83 FR 7223 - Kenneth N. Woliner, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 34 (February 20, 2018)

[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7223-7226]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03299]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-37]


Kenneth N. Woliner, M.D.; Decision and Order

    On June 6, 2017, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (DEA), issued an Order to 
Show Cause to Kenneth N. Woliner, M.D. (Respondent), of Boca Raton, 
Florida. The Show Cause Order proposed the revocation of Respondent's 
DEA Certificate of Registration No. BW6830500 on the ground that he 
``do[es] not have authority to handle controlled substances in the 
State of Florida, the [S]tate in which [he is] registered with the 
DEA.'' Order to Show Cause, at 1 (citing 21 U.S.C. 823(f) and 
824(a)(3)).
    With respect to the Agency's jurisdiction, the Show Cause Order 
alleged that Respondent is the holder of Certificate of Registration 
No. BW6830500, pursuant to which he is authorized to dispense 
controlled substances as a practitioner in schedules II through V, at 
the registered address of 9325 Glades Road, Suite 104, Boca Raton, 
Florida. Id. The Order also alleged that this registration does not 
expire until May 31, 2018. Id.
    Regarding the substantive grounds for the proceeding, the Show 
Cause Order alleged that on December 29, 2016, the Florida Board of 
Medicine ``revoked [his] authority to practice medicine,'' and he is 
therefore ``without authority to handle controlled substances in 
Florida, the [S]tate in which [he is] registered with the DEA.'' Id. 
Based on his ``lack of authority to [dispense] controlled substances in 
. . . Florida,'' the Order asserted that ``DEA must revoke'' his 
registration. Id. (citing 21 U.S.C. 823(f)(1) and 824(a)(3)).
    The Show Cause Order notified Respondent of (1) his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, (2) the procedure for electing either option, and 
(3) the consequence for failing to elect either option. Id. at 2 
(citing 21 CFR 1301.43). The Show Cause Order also notified Respondent 
of his right to submit a corrective action plan (hereinafter, CAP) to 
the Assistant Administrator, Diversion Control Division, and the 
procedure for doing so. Id. at 2-3.
    On July 6, 2017, Respondent filed a letter with the Office of 
Administrative Law Judges pursuant to which he requested a hearing on 
the allegations of the Show Cause Order. Letter from Respondent to 
Hearing Clerk (dated July 3, 2017) (hereinafter, Hearing Request). In 
his letter, Respondent did not dispute that his Florida medical license 
``was revoked.'' Id. at 1. He maintained, however, that his license 
``was revoked for issues not relating to controlled substances; and 
that the revocation . . . is currently under appeal at Florida's 
District Court of Appeal.'' Id. Respondent also advised that he ``has 
not been convicted of any crime, much less one involving controlled 
substances.'' Id. Also on July 6, 2017, Respondent submitted his CAP by 
letter to the Assistant Administrator, Diversion Control Division. 
Letter from Respondent to Assistant Administrator Louis J. Milione 
(dated July 3, 2017). In his CAP, Respondent explained:

    My corrective action plan is to have my case overturned on 
appeal. The Initial Brief on the Merits was filed on 6/7/2017. 
Barring the Court granting extensions of time (if filed), the 
Department of Health is was [sic] required to file their Answer 
Brief by 6/27/2017, and our Reply is due 20 days after service of 
the Answer Brief.
    It would seem prudent for the DEA to ``postpone the 
proceedings'' until the 1st District Court of Appeal rules on this 
matter.

Id. at 1.

    Upon receipt of Respondent's Hearing Request and CAP, the matter 
was placed on the docket of the Office of Administrative Law Judges and 
assigned to Chief Administrative Law Judge John J. Mulrooney, II 
(hereinafter, CALJ). On July 6, 2017, the CALJ issued an order noting 
that Respondent was appearing pro se and advised him ``that he has the 
right to seek representation by a qualified attorney at his own 
expense.'' Order Directing the Filing of Government Evidence of Lack of 
State Authority Allegation and Briefing Schedule, at 1 & n.1 (citing 21 
CFR 1316.50). The CALJ also ordered the Government to file evidence to 
support the allegation that Respondent lacks state authority to handle 
controlled substances and an accompanying motion for summary 
disposition no later than July 18, 2017. Id. The CALJ further directed 
Respondent to file his response to any summary disposition motion no 
later than August 1, 2017. Id. at 2.
    On July 6, 2017, the Acting Assistant Administrator received 
Respondent's CAP letter. See Letter from Acting Assistant Administrator 
Demetra Ashley to Respondent (dated July 11, 2017) (hereinafter CAP 
Rejection Ltr), at 1. However, on July 10, 2017, before the Acting 
Assistant Administrator had ruled on Respondent's CAP (and eight days 
before its summary disposition motion was due), the Government filed 
its Motion for Summary Disposition. In its Motion, the Government 
argued that it is undisputed that the Florida Board of Medicine revoked 
Respondent's Florida medical license. Government's Motion for Summary 
Disposition (Govt. Mot.), at 2. The Government further argued ``that 
the possession of authority to dispense controlled substances under the 
laws of the State in which a practitioner engages in professional 
practice is a fundamental condition for both obtaining and maintaining 
a practitioner's registration'' under the Controlled Substances Act 
(CSA). Id. at 3 (citation omitted). As support for its summary 
disposition request, the Government attached, inter alia, a certified 
copy of the Florida Board of Medicine's December 29, 2016 ``Final 
Order'' revoking Respondent's license to

[[Page 7224]]

practice medicine in the State of Florida. See Govt. Mot., Appendix 
(Appx.) B, at 13.\1\ On July 11, 2017, the Acting Assistant 
Administrator rejected Respondent's CAP and further ``determined there 
is no potential modification of your [ ]CAP that could or would alter 
my decision in this regard.'' CAP Rejection Ltr, at 1.
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    \1\ The Government also attached a Declaration from a Diversion 
Investigator assigned to DEA's West Palm Beach Office stating that 
the Florida Board's Order attached to the Government's motion for 
summary decision ``is a certified copy of the documents I obtained 
from the Florida Board of Medicine.'' Govt. Mot., Appx. C, at 1.
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    On August 1, 2017, Respondent filed a responsive pleading that 
opposed the Government's Motion and requested a stay in the 
proceedings. Respondent's Opposition to Government's Motion for Summary 
Disposition (hereinafter, Resp. Opp. or Opposition). Although 
Respondent did not dispute that his medical license had been revoked by 
Florida's Board of Medicine, he contended that this fact does not 
categorically support the revocation of his registration. Id. at 6 
(citing Joe W. Morgan, D.O., 78 FR 61961 (2013)). He also argued that 
revoking his registration without an administrative hearing violates 
his rights under the Fifth Amendment's Due Process Clause. Id. He 
further argued that ``the Government has not shown that Respondent's 
DEA registration is inconsistent with the public interest by any factor 
in Sec.  824(a)(4) because, inter alia, (1) the ``State of Florida has 
not made a recommendation regarding Respondent's ability to prescribe 
controlled substances,'' (2) Respondent has not been charged or 
convicted of a federal or state crime related to controlled substances, 
and (3) that ``[t]he disciplinary event in question did not relate to 
controlled substances in any fashion.'' Id. at 9. Finally, Respondent 
argued that the Agency should delay any decision to revoke his 
registration because the Government would not be prejudiced and he 
believes that he ``is very much likely to prevail in his appeal'' 
before Florida's 1st District Court of Appeal, which he ``expected'' 
would decide the merits of his appeal ``no later than September 19, 
2017.'' Id. at 10-12.
    The CALJ rejected Respondent's request for a stay, noting that 
``revocation is warranted even where a practitioner's state authority 
has been summarily suspended and the State has yet to provide the 
practitioner with a hearing to challenge the State's action and at 
which he . . . may ultimately prevail.'' Order Denying the Respondent's 
Request for Stay, Granting the Government's Motion for Summary 
Disposition, and Recommended Rulings, Findings of Fact, Conclusions of 
Law, and Decision of the Administrative Law Judge (R.D.), at 4 
(internal quotations and citations omitted). The CALJ also concluded 
that Respondent had no constitutional right to a hearing before the 
Agency because he ``was apparently afforded a full hearing, where he 
was represented by counsel, before the [Florida] Board revoked his 
medical license.'' Id. at 4 & n.3. The CALJ noted that DEA has 
previously held ``that a stay in administrative enforcement proceedings 
is `unlikely to ever be justified' due to ancillary proceedings 
involving the Respondent.'' Id. at 4 (quoting Grider Drug #1 & Grider 
Drug #2, 77 FR 44070, 44104 n.97 (2012)).\2\ The CALJ also rejected 
Respondent's claim that the loss of his Florida medical license 
categorically supports the revocation of his DEA registration and found 
Respondent's reliance on the Joe W. Morgan, D.O. case and others to be 
misplaced. Id. at 6 n.9.
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    \2\ I agree with this statement of the Agency's precedents. 
However, the CALJ also cited Odette L. Campbell, 80 FR 41062 (2015), 
as contrary authority. See id. The CALJ characterized Campbell as 
``holding revocation proceedings in abeyance at the post-hearing 
adjudication level for a lengthy period pending the resolution of 
both criminal fraud charges and concurrent state administrative 
proceedings against the respondent,'' id., even though I have 
repeatedly issued final decisions rejecting this reading of 
Campbell. See e.g., Judson H. Somerville, 82 FR 21408, 21409 n.3 
(2017). For the same reasons set forth in those cases, including the 
fact that Campbell involved an application and not a revocation at 
the time the proceeding was held in abeyance, I again reject the 
CALJ's reading of Campbell.
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    The CALJ then found summary disposition appropriate in this case 
because ``no dispute exists over the fact that the Respondent currently 
lacks state authority to handle controlled substances in Florida due to 
the Board['s] Order dated December 29, 2017, which revoked his state 
license to practice medicine.'' Id. at 7. Reasoning that ``[b]ecause . 
. . Respondent lacks state authority at the present time . . . he is 
not entitled to maintain his DEA registration,'' the CALJ granted the 
Government's request for summary disposition and recommended that I 
revoke Respondent's registration and deny any pending applications. Id.
    Neither party filed exceptions to the CALJ's Recommended 
Decision.\3\ Thereafter, the record was forwarded to my Office for 
Final Agency Action. Having reviewed the record, I adopt the CALJ's 
factual finding that Respondent's medical license has been revoked and 
his ultimate conclusion that Respondent does not hold authority under 
Florida law to handle controlled substances, the State in which he 
holds his registration with the Agency, and is thus not entitled to 
maintain his registration. I also adopt the CALJ's ruling rejecting 
Respondent's request for a stay of this proceeding. I further adopt the 
CALJ's recommendation that I revoke his registration and deny any 
pending application. I make the following factual findings.
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    \3\ Although Respondent reached out to the CALJ's law clerk to 
determine the ``process for filing `exceptions,' '' and the law 
clerk advised Respondent of that process and directed Respondent to 
21 CFR 1316.66, the administrative record does not include any 
exceptions filed by Respondent. Aug. 8, 2008 Email from Law Clerk to 
Respondent, at 1. Government counsel was carbon copied on the entire 
email exchange. See id.
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Findings of Fact

    Respondent is a holder of DEA Certificate of Registration No. 
BW6830500, pursuant to which he is authorized to dispense controlled 
substances in schedules II through V as a practitioner, at the address 
of Holistic Family Medicine, LLC, 9325 Glades Road, Suite 104, Boca 
Raton, Florida. Govt. Mot., Appx. A. This registration does not expire 
until May 31, 2018. Id.
    On December 29, 2016, the Florida Board of Medicine issued a final 
order revoking Respondent's license to practice medicine in the State 
of Florida. Govt. Mot., Appx. B, at 13. The Florida Board adopted the 
recommended order of the state administrative law judge who conducted a 
hearing at which Respondent was present and represented by counsel. Id. 
at 1. The Board considered the Recommended Order, Exceptions to the 
Recommended Order and Response to Exceptions, and adopted the 
conclusions of law set forth in the Recommended Order,\4\ and ordered 
that Respondent's Florida license to practice medicine be revoked as of 
December 29, 2016. Id. at 13.
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    \4\ The Recommended Order of the Florida Administrative Law 
Judge was not included in the Government's evidence.
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    On August 28, 2017, the 1st District Court of Appeals of Florida 
affirmed the decision and final order of the Florida Department of 
Health revoking Respondent's license to practice medicine, and denied 
rehearing on October 9, 2017. Kenneth Woliner, M.D. v. Department of 
Health, No. 1D17-682, slip op. at 1 (Fla. Dist. Ct. App. 1st District 
Aug. 28, 2017), and reh'g denied 2017 WL 3696794 (October 9, 2017). I 
take official notice of this unpublished decision \5\ and find that 
Respondent

[[Page 7225]]

does not possess authority to practice medicine in the State of 
Florida, the State in which he is registered.
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    \5\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and 
DEA's regulations, Respondent is ``entitled on timely request to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). To allow Respondent the opportunity to refute the 
facts of which I take official notice, Respondent may file a motion 
for reconsideration within 15 calendar days of service of this order 
which shall commence on the date this order is mailed.
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Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
CSA, ``upon a finding that the registrant . . . has had his State 
license . . . suspended [or] revoked . . . by competent State authority 
and is no longer authorized by State law to engage in the . . . 
dispensing of controlled substances.'' Also, DEA has long held that the 
possession of authority to dispense controlled substances under the 
laws of the State in which a practitioner engages in professional 
practice is a fundamental condition for obtaining and maintaining a 
practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371 
(2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see 
also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State authorization 
to dispense or otherwise handle controlled substances is a prerequisite 
to the issuance and maintenance of a Federal controlled substances 
registration.'').
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined ``the term `practitioner' [to] mean[ ] a . . . 
physician . . . or other person 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.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f).
    Here, the dispositive question is whether Respondent is currently 
authorized to dispense controlled substances in Florida, the State in 
which he is registered. It is undisputed that Florida's Board of 
Medicine revoked Respondent's license to practice medicine. In his 
recommendation, the CALJ also stated that ``no dispute exists over the 
fact that the Respondent currently lacks state authority to handle 
controlled substances in Florida due to the Board['s] Order . . . which 
revoked his state license to practice medicine.'' R.D., at 7.
    Respondent, however, argues in his Opposition that ``[t]he State of 
Florida has not made a recommendation regarding Respondent's ability to 
prescribe controlled substances''--casting doubt on the CALJ's 
statement that it is undisputed that Respondent lacks this ability. 
Resp. Opp. at 9. Thus, the question of whether Respondent is currently 
authorized to dispense controlled substances in Florida is in dispute.
    This question is not a question of fact but of law. If this 
question were purely a fact question, as the CALJ suggests, then 
summary disposition in this case would have been inappropriate. 
However, I find that this dispositive question is a disputed legal 
question, not a question of fact. Specifically, under Florida law, a `` 
`[p]ractitioner' '' includes ``a physician licensed under chapter 458'' 
of the Florida statutes, and a `` `[p]hysician' '' under chapter 458 
``means a person who is licensed to practice medicine in'' Florida. 
Fla. Stat. Sec. Sec.  893.02(23), 458.305(4). Florida law also states 
that the ``[p]ractice of medicine,'' in turn, ``means the diagnosis, 
treatment, operation, or prescription for any human disease, pain, 
injury, deformity, or other physical or mental condition.'' Id. Sec.  
458.305(3). Thus, I find that Florida law prohibits Respondent from 
dispensing controlled substances within the meaning of the CSA because, 
when the Florida Board of Medicine revoked his license to practice 
medicine on December 29, 2016, it had the legal effect of also taking 
away Respondent's authority to issue any prescriptions for any 
``physical or mental condition.'' See Christina B. Paylan, M.D., 80 FR 
69979, 69979 (2015) (holding that Respondent ``lacks authority under 
Florida law to dispense controlled substances within the meaning of the 
CSA'' because ``Respondent's license `to practice as a medical doctor' 
'' had been suspended) (citing Fla. Stat. Sec. Sec.  458.305(3), (4)); 
Reams v. State, 279 So. 2d 839, 842 (Fla. 1973) (holding that 
prescribing ``vitamins or food'' rather than ``medicines'' without a 
medical license constitutes an unlicensed practice of medicine under 
Florida law).
    Accordingly, as a matter of law, Respondent lacked the authority to 
handle controlled substances in Florida beginning on December 29, 2016 
(when the Florida Board of Medicine revoked his State medical license), 
and he is therefore not entitled to maintain his DEA registration.
    Moreover, because ``the controlling question'' in a proceeding 
brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA 
registration ``is currently authorized to handle controlled substances 
in the [S]tate,'' Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 
FR 12847, 12848 (1997)), the Agency has also long held that revocation 
is warranted even where a practitioner has lost his state authority by 
virtue of the State's use of summary process and the State has yet to 
provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR 
18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). For 
the same reasons, given that the Florida Board of Medicine had revoked 
Respondent's state license, it is of no consequence that Respondent 
could have prevailed on his appeal to the 1st District Court of Appeals 
of Florida.\6\ In any event, and as already noted, that court has since 
affirmed the revocation of Respondent's medical license.
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    \6\ Similarly, and contrary to Respondent's claim, Due Process 
did not require the CALJ to delay summary disposition of the case 
until his appeal to the First District Court of Appeals of Florida 
had been decided. Resp. Opp. at 10-12. Rather, Due Process required 
the CALJ to provide Respondent the opportunity to respond to the 
Order to Show Cause and the Government's Motion for Summary 
Disposition. The CALJ did provide Respondent such an opportunity, 
and the Respondent did so respond.
     I also agree with the CALJ's recommendation (R.D. at 6 n.9) 
that I reject, and I do reject, Respondent's argument that 
revocation is not required in this case based on the Joe W. Morgan 
case and the other Agency precedent cited by Respondent.
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    As for Respondent's CAP, I conclude that there were adequate 
grounds for denying it. Specifically, Respondent's position in his CAP 
is identical to his principal argument seeking a stay of summary 
disposition of the Show Cause Order that I have already rejected; 
namely, that his DEA registration should not be revoked until the 
conclusion of his appeal to Florida's 1st District Court of Appeal. 
Thus, I agree with the Agency's denial of Respondent's CAP for the same 
reasons I set forth above for denying Respondent's identical argument 
to stay summary disposition. In addition, like his stay argument, the 
need to address the adequacy of Respondent's CAP is now moot because 
his appeal was denied.
    I will therefore reject Respondent's CAP and adopt the CALJ's 
recommendation that I revoke Respondent's registration and deny any

[[Page 7226]]

pending applications to renew or modify his registration. See R.D. at 
7.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration No. BW6830500, issued to Kenneth N. Woliner, M.D., be, and 
it hereby is, revoked. I further order that any pending application of 
Kenneth N. Woliner to renew or modify the above registration, or any 
pending application of Kenneth N. Woliner for any other registration, 
be, and it hereby is, denied. This Order is effective immediately.\7\
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    \7\ For the same reasons which led the Florida Board of Medicine 
to revoke Respondent's medical license, I conclude that the public 
interest necessitates that this Order be effective immediately. 21 
CFR 1316.67.

    Dated: February 7, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-03299 Filed 2-16-18; 8:45 am]
 BILLING CODE 4410-09-P