80 FR 28689 - Maryanne Phillips-Elias, 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 | 28689-28693 | |
| FR Document | 2015-12023 |
[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)] [Notices] [Pages 28689-28693] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12023] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 14-27] Maryanne Phillips-Elias, M.D.; Decision and Order On October 23, 2014, Administrative Law Judge (ALJ) Christopher McNeil issued the attached Recommended Decision. Therein, the ALJ found that it was undisputed that Respondent's Nevada Controlled Substance Registration had been revoked and that she does not possess authority to dispense controlled substances in Nevada, the State in which she holds her DEA registration. R.D. at 6; see also id. at 2. The ALJ thus concluded that Respondent is no longer a practitioner within the meaning of the Controlled Substances Act and is therefore not entitled to be registered. He therefore recommended that I ``deny Respondent's application for a DEA Certificate of Registration.'' R.D. at 9. There is, however, no evidence that an application is currently pending before the Agency. Rather, the Government seeks the revocation of Respondent's registration, which does not expire until March 31, 2017, and authorizes her to dispense controlled substances in schedules II through V, at registered premises located in Henderson, Nevada. Order to Show Cause, at 1. Pursuant to 21 U.S.C. 824(a)(3), ``[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has had [her] State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.'' This Agency has further held that notwithstanding that this provision grants the Agency authority to suspend or revoke a registration, other provisions of the Controlled Substances Act ``make plain that a practitioner can neither obtain nor maintain a DEA registration unless the practitioner currently has authority under state law to handle controlled substances.'' James L. Hooper, 76 FR 71371, 71372 (2011), pet. for rev. denied, Hooper v. Holder, 481 F. App'x 826 (4th Cir. 2012). These provisions include section 102(21), which defines the term ``practitioner'' to ``mean[ ] a physician . . . licensed, registered, or otherwise permitted, by . . . the jurisdiction in which [s]he practices . . . to distribute, dispense, [or] administer . . . a [[Page 28690]] controlled substance in the course of professional practice,'' 21 U.S.C. 802(21), as well as section 303(f), which directs that ``[t]he 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 [s]he practices.'' Id. Sec. 823(f). Based on these provisions, the Agency has long held that revocation is warranted even where a state order has summarily suspended a practitioner's controlled substances authority and the state agency's order remains subject to challenge in either administrative or judicial proceedings.\1\ See Gary Alfred Shearer, 78 FR 19009 (2013); Carmencita E. Gallora, 60 FR 47967 (1995). --------------------------------------------------------------------------- \1\ I thus also reject Respondent's contention that because she ``has not acted [in a manner] inconsistent with [the] public interest as laid out in'' section 823(f), ``DEA has discretion to carve out an exception in this case'' to the CSA's requirement that she possess state authority to hold a DEA registration. Resp. Reply, at 4. As explained above, this is a requirement imposed by statute which DEA has no authority to waive. --------------------------------------------------------------------------- Respondent argues that she ``should be given a hearing to present evidence to refute the legitimacy of the revocation'' of her state registration by the Nevada Pharmacy Board. Respondent's Reply to the Govt.'s Mot. for Summary Judgment, at 2. According to Respondent, the Nevada Board's Order is invalid ``because the Board never identified the specific grounds for which [her] license should be revoked in Nevada.'' Id. at 3. Respondent thus seeks to collaterally attack the Nevada Board's Order. However, ```DEA has repeatedly held that a registrant cannot collaterally attack the results of a state criminal or administrative proceeding in a proceeding brought under section 304 [21 U.S.C. 824] of the CSA.''' Calvin Ramsey, 76 FR 20034, 20036 (2011) (quoting Hicham K. Riba, 73 FR 75773, 75774 (2008) (other citations omitted)); see also Shahid Musud Siddiqui, 61 FR 14818 (1996); Robert A. Leslie, 60 FR 14004 (1995). Respondent must therefore seek relief from the State Board's Order in those administrative and judicial forums provided by the State. Her various contentions as to the validity of the Nevada Pharmacy Board's order are therefore not material to this Agency's resolution of whether she is entitled to maintain her DEA registration. As for her argument that the Agency's use of summary disposition to revoke her DEA registration has denied her ``fundamental fairness'' because DEA regulations provide that she is entitled to a hearing, Resp. Reply at 3; ``summary judgment has been used for more than 100 years to resolve legal `actions in which there is no genuine issue as to any material fact' and has never been deemed to violate Due Process.'' Ramsey, 76 FR at 20036 (citing Fed. R. Civ. P. 56 (Advisory Committee Notes--1937 Adoption) and Codd v. Velger, 429 U.S. 624, 627 (1977)). Respondent was provided with the opportunity to dispute the material fact which is dispositive of the Government's allegation that she lacks authority to dispense controlled substances in the State in which she is registered and therefore cannot remained registered. I thus reject her contention that the use of summary disposition denied her fundamental fairness. Accordingly, for reasons explained above and with the caveat that there is no application pending before the Agency, I adopt the ALJ's factual finding that Respondent's Nevada controlled substance registration has been revoked and therefore she does not possess authority under Nevada law to dispense controlled substances. I further adopt the ALJ's legal conclusion that Respondent is no longer a practitioner within the meaning of the CSA and is therefore not entitled to be registered. However, because there is no application currently pending before the Agency, I do not adopt those portions of his opinion which discuss whether Respondent's application should be granted or denied, including his Recommendation that I deny her application. Instead, for reasons explained above, I will order that Respondent's registration be revoked. Order Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 28 CFR 0.100(b) I order that DEA Certificate of Registration FP2501648 issued to Maryanne Phillips-Elias be, and it hereby is, revoked. This Order is effectively immediately. Dated: May 1, 2015 Michele M. Leonhart, Administrator. Brian Bayly, Esq., for the Government. Michael Khouri, Esq., and Ashley K. Kagasoff, Esq., for the Respondent. RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE Nature of the Case and Procedural History Administrative Law Judge Christopher B. McNeil. Maryanne Phillips- Elias, M.D., the respondent in this case, is registered with the DEA as a practitioner in Schedules II through V under Drug Enforcement Administration (DEA) certificate registration number FP2501648 at 9065 S. Peco Rd., Ste. 250, Henderson, NV 89074.\1\ The registration number expires by its own terms on March 31, 2017.\2\ --------------------------------------------------------------------------- \1\ Order to Show Cause dated Sept. 17, 2014 at 1. \2\ Id. --------------------------------------------------------------------------- On September 17, 2014, the Deputy Administrator of the Drug Enforcement Administration, Office of Diversion Control, filed an Order to Show Cause as to why the DEA should not revoke her current certificate of registration, deny any applications for renewal or modification, and deny any application for any other DEA registration pursuant to 21 U.S.C. 823(f) and 21 U.S.C. 824(a)(3).\3\ As grounds for revocation, the Government alleges that Respondent does not have authority to handle controlled substances in Nevada, the State in which Respondent is registered with the DEA.\4\ --------------------------------------------------------------------------- \3\ Id. \4\ Id. --------------------------------------------------------------------------- On September 26, 2014, Respondent, through her Attorneys, Ashley K. Kagasoff, Esq., and Michael Khouri, Esq., filed a timely request for hearing.\5\ Respondent does not dispute that her controlled substance registration was revoked by the Nevada State Board of Pharmacy.\6\ Instead, Respondent asserts that the Nevada State Board of Pharmacy acted on grounds that did not warrant discipline and that the Board's decision was arbitrary.\7\ Respondent has a writ, Maryanne Phillips v. Nevada State Board of Pharmacy,\8\ pending in the First Judicial Court of Carson City County, Nevada to set aside the decision to revoke Respondent's registration.\9\ Respondent asks me to delay any hearing until the writ is resolved.\10\ Alternatively, if the delay is not granted, Respondent expresses her wish to continue with the hearing as planned.\11\ --------------------------------------------------------------------------- \5\ Respondent's Request for Hearing dated Sept. 23, 2014 at 1, received by DEA Sept. 26, 2014. \6\ Id. \7\ Id. \8\ Case No. 14-OC-00064. \9\ Respondent's Request for Hearing at 1. \10\ Id. \11\ Id. --------------------------------------------------------------------------- [[Page 28691]] I received the Government's Motion for Summary Judgment on October 8, 2014, with proof of service upon Respondent, accompanied by supporting documentation.\12\ In my Order of September 30, 2014, I directed the Government to provide evidence to support the allegation that Respondent lacks state authority to handle controlled substances.\13\ The factual premise relied upon by the Government in support of its motion is that Respondent does not have a controlled substance registration issued by the Nevada State Board of Pharmacy, the state in which Respondent is registered.\14\ Additionally, in the same Order, I provided Respondent the opportunity to respond to the Government's Motion for Summary Judgment.\15\ That response was due seven business days after service of the Government's motion on opposing parties.\16\ On October 17, 2014, I received Respondent's timely response.\17\ The Government exercised its right to reply to the response and submitted a reply on October 22, 2014.\18\ Drawing from the motion and briefs submitted, I find as follows: --------------------------------------------------------------------------- \12\ Government's Motion for Summary Judgment dated Oct. 7, 2014 at 1-18, received by DEA Oct. 8, 2014. \13\ Order for Briefing on Allegations Concerning Respondent's Lack of State Authority dated Sept. 30, 2014 at 1. \14\ Government's Motion for Summary Judgment at 1-3. \15\ Order for Briefing on Allegations Concerning Respondent's Lack of State Authority at 2. \16\ Id. \17\ Respondent Maryanne Phillips-Elias, M.D. Reply to the Government's Motion for Summary Judgment and Declaration of Ashley K. Kagasoff in Support Thereof dated Oct. 16, 2014 at 1. Note that the fax was received at 6:00pm E.D.T. on October 16, 2014. As the document was received after normal business hours, the document is treated as if it was received on October 17, 2014. Regardless, the response was timely received. \18\ Government's Reply in Support of its Motion to Summary Judgment dated Oct. 22, 2014 at 1. --------------------------------------------------------------------------- Issue The substantial issue raised by the Government rests on an undisputed fact. The Government asserts that Respondent's application must be summarily denied because Respondent does not have a controlled substance registration issued by the state in which she intends to practice.\19\ Under DEA precedent, a practitioner's DEA Certificate of Registration for controlled substances must be summarily revoked if the applicant is not authorized to handle controlled substances in the state in which she maintains DEA registration.\20\ Unless from the pleadings now before me there is a material issue regarding Respondent's authority to handle controlled substances in Nevada, the application must be denied summarily, without a hearing. --------------------------------------------------------------------------- \19\ Government's Motion for Summary Judgment at 1-2. \20\ See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also House of Medicine, 79 FR 4959, 4961 (DEA 2014); Deanwood Pharmacy, 68 FR 41662-01 (DEA July 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669- 02 (DEA November 13, 2012); Alan H. Olefsky, M.D., 72 FR 42127-01 (DEA August 1, 2007); Layfe Robert Anthony, M.D., 67 FR 15811 (DEA May 20, 2002); George Thomas, PA-C, 64 FR 15811-02 (DEA April 1, 1999); Shahid Musud Siddiqui, M.D., 61 FR 14818-02 (DEA April 4, 1996); Michael D. Lawton, M.D., 59 FR 17792-01 (DEA April 14, 1994); Abraham A. Chaplan, M.D., 57 FR 55280-03 (DEA November 24, 1992). See also Bio Diagnosis Int'l, 78 FR 39327-03, 39331 (DEA July 1, 2013) (distinguishing distributor applicants from other ``practitioners'' in the context of summary disposition analysis). --------------------------------------------------------------------------- Respondent's Contentions In Respondent's Reply to the Motion for Summary Judgment, Respondent never disputes the Government's contention that she is not currently licensed by the State of Nevada to dispense controlled substances.\21\ Instead, Respondent asserts three legal arguments. Respondent's first legal argument is that Respondent should be given a hearing to present evidence to refute the legitimacy of the revocation.\22\ Respondent states her belief that the matter should be determined following the resolution of Respondent's writ and that the Nevada State Board of Pharmacy relied on insufficient grounds to revoke her state controlled substance registration.\23\ Respondent's second argument is that she has been denied fundamental fairness by the DEA.\24\ Respondent writes that ``it does not make any sense that Respondent is given the right to a hearing only to get denied one, once the request is made.'' \25\ Finally, Respondent asserts that the DEA has discretion to do what is in the best interest of promoting the public interest.\26\ After stating the five public interest factors provided by 21 U.S.C. 823(f), Respondent declares that allowing her to retain her license is not inconsistent with the public interest.\27\ --------------------------------------------------------------------------- \21\ Reply to the Government's Motion for Summary Judgment at 2. \22\ Id. \23\ Id. at 2-3. \24\ Id. at 3. \25\ Id. \26\ Id. at 4. \27\ Id. --------------------------------------------------------------------------- Scope of Authority On September 17, 2014, the Deputy Administrator of the Drug Enforcement Administration, Office of Diversion Control, filed an Order to Show Cause proposing to deny the application pursuant to 21 U.S.C. 824(a)(3) and 21 U.S.C. 823(f).\28\ --------------------------------------------------------------------------- \28\ Order to Show Cause at 1. --------------------------------------------------------------------------- Respondent believes that she should be given a hearing to present evidence to refute the legitimacy of the revocation following the resolution of Respondent's writ to demonstrate that the Nevada State Board of Pharmacy relied on insufficient grounds to revoke her state controlled substance registration.\29\ However, the case before me is presented under a grant of authority to recommend that the Administrator either continue or revoke Respondent's Certificate of Registration for controlled substances. Pursuant to 21 U.S.C. 823(f), the DEA may grant such an application only to a ``practitioner.'' Under 21 U.S.C. 802(21), a ``practitioner'' must be ``licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute [or] dispense . . . controlled substance[s.]'' Given this statutory language, the DEA Administrator does not have the authority under the Controlled Substances Act to grant a registration to a practitioner if that practitioner is not authorized to dispense controlled substances.\30\ --------------------------------------------------------------------------- \29\ Reply to the Government's Motion for Summary Judgment at 2- 3. \30\ See Abraham A. Chaplan, M.D., 57 FR 55280-03, 55280 (DEA November 24, 1992), and cases cited therein. In Chaplan, DEA Administrator Robert C. Bonner adopts the ALJ's opinion that ``the DEA lacks statutory power to register a practitioner unless the practitioner holds state authority to handle controlled substances.'' Id. --------------------------------------------------------------------------- The fact that Respondent is currently in the process of appealing what she views as an unjust decision of the Nevada State Board of Pharmacy does not change this outcome. As the Government notes, the assertion that she might prevail in overturning the Board's revocation order is ``highly speculative.'' \31\ Even if Respondent was very likely to succeed on appeal, summary disposition is still appropriate. As the Government notes in its Reply in Support of its Motion for Summary Judgment, ``[a]ll that matters is that Respondent lacks state authority to dispense or distribute controlled substances.'' \32\ Under no circumstances is the DEA authorized to provide a doctor, such as Respondent, the ability to dispense controlled substances when the doctor does not possess their state controlled substance registration. This limitation is not without meaning. In the first subchapter of the Controlled Substances Act (CSA), 21 U.S.C. 801, [[Page 28692]] Congress acknowledged that controlled substances when utilized improperly ``have a substantial and detrimental effect on the health and general welfare of the American people.'' \33\ Mandating that a practitioner possess state authority before providing a practitioner the privilege to handle controlled substances lowers the risk of diversion by illegitimate or unqualified practitioners. --------------------------------------------------------------------------- \31\ Government's Motion for Summary Judgment at 3. \32\ Government's Reply in Support of its Motion to Summary Judgment at 2. \33\ Controlled Substances Act. 21 U.S.C. 801(1). 1970. --------------------------------------------------------------------------- Respondent also alleges that she has been denied fundamental fairness by the DEA.\34\ Specifically, Respondent cites that fact that the Government's Order to Show Cause provides her notice of the opportunity of a hearing to show cause why the DEA should not revoke her DEA certificate of registration, but later denies her a hearing.\35\ Although Respondent may believe it is unfair that the DEA denies her a hearing after issuing an Order to Show Cause, Respondent has failed to show that any disputed material fact is involved regarding her state controlled substance registration. If Respondent through her Reply to Government's Motion for Summary Judgment demonstrated that there was a dispute as to the material fact of whether her state controlled substance registration was revoked, I would not have dismissed this case without a comprehensive hearing. However, the inability for the DEA to grant Respondent a DEA certificate of registration without a valid state controlled substance registration prevents further consideration of this matter. --------------------------------------------------------------------------- \34\ Reply to the Government's Motion for Summary Judgment at 3. Respondent's allegation does not directly allege a violation of her constitutional right to due process. Respondent's failure to make a conspicuous claim regarding due process has led to a waiver of this constitutional claim. However, if Respondent chooses to submit exceptions to this order referencing her constitutional right to due process, she may succeed in preserving the issue for appeal. \35\ Id. at 3; Order to Show Cause at 1. --------------------------------------------------------------------------- Respondent's final argument is that the DEA has discretion to act in the public interest to not revoke Respondent's federal certificate of registration.\36\ In her Reply to Government's Motion for Summary Judgment, Respondent correctly notes that to determine whether a DEA certificate of registration is in the public interest, a DEA ALJ must consider the factors enumerated under 21 U.S.C. 823(f).\37\ Respondent proceeds to apply the factors to her specific situation to make the argument that she should not lose her DEA certificate of registration.\38\ Quoting the Declaration of Ashley Kagasoff,\39\ Respondent cites statements such as that she has never been convicted of a federal or state crime to support the notion that not revoking her DEA COR is consistent with the public interest.\40\ Such statements made by Respondent are unpersuasive. If Respondent is successful in her writ and her state license to dispense controlled substances is restored, she is welcome to immediately apply for a new DEA certificate of registration. If Respondent's application for a new registration is opposed by the DEA and Respondent exercises her right to a hearing, it is at that time--not before that time--that a DEA ALJ will hear evidence from both Respondent and the Government as to whether the registration is consistent with the public interest. --------------------------------------------------------------------------- \36\ Reply to the Government's Motion for Summary Judgment at 4- 5. \37\ Id. at 4. See also 21 U.S.C. 823(f). \38\ Reply to the Government's Motion for Summary Judgment at 4- 5. \39\ See Declaration of Ashley K. Kagasoff in Support Thereof. \40\ Reply to the Government's Motion for Summary Judgment at 4. --------------------------------------------------------------------------- Facts Given this body of law, the material fact here, indeed the sole fact of consequence, is whether Respondent is authorized by the State of Nevada to dispense controlled substances. Where, as here, no material fact is in dispute, there is no need for an evidentiary hearing and summary disposition is appropriate.\41\ The sole question of fact before me can be addressed, and has been addressed, by the pleadings submitted to me by the parties. Our record includes no dispute regarding the Government's contention that the authority of Dr. Phillips-Elias to dispense controlled substances in Nevada was revoked by the Nevada State Board of Pharmacy on June 13, 2014.\42\ The reasons for the revocation are not material, given the statutory language set forth above. --------------------------------------------------------------------------- \41\ See Michael G. Dolin, M.D., 65 FR 5661 (DEA February 4, 2000); see also Philip E. Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff'd sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984). \42\ Order to Show Cause at 1. --------------------------------------------------------------------------- Analysis, Findings of Fact and Conclusions of Law In determining whether to grant the Government's Motion for Summary Disposition, I am required to apply the principle of law that holds such a motion may be granted in an administrative proceeding if no material question of fact exists: It is settled law that when no fact question is involved or the facts are agreed, a plenary, adversary administrative proceeding involving evidence, cross-examination of witnesses, etc., is not obligatory--even though a pertinent statute prescribes a hearing. In such situations, the rationale is that Congress does not intend administrative agencies to perform meaningless tasks (citations omitted).\43\ \43\ NLRB v. International Assoc. of Bridge, 549 F.2d 634, 638 (9th Cir. 1977) (quoting United States v. Consolidated Mines & Smelting Co., Ltd., 455 F.2d 432, 453 (9th Cir. 1971)). --------------------------------------------------------------------------- In this context, I am further guided by prior decisions before the DEA involving certificate holders who lacked licenses to distribute or dispense controlled substances. On the issue of whether an evidentiary hearing is required, ``it is well settled that when there is no question of material fact involved, there is no need for a plenary, administrative hearing.'' \44\ Under this guidance, the Government's motion must be sustained unless a material fact question has been presented. --------------------------------------------------------------------------- \44\ See Michael G. Dolin, M.D., 65 FR 5661 (DEA February 4, 2000); Jesus R. Juarez, M.D., 62 FR 14945 (DEA March 28, 1997); see also Philip E. Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff'd sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984). --------------------------------------------------------------------------- The sole determinative fact now before me is that Respondent lacks a Nevada controlled substance registration. In order for a doctor to receive a DEA registration authorizing her to dispense controlled substances under 21 U.S.C. 823(f), she must meet the definition of ``practitioner'' as found in the Controlled Substances Act.\45\ Such a person must be ``licensed, registered, or otherwise permitted by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.'' \46\ Delegating to the Attorney General the authority to determine who may or may not be registered to perform these duties, Congress permitted such registration only to ``practitioners'' as defined by the Controlled Substances Act.\47\ --------------------------------------------------------------------------- \45\ 21 U.S.C. 802(21). \46\ Id. \47\ 21 U.S.C. 823(f). --------------------------------------------------------------------------- As cited by the Government in its Motion for Summary Judgment, there is substantial authority both through agency precedent and through decisions of courts in review of that precedent, holding that a doctor's DEA controlled substance registration is dependent upon the doctor having a state license to dispense controlled substances.\48\ Under the doctrine before me, the Government meets its burden of [[Page 28693]] establishing grounds to deny an application for registration upon sufficient proof establishing the applicant does not possess a state controlled substance registration. That proof is in the record before me, and it warrants the summary revocation of Respondent's DEA Certificate of Registration. --------------------------------------------------------------------------- \48\ Government's Motion for Summary Judgment at 1-3 and cases cited therein. --------------------------------------------------------------------------- I am mindful of the arguments raised by Respondent in her Reply to the Government's Motion for Summary Judgment, including the fact that Respondent is currently appealing the revocation of her state controlled substance registration.\49\ These difficulties do not, however, change the fact that without a state controlled substance registration, Respondent is not a ``practitioner'' and cannot be granted a Certificate of Registration. --------------------------------------------------------------------------- \49\ Reply to the Government's Motion for Summary Judgment at 2- 3. --------------------------------------------------------------------------- Some care should be taken to assure the parties that the actions taken in this administrative proceeding conform to constitutional requirements. I have examined the parties' contentions with an eye towards ensuring all tenets of due process have been adhered to. There is, however, no authority for me to evaluate the facts that underlie Respondent's contentions. In the proceedings now before me, the only material question was answered by Respondent in her Request for Hearing. Further, while the Order to Show Cause sets forth a non- exhaustive summary of facts and law relevant to a determination that granting this application would be inconsistent with the public interest under 21 U.S.C. 823(f), the conclusion, order and recommendation that follow are based solely on a finding that Respondent is not a ``practitioner'' as that term is defined by 21 U.S.C. 802(21), and I make no finding regarding whether granting this application would or would not be inconsistent with the public interest. Order Granting the Government's Motion for Summary Disposition and Recommendation I find there is no genuine dispute regarding whether Respondent is a ``practitioner'' as that term is defined by 21 U.S.C. 802(21), and that based on the record the Government has established that Respondent is not a practitioner and is not authorized to dispense controlled substances in the state in which she seeks to operate under a DEA Certificate of Registration. I find no other material facts at issue, for the reasons set forth in the Government's Motion for Summary Disposition. Accordingly, I GRANT the Government's Motion for Summary Disposition. Upon this finding, I ORDER that this case be forwarded to the Administrator for final disposition and I RECOMMEND the Administrator DENY Respondent's application for a DEA Certificate of Registration. Dated: October 23, 2014. Christopher B. McNeil, Administrative Law Judge. [FR Doc. 2015-12023 Filed 5-18-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices 28689
status confounds logic. Stated differently, the precedent that normal hardships to the DEPARTMENT OF JUSTICE
level of care exercised on Dr. Aguilar’s scrips practitioner, and even the surrounding
was the same as every other controlled community, which are attendant upon the Drug Enforcement Administration
substance scrip issued during the relevant denial of a registration, are not a relevant
period. The Agency has revoked based on as consideration in determining whether status [Docket No. 14–27]
few as two acts of intentional diversion, and as a COR registrant is in the public interest
it held that one such act can be sufficient. within the meaning of the CSA. Cheek, 76 FR Maryanne Phillips-Elias, M.D.; Decision
MacKay, 75 FR at 4997; Krishna-Iyer, 74 FR at 66972–73; Owens, 74 FR at 36757; and Order
at 463. While the dispensing acts proven on Abbadessa, 74 FR at 10078.
this record may not have been intentional, On October 23, 2014, Administrative
Finally, insofar as the Respondents point to
there were certainly well more than one or Law Judge (ALJ) Christopher McNeil
the fact that the Government’s theory of the
two. case and its evidence have never relied on
issued the attached Recommended
Similarly, that the Respondents argue the absence of a legitimate medical purpose Decision. Therein, the ALJ found that it
(without specific figures) that they have (LMP) for any of the scrips in question, it is was undisputed that Respondent’s
made ‘‘minimal’’ pecuniary gain due to their Nevada Controlled Substance
certainly true that the Agency has looked at
lack of care helps their respective causes not Registration had been revoked and that
the LMP issue where prescriptions were
at all. A reduced profit margin is no more
issued by a prescriber who lacked proper she does not possess authority to
persuasive evidence in the context of a
registrant pharmacy as it would be in the authorization. Kam, 78 FR at 62698. dispense controlled substances in
case of a street dealer in illicit drugs. The However, that the Government has advanced Nevada, the State in which she holds
focus is on maintaining a closed regulatory no LMP evidence does not mitigate the her DEA registration. R.D. at 6; see also
system that protects the public from the evidence that was received regarding the id. at 2. The ALJ thus concluded that
unlawful distribution of controlled Respondents’ breach in their respective Respondent is no longer a practitioner
substances. Gonzales, 545 U.S. at 13. A duties of due care in ensuring that controlled within the meaning of the Controlled
registrant’s voluntary decision to abandon substance prescriptions were authorized by a
Substances Act and is therefore not
the most basic of its registrant obligations practitioner with a valid COR.
Regarding the material false
entitled to be registered. He therefore
should not result in any profit. Further, as is
misrepresentations intentionally placed into recommended that I ‘‘deny
true with the Respondents’ argument
regarding the relative percentage of scrips the COR applications, Moro-Perez doggedly Respondent’s application for a DEA
that can be attributed to Dr. Aguilar, in an adhered to his illogical position that he was Certificate of Registration.’’ R.D. at 9.
environment where no serious COR checking reasonable in representing on the COR There is, however, no evidence that
was employed, there is no basis in reason for applications that neither pharmacy had ever an application is currently pending
evaluating the money Moro-Perez’s surrendered a registration for cause. By before the Agency. Rather, the
pharmacies made from prescriptions Moro-Perez’s intractable logic, the dismissal Government seeks the revocation of
authorized by Dr. Aguilar as compared to of an indictment against him (not either Respondent’s registration, which does
those by other practitioners. Who knows pharmacy) that occurred after the for-cause not expire until March 31, 2017, and
which of the issuing prescribers were surrender of Best Pharma’s COR, but before authorizes her to dispense controlled
actually registered? Hence, that the the for-cause surrender of Farmacia Nueva’s
‘‘pecuniary benefits gained’’ from dispensing substances in schedules II through V, at
COR, rendered both surrenders no longer ‘‘for
controlled substances on Dr. Aguilar’s scrips registered premises located in
cause.’’ Moro-Perez is an experienced COR
‘‘is minimal’’ 102 means nothing and mitigates holder and an educated, veteran pharmacist.
Henderson, Nevada. Order to Show
nothing. His insistence that his false response to an Cause, at 1.
As discussed in detail, supra, the application query regarding whether each Pursuant to 21 U.S.C. 824(a)(3), ‘‘[a]
Respondents argument that they turned pharmacy had ever surrendered a COR for registration . . . to . . . dispense a
down ‘‘many’’ of Dr. Aguilar’s prescriptions cause was some sort of reasonable controlled substance . . . may be
they thought to be illegitimate actually misunderstanding is simply not credible and suspended or revoked by the Attorney
exacerbates the pharmacies’ positions. defeats the Respondents’ efforts to meet the General upon a finding that the
Turning down ‘‘many’’ prescriptions from Dr. Government’s case. The false registrant . . . has had [her] State
Aguilar that pharmacists determined to be misrepresentation regarding the errant denial
illegitimate should have caused increased license or registration suspended,
of the Respondents’ prior surrenders for revoked, or denied by competent State
circumspection about dispensing on
cause are sufficiently egregious on their face authority and is no longer authorized by
Aguilar’s scrips. Instead, even by their own
to warrant sanction, and the denial of the State law to engage in the . . .
account, the pharmacies identified Dr.
Respondents’ applications here serve the
Aguilar as a problematic prescriber, never
Agency’s interest in deterring false
dispensing of controlled substances.’’
checked his COR status, and kept dispensing This Agency has further held that
statements on the applications that it
many of the prescriptions he authorized. notwithstanding that this provision
depends upon in its decisionmaking.
In their closing brief, the Respondents ask grants the Agency authority to suspend
The Respondents have, thus, failed to rebut
that, in making its decision on the COR
the Government’s prima facie case regarding or revoke a registration, other provisions
applications, the Agency consider that
‘‘[t]here are . . . more than 40 employees either material falsification of their of the Controlled Substances Act ‘‘make
among two pharmacies whose welfare applications or a balancing of the public plain that a practitioner can neither
depend on their jobs at the pharmacies [and interest factors. Further, consideration of the obtain nor maintain a DEA registration
that in] small towns like San Sebastian and egregiousness of the offenses, coupled with unless the practitioner currently has
Moca in Puerto Rico, this means a lot.’’ ALJ the Agency’s interest in both specific authority under state law to handle
Ex. 24, at 21 (internal transcript citations deterrence regarding these pharmacies, and
general deterrence among the regulated
controlled substances.’’ James L.
omitted). Even setting aside for a moment Hooper, 76 FR 71371, 71372 (2011), pet.
Moro-Perez’s testimony that controlled community, supports the denial of both COR
applications. Accordingly, the Respondents’ for rev. denied, Hooper v. Holder, 481 F.
substances account for only 10–15% of the
respective applications for DEA Certificates App’x 826 (4th Cir. 2012).
prescription medications dispensed at each
tkelley on DSK3SPTVN1PROD with NOTICES
of Registration should be DENIED. These provisions include section
of the Respondent pharmacies,103 any blame
for the lost jobs must properly be laid at the 102(21), which defines the term
Dated: October 24, 2013.
feet of the Respondents themselves, and ‘‘practitioner’’ to ‘‘mean[ ] a physician
s/JOHN J. MULROONEY, II,
Moro-Perez in particular. It is settled Agency . . . licensed, registered, or otherwise
Chief Administrative Law Judge. permitted, by . . . the jurisdiction in
102 ALJ Ex. 24, at 21. [FR Doc. 2015–12043 Filed 5–18–15; 8:45 am] which [s]he practices . . . to distribute,
103 Tr. 244–45. BILLING CODE 4410–09–P dispense, [or] administer . . . a
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![28690 Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices
controlled substance in the course of regulations provide that she is entitled RECOMMENDED RULING, FINDINGS
professional practice,’’ 21 U.S.C. to a hearing, Resp. Reply at 3; OF FACT, CONCLUSIONS OF LAW,
802(21), as well as section 303(f), which ‘‘summary judgment has been used for AND DECISION OF THE
directs that ‘‘[t]he Attorney General more than 100 years to resolve legal ADMINISTRATIVE LAW JUDGE
shall register practitioners . . . to ‘actions in which there is no genuine Nature of the Case and Procedural
dispense . . . controlled substances issue as to any material fact’ and has History
. . . if the applicant is authorized to never been deemed to violate Due
dispense . . . controlled substances Process.’’ Ramsey, 76 FR at 20036 Administrative Law Judge
under the laws of the State in which (citing Fed. R. Civ. P. 56 (Advisory Christopher B. McNeil. Maryanne
[s]he practices.’’ Id. § 823(f). Based on Committee Notes—1937 Adoption) and Phillips-Elias, M.D., the respondent in
these provisions, the Agency has long Codd v. Velger, 429 U.S. 624, 627 this case, is registered with the DEA as
held that revocation is warranted even a practitioner in Schedules II through V
(1977)). Respondent was provided with
where a state order has summarily under Drug Enforcement Administration
the opportunity to dispute the material
suspended a practitioner’s controlled (DEA) certificate registration number
fact which is dispositive of the FP2501648 at 9065 S. Peco Rd., Ste. 250,
substances authority and the state
agency’s order remains subject to Government’s allegation that she lacks Henderson, NV 89074.1 The registration
challenge in either administrative or authority to dispense controlled number expires by its own terms on
judicial proceedings.1 See Gary Alfred substances in the State in which she is March 31, 2017.2
Shearer, 78 FR 19009 (2013); registered and therefore cannot
On September 17, 2014, the Deputy
Carmencita E. Gallora, 60 FR 47967 remained registered. I thus reject her Administrator of the Drug Enforcement
(1995). contention that the use of summary Administration, Office of Diversion
Respondent argues that she ‘‘should disposition denied her fundamental Control, filed an Order to Show Cause
be given a hearing to present evidence fairness. as to why the DEA should not revoke
to refute the legitimacy of the Accordingly, for reasons explained her current certificate of registration,
revocation’’ of her state registration by above and with the caveat that there is deny any applications for renewal or
the Nevada Pharmacy Board. no application pending before the modification, and deny any application
Respondent’s Reply to the Govt.’s Mot. Agency, I adopt the ALJ’s factual finding for any other DEA registration pursuant
for Summary Judgment, at 2. According that Respondent’s Nevada controlled to 21 U.S.C. 823(f) and 21 U.S.C.
to Respondent, the Nevada Board’s substance registration has been revoked 824(a)(3).3 As grounds for revocation,
Order is invalid ‘‘because the Board the Government alleges that Respondent
and therefore she does not possess
never identified the specific grounds for does not have authority to handle
authority under Nevada law to dispense
which [her] license should be revoked controlled substances in Nevada, the
controlled substances. I further adopt
in Nevada.’’ Id. at 3. State in which Respondent is registered
Respondent thus seeks to collaterally the ALJ’s legal conclusion that
Respondent is no longer a practitioner with the DEA.4
attack the Nevada Board’s Order. On September 26, 2014, Respondent,
However, ‘‘‘DEA has repeatedly held within the meaning of the CSA and is
therefore not entitled to be registered. through her Attorneys, Ashley K.
that a registrant cannot collaterally Kagasoff, Esq., and Michael Khouri,
attack the results of a state criminal or However, because there is no
application currently pending before the Esq., filed a timely request for hearing.5
administrative proceeding in a Respondent does not dispute that her
proceeding brought under section 304 Agency, I do not adopt those portions of
controlled substance registration was
[21 U.S.C. 824] of the CSA.’’’ Calvin his opinion which discuss whether
revoked by the Nevada State Board of
Ramsey, 76 FR 20034, 20036 (2011) Respondent’s application should be Pharmacy.6 Instead, Respondent asserts
(quoting Hicham K. Riba, 73 FR 75773, granted or denied, including his that the Nevada State Board of
75774 (2008) (other citations omitted)); Recommendation that I deny her Pharmacy acted on grounds that did not
see also Shahid Musud Siddiqui, 61 FR application. Instead, for reasons warrant discipline and that the Board’s
14818 (1996); Robert A. Leslie, 60 FR explained above, I will order that decision was arbitrary.7 Respondent has
14004 (1995). Respondent must Respondent’s registration be revoked. a writ, Maryanne Phillips v. Nevada
therefore seek relief from the State State Board of Pharmacy,8 pending in
Board’s Order in those administrative Order
the First Judicial Court of Carson City
and judicial forums provided by the County, Nevada to set aside the decision
Pursuant to the authority vested in me
State. Her various contentions as to the to revoke Respondent’s registration.9
by 21 U.S.C. 824(a) and 28 CFR 0.100(b)
validity of the Nevada Pharmacy Respondent asks me to delay any
I order that DEA Certificate of
Board’s order are therefore not material hearing until the writ is resolved.10
to this Agency’s resolution of whether Registration FP2501648 issued to
Maryanne Phillips-Elias be, and it Alternatively, if the delay is not granted,
she is entitled to maintain her DEA Respondent expresses her wish to
registration. hereby is, revoked. This Order is
effectively immediately. continue with the hearing as planned.11
As for her argument that the Agency’s
use of summary disposition to revoke Dated: May 1, 2015 1 Order to Show Cause dated Sept. 17, 2014 at 1.
her DEA registration has denied her Michele M. Leonhart, 2 Id.
‘‘fundamental fairness’’ because DEA 3 Id.
Administrator.
4 Id.
1I thus also reject Respondent’s contention that Brian Bayly, Esq., for the Government.
tkelley on DSK3SPTVN1PROD with NOTICES
5 Respondent’s Request for Hearing dated Sept.
because she ‘‘has not acted [in a manner] 23, 2014 at 1, received by DEA Sept. 26, 2014.
inconsistent with [the] public interest as laid out Michael Khouri, Esq., and Ashley K. 6 Id.
in’’ section 823(f), ‘‘DEA has discretion to carve out Kagasoff, Esq., for the Respondent. 7 Id.
an exception in this case’’ to the CSA’s requirement 8 Case No. 14–OC–00064.
that she possess state authority to hold a DEA
9 Respondent’s Request for Hearing at 1.
registration. Resp. Reply, at 4. As explained above,
10 Id.
this is a requirement imposed by statute which DEA
has no authority to waive. 11 Id.
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![Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices 28691
I received the Government’s Motion registration.20 Unless from the pleadings pursuant to 21 U.S.C. 824(a)(3) and 21
for Summary Judgment on October 8, now before me there is a material issue U.S.C. 823(f).28
2014, with proof of service upon regarding Respondent’s authority to Respondent believes that she should
Respondent, accompanied by handle controlled substances in Nevada, be given a hearing to present evidence
supporting documentation.12 In my the application must be denied to refute the legitimacy of the revocation
Order of September 30, 2014, I directed summarily, without a hearing. following the resolution of Respondent’s
the Government to provide evidence to writ to demonstrate that the Nevada
Respondent’s Contentions State Board of Pharmacy relied on
support the allegation that Respondent
lacks state authority to handle In Respondent’s Reply to the Motion insufficient grounds to revoke her state
controlled substances.13 The factual for Summary Judgment, Respondent controlled substance registration.29
never disputes the Government’s However, the case before me is
premise relied upon by the Government
contention that she is not currently presented under a grant of authority to
in support of its motion is that
licensed by the State of Nevada to recommend that the Administrator
Respondent does not have a controlled
dispense controlled substances.21 either continue or revoke Respondent’s
substance registration issued by the Instead, Respondent asserts three legal Certificate of Registration for controlled
Nevada State Board of Pharmacy, the arguments. Respondent’s first legal substances. Pursuant to 21 U.S.C. 823(f),
state in which Respondent is argument is that Respondent should be the DEA may grant such an application
registered.14 Additionally, in the same given a hearing to present evidence to only to a ‘‘practitioner.’’ Under 21
Order, I provided Respondent the refute the legitimacy of the revocation.22 U.S.C. 802(21), a ‘‘practitioner’’ must be
opportunity to respond to the Respondent states her belief that the ‘‘licensed, registered, or otherwise
Government’s Motion for Summary matter should be determined following permitted, by the United States or the
Judgment.15 That response was due the resolution of Respondent’s writ and jurisdiction in which he practices or
seven business days after service of the that the Nevada State Board of does research, to distribute [or] dispense
Government’s motion on opposing Pharmacy relied on insufficient grounds . . . controlled substance[s.]’’ Given this
parties.16 On October 17, 2014, I to revoke her state controlled substance statutory language, the DEA
received Respondent’s timely registration.23 Respondent’s second Administrator does not have the
response.17 The Government exercised argument is that she has been denied authority under the Controlled
its right to reply to the response and fundamental fairness by the DEA.24 Substances Act to grant a registration to
submitted a reply on October 22, Respondent writes that ‘‘it does not a practitioner if that practitioner is not
2014.18 Drawing from the motion and make any sense that Respondent is authorized to dispense controlled
briefs submitted, I find as follows: given the right to a hearing only to get substances.30
denied one, once the request is The fact that Respondent is currently
Issue made.’’ 25 Finally, Respondent asserts in the process of appealing what she
The substantial issue raised by the that the DEA has discretion to do what views as an unjust decision of the
Government rests on an undisputed fact. is in the best interest of promoting the Nevada State Board of Pharmacy does
The Government asserts that public interest.26 After stating the five not change this outcome. As the
Respondent’s application must be public interest factors provided by 21 Government notes, the assertion that she
summarily denied because Respondent U.S.C. 823(f), Respondent declares that might prevail in overturning the Board’s
does not have a controlled substance allowing her to retain her license is not revocation order is ‘‘highly
inconsistent with the public interest.27 speculative.’’ 31 Even if Respondent was
registration issued by the state in which
very likely to succeed on appeal,
she intends to practice.19 Under DEA Scope of Authority summary disposition is still
precedent, a practitioner’s DEA On September 17, 2014, the Deputy appropriate. As the Government notes
Certificate of Registration for controlled Administrator of the Drug Enforcement in its Reply in Support of its Motion for
substances must be summarily revoked Administration, Office of Diversion Summary Judgment, ‘‘[a]ll that matters
if the applicant is not authorized to Control, filed an Order to Show Cause is that Respondent lacks state authority
handle controlled substances in the proposing to deny the application to dispense or distribute controlled
state in which she maintains DEA
substances.’’ 32 Under no circumstances
20 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also
is the DEA authorized to provide a
12 Government’s Motion for Summary Judgment House of Medicine, 79 FR 4959, 4961 (DEA 2014);
dated Oct. 7, 2014 at 1–18, received by DEA Oct. Deanwood Pharmacy, 68 FR 41662–01 (DEA July
doctor, such as Respondent, the ability
8, 2014. 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669– to dispense controlled substances when
13 Order for Briefing on Allegations Concerning 02 (DEA November 13, 2012); Alan H. Olefsky, the doctor does not possess their state
Respondent’s Lack of State Authority dated Sept. M.D., 72 FR 42127–01 (DEA August 1, 2007); Layfe controlled substance registration. This
30, 2014 at 1. Robert Anthony, M.D., 67 FR 15811 (DEA May 20,
2002); George Thomas, PA–C, 64 FR 15811–02
limitation is not without meaning. In
14 Government’s Motion for Summary Judgment
at 1–3. (DEA April 1, 1999); Shahid Musud Siddiqui, M.D., the first subchapter of the Controlled
15 Order for Briefing on Allegations Concerning 61 FR 14818–02 (DEA April 4, 1996); Michael D. Substances Act (CSA), 21 U.S.C. 801,
Respondent’s Lack of State Authority at 2. Lawton, M.D., 59 FR 17792–01 (DEA April 14,
16 Id. 1994); Abraham A. Chaplan, M.D., 57 FR 55280– 28 Order to Show Cause at 1.
03 (DEA November 24, 1992). See also Bio 29 Reply
17 Respondent Maryanne Phillips-Elias, M.D. to the Government’s Motion for
Diagnosis Int’l, 78 FR 39327–03, 39331 (DEA July
Reply to the Government’s Motion for Summary Summary Judgment at 2–3.
1, 2013) (distinguishing distributor applicants from
Judgment and Declaration of Ashley K. Kagasoff in other ‘‘practitioners’’ in the context of summary
30 See Abraham A. Chaplan, M.D., 57 FR 55280–
Support Thereof dated Oct. 16, 2014 at 1. Note that disposition analysis). 03, 55280 (DEA November 24, 1992), and cases
the fax was received at 6:00pm E.D.T. on October cited therein. In Chaplan, DEA Administrator
tkelley on DSK3SPTVN1PROD with NOTICES
21 Reply to the Government’s Motion for
16, 2014. As the document was received after Robert C. Bonner adopts the ALJ’s opinion that ‘‘the
Summary Judgment at 2.
normal business hours, the document is treated as 22 Id.
DEA lacks statutory power to register a practitioner
if it was received on October 17, 2014. Regardless, unless the practitioner holds state authority to
23 Id. at 2–3.
the response was timely received. handle controlled substances.’’ Id.
18 Government’s Reply in Support of its Motion 24 Id. at 3. 31 Government’s Motion for Summary Judgment
25 Id.
to Summary Judgment dated Oct. 22, 2014 at 1. at 3.
19 Government’s Motion for Summary Judgment 26 Id. at 4. 32 Government’s Reply in Support of its Motion
at 1–2. 27 Id. to Summary Judgment at 2.
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![28692 Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices
Congress acknowledged that controlled lose her DEA certificate of registration.38 agreed, a plenary, adversary
substances when utilized improperly Quoting the Declaration of Ashley administrative proceeding involving
‘‘have a substantial and detrimental Kagasoff,39 Respondent cites statements evidence, cross-examination of
effect on the health and general welfare such as that she has never been witnesses, etc., is not obligatory—even
of the American people.’’ 33 Mandating convicted of a federal or state crime to though a pertinent statute prescribes a
that a practitioner possess state support the notion that not revoking her hearing. In such situations, the rationale
authority before providing a practitioner DEA COR is consistent with the public is that Congress does not intend
the privilege to handle controlled interest.40 Such statements made by administrative agencies to perform
substances lowers the risk of diversion Respondent are unpersuasive. If meaningless tasks (citations omitted).43
by illegitimate or unqualified Respondent is successful in her writ and In this context, I am further guided by
practitioners. her state license to dispense controlled prior decisions before the DEA
Respondent also alleges that she has substances is restored, she is welcome involving certificate holders who lacked
been denied fundamental fairness by the to immediately apply for a new DEA licenses to distribute or dispense
DEA.34 Specifically, Respondent cites certificate of registration. If controlled substances. On the issue of
that fact that the Government’s Order to Respondent’s application for a new whether an evidentiary hearing is
Show Cause provides her notice of the registration is opposed by the DEA and required, ‘‘it is well settled that when
opportunity of a hearing to show cause Respondent exercises her right to a there is no question of material fact
why the DEA should not revoke her hearing, it is at that time—not before involved, there is no need for a plenary,
DEA certificate of registration, but later that time—that a DEA ALJ will hear administrative hearing.’’ 44 Under this
denies her a hearing.35 Although evidence from both Respondent and the guidance, the Government’s motion
Respondent may believe it is unfair that Government as to whether the must be sustained unless a material fact
the DEA denies her a hearing after registration is consistent with the public question has been presented.
issuing an Order to Show Cause, interest. The sole determinative fact now
Respondent has failed to show that any before me is that Respondent lacks a
disputed material fact is involved Facts Nevada controlled substance
regarding her state controlled substance Given this body of law, the material registration. In order for a doctor to
registration. If Respondent through her fact here, indeed the sole fact of receive a DEA registration authorizing
Reply to Government’s Motion for consequence, is whether Respondent is her to dispense controlled substances
Summary Judgment demonstrated that authorized by the State of Nevada to under 21 U.S.C. 823(f), she must meet
there was a dispute as to the material dispense controlled substances. Where, the definition of ‘‘practitioner’’ as found
fact of whether her state controlled as here, no material fact is in dispute, in the Controlled Substances Act.45
substance registration was revoked, I there is no need for an evidentiary Such a person must be ‘‘licensed,
would not have dismissed this case hearing and summary disposition is registered, or otherwise permitted by
without a comprehensive hearing. appropriate.41 The sole question of fact . . . the jurisdiction in which he
However, the inability for the DEA to before me can be addressed, and has practices . . . to distribute, dispense,
grant Respondent a DEA certificate of been addressed, by the pleadings [or] administer . . . a controlled
registration without a valid state submitted to me by the parties. Our substance in the course of professional
controlled substance registration record includes no dispute regarding the practice.’’ 46 Delegating to the Attorney
prevents further consideration of this Government’s contention that the General the authority to determine who
matter. authority of Dr. Phillips-Elias to may or may not be registered to perform
Respondent’s final argument is that dispense controlled substances in these duties, Congress permitted such
the DEA has discretion to act in the Nevada was revoked by the Nevada registration only to ‘‘practitioners’’ as
public interest to not revoke State Board of Pharmacy on June 13, defined by the Controlled Substances
Respondent’s federal certificate of 2014.42 The reasons for the revocation Act.47
registration.36 In her Reply to are not material, given the statutory As cited by the Government in its
Government’s Motion for Summary language set forth above. Motion for Summary Judgment, there is
Judgment, Respondent correctly notes substantial authority both through
Analysis, Findings of Fact and agency precedent and through decisions
that to determine whether a DEA
Conclusions of Law of courts in review of that precedent,
certificate of registration is in the public
interest, a DEA ALJ must consider the In determining whether to grant the holding that a doctor’s DEA controlled
factors enumerated under 21 U.S.C. Government’s Motion for Summary substance registration is dependent
823(f).37 Respondent proceeds to apply Disposition, I am required to apply the upon the doctor having a state license
the factors to her specific situation to principle of law that holds such a to dispense controlled substances.48
make the argument that she should not motion may be granted in an Under the doctrine before me, the
administrative proceeding if no material Government meets its burden of
33 Controlled Substances Act. 21 U.S.C. 801(1). question of fact exists:
43 NLRB v. International Assoc. of Bridge, 549
1970. It is settled law that when no fact
34 Reply to the Government’s Motion for F.2d 634, 638 (9th Cir. 1977) (quoting United States
Summary Judgment at 3. Respondent’s allegation
question is involved or the facts are v. Consolidated Mines & Smelting Co., Ltd., 455
does not directly allege a violation of her F.2d 432, 453 (9th Cir. 1971)).
38 Reply to the Government’s Motion for 44 See Michael G. Dolin, M.D., 65 FR 5661 (DEA
constitutional right to due process. Respondent’s
failure to make a conspicuous claim regarding due Summary Judgment at 4–5. February 4, 2000); Jesus R. Juarez, M.D., 62 FR
process has led to a waiver of this constitutional 39 See Declaration of Ashley K. Kagasoff in 14945 (DEA March 28, 1997); see also Philip E.
tkelley on DSK3SPTVN1PROD with NOTICES
claim. However, if Respondent chooses to submit Support Thereof. Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff’d
exceptions to this order referencing her 40 Reply to the Government’s Motion for sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir.
constitutional right to due process, she may succeed Summary Judgment at 4. 1984).
in preserving the issue for appeal. 41 See Michael G. Dolin, M.D., 65 FR 5661 (DEA 45 21 U.S.C. 802(21).
35 Id. at 3; Order to Show Cause at 1. 46 Id.
February 4, 2000); see also Philip E. Kirk, M.D., 48
36 Reply to the Government’s Motion for FR 32887 (DEA July 19, 1983), aff’d sub nom. Kirk 47 21 U.S.C. 823(f).
Summary Judgment at 4–5. v. Mullen, 749 F.2d 297 (6th Cir. 1984). 48 Government’s Motion for Summary Judgment
37 Id. at 4. See also 21 U.S.C. 823(f). 42 Order to Show Cause at 1. at 1–3 and cases cited therein.
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![Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices 28693
establishing grounds to deny an Accordingly, I GRANT the On March 2, the Government filed its
application for registration upon Government’s Motion for Summary Motion for Summary Disposition with
sufficient proof establishing the Disposition. the Office of Administrative Law Judges.
applicant does not possess a state Upon this finding, I ORDER that this Motion for Summ. Disp., at 1. In the
controlled substance registration. That case be forwarded to the Administrator Certificate of Service, the Government
proof is in the record before me, and it for final disposition and I represented that it had served the
warrants the summary revocation of RECOMMEND the Administrator DENY Motion by facsimile, but not by first
Respondent’s DEA Certificate of Respondent’s application for a DEA class mail or email.1 Id. at 4. In its
Registration. Certificate of Registration. Objections, Respondent asserts that he
I am mindful of the arguments raised ‘‘did not respond to the DEA Motion for
Dated: October 23, 2014.
by Respondent in her Reply to the Summary Disposition because he was
Government’s Motion for Summary Christopher B. McNeil,
unaware of any such motion until the
Judgment, including the fact that Administrative Law Judge.
ALJ’s Order granting such motion.’’
Respondent is currently appealing the [FR Doc. 2015–12023 Filed 5–18–15; 8:45 am] Objections, at 1.
revocation of her state controlled BILLING CODE 4410–09–P As stated above, on March 11, the ALJ
substance registration.49 These issued his Recommended Decision.
difficulties do not, however, change the Therein, the ALJ noted that the
fact that without a state controlled DEPARTMENT OF JUSTICE Government had attached a copy of the
substance registration, Respondent is Emergency Order of Suspension issued
not a ‘‘practitioner’’ and cannot be Drug Enforcement Administration
by the Kentucky Board of Medical
granted a Certificate of Registration. Licensure; the Order, which was issued
Some care should be taken to assure [Docket No. 15–13] on November 24, 2014, suspended
the parties that the actions taken in this Respondent’s Kentucky medical license
administrative proceeding conform to Sharad C. Patel, M.D.; Decision and ‘‘effectively immediately upon its
constitutional requirements. I have Order receipt.’’ Mot. For Supp. Disp.,
examined the parties’ contentions with Attachment 1, at 18.
On March 11, 2015, Administrative
an eye towards ensuring all tenets of In his Recommended Decision, the
Law Judge (ALJ) Christopher B. McNeil
due process have been adhered to. ALJ noted that Respondent had not filed
issued the attached Recommended
There is, however, no authority for me a response to the Government’s motion.
Decision (cited as R.D.). Thereafter, on
to evaluate the facts that underlie R.D. at 2. However, the ALJ also noted
April 1, Respondent filed a pleading
Respondent’s contentions. In the that in his hearing request, Respondent
entitled as ‘‘Objections to Findings of
proceedings now before me, the only had ‘‘admit[ted] that his license is
Fact, Conclusions of Law, and
material question was answered by temporary [sic] suspended’’ but that ‘‘he
Recommended Decision of the
Respondent in her Request for Hearing. expects to prevail before the medical
Administrative Law Judge (hereinafter,
Further, while the Order to Show Cause board at an upcoming hearing on May
Resp. Objections). Therein, Respondent
sets forth a non-exhaustive summary of 18, 2015.’’ Id. at 3. As explained in his
objected to the entry of the ALJ’s
facts and law relevant to a decision, the ALJ found that there was
Recommended Decision, on the ground
determination that granting this no dispute that Respondent ‘‘is not
that ‘‘he was never properly, or
application would be inconsistent with authorized to handle controlled
sufficiently, served with the
the public interest under 21 U.S.C. substances in the State in which he
[Government’s] initial motion’’ for
823(f), the conclusion, order and maintains his registration’’ and is
summary disposition and therefore ‘‘did
recommendation that follow are based therefore not a practitioner within the
not respond to the . . . [m]otion . . .
solely on a finding that Respondent is meaning of the Controlled Substances
because he was unaware of any such
not a ‘‘practitioner’’ as that term is Act. Id. The ALJ thus recommended that
motion until the ALJ’s Order granting
defined by 21 U.S.C. 802(21), and I Respondent’s registration be revoked
such motion.’’ Objections, at 1.
make no finding regarding whether and that any pending application be
Respondent argues that in his request
granting this application would or denied.
for hearing, his attorneys provided both
would not be inconsistent with the Thereafter, the ALJ forwarded the
a mailing address and email address for
public interest. record to me, noting in his letter that
receiving the ‘‘notices to be sent
Order Granting the Government’s pursuant to the proceeding.’’ 21 CFR Respondent’s objections were not timely
Motion for Summary Disposition and 1316.47(a); Objections at 1. Respondent filed. Letter from ALJ to Administrator
Recommendation did not, however, provide a fax number. (Apr. 7, 2015), at 2. The ALJ also
Id. at 2. provided a copy of a Transmission
I find there is no genuine dispute Verification Report showing that the
regarding whether Respondent is a Thereafter, Respondent received the
ALJ’s Order for Briefing on Allegations Recommended Decision was
‘‘practitioner’’ as that term is defined by successfully faxed to Respondent’s
21 U.S.C. 802(21), and that based on the Concerning Respondent’s Lack of State
record the Government has established Authority’’ by First Class Mail. Id. The 1 Respondent’s contention regarding the
that Respondent is not a practitioner ALJ’s Order specified the date (Mar. 2, inadequacy of service is not without merit. Of note,
and is not authorized to dispense 2015) by which the Government was to Respondent did not consent to the service of
controlled substances in the state in provide its evidence and arguments (as pleadings by facsimile and the ALJ’s Order for
well as its motion for summary Briefing on Allegation Concerning Respondent’s
which she seeks to operate under a DEA Lack of State Authority did not authorize service of
tkelley on DSK3SPTVN1PROD with NOTICES
Certificate of Registration. I find no disposition) in support of its contention pleadings in this manner. Moreover, while the use
other material facts at issue, for the that Respondent does not possess ‘‘state of electronic means has the advantage of faster
reasons set forth in the Government’s authority to handle controlled service—at least where the transmission is
substances,’’ as well as the date by successful—a hard copy should still be sent by
Motion for Summary Disposition. mail, courier, or third party commercial carrier
which Respondent was to file his unless the serving party contacts the other party
49 Reply to the Government’s Motion for response (Mar. 9) to any such motion. and affirmatively determines that the entire
Summary Judgment at 2–3. Id. document was received.
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Document Created: 2015-12-15 15:29:41
Document Modified: 2015-12-15 15:29:41
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| FR Citation | 80 FR 28689 |
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