydrocodone appointment); GE–17, at 3 (same); GE–18, at 3 Even beyond this, the Respondent
prescriptions on five occasions to (asking for Norco before the first undercover took extra efforts to facilitate the
appointment); see GE–16, file 2015–04–02_15–04– diversion of drugs to CI. The
undercover agents, for 190 total dosage 43_EDT, at 1–2 (asking for a double dosage,
units of hydrocodone tablets and 72 presumably of Norco, before the second undercover
Respondent discussed the scheduling of
total dosage units of hydrocodone appointment); see also GE–28, file 2015–04–28_20– Agent 1 and Agent 2’s appointments
syrup. ALJ–1, at 11. The Government 23–38_EDT, at 1 (asking for cough medicine before with CI, and CI reminded him about the
alleged that, on four of those occasions, the third and fourth undercover appointments); GE– timing of those appointments.64 The
29, at 7 (same); GE–38, at 3–4 (asking for a ‘‘big
the Respondent knew that CI would bottle’’ of cough syrup before the third and fourth
Respondent asked CI to tell her friends
receive a portion of the prescribed undercover appointments); GE–39, at 5 (asking for to pretend they had headaches and act
medications. ALJ–1, at 3–4. cough medicine before the third and fourth like legitimate patients.65 After the third
undercover appointments). and fourth undercover appointments,
A. Undercover Appointments 1 through 59 GE–28, file 2015–04–22_13–03–23_EDT, at 4–
the Respondent praised Agent 1 and
4 5 (expressing his desire to remain ignorant before
Agent 2 for acting very appropriately by
the third and fourth undercover appointments); GE–
The evidence against the Respondent 28, file 2015–04–27_14–45–16_EDT, at 1 (same); going ‘‘through the motions.’’ GE–40, at
regarding the first four undercover GE–38, at 2 (same). The Respondent even stated at 2. After each of the first four
appointments is significant, conclusive, one point, ‘‘if [Agent 1 is] coming in for what I think appointments, CI told the Respondent
she’s coming in, tell her not to tell me that. That
and uncontested. needs to be your secret. I don’t wanna know that. that she had received the drugs
The Respondent compared his She needs to have a headache and I will treat her prescribed to Agent 1 and Agent 2; in
diversion of drugs to CI with going to for a headache, and so don’t mind giving her response, the Respondent stated that he
‘‘buy drugs at a crack house.’’ GE–28, prescriptions to treat a headache.’’ GE–17, at 7. was happy to help get drugs to CI.66
60 GE–16, file 2015–04–07_13–29–34_EDT, at 2
file 2015–04–22_13–03–23_EDT, at 2. In It is true that the Respondent
(discussing CI accompanying Agent 1 to her
some sense, this was an apt description. appointment); GE–16, file 2015–04–07_18–28–45_ conducted appointments with Agents 1
Whenever CI asked the Respondent for EDT, at 7–8 (same); GE–16, file 2015–04–08_10–16– and 2, and wrote notes in their medical
drugs, he would attempt to convey them 03_EDT, at 1 (saying that Agent 1 knew about their files. In that aspect, this case is similar
to her. Prior to each of the first four relationship); GE–17, at 6–7 (identifying Agent 1
to Robert F. Hunt, D.O., 75 FR 49995
undercover appointments, CI clearly before the first undercover appointment); GE–21, at
5–6 (identifying Agent 1 before the second (2010). Dr. Hunt had said that he wrote
and repeatedly asked the Respondent undercover appointment); see GE–21, at 8 (asking information on a patient’s chart ‘‘just to
for controlled substances.57 CI the Respondent to bring Agent 1’s prescriptions to cover [his] ass.’’ Id. at 50003. The DEA
specifically named certain controlled his rendezvous with CI at Walmart to save her
held that this statement made it ‘‘clear
substances that she wanted the money); see also GE–28, file 2015–04–22_13–03–
23_EDT, at 4–5 (recognizing Agent 1 as CI’s friend that [Dr. Hunt] knew that he lacked a
Respondent to prescribe to Agent 1 and before the third and fourth undercover legitimate medical purpose for
Agent 2 to divert to her.58 Although the appointments); GE–28, file 2015–04–28_20–23–38_ prescribing’’ controlled substances. Id.
EDT, at 1 (identifying Agent 1 and Agent 2 as CI’s
56 In its post-hearing brief, the Government friends before the third and fourth undercover
Similarly, although the Respondent
argued that this conduct should be analyzed under appointments); GE–40, at 2 (recognizing that, at the
63 GE–28, file 2015–04–27_14–45–16_EDT, at 1.
Factor Five. ALJ–35, at 21–24. However, in the time of Agent 2’s appointment, the Respondent
knew that Agent 2 was affiliated with CI and Agent 64 GE–18, at 3 (discussing the first undercover
Government’s OSC/ISO and its presentation of
evidence at the hearing, the Government made a 1). appointment); GE–23 (discussing, before the second
strong argument that the Respondent’s prescriptions 61 GE–16, file 2015–03–18_11–03–33_EDT, at 2– undercover appointment, the need to space out the
to the undercover agents violated state and federal 4 (suggesting that CI could send a friend in to get appointments more); see GE–16, file 2015–04–06_
laws, and were acts of knowing diversion which prescriptions before the first undercover 20–59–35_EDT, at 2 (discussing the second
reflected poorly on the Respondent’s experience in appointment); GE–17, at 3 (same, and undercover appointment); see also GE–28, file
dispensing controlled substances. Therefore, acknowledging, before the first undercover 2015–04–22_10–28–41_EDT, at 3–4 (discussing the
analysis of this conduct under Factors Two and appointment, that any prescriptions to CI’s friends third and fourth undercover appointments); GE–28,
Four is appropriate. would be diverted to CI); GE–17, at 7 (advising that file 2015–04–22_13–03–23_EDT, at 4 (same); GE–
57 GE–16, file 2015–03–16_18–51–48_EDT, at 20– the prescriptions he gave to Agent 1 would be fine 28, file 2015–04–28_20–23–38_EDT, at 1 (same);
21, 24–26 (expressing that CI was seeking drugs for CI to take); GE–18, at 3 (stating, before the first GE–29, at 7 (same).
before the first undercover appointment); GE–16, undercover appointment, that the Respondent 65 GE–18, at 3 (instructing CI to tell Agent 1 to
file 2015–03–18_11–03–33_EDT, at 2 (same); GE– would write prescriptions for Agent 1 so CI could ‘‘play it straight’’ and tell him what he needed to
17, at 4 (same); see GE–16, file 2015–04–02_14–15– have the medication); see GE–14, at 1 (identifying write in his chart at the first undercover
50_EDT, at 1 (expressing that CI was seeking drugs Agent 1 as CI’s friend, and discussing how the appointment).
before the second undercover appointment, and Respondent ‘‘hooked [CI] up,’’ before the second 66 GE–14, at 1 (telling CI, after the first undercover
mstockstill on DSK3G9T082PROD with NOTICES
indicating that she had taken all of the drugs from undercover appointment); GE–16, file 2015–04–02_ appointment, that he was happy to meet Agent 1
the first appointment too quickly); see also GE–28, 14–15–50_EDT, at 1–2 (same); GE–21, at 13 and hoped it helped, and receiving thanks from CI
file 2015–04–13_20–26–31_EDT, at 7 (expressing (thanking the Respondent for ‘‘hooking’’ her up for ‘‘hooking’’ her up); GE–14, at 2 (acknowledging
that CI was seeking more drugs before the third and before the second undercover appointment); GE–28, that the prescriptions that he gave to Agent 1 went
fourth undercover appointments); GE–28, file 2015– file 2015–04–28_20–23–38_EDT, at 1 (asking the to CI); GE–19, at 1 (asking CI if everything ‘‘went
04–28_20–23–38_EDT, at 1 (same); GE–38, at 2–3 Respondent to ‘‘[h]ook’’ up CI’s friend before the smooth with getting your medication’’ and
(same). third and fourth undercover appointments). expressing that he was happy to help); GE–40, at
58 GE–16, file 2015–03–17_13–07–36_EDT, at 4 62 E.g., GE–16, file 2015–04–02_14–15–50_EDT, at 1–2 (asking CI if she got the medication and
(asking for Lorcet/Norco before the first undercover 2; GE–16, file 2015–04–02_15–04–43_EDT, at 1–2. expressing that he was ‘‘glad all that worked out’’).
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![54846 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
conducted appointments with Agents 1 prescribed a total of 160 units of Norco professional practice and lacked a
and 2 and wrote notes in their medical and eight ounces of Hycodan to the legitimate medical purpose. See Danton,
files, the Respondent’s statements to CI undercover agents, who he believed 76 Fed. Reg. at 60901. Therefore, the
before and after each of the first four would divert those drugs to CI.67 The Government’s allegations that the first
appointments made it clear that the Respondent repeatedly joked about four undercover appointments violated
Respondent was unquestionably providing CI access to all the drugs that 21 U.S.C. §§ 841(a) and 842(a), and 21
prescribing controlled substances to she wanted.68 Even though the CFR § 1306.04(a) are SUSTAINED by a
Agents 1 and 2 to intentionally divert Respondent did not take his preponderance of the evidence, and
drugs to CI. His statements also make responsibilities as a registrant seriously, weigh in favor of the revocation sought
clear that the records he was keeping he did understand the potential legal by the Government.
concerning Agents 1 and 2 were merely consequences of his actions. The To the extent that the Respondent’s
to keep the Mississippi Board Respondent repeatedly expressed a fear actions are interpreted as prescribing
investigators at bay. E.g., GE–18, at 3. of getting in trouble for diverting drugs controlled substances to CI indirectly,71
Moreover, the fact that a registrant to CI.69 This reflects that the his prescriptions are grave violations of
conducted a medical appointment Respondent undoubtedly knew that his 21 CFR 1306.04(a). On this point, this
before prescribing controlled substances actions were wrong.70 case bears a striking similarity to
does not, standing by itself, validate the I find that, during the first four Annicol Marrocco, M.D., 80 FR 28695
prescriptions issued; rather, an undercover appointments, the (2015). In that case, Dr. Marrocco
appointment may be used by a Respondent knew that Agent 1 and prescribed controlled substances to her
prescriber as ‘‘a sham justification to Agent 2 were not real patients and that lover, but did not physically see her
support an unlawful prescription.’’ at least some of the medications he lover for three to six months while he
McNichol, 77 Fed. Reg. at 57148. An prescribed to them would be given to CI. was using those prescriptions. Id. at
appointment can constitute a I find that the Respondent prescribed 28703. The DEA found that Dr.
perfunctory, sham examination if the medications to Agent 1 and Agent 2 Marrocco lacked a legitimate purpose
registrant ‘‘already agreed to issue’’ upon CI’s request for those medications. for her prescriptions because she was
certain prescriptions to a patient. Darryl I further find that, when the Respondent unable to supervise her lover’s use of
J. Mohr, M.D., 77 Fed. Reg. 34998, 35000 wrote prescriptions to Agent 1 and his medication, which reflected ‘‘a
(2012). Agent 2 during those four appointments, stunning disregard for [Dr. Marrocco’s]
This is precisely what happened here. the Respondent intended to divert drugs obligations as a prescriber of controlled
Before each of the first four undercover to CI. Thus, by ‘‘providing evidence substances.’’ Id.; see Figueroa, 73 FR at
appointments, the record showing that [the Respondent] 40381 (noting that failure to see a
unambiguously shows that the knowingly diverted drugs,’’ the patient before prescribing medication
Respondent knew exactly what he deviates from the legitimate practice of
Government proved that the Respondent
would prescribe to Agents 1 and 2 medicine). Similarly, other than two
acted outside of the usual course of his
before they ever walked through his brief interactions in public places, the
door, because he knew what drugs CI 67 GE–11, at 1 (prescribing 40 units of Norco 10/ Respondent never saw CI while he was
had requested. For example, the 325 to Agent 1 at the first undercover appointment); prescribing controlled substances to
Respondent prescribed Hycodan to GE–26, at 1 (prescribing 40 units of Norco 10/325 Agent 1 and Agent 2 to divert to CI.
Agent 1, even though she was not to Agent 1 at the second undercover appointment); Therefore, the Respondent could not
GE–32 (prescribing 40 units of Norco 10/325 to
coughing during her appointment, Agent 1 at the third undercover appointment); GE–
monitor CI’s use of controlled
because he had told CI that he would get 33, at 1 (prescribing eight ounces of Hycodan to substances.
eight ounces of cough syrup to her. GE– Agent 1 at the third undercover appointment); GE– Additionally, prescribing controlled
33, at 1; GE–38, at 3–4, 8; Tr. 113. 36, at 1 (prescribing 40 units of Norco 10/325 to substances based on a patient’s request,
Following the second appointment, the Agent 2 at the fourth undercover appointment). ‘‘rather than the result of the application
68 GE–16, file 2015–03–17_13–07–36_EDT, at 7
Respondent himself acknowledged the (joking before the first undercover appointment);
of the physician’s medical judgment,’’
sham nature of the appointment; he GE–16, file 2015–03–18_11–03–33_EDT, at 4 lacks a legitimate medical purpose.
stated that he had made small talk with (same); GE–16, file 2015–04–02_15–04–43_EDT, at Golden, 61 FR at 24812 (citing
Agent 1 because ‘‘we had to be in there 1–2 (joking before the second undercover Dougherty, 60 FR 55047; Borcherding,
appointment); GE–29, at 9 (joking after the third
more than ten seconds’’ so that his and fourth undercover appointments); GE–38, at 2
60 FR 28796). The Respondent’s
‘‘nosy nurse’’ would not think, ‘‘[d]ang, (joking before the third and fourth undercover prescriptions to Agent 1 and Agent 2
why is this appointment over with in appointments). were based only on CI’s request for
ten seconds?’’ GE–27, at 1, 5. It is not 69 GE–16, file 2015–03–17_13–07–36_EDT, at 7
certain controlled substances, not on
surprising that, during Agent 1’s second (admitting fear before the first undercover any physical examination or medical
appointment); GE–16, file 2015–04–02_14–15–50_
appointment, the Respondent did not EDT, at 2 (instructing CI to keep things hidden);
evaluation. Under Mississippi
bother to conduct even a sham physical GE–17, at 2 (expressing fear before the first Administrative Rule 1.4(a), such
examination. See GE–24–25; Tr. 103–04, undercover appointment); see GE–14, at 1 prescribing establishes that the
132. (expressing fear after the first undercover Respondent lacked good faith in issuing
The facts of this case present an appointment); GE–16, file 2015–04–02_15–04–43_
EDT, at 2 (discussing avoiding detection before the
these prescriptions.
appalling and flagrant disregard of a second undercover appointment); GE–16, file 2015– For these reasons, to the extent that
registrant’s duty to prescribe controlled 04–07_13–29–34_EDT, at 2 (same); GE–16, file the Respondent’s 2015 prescriptions to
substances only to legitimate patients. 2015–04–07_18–28–45_EDT, at 7–8 (same); see also Agent 1 and Agent 2 are perceived as
While the Respondent told CI that his GE–28, file 2015–04–22_10–28–41_EDT, at 3–4
indirect prescriptions to CI, they clearly
mstockstill on DSK3G9T082PROD with NOTICES
(expressing concern about getting caught before the
feelings for her needed to be ‘‘totally third and fourth undercover appointments); GE–28, violate Mississippi Administrative
separate from [his] medical practice,’’ file 2015–04–22_13–03–23_EDT, at 4 (same); GE– Rules 1.4 and 1.16, Mississippi Code
GE–20, he was unable to follow his own 38, at 2 (same). §§ 73–25–29(3) and (13), and 21 CFR
70 See GE–16, file 2015–03–18_11–03–33_EDT, at
internal guidance. In fact, the size of the 1306.04(a), and the Government’s
2–3 (reflecting his knowledge that his actions were
Respondent’s diversion was significant: wrongful before the first undercover appointment); allegations to that effect are
during the first four undercover GE–38, at 8 (expressing his fear that he might be
appointments, the Respondent ‘‘busted’’ by the ‘‘drug police’’). 71 See supra note 43.
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![Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 54847
SUSTAINED by a preponderance of the Agent 1 immediately preceding Agent evidence test, the evidence must ‘do
evidence, and weigh in favor of the 1’s October 2015 appointment. At the more than create a suspicion of the
revocation sought by the Government. appointment, Agent 1 met with the existence of the fact to be established.’’’
In addition, the Respondent diverted Respondent, who examined her ears, Alvin Darby, M.D., 75 FR 26993, 26999
controlled substances to CI through the nose, and throat. Tr. 120, 132. The n.31 (2010) (citing NLRB v. Columbian
undercover agents after he knew that CI Respondent appeared to not remember Enameling & Stamping Co., 306 U.S.
attempted to commit suicide. Such Agent 1. Tr. 120, 135, 452; see GE–42– 292, 300 (1939)). The Government failed
actions reflect an astonishing level of 43. to meet this burden. The Government
irresponsibility in the Respondent’s Only the first portion of the offered insufficient evidence to support
prescribing activity. In McNichol, the appointment was recorded, and no a conclusion that the Respondent knew
DEA held under Factors Two and Four witnesses were able to confidently recall or should have known that, five and a
that a prescriber’s statement, which the whole conversation between Agent half months after last seeing Agent 1,
reflected concern about putting a patient 1 and the Respondent. In response to and while reviewing a new medical
potentially ‘‘in jeopardy of overdose,’’ Agent 1’s inquiry, the Respondent chart, her requests during the October
made it ‘‘clear that [the prescriber] indicated during the appointment that 2015 appointment were fraudulent.
believed that [the patient] was a drug he did not remember Agent 2. GE–42– Therefore, the Government’s allegations
abuser.’’ 77 FR at 57149. Similarly, in 43. When Agent 1 asked the Respondent that the fifth undercover appointment
Jayam Krishna-Iyer, the DEA held that if he had heard from CI lately, the violated 21 U.S.C. 841(a) and 842(a),
‘‘[a] practitioner who ignores the Respondent paused, and looked and 21 CFR 1306.04(a), because the
warning signs that [his] patients are surprised, before saying that he had not. Respondent knew or should have
either personally abusing or diverting Tr. 122–23, 135, 452–53. Agent 1 said known that Agent 1’s prescription
controlled substances commits ‘acts that she needed the ‘‘same as before,’’ requests were fraudulent are NOT
inconsistent with the public interest,’ 21 but did not tell the Respondent that she SUSTAINED.
U.S.C. 824(a)(4), even if [he] is merely had any specific complaints. GE–42–43;
gullible or naı̈ve.’’ 74 FR at 460 n.3. Tr. 454. The Respondent discussed the Allegation 5: Prescriptions Issued in
Additionally, it is ‘‘relevant that [a efficacy of medication with Agent 1. 2014 and 2015
registrant], knowing that the CI had GE–43, at 2–3. Agent 1 never said she The Government alleged that, from
been treated for drug abuse, facilitated had a cough. GE–42–43; Tr. 126, 454. February 2014 to October 2015, the
her access to controlled substances.’’ Nonetheless, the Respondent prescribed Respondent unlawfully prescribed
Golden, 61 FR at 24812. cough syrup, among other things, to controlled substances in violation of 21
Here, the facts indicate that the Agent 1. GE–45; Tr. 139. U.S.C. 841(a) and 842(a). ALJ–1, at 2.
Respondent knew his prescribing The Respondent’s medical file for Specifically, the Government alleged
actions put CI’s health in danger. The Agent 1 indicated that Agent 1 had that the Respondent prescribed
Respondent knew that CI previously ‘‘migraine headaches, as before Weather controlled substances when he knew or
had attempted to commit suicide using changes may make it worse Maxalt should have known that they were not
drugs he prescribed to her. He knew she helps most of the time Norco works prescribed for legitimate medical
was still depressed. GE–28, file 2015– okay as a backup Dry [illegible] cough; purposes, and were not written in the
04–15_21–30–59_EDT, at 9. He no [illegible] to be allergy related usual course of professional practice, in
expressed fear and concern that she Allergy symptoms Ears clear OC/OP violation of 21 CFR 1306.04(a) and
would take too many pills, resulting in clear Nose c̄ somewhat [illegible] Lungs Mississippi Code §§ 41–29–137(a)(1)
‘‘unfixably bad’’ damage and a ‘‘long, clear.’’ GE–60, at 4. The Respondent and 41–29–141(1). ALJ–1, at 2. Those
agonizing, painful way to go.’’ GE–14, at also recorded that he wrote five sections of the Mississippi Code provide
1; GE–17, at 4. In spite of all of this, the prescriptions to CI, including 30 units of that it is illegal for practitioners to
Respondent continued to divert Norco 5/325 and four ounces of dispense Schedule II controlled
controlled substances to CI and said he Hycodan. GE–60, at 4. substances without a valid written
was ‘‘glad’’ to do so. GE–19, at 1; GE– These facts summarize the totality of prescription. Miss. Code §§ 41–29–
40, at 1; Tr. 230–31. Under these the evidence before me concerning the 137(a)(1), 41–29–141(1).
circumstances, the Respondent’s October 2015 undercover appointment. Under Allegation 1, I sustained the
continued prescribing controlled of Based on these facts, I find that there is Government’s allegations that the
substances to CI reflects negatively on not substantial evidence that the Respondent’s 2014 prescriptions to CI
the Respondent’s experience in Respondent knew or should have on May 22, June 17, September 11,
dispensing controlled substances. known that Agent 1’s prescription October 6, and December 4 were outside
requests were fraudulent. The the usual course of his professional
B. Undercover Appointment #5 recordings and testimony do not clearly practice and were illegitimate
Although the Government did not indicate that Agent 1 was presenting prescriptions that violated 21 CFR
allege that the Respondent’s sham symptoms to the Respondent. 1306.04(a). Under Allegation 2, I
prescriptions to Agent 1 during the fifth Agent 1’s patient file indicated that the sustained the Government’s allegations
undercover appointment were knowing Respondent examined Agent 1, recorded that the Respondent’s 2014
attempts to divert drugs to CI, the her complaints, and recorded the prescriptions to CI on April 9, May 19,
Government alleged that the October prescriptions he gave to her. July 24, and September 8 were outside
2015 prescriptions violated 21 U.S.C. Importantly, the Government did not the usual course of his professional
841(a) and 842(a) and 21 CFR 1306.04(a) allege that the Respondent’s medical practice and were illegitimate
mstockstill on DSK3G9T082PROD with NOTICES
because the Respondent knew or should record for Agent 1 from the October prescriptions that violated 21 CFR
have known that Agent 1’s prescription appointment was deficient; it only 1306.04(a). Under Allegation 3, I
requests were fraudulent. See ALJ–1, at alleged that he knew or should have sustained the Government’s allegations
3–4. known that Agent 1’s prescription that the Respondent’s 2014
The Government presented no requests were fraudulent. The prescriptions to Kid 2 on February 7,
evidence of any communications Government bears the burden of proof July 23, September 2, and November 3,
between the Respondent and CI or on this point. ‘‘[U]nder the substantial and the Respondent’s prescriptions to
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![54848 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
Kid 1 on June 17 and November 19, this Demerol prescription was improper. issued illegitimate prescriptions to CI
were outside the usual course of his The Government did not allege or argue and others for multiple types of drugs
professional practice and were that the Respondent failed to conduct a based solely on CI’s request. The
illegitimate prescriptions that violated physical examination of CI, or failed to Government has proven that, on
21 CFR 1306.04(a). Finally, under maintain proper medical charts, when multiple occasions, the Respondent
Allegation 4, I sustained the he prescribed Demerol to CI. The knowingly issued fraudulent
Government’s allegations that the Government did not allege or argue that prescriptions with the intent to divert
Respondent’s prescriptions written the Respondent knew or anticipated that drugs to CI. The Respondent’s improper
during the first four undercover CI would attempt to commit suicide prescribing constituted an egregious
appointments in 2015 were fraudulent using the Demerol he prescribed to her. level of intentional diversion.
and violated 21 CFR 1306.04(a). The Government did not even allege or
I have held that all of these Accordingly, Factors Two and Four
argue that the Respondent possessed weigh heavily against the Respondent,
prescriptions were issued outside of the anything other than a legitimate intent
Respondent’s usual course of and the Government has established a
to treat CI’s physical symptoms when he
professional practice and were not prima facie case supporting revocation
prescribed Demerol to her. Therefore, to
issued for legitimate medical purposes. the extent that the Government alleged of the Respondent’s registration.
Therefore, the Government’s allegation that the Respondent’s Demerol Further, after evaluating all of the above
that the Respondent violated 21 CFR prescription to CI merits revocation of established facts, I find that
1306.04(a) is SUSTAINED by a his COR, the Government’s allegation is considerations of both specific and
preponderance of the evidence, and NOT SUSTAINED. general deterrence also weigh in favor of
weighs in favor of the revocation sought Under Factors Two and Four,73 the revocation in this case.
by the Government. The Government Respondent’s prescribing conduct Because the Government has made a
also established that some prescriptions indicates that his continued registration prima facie case that the Respondent’s
were invalid because CI, rather than the is not in the public interest. Therefore, continued registration would be
named patient, was the actual intended Factors Two and Four militate strongly inconsistent with the public interest, the
recipient of several prescriptions. The in favor of revocation of the
Government’s allegations that the Respondent had the burden of
Respondent’s COR. production to ‘‘present[] sufficient
Respondent’s six prescriptions to CI’s
children, identified supra, and 2015 RECOMMENDATION mitigating evidence’’ to show why he
hydrocodone combination product can be entrusted with a registration. See
Even if the Respondent had
prescriptions to the undercover agents Med. Shoppe—Jonesborough, 73 FR at
knowingly attempted to divert
at the first four undercover 387 (quoting Samuel S. Jackson, D.D.S.,
controlled substances to CI only one
appointments violated Mississippi Code time, that alone would have been 72 FR 23848, 23853 (2007)).
§§ 41–29–137(a)(1) and 41–29–141(1) sufficient to make a prima facie case for Specifically, to rebut the Government’s
are SUSTAINED.72 Because the revocation of the Respondent’s license. prima facie case, the Respondent must
Respondent issued illegitimate See MacKay v. DEA, 664 F.3d 808, 819 have both accepted responsibility for his
prescriptions, the Government’s (10th Cir. 2011). ‘‘[P]roof of a single act actions and demonstrated that he would
allegations that the Respondent violated of intentional or knowing diversion is not engage in future misconduct.
21 U.S.C. 841(a) and 842(a) are sufficient to satisfy the Government’s Stodola, 74 FR at 20734–35. However,
SUSTAINED by a preponderance of the prima facie burden of showing that a the Respondent offered no evidence 74
evidence, and weigh in favor of the practitioner’s continued registration is that he accepted responsibility for his
revocation sought by the Government. inconsistent with the public interest, misconduct or reformed his ways.
Allegation 6: Meperidine Used in and if unrebutted by a showing that the Therefore, the Respondent failed to
Suicide Attempt practitioner accepts responsibility for rebut the Government’s prima facie
The Government alleged that the his misconduct and will not engage in case.
Respondent prescribed 30 dosage units future misconduct, warrants the Because the Government proved that
of meperidine 50 mg to CI, which she revocation of a registration.’’ McNichol, the Respondent’s registration is
used to try to kill herself. ALJ–1, at 3. 77 FR at 57145 (internal citations
inconsistent with the public interest,
The evidence shows that the omitted); see also Krishna-Iyer, 74 FR at
and because the Respondent failed to
Respondent prescribed Demerol to CI on 462–64; Alan H. Olefsky, 57 FR 928,
rebut the Government’s prima facie
September 2, 2014. GE–2, at 12; GE–49, 928–29 (1992). In cases of knowing
diversion, ‘‘the [DEA] has an interest in case, I RECOMMEND that the
at 2; Tr. 222, 296–97, 317–18, 382. The Respondent’s DEA Certificate of
Respondent appears to have been the deterring [the Respondent] and others
from engaging in similar egregious Registration be REVOKED and any
only person to prescribe Demerol to CI. applications for renewal or modification
See GE–49. CI used the Demerol to behavior.’’ Michael A. White, M.D., 79
FR 62957, 62967 (2014). of his license be DENIED.
attempt to commit suicide in December
2014. Tr. 222, 315–17. The Government, Here, the Government has proven far Dated: June 1, 2016
however, did not specify or argue why more than one act of knowing diversion. s/Charles Wm. Dorman
The Government has proven that the
72 Hydrocodone combination products were Respondent repeatedly and continually Administrative Law Judge
[FR Doc. 2016–19595 Filed 8–16–16; 8:45 am]
reclassified by the federal government as Schedule
mstockstill on DSK3G9T082PROD with NOTICES
II controlled substances as of October 6, 2014. Stip. 73 Both parties specifically discussed Factor Five BILLING CODE 4410–09–P
6. The Government has not shown how in their post-hearing briefs. Factor Five considers
hydrocodone combination products are scheduled conduct not otherwise addressed under Factors One 74 The Government requested that I draw an
in the state of Mississippi. The Government’s through Four. 21 U.S.C. 823(f)(5). As discussed
allegations that the Respondent’s prescriptions supra, the Respondent’s actions in this case are adverse inference against the Respondent because
predating October 6, 2014, violated Mississippi most appropriately analyzed under Factors Two of his failure to testify at the hearing. ALJ–35, at 27–
Code §§ 41–29–137(a)(1) and 41–29–141(1), which and Four. Therefore, consideration of this conduct 28. However, I decline to do so because an adverse
only address Schedule II controlled substances, are under Factor Five, the ‘‘catch-all’’ factor, is inference is unnecessary in light of the
NOT SUSTAINED. inappropriate. overwhelming evidence against the Respondent.
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Document Created: 2018-02-09 11:35:07
Document Modified: 2018-02-09 11:35:07
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| FR Citation | 81 FR 54822 |
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