80 FR 28695 - Annicol Marrocco, M.D.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 96 (May 19, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 96 (May 19, 2015)
| Page Range | 28695-28706 | |
| FR Document | 2015-12035 |
[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)] [Notices] [Pages 28695-28706] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12035] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 13-34] Annicol Marrocco, M.D.; Decision and Order On May 17, 2013, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Annicol Marrocco, M.D., (hereinafter, Respondent), of Mahwah, New Jersey. ALJ Ex. 1. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration BM8059102, which authorized her to dispense controlled substances in schedules II through V, at the registered address of Olean General Hospital, 515 Main Street, Olean, New York 14760, on the ground that her ``continued registration is inconsistent with the public interest.'' Id. (citing 21 U.S.C. 823(f) and 824(a)(4)). The Show Cause Order specifically alleged that between January 2008 and August 2009, Respondent issued approximately twenty-one prescriptions to S.C. for oxycodone, a schedule II controlled substance, ``outside the usual course of professional practice and for other than a legitimate medical purpose.'' Id. (citing 21 U.S.C. 841(a) and 21 CFR 1306.04(a)). The Show Cause Order further alleged that Respondent failed to maintain medical records supporting the prescriptions, in violation of Florida law; that she was in a personal relationship with S.C.; and that she ``did not examine S.C. except to [[Page 28696]] listen to his heart and lungs.'' Id. at 1-2, 4-5 (citing Fla. Admin Rule 64B8-9.003 and 64B8-9.013). Next, the Show Cause Order alleged that Respondent had failed to both date and include S.C.'s address on multiple prescriptions, in violation of 21 CFR 1306.05(a). Id. at 2. The Show Cause Order then alleged that Respondent had violated DEA regulations that, while allowing a practitioner to issue multiple prescriptions for a schedule II controlled substance, limit the quantity of the prescriptions to a 90-day supply, require that a prescription include the earliest date on which it can be filled, and require that each prescription be issued for a legitimate medical purpose. Id. at 2-4 (citing 21 CFR 1306.12(b)(1)). Next, the Show Cause Order alleged that Respondent ``violated Federal law on at least forty-nine occasions'' by issuing controlled substance prescriptions while practicing as a contract emergency room physician at the Northern Navajo Medical Center in Shiprock, New Mexico, while being registered in New York. Id. at 5. The Government further alleged that ``[i]ssuing controlled substance prescriptions in one state under a DEA registration issued for another state is a violation of 21 U.S.C. 822(e) . . . which require[s] separate registrations for separate locations.'' Id. (also citing 21 CFR 1301.12(a) & (b)(3)). The Government also alleged that Respondent knowingly and willfully violated these provisions, alleging that ``DEA personnel informed you and your attorney that to move your DEA registration to New Mexico you must first be properly licensed to practice medicine in New Mexico'' and that she ``ha[s] never held a New Mexico medical license.'' Id. Finally, the Show Cause Order alleged that Respondent ``no longer maintain[s] a medical practice at [her] registered address'' and that she violated DEA regulations by ``[f]ail[ing] to keep [her] registered address current with the'' Agency. Id. (citing 21 CFR 1301.51). Respondent timely requested a hearing on the allegations; the matter was then placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge Christopher B. McNeil (hereinafter, ALJ). ALJ Ex. 2. Following pre-hearing procedures, the ALJ conducted a hearing on August 21 and September 11, 2013, at which both parties called witnesses to testify and introduced documentary evidence. Following the hearing, both parties submitted briefs containing their proposed findings of fact and conclusions of law. On November 12, 2013, the ALJ issued his Recommended Decision. Therein, the ALJ found that the Government had established a prima facie case that Respondent's continued registration would be inconsistent with the public interest and that she had failed to rebut the Government's showing. R.D. at 75. The ALJ thus recommended that Respondent's registration be revoked. Id. With respect to factor one--the recommendation of the state licensing authority--the ALJ found that ``Respondent has a history of substantial and material disciplinary action taken by the medical licensing boards of three states'' and that the boards of Florida and New York have ``permanently limit[ed] [her] authority to prescribe controlled substances.'' Id. at 72. The ALJ thus concluded that ``maintaining Respondent's unrestricted DEA registration would be inconsistent with the public interest.'' Id. With respect to factor two--Respondent's experience in dispensing controlled substances--the ALJ found ``that despite eighteen years of experience as an emergency medicine physician, Respondent lacked the experience necessary to identify and appropriately respond to drug- seeking behavior.'' Id. The ALJ also found that Respondent ``lacked the experience necessary to appreciate the need to contact the DEA when questions arose regarding the need for in-state certification after she relocated her principal place of business or professional practice from New York to New Mexico.'' Id. The ALJ thus found that factor two supports a finding that Respondent's continued registration is ``inconsistent with the public interest.'' Id. As for factor four--compliance with applicable laws related to controlled substances--the ALJ found that Respondent violated 21 CFR 1306.04(a) by issuing multiple prescriptions for schedule II controlled substances, including OxyContin and oxycodone to S.C., while in a personal relationship with him, and that she acted outside the usual course of professional practice in issuing the prescriptions and lacked a legitimate medical purpose. R.D. 69-70. The ALJ further found that: (1) Respondent issued the prescriptions ``without maintaining medical records or justifying the prescriptions in violation of 21 CFR 1306.04(a)''; (2) Respondent issued OxyContin prescriptions, which were undated, in violation of 21 CFR 1306.05(a); (3) Respondent issued OxyContin prescriptions, which ``lacked the patient's address, in violation of 21 CFR 1306.05(a)''; (4) Respondent issued multiple prescriptions for schedule II controlled substances which lacked ``the earlier date on which'' the prescription could be filled, in violation of 1306.12(b)(1); and (5) Respondent violated the State of Florida's ``Standards for the Use of Controlled Substances for the Treatment of Pain,'' as well as the State's regulation regarding the adequacy of medical records. Id. at 73. The ALJ further concluded that ``[i]ssuing controlled substance prescriptions in one state under a DEA registration issued for practice in another state is a violation of 21 U.S.C. 822(e) and 21 CFR 1301.12(a) and (b)(3).'' Id. at 74. While noting that an Agency regulation exempts an official of various federal agencies and the armed forces from these requirements, the ALJ found that because Respondent was a contract-physician she was not exempt under the regulation. Id. Based on his finding that ``[b]etween December 28, 2012 and June 8, 2013, Respondent issued prescriptions for controlled substances from her principal place of business or professional practice in Shiprock, New Mexico,'' while ``using the DEA registration that was issued to her for her practice in New York,'' the ALJ concluded that Respondent violated these provisions. Id. The ALJ thus found that factor four supports a finding that Respondent's continued registration ``would be inconsistent with the public interest.'' Id. The ALJ further found that factor five--such other conduct which may threaten public health and safety--supports the conclusion that Respondent's continued registration ``would be inconsistent with the public interest.'' Id. at 74-75. As support for his conclusion, the ALJ found that Respondent lacked ``candor with the'' Agency, that she ``willful[ly] fail[ed] to determine her obligations when relocating from New York to New Mexico,'' and that she ``refus[ed] to cooperate with the [Agency's] inquiry regarding liability issues in her renewal application.'' Id. at 75. Finally, the ALJ found that Respondent ``failed to affirmatively acknowledge specific acts of improper prescribing,'' as well as that she had ``failed to establish by credible and substantial evidence effective steps taken in remediation as would warrant a sanction other than revocation.'' Id. The ALJ thus found that ``the Government has established cause to revoke Respondent's . . . registration.'' Id. Both parties filed exceptions to the ALJ's Recommended Decision. Having [[Page 28697]] considered the record in its entirety, including the parties' exceptions, I conclude that the Government has established that granting Respondent's application would be inconsistent with the public interest and that Respondent has failed to rebut the Government's prima facie case. Accordingly, I will adopt the ALJ's recommendation that I deny any pending application for a new registration. I make the following factual findings. Findings Respondent's Licensure Status, the State Board Actions, and Registration Status Respondent is a board-certified physician in emergency medicine. See RX A, at 2. Respondent completed her residency in emergency medicine in 1998 and since then has worked at hospitals in New Jersey, Pennsylvania, New York, Florida, and New Mexico. Id. at 1-2. While Respondent holds an active license in New York, Florida, and Pennsylvania, she has been disciplined by the medical boards of each of these States, based on her prescribing of controlled substances to S.C., with whom she had a personal relationship while she was practicing in Florida. See GX 9, 11, 12, 13. In the Settlement Agreement she entered into with the Florida Board, ``Respondent neither admit[ted] nor denie[d] the allegations of fact contained in the [Board's] Administrative Complaint.'' GX 8, at 2. However, she did ``admit[] that the facts alleged in the Administrative Complaint, if proven,\1\ would constitute violations of Chapter 458, Florida Statutes, as alleged in the Administrative Complaint.'' Id. --------------------------------------------------------------------------- \1\ These allegations largely track what the Government alleged and I find proved in this matter. See GX 7, at 1-7. --------------------------------------------------------------------------- More specifically, the State alleged that ``Respondent failed to meet the prevailing standard of care in regard to Patient S.C. in one or more of the following ways.'' GX 7, at 9. The State alleged that Respondent ``fail[ed] to adequately assess and/or diagnose Patient S.C. with chronic pain,'' ``fail[ed] to appropriately treat . . . S.C.,'' ``fail[ed] to use alternative treatment methods,'' ``prescrib[ed] S.C. an inappropriate and/or excessive quantity of [R]oxicodone, oxycodone, and/or OxyContin,'' ``fail[ed] to obtain laboratory results and/or diagnostic scans to collaborate [sic] or monitor S.C.'s condition,'' and ``fail[ed] to properly monitor and/or follow up on . . . S.C.'s condition.'' Id. at 9-10 (citing Fla. Stat. Sec. 458.331(1)(t)). The State further alleged that ``Respondent prescribed [R]oxycodone, oxycodone, and/or OxyContin to Patient S.C., in an inappropriate manner and/or in excessive quantities, which is outside the course of Respondent's professional practice.'' Id. at 11-12. The State thus alleged that Respondent violated Florida law ``by prescribing controlled substances other than in the course of her professional practice.'' Id. at 12 (citing Fla. Stat. Sec. 458.331(1)(q)). Finally, the State alleged that Respondent violated Florida law by ``fail[ing] to maintain complete medical records that justify the course of treatment [that she] provided to . . . S.C.'' Id. at 10; see also id. at 11 (citing Fla. Stat. Sec. 458.331(1)(m)). Pursuant to the Settlement Agreement she entered into with Florida, Respondent received a letter of concern, was fined $5,000, and was required to reimburse the Florida Department of Health's costs of investigating and prosecuting the matter in an amount between $5,587.55 and $6,587.55. GX 8, at 2-3. Respondent was also required to perform 25 hours of community service, as well as to attend ten (10) hours of Continuing Medical Education (CME) in ``Appropriate Prescribing Practices'' and two (2) hours of CME in ``Proper Medical Record Keeping.'' Id. at 4-5. Finally, the Board prohibited Respondent from ``prescrib[ing] controlled substances to persons with whom [she] is in a personal, familial or non-familial, relationship.'' GX 8, at 2-5.\2\ --------------------------------------------------------------------------- \2\ Based on the Florida Board's action, New York State Board for Professional Medical Conduct imposed a ``Censure and Reprimand,'' prohibited her from prescribing to persons with whom she is in a relationship, placed her on probation for three years, and fined her $1500. GX 11. Also, based on the actions of the Florida and New York Boards, the Pennsylvania State Board of Medicine imposed a $5000 civil penalty on her. GX 13. --------------------------------------------------------------------------- As of the hearing, Respondent was working as a contract physician at the Northern Navajo Medical Center, a facility of the Indian Health Service (IHS), which is located in Shiprock, New Mexico; Respondent has worked at this hospital since August 2012. RX A, at 1; Tr. 163. Respondent is not licensed to practice medicine by the State of New Mexico. RX A, at 2. Respondent also held DEA Certificate Registration BM8059102, pursuant to which she was authorized to dispense controlled substances in schedules II through V, at the registered location of Olean General Hospital, 515 Main St., Olean, New York 14760. GX 20, at 1. This registration had an expiration date of January 31, 2015. Id. On December 31, 2014, Respondent applied for a renewal of this registration and sought to change her registered location to the Northern Navajo Medical Center, P.O. Box 160, Highway 491 North, Shiprock, New Mexico. See Government's Notice of Respondent's Filing of Renew Application and Change of Address Request, at 6-8. Thereafter, on January 23, 2015, Respondent submitted a letter seeking to change her registered location to Doctors Express Urgent Care, 1444 W. Passyunk Ave, Philadelphia, PA. Id. at 8. However, at the time Respondent submitted her renewal application, the Agency had issued the Order to Show Cause. A DEA regulation applicable to an applicant who has been served with an Order to Show Cause provides: In the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least 45 days before the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Administrator so issues his/her order. The Administrator may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for reregistration at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Administrator finds that such extension is not inconsistent with the public health and safety. 21 CFR 1301.36(i). Respondent did not file her renewal application more than 45 days before her registration was due to expire and thus her registration was not automatically extended pending the issuance of this Decision and Final Order. Based on my review of the record in this matter, I further conclude that the extension of her registration would be ``inconsistent with the public health and safety.'' Id. Accordingly, I hold that her registration expired on January 31, 2015. See Ralph J. Chambers, 79 FR 4962 (2014) (citing Paul H. Volkman, 73 FR 30630, 30641 (2008)). However, I conclude that her application remains pending before the Agency. See id. The Allegations That Respondent Unlawfully Prescribed Controlled Substances to S.C. Between February 2007 and August 2009, Respondent worked as an ER physician at the Physicians Regional Medical Center in Naples, Florida. RX A, at 1. According to Respondent, in August 2007, she met S.C., a budding reality TV star, when he came to the ER [[Page 28698]] with a broken hand and she treated him by splinting his hand and prescribing Percocet to him.\3\ Tr. 207-08. A week or two later, Respondent was told by an x-ray technician that S.C. worked for Ticket Master and that he was hosting a fund-raising event at a local coffee shop. Id. at 211. Respondent went to the coffee shop to see if she could get tickets from S.C for an upcoming football game. Id. Thereafter, Respondent and S.C. entered into a personal relationship. Id. --------------------------------------------------------------------------- \3\ Over the Government's objection, the ALJ allowed Respondent to testify by telephone from her lawyer's office, rather than in person or by appearing at a DEA facility which has Video- Teleconferencing (VTC) capability. Gov. Exceptions, at 2-6. The Government took exception to this ruling. While the Government makes no claim that Respondent's counsels acted improperly at any time during her testimony, it is manifest that where a witness is allowed to testify by telephone, notes could be passed to the witness during the testimony without the ALJ or Government Counsel ever being aware of this. So too, the use of telephone testimony raises a greater risk that during breaks in the proceeding, the witness could discuss her testimony with others. I find the Government's exception to be well taken. This is not to say that every witness must testify either in person or by VTC. However, a respondent will invariably be a highly important, if not the most important witness in a proceeding, and thus, under no circumstance is it proper to allow a respondent to testify by telephone. As for other witnesses, with the exception of a witness who testifies only as to the authentication or foundation of proposed exhibits, the taking of testimony by telephone is disfavored and may be used only upon a showing that exceptional circumstances exist and that the failure to obtain a witness's testimony will result in a denial of due process. --------------------------------------------------------------------------- Respondent did not prescribe any controlled substances to S.C. until January 18, 2008, when she wrote him a prescription for 90 tablets of oxycodone 30mg. GX 1, at 1. Respondent did not recall exactly where she wrote the prescription (this having occurred at either her home or S.C.'s) but acknowledged that it was not at either of the hospitals (both of which were located in Fort Myers, Florida) which were listed on the prescription form she used. Tr. 213. When asked whether she performed a physical exam on this occasion, Respondent testified: I conducted a physical exam. I don't know if it was on that specific date, but prior to me issuing this prescription, I had gotten to know him very well, and I learned more about his chronic pain syndrome, and he was a smoker. So, I did, I had listened to his heart and lungs many times before.\4\ --------------------------------------------------------------------------- \4\ At several other points in her testimony, Respondent described the physical exam as listening to S.C.'s heart and lungs, and made no reference to any other tests she did. For example, when asked ``How often did you perform a physical examination of S.C. in the course of issuing prescriptions to him?,'' she answered: I can't say for certain, but I did listen--like I said, I mean, he was a smoker, so I did listen to his . . . heart and lungs, which is one of the main exams on a physical, on a regular basis, because I usually had my stethoscope with me, and you know, whenever I saw him, I just did a general, you know--was able to generally assess his overall health and well-being, just from interacting with him and speaking to his family. Tr. 244-45. Notably, only after Respondent was asked by the Government if she specifically examined S.C.'s back and neck did she assert that she palpated him ``along the spine and surrounding areas.'' Id. at 263. Id. When then asked by the Government if subsequent to the August 2007 ER visit, she ``had met with him in a clinical capacity prior to'' --------------------------------------------------------------------------- issuing the January 18 prescription, Respondent answered: I don't understand what you mean, clinical capacity. We developed a friendship, and we . . . were involved in a relationship, at that time. So, you know, I had gotten to know him personally. I knew his family, and you know, we had discussed a lot of his medical conditions, I had discussed with him and his family. Id. When then asked where she had conducted her physical examinations of S.C., Respondent stated ``[e]ither by my home or his home.'' Id. 215. When asked how she had assessed his pain level, Respondent testified: ``Just by asking him and just seeing how his overall well- being was.'' Id. at 215-16. Respondent then asserted that S.C. had told her that ``he was in excruciating pain. He couldn't function without being on his pain medicine.'' Id. at 216. Respondent admitted, however, that she did not create ``any formal records'' for the prescriptions. Id. Nor did she create a written treatment plan for S.C. Id. at 218. She further admitted that she did not order any additional tests, because she was ``work[ing] outside [the] emergency department'' and that ``that was already conducted by his pain management specialist.'' Id. at 232-33. When then asked what was the medical purpose of the prescription, Respondent testified that S.C. ``was in a pain management clinic, up until about November or December of 2007, and he was transitioning. He said he lost his medical insurance. He was trying to find a new treating physician for his chronic pain.'' Id. at 216. According to Respondent, S.C. told her that he had back fractures and neck injuries from doing acting stunts and motorcycle racing. Id. at 246. Respondent further explained that S.C. was ``starting to do a lot of traveling at that time'' as he was auditioning for various ``acting jobs,'' and that he asked her if she could help him out until he could get insurance and ``see another provider.'' Id. at 216-17; 234. According to Respondent, she looked at the labels of the prescriptions S.C. had received from the pain management specialist who had previously treated him and ``then copied the prescription off the bottles.'' Id. at 217. Respondent further denied having made a diagnosis of chronic pain, stating that ``that was established already'' by S.C.'s ``prior physician[].'' Id. at 229. While Respondent admitted that she ``was not familiar with treating chronic pain,'' she did not contact the pain management doctor who had previously treated S.C., explaining that S.C. had told her that ``he was no longer involved with his care, and he did not wish to . . . see that physician any longer.'' Id. at 218-19. Respondent explained that she relied on what S.C. and his family had told her, as well as some of his medical records, although she did not look through all of his records. Id. When then asked how she knew that his prior physician would have continued S.C. on controlled substances, Respondent answered that ``[w]hen you're on controlled substances you just don't stop . . . you have to go through either a weaning process or--that's why it requires a specialist to . . . continue treating once you're up to a certain number of high dose pain medication.'' Id. at 234-35. She also claimed that his family told her that S.C. did not have a history of substance abuse. Id. at 232. Respondent acknowledged that it ``was [her] error'' to accept S.C.'s word instead of contacting his prior physician. Id. at 219. She further maintained that she trusted S.C., that ``his family backed up his story,'' and that she had ``no reason to believe at the time'' that she ``was being deceived.'' Id. at 220. She also stated that she was in ``a very good friendship'' with S.C. and that over time, she ``lost the physician/patient relationship'' and ``was not objective.'' Id. On or about February 7, 2008, Respondent wrote S.C. three undated prescriptions for OxyContin 80mg.\5\ See GX 1, at 3, 5, and 7. The prescriptions, which authorized the dispensing of 100 dosage units q12h, 200 dosage units q8h, and 100 dosage units q8h, all lacked S.C.'s address. See id. Moreover, none of the prescriptions listed ``the earliest date on which'' it could be filled as required by 21 CFR 1306.12(b)(1)(ii). See id. Based on Respondent's dosing [[Page 28699]] instructions, the prescriptions provided S.C. with 149 days' supply of the drug. --------------------------------------------------------------------------- \5\ The prescriptions were written on the prescription forms of the Physicians Regional Medical Center and were sequentially numbered from 007424 through 007426. GX 1, at 3-7. While the prescriptions were undated, the evidence shows that prescription number 007425 for 200 OxyContin 80mg. was filled on February 7, 2008. Id. at 4. --------------------------------------------------------------------------- The evidence further shows that S.C. filled the prescription for 200 tablets at a cost of $2,328.00. Id. at 4. Yet Respondent repeatedly claimed that she ``was trying to offer a short-term, fix for his situation'' because ``[h]e was short on money,'' Tr. 236, even though he was working at a local radio station. Id. at 238-39. Respondent further claimed that S.C. had told her that an office visit with a pain management specialist cost ``about $400 or $500'' not counting the cost of any prescriptions, and that she trusted what he told her. Id. at 239. She also claimed that she was unfamiliar with the cost of various drugs. Id. at 237. Regarding the OxyContin 80mg prescriptions, Respondent stated that she had ``probably not'' physically examined S.C. ``because [she] had done it in the past.'' Tr. 231. Respondent then claimed that she had assessed S.C.'s pain level by ``his appearance and how he would tell me he was feeling.'' Id. Respondent did not create a record for the prescriptions. Id. at 231-32. Notwithstanding the quantity of drugs provided by these prescriptions, on or about March 10, 2008,\6\ Respondent issued S.C. three more prescriptions, each of which was for 450 oxycodone 30mg, with a dosing instruction to take up to 15 tablets per day ``as needed for pain.'' GX 1, at 9, 11, and 13. As before, the prescriptions were not dated, did not include S.C.'s address, and lacked the earliest date on which they could be filled.\7\ Id. The evidence further shows that S.C. filled each of the prescriptions on March 10, 2008, and paid $280.74 for each one. Id. at 10, 12, and 14. --------------------------------------------------------------------------- \6\ Here again, the prescriptions were written on the forms of the Physicians Regional Medical Center and were numbered 009325, 009326, and 009329. GX 1, at 9, 11, and 13. \7\ If the drugs were actually taken at fifteen tablets per day, the prescriptions would have provided an additional 90 days' supply. --------------------------------------------------------------------------- Here again, Respondent could not state ``for certain'' that she performed a physical exam on S.C. when she issued these prescriptions. Tr. 244. However, Respondent testified that she issued the prescriptions at S.C.'s home because ``this was when he was getting ready to go to Los Angeles for his acting job.'' Id. at 245. She also testified that she assessed S.C.'s pain level by ``[j]ust interacting with him, asking how he was feeling,'' and by S.C. letting her know whether he ``was having a good day or a bad day.'' Id. at 245-46. As for why she did not date the prescriptions and include S.C.'s address, Respondent testified that: I know I was very distracted when I would write the prescriptions, because it was either at his home or my home, and he had a three- year-old child. It was usually--it was usually at his home. He had a three-year-old, or a four-year-old, at the time. There were two dogs, a monkey in the house. There was a loud . . . his father was hard of hearing, so . . . the TV was on very loud, and it was a very distracting environment. I don't . . . you know, I cannot explain exactly why the date wasn't on them, because I know that the date needs to be on them. So, I can just . . . go back in my mind and know that it was very distracting. Tr. 222. Later in her testimony, Respondent explained that S.C. had two German Shepherds, and that there was also a mutt (which he apparently did not own) that was allowed to come into the house. Id. at 340. And then there was the monkey, which according to Respondent, was ``three or four feet'' tall and ``dangerous,'' but was nonetheless allowed to run free in the house. Id. at 340-41. As for why she had written the three oxycodone 30mg prescriptions which were filled on March 10, Respondent offered the following testimony: I'm just trying to recall, because also, on multiple times, I was told the prescriptions were either lost or destroyed by the animals in the house, by the monkey . . . the monkey was . . . he would take the pill bottle, open it, and throw it in the pool, or you know, various different times . . . I was told that they were lost or stolen or left behind at the different hotels he was staying at. I just can't--you know, it's unclear, which set of prescriptions it may have occurred with, but it happened on numerous occasions, which is why there is [sic] a number of prescriptions. Id. at 240-41. Respondent further maintained that S.C.'s stories regarding the monkey were believable because he ``would try to rip up my clothes and my shoes and he would take anything and just try to shred it.'' Id. at 341. As a further reason for why she wrote the multiple prescriptions, Respondent explained that there were occasions in which S.C. would call and tell her that the pharmacy was either ``out of stock for a particular brand name or particular dosage.'' Id. at 241; see also id. at 245 (``this was around the time where he told me the prescriptions were being destroyed or lost or left at one pharmacy or another, because they weren't in stock''). At this point, S.C. apparently left the area and went off to pursue his acting career. Tr. 227. As for why she had issued the multiple OxyContin prescriptions, Respondent testified that S.C. had told her that he was going to be in Los Angeles for ``three to six months'' to film a show for MTV and ``he wanted to make sure he didn't run out of pain medication while he was there.'' Id. She also testified that she was unaware that she could write ``do not fill until a certain date'' on the prescriptions. Id. Following his appearance on the MTV show and his return to Florida (sometime around October 2008), S.C. was ``getting a lot of opportunities to travel, to do commercials, to do auditions,'' and contracts. Id. at 249. According to Respondent, S.C. asked her if she could continue to help him out ``because he was doing a lot of travelling'' and it was hard for him to find ``a physician in a different state.'' Id. Respondent agreed to do so and resumed prescribing to him. In her testimony, Respondent did not explain why given S.C.'s success, he could not afford health insurance and find a pain management specialist. On January 20, 2009, Respondent resumed prescribing to S.C., issuing him a prescription for 40 Roxicodone 30mg, with a dosing instruction of TID or one tablet, three times a day. GX 1, at 15. Between February 3 and March 6, 2009, Respondent issued S.C. the following prescriptions, all of which had a dosing instruction of TID, or one tablet three times a day: ------------------------------------------------------------------------ Date Drug and quantity ------------------------------------------------------------------------ 2/3/09............................ 90 Roxicodone 30mg. 2/3/09............................ 90 Roxicodone 30mg. 2/9/09............................ 90 Roxicodone 30mg. 2/9/09............................ 90 Roxicodone 30mg. 2/9/09............................ 90 Roxicodone 30mg. 2/10/09........................... 90 Roxicodone 30mg. 2/10/09........................... 90 Roxicodone 30mg. 2/10/09........................... 90 Roxicodone 30mg. 2/20/09........................... 90 Roxicodone 30mg. 2/20/09........................... 90 Roxicodone 30mg. 3/6/09............................ 90 Roxicodone 30mg. 3/6/09............................ 280 Roxicodone 15mg. ------------------------------------------------------------------------ See GX 1, at 17-35. Based on Respondent's dosing instruction of TID, a single oxycodone 30mg prescription would have provided S.C. with a thirty-day supply; thus, a single prescription issued on February 3rd, should have lasted him through March 5th.\8\ However, the prescriptions Respondent wrote S.C. between February 3 and March 6 authorized the dispensing of 990 tablets of oxycodone 30mg, an eleven-month supply; the prescription for 280 oxycodone 15mg [[Page 28700]] provided S.C. with more than another 1.5 month's supply of the drug. --------------------------------------------------------------------------- \8\ It is acknowledged that the pharmacy which filled one of the February 3, 2009 prescriptions dispensed only 54 tablets on that date. GX 1, at 17-18. However, even if S.C. was unable to obtain the remaining 46 tablets from the pharmacy within 72 hours as required by DEA's regulation, see 21 CFR 1306.13(a), Respondent did not explain why it was necessary to write S.C. a second prescription on that date for a full 90 tablets. --------------------------------------------------------------------------- As for why Respondent issued multiple prescriptions on February 3, 2009, Respondent testified that ``that they were not in stock at the particular pharmacy that he initially went to,'' so S.C. ``called me or told me that he had left the prescription [and] needed a new one, so he could bring it to whatever other pharmacy he was using.'' Tr. 251. However, the evidence shows only that the pharmacy partially filled the prescription in the amount of 54 tablets. GX 1, at 17. Respondent then asserted that she ``never realized that [the prescriptions] were being filled'' and that she ``thought they were either being destroyed'' or ``not being filled at all.'' Id. at 251-52. However, Respondent never called any of the pharmacies S.C. used and ``never got word from the pharmacist that they were being filled.'' Id. at 252; see also id. at 241 (``I was never phoned by any of these pharmacists, telling me that these prescriptions were being filled. I had no idea, because I did not have any records of the number of prescriptions I wrote.''). Respondent then testified that she did not find S.C.'s claim suspicious because in the ER, ``there were multiple times where patients would'' complain that a pharmacy would not have a particular narcotic or dosage. Id. at 252. When asked why the pharmacies would not have just returned the prescriptions to S.C. if the drug was out of stock, Respondent testified that she thought ``that is how they operated down there'' and added that she ``was new to the State.'' Id. at 253. However, Respondent has been licensed in Florida since August 2004 and had worked there since at least December 2004.\9\ RX A, at 1- 2. Respondent could not recall whether she had ever had another patient ask for a replacement prescription claiming that a pharmacist had said a drug was out of stock and yet kept the prescription. Id. at 254-55. --------------------------------------------------------------------------- \9\ Prior to working in Naples, Respondent worked at a hospital in Fort Myers. RX A, at 1-2. --------------------------------------------------------------------------- Regarding the February 3, 2009 prescriptions, Respondent again could not recall if she had done a physical examination. Id. at 255. While Respondent claimed that she had assessed S.C.'s pain level in the same manner as before, she admitted that she did not create a medical record or a written treatment plan. Id. at 255-56. Nor could she specifically recall if, on this occasion, she had discussed the risks and benefits of using controlled substances. Id. at 256. As for why she issued three prescriptions on February 9, 2009 instead of a single prescription for 270 tablets, Respondent answered that ``[t]he particular pharmacy . . . didn't have that quantity in stock'' so she split the prescriptions. Id. at 260-61. Again, Respondent could not recall if she had conducted a physical exam on S.C. on this date, id. at 262, and acknowledged that she did not create a medical record for these prescriptions or a written treatment plan. Id. at 264. She claimed, however, that she had assessed his pain level in the same manner as before, and that she had discussed the risks and benefits of using controlled substances on this occasion. Id. at 265, 273. Respondent further testified that she used the same approach in assessing S.C.'s need for oxycodone for all of the prescriptions (other than the one she wrote during his ER visit). Id. at 274. Moreover, when asked why she had issued these three prescriptions given that she had issued two similar prescriptions only six days earlier, Respondent testified that she believed that S.C. had begun having seizures and was becoming forgetful. Id. at 266. Continuing, Respondent testified that: ``I believe he was--he may have been having seizures, which I found out in May, when I went over [to] his house . . . and he was acting confused . . . and he was in a post-seizure state . . . and I . . . told [his] mom that he was having seizures.'' Id. at 266-67. However, Respondent then testified that ``this was actually in--it was around May.'' Id. at 267.\10\ Still later in her testimony, Respondent explained that ``it was my understanding that he was being truthful and they were truly lost or misplaced or destroyed or left at the pharmacist and never filled. Id. at 274. --------------------------------------------------------------------------- \10\ The evidence shows that S.C. was hospitalized for seizures on two occasions, May 28, 2009, and July 3, 2009. See GX 15 & 16. --------------------------------------------------------------------------- The evidence shows that the two February 3 prescriptions were filled on February 3 and 5, and that three February 9 prescriptions were filled on February 9, 11, and 16. GX 1, at 18, 19, 21, 23, and 25. So too, the evidence shows that the three prescriptions Respondent wrote on February 10, were filled on February 13, 14, and 17; the two prescriptions she wrote on February 20, were filled on February 21 and 25; and the two prescriptions she wrote on March 6, were filled on March 6 and 9. See id. at 26-35. On questioning by her counsel, Respondent testified that she did not become aware that S.C. had been arrested for doctor-shopping ``until after the case was already over.'' Tr. 348-49. On further questioning by her counsel, and inconsistent with her earlier testimony that the last prescription she wrote for S.C. was in August 2009, id. at 267, Respondent denied having written S.C. any more prescriptions ``after the last emergency room visit.'' Id. at 349. Yet the evidence shows that S.C.'s last ER visit was on July 3, 2009, see GX 15, and the evidence further shows that on July 31, 2009, Respondent issued S.C. a prescription for 30 Roxicodone 15mg. GX 1, at 36. The evidence further showed that Respondent and S.C. drove to a Publix pharmacy where the prescription was filled. Tr. 97-98. Respondent remained in the car while S.C. went in to the store to fill the prescription. Id. at 98. According to the pharmacist, ``S.C. was very chatty and used a lot of small talk'' about being on a reality TV show ``as if he was trying to distract'' her. Id. at 97, 105. After the pharmacist handed the filled prescription to S.C., he ``eagerly took the prescription . . . and quickly headed to the back of the store.'' Id. at 97. Finding S.C.'s behavior suspicious, the pharmacist called the hospital ER to verify the prescription and was told that Respondent was under investigation and was asked to fax the prescription to the ER and to call the sheriff. Id. at 101. The pharmacist then asked an assistant store manager to go into the bathroom and check on S.C. GX 6. While the pharmacist was still on the phone, S.C. reappeared at the pharmacy counter and asked if there was a problem with the prescription. Tr. 98. The pharmacist told S.C. that she ``need[ed] to clarify the prescription and'' asked him if she could have it back; S.C. complied. Id. The pharmacist then counted the tablets and found that two were missing. Id. S.C. then told the pharmacist that ``if there are any questions regarding this prescription the doctor is my girlfriend and she is out in the car.'' Id. The pharmacist then proceeded to the parking lot and found Respondent in a car; the pharmacist asked Respondent for her driver's license, and after determining that it was Respondent, asked if she had written the prescription. Id. Respondent ``said `yes.''' Id. The pharmacist then returned to the pharmacy and found that ``S.C. was still there''; S.C. ``was very anxious and ask[ed] if he was going to be arrested.'' Id. The pharmacist went back inside the pharmacy, called the ER again and verified that Respondent was still employed there. Id. at 98-99. After being told that she was, the pharmacist gave the prescription back to S.C. and called the sheriff. Id. at 99. [[Page 28701]] Respondent testified that she still believes that the prescriptions she issued S.C. were within the usual course of professional practice and for a legitimate medical purpose. Id. at 277. However, Respondent then stated that ``[i]n hindsight . . . my judgment was impaired because of the relationship I had with the individual,'' the prescriptions ``were not within . . . the standards of my medical practice.'' Id. Yet Respondent later asserted that she ``was definitely manipulated and taken advantage of. I was victimized.'' Id. at 350. Respondent also testified that at the time she wrote the prescriptions she believed they were ``medically necessary'' because there was a ``prior diagnosis of chronic pain.'' Id. And when asked whether, ``[s]itting here today, knowing what you do today, do you still believe that they were medically necessary at the time?'' Respondent answered: ``[y]es.'' Id. Respondent did acknowledge that she violated Florida's regulations by failing to ``keep proper documentation of each visit.'' Id. at 351. She then maintained that through the continuing medical education course she was required to take under the Florida Board's Order, ``I realize that will never happen again.'' Id.\11\ --------------------------------------------------------------------------- \11\ During its examination of Respondent, the Government asked her if her attorney had spoken ``with a DEA representative about whether [she] needed to obtain a DEA registration in New Mexico.'' Tr. 199. Respondent's counsel objected, asserting that this was a privileged communication and the ALJ sustained the objection. Id.; see also R.D. at 39 (``I sustained [Respondent's] objection to the question, finding that the response was likely to call for the disclosure of information protected by the attorney client privilege. I continue to believe the sought-after response would likely have called for [Respondent] to disclose what Mr. Leider [her attorney] did or did not tell her in the course of his representation of her.''). Notably, in his Recommended Decision, the ALJ did not cite a single case to support his ruling and I conclude that his ruling was erroneous. ``The privilege `protects only those disclosures necessary to obtain informed legal advice which might not have been made absent the privilege.' '' In re Walsh, 623 F.2d 489,494 (7th Cir. 1980) (quoting Fisher v. United States, 425 U.S. 391, 403 (1976)). Moreover, ```when an attorney conveys to his client facts acquired from other persons or sources, those facts are not privileged.' '' See In re Sealed Case, 737 F.2d 94, 100 (D.C. Cir. 1984)) (quoting Brinton v. Department of State, 636 F.2d 600, 604 (D.C. Cir. 1980) (footnote omitted)). Because the question did not ask Respondent to disclose what facts she had communicated to her lawyer or the legal advice she received from her lawyer, the ALJ erred in barring the testimony. See United States v. DeFazio, 899 F.2d 626, 635 (7th Cir. 1990) (holding that where attorney ``testified only to what [an] IRS agent said to him, and that he later relayed those statements to [defendant,] [t]he content of this testimony is unprivileged because it did not reveal, either directly or implicitly, legal advice given [defendant] or any client confidences''). --------------------------------------------------------------------------- Discussion Section 303(f) of the Controlled Substances Act (CSA) provides that an application for a practitioner's registration may be denied ``if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest.'' 21 U.S.C. 823(f). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant's experience in dispensing . . . controlled substances. (3) The applicant'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. Id. Sec. 823(f). ``These factors are . . . considered in the disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I ``may rely on any one or a combination of factors[,] and may give each factor the weight [I] deem[] appropriate in determining whether a registration should be revoked. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ``need not make explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\12\ --------------------------------------------------------------------------- \12\ ``In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821. --------------------------------------------------------------------------- In this matter, I have considered all of the factors and conclude that the Government's evidence with respect to factors two (Respondent's experience in dispensing controlled substances), four (Respondent's compliance with applicable laws related to controlled substances), and five (such other conduct) establishes that she ``has committed such acts as would render [her] registration under section 823 of this title inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). While I do not adopt the ALJ findings that Respondent violated federal law by issuing prescriptions while working as a contract physician at the Northern Navajo Medical Center without being registered in New Mexico, I find that Respondent acted outside the usual course of professional practice and lacked a legitimate medical purpose in issuing the prescriptions to S.C. Notwithstanding her claim that her conduct in prescribing to S.C. is an aberration, I find it to be egregious. And based on her insistence that even now, she still believes these prescriptions were legitimate, I conclude that Respondent has failed to produce sufficient evidence to demonstrate why she should be entrusted with a registration.\13\ --------------------------------------------------------------------------- \13\ I acknowledge that Respondent remains licensed in various States, including Pennsylvania, the State where she seeks registration and therefore meets the CSA's prerequisite for holding a practitioner's registration in that State. See 21 U.S.C. 823(f) (``The Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.''). However, the possession of state authority ```is not dispositive of the public interest inquiry.''' George Mathew, 75 FR 66138, 66145 (2010), pet. for rev. denied Mathew v. DEA, No. 10- 73480, slip op. at 5 (9th Cir., Mar. 16, 2012); see also Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009). As the Agency has long held, ``the Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.'' Mortimer Levin, 57 FR 8680, 8681 (1992). Accordingly, this factor is not dispositive either for, or against, the granting of Respondent's applications. Paul Weir Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)). As for factor three, there is no evidence that Respondent has been convicted of an offense ``relating to the manufacture, distribution or dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). The Agency has therefore held that ``the absence of such a conviction is of considerably less consequence in the public interest inquiry'' and is therefore not dispositive. Id. --------------------------------------------------------------------------- Factors Two and Four--Respondent's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances To effectuate the dual goals of conquering drug abuse and controlling both the legitimate and illegitimate traffic in controlled substances, ``Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except [[Page 28702]] in a manner authorized by the CSA.'' Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the maintenance of the closed regulatory system, a controlled substance may only be dispensed upon a lawful prescription issued by a practitioner. Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011). Fundamental to the CSA's scheme is the Agency's longstanding regulation, which states that ``[a] prescription for a controlled substance [is not] effective [unless it is] issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.'' 21 CFR 1306.04(a). This regulation further provides that ``an 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. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.'' Id. As the Supreme Court has explained, ``the 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.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005), cert. denied, 574 U.S. 1113 (2006) (stating that the prescription requirement likewise stands as a proscription against doctors acting not ``as a healer[,] but as a seller of wares''). Under the CSA, it is fundamental that a practitioner must establish and maintain a legitimate doctor-patient relationship in order to act ``in the usual course of . . . professional practice'' and to issue a prescription for a ``legitimate medical purpose.'' Paul H. Volkman, 73 FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence established that the physician exceeded the bounds of professional practice, when ``he gave inadequate physical examinations or none at all,'' ``ignored the results of the tests he did make,'' and ``took no precautions against . . . misuse and diversion''). The CSA, however, generally looks to state law to determine whether a doctor and patient have established a legitimate doctor-patient relationship. Volkman, 73 FR at 30642. In Florida, a physician is barred from ``prescribing, dispensing, administering, mixing, or otherwise preparing . . . any controlled substance, other than in the course of the physician's professional practice.'' Fla. Stat. Sec. 458.331(q). The statute further explains that ``prescribing, dispensing . . . or otherwise preparing . . . controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice.'' Id.; see also Fla. Stat. Sec. 893.05(1) (``A practitioner, in good faith and in the course of his or her professional practice only, may prescribe . . . a controlled substance[.]''). As found above, while Respondent neither admitted nor denied the factual allegations of the Administrative Complaint which was filed against her by the Florida Board, she did admit that if those facts were proven, they would establish violations of the Florida Statutes as alleged in the Complaint, including not only that she failed to meet the prevailing standard of care, but also that she prescribed controlled substances other than in the course of her professional practice. See GX 8, at 2 (citing Fla. Stat. Chap. 458). In this proceeding, the material facts set forth in the Board's complaint have been proven. Moreover, under the Florida Board of Medicine's then-existing Standards for the Use of Controlled Substances for the Treatment of Pain: A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatment for pain, underlying or coexisting disease or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. Fla. Admin R. 64B8-9.013(3)(a).\14\ --------------------------------------------------------------------------- \14\ This version of the Standards was promulgated in 1999, amended in both 2002 and 2003, and remained in effect until a new version of the Standards was promulgated in 2010. --------------------------------------------------------------------------- The State's Standards also required a physician ``to keep accurate and complete records to include, but not be limited to: 1. [t]he medical history and physical examination, including history of drug abuse or dependence, as appropriate; 2. [d]iagnostic, therapeutic, and laboratory results; 3. [e]valuations and consultations; 4. [t]reatment objectives; 5. [d]iscussion of risks and benefits; 6.[t]reatments; 7. [m]edications (including date, type, dosage, and quantity prescribed); 8. [i]nstructions and agreements; and 9. [p]eriodic reviews.'' Id. at 64B8-9.013(f). While Respondent asserted that she did a physical examination and that she knew ``about [S.C.'s] chronic pain syndrome'' from talking to both him and his parents, Tr. 214, the fact remains that she failed to document and maintain any medical records to support the prescriptions. Indeed, she specifically denied having diagnosed S.C. as having chronic pain, asserting that the diagnosis ``was established already'' by S.C.'s ``prior physician,'' id. at 229, and that she wrote the prescriptions by ``cop[ying] the prescription off the bottles'' S.C. showed her. Id. at 217. Yet, notwithstanding that those prescriptions were legally required to contain the name of the prescribing physician, see 21 CFR 1306.14(a), and no claim is made that they did not, Respondent never called S.C.'s prior physician.\15\ --------------------------------------------------------------------------- \15\ Respondent also testified that she looked at S.C.'s medical records. Thus, she clearly had available to her information as to Respondent's prior physician. While Respondent testified that S.C. was no longer seeing this physician because ``he lost his medical insurance,'' id. at 216, as well as that ``he did not wish to . . . see that physician any longer,'' id. at 219, because she never called the physician, she had no idea if S.C. had told her the truth or if his prior physician had discharged him. --------------------------------------------------------------------------- When then asked how she knew if Respondent's prior physician would have continued S.C. on narcotic controlled substances, Respondent replied that ``[w]hen you're on controlled substances you just don't stop . . . you have to go through either a weaning process--that's why it requires a specialist to . . . continue treating once you're up to a certain number of high dose pain medication.'' Tr. 234-35. Unexplained by Respondent is why she wrote S.C. prescriptions totaling 400 dosage units of OxyContin 80mg, given her testimony that a patient who is on a ``high dose [of] pain medication,'' ``requires a specialist,'' id., which she is not, as well as her admission that she ``was not familiar with treating chronic pain.'' Id. at 218. Moreover, Respondent repeatedly provided S.C. with prescriptions which enabled him to obtain schedule II controlled substances including OxyContin 80mg and oxycodone 30mg, drugs which are among the most highly abused and diverted controlled substances, in quantities which greatly exceeded both her own dosing instructions and DEA regulations. As found above, on or about February 7, 2008, Respondent issued S.C. prescriptions for 400 dosage units of OxyContin 80mg. Putting aside that Respondent wrote two different dosing instructions on the three prescriptions [[Page 28703]] (one prescription calling for one tablet every 12 hours, the other two calling for one tablet every eight hours), these dosing instructions provided S.C. with more than a 149-day supply of the drug.\16\ However, under DEA regulations, Respondent could lawfully prescribe a maximum of a 90-day supply. See 21 CFR 1306.12(b)(1). --------------------------------------------------------------------------- \16\ This calculation was based on Respondent's actual dosing instructions for each prescription. These three prescriptions would have provided a 200-day supply of the drug had I calculated this figure using a dosing instruction of one tablet every twelve hours for all three prescriptions, which is consistent with the manufacturer's prescribing instructions. See Physician's Desk Reference 2707 (61st ed. 2007) (``It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h.''); see also id. (``The intent of the titration period is to establish a patient- specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary.''). --------------------------------------------------------------------------- Notwithstanding that she had written the three OxyContin prescriptions only one month earlier and that if Respondent took the drugs in accordance with her dosing instructions, he would have had at least a four-month supply of the drug remaining, on or about March 10, 2008, Respondent wrote S.C. three more prescriptions. Each of these prescriptions authorized the dispensing of 450 dosage units of oxycodone 30mg, and, with a dosing instruction of up to 15 tablets or 450 milligrams per day, provided S.C. with an additional thirty-day supply. By comparison, the OxyContin prescriptions provided a daily dose of 160 or 240mg per day. Assuming S.C. took the full fifteen tablets per day, the three March 10, 2008 prescriptions provided S.C. with an additional 90-day supply of oxycodone. Thus, based on her own dosing instructions, the February and March 2008 prescriptions provided S.C. with nearly an eight-month supply of oxycodone. As for why she issued these six prescriptions, Respondent offered multiple explanations. First, regarding the OxyContin prescriptions, Respondent testified that S.C. had told her he was going to be in Los Angeles for three to six months filming a show for MTV and did not want to run out of medication. Tr. 227. Second, she asserted that S.C. told her that the monkey ``would take the pill bottle, open it, and throw it in the pool.'' Id. at 240-41. Third, she claimed that S.C required additional prescriptions because the pharmacy was either out of stock of the particular brand or dosage, or that he left the prescription at the pharmacy. Id. at 241 & 245. None of these explanations provides a persuasive justification that mitigates her misconduct. As for the first one, surely the Los Angeles area has an ample supply of pain management specialists who could have treated S.C. were he to run out of medication. Moreover, even if S.C. was a legitimate patient, given her testimony that patients on high doses of narcotics require a specialist to continue their treatment, Respondent's decision to provide S.C. with an eight-month supply of oxycodone when she had no ability to supervise his medication use--not that that ever appeared to be a concern to her--reflects a stunning disregard for her obligations as a prescriber of controlled substances. See Gonzales, 546 U.S. at 274 (``the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse''). As for the explanation that S.C. told her that he needed additional prescriptions because the pharmacies were out of either the branded medication (such as OxyContin) or the particular dosage strength, or that he left the prescription at the pharmacy, Respondent never called any of the pharmacies to verify S.C.'s claims. Tr. 241 & 252. Moreover, even if the pharmacies S.C. used were out of OxyContin, Respondent offered no explanation as to why, in a one-month period, she increased S.C.'s daily dose of oxycodone from either 160 or 240mgs per day (depending upon which prescription she wrote) to 450mgs per day. Then there is Respondent's testimony that she believed S.C. when he told her that his pet monkey was opening his pill bottles and throwing the drugs in the pool. While Respondent initially offered this far- fetched story to explain why she had written the three undated oxycodone 30mg prescriptions, all of which were filled on the same date (March 10, 2008) and bore serial numbers suggesting they were all written in close temporal proximity, she offered no testimony to the effect that she had asked to see the pill bottles to determine if the prescriptions had actually been filled. Moreover, Respondent eventually backtracked on this testimony, explaining that it was ``unclear[] which set of prescriptions it may have occurred with.'' Tr. 241. Accordingly, I find this testimony incredible. Respondent further violated DEA regulations because she failed to date the three March 2008 prescriptions and include S.C.'s address on them. See 21 CFR 1306.05(a) (``All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient . . . .''). As for why she did not date the prescriptions and include S.C.'s address on them, Respondent offered the ludicrous explanation that because of a young child, the dogs, the monkey, and S.C.'s hard-of-hearing father (who required that the volume on the TV be ``very loud''), ``it was a very distracting environment.'' Tr. 222. Yet somehow Respondent was able to include on the prescriptions the drug name, the dosage strength, the quantity, a dosing instruction, as well as her DEA number, printed name and signature. In short, I do not find her testimony credible as to why the prescriptions were undated. While Respondent apparently ceased her prescribing to S.C. while he was in Los Angeles, she resumed prescribing to him in January 2009, notwithstanding that with his opportunities and the ``contracts he was getting,'' S.C. presumably could have afforded to see a pain management specialist. Tr. 249. As found above, between February 3 and March 6, 2009, Respondent issued S.C. eleven prescriptions for 90 Roxicodone (oxycodone) 30mg. Moreover, on several dates, Respondent issued S.C. two or more prescriptions. Based on her dosing instruction of one tablet, three times per day, the prescriptions authorized the dispensing of 990 tablets of oxycodone 30mg, or an eleven-month supply of the drug. Moreover, on March 6, Respondent issued S.C. a prescription for 280 Roxicodone 15 mg (also with a dosing instruction of one tablet, three times per day). Thus, between February 3 and March 6, 2009, Respondent's prescriptions provided S.C. with more than a one-year supply of oxycodone if he actually took the drugs as directed. As for why she issued S.C. the two February 3 prescriptions, Respondent testified that S.C. had called her and told her that the pharmacy he initially went to was out of stock and that he left the prescription there. Once again, Respondent merely accepted S.C.'s story, which was only partially true, and did not call the pharmacy. While Respondent maintained that she did not find this suspicious because some of her ER patients had complained that a pharmacy would not have a particular drug, she could not recall if she had ever had another patient claim that he/she needed a new prescription because the pharmacist had kept it. When then asked why the pharmacist would not have simply returned the prescription to S.C., Respondent [[Page 28704]] asserted that was ``how they operated down there'' and that she ``was new to the State,'' even though she had worked in Florida for more than four years at that point. Yet the evidence shows that every single prescription she issued to S.C. in this period was filled, see GX 1, at 17-35, and while the first February 3 prescription was only partially filled (with the pharmacy dispensing 54 tablets), even if the pharmacy could not fill the remaining portion of the prescription within 72 hours, see 21 CFR 1306.13(a), there was no need for Respondent to issue him a second prescription for a full 90 tablets. As for why she then issued S.C. three more prescriptions just six days later (on Feb. 9), Respondent initially claimed that S.C. had begun having seizures and was becoming forgetful, but then acknowledged that this did not happen until three months later. Other than in her earlier ludicrous testimony that the monkey was throwing S.C.'s drugs in the pool or that Respondent was leaving the drugs in his hotel room, or the drugs had been stolen--none of which was documented in a medical record because she maintained none on S.C.--Respondent failed to address why she issued S.C. three more prescriptions the next day. So too, Respondent failed to address why she wrote the multiple prescriptions on February 20 and March 6. In her testimony, Respondent maintained ``that over time'' she ``lost the physician/patient relationship.'' Tr. 220. To the contrary, the evidence suggests that the only time she prescribed to S.C. pursuant to a valid doctor-patient relationship was in August 2007, when she treated him for his broken hand in the ER. Her testimony as to whether she performed physical examinations of S.C. was exceedingly vague and changed, both as to the dates she performed these exams and the scope of the exams. Indeed, she explicitly denied having even made a diagnosis, id. at 229, claiming that S.C.'s prior physician had done that, and yet she proceeded to provide him with prescriptions for more than 1750 tablets of two of the most highly abused prescription narcotics (400 OxyContin 80mg and 1350 oxycodone 30mg) without even calling S.C.'s prior physician. She also offered no explanation for the inconsistency between the dosing instructions on the various OxyContin prescriptions or for increasing S.C.'s daily dose of oxycodone from 240mgs (per the OxyContin prescriptions) to 450mgs per day (per the oxycodone 30 prescriptions) only one month later. Moreover, she provided the first set of prescriptions with full knowledge that S.C. was going off to California for several months and that she would have no ability to monitor him. And she failed to create any medical records and a written treatment plan. As for the 2009 prescriptions, notwithstanding that she had not ``treated'' S.C. in nearly ten months, she could not recall if she had done a physical exam. Moreover, within a one- month period, she provided him with more than a one-year supply of oxycodone based on her own dosing instructions. As for her testimony that she believed the various excuses S.C. offered for why he needed additional prescriptions, and did so even when the excuse was patently absurd, the ALJ did not find this credible. Nor do I. And here again, she failed to create any medical records and a written treatment plan. I therefore conclude that with the exception of the Percocet prescription she wrote when she treated S.C. in the ER, Respondent repeatedly acted outside of the usual course of professional practice and lacked a legitimate medical purpose when she prescribed oxycodone (including OxyContin) to him. See 21 CFR 1306.04(a). While Respondent contends ``that her actions were not for personal gain,'' Resp. Post- Hrng. Br. at 36, to sustain a violation, the Government was not required to prove that she provided the prescriptions in exchange for either money or to obtain S.C.'s affection. In sum, I conclude that Respondent knowingly diverted controlled substances when she prescribed to S.C. I also conclude that Respondent violated Agency regulations requiring that she: (1) Date the prescriptions as of the date of their issuance, 21 CFR 1306.05(a); (2) include S.C.'s address on the prescriptions, see id. ; (3) where issuing multiple prescriptions for schedule II drugs, not prescribe more than a 90-day supply, 21 CFR 1306.12(b)(1); and (4) where issuing multiple prescriptions, ``provide[] written instructions on each prescription . . . indicating the earliest date on which a pharmacy may fill each prescription. Id. 1306.12(b)(ii). She also violated Florida law and regulations by failing to create medical records. Respondent nonetheless argues that she ``has had a long career in emergency medicine and has had no instances of malpractice or disciplinary action prior to the instant case.'' Resp. Exceptions, at 11. She further contends that ``[t]he events surrounding her relationship with S.C. and her treatment of his purported medical conditions represent an aberrant set of circumstances that are unlikely to ever be repeated.'' Id. It is acknowledged that except for the matters at issue here, Respondent has practiced medicine as an ER physician for approximately sixteen years and dispensed controlled substances without incident. It also acknowledged that two of her co-workers wrote letters attesting to her ability as a clinician. See RX P & R. I nonetheless reject her contention that her misconduct is an aberration. As the evidence shows, Respondent engaged in two separate bouts of unlawful prescribing. Indeed, while her prescribings to S.C. in the February-March 2008 time period were egregious (providing him with 1750 tablets of highly abused schedule II narcotics), in January 2009, she resumed prescribing to him, providing him with more than another 1,000 pills of this highly abused narcotic in a one-month period. Moreover, notwithstanding her admitted lack of familiarity with treating chronic pain, and that while S.C. was in LA, she had months to reflect on her prescribing practices with respect to him as well as to familiarize herself with Florida's standards for using controlled substances to treat pain, Respondent resumed prescribing to S.C. a highly abused narcotic in unlawful quantities, see 21 CFR 1306.12(b)(1), that also greatly exceeded what was medically necessary according to her own dosing instructions. I therefore find that the Government's evidence with respect to factors two and four establishes that Respondent has committed such acts as to render her ``registration inconsistent with the public interest.'' \17\ I further find that [[Page 28705]] Respondent's misconduct was egregious and makes out a prima facie case for denying her application. --------------------------------------------------------------------------- \17\ While I have considered the allegation that Respondent violated the CSA by issuing prescriptions while working at the Northern Navajo Medical Center without being licensed by New Mexico and registered with DEA in that State, I decline to rule on the allegation because several material issues have not been adequately addressed. While the Government elicited testimony from a registration program specialist to the effect that in order for Respondent to obtain a registration in New Mexico, she was required to obtain a New Mexico medical license, it is unclear whether New Mexico has authority to require a federal contract physician to be licensed in the State if she works solely at an IHS facility. The limited case law suggests to the contrary. See Taylor v. United States, 821 F.2d 1428, 1431 (9th Cir. 1987) (noting that under the Supremacy Clause, a State ``lacks power to require licensing of federal health care providers and physicians'' and that ``[t]he United States has . . . essentially deemed [an] Army [h]ospital and its staff fit to provide health care services''); United States v. Composite State Bd. of Medical Examiners, 656 F.2d 131, 135 n.4 (5th Cir. 1981) (citing Sperry v. Florida ex rel. Florida Bar, 373 U.S. 379 (1963)). Cf. 25 U.S.C. 1621t (``Licensed health professionals employed by a tribal health program shall be exempt, if licensed in any State, from the licensing requirements of the State in which the tribal health program performs the services described in the contract or compact of the tribal health program under the Indian Self-Determination and Education Assistance Act.''). However, this determination is not within the Agency's authority. Moreover, the Government does not address whether a physician is nonetheless required to obtain a registration specific to an IHS facility if the State lacks authority to require a physician to obtain a license in that State, or whether a physician who does not possess a license in the State where the facility is located and is not required to possess such a license, can nonetheless obtain a registration for that location. Because I find that the Government has otherwise proved that Respondent's continued registration is inconsistent with public interest and that she has failed to produce sufficient evidence to rebut this conclusion, I decline to remand the matter or issue a briefing order. On this record, I decline to adopt the ALJ's conclusions of law (# 8, 9, and 10) that Respondent violated federal law because she issued prescriptions while practicing at the Northern Navajo Medical Center without being registered in New Mexico and that she is not exempt from registration in that State. See R.D. 74. I also decline to adopt the ALJ's finding that Respondent's ``decision to rely exclusively on representations made to her by her future employers constitutes a willful and reckless disregard for her duty to inquire of the DEA regarding the need for re-registration and in-state licensure,'' R.D. at 64, and that this is actionable misconduct under factor five. Id. --------------------------------------------------------------------------- Factor Five--Such Other Conduct Which May Threaten Public Health and Safety The ALJ also found that Respondent engaged in actionable misconduct under this factor. More specifically, the ALJ found, inter alia, that: (1) Respondent lacked candor in her testimony regarding her prescribings to S.C.; and (2) she failed to cooperate with DEA Investigators who were investigating her 2012 renewal application. R.D. at 63-66. Of these, I conclude that only the first finding is supported by substantial evidence. As for the second contention, the evidence showed that during the course of investigating her renewal application, Agency Investigators went to a hospital at which Respondent was then working and asked to speak to her about the ``yes'' answer she had provided to one of the liability questions on the application. Tr. 388. Respondent declined to answer any questions without an attorney being present. Id. While the Investigators then explained ``this was not a criminal investigation'' and that it ``was purely regulatory in scope'' as it involved the Florida Board matter, Respondent again refused ``to discuss the matter.'' Id. at 390. The DI then testified that he was never able to complete his interview of Respondent. Id. at 391; 398. Based on this evidence, the ALJ found that Respondent ``flatly refused to answer [the DI's] questions to resolve the liability issues she noted on her renewal application in the absence of an attorney, and made no attempt to arrange a subsequent meeting with [the DI], with or without counsel.'' R.D. at 65-66. The ALJ thus reasoned that ``Respondent's failure to cooperate . . . suggests a substantial and willful disregard for her duty to comply with DEA directives as a regulated entity'' and ``[t]his conduct threatens public health and safety.'' Id. at 66. I find the ALJ's reasoning unpersuasive. Respondent was entitled to consult with her attorney before answering the DI's questions and had no obligation to agree to an interview without her attorney being present. Moreover, the DI offered no testimony to the effect that he made any further attempt to interview her, let alone that she rebuffed a further interview request or that she agreed to an interview and then failed to follow through. Accordingly, I reject the ALJ's finding and conclusion as unsupported by substantial evidence. However, I agree with the ALJ's legal conclusion that Respondent lacked candor in her testimony. More specifically, as ultimate factfinder, see 5 U.S.C. 557(b), I do not find credible her testimony that she did not know ``exactly why'' she did not include the date and S.C.'s address on the OxyContin 80mg and Oxycodone 30mg prescriptions other than that S.C.'s house was a ``very distracting'' environment. Tr. 222. As found above, notwithstanding her assertion, Respondent was not so distracted that she failed to include on the prescriptions such required information as the name of the drug, its dosage strength, the quantity, and her signature. Id. Nor do I find credible her testimony that she palpated S.C.'s back and neck as part of the physical exams she claimed to have performed. Id. at 263. As found above, at several earlier points in her testimony, Respondent described the physical exam she performed as listening to S.C.'s heart and lungs, making no mention of having palpated any part of S.C. See id. at 214 & 244-45. Indeed, she asserted that she palpated S.C.'s back and neck only after the Government specifically asked her if she did. Id. at 263. Finally, I do not find credible Respondent's testimony that she wrote the multiple oxycodone 30mg prescriptions because she actually believed S.C.'s claim that the monkey had taken the pill bottle, managed to open it, and then threw the medication in the pool. Id. at 240-41, 341. Accordingly, I find that substantial evidence supports a finding that Respondent lacked candor when she testified in this proceeding. See Hoxie v. DEA, 419 F.3d 477, 483 (``Candor during DEA investigations properly is considered by the DEA to be an important factor when assessing whether a . . . registration is consistent with the public interest.''). Thus, I conclude that the record supports a finding that Respondent lacked candor when she testified in this proceeding and that she has committed such other conduct which may threaten public health and safety. 21 U.S.C. 823(f)(5). Sanction Under Agency precedent, where, as here, ``the Government has proved that [an applicant] has committed acts inconsistent with the public interest, the [applicant] must `` `present sufficient mitigating evidence to assure the Administrator that [she] can be entrusted with the responsibility carried by such a registration.' ''' '' Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover, because `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has repeatedly held that where [an applicant] has committed acts inconsistent with the public interest, the [applicant] must accept responsibility for [her] actions and demonstrate that [she] will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an ``important factor[]'' in the public interest determination). So too, in making the public interest determination, ``this Agency places great weight on an [applicant's] candor, both during an investigation and in [a] subsequent proceeding.'' Robert F. Hunt, 75 FR 49995, 50004 (2010) (citing The Lawsons, Inc., t/a The Medicine Shoppe Pharmacy, 72 FR 74334, 74338 (2007) (quoting Hoxie, 419 F.3d at 483 (``Candor during DEA investigations properly is considered by the DEA to be an important factor when assessing whether a . . . registration is consistent with the public interest.''))). Moreover, while an applicant must accept responsibility and demonstrate that she will not engage in future misconduct in order to establish that her registration is consistent with the public [[Page 28706]] interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of an applicant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a respondent can ``argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). Moreover, as I have noted in several cases, `` `[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be revoked' '' or an application should be denied. Gaudio, 74 FR at 10094 (quoting Southwood, 72 FR at 36504 (2007)); see also Robert Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 76 FR 45867, 45868 (2011). This is so, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36504). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of ``deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions'').\18\ --------------------------------------------------------------------------- \18\ Thus, in Gaudio, ``I explained that `even when a proceeding serves a remedial purpose, an administrative agency can properly consider the need to deter others from engaging in similar acts.' '' 74 FR at 10094 (quoting Southwood, 72 FR at 36504) (citing Butz v. Glover Livestock Commission Co., Inc., 411 U.S. 182, 187-88 (1973)); cf. McCarthy, 406 F.3d at 189 (``Although general deterrence is not, by itself, sufficient justification for expulsion or suspension, we recognize that it may be considered as part of the overall remedial inquiry.''); Paz Securities, Inc., et al. v. SEC, 494 F.3d 1059, 1066 (D.C. Cir. 2007) (agreeing with McCarthy). In Gaudio, I further noted that the ``[c]onsideration of the deterrent effect of a potential sanction is supported by the CSA's purpose of protecting the public interest, see 21 U.S.C. 801, and the broad grant of authority conveyed in the statutory text, which authorizes the [suspension or] revocation of a registration when a registrant `has committed such acts as would render [his] registration . . . inconsistent with the public interest,' id. Sec. 824(a)(4), and [which] specifically directs the Attorney General to consider [`such other conduct which may threaten public health and safety,' id. Sec. 823(f)].'' 74 FR at 10094 (quoting Southwood, 72 FR at 36504). Unlike factors two (``[t]he applicant's experience in dispensing'') and three (``[t]he applicant's conviction record''), neither factor four (``Compliance with applicable laws related to controlled substances'') nor factor five (``Such other conduct which may threaten public health and safety'') contain the limiting words of ``[t]he applicant.'' As the Supreme Court has held, ``[w]here Congress includes particular language in one section of a statute but omits it in another section of the same Act, it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion.'' Russello v. United States, 464 U.S. 16, 23 (1983). Thus, the text of factors four and five suggest that these factors are not limited to assessing the specific practitioner's compliance with applicable laws and whether she has engaged in ``such other conduct'' (such as giving false testimony), but rather, authorizes the Agency to also consider the effect of a sanction on inducing compliance with federal law by other practitioners. --------------------------------------------------------------------------- In his decision, the ALJ acknowledged that Respondent produced some evidence of remedial measures she has undertaken. R.D. at 68. More specifically, the evidence shows that Respondent completed a four-day course in controlled substance management and a two-day course in medical record keeping. RXs F & I. However, based on Respondent's testimony, the ALJ also found that ``it is far from clear that the courses have brought about changes in [her] that would support continued DEA registration.'' R.D. at 68. As the ALJ explained, ``[e]ven now, Respondent would attribute her action to being victimized by . . . SC's conduct, while averring that she believed, at the time, that her prescription practice was compliant with DEA regulations.'' Id. The ALJ thus concluded that ``Respondent has [not] admitted to the full extent of her . . . misconduct.'' Id. Respondent takes exception to the ALJ's conclusion that she has failed to accept responsibility for her misconduct, contending that this ``is contradicted by the facts in the record.'' Exceptions, at 2. Respondent argues that she ``readily admitted to losing the physician- patient relationship when treating S.C.'' and that she ``also admitted that she violated Florida law and standards of practice when she treated S.C. without creating a medical record, [a] written treatment plan, etc.'' Id. at 3-4. It is acknowledged that at various points in her testimony, Respondent admitted to several professional failings. For example, she admitted that it was her error to accept S.C.'s word rather than call his prior physician. She also testified that she ``lost the physician/ patient relationship'' and ``was not objective.'' Still later, she testified that ``[i]n hindsight . . . my judgment was impaired because of the relationship I had with the individual'' and that the prescriptions ``were not within . . . the standards of my medical practice.'' And she also admitted that she violated Florida's regulations by failing to ``keep proper documentation.'' While this testimony would have supported a finding that Respondent has accepted responsibility for her misconduct, at other points, she offered testimony that substantially undermines this conclusion. Notwithstanding her earlier admission that she lost the doctor/patient relationship (not that she ever had one outside of S.C.'s ER visit), she then testified that ``I was definitely manipulated and taken advantage of. I was victimized.'' Tr. 350. Respondent's statement is simply irreconcilable with the obligations imposed on a physician who is entrusted with the authority to prescribe controlled substances. So too, notwithstanding her testimony that the prescriptions ``were not within . . . the standards of my medical practice'' and her having taken a course in controlled substance management, Respondent testified that she still believes she issued the prescriptions for a legitimate medical purpose. Tr. 277. Still later in her testimony--and after maintaining that she was victimized by S.C.--she again testified that knowing what she knows today, she still believes that the prescriptions were medically necessary. Id. at 277-78. In short, this suggests that Respondent has learned nothing from the various state board proceedings, the course she took in controlled substance management, or this Proceeding. Accordingly, I have no confidence that she will refrain from similar acts were she to become love struck with a drug abuser or diverter in the future. Her equivocal testimony provides substantial evidence to support a finding that she does not accept responsibility for her misconduct. As explained above, notwithstanding her contention that her prescribing to S.C. is an aberration, I find that her misconduct was egregious. Moreover, as found above, Respondent lacked candor in her testimony. Accordingly, I conclude that denial of her application is necessary to protect the public interest. Order Pursuant to the authority vested in me by 21 U.S. C. 823(f), as well as 28 CFR 0.100(b), I order that the application of Annicol Marrocco, M.D., for a DEA Certificate of Registration as a practitioner be, and it hereby is, denied. This Order is effective June 18, 2015. Dated: May 4, 2015. Michele M. Leonhart, Administrator. [FR Doc. 2015-12035 Filed 5-18-15; 8:45 am] BILLING CODE 4410-09-P
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hereby is, denied. This Order is Respondent’s Request for Hearing, Order Granting the Government’s Motion for
effectively immediately. Respondent admits that his license is Summary Disposition and Recommendation
temporary suspended. Respondent further I find there is no genuine dispute regarding
Dated: May 1, 2015. states that he expects to prevail before the whether Respondent is a ‘‘practitioner’’ as
Michele M. Leonhart, medical board at an upcoming hearing on that term is defined by 21 U.S.C. 802(21), and
Administrator. May 18, 2015. Finally he notes that his DEA that based on the record the Government has
Certificate of Registration will expire by its established that Respondent is not a
Brian Bayly, Esq., for the Government. own terms on March 31, 2015, and alleges
Marc S. Murphy, Esq., and Michael Denbow, practitioner and is not authorized to dispense
that he is prohibited from applying for his controlled substances in the state in which
Esq., for the Respondent. DEA certificate until the Kentucky medical he seeks to practice with a DEA Certificate
Order Granting the Government’s Motion for board acts upon his suspension. of Registration. I find no other material facts
Summary Disposition and Findings of Fact, The substantial issue raised by the at issue. Accordingly, I GRANT the
Conclusions of Law, and Recommended Government rests on an undisputed fact. The Government’s Motion for Summary
Decision of the Administrative Law Judge Government asserts that Respondent’s DEA Disposition.
Certificate of Registration must be revoked Upon this finding, I ORDER that this case
Administrative Law Judge Christopher B.
because Respondent does not have a medical be forwarded to the Administrator for final
McNeil. On January 29, 2015, the Deputy
license issued by the state in which he disposition and I recommended that
Assistant Administrator of the Drug
practices — a fact which Respondent does Respondent’s DEA Certificate of Registration
Enforcement Administration issued an Order
to Show Cause as to why the DEA should not not deny. Under DEA precedent, a should be REVOKED and any pending
revoke DEA Certificate of Registration practitioner’s DEA Certificate of Registration application for the renewal or modification of
Number FP2719245 issued to Sharad C. for controlled substances must be summarily the same should be DENIED.
Patel, M.D., the Respondent in this matter. revoked if the applicant is not authorized to
handle controlled substances in the state in Dated: March 11, 2015.
The Order seeks to revoke Respondent’s
registration pursuant to 21 U.S.C. 824(a)(3) which he maintains his DEA registration.1 Christopher B. McNeil,
and 823(f), and to deny any pending Pursuant to 21 U.S.C. 823(f), only a Administrative Law Judge.
applications for renewal or modification of ‘‘practitioner’’ may receive a DEA [FR Doc. 2015–12025 Filed 5–18–15; 8:45 am]
such registration, and deny any applications registration. Under 21 U.S.C. 802(21), a
BILLING CODE 4410–09–P
for any new DEA registrations pursuant to 21 ‘‘practitioner’’ must be ‘‘licensed, registered,
U.S.C. 823(f). As grounds for denial, the or otherwise permitted, by the United States
Government alleges that Respondent is or the jurisdiction in which he practices or
‘‘without authority to handle controlled does research, to distribute [or] dispense . . . DEPARTMENT OF JUSTICE
substances in Kentucky, the state in which controlled substance[s.]’’ Given this statutory
[Respondent is] registered with the DEA.’’ language, the DEA Administrator does not Drug Enforcement Administration
On February 20, 2015, the DEA’s Office of have the authority under the Controlled [Docket No. 13–34]
Administrative Law Judges received Substances Act to maintain a practitioner’s
Respondent’s written request for a hearing, registration if that practitioner is not Annicol Marrocco, M.D.; Decision and
which is dated February 19, 2015. authorized to dispense controlled
substances.2 As noted by the Government in
Order
Respondent states that his medical license is
‘‘temporarily suspended’’ by the state’s its Motion for Summary Disposition, On May 17, 2013, the Deputy
medical board and that he plans to challenge Respondent’s concern regarding the Assistant Administrator, Office of
the suspension in an upcoming state impending expiration of his DEA registration Diversion Control, Drug Enforcement
administrative hearing scheduled for May 18, is unfounded. Under 21 CFR 1301.36(i),
incorrectly cited by the Government as 21
Administration, issued an Order to
2015.
On February 23, 2015 this Office issued an CFR 1306.36(i), the existing registration of an Show Cause to Annicol Marrocco, M.D.,
Order for Briefing on Allegations Concerning applicant for reregistration will be (hereinafter, Respondent), of Mahwah,
Respondent’s Lack of State Authority. In the automatically extended until the New Jersey. ALJ Ex. 1. The Show Cause
Order, I mandated that the Government Administrator issues her order if the Order proposed the revocation of
provide evidence to support the allegation applicant applies for reregistration.3 Respondent’s DEA Certificate of
that Respondent lacks state authority to As detailed above, only a ‘‘practitioner’’ Registration BM8059102, which
handle controlled substances and if may receive a DEA registration. Therefore, I authorized her to dispense controlled
appropriate file a motion for summary will recommend the revocation of substances in schedules II through V, at
disposition no later than 2:00 p.m. Eastern Respondent’s DEA registration.
Standard Time (EST) on March 2, 2015. On
the registered address of Olean General
March 2, 2015, the Government timely 1 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also
Hospital, 515 Main Street, Olean, New
submitted a brief in support of the allegation House of Medicine, 79 FR 4959, 4961 (DEA Jan. 30, York 14760, on the ground that her
regarding state authority and filed a Motion 2014); Deanwood Pharmacy, 68 FR 41662–01 (DEA ‘‘continued registration is inconsistent
for Summary Disposition. According to the July 14, 2003); Wayne D. Longmore, M.D., 77 FR with the public interest.’’ Id. (citing 21
Government’s brief, the Board of Medical 67669–02 (DEA Nov. 13, 2012); Alan H. Olefsky, U.S.C. 823(f) and 824(a)(4)).
Licensure of the Commonwealth of Kentucky M.D., 72 FR 42127–01 (DEA Aug. 1, 2007); Layfe
Robert Anthony, M.D., 67 FR 15811 (DEA May 20,
The Show Cause Order specifically
issued an Emergency Order of Suspension alleged that between January 2008 and
2002); George Thomas, PA–C, 64 FR 15811–02
suspending Respondent’s license to practice (DEA Apr. 1, 1999); Shahid Musud Siddiqui, M.D., August 2009, Respondent issued
medicine, effective November 24, 2014. The 61 FR 14818–02 (DEA April 4, 1996); Michael D.
Government attached the emergency order
approximately twenty-one prescriptions
Lawton, M.D., 59 FR 17792–01 (DEA Apr. 14, 1994);
pertaining to Respondent to the Motion for Abraham A. Chaplan, M.D., 57 FR 55280–03 (DEA
to S.C. for oxycodone, a schedule II
Summary Disposition. Based on this Nov. 24, 1992). See also Bio Diagnosis Int’l, 78 FR controlled substance, ‘‘outside the usual
suspension, the Government moved for a 39327–03, 39331 (DEA July 1, 2013) (distinguishing course of professional practice and for
summary disposition of these proceedings. distributor applicants from other ‘‘practitioners’’ in other than a legitimate medical
In my Order for Briefing on Allegations the context of summary disposition analysis).
2 See Abraham A. Chaplan, M.D., 57 FR 55280–
purpose.’’ Id. (citing 21 U.S.C. 841(a)
Concerning Respondent’s Lack of State
tkelley on DSK3SPTVN1PROD with NOTICES
03, 55280 (DEA Nov. 24, 1992), and cases cited and 21 CFR 1306.04(a)). The Show
Authority, I also provided Respondent the Cause Order further alleged that
therein. In Chaplan, DEA Administrator Robert C.
opportunity to respond to the Government’s
allegations with a brief due not later than
Bonner adopts the ALJ’s opinion that ‘‘the DEA Respondent failed to maintain medical
lacks statutory power to register a practitioner records supporting the prescriptions, in
2:00 p.m. EST on March 9, 2015. As of today, unless the practitioner holds state authority to
no brief was received and therefore the handle controlled substances.’’ Id. violation of Florida law; that she was in
Government’s Motion for Summary 3 See also Ronald J. Riegel, D.V.M., 63 FR 67132– a personal relationship with S.C.; and
Disposition will stand unopposed. In 01, 67132 (DEA Dec. 4, 1998). that she ‘‘did not examine S.C. except to
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listen to his heart and lungs.’’ Id. at 1– On November 12, 2013, the ALJ 1306.05(a)’’; (4) Respondent issued
2, 4–5 (citing Fla. Admin Rule 64B8– issued his Recommended Decision. multiple prescriptions for schedule II
9.003 and 64B8–9.013). Therein, the ALJ found that the controlled substances which lacked ‘‘the
Next, the Show Cause Order alleged Government had established a prima earlier date on which’’ the prescription
that Respondent had failed to both date facie case that Respondent’s continued could be filled, in violation of
and include S.C.’s address on multiple registration would be inconsistent with 1306.12(b)(1); and (5) Respondent
prescriptions, in violation of 21 CFR the public interest and that she had violated the State of Florida’s
1306.05(a). Id. at 2. The Show Cause failed to rebut the Government’s ‘‘Standards for the Use of Controlled
Order then alleged that Respondent had showing. R.D. at 75. The ALJ thus Substances for the Treatment of Pain,’’
violated DEA regulations that, while recommended that Respondent’s as well as the State’s regulation
allowing a practitioner to issue multiple registration be revoked. Id. regarding the adequacy of medical
prescriptions for a schedule II With respect to factor one—the records. Id. at 73.
controlled substance, limit the quantity recommendation of the state licensing The ALJ further concluded that
of the prescriptions to a 90-day supply, authority—the ALJ found that ‘‘[i]ssuing controlled substance
require that a prescription include the ‘‘Respondent has a history of substantial prescriptions in one state under a DEA
earliest date on which it can be filled, and material disciplinary action taken registration issued for practice in
and require that each prescription be by the medical licensing boards of three another state is a violation of 21 U.S.C.
issued for a legitimate medical purpose. states’’ and that the boards of Florida 822(e) and 21 CFR 1301.12(a) and
Id. at 2–4 (citing 21 CFR 1306.12(b)(1)). and New York have ‘‘permanently (b)(3).’’ Id. at 74. While noting that an
Next, the Show Cause Order alleged limit[ed] [her] authority to prescribe Agency regulation exempts an official of
that Respondent ‘‘violated Federal law controlled substances.’’ Id. at 72. The various federal agencies and the armed
on at least forty-nine occasions’’ by ALJ thus concluded that ‘‘maintaining forces from these requirements, the ALJ
issuing controlled substance Respondent’s unrestricted DEA found that because Respondent was a
prescriptions while practicing as a registration would be inconsistent with contract-physician she was not exempt
the public interest.’’ Id. under the regulation. Id. Based on his
contract emergency room physician at
With respect to factor two— finding that ‘‘[b]etween December 28,
the Northern Navajo Medical Center in
Respondent’s experience in dispensing 2012 and June 8, 2013, Respondent
Shiprock, New Mexico, while being controlled substances—the ALJ found issued prescriptions for controlled
registered in New York. Id. at 5. The ‘‘that despite eighteen years of substances from her principal place of
Government further alleged that experience as an emergency medicine business or professional practice in
‘‘[i]ssuing controlled substance physician, Respondent lacked the Shiprock, New Mexico,’’ while ‘‘using
prescriptions in one state under a DEA experience necessary to identify and the DEA registration that was issued to
registration issued for another state is a appropriately respond to drug-seeking her for her practice in New York,’’ the
violation of 21 U.S.C. 822(e) . . . which behavior.’’ Id. The ALJ also found that ALJ concluded that Respondent violated
require[s] separate registrations for Respondent ‘‘lacked the experience these provisions. Id. The ALJ thus found
separate locations.’’ Id. (also citing 21 necessary to appreciate the need to that factor four supports a finding that
CFR 1301.12(a) & (b)(3)). The contact the DEA when questions arose Respondent’s continued registration
Government also alleged that regarding the need for in-state ‘‘would be inconsistent with the public
Respondent knowingly and willfully certification after she relocated her interest.’’ Id.
violated these provisions, alleging that principal place of business or The ALJ further found that factor
‘‘DEA personnel informed you and your professional practice from New York to five—such other conduct which may
attorney that to move your DEA New Mexico.’’ Id. The ALJ thus found threaten public health and safety—
registration to New Mexico you must that factor two supports a finding that supports the conclusion that
first be properly licensed to practice Respondent’s continued registration is Respondent’s continued registration
medicine in New Mexico’’ and that she ‘‘inconsistent with the public interest.’’ ‘‘would be inconsistent with the public
‘‘ha[s] never held a New Mexico Id. interest.’’ Id. at 74–75. As support for
medical license.’’ Id. Finally, the Show As for factor four—compliance with his conclusion, the ALJ found that
Cause Order alleged that Respondent applicable laws related to controlled Respondent lacked ‘‘candor with the’’
‘‘no longer maintain[s] a medical substances—the ALJ found that Agency, that she ‘‘willful[ly] fail[ed] to
practice at [her] registered address’’ and Respondent violated 21 CFR 1306.04(a) determine her obligations when
that she violated DEA regulations by by issuing multiple prescriptions for relocating from New York to New
‘‘[f]ail[ing] to keep [her] registered schedule II controlled substances, Mexico,’’ and that she ‘‘refus[ed] to
address current with the’’ Agency. Id. including OxyContin and oxycodone to cooperate with the [Agency’s] inquiry
(citing 21 CFR 1301.51). S.C., while in a personal relationship regarding liability issues in her renewal
Respondent timely requested a with him, and that she acted outside the application.’’ Id. at 75.
hearing on the allegations; the matter usual course of professional practice in Finally, the ALJ found that
was then placed on the docket of the issuing the prescriptions and lacked a Respondent ‘‘failed to affirmatively
Office of Administrative Law Judges and legitimate medical purpose. R.D. 69–70. acknowledge specific acts of improper
assigned to Administrative Law Judge The ALJ further found that: (1) prescribing,’’ as well as that she had
Christopher B. McNeil (hereinafter, Respondent issued the prescriptions ‘‘failed to establish by credible and
ALJ). ALJ Ex. 2. Following pre-hearing ‘‘without maintaining medical records substantial evidence effective steps
procedures, the ALJ conducted a or justifying the prescriptions in taken in remediation as would warrant
tkelley on DSK3SPTVN1PROD with NOTICES
hearing on August 21 and September 11, violation of 21 CFR 1306.04(a)’’; (2) a sanction other than revocation.’’ Id.
2013, at which both parties called Respondent issued OxyContin The ALJ thus found that ‘‘the
witnesses to testify and introduced prescriptions, which were undated, in Government has established cause to
documentary evidence. Following the violation of 21 CFR 1306.05(a); (3) revoke Respondent’s . . . registration.’’
hearing, both parties submitted briefs Respondent issued OxyContin Id.
containing their proposed findings of prescriptions, which ‘‘lacked the Both parties filed exceptions to the
fact and conclusions of law. patient’s address, in violation of 21 CFR ALJ’s Recommended Decision. Having
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considered the record in its entirety, The State further alleged that On December 31, 2014, Respondent
including the parties’ exceptions, I ‘‘Respondent prescribed [R]oxycodone, applied for a renewal of this registration
conclude that the Government has oxycodone, and/or OxyContin to Patient and sought to change her registered
established that granting Respondent’s S.C., in an inappropriate manner and/or location to the Northern Navajo Medical
application would be inconsistent with in excessive quantities, which is outside Center, P.O. Box 160, Highway 491
the public interest and that Respondent the course of Respondent’s professional North, Shiprock, New Mexico. See
has failed to rebut the Government’s practice.’’ Id. at 11–12. The State thus Government’s Notice of Respondent’s
prima facie case. Accordingly, I will alleged that Respondent violated Florida Filing of Renew Application and
adopt the ALJ’s recommendation that I law ‘‘by prescribing controlled Change of Address Request, at 6–8.
deny any pending application for a new substances other than in the course of Thereafter, on January 23, 2015,
registration. I make the following factual her professional practice.’’ Id. at 12 Respondent submitted a letter seeking to
findings. (citing Fla. Stat. § 458.331(1)(q)). change her registered location to
Findings Finally, the State alleged that Doctors Express Urgent Care, 1444 W.
Respondent violated Florida law by Passyunk Ave, Philadelphia, PA. Id. at
Respondent’s Licensure Status, the ‘‘fail[ing] to maintain complete medical 8.
State Board Actions, and Registration records that justify the course of However, at the time Respondent
Status treatment [that she] provided to . . . submitted her renewal application, the
Respondent is a board-certified S.C.’’ Id. at 10; see also id. at 11 (citing Agency had issued the Order to Show
physician in emergency medicine. See Fla. Stat. § 458.331(1)(m)). Cause. A DEA regulation applicable to
RX A, at 2. Respondent completed her Pursuant to the Settlement Agreement an applicant who has been served with
residency in emergency medicine in she entered into with Florida, an Order to Show Cause provides:
1998 and since then has worked at Respondent received a letter of concern, In the event that an applicant for
hospitals in New Jersey, Pennsylvania, was fined $5,000, and was required to reregistration (who is doing business under a
New York, Florida, and New Mexico. Id. reimburse the Florida Department of registration previously granted and not
at 1–2. While Respondent holds an Health’s costs of investigating and revoked or suspended) has applied for
active license in New York, Florida, and reregistration at least 45 days before the date
prosecuting the matter in an amount on which the existing registration is due to
Pennsylvania, she has been disciplined between $5,587.55 and $6,587.55. GX 8, expire, the existing registration of the
by the medical boards of each of these at 2–3. Respondent was also required to applicant shall automatically be extended
States, based on her prescribing of perform 25 hours of community service, and continue in effect until the date on
controlled substances to S.C., with as well as to attend ten (10) hours of which the Administrator so issues his/her
whom she had a personal relationship Continuing Medical Education (CME) in order. The Administrator may extend any
while she was practicing in Florida. See ‘‘Appropriate Prescribing Practices’’ and other existing registration under the
GX 9, 11, 12, 13. two (2) hours of CME in ‘‘Proper circumstances contemplated in this section
In the Settlement Agreement she Medical Record Keeping.’’ Id. at 4–5.
even though the registrant failed to apply for
entered into with the Florida Board, reregistration at least 45 days before
Finally, the Board prohibited expiration of the existing registration, with or
‘‘Respondent neither admit[ted] nor Respondent from ‘‘prescrib[ing]
denie[d] the allegations of fact without request by the registrant, if the
controlled substances to persons with Administrator finds that such extension is
contained in the [Board’s]
whom [she] is in a personal, familial or not inconsistent with the public health and
Administrative Complaint.’’ GX 8, at 2. safety.
non-familial, relationship.’’ GX 8, at 2–
However, she did ‘‘admit[] that the facts
5.2 21 CFR 1301.36(i).
alleged in the Administrative
Complaint, if proven,1 would constitute As of the hearing, Respondent was Respondent did not file her renewal
violations of Chapter 458, Florida working as a contract physician at the application more than 45 days before
Statutes, as alleged in the Northern Navajo Medical Center, a her registration was due to expire and
Administrative Complaint.’’ Id. facility of the Indian Health Service thus her registration was not
More specifically, the State alleged (IHS), which is located in Shiprock, automatically extended pending the
that ‘‘Respondent failed to meet the New Mexico; Respondent has worked at issuance of this Decision and Final
prevailing standard of care in regard to this hospital since August 2012. RX A, Order. Based on my review of the record
Patient S.C. in one or more of the at 1; Tr. 163. Respondent is not licensed in this matter, I further conclude that
following ways.’’ GX 7, at 9. The State to practice medicine by the State of New the extension of her registration would
alleged that Respondent ‘‘fail[ed] to Mexico. RX A, at 2. be ‘‘inconsistent with the public health
adequately assess and/or diagnose Respondent also held DEA Certificate and safety.’’ Id. Accordingly, I hold that
Patient S.C. with chronic pain,’’ Registration BM8059102, pursuant to her registration expired on January 31,
‘‘fail[ed] to appropriately treat . . . which she was authorized to dispense 2015. See Ralph J. Chambers, 79 FR
S.C.,’’ ‘‘fail[ed] to use alternative controlled substances in schedules II 4962 (2014) (citing Paul H. Volkman, 73
treatment methods,’’ ‘‘prescrib[ed] S.C. through V, at the registered location of FR 30630, 30641 (2008)). However, I
an inappropriate and/or excessive Olean General Hospital, 515 Main St., conclude that her application remains
quantity of [R]oxicodone, oxycodone, Olean, New York 14760. GX 20, at 1. pending before the Agency. See id.
and/or OxyContin,’’ ‘‘fail[ed] to obtain This registration had an expiration date The Allegations That Respondent
laboratory results and/or diagnostic of January 31, 2015. Id. Unlawfully Prescribed Controlled
scans to collaborate [sic] or monitor Substances to S.C.
S.C.’s condition,’’ and ‘‘fail[ed] to 2 Based on the Florida Board’s action, New York
tkelley on DSK3SPTVN1PROD with NOTICES
properly monitor and/or follow up on State Board for Professional Medical Conduct
Between February 2007 and August
. . . S.C.’s condition.’’ Id. at 9–10 (citing imposed a ‘‘Censure and Reprimand,’’ prohibited 2009, Respondent worked as an ER
Fla. Stat. § 458.331(1)(t)).
her from prescribing to persons with whom she is physician at the Physicians Regional
in a relationship, placed her on probation for three Medical Center in Naples, Florida. RX
years, and fined her $1500. GX 11. Also, based on
1 These allegations largely track what the the actions of the Florida and New York Boards, the
A, at 1. According to Respondent, in
Government alleged and I find proved in this Pennsylvania State Board of Medicine imposed a August 2007, she met S.C., a budding
matter. See GX 7, at 1–7. $5000 civil penalty on her. GX 13. reality TV star, when he came to the ER
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with a broken hand and she treated him Id. When then asked by the Government from the pain management specialist
by splinting his hand and prescribing if subsequent to the August 2007 ER who had previously treated him and
Percocet to him.3 Tr. 207–08. A week or visit, she ‘‘had met with him in a ‘‘then copied the prescription off the
two later, Respondent was told by an x- clinical capacity prior to’’ issuing the bottles.’’ Id. at 217. Respondent further
ray technician that S.C. worked for January 18 prescription, Respondent denied having made a diagnosis of
Ticket Master and that he was hosting answered: chronic pain, stating that ‘‘that was
a fund-raising event at a local coffee I don’t understand what you mean, clinical established already’’ by S.C.’s ‘‘prior
shop. Id. at 211. Respondent went to the capacity. We developed a friendship, and we physician[].’’ Id. at 229.
coffee shop to see if she could get tickets . . . were involved in a relationship, at that While Respondent admitted that she
from S.C for an upcoming football game. time. So, you know, I had gotten to know him ‘‘was not familiar with treating chronic
Id. Thereafter, Respondent and S.C. personally. I knew his family, and you know,
we had discussed a lot of his medical pain,’’ she did not contact the pain
entered into a personal relationship. Id.
Respondent did not prescribe any conditions, I had discussed with him and his management doctor who had previously
controlled substances to S.C. until family. treated S.C., explaining that S.C. had
January 18, 2008, when she wrote him told her that ‘‘he was no longer involved
Id. with his care, and he did not wish to
a prescription for 90 tablets of When then asked where she had
oxycodone 30mg. GX 1, at 1. . . . see that physician any longer.’’ Id.
conducted her physical examinations of
Respondent did not recall exactly where at 218–19. Respondent explained that
S.C., Respondent stated ‘‘[e]ither by my
she wrote the prescription (this having she relied on what S.C. and his family
home or his home.’’ Id. 215. When
occurred at either her home or S.C.’s) had told her, as well as some of his
asked how she had assessed his pain
but acknowledged that it was not at medical records, although she did not
level, Respondent testified: ‘‘Just by
either of the hospitals (both of which look through all of his records. Id.
asking him and just seeing how his
were located in Fort Myers, Florida) overall well-being was.’’ Id. at 215–16. When then asked how she knew that
which were listed on the prescription Respondent then asserted that S.C. had his prior physician would have
form she used. Tr. 213. When asked told her that ‘‘he was in excruciating continued S.C. on controlled
whether she performed a physical exam pain. He couldn’t function without substances, Respondent answered that
on this occasion, Respondent testified: being on his pain medicine.’’ Id. at 216. ‘‘[w]hen you’re on controlled substances
I conducted a physical exam. I don’t know Respondent admitted, however, that she you just don’t stop . . . you have to go
if it was on that specific date, but prior to me did not create ‘‘any formal records’’ for through either a weaning process or—
issuing this prescription, I had gotten to the prescriptions. Id. Nor did she create that’s why it requires a specialist to . . .
know him very well, and I learned more continue treating once you’re up to a
a written treatment plan for S.C. Id. at
about his chronic pain syndrome, and he was
a smoker. So, I did, I had listened to his heart 218. She further admitted that she did certain number of high dose pain
and lungs many times before.4 not order any additional tests, because medication.’’ Id. at 234–35. She also
she was ‘‘work[ing] outside [the] claimed that his family told her that S.C.
3 Over the Government’s objection, the ALJ emergency department’’ and that ‘‘that did not have a history of substance
allowed Respondent to testify by telephone from was already conducted by his pain abuse. Id. at 232. Respondent
her lawyer’s office, rather than in person or by management specialist.’’ Id. at 232–33. acknowledged that it ‘‘was [her] error’’
appearing at a DEA facility which has Video-
Teleconferencing (VTC) capability. Gov. When then asked what was the to accept S.C.’s word instead of
Exceptions, at 2–6. The Government took exception medical purpose of the prescription, contacting his prior physician. Id. at
to this ruling. Respondent testified that S.C. ‘‘was in a 219. She further maintained that she
While the Government makes no claim that pain management clinic, up until about trusted S.C., that ‘‘his family backed up
Respondent’s counsels acted improperly at any time
during her testimony, it is manifest that where a
November or December of 2007, and he his story,’’ and that she had ‘‘no reason
witness is allowed to testify by telephone, notes was transitioning. He said he lost his to believe at the time’’ that she ‘‘was
could be passed to the witness during the testimony medical insurance. He was trying to find being deceived.’’ Id. at 220. She also
without the ALJ or Government Counsel ever being a new treating physician for his chronic stated that she was in ‘‘a very good
aware of this. So too, the use of telephone testimony
raises a greater risk that during breaks in the pain.’’ Id. at 216. According to friendship’’ with S.C. and that over
proceeding, the witness could discuss her Respondent, S.C. told her that he had time, she ‘‘lost the physician/patient
testimony with others. back fractures and neck injuries from relationship’’ and ‘‘was not objective.’’
I find the Government’s exception to be well doing acting stunts and motorcycle Id.
taken. This is not to say that every witness must
testify either in person or by VTC. However, a
racing. Id. at 246. On or about February 7, 2008,
respondent will invariably be a highly important, if Respondent further explained that Respondent wrote S.C. three undated
not the most important witness in a proceeding, and S.C. was ‘‘starting to do a lot of traveling prescriptions for OxyContin 80mg.5 See
thus, under no circumstance is it proper to allow at that time’’ as he was auditioning for
a respondent to testify by telephone. As for other GX 1, at 3, 5, and 7. The prescriptions,
witnesses, with the exception of a witness who
various ‘‘acting jobs,’’ and that he asked which authorized the dispensing of 100
testifies only as to the authentication or foundation her if she could help him out until he dosage units q12h, 200 dosage units
of proposed exhibits, the taking of testimony by could get insurance and ‘‘see another q8h, and 100 dosage units q8h, all
telephone is disfavored and may be used only upon provider.’’ Id. at 216–17; 234. According
a showing that exceptional circumstances exist and lacked S.C.’s address. See id. Moreover,
that the failure to obtain a witness’s testimony will
to Respondent, she looked at the labels none of the prescriptions listed ‘‘the
result in a denial of due process. of the prescriptions S.C. had received earliest date on which’’ it could be filled
4 At several other points in her testimony,
as required by 21 CFR 1306.12(b)(1)(ii).
Respondent described the physical exam as had my stethoscope with me, and you know,
listening to S.C.’s heart and lungs, and made no whenever I saw him, I just did a general, you
See id. Based on Respondent’s dosing
tkelley on DSK3SPTVN1PROD with NOTICES
reference to any other tests she did. For example, know—was able to generally assess his overall
when asked ‘‘How often did you perform a physical health and well-being, just from interacting with 5 The prescriptions were written on the
examination of S.C. in the course of issuing him and speaking to his family. prescription forms of the Physicians Regional
prescriptions to him?,’’ she answered: Tr. 244–45. Notably, only after Respondent was Medical Center and were sequentially numbered
I can’t say for certain, but I did listen—like I said, asked by the Government if she specifically from 007424 through 007426. GX 1, at 3–7. While
I mean, he was a smoker, so I did listen to his . . . examined S.C.’s back and neck did she assert that the prescriptions were undated, the evidence shows
heart and lungs, which is one of the main exams she palpated him ‘‘along the spine and surrounding that prescription number 007425 for 200 OxyContin
on a physical, on a regular basis, because I usually areas.’’ Id. at 263. 80mg. was filled on February 7, 2008. Id. at 4.
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instructions, the prescriptions provided I know I was very distracted when I would ‘‘he wanted to make sure he didn’t run
S.C. with 149 days’ supply of the drug. write the prescriptions, because it was either out of pain medication while he was
The evidence further shows that S.C. at his home or my home, and he had a three- there.’’ Id. She also testified that she
year-old child. It was usually—it was usually was unaware that she could write ‘‘do
filled the prescription for 200 tablets at
at his home.
a cost of $2,328.00. Id. at 4. Yet He had a three-year-old, or a four-year-old,
not fill until a certain date’’ on the
Respondent repeatedly claimed that she at the time. There were two dogs, a monkey prescriptions. Id.
‘‘was trying to offer a short-term, fix for in the house. There was a loud . . . his father Following his appearance on the MTV
his situation’’ because ‘‘[h]e was short was hard of hearing, so . . . the TV was on show and his return to Florida
on money,’’ Tr. 236, even though he was very loud, and it was a very distracting (sometime around October 2008), S.C.
working at a local radio station. Id. at environment. I don’t . . . you know, I cannot was ‘‘getting a lot of opportunities to
238–39. Respondent further claimed explain exactly why the date wasn’t on them, travel, to do commercials, to do
that S.C. had told her that an office visit because I know that the date needs to be on auditions,’’ and contracts. Id. at 249.
them. So, I can just . . . go back in my mind According to Respondent, S.C. asked
with a pain management specialist cost
and know that it was very distracting. her if she could continue to help him
‘‘about $400 or $500’’ not counting the
cost of any prescriptions, and that she Tr. 222. Later in her testimony, out ‘‘because he was doing a lot of
trusted what he told her. Id. at 239. She Respondent explained that S.C. had two travelling’’ and it was hard for him to
also claimed that she was unfamiliar German Shepherds, and that there was find ‘‘a physician in a different state.’’
with the cost of various drugs. Id. at also a mutt (which he apparently did Id. Respondent agreed to do so and
237. not own) that was allowed to come into resumed prescribing to him. In her
Regarding the OxyContin 80mg the house. Id. at 340. And then there testimony, Respondent did not explain
prescriptions, Respondent stated that was the monkey, which according to why given S.C.’s success, he could not
she had ‘‘probably not’’ physically Respondent, was ‘‘three or four feet’’ tall afford health insurance and find a pain
examined S.C. ‘‘because [she] had done and ‘‘dangerous,’’ but was nonetheless management specialist.
it in the past.’’ Tr. 231. Respondent then allowed to run free in the house. Id. at On January 20, 2009, Respondent
claimed that she had assessed S.C.’s 340–41. resumed prescribing to S.C., issuing him
pain level by ‘‘his appearance and how As for why she had written the three a prescription for 40 Roxicodone 30mg,
he would tell me he was feeling.’’ Id. oxycodone 30mg prescriptions which with a dosing instruction of TID or one
Respondent did not create a record for were filled on March 10, Respondent tablet, three times a day. GX 1, at 15.
the prescriptions. Id. at 231–32. offered the following testimony: Between February 3 and March 6, 2009,
Notwithstanding the quantity of drugs I’m just trying to recall, because also, on Respondent issued S.C. the following
provided by these prescriptions, on or multiple times, I was told the prescriptions prescriptions, all of which had a dosing
about March 10, 2008,6 Respondent were either lost or destroyed by the animals instruction of TID, or one tablet three
issued S.C. three more prescriptions, in the house, by the monkey . . . the monkey times a day:
each of which was for 450 oxycodone was . . . he would take the pill bottle, open
it, and throw it in the pool, or you know, Date Drug and quantity
30mg, with a dosing instruction to take various different times . . . I was told that
up to 15 tablets per day ‘‘as needed for they were lost or stolen or left behind at the 2/3/09 ................... 90 Roxicodone 30mg.
pain.’’ GX 1, at 9, 11, and 13. As before, different hotels he was staying at. 2/3/09 ................... 90 Roxicodone 30mg.
the prescriptions were not dated, did I just can’t—you know, it’s unclear, which 2/9/09 ................... 90 Roxicodone 30mg.
not include S.C.’s address, and lacked set of prescriptions it may have occurred 2/9/09 ................... 90 Roxicodone 30mg.
the earliest date on which they could be with, but it happened on numerous 2/9/09 ................... 90 Roxicodone 30mg.
filled.7 Id. The evidence further shows occasions, which is why there is [sic] a 2/10/09 ................. 90 Roxicodone 30mg.
number of prescriptions. 2/10/09 ................. 90 Roxicodone 30mg.
that S.C. filled each of the prescriptions 2/10/09 ................. 90 Roxicodone 30mg.
on March 10, 2008, and paid $280.74 for Id. at 240–41. Respondent further 2/20/09 ................. 90 Roxicodone 30mg.
each one. Id. at 10, 12, and 14. maintained that S.C.’s stories regarding 2/20/09 ................. 90 Roxicodone 30mg.
Here again, Respondent could not the monkey were believable because he 3/6/09 ................... 90 Roxicodone 30mg.
state ‘‘for certain’’ that she performed a ‘‘would try to rip up my clothes and my 3/6/09 ................... 280 Roxicodone 15mg.
physical exam on S.C. when she issued shoes and he would take anything and
these prescriptions. Tr. 244. However, just try to shred it.’’ Id. at 341. See GX 1, at 17–35.
Respondent testified that she issued the As a further reason for why she wrote Based on Respondent’s dosing
prescriptions at S.C.’s home because the multiple prescriptions, Respondent instruction of TID, a single oxycodone
‘‘this was when he was getting ready to explained that there were occasions in 30mg prescription would have provided
go to Los Angeles for his acting job.’’ Id. which S.C. would call and tell her that S.C. with a thirty-day supply; thus, a
at 245. She also testified that she the pharmacy was either ‘‘out of stock single prescription issued on February
assessed S.C.’s pain level by ‘‘[j]ust for a particular brand name or particular 3rd, should have lasted him through
interacting with him, asking how he was dosage.’’ Id. at 241; see also id. at 245 March 5th.8 However, the prescriptions
feeling,’’ and by S.C. letting her know (‘‘this was around the time where he Respondent wrote S.C. between
whether he ‘‘was having a good day or told me the prescriptions were being February 3 and March 6 authorized the
a bad day.’’ Id. at 245–46. destroyed or lost or left at one pharmacy dispensing of 990 tablets of oxycodone
As for why she did not date the or another, because they weren’t in 30mg, an eleven-month supply; the
prescriptions and include S.C.’s stock’’). prescription for 280 oxycodone 15mg
address, Respondent testified that: At this point, S.C. apparently left the 8 It is acknowledged that the pharmacy which
tkelley on DSK3SPTVN1PROD with NOTICES
area and went off to pursue his acting filled one of the February 3, 2009 prescriptions
6 Here again, the prescriptions were written on career. Tr. 227. As for why she had dispensed only 54 tablets on that date. GX 1, at 17–
the forms of the Physicians Regional Medical Center issued the multiple OxyContin 18. However, even if S.C. was unable to obtain the
and were numbered 009325, 009326, and 009329. prescriptions, Respondent testified that remaining 46 tablets from the pharmacy within 72
GX 1, at 9, 11, and 13. hours as required by DEA’s regulation, see 21 CFR
7 If the drugs were actually taken at fifteen tablets S.C. had told her that he was going to 1306.13(a), Respondent did not explain why it was
per day, the prescriptions would have provided an be in Los Angeles for ‘‘three to six necessary to write S.C. a second prescription on
additional 90 days’ supply. months’’ to film a show for MTV and that date for a full 90 tablets.
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provided S.C. with more than another As for why she issued three On further questioning by her counsel,
1.5 month’s supply of the drug. prescriptions on February 9, 2009 and inconsistent with her earlier
As for why Respondent issued instead of a single prescription for 270 testimony that the last prescription she
multiple prescriptions on February 3, tablets, Respondent answered that ‘‘[t]he wrote for S.C. was in August 2009, id.
2009, Respondent testified that ‘‘that particular pharmacy . . . didn’t have at 267, Respondent denied having
they were not in stock at the particular that quantity in stock’’ so she split the written S.C. any more prescriptions
pharmacy that he initially went to,’’ so prescriptions. Id. at 260–61. Again, ‘‘after the last emergency room visit.’’
S.C. ‘‘called me or told me that he had Respondent could not recall if she had Id. at 349. Yet the evidence shows that
left the prescription [and] needed a new conducted a physical exam on S.C. on S.C.’s last ER visit was on July 3, 2009,
one, so he could bring it to whatever this date, id. at 262, and acknowledged see GX 15, and the evidence further
other pharmacy he was using.’’ Tr. 251. that she did not create a medical record shows that on July 31, 2009, Respondent
However, the evidence shows only that for these prescriptions or a written issued S.C. a prescription for 30
the pharmacy partially filled the treatment plan. Id. at 264. She claimed, Roxicodone 15mg. GX 1, at 36.
prescription in the amount of 54 tablets. however, that she had assessed his pain The evidence further showed that
GX 1, at 17. Respondent then asserted level in the same manner as before, and Respondent and S.C. drove to a Publix
that she ‘‘never realized that [the that she had discussed the risks and pharmacy where the prescription was
prescriptions] were being filled’’ and benefits of using controlled substances filled. Tr. 97–98. Respondent remained
that she ‘‘thought they were either being on this occasion. Id. at 265, 273. in the car while S.C. went in to the store
destroyed’’ or ‘‘not being filled at all.’’ Respondent further testified that she to fill the prescription. Id. at 98.
Id. at 251–52. However, Respondent used the same approach in assessing According to the pharmacist, ‘‘S.C. was
never called any of the pharmacies S.C. S.C.’s need for oxycodone for all of the very chatty and used a lot of small talk’’
used and ‘‘never got word from the prescriptions (other than the one she about being on a reality TV show ‘‘as if
pharmacist that they were being filled.’’ wrote during his ER visit). Id. at 274. he was trying to distract’’ her. Id. at 97,
Id. at 252; see also id. at 241 (‘‘I was Moreover, when asked why she had 105. After the pharmacist handed the
never phoned by any of these issued these three prescriptions given filled prescription to S.C., he ‘‘eagerly
pharmacists, telling me that these that she had issued two similar took the prescription . . . and quickly
prescriptions were being filled. I had no prescriptions only six days earlier, headed to the back of the store.’’ Id. at
idea, because I did not have any records Respondent testified that she believed 97. Finding S.C.’s behavior suspicious,
of the number of prescriptions I that S.C. had begun having seizures and the pharmacist called the hospital ER to
wrote.’’). was becoming forgetful. Id. at 266. verify the prescription and was told that
Respondent then testified that she did Continuing, Respondent testified that: ‘‘I Respondent was under investigation
not find S.C.’s claim suspicious because believe he was—he may have been and was asked to fax the prescription to
in the ER, ‘‘there were multiple times having seizures, which I found out in the ER and to call the sheriff. Id. at 101.
where patients would’’ complain that a May, when I went over [to] his house The pharmacist then asked an assistant
pharmacy would not have a particular . . . and he was acting confused . . . store manager to go into the bathroom
narcotic or dosage. Id. at 252. When and he was in a post-seizure state . . . and check on S.C. GX 6.
asked why the pharmacies would not and I . . . told [his] mom that he was While the pharmacist was still on the
have just returned the prescriptions to having seizures.’’ Id. at 266–67. phone, S.C. reappeared at the pharmacy
S.C. if the drug was out of stock, However, Respondent then testified that counter and asked if there was a
Respondent testified that she thought ‘‘this was actually in—it was around problem with the prescription. Tr. 98.
‘‘that is how they operated down there’’ May.’’ Id. at 267.10 Still later in her The pharmacist told S.C. that she
and added that she ‘‘was new to the testimony, Respondent explained that ‘‘need[ed] to clarify the prescription
State.’’ Id. at 253. However, Respondent ‘‘it was my understanding that he was and’’ asked him if she could have it
has been licensed in Florida since being truthful and they were truly lost back; S.C. complied. Id. The pharmacist
August 2004 and had worked there or misplaced or destroyed or left at the then counted the tablets and found that
since at least December 2004.9 RX A, at pharmacist and never filled. Id. at 274. two were missing. Id. S.C. then told the
The evidence shows that the two pharmacist that ‘‘if there are any
1–2. Respondent could not recall
February 3 prescriptions were filled on questions regarding this prescription the
whether she had ever had another
February 3 and 5, and that three doctor is my girlfriend and she is out in
patient ask for a replacement
February 9 prescriptions were filled on the car.’’ Id.
prescription claiming that a pharmacist
February 9, 11, and 16. GX 1, at 18, 19,
had said a drug was out of stock and yet The pharmacist then proceeded to the
21, 23, and 25. So too, the evidence
kept the prescription. Id. at 254–55. parking lot and found Respondent in a
shows that the three prescriptions
Regarding the February 3, 2009 car; the pharmacist asked Respondent
Respondent wrote on February 10, were
prescriptions, Respondent again could for her driver’s license, and after
filled on February 13, 14, and 17; the
not recall if she had done a physical determining that it was Respondent,
two prescriptions she wrote on February
examination. Id. at 255. While asked if she had written the
20, were filled on February 21 and 25;
Respondent claimed that she had prescription. Id. Respondent ‘‘said
and the two prescriptions she wrote on
assessed S.C.’s pain level in the same ‘yes.’’’ Id. The pharmacist then returned
March 6, were filled on March 6 and 9.
manner as before, she admitted that she to the pharmacy and found that ‘‘S.C.
See id. at 26–35.
did not create a medical record or a was still there’’; S.C. ‘‘was very anxious
On questioning by her counsel,
written treatment plan. Id. at 255–56. and ask[ed] if he was going to be
Respondent testified that she did not
tkelley on DSK3SPTVN1PROD with NOTICES
Nor could she specifically recall if, on arrested.’’ Id. The pharmacist went back
become aware that S.C. had been
this occasion, she had discussed the inside the pharmacy, called the ER
arrested for doctor-shopping ‘‘until after
risks and benefits of using controlled again and verified that Respondent was
the case was already over.’’ Tr. 348–49.
substances. Id. at 256. still employed there. Id. at 98–99. After
10 The evidence shows that S.C. was hospitalized being told that she was, the pharmacist
9 Priorto working in Naples, Respondent worked for seizures on two occasions, May 28, 2009, and gave the prescription back to S.C. and
at a hospital in Fort Myers. RX A, at 1–2. July 3, 2009. See GX 15 & 16. called the sheriff. Id. at 99.
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Respondent testified that she still Discussion not adopt the ALJ findings that
believes that the prescriptions she Section 303(f) of the Controlled Respondent violated federal law by
issued S.C. were within the usual course Substances Act (CSA) provides that an issuing prescriptions while working as a
of professional practice and for a application for a practitioner’s contract physician at the Northern
legitimate medical purpose. Id. at 277. registration may be denied ‘‘if the Navajo Medical Center without being
However, Respondent then stated that Attorney General determines that the registered in New Mexico, I find that
‘‘[i]n hindsight . . . my judgment was issuance of such registration . . . would Respondent acted outside the usual
impaired because of the relationship I be inconsistent with the public course of professional practice and
had with the individual,’’ the interest.’’ 21 U.S.C. 823(f). With respect lacked a legitimate medical purpose in
prescriptions ‘‘were not within . . . the to a practitioner, the Act requires the issuing the prescriptions to S.C.
standards of my medical practice.’’ Id. consideration of the following factors in Notwithstanding her claim that her
Yet Respondent later asserted that she making the public interest conduct in prescribing to S.C. is an
‘‘was definitely manipulated and taken determination: aberration, I find it to be egregious. And
advantage of. I was victimized.’’ Id. at based on her insistence that even now,
(1) The recommendation of the appropriate she still believes these prescriptions
350. State licensing board or professional were legitimate, I conclude that
Respondent also testified that at the disciplinary authority.
(2) The applicant’s experience in
Respondent has failed to produce
time she wrote the prescriptions she sufficient evidence to demonstrate why
believed they were ‘‘medically dispensing . . . controlled substances.
(3) The applicant’s conviction record under she should be entrusted with a
necessary’’ because there was a ‘‘prior Federal or State laws relating to the registration.13
diagnosis of chronic pain.’’ Id. And manufacture, distribution, or dispensing of
when asked whether, ‘‘[s]itting here controlled substances. Factors Two and Four—Respondent’s
today, knowing what you do today, do (4) Compliance with applicable State, Experience in Dispensing Controlled
you still believe that they were Federal, or local laws relating to controlled Substances and Compliance With
medically necessary at the time?’’ substances. Applicable Laws Related to Controlled
Respondent answered: ‘‘[y]es.’’ Id. (5) Such other conduct which may threaten Substances
the public health and safety.
Respondent did acknowledge that she To effectuate the dual goals of
violated Florida’s regulations by failing Id. § 823(f). conquering drug abuse and controlling
‘‘These factors are . . . considered in both the legitimate and illegitimate
to ‘‘keep proper documentation of each
the disjunctive.’’ Robert A. Leslie, M.D., traffic in controlled substances,
visit.’’ Id. at 351. She then maintained
68 FR 15227, 15230 (2003). It is well ‘‘Congress devised a closed regulatory
that through the continuing medical
settled that I ‘‘may rely on any one or system making it unlawful to
education course she was required to
a combination of factors[,] and may give manufacture, distribute, dispense, or
take under the Florida Board’s Order, ‘‘I
each factor the weight [I] deem[] possess any controlled substance except
realize that will never happen again.’’
appropriate in determining whether a
Id.11
registration should be revoked. Id.; see 13 I acknowledge that Respondent remains
11 During its examination of Respondent, the
also MacKay v. DEA, 664 F.3d 808, 816 licensed in various States, including Pennsylvania,
(10th Cir. 2011); Volkman v. DEA, 567 the State where she seeks registration and therefore
Government asked her if her attorney had spoken meets the CSA’s prerequisite for holding a
‘‘with a DEA representative about whether [she] F.3d 215, 222 (6th Cir. 2009); Hoxie v. practitioner’s registration in that State. See 21
needed to obtain a DEA registration in New DEA, 419 F.3d 477, 482 (6th Cir. 2005). U.S.C. 823(f) (‘‘The Attorney General shall register
Mexico.’’ Tr. 199. Respondent’s counsel objected, Moreover, while I am required to practitioners . . . to dispense . . . controlled
asserting that this was a privileged communication substances . . . if the applicant is authorized to
and the ALJ sustained the objection. Id.; see also
consider each of the factors, I ‘‘need not dispense . . . controlled substances under the laws
R.D. at 39 (‘‘I sustained [Respondent’s] objection to make explicit findings as to each one.’’ of the State in which he practices.’’).
the question, finding that the response was likely MacKay, 664 F.3d at 816 (quoting However, the possession of state authority ‘‘‘is
to call for the disclosure of information protected Volkman, 567 F.3d at 222 (quoting not dispositive of the public interest inquiry.’’’
by the attorney client privilege. I continue to George Mathew, 75 FR 66138, 66145 (2010), pet. for
believe the sought-after response would likely have
Hoxie, 419 F.3d at 482)).12
rev. denied Mathew v. DEA, No. 10–73480, slip op.
called for [Respondent] to disclose what Mr. Leider In this matter, I have considered all of at 5 (9th Cir., Mar. 16, 2012); see also Patrick W.
[her attorney] did or did not tell her in the course the factors and conclude that the Stodola, 74 FR 20727, 20730 n.16 (2009). As the
of his representation of her.’’). Government’s evidence with respect to Agency has long held, ‘‘the Controlled Substances
Notably, in his Recommended Decision, the ALJ factors two (Respondent’s experience in Act requires that the Administrator . . . make an
did not cite a single case to support his ruling and independent determination [from that made by state
I conclude that his ruling was erroneous. ‘‘The dispensing controlled substances), four officials] as to whether the granting of controlled
privilege ‘protects only those disclosures necessary (Respondent’s compliance with substance privileges would be in the public
to obtain informed legal advice which might not applicable laws related to controlled interest.’’ Mortimer Levin, 57 FR 8680, 8681 (1992).
have been made absent the privilege.’ ’’ In re Walsh, substances), and five (such other Accordingly, this factor is not dispositive either for,
623 F.2d 489,494 (7th Cir. 1980) (quoting Fisher v. or against, the granting of Respondent’s
United States, 425 U.S. 391, 403 (1976)). Moreover, conduct) establishes that she ‘‘has applications. Paul Weir Battershell, 76 FR 44359,
‘‘‘when an attorney conveys to his client facts committed such acts as would render 44366 (2011) (citing Edmund Chein, 72 FR 6580,
acquired from other persons or sources, those facts [her] registration under section 823 of 6590 (2007), pet. for rev. denied Chein v. DEA, 533
are not privileged.’ ’’ See In re Sealed Case, 737 F.2d F.3d 828 (D.C. Cir. 2008)).
this title inconsistent with the public
94, 100 (D.C. Cir. 1984)) (quoting Brinton v. As for factor three, there is no evidence that
Department of State, 636 F.2d 600, 604 (D.C. Cir. interest.’’ 21 U.S.C. 824(a)(4). While I do Respondent has been convicted of an offense
1980) (footnote omitted)). Because the question did ‘‘relating to the manufacture, distribution or
not ask Respondent to disclose what facts she had 12 ‘‘In short, this is not a contest in which score dispensing of controlled substances.’’ 21 U.S.C.
communicated to her lawyer or the legal advice she is kept; the Agency is not required to mechanically 823(f)(3). However, there are a number of reasons
received from her lawyer, the ALJ erred in barring count up the factors and determine how many favor why even a person who has engaged in misconduct
tkelley on DSK3SPTVN1PROD with NOTICES
the testimony. See United States v. DeFazio, 899 the Government and how many favor the registrant. may never have been convicted of an offense under
F.2d 626, 635 (7th Cir. 1990) (holding that where Rather, it is an inquiry which focuses on protecting this factor, let alone prosecuted for one. Dewey C.
attorney ‘‘testified only to what [an] IRS agent said the public interest; what matters is the seriousness MacKay, 75 FR 49956, 49973 (2010), pet. for rev.
to him, and that he later relayed those statements of the registrant’s misconduct.’’ Jayam Krishna-Iyer, denied MacKay v. DEA, 664 F.3d 808 (10th Cir.
to [defendant,] [t]he content of this testimony is 74 FR 459, 462 (2009). Accordingly, as the Tenth 2011). The Agency has therefore held that ‘‘the
unprivileged because it did not reveal, either Circuit has recognized, findings under a single absence of such a conviction is of considerably less
directly or implicitly, legal advice given [defendant] factor can support the revocation of a registration. consequence in the public interest inquiry’’ and is
or any client confidences’’). MacKay, 664 F.3d at 821. therefore not dispositive. Id.
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in a manner authorized by the CSA.’’ mixing, or otherwise preparing . . . any and agreements; and 9. [p]eriodic
Gonzales v. Raich, 545 U.S. 1, 13 (2005). controlled substance, other than in the reviews.’’ Id. at 64B8–9.013(f).
Consistent with the maintenance of the course of the physician’s professional While Respondent asserted that she
closed regulatory system, a controlled practice.’’ Fla. Stat. § 458.331(q). The did a physical examination and that she
substance may only be dispensed upon statute further explains that knew ‘‘about [S.C.’s] chronic pain
a lawful prescription issued by a ‘‘prescribing, dispensing . . . or syndrome’’ from talking to both him and
practitioner. Carlos Gonzalez, M.D., 76 otherwise preparing . . . controlled his parents, Tr. 214, the fact remains
FR 63118, 63141 (2011). substances, inappropriately or in that she failed to document and
Fundamental to the CSA’s scheme is excessive or inappropriate quantities is maintain any medical records to support
the Agency’s longstanding regulation, not in the best interest of the patient and the prescriptions. Indeed, she
which states that ‘‘[a] prescription for a is not in the course of the physician’s specifically denied having diagnosed
controlled substance [is not] effective professional practice.’’ Id.; see also Fla. S.C. as having chronic pain, asserting
[unless it is] issued for a legitimate Stat. § 893.05(1) (‘‘A practitioner, in that the diagnosis ‘‘was established
medical purpose by an individual good faith and in the course of his or her already’’ by S.C.’s ‘‘prior physician,’’ id.
practitioner acting in the usual course of professional practice only, may at 229, and that she wrote the
his professional practice.’’ 21 CFR prescribe . . . a controlled prescriptions by ‘‘cop[ying] the
1306.04(a). This regulation further substance[.]’’). prescription off the bottles’’ S.C. showed
provides that ‘‘an order purporting to be As found above, while Respondent her. Id. at 217. Yet, notwithstanding that
a prescription issued not in the usual neither admitted nor denied the factual those prescriptions were legally
course of professional treatment . . . is allegations of the Administrative required to contain the name of the
not a prescription within the meaning Complaint which was filed against her prescribing physician, see 21 CFR
and intent of [21 U.S.C. 829] and . . . by the Florida Board, she did admit that 1306.14(a), and no claim is made that
the person issuing it, shall be subject to if those facts were proven, they would they did not, Respondent never called
the penalties provided for violations of establish violations of the Florida S.C.’s prior physician.15
the provisions of law relating to Statutes as alleged in the Complaint, When then asked how she knew if
controlled substances.’’ Id. including not only that she failed to Respondent’s prior physician would
As the Supreme Court has explained, meet the prevailing standard of care, but have continued S.C. on narcotic
‘‘the prescription requirement . . . also that she prescribed controlled controlled substances, Respondent
ensures patients use controlled substances other than in the course of replied that ‘‘[w]hen you’re on
substances under the supervision of a controlled substances you just don’t
her professional practice. See GX 8, at
doctor so as to prevent addiction and stop . . . you have to go through either
2 (citing Fla. Stat. Chap. 458). In this
recreational abuse. As a corollary, [it] a weaning process—that’s why it
proceeding, the material facts set forth
also bars doctors from peddling to requires a specialist to . . . continue
in the Board’s complaint have been
patients who crave the drugs for those treating once you’re up to a certain
proven.
prohibited uses.’’ Gonzales v. Oregon, number of high dose pain medication.’’
Moreover, under the Florida Board of
546 U.S. 243, 274 (2006) (citing United Tr. 234–35. Unexplained by Respondent
States v. Moore, 423 U.S. 122, 135, 143 Medicine’s then-existing Standards for is why she wrote S.C. prescriptions
(1975)); United States v. Alerre, 430 the Use of Controlled Substances for the totaling 400 dosage units of OxyContin
F.3d 681, 691 (4th Cir. 2005), cert. Treatment of Pain: 80mg, given her testimony that a patient
denied, 574 U.S. 1113 (2006) (stating A complete medical history and physical who is on a ‘‘high dose [of] pain
that the prescription requirement examination must be conducted and medication,’’ ‘‘requires a specialist,’’ id.,
likewise stands as a proscription against documented in the medical record. The which she is not, as well as her
doctors acting not ‘‘as a healer[,] but as medical record should document the nature admission that she ‘‘was not familiar
and intensity of the pain, current and past
a seller of wares’’). treatment for pain, underlying or coexisting
with treating chronic pain.’’ Id. at 218.
Under the CSA, it is fundamental that disease or conditions, the effect of the pain
Moreover, Respondent repeatedly
a practitioner must establish and on physical and psychological function, and provided S.C. with prescriptions which
maintain a legitimate doctor-patient history of substance abuse. The medical enabled him to obtain schedule II
relationship in order to act ‘‘in the usual record also should document the presence of controlled substances including
course of . . . professional practice’’ one or more recognized medical indications OxyContin 80mg and oxycodone 30mg,
and to issue a prescription for a for the use of a controlled substance. drugs which are among the most highly
‘‘legitimate medical purpose.’’ Paul H. Fla. Admin R. 64B8–9.013(3)(a).14 abused and diverted controlled
Volkman, 73 FR 30629, 30642 (2008), The State’s Standards also required a substances, in quantities which greatly
pet. for rev. denied, 567 F.3d 215, 223– physician ‘‘to keep accurate and exceeded both her own dosing
24 (6th Cir. 2009); see also Moore, 423 complete records to include, but not be instructions and DEA regulations. As
U.S. at 142–43 (noting that evidence limited to: 1. [t]he medical history and found above, on or about February 7,
established that the physician exceeded 2008, Respondent issued S.C.
physical examination, including history
the bounds of professional practice, prescriptions for 400 dosage units of
of drug abuse or dependence, as
when ‘‘he gave inadequate physical OxyContin 80mg. Putting aside that
appropriate; 2. [d]iagnostic, therapeutic,
examinations or none at all,’’ ‘‘ignored Respondent wrote two different dosing
and laboratory results; 3. [e]valuations
the results of the tests he did make,’’ instructions on the three prescriptions
and consultations; 4. [t]reatment
and ‘‘took no precautions against . . . objectives; 5. [d]iscussion of risks and
misuse and diversion’’). The CSA, benefits; 6.[t]reatments; 7. [m]edications
15 Respondent also testified that she looked at
tkelley on DSK3SPTVN1PROD with NOTICES
S.C.’s medical records. Thus, she clearly had
however, generally looks to state law to (including date, type, dosage, and available to her information as to Respondent’s
determine whether a doctor and patient quantity prescribed); 8. [i]nstructions prior physician. While Respondent testified that
have established a legitimate doctor- S.C. was no longer seeing this physician because
patient relationship. Volkman, 73 FR at ‘‘he lost his medical insurance,’’ id. at 216, as well
14 This version of the Standards was promulgated as that ‘‘he did not wish to . . . see that physician
30642. in 1999, amended in both 2002 and 2003, and any longer,’’ id. at 219, because she never called the
In Florida, a physician is barred from remained in effect until a new version of the physician, she had no idea if S.C. had told her the
‘‘prescribing, dispensing, administering, Standards was promulgated in 2010. truth or if his prior physician had discharged him.
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(one prescription calling for one tablet None of these explanations provides a CFR 1306.05(a) (‘‘All prescriptions for
every 12 hours, the other two calling for persuasive justification that mitigates controlled substances shall be dated as
one tablet every eight hours), these her misconduct. As for the first one, of, and signed on, the day when issued
dosing instructions provided S.C. with surely the Los Angeles area has an and shall bear the full name and address
more than a 149-day supply of the ample supply of pain management of the patient . . . .’’). As for why she
drug.16 However, under DEA specialists who could have treated S.C. did not date the prescriptions and
regulations, Respondent could lawfully were he to run out of medication. include S.C.’s address on them,
prescribe a maximum of a 90-day Moreover, even if S.C. was a legitimate Respondent offered the ludicrous
supply. See 21 CFR 1306.12(b)(1). patient, given her testimony that explanation that because of a young
Notwithstanding that she had written patients on high doses of narcotics child, the dogs, the monkey, and S.C.’s
the three OxyContin prescriptions only require a specialist to continue their hard-of-hearing father (who required
one month earlier and that if treatment, Respondent’s decision to that the volume on the TV be ‘‘very
Respondent took the drugs in provide S.C. with an eight-month loud’’), ‘‘it was a very distracting
accordance with her dosing supply of oxycodone when she had no environment.’’ Tr. 222. Yet somehow
instructions, he would have had at least ability to supervise his medication Respondent was able to include on the
a four-month supply of the drug use—not that that ever appeared to be prescriptions the drug name, the dosage
remaining, on or about March 10, 2008, a concern to her—reflects a stunning strength, the quantity, a dosing
Respondent wrote S.C. three more disregard for her obligations as a instruction, as well as her DEA number,
prescriptions. Each of these prescriber of controlled substances. See printed name and signature. In short, I
prescriptions authorized the dispensing Gonzales, 546 U.S. at 274 (‘‘the do not find her testimony credible as to
of 450 dosage units of oxycodone 30mg, prescription requirement . . . ensures why the prescriptions were undated.
and, with a dosing instruction of up to patients use controlled substances While Respondent apparently ceased
15 tablets or 450 milligrams per day, under the supervision of a doctor so as her prescribing to S.C. while he was in
provided S.C. with an additional thirty- to prevent addiction and recreational Los Angeles, she resumed prescribing to
day supply. By comparison, the abuse’’). him in January 2009, notwithstanding
OxyContin prescriptions provided a As for the explanation that S.C. told that with his opportunities and the
daily dose of 160 or 240mg per day. her that he needed additional ‘‘contracts he was getting,’’ S.C.
Assuming S.C. took the full fifteen prescriptions because the pharmacies presumably could have afforded to see
tablets per day, the three March 10, were out of either the branded a pain management specialist. Tr. 249.
2008 prescriptions provided S.C. with medication (such as OxyContin) or the As found above, between February 3
an additional 90-day supply of particular dosage strength, or that he left and March 6, 2009, Respondent issued
the prescription at the pharmacy, S.C. eleven prescriptions for 90
oxycodone. Thus, based on her own
Respondent never called any of the Roxicodone (oxycodone) 30mg.
dosing instructions, the February and
pharmacies to verify S.C.’s claims. Tr. Moreover, on several dates, Respondent
March 2008 prescriptions provided S.C.
241 & 252. Moreover, even if the issued S.C. two or more prescriptions.
with nearly an eight-month supply of Based on her dosing instruction of
pharmacies S.C. used were out of
oxycodone. one tablet, three times per day, the
OxyContin, Respondent offered no
As for why she issued these six prescriptions authorized the dispensing
explanation as to why, in a one-month
prescriptions, Respondent offered period, she increased S.C.’s daily dose of 990 tablets of oxycodone 30mg, or an
multiple explanations. First, regarding of oxycodone from either 160 or 240mgs eleven-month supply of the drug.
the OxyContin prescriptions, per day (depending upon which Moreover, on March 6, Respondent
Respondent testified that S.C. had told prescription she wrote) to 450mgs per issued S.C. a prescription for 280
her he was going to be in Los Angeles day. Roxicodone 15 mg (also with a dosing
for three to six months filming a show Then there is Respondent’s testimony instruction of one tablet, three times per
for MTV and did not want to run out of that she believed S.C. when he told her day). Thus, between February 3 and
medication. Tr. 227. Second, she that his pet monkey was opening his March 6, 2009, Respondent’s
asserted that S.C. told her that the pill bottles and throwing the drugs in prescriptions provided S.C. with more
monkey ‘‘would take the pill bottle, the pool. While Respondent initially than a one-year supply of oxycodone if
open it, and throw it in the pool.’’ Id. offered this far-fetched story to explain he actually took the drugs as directed.
at 240–41. Third, she claimed that S.C why she had written the three undated As for why she issued S.C. the two
required additional prescriptions oxycodone 30mg prescriptions, all of February 3 prescriptions, Respondent
because the pharmacy was either out of which were filled on the same date testified that S.C. had called her and
stock of the particular brand or dosage, (March 10, 2008) and bore serial told her that the pharmacy he initially
or that he left the prescription at the numbers suggesting they were all went to was out of stock and that he left
pharmacy. Id. at 241 & 245. written in close temporal proximity, she the prescription there. Once again,
offered no testimony to the effect that Respondent merely accepted S.C.’s
16 This calculation was based on Respondent’s
she had asked to see the pill bottles to story, which was only partially true, and
actual dosing instructions for each prescription. determine if the prescriptions had did not call the pharmacy.
These three prescriptions would have provided a
200-day supply of the drug had I calculated this actually been filled. Moreover, While Respondent maintained that
figure using a dosing instruction of one tablet every Respondent eventually backtracked on she did not find this suspicious because
twelve hours for all three prescriptions, which is this testimony, explaining that it was some of her ER patients had complained
consistent with the manufacturer’s prescribing ‘‘unclear[] which set of prescriptions it that a pharmacy would not have a
instructions. See Physician’s Desk Reference 2707
tkelley on DSK3SPTVN1PROD with NOTICES
(61st ed. 2007) (‘‘It is most appropriate to increase may have occurred with.’’ Tr. 241. particular drug, she could not recall if
the q12h dose, not the dosing frequency. There is Accordingly, I find this testimony she had ever had another patient claim
no clinical information on dosing intervals shorter incredible. that he/she needed a new prescription
than q12h.’’); see also id. (‘‘The intent of the Respondent further violated DEA because the pharmacist had kept it.
titration period is to establish a patient-specific
q12h dose that will maintain adequate analgesia
regulations because she failed to date When then asked why the pharmacist
with acceptable side effects for as long as pain relief the three March 2008 prescriptions and would not have simply returned the
is necessary.’’). include S.C.’s address on them. See 21 prescription to S.C., Respondent
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asserted that was ‘‘how they operated prescriptions with full knowledge that an aberrant set of circumstances that are
down there’’ and that she ‘‘was new to S.C. was going off to California for unlikely to ever be repeated.’’ Id.
the State,’’ even though she had worked several months and that she would have It is acknowledged that except for the
in Florida for more than four years at no ability to monitor him. And she matters at issue here, Respondent has
that point. Yet the evidence shows that failed to create any medical records and practiced medicine as an ER physician
every single prescription she issued to a written treatment plan. for approximately sixteen years and
S.C. in this period was filled, see GX 1, As for the 2009 prescriptions, dispensed controlled substances
at 17–35, and while the first February 3 notwithstanding that she had not without incident. It also acknowledged
prescription was only partially filled ‘‘treated’’ S.C. in nearly ten months, she that two of her co-workers wrote letters
(with the pharmacy dispensing 54 could not recall if she had done a attesting to her ability as a clinician. See
tablets), even if the pharmacy could not physical exam. Moreover, within a one- RX P & R.
fill the remaining portion of the month period, she provided him with I nonetheless reject her contention
prescription within 72 hours, see 21 more than a one-year supply of that her misconduct is an aberration. As
CFR 1306.13(a), there was no need for oxycodone based on her own dosing the evidence shows, Respondent
Respondent to issue him a second instructions. As for her testimony that engaged in two separate bouts of
prescription for a full 90 tablets. she believed the various excuses S.C. unlawful prescribing. Indeed, while her
As for why she then issued S.C. three offered for why he needed additional prescribings to S.C. in the February–
more prescriptions just six days later prescriptions, and did so even when the March 2008 time period were egregious
(on Feb. 9), Respondent initially excuse was patently absurd, the ALJ did (providing him with 1750 tablets of
claimed that S.C. had begun having not find this credible. Nor do I. And highly abused schedule II narcotics), in
seizures and was becoming forgetful, here again, she failed to create any January 2009, she resumed prescribing
but then acknowledged that this did not medical records and a written treatment to him, providing him with more than
happen until three months later. Other plan. another 1,000 pills of this highly abused
than in her earlier ludicrous testimony I therefore conclude that with the narcotic in a one-month period.
that the monkey was throwing S.C.’s exception of the Percocet prescription Moreover, notwithstanding her admitted
drugs in the pool or that Respondent she wrote when she treated S.C. in the lack of familiarity with treating chronic
was leaving the drugs in his hotel room, ER, Respondent repeatedly acted pain, and that while S.C. was in LA, she
or the drugs had been stolen—none of outside of the usual course of had months to reflect on her prescribing
which was documented in a medical professional practice and lacked a practices with respect to him as well as
record because she maintained none on to familiarize herself with Florida’s
legitimate medical purpose when she
S.C.—Respondent failed to address why standards for using controlled
prescribed oxycodone (including
she issued S.C. three more prescriptions substances to treat pain, Respondent
OxyContin) to him. See 21 CFR
the next day. So too, Respondent failed resumed prescribing to S.C. a highly
1306.04(a). While Respondent contends
to address why she wrote the multiple abused narcotic in unlawful quantities,
‘‘that her actions were not for personal
prescriptions on February 20 and March see 21 CFR 1306.12(b)(1), that also
gain,’’ Resp. Post-Hrng. Br. at 36, to
6. greatly exceeded what was medically
In her testimony, Respondent sustain a violation, the Government was
not required to prove that she provided necessary according to her own dosing
maintained ‘‘that over time’’ she ‘‘lost instructions.
the physician/patient relationship.’’ Tr. the prescriptions in exchange for either
money or to obtain S.C.’s affection. In I therefore find that the Government’s
220. To the contrary, the evidence evidence with respect to factors two and
suggests that the only time she sum, I conclude that Respondent
knowingly diverted controlled four establishes that Respondent has
prescribed to S.C. pursuant to a valid committed such acts as to render her
doctor-patient relationship was in substances when she prescribed to S.C.
I also conclude that Respondent ‘‘registration inconsistent with the
August 2007, when she treated him for
violated Agency regulations requiring public interest.’’ 17 I further find that
his broken hand in the ER. Her
testimony as to whether she performed that she: (1) Date the prescriptions as of
17 While I have considered the allegation that
physical examinations of S.C. was the date of their issuance, 21 CFR Respondent violated the CSA by issuing
exceedingly vague and changed, both as 1306.05(a); (2) include S.C.’s address on prescriptions while working at the Northern Navajo
to the dates she performed these exams the prescriptions, see id. ; (3) where Medical Center without being licensed by New
issuing multiple prescriptions for Mexico and registered with DEA in that State, I
and the scope of the exams. Indeed, she decline to rule on the allegation because several
explicitly denied having even made a schedule II drugs, not prescribe more material issues have not been adequately addressed.
diagnosis, id. at 229, claiming that S.C.’s than a 90-day supply, 21 CFR While the Government elicited testimony from a
prior physician had done that, and yet 1306.12(b)(1); and (4) where issuing registration program specialist to the effect that in
she proceeded to provide him with multiple prescriptions, ‘‘provide[] order for Respondent to obtain a registration in New
Mexico, she was required to obtain a New Mexico
prescriptions for more than 1750 tablets written instructions on each medical license, it is unclear whether New Mexico
of two of the most highly abused prescription . . . indicating the earliest has authority to require a federal contract physician
prescription narcotics (400 OxyContin date on which a pharmacy may fill each to be licensed in the State if she works solely at an
80mg and 1350 oxycodone 30mg) prescription. Id. 1306.12(b)(ii). She also IHS facility. The limited case law suggests to the
contrary. See Taylor v. United States, 821 F.2d
without even calling S.C.’s prior violated Florida law and regulations by 1428, 1431 (9th Cir. 1987) (noting that under the
physician. She also offered no failing to create medical records. Supremacy Clause, a State ‘‘lacks power to require
explanation for the inconsistency Respondent nonetheless argues that licensing of federal health care providers and
between the dosing instructions on the she ‘‘has had a long career in emergency physicians’’ and that ‘‘[t]he United States has . . .
essentially deemed [an] Army [h]ospital and its staff
tkelley on DSK3SPTVN1PROD with NOTICES
various OxyContin prescriptions or for medicine and has had no instances of fit to provide health care services’’); United States
increasing S.C.’s daily dose of malpractice or disciplinary action prior v. Composite State Bd. of Medical Examiners, 656
oxycodone from 240mgs (per the to the instant case.’’ Resp. Exceptions, at F.2d 131, 135 n.4 (5th Cir. 1981) (citing Sperry v.
OxyContin prescriptions) to 450mgs per 11. She further contends that ‘‘[t]he Florida ex rel. Florida Bar, 373 U.S. 379 (1963)). Cf.
25 U.S.C. 1621t (‘‘Licensed health professionals
day (per the oxycodone 30 events surrounding her relationship employed by a tribal health program shall be
prescriptions) only one month later. with S.C. and her treatment of his exempt, if licensed in any State, from the licensing
Moreover, she provided the first set of purported medical conditions represent requirements of the State in which the tribal health
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![Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices 28705
Respondent’s misconduct was egregious answer [the DI’s] questions to resolve Accordingly, I find that substantial
and makes out a prima facie case for the liability issues she noted on her evidence supports a finding that
denying her application. renewal application in the absence of an Respondent lacked candor when she
attorney, and made no attempt to testified in this proceeding. See Hoxie v.
Factor Five—Such Other Conduct
arrange a subsequent meeting with [the DEA, 419 F.3d 477, 483 (‘‘Candor during
Which May Threaten Public Health and
DI], with or without counsel.’’ R.D. at DEA investigations properly is
Safety
65–66. The ALJ thus reasoned that considered by the DEA to be an
The ALJ also found that Respondent ‘‘Respondent’s failure to cooperate . . . important factor when assessing
engaged in actionable misconduct under suggests a substantial and willful whether a . . . registration is consistent
this factor. More specifically, the ALJ disregard for her duty to comply with with the public interest.’’). Thus, I
found, inter alia, that: (1) Respondent DEA directives as a regulated entity’’ conclude that the record supports a
lacked candor in her testimony and ‘‘[t]his conduct threatens public finding that Respondent lacked candor
regarding her prescribings to S.C.; and health and safety.’’ Id. at 66. when she testified in this proceeding
(2) she failed to cooperate with DEA I find the ALJ’s reasoning and that she has committed such other
Investigators who were investigating her unpersuasive. Respondent was entitled conduct which may threaten public
2012 renewal application. R.D. at 63–66. to consult with her attorney before health and safety. 21 U.S.C. 823(f)(5).
Of these, I conclude that only the first answering the DI’s questions and had no
finding is supported by substantial obligation to agree to an interview Sanction
evidence. without her attorney being present. Under Agency precedent, where, as
As for the second contention, the Moreover, the DI offered no testimony to here, ‘‘the Government has proved that
evidence showed that during the course the effect that he made any further [an applicant] has committed acts
of investigating her renewal application, attempt to interview her, let alone that inconsistent with the public interest, the
Agency Investigators went to a hospital she rebuffed a further interview request [applicant] must ‘‘ ‘present sufficient
at which Respondent was then working or that she agreed to an interview and mitigating evidence to assure the
and asked to speak to her about the then failed to follow through. Administrator that [she] can be
‘‘yes’’ answer she had provided to one Accordingly, I reject the ALJ’s finding entrusted with the responsibility carried
of the liability questions on the and conclusion as unsupported by by such a registration.’ ’’’ ’’ Medicine
application. Tr. 388. Respondent substantial evidence. Shoppe-Jonesborough, 73 FR 364, 387
declined to answer any questions However, I agree with the ALJ’s legal (2008) (quoting Samuel S. Jackson, 72
without an attorney being present. Id. conclusion that Respondent lacked FR 23848, 23853 (2007) (quoting Leo R.
While the Investigators then explained candor in her testimony. More Miller, 53 FR 21931, 21932 (1988))).
‘‘this was not a criminal investigation’’ specifically, as ultimate factfinder, see 5 ‘‘Moreover, because ‘past performance is
and that it ‘‘was purely regulatory in U.S.C. 557(b), I do not find credible her the best predictor of future
scope’’ as it involved the Florida Board testimony that she did not know performance,’ ALRA Labs, Inc. v. DEA,
matter, Respondent again refused ‘‘to ‘‘exactly why’’ she did not include the 54 F.3d 450, 452 (7th Cir. 1995), [DEA]
discuss the matter.’’ Id. at 390. The DI date and S.C.’s address on the has repeatedly held that where [an
then testified that he was never able to OxyContin 80mg and Oxycodone 30mg applicant] has committed acts
complete his interview of Respondent. prescriptions other than that S.C.’s inconsistent with the public interest, the
Id. at 391; 398. house was a ‘‘very distracting’’ [applicant] must accept responsibility
Based on this evidence, the ALJ found environment. Tr. 222. As found above, for [her] actions and demonstrate that
that Respondent ‘‘flatly refused to notwithstanding her assertion, [she] will not engage in future
Respondent was not so distracted that misconduct.’’ Medicine Shoppe, 73 FR
program performs the services described in the she failed to include on the at 387; see also Jackson, 72 FR at 23853;
contract or compact of the tribal health program
under the Indian Self-Determination and Education
prescriptions such required information John H. Kennedy, 71 FR 35705, 35709
Assistance Act.’’). However, this determination is as the name of the drug, its dosage (2006); Prince George Daniels, 60 FR
not within the Agency’s authority. strength, the quantity, and her signature. 62884, 62887 (1995). See also Hoxie v.
Moreover, the Government does not address Id. DEA, 419 F.3d at 483 (‘‘admitting fault’’
whether a physician is nonetheless required to Nor do I find credible her testimony is ‘‘properly consider[ed]’’ by DEA to be
obtain a registration specific to an IHS facility if the
State lacks authority to require a physician to obtain that she palpated S.C.’s back and neck an ‘‘important factor[]’’ in the public
a license in that State, or whether a physician who as part of the physical exams she interest determination).
does not possess a license in the State where the claimed to have performed. Id. at 263. So too, in making the public interest
facility is located and is not required to possess
such a license, can nonetheless obtain a registration
As found above, at several earlier points determination, ‘‘this Agency places
for that location. in her testimony, Respondent described great weight on an [applicant’s] candor,
Because I find that the Government has otherwise the physical exam she performed as both during an investigation and in [a]
proved that Respondent’s continued registration is listening to S.C.’s heart and lungs, subsequent proceeding.’’ Robert F.
inconsistent with public interest and that she has
failed to produce sufficient evidence to rebut this
making no mention of having palpated Hunt, 75 FR 49995, 50004 (2010) (citing
conclusion, I decline to remand the matter or issue any part of S.C. See id. at 214 & 244– The Lawsons, Inc., t/a The Medicine
a briefing order. On this record, I decline to adopt 45. Indeed, she asserted that she Shoppe Pharmacy, 72 FR 74334, 74338
the ALJ’s conclusions of law (# 8, 9, and 10) that palpated S.C.’s back and neck only after (2007) (quoting Hoxie, 419 F.3d at 483
Respondent violated federal law because she issued
prescriptions while practicing at the Northern the Government specifically asked her if (‘‘Candor during DEA investigations
Navajo Medical Center without being registered in she did. Id. at 263. properly is considered by the DEA to be
New Mexico and that she is not exempt from Finally, I do not find credible an important factor when assessing
tkelley on DSK3SPTVN1PROD with NOTICES
registration in that State. See R.D. 74. I also decline Respondent’s testimony that she wrote
to adopt the ALJ’s finding that Respondent’s
whether a . . . registration is consistent
‘‘decision to rely exclusively on representations the multiple oxycodone 30mg with the public interest.’’))).
made to her by her future employers constitutes a prescriptions because she actually Moreover, while an applicant must
willful and reckless disregard for her duty to believed S.C.’s claim that the monkey accept responsibility and demonstrate
inquire of the DEA regarding the need for re-
registration and in-state licensure,’’ R.D. at 64, and
had taken the pill bottle, managed to that she will not engage in future
that this is actionable misconduct under factor five. open it, and then threw the medication misconduct in order to establish that her
Id. in the pool. Id. at 240–41, 341. registration is consistent with the public
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![28706 Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices
interest, DEA has repeatedly held these In his decision, the ALJ acknowledged While this testimony would have
are not the only factors that are relevant that Respondent produced some supported a finding that Respondent has
in determining the appropriate sanction. evidence of remedial measures she has accepted responsibility for her
See, e.g., Joseph Gaudio, 74 FR 10083, undertaken. R.D. at 68. More misconduct, at other points, she offered
10094 (2009); Southwood specifically, the evidence shows that testimony that substantially undermines
Pharmaceuticals, Inc., 72 FR 36487, Respondent completed a four-day this conclusion. Notwithstanding her
36504 (2007). Obviously, the course in controlled substance earlier admission that she lost the
egregiousness and extent of an management and a two-day course in doctor/patient relationship (not that she
applicant’s misconduct are significant medical record keeping. RXs F & I. ever had one outside of S.C.’s ER visit),
factors in determining the appropriate However, based on Respondent’s she then testified that ‘‘I was definitely
sanction. See Jacobo Dreszer, 76 FR testimony, the ALJ also found that ‘‘it is manipulated and taken advantage of. I
19386, 19387–88 (2011) (explaining that far from clear that the courses have was victimized.’’ Tr. 350. Respondent’s
a respondent can ‘‘argue that even brought about changes in [her] that statement is simply irreconcilable with
though the Government has made out a would support continued DEA the obligations imposed on a physician
prima facie case, his conduct was not so registration.’’ R.D. at 68. As the ALJ who is entrusted with the authority to
egregious as to warrant revocation’’); explained, ‘‘[e]ven now, Respondent prescribe controlled substances.
Paul H. Volkman, 73 FR 30630, 30644 would attribute her action to being
victimized by . . . SC’s conduct, while So too, notwithstanding her testimony
(2008); see also Gregory D. Owens, 74
averring that she believed, at the time, that the prescriptions ‘‘were not within
FR 36751, 36757 n.22 (2009).
Moreover, as I have noted in several that her prescription practice was . . . the standards of my medical
cases, ‘‘ ‘[n]either Jackson, nor any other compliant with DEA regulations.’’ Id. practice’’ and her having taken a course
agency decision, holds . . . that the The ALJ thus concluded that in controlled substance management,
Agency cannot consider the deterrent ‘‘Respondent has [not] admitted to the Respondent testified that she still
value of a sanction in deciding whether full extent of her . . . misconduct.’’ Id. believes she issued the prescriptions for
a registration should be revoked’ ’’ or an Respondent takes exception to the a legitimate medical purpose. Tr. 277.
application should be denied. Gaudio, ALJ’s conclusion that she has failed to Still later in her testimony—and after
74 FR at 10094 (quoting Southwood, 72 accept responsibility for her maintaining that she was victimized by
FR at 36504 (2007)); see also Robert misconduct, contending that this ‘‘is S.C.—she again testified that knowing
Raymond Reppy, 76 FR 61154, 61158 contradicted by the facts in the record.’’ what she knows today, she still believes
(2011); Michael S. Moore, 76 FR 45867, Exceptions, at 2. Respondent argues that that the prescriptions were medically
45868 (2011). This is so, both with she ‘‘readily admitted to losing the necessary. Id. at 277–78.
respect to the respondent in a particular physician-patient relationship when In short, this suggests that Respondent
case and the community of registrants. treating S.C.’’ and that she ‘‘also has learned nothing from the various
See Gaudio, 74 FR at 10095 (quoting admitted that she violated Florida law state board proceedings, the course she
Southwood, 71 FR at 36504). Cf. and standards of practice when she took in controlled substance
McCarthy v. SEC, 406 F.3d 179, 188–89 treated S.C. without creating a medical management, or this Proceeding.
(2d Cir. 2005) (upholding SEC’s express record, [a] written treatment plan, etc.’’ Accordingly, I have no confidence that
adoptions of ‘‘deterrence, both specific Id. at 3–4. she will refrain from similar acts were
and general, as a component in It is acknowledged that at various she to become love struck with a drug
analyzing the remedial efficacy of points in her testimony, Respondent abuser or diverter in the future. Her
sanctions’’).18 admitted to several professional failings. equivocal testimony provides
For example, she admitted that it was substantial evidence to support a
18 Thus, in Gaudio, ‘‘I explained that ‘even when her error to accept S.C.’s word rather finding that she does not accept
a proceeding serves a remedial purpose, an than call his prior physician. She also responsibility for her misconduct.
administrative agency can properly consider the testified that she ‘‘lost the physician/
need to deter others from engaging in similar acts.’ ’’
patient relationship’’ and ‘‘was not As explained above, notwithstanding
74 FR at 10094 (quoting Southwood, 72 FR at her contention that her prescribing to
36504) (citing Butz v. Glover Livestock Commission objective.’’ Still later, she testified that
Co., Inc., 411 U.S. 182, 187–88 (1973)); cf. ‘‘[i]n hindsight . . . my judgment was S.C. is an aberration, I find that her
McCarthy, 406 F.3d at 189 (‘‘Although general impaired because of the relationship I misconduct was egregious. Moreover, as
deterrence is not, by itself, sufficient justification
had with the individual’’ and that the found above, Respondent lacked candor
for expulsion or suspension, we recognize that it in her testimony. Accordingly, I
may be considered as part of the overall remedial prescriptions ‘‘were not within . . . the
inquiry.’’); Paz Securities, Inc., et al. v. SEC, 494 standards of my medical practice.’’ And conclude that denial of her application
F.3d 1059, 1066 (D.C. Cir. 2007) (agreeing with she also admitted that she violated is necessary to protect the public
McCarthy). In Gaudio, I further noted that the
Florida’s regulations by failing to ‘‘keep interest.
‘‘[c]onsideration of the deterrent effect of a potential
sanction is supported by the CSA’s purpose of proper documentation.’’ Order
protecting the public interest, see 21 U.S.C. 801,
and the broad grant of authority conveyed in the safety’’) contain the limiting words of ‘‘[t]he Pursuant to the authority vested in me
statutory text, which authorizes the [suspension or] applicant.’’ As the Supreme Court has held,
revocation of a registration when a registrant ‘has
by 21 U.S. C. 823(f), as well as 28 CFR
‘‘[w]here Congress includes particular language in
committed such acts as would render [his] one section of a statute but omits it in another 0.100(b), I order that the application of
registration . . . inconsistent with the public section of the same Act, it is generally presumed Annicol Marrocco, M.D., for a DEA
interest,’ id. § 824(a)(4), and [which] specifically that Congress acts intentionally and purposely in Certificate of Registration as a
directs the Attorney General to consider [‘such the disparate inclusion or exclusion.’’ Russello v.
other conduct which may threaten public health
practitioner be, and it hereby is, denied.
United States, 464 U.S. 16, 23 (1983). Thus, the text
tkelley on DSK3SPTVN1PROD with NOTICES
and safety,’ id. § 823(f)].’’ 74 FR at 10094 (quoting of factors four and five suggest that these factors are This Order is effective June 18, 2015.
Southwood, 72 FR at 36504). not limited to assessing the specific practitioner’s Dated: May 4, 2015.
Unlike factors two (‘‘[t]he applicant’s experience compliance with applicable laws and whether she
in dispensing’’) and three (‘‘[t]he applicant’s has engaged in ‘‘such other conduct’’ (such as Michele M. Leonhart,
conviction record’’), neither factor four giving false testimony), but rather, authorizes the Administrator.
(‘‘Compliance with applicable laws related to Agency to also consider the effect of a sanction on
[FR Doc. 2015–12035 Filed 5–18–15; 8:45 am]
controlled substances’’) nor factor five (‘‘Such other inducing compliance with federal law by other
conduct which may threaten public health and practitioners. BILLING CODE 4410–09–P
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Document Created: 2015-12-15 15:30:17
Document Modified: 2015-12-15 15:30:17
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