[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4944-4954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01840]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21-11]
Michael E. Smith, D.V.M.; Decision and Order
On December 3, 2020, a former Assistant Administrator, Diversion
Control Division, of the Drug Enforcement Administration (hereinafter,
DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to
Michael E. Smith, D.V.M. (hereinafter, Respondent) of Zanesville, Ohio.
Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (OSC), at 1 and
5. The OSC proposed the denial of Respondent's application for DEA
Certificate of Registration No. W20010614C (hereinafter, COR or
registration) and the denial of any applications for any other DEA
registrations pursuant to 21 U.S.C. 824(a)(2) and 824(a)(4) because
Respondent was convicted of a felony related to controlled substances
and because ``[Respondent's] registration would be inconsistent with
the public interest, as that term is defined in 21 U.S.C. 823(f).'' Id.
at 1.
On January 1, 2021, the Respondent timely requested a hearing,
which commenced (and ended) on April 19, 2021, at the DEA Hearing
Facility in Arlington, Virginia with the parties, counsel, and
witnesses participating via video teleconference (VTC). On June 30,
2021, Administrative Law Judge Paul E. Soeffing (hereinafter, the ALJ)
issued his Recommended Rulings, Findings of Fact, Conclusions of Law,
and Decision of the Administrative Law Judge (hereinafter, Recommended
Decision or RD).
By letter dated August 5, 2021, the ALJ certified and transmitted
the record to me for final Agency action. In the letter, the ALJ
advised that the Respondent filed untimely exceptions to the Recommend
Decision on July 26, 2021. The ALJ stated that the Respondent had
received an extension of time to file his exceptions by 2:00 p.m. ET on
July 26, but did not file them until 2:58 p.m. ET. The ALJ also advised
that the Government filed its Response to the Respondent's Exceptions
on August 5, 2021.
Having reviewed the entire record, I find Respondent's Exceptions
without merit and I adopt the ALJ's rulings, findings of fact as
modified, conclusions of law and recommended sanction with minor
modifications, where noted herein.*\A\ Although Respondent's Exceptions
were untimely, in this case, I decided to nonetheless consider and
address each of Respondent's Exceptions, and issue my final Order in
this case following the Recommended Decision.
---------------------------------------------------------------------------
*\A\ I have made minor, nonsubstantive, grammatical changes to
the RD and nonsubstantive conforming edits. Where I have made
substantive changes, omitted language for brevity or relevance, or
where I have added to or modified the Chief ALJ's opinion, I have
noted the edits in brackets, and I have included specific
descriptions of the modifications in brackets or in footnotes marked
with an asterisk and a letter. Within those brackets and footnotes,
the use of the personal pronoun ``I'' refers to myself--the
Administrator.
---------------------------------------------------------------------------
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Paul E. Soeffing
U.S. Administrative Law Judge
June 30, 2021
*\B\ The issue in this case is whether the record as a whole
establishes by a preponderance of the evidence that the Respondent's
application for a DEA COR, Control No. W20010614C, should be denied,
and any other pending applications for additional registrations should
be denied, pursuant to 21 U.S.C. 824(a)(2) and (a)(4), because the
Respondent has been convicted of a felony relating to controlled
substances, and because his registration would be inconsistent with the
public interest, as that term is defined in 21 U.S.C. 823(f).
---------------------------------------------------------------------------
*\B\I have omitted the RD's discussion of the procedural history
to avoid repetition with my introduction.
---------------------------------------------------------------------------
After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
of law below.
I. Findings of Fact
A. Allegations
The Government alleges that the Respondent's application for a DEA
COR, Control No. W20010614C, should be denied and any applications by
the Respondent for any other DEA registrations should be denied,
pursuant to 21 U.S.C. 824, because (1) Respondent has been convicted of
a felony relating to controlled substances; and (2) that registration
would be inconsistent with the public interest, as that term is defined
in 21 U.S.C. 823(f).
B. Stipulations
The Government and the Respondent agreed to fourteen stipulations,
which I recommend be accepted as fact in these proceedings:
1. Respondent was previously registered with the DEA to handle
controlled substances in Schedules II through V under DEA COR No.
FS1126146 at 100 Sally Road, Zanesville, Ohio 43701.
2. Respondent surrendered DEA COR No. FS1126146 for cause on or
about July 20, 2015, pursuant to his plea agreement in Case CR2015-
0052, State of Ohio v. Michael E. Smith.
3. Respondent submitted an electronic application for a new DEA
COR on or about February 3, 2020.
4. Government Exhibit No. 1 is a true and correct copy of
Respondent's February 3, 2020 application for a DEA COR.
5. Government Exhibit No. 2 is a true and correct copy of the
Certification of Registration History showing Respondent's answers
to the liability questions from his February 3, 2020 application for
a DEA COR.
6. Government Exhibit No. 3 is a true and correct copy of the
docket sheet in Case CR2015-0052, State of Ohio v. Michael E. Smith.
7. Government Exhibit No. 4 is a true and correct copy of
Respondent's signed plea agreement, dated July 20, 2015, in Case
CR2015-0052, State of Ohio v. Michael E. Smith.
8. Government Exhibit No. 5 is a true and correct copy of the
court's entry of Respondent's plea agreement, dated July 23,
[[Page 4945]]
2015, in Case CR2015-0052, State of Ohio v. Michael E. Smith.
9. Government Exhibit No. 6 is a true and correct copy of the
court's entry of Respondent's sentence, dated October 7, 2015, in
Case CR2015-0052, State of Ohio v. Michael E. Smith.
10. Government Exhibit No. 7 is a true and correct copy of the
transcript of Respondent's plea hearing, dated July 20, 2015, in
Case CR2015-0052, State of Ohio v. Michael E. Smith.
11. Government Exhibit No. 8 is a true and correct copy of the
transcript of Respondent's sentencing hearing, dated October 5,
2015, in Case CR2015-0052, State of Ohio v. Michael E. Smith.
12. DEA lists Dilaudid (hydromorphone) as a Schedule II
controlled substance under 21 CFR 1308.12(b)(1)(vii).
13. DEA lists oxycodone as a Schedule II controlled substance
under 21 CFR 1308.12(b)(1)(xiii).
14. Dr. Smith currently holds an unrestricted license to
practice veterinary medicine and surgery in the State of Ohio.
C. Government's Case-in-Chief
The Government presented its case in chief through the testimony of
a single witness, Diversion Investigator (DI) K.P.
K.P. has worked for the DEA as a DI in Columbus, Ohio since May
2019. Tr. 14. She has been a DI since January 2019. Tr. 14-15. Her
mission is to prevent, detect, and investigate diversion of controlled
substances. Tr. 15. She conducts inspections, schedules investigations,
and ensures registrants are in compliance with applicable laws. Tr. 15.
If an applicant answers ``yes'' to a liability question \1\ on the
application, it will get flagged and assigned to a DI. Tr. 15-16. Once
K.P. is assigned a new application for review, she will first read
through the application and will then run a criminal history check. Tr.
16-17.
---------------------------------------------------------------------------
\1\ This includes whether an applicant had prior issues with
controlled substances, convictions, or any disciplinary action on a
state or federal controlled substance license. Tr. 16.
---------------------------------------------------------------------------
K.P. was assigned the Respondent's case because Respondent answered
``yes'' to three of the liability questions on the DEA Form 224,
Application for Registration (``application'').\2\ Tr. 17-19; Gov't Ex.
1 at 1. To the best of K.P.'s knowledge, the Respondent answered these
questions correctly on his application. Tr. 38. After being assigned
the case, K.P. called the Respondent. Tr. 17. She then reviewed the
Ohio Veterinary Medical Licensing Board (``the Board'') action on his
previous state license and realized he had a new Ohio state license.
Tr. 18. She then ran his criminal history and submitted a request to
Muskingum County for documents relating to the Respondent's criminal
history. Tr. 18, 25-37; See Gov't Exs. 3-8. Throughout the
investigation, K.P. spoke to the Respondent two or three times on the
phone. Tr. 39. Otherwise, she was in contact with his counsel, Mr. I.
Tr. 39. K.P. never met with the Respondent in person. Tr. 39.
---------------------------------------------------------------------------
\2\ The Respondent submitted this application in February 2020.
Stip. 3; Tr. 19; Gov't Exs. 1, 2.
---------------------------------------------------------------------------
In his answer to the first liability question, the Respondent
stated that he pled guilty to ten counts of Illegal Processing of Drug
Documents, had surrendered his vet license and his DEA registration,
and served seventeen months of incarceration. Tr. 24; Gov't Ex. 2.\3\
K.P. was concerned because the Respondent indicated he was addicted to
opiates and had written prescriptions under his COR for dogs, but took
them for his own personal use. Tr. 23-24; Gov't Ex. 2. K.P. asserted
that the DEA's concern with granting the Respondent's application for
registration is that the Respondent would not be able to responsibly
handle a DEA registration because he has a proven history of misusing
it. Tr. 40. The Respondent's guilty plea to ten counts of Illegal
Processing of Drug Documents was significant to her because she
believed it showed that the Respondent was not responsible with his
registration. Tr. 24, 40.
---------------------------------------------------------------------------
\3\ The Government presented evidence indicating that the
Respondent pled guilty in State of Ohio v. Michael E. Smith, No.
CR2015-0052 to ten counts of ``Illegal Processing of Drug
Documents,'' in violation of Ohio Revised Code (``ORC'') Sec.
2925.23(B)(1), which is a fourth-degree felony. Gov't Ex. 4. The
Respondent also pled guilty to ``Having a Weapon While Under
Disability'' in violation of ORC Sec. 2923.13(A)(3), a third-degree
felony. Id.
---------------------------------------------------------------------------
K.P. did not believe that the Respondent had provided her with
proof that he had been working on his addiction. Tr. 40. Although he
provided her with certificates of the programs he completed, none were
more recent than 2017. Tr. 40-41. She did not have an opinion on how
often the Respondent should be attending a rehabilitation program or
attending meetings. Tr. 41-42.
K.P.'s testimony was primarily focused on the non-controversial
introduction of documentary evidence and her contact with this case.\4\
Her testimony was generally consistent and genuine and there was no
indication she harbors any animosity towards the Respondent. As a
public servant, K.P. has no personal stake in the DEA's action on the
Respondent's application for registration. I therefore find her
testimony to be entirely credible and it will be afforded considerable
weight.
---------------------------------------------------------------------------
\4\ Although the Government called K.P. as a rebuttal witness to
introduce into evidence additional documentary evidence, the
tribunal sustained the Respondent's objection to proposed Government
Exhibit 9 being admitted into evidence. Tr. 163-67.
---------------------------------------------------------------------------
D. Respondent's Case
The Respondent presented his case in chief through the testimony of
four witnesses: himself and three character witnesses A.B., R.W., and
G.G.
Respondent
The Respondent graduated from Ohio State University and obtained
his degree in 1994. Tr. 44-45; Gov't Ex. 1 at 1.\5\ He worked with his
father in a private practice, where they saw over 10,000 clients,
including over thirty-seven species of animals from seven counties. Tr.
45. He is prepared to handle situations in internal medicine, emergency
medicine, preventive care, and surgical procedures. Tr. 46. The
Respondent currently has a veterinary practice, Smith Veterinary
Services, in Muskingum County, Zanesville, Ohio, which is mainly a
rural area. Tr. 44-46.
---------------------------------------------------------------------------
\5\ Although not specified in the testimony, this appears to be
when the Respondent graduated from Veterinary school. See Gov't Ex.
1 at 1.
---------------------------------------------------------------------------
Within a few years of graduating, the Respondent's veterinary
license was disciplined for the first time. Tr. 46-47. One night,
sometime in the 1990's, a client offered him cocaine, he took it, and
ultimately became addicted to cocaine.\6\ Tr. 47, 122. He was arrested
with a possession charge and reprimanded by the Board with a two-year
suspension of his license. Tr. 48, 110. When he was first arrested, he
was put on probation, but he violated that probation and served a
sentence. Tr. 128. He was incarcerated for eight months total for this
drug conviction.\7\ Tr. 129. The Board set conditions on the
reinstatement of his license in a settlement agreement in 2000,
including the requirement that he complete a rehabilitation program and
demonstrate that he was capable of operating in a proper manner.\8\ Tr.
48-49; 131-33.
[[Page 4946]]
When his license was reinstated, he went back to working with his
father. Tr. 49. His father died in 2010, but he continued to work in
the office with his half-sister, who was also a veterinarian. Tr. 50.
They ultimately ``parted ways'' in the fall of 2011. Tr. 50-51. At this
point, the Respondent had been sober for approximately thirteen years.
Tr. 120.
---------------------------------------------------------------------------
\6\ When questioned by the tribunal as to the year he first
started abusing drugs, the Respondent stated that he ``may have had
casual use throughout my youth'' which would presumably predate this
cocaine use after he became a licensed veterinarian and was ``well
into [his] 30's.'' Tr. 119-20.
\7\ Respondent's first drug conviction, for cocaine, was in
1997. Tr. 129; Gov't Ex. 7 at 14:21-22. In the sentencing transcript
for the Respondent's 2015 conviction, his defense attorney indicates
the Respondent served a six-month sentence for the 1997 conviction.
Gov't Ex. 8 at 6:4-5.
\8\ During the testimony, there was some confusion as the
Respondent's Prehearing Statement indicated there was a settlement
agreement with the Board in 2005. ALJ Ex. 8 at 2. The Respondent's
counsel also referenced a 2005 settlement agreement with the Board,
but the Respondent clarified that the settlement agreement was in
2000. Tr. 48. According to the Respondent and his counsel, the 2005
date listed in the Respondent's Prehearing Statement is a
typographical error and the year should actually be 2000. Tr. 130-
32.
---------------------------------------------------------------------------
In October of 2011, he learned that he had avascular necrosis of
both of his hips, which he found to be quite painful. Tr. 51. He was
prescribed opiates by the emergency room doctor, likely Percocet, after
this diagnosis, and continued receiving opiate prescriptions after
having hernias repaired in November 2011. Tr. 51, 52, 120. He had hip
replacement surgery in January 2012. Tr. 52. He continued to receive
opiate prescriptions from various doctors until a doctor indicated that
he would no longer prescribe him opiates. Tr. 52-53. He then reached
out to a surgeon who prescribed him opiates after the Respondent ``used
an argument of professional courtesy,'' but this doctor ultimately
stopped prescribing opiates to him. Tr. 53. The Respondent then started
doing illegal activities \9\ to acquire his own drugs for about three
or four months. Tr. 53 (``went on for maybe three months''); Tr. 83
(``over a four-month period''). A pharmacist friend called and asked
about one of the prescriptions the Respondent wrote and he lied and
told the pharmacist that the prescription was ``okay.'' \10\ Tr. 53.
This incident prompted him to seek help. He started going to meetings
and took part in a faith-based rehabilitative program, Alcohol Chemical
Tobacco Symposium (``ACTS'') prior to his incarceration.\11\ Tr. 53-55,
62; Resp't Ex. C.
---------------------------------------------------------------------------
\9\ This appears to be a reference to the Respondent's criminal
activity of writing prescriptions in the names of dogs that he or
others would then fill so that the Respondent could use the drugs to
satisfy his addiction.
\10\ The Respondent later testified that this was a turning
point for him where he realized that ``[n]ot only was I destroying
myself, now I put him in a position of where he shouldn't have been
and I came to the realization that what I was doing to myself, I may
have been contributing this to happening to others as well.'' Tr.
97.
\11\ The Respondent later testified that he took part in the
program post-incarceration. Tr. 62. Furthermore, the certificate of
completion for this ACTS program is dated August 16, 2017. Resp't
Ex. C.
---------------------------------------------------------------------------
The Respondent was ultimately served with a warrant in September
2012. Tr. 56. After receiving the warrant, he went to church, attended
Alcoholics Anonymous (``AA'') and Narcotics Anonymous (``NA'')
meetings, and continued to practice as a vet.\12\ Tr. 57. Criminal
charges were filed against him in 2015, and he was arrested. Tr. 58.
The Respondent pleaded guilty to ten counts of Illegal Processing of
Drug Documents. Tr. 58-59. The Respondent admitted that he pleaded
guilty to ten counts of Illegal Processing of Drug Documents based on a
scheme whereby he would write false prescriptions for dogs that he did
not examine, and would either fill those prescriptions and take the
pills for his own use or would sell the prescriptions to others.\13\
Tr. 101-02. He also admitted that by issuing those prescriptions, in
most cases, he did so without a legitimate medical purpose and outside
the usual course of professional practice. Tr. 103.
---------------------------------------------------------------------------
\12\ The Respondent did not provide documentation of his
attendance when he went to these meetings since he ``went on [his]
own accord'' and ``the only time [he] signed was when [he] was
incarcerated'' or ``back in the 90s when [the Courts] wanted [him]
to have a paper signed.'' Tr. 57.
\13\ The Respondent qualified his answer by saying ``[a] few of
the prescriptions were actually for dogs that were damaged
horribly.'' Tr. 102.
---------------------------------------------------------------------------
He denied using marijuana or smoking crack in 2011 or 2012. Tr.
122. But see Gov't Ex. 8 at 21:1-11, 22:7-14 (During the 2015
sentencing hearing, the Respondent testified that prior to his arrest
he was smoking marijuana almost daily and started smoking crack again
in 2011). He testified that he did not recall making the statement to
the trial judge in 2015 that he was smoking crack, although he may have
used powdered cocaine in early 2012. Tr. 124. He also did not recall
making the statement in 2015 to the trial judge that he was smoking
marijuana, and he did not recall smoking marijuana in 2011 or 2012. Tr.
125. However, he later testified he probably last smoked marijuana
during his opiate addiction in 2011 or 2012. Tr. 125-26. He also did
not recall a period when he was smoking marijuana almost daily. Tr.
126-27. He stated that he did not ``recall all that was going on''
during the time of his opiate addiction and his ``mind was horribly
confused . . . and everything is a daze.'' Tr. 126.
The Respondent was also given a twenty-four-month sentence for a
gun violation.\14\ Tr. 127; Gov't Ex. 6 at 2; Gov't Ex. 8 at 19-20. He
served a seventeen-month prison sentence for his drug-related crimes
from late 2015 until spring 2017, and received about thirty days off
his sentence for good behavior. Tr. 59, 64. But see Tr. 127 (The
Respondent testified that he served a concurrent twenty-four-month
sentence for his gun-related crime with about thirty days off his
sentence for good behavior.). While incarcerated, he surrendered his
veterinary license to the Board. Tr. 63.
---------------------------------------------------------------------------
\14\ The Respondent was a convicted felon in possession of a
firearm, which he had used after his felony conviction. Gov't Ex. 8
at 19-20. At the hearing for the instant case, the Respondent
admitted to having ``a deer shotgun and a .22 rifle here for
protection for [his] office and family.'' Tr. 127.
---------------------------------------------------------------------------
While he was incarcerated, he applied to the Seeking a New
Direction (``SAND'') program, which had limited seating, attended NA
and AA meetings weekly to bi-weekly, and chaired some NA meetings. Tr.
59-61, 103; Resp't Ex. B.\15\ Also while incarcerated, he applied to
and was accepted into the Kairos Inside Weekend Program, which is a
faith-based organization where a group of men take part in ``a complete
weekend of spirituality,'' learning to love themselves and forgive
others. Tr. 60, 103; Resp't Ex. D.
---------------------------------------------------------------------------
\15\ The Respondent testified that the Certificate of Completion
for the Intensive Outpatient Program of Hocking County that was
admitted into evidence as Respondent's Exhibit B is the same program
as the SAND program. Tr. 60-61, 103.
---------------------------------------------------------------------------
After being released from jail, he thanked God, took care of his
wife, found employment, and took part in the ACTS program. Tr. 62, 64;
Resp't Ex. C. This program focused him on maintaining his sobriety. Tr.
96. He also got a job at Winland's Complete Landscaping as a laborer,
then advanced to head mower and trained others. Tr. 64, 66-67. Despite
pain from his hip, he never used opiates or other illegal substances
while employed there, and ``will never touch another one.'' Tr. 65.
Instead, he took over-the-counter Ibuprofen and Tylenol and was
prescribed Meloxicam and Flexeril, a muscle relaxant. Tr. 65, 99.
Post-release, he attended AA and NA meetings. Tr. 65. He ``used to
go a lot,'' but he has ``pulled back some'' and now goes when he feels
``a little stressed'' to hear other addicts, including ``ones that are
newly trying to recover,'' so he can ``recall the pain, the discomfort,
the dysfunction.'' Tr. 66.
When the Respondent applied for his veterinary license to be
reinstated in Ohio, the Board initially denied his application. Tr. 68.
The Board then held a hearing and decided ``the same day'' to reinstate
his license. Tr. 69; Resp't Ex. A. His veterinary license was
reactivated in January 2020. Tr. 67, 70, 87. Despite the fact that the
Board's decision stated that it was issuing him a license ``with a
reprimand letter,'' the Respondent asserts that he did not receive such
a letter. Tr. 107, 109; Resp't Ex. A at 3. The Respondent further
testified that there are no restrictions on his veterinary license and
there was no discipline or reprimand. Tr. 69. The Board did not require
any particular
[[Page 4947]]
rehabilitation or monitoring by the Board for his current license. Tr.
110-11. In its Finding and Order, the Board did suggest that the
Respondent ``operate his practice under direct supervision by a
licensed veterinarian.'' Tr. 107-08, 135-36; Gov't Ex. A at 3. The
Respondent is not doing that. Tr. 107-08, 135. The Board's Finding and
Order also suggested that he attend Ohio Physicians' Health Plan
counseling for five years. Tr. 108, 134-35; Gov't Ex. A at 3.
Respondent is also not doing this because when he previously looked
into it--back in the 1990's--it was quite expensive and he would have
to commute to Columbus, Ohio.\16\ Tr. 108, 134-35. The Board has not
checked in on the Respondent since reinstating his license. Tr. 69-70.
---------------------------------------------------------------------------
\16\ Upon further questioning by the tribunal, the Respondent
admitted that he did not know if the Ohio Physicians' Health Plan
counseling is currently an in-person program, nor did he know if
financial assistance or a lower fee arrangement might be available
to him. Tr. 134-35. The Respondent further admitted that ``I don't
know what the program actually consists of or how they run it, at
this time.'' Tr. 134. It therefore appears that the Respondent
rejected out of hand any consideration of participating in the
program based on his understanding of the program as it existed over
twenty years ago, without making any inquiry as to how he might take
part in or benefit from the program as it exists today. There did
not seem to be any inquiry or investigation by the Respondent since
the 1990's to justify his testimony that ``[i]t's very expensive''
and ``something [he] could not afford.'' Tr. 108.
---------------------------------------------------------------------------
The Respondent built up his practice and set up an office in his
house as a sole practitioner with his wife as his secretary and
assistant. Tr. 70, 93-94, 106. He has seen approximately 1,000 patients
since his license was reinstated. Tr. 70. The Respondent is
specifically seeking the use of Schedule III, IV, and V drugs including
Ketamine, which he would use as an anesthetic. Tr. 71-72, 90. He is
also requesting Diazepam and Phenobarbital, which are used on animals
having seizures. Tr. 73, 90. He is also seeking the use of testosterone
and estrogen, which can be used on dogs with prostatitis. Tr. 74, 90.
He is also seeking use of Nandrolene, an anabolic steroid, and Telazol,
a short-acting narcotic. Tr. 75-76, 90. The Respondent would only
administer these controlled substances, except for Phenobarbital, which
he would prescribe to epileptic dogs. Tr. 91, 92. The Respondent is
aware that Ketamine and Diazepam are controlled substances that are
diverted. Tr. 94-95.
Every day, he prays, and he has learned many concepts and tools
through NA and his rehabilitation programs. Tr. 79, 137-38. He has
learned that addiction is ``a lifelong condition and it needs proper
maintenance'' and that sobriety ``takes work, it takes maintenance.''
Tr. 80, 111. He would describe himself as ``a grateful recovered
addict.'' Tr. 112. He also believes that addiction is ``part of [his]
personality.'' Tr. 121. He testified that he appreciates that the Board
reinstated his license and ``can guarantee [he] would never, ever, ever
abuse that authority again.'' Tr. 81.\17\
---------------------------------------------------------------------------
\17\ At the conclusion of his direct examination, the Respondent
read a prepared statement to the tribunal. Tr. 81-86. He explained
that he does not ``make light of the abuse of the trust given to my
profession.'' Tr. 83. He admitted that he was convicted of the
Illegal Processing of Drug Documents and has not lied or denied any
of that. Tr. 83. He stated that he realized his actions harmed
himself and potentially others and he regrets that. Tr. 83-84. He
has also reviewed the standards for record-keeping for controlled
substances, purchased key locks and a key lockbox, and will comply
with all necessary regulations. Tr. 85, 116.
---------------------------------------------------------------------------
Since his incarceration, the Respondent has not taken any classes
or continuing education regarding his responsibilities and duties as
someone with the authority to prescribe and administer controlled
substances, but he did review regulations for the storage of controlled
substances and record-keeping. Tr. 85, 116. The Respondent testified
that he was ``not aware of any classes'' regarding responsibilities and
duties of those with the authority to prescribe and administer
controlled substances. Tr. 116. The last time the Respondent used an
illegal controlled substance or any properly prescribed controlled
substance was in 2012. Tr. 56, 96-98. He has been drug tested ``[m]any
times'' since 2012 and has never had a positive result.\18\ Tr. 56.
---------------------------------------------------------------------------
\18\ The Respondent did not offer into evidence any
documentation of any drug test results he may have had over the
years. Nor did the Respondent testify regarding what drugs he was
tested for or when he last submitted to a drug test.
---------------------------------------------------------------------------
The Respondent stated that what is currently different as it
relates to his prescribing or administering of controlled substances is
the fact that he is no longer addicted to opiates. Tr. 111-12. He also
does not continue to associate with any of the people he provided false
prescriptions to in 2012. Tr. 112. The Respondent asserts that he did
not provide drugs to his son (or any other relatives), either by
prescribing or diverting them. Tr. 113, 115-16, 117-18. But see Gov't
Ex. 8 at 16:17-18 (The Respondent stated that he ``became addicted
[himself] and [his] son as well . . . .''); Gov't Ex. 8 at 18:15-19 (At
the sentencing hearing, the trial judge stated ``you probably don't
even know who all the victims are that got those drugs, do you?'' to
which the Respondent replied ``One was my son, one was myself, I know
that.'').
The Respondent believes a DEA COR would allow him to ``practice at
a higher level'' and would provide for a ``better outcome or safety.''
Tr. 71, 76-77. The State of Ohio has never taken an action against his
veterinary license due to the care he provided or failed to provide to
an animal.\19\ Tr. 77. The Respondent stated that he does not plan on
writing prescriptions and trading them for drugs and he takes
responsibility for his actions. Tr. 77, 137.
---------------------------------------------------------------------------
\19\ Although the Board may not have ever taken action against
his license, this certainly does not mean that the Respondent has at
all times provided proper care. The Respondent testified that one of
the illegal prescriptions he wrote drew the attention of the filling
pharmacist who questioned the legitimacy of the prescription. Tr.
53, 97. Though this prescription was diverted for illegal human use,
the medical records of the animal patient would presumably falsely
reflect that the animal had been prescribed the drug.
---------------------------------------------------------------------------
Regarding the Respondent's credibility, I note several areas of his
testimony where there were inconsistencies or where his testimony was
in direct opposition to previous testimony or established facts. First,
the Respondent's testimony in this hearing that he never provided drugs
to his son is in direct conflict with testimony he provided in his 2015
criminal proceedings as reflected in the sentencing transcript. Second,
the Respondent's testimony in this hearing that he was not abusing
other drugs, specifically crack and marijuana, at the time that he
developed his addiction to opiates conflicts with testimony he
provided, as reflected in the transcript, to the court during his 2015
sentencing. Third, the Respondent first testified that the Ohio
Physicians' Health Plan counseling was too expensive for him to afford
and also too far away for him to attend the in-person sessions.
However, upon further examination by the tribunal, Respondent admitted
he did not make any inquiries into the program after receiving the
Board's Finding and Order and that his testimony was based on an
inquiry he made back in the 1990's. Based on these inconsistencies in
the Respondent's statements, and Respondent's uninformed (to be
charitable) initial testimony regarding the Ohio Physicians' Health
Plan counseling, I cannot fully credit the Respondent's testimony.
A.B.
A.B. has known the Respondent since 1995 and has taken her pets to
him as her veterinarian since that time, except when he was not able to
practice. Tr. 142-43. She is not a veterinarian and has never
prescribed or administered controlled substances. Tr. 147-48. She knows
that the Respondent was unable
[[Page 4948]]
to practice because he lost his license due to ``some mistakes with
drugs.'' Tr. 143. She has chronically ill animals--puppy mill
survivors--that she takes to the Respondent for care because their
severe illnesses require someone who will take the time to ``keep these
dogs going.'' Tr. 143-45. The Respondent has always taken time to sit
down and order lab tests. Tr. 144. She has never seen the Respondent
appear to be under the influence of drugs or alcohol during any of her
visits. Tr. 146-47. She trusts the Respondent. Tr. 147.
A.B. was called as a character witness,\20\ and although the depth
of her knowledge of the Respondent's suitability to act as a
responsible DEA registrant is extremely limited, she presented
testimony that was sufficiently cogent, detailed, plausible, and
internally consistent to be considered generally creditable. Although
A.B. has known the Respondent for over twenty-five years, her
interactions with him have been limited to the times over the years
when she has brought her animals to him for care. Nevertheless, I
credit her testimony that the Respondent has rendered compassionate
care to her animals and has never appeared to be under the influence of
alcohol or drugs.
---------------------------------------------------------------------------
\20\ Tr. 140.
---------------------------------------------------------------------------
R.W.
The Respondent was employed by R.W.'s landscaping \21\ company
about three and a half years ago. Tr. 150. R.W. is not a veterinarian
and has never prescribed or administered controlled substances. Tr.
153. Although the Respondent had felony convictions, R.W. needed
employees and the Respondent was ``up front and honest'' with him about
his situation, so R.W. gave him a chance. Tr. 150. The Respondent
passed the initial drug test and never appeared to be under the
influence of drugs or alcohol while he worked for R.W. Tr. 150-51. He
was a hard worker and R.W. trusts him. Tr. 151. R.W. takes all of his
pets to the Respondent for veterinary care. Tr. 151-52. The Respondent
has never appeared to be under the influence of drugs or alcohol when
R.W. brought his animals to the clinic. Tr. 152.
---------------------------------------------------------------------------
\21\ Although R.W. did not testify as to the type of business he
operates, he did describe the Respondent's responsibilities as
``mowing'' and being ``in charge of the mowing crew.'' Tr. 151. The
Respondent also previously testified that he worked for W.'s
Complete Landscaping, a landscaping service. Tr. 64.
---------------------------------------------------------------------------
R.W. was called as a character witness \22\ and, like the first
character witness, although the depth of his knowledge of the
Respondent's suitability to act as a responsible DEA registrant is
extremely limited, he presented testimony that was sufficiently cogent,
detailed, plausible, and internally consistent to be considered
generally creditable. As a past employer, R.W. had more opportunities
to observe the Respondent's condition on a day-to-day basis and he also
had a stake in the Respondent remaining sober while employed. I
therefore credit his testimony that the Respondent passed an initial
drug test and maintained sobriety during the course of his employment.
---------------------------------------------------------------------------
\22\ Tr. 140.
---------------------------------------------------------------------------
G.G.
The Respondent and the Respondent's father had taken care of G.G.'s
cats in 1990.\23\ Tr. 156. G.G. ran an animal shelter, which he took
over in 1992, until he retired in 2005. Tr. 156-57. G.G. does not keep
in contact with anybody from the shelter. Tr. 159. The Respondent's
father and the Respondent worked with this shelter, taking care of
animals. Tr. 156. G.G. is not a veterinarian and he does not have a DEA
COR. Tr. 160-61. G.G. believed that the Respondent was very
knowledgeable in pet care and would explain to his clients how to care
for their pets. Tr. 158. G.G. currently takes his dog to the
Respondent. Tr. 158. Despite the fact that the Respondent is a
convicted felon, it has never come up in conversation because he
believes the Respondent's concern is what he can do for the pets. Tr.
158-59. G.G. has never seen the Respondent appear to be under the
influence of drugs or alcohol. Tr. 159. While G.G. worked at the
shelter, he never heard any complaints about the Respondent's care. Tr.
159-60.
---------------------------------------------------------------------------
\23\ The Respondent testified he did not graduate from
veterinary school until 1994 and he then went into private practice
with his father. Tr. 44-45. While G.G. may have been mistaken as to
whether the Respondent had personally cared for his cats as early as
1990, the Respondent also testified that he had ``managed dogs and
horses and cats'' since he was six, (Tr. 68), so it is plausible
that the Respondent was assisting in his father's practice in 1990
in some capacity.
---------------------------------------------------------------------------
G.G. was called as a character witness \24\ and, like the other two
character witnesses, although the depth of his knowledge of the
Respondent's suitability to act as a responsible DEA registrant is
extremely limited, he presented testimony that was sufficiently cogent,
detailed, plausible, and internally consistent to be considered
generally creditable. Because G.G. retired from the animal shelter in
2005, well before the Respondent's most recent drug violations, and
because he has not kept in touch with people at the animal shelter, I
find that the substance of his testimony is more relevant as a client
who takes his dog to the Respondent for care. I therefore credit his
testimony that the Respondent has rendered compassionate care to his
dog and has never appeared to be under the influence of alcohol or
drugs.
---------------------------------------------------------------------------
\24\ Tr. 140.
---------------------------------------------------------------------------
Other facts necessary for a disposition of this case are set forth
in the balance of this Recommended Decision.
II. Discussion
The burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard. Steadman v. SEC, 450 U.S. 91,
100-01 (1981). The Administrator's factual findings will be sustained
on review to the extent they are supported by ``substantial evidence.''
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). The Supreme Court has
defined ``substantial evidence'' as such ``relevant evidence as a
reasonable mind might accept as adequate to support a conclusion.''
Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). While ``the
possibility of drawing two inconsistent conclusions from the evidence''
does not limit the Administrator's ability to find facts on either side
of the contested issues in the case, Shatz v. U.S. Dep't of Justice,
873 F.2d 1089, 1092 (8th Cir. 1989), all ``important aspect[s] of the
problem,'' such as a respondent's defense or explanation that runs
counter to the Government's evidence must be considered. Wedgewood
Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007). The ultimate
disposition of the case must ``be in accordance with the weight of the
evidence, not simply supported by enough evidence to justify, if the
trial were to a jury, a refusal to direct a verdict when the conclusion
sought to be drawn from it is one of fact for the jury.'' Steadman, 450
U.S. at 99 (internal quotation marks omitted).
Regarding the exercise of discretionary authority, the courts have
recognized that gross deviations from past agency precedent must be
adequately supported, Morall v. DEA, 412 F.3d 165, 183 (D.C. Cir.
2005), but ``mere unevenness'' in application does not, standing alone,
render a particular discretionary action unwarranted. Chein v. DEA, 533
F.3d 828, 835 (D.C. Cir. 2008) (citing Butz v. Glover Livestock Comm'n
Co., 411 U.S. 182, 188 (1973)). It is well-settled that because the
Administrative Law Judge has had the opportunity to observe the
demeanor and conduct of hearing witnesses, the factual findings set
forth in this
[[Page 4949]]
Recommended Decision are entitled to significant deference, Universal
Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951), and that this
Recommended Decision constitutes an important part of the record that
must be considered in the Administrator's decision. Morall, 412 F.3d at
179. However, any recommendations set forth herein regarding the
exercise of discretion are by no means binding on the Administrator and
do not limit the exercise of that discretion. 5 U.S.C. 557(b); River
Forest Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974);
Attorney General's Manual on the Administrative Procedure Act Sec. 8
(1947).
In the adjudication of a denial of a DEA registration, the DEA has
the burden of proving that the requirements for such registration are
not satisfied. 21 CFR 1301.44(d). Where the Government has sustained
its burden and made its prima facie case, a respondent must both accept
responsibly for his actions and demonstrate that he will not engage in
future misconduct. Patrick W. Stodola, M.D., 74 FR 20,727, 20,734
(2009). Acceptance of responsibility and remedial measures are assessed
in the context of the ``egregiousness of the violations and the [DEA's]
interest in deterring similar misconduct by [the] Respondent in the
future as well as on the part of others.'' David A. Ruben, M.D., 78 FR
38,363, 38,364 (2013).
A. 21 U.S.C. 824(a)(2): Felony Related to Controlled Substances
The Government alleges that the Respondent's COR application should
be denied because he has been convicted of a felony related to
controlled substances, pursuant to 21 U.S.C. 824(a)(2). Under this
provision, the Attorney General may deny,*\C\ revoke, or suspend a
registration issued under 21 U.S.C. 823 ``upon a finding that the
registrant . . . has been convicted of a felony under this subchapter
or subchapter II of this chapter or any other law of the United States,
or of any State, relating to any substance defined in this subchapter
as a controlled substance or a list I chemical.'' 21 U.S.C.
824(a)(2)(emphasis added). Under 21 U.S.C. 824(a)(2), a felony
conviction related to controlled substances is a lawful basis to revoke
a COR, but the question of whether the registration is revoked is a
matter of discretion. Alexander Drug Co., Inc., 66 FR 18,299, 18,302
(2001).
---------------------------------------------------------------------------
*\C\ A provision of section 824 may be the basis for the denial
of a practitioner registration application and allegations related
to section 823 remain relevant to the adjudication of a practitioner
registration application when a provision of section 824 is
involved. See Robert Wayne Locklear, M.D., 86 FR 33,738, 33,744-45.
---------------------------------------------------------------------------
The Government alleges that on July 20, 2015, the Respondent
pleaded guilty to ten counts of Illegal Processing of Drug Documents in
violation of Ohio Rev. Code. Ann. Sec. 2925.23(B)(1),\25\ and that the
Respondent was sentenced to seventeen months of imprisonment to be
served concurrently with a twenty-four-month prison sentence for a
weapons charge.*\D\ ALJ Ex. 1 at 2 ] 7. The Government further alleges
that these ten convictions were based on a scheme in which the
Respondent prepared false prescriptions for opioid medications,
including hydromorphone and oxycodone/acetaminophen, for canines that
did not exist or that the Respondent did not examine, and that the
Respondent would either fill these prescriptions for his personal use
or sell the prescriptions to others in exchange for cash or other
controlled substances. ALJ Ex. 1 at 2-3 ] 8.
---------------------------------------------------------------------------
\25\ Ohio Rev. Code. Ann. Sec. 2925.23(B)(1) states that ``[n]o
person shall intentionally make, utter, or sell, or knowingly
possess any of the following that is false or forged: (1)
Prescription.''
*\D\ Although discussed herein as background, I am not
considering the weapons charge under 21 U.S.C. 824(a)(2).
---------------------------------------------------------------------------
The Government provided a copy of the Respondent's signed guilty
plea in which the Respondent pleaded guilty to ten counts of Illegal
Processing of Drug Documents and one count of Having a Weapon While
Under Disability.\26\ Gov't Ex. 4. The Respondent also admitted that he
pleaded guilty to ten counts of Illegal Processing of Drug Documents in
his Application for Registration, Form DEA 224 (``application''). Gov't
Ex. 2 at 1-2. Specifically, in response to background question one on
the application, which asks whether the applicant has ``ever been
convicted of a crime in connection with controlled substance(s) under
state or federal law,'' the Respondent responded ``Yes'' and indicated
the following:
---------------------------------------------------------------------------
\26\ The Government provided a copy of the signed plea agreement
from the Muskingum County Court of Common Pleas. Gov't Ex. 4. The
parties stipulated that this document is a true and correct copy of
Respondent's signed plea agreement, dated July 20, 2015, in Case
CR2015-0052, State of Ohio v. Michael E. Smith. Stip. 7.
Incident Date: 10/05/2015 Incident Location: MUSKINGUM COUNTY
OHIO Incident Nature: IN 2012 I BECAME ADDICTED TO OPIATES AFTER 5
STRAIGHT MONS OF DR. PRESCRIBED OPIATES FOR 2 MAJOR SURGERIES. WHEN
THE DRS. FINALLY STOPPED THEM I WROTE OPIATE PRESCRIPTIONS FOR DOGS
AND TOOK SOME FOR MY OWN USE. I DID THIS OVER A THREE MONTH PERIOD
UNTIL I CAME TO MY SENSES AND SOUGHT HELP FOR MY ADDICTION. Incident
Result: IN 2015 AFTER BEING CHARGED I PLEAD GUILTY TO 10 COUNTS OF
ILLEGAL PROCESSING OF DRUG DOCUMENTS AND SURRENDERED MY VET. LICENSE
AND MY DEA REGISTRATION. I SERVED 17 MONS. INCARCERATED AND
---------------------------------------------------------------------------
COMPLETED 2 REHABILITATION/RECOVERY PROGRAMS . . . .
Gov't Ex. 1 at 1-2 (emphasis in original).
The Respondent also testified at the April 19, 2021 hearing that he
had pleaded guilty to ``10 counts . . . of illegal processing of drug
documents'' and that he received a seventeen-month sentence for these
charges and served all seventeen months, except ``possibly 30 days off
the sentence for good behavior.'' Tr. 58-59, 101.
During cross-examination, the Government referenced ALJ Exhibit 1,
the Order to Show Cause for the instant case. Tr. 100.\27\ The
Government read through Paragraphs 7 and 8, and the Respondent agreed
he pleaded guilty to these ten counts of Illegal Processing of Drug
Documents. Tr. 101. The Government also asked the Respondent whether
these false prescriptions were based on a scheme whereby he would write
false prescriptions for dogs the Respondent did not examine and would
then fill those prescriptions for his own use or would sell the
prescriptions to others. Tr. 102; ALJ Ex. 1 at 3 ] 11. The Respondent
indicated that although a ``few of the prescriptions were actually for
dogs that were damaged horribly,'' he ``did write prescriptions that
should not have been written so [he] could acquire these drugs to feed
[his] addiction. [He] fully admit[s] . . . freely admit[s] that.'' Tr.
102. The Respondent also testified that he knew ``some people did
acquire'' these false prescriptions. Tr. 102. Although the Respondent
did not testify at the April 19, 2021 hearing that the specific
controlled substances included hydromorphone and oxycodone, the
transcript from his guilty plea, which was stipulated to by the
parties, indicates that this scheme indeed included prescriptions for
hydromorphone/Dilaudid, and oxycodone/APAP, which are both Schedule II
controlled substances. Gov't Ex. 7 at 14; See Stip. 10, 12, 13.
---------------------------------------------------------------------------
\27\ The Government ``shared'' this document on the screen so
the Respondent, who was attending the hearing from a different
physical location from his counsel, (Tr. 6), and did not have copies
of the ALJ exhibits, was able to follow along with this line of
questioning. Tr. 100.
---------------------------------------------------------------------------
Therefore, through the Respondent's testimony, the exhibits, and
the stipulations, there is no controversy that the Respondent has
pleaded guilty to ten counts of Illegal Processing of Drug Documents in
violation of Ohio Rev.
[[Page 4950]]
Code Ann. Sec. 2925.23(B)(1), was sentenced to seventeen months
imprisonment to be served concurrently with a twenty-four month prison
sentence for a weapons charge, and that these counts were based on a
scheme by which the Respondent prepared false prescriptions for canines
that did not exist or that he did not examine, and that he either
filled the prescriptions for his own use or sold the false
prescriptions to others in exchange for cash or other controlled
substances.
Therefore, the allegations set forth in the OSC Allegations 7 and 8
are Sustained.
B. 21 U.S.C. 823(f): Public Interest Determination
Pursuant to 21 U.S.C. 823(f), the Administrator may deny an
application for a registration if persuaded that maintaining such
registration would be inconsistent with the public interest. The
following factors shall be considered in determining the public
interest:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
``These factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Any one or a combination
of factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Agency may properly give each factor
whatever weight it deems appropriate in determining whether a
registrant's registration should be revoked. Id.; David H. Gillis,
M.D., 58 FR 37,507, 37,508 (1993); see also Morall, 412 F.3d at 173-74
(D.C. Cir. 2005); Henry J. Schwarz, Jr., M.D., 54 FR 16,422, 16,424
(1989).
Moreover, the Agency is ``not required to make findings as to all
of the factors,'' Hoxie, 419 F.3d at 482; see also Morall, 412 F.3d at
173, and is not required to discuss consideration of each factor in
equal detail, or even every factor in any detail. Trawick v. DEA, 861
F.2d 72, 76 (4th Cir. 1988) (holding that the Administrator's
obligation to explain the decision rationale may be satisfied even if
only minimal consideration is given to the relevant factors, and that
remand is required only when it is unclear whether the relevant factors
were considered at all). The balancing of the public interest factors
``is not a contest in which score is kept; the Agency is not required
to mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest . . . .'' Jayam
Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
Factors Two, Three, and Four
The Government contends that granting the Respondent's application
for registration would be inconsistent with the public interest based
on Factors Two, Three, and Four.\28\ ALJ Ex. 1 at 3 ] 10. Under Factor
Two, the DEA analyzes a registrant's ``experience in dispensing . . .
controlled substances.'' 21 U.S.C. 823(f)(2). This analysis focuses on
the registrant's acts that are inconsistent with the public interest,
rather than on a registrant's neutral or positive acts and experience.
Kansky J. Delisma, M.D., 85 FR 23,845, 23,852 (2020) (citing Randall L.
Wolff, M.D., 77 FR 5106, 5121 n.25 (2012)). Likewise, under Factor
Four, the DEA analyzes an applicant's compliance with Federal and state
laws, with the analysis focusing on violations of state and Federal
laws and regulations concerning controlled substances. 21 U.S.C.
823(f)(4); Kansky J. Delisma, M.D., 85 FR 23,852 (citing Volkman v.
DEA, 567 F.3d 215, 223-24 (6th Cir. 2009). Under Factor Three, the
tribunal may consider a registrant's ``conviction record under Federal
or State laws relating to the manufacture, distribution, or dispensing
of controlled substances.'' 21 U.S.C. 823(f)(3). A guilty plea may be
considered under the third factor of the public interest standard. Mark
P. Koch, D.O., 79 FR 18,714, 18,734 n.121 (2014).
---------------------------------------------------------------------------
\28\ The record contains no recommendation from any state
licensing board or professional disciplinary authority (Factor One),
but, aside from cases establishing a complete lack of state
authority, the presence or absence of such a recommendation has not
historically been a case-dispositive issue under the Agency's
precedent. Stodola, M.D., 74 FR 20,730 n.16; Krishna-Iyer, 74 FR
461. Two different forms of recommendations have appeared in Agency
decisions: (1) An explicit recommendation regarding the DEA's
decision to issue or sanction a COR; and (2) the action of the
relevant state authority regarding state licensure under its
jurisdiction on the same matter that is the basis for the OSC. Mark
A. Wimbley, 86 FR 20,713, 20,725 (2021); see also, Jennifer L. St.
Croix, M.D., 86 FR 19,010, 19,022 (2021) (Agency affords minimal
weight to a state board reprimand due to differences in evidence
considered by the state in issuing its order.); Jeanne E. Germeil,
M.D., 85 FR 73,786, 73,799 (2020) (Agency recognizes that its prior
final orders have considered this dichotomy of sources for Factor
One consideration). In the instant case, the Board did reinstate the
Respondent's veterinary license in a Finding and Order dated
November 14, 2019, after he surrendered it in 2015. See Resp't Ex.
A; ALJ Ex. 20 at 10 (``There is approval from the Ohio Veterinary
Medical Board. They granted Dr. Smith an unrestricted veterinary
license, knowing his history of drug use and addiction.''). The
Respondent currently has an Ohio veterinary license. Therefore,
although not determinative in this proceeding, Factor One tends to
lean in favor of the Respondent. As the Government's allegations and
evidence fit squarely within the parameters of Factors Two, Three,
and Four and do not raise ``other conduct which may threaten the
public health and safety,'' 21 U.S.C. 823(f)(5), Factor Five
militates neither for nor against the sanction sought by the
Government in this case.
---------------------------------------------------------------------------
Regarding Factor Two, the Respondent has approximately seven years
of experience \29\ with dispensing controlled substances as a
veterinarian. Gov't Ex. 2 at 1. In 2015, after pleading guilty to ten
counts of Illegal Processing of Drug Documents, the Respondent
surrendered his registration. As discussed supra, the Respondent
admitted that he wrote false prescriptions ``that should not have been
written so [he] could acquire these drugs to feed [his] addiction.''
Tr. 102. He also admitted that ``some people did acquire'' some of
these false prescriptions. Tr. 102, 112. These prescriptions included
hydromorphone/Dilaudid, a Schedule II controlled substance, and
oxycodone/APAP, also a Schedule II controlled substance. Gov't Ex. 7 at
14; Stips. 12, 13.
---------------------------------------------------------------------------
\29\ The Respondent's first and only DEA registration, COR No.
FS1126146, was assigned to the Respondent on October 22, 2008, and
was surrendered for cause on July 27, 2015. Gov't Ex. 2 at 1.
---------------------------------------------------------------------------
As it relates to Factor Four, the record establishes multiple
instances in which the Respondent failed to comply with applicable
Federal and State laws. The Government alleges that the Respondent
violated 21 U.S.C. 841(a), 842(a), and Ohio Admin. Code 4729:5-30.\30\
ALJ Ex. 1 at 3 ] 11. The Controlled Substances Act's (``CSA'') general
criminal provision is contained in 21 U.S.C. 841(a), and in relevant
part states: ``[e]xcept as authorized by this subchapter, it shall be
unlawful for any person knowingly or intentionally . . . to
manufacture, distribute, or dispense, or possess with intent to
manufacture, distribute, or dispense, a controlled
[[Page 4951]]
substance.'' 21 U.S.C. 841(a)(1). ``Congress devised a closed
regulatory system making it unlawful to manufacture, distribute,
dispense, or possess any controlled substance except in a manner
authorized by the CSA'' to prevent abuse and diversion of controlled
substances. Gonzales v. Raich, 545 U.S. 1, 13 (2005). DEA regulations
require that for a prescription for a controlled substance to be
effective it must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of professional
practice. 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\30\ While OSC Allegation 11 charges the Respondent with
violating Ohio Admin. Code 4729:5-30, the Government did not present
any evidence on this issue during the hearing and did not address
the issue in its post-hearing brief. Therefore, the Government has
apparently abandoned this particular portion of OSC Allegation 11.
See George Pursley, M.D., 85 FR 80,162, 80,181-82, 80,185 (2020)
(finding the Government abandoned allegation by not addressing it
within its post-hearing brief). I also take official notice that
this particular administrative code section was rescinded, effective
March 15, 2021. Ohio Admin. Code 4729:5-30 (LexisNexis 2021).
---------------------------------------------------------------------------
Under the CSA, a veterinarian falls within the definition of a
practitioner, and upon obtaining a registration, a veterinarian has
legal authority to prescribe, administer or distribute a controlled
substance to an ``ultimate user,'' who is a person who has lawfully
obtained a controlled substance ``for an animal owned by him or a
member of his household.'' Daniel Koller, D.V.M., 71 FR 66,975, 66,981
(2006) (citing 21 U.S.C. 802(21), (27)).
As discussed supra, the Government referenced ALJ Exhibit 1 and
read through OSC Allegations 10 and 11. Tr. 101-03. The Respondent
indicated that he understood the allegations and that he was guilty of
the alleged conduct. Tr. 101-03.
Regarding Factor Three, as discussed at length throughout this
Recommended Decision, the Respondent's guilty plea, which may be
considered under the third factor of the public interest standard,\31\
included ten counts of Illegal Processing of Drug Documents, which
related to a scheme by which the Respondent would write fraudulent
prescriptions which he would either fill himself, taking the pills for
his own use, or would sell to others. Tr. 101-02. The Respondent began
doing these ``illegal activities'' to acquire drugs for himself after
he was unable to obtain further valid opioid prescriptions from other
practitioners. Tr. 53, 83.
---------------------------------------------------------------------------
\31\ Koch, 79 FR 18,734 n.121.
---------------------------------------------------------------------------
Therefore, OSC Allegation 10 is Sustained and OSC Allegation 11 is
Sustained in Part to the extent that the Respondent unlawfully issued
prescriptions for controlled substances in violation of 21 U.S.C.
841(a) and 842(a), specifically, by issuing fraudulent prescriptions
and then converting those prescriptions to his own use or selling them,
and that the Respondent issued prescriptions for controlled substances
outside the usual course of professional practice and not for a
legitimate medical purpose, (21 CFR 1306.04(a)). OSC Allegation 11 is
Not Sustained in Part to the extent that the Respondent violated Ohio
Admin. Code 4729:5-30.
As it relates to the Respondent's experience in dispensing
controlled substances, the Respondent's compliance with applicable
State and Federal laws relating to controlled substances, and the
Respondent's conviction record under Federal or State laws relating to
the manufacture, distribution, or dispensing of controlled substances,
Factors Two, Three, and Four militate strongly in favor of the
Government's position that granting the Respondent a DEA registration
is inconsistent with the public interest.
Based upon my review of the allegations by the Government, it is
necessary to determine if it has met its prima facie burden of proving
the requirements for a sanction pursuant to 21 U.S.C. 824(a).
It is clear from the stipulations, the Government's evidence, and
the Respondent's position in this matter that there is no controversy
between the parties that the Respondent was convicted of the underlying
criminal charges. The Government's evidence clearly demonstrates the
necessary elements of proof under 21 U.S.C. 824 and I find that the
Government has established a prima facie case for denial of the
Respondent's application for registration.
III. Sanction
A. Acceptance of Responsibility and Rehabilitative Measures
With the Government's prima facie burden having been met, an
unequivocal acceptance of responsibility stands as a condition
precedent for the Respondent to prevail. Jones Total Health Care
Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79,188, 79,201
(2016). This feature of the Agency's interpretation of its statutory
mandate on the exercise of its discretionary function under the CSA has
been sustained on review. MacKay v. DEA, 664 F.3d 808, 819-20 (10th
Cir. 2011). Accordingly, the Respondent must ``present[ ] sufficient
mitigating evidence to assure the Administrator that [he] can be
entrusted with the responsibility carried by such a registration.''
Medicine Shoppe-Jonesborough, 73 FR 363, 387 (2008) (quoting Samuel S.
Jackson, 72 FR 23,848, 23,853 (2007)). As past performance is the best
predictor of future performance, the DEA has repeatedly held that where
an applicant has committed acts inconsistent with the public interest,
the applicant must accept responsibility for its actions and
demonstrate that it will not engage in future misconduct. ALRA Labs,
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995).
Although the Respondent ``freely admit[s] [he] did wrong,'' his
language was conditional, and as opposed to taking unequivocal
responsibility, the record is replete with examples of the Respondent
placing the blame of his addiction on others, including a former client
and his doctors. Tr. 112. For example, when he discussed using cocaine
a few years after graduating from veterinary school, he prefaced this
by explaining that a lot his previous friends from high school ``were
using illicit drugs including cocaine'' and that he did not ``know much
about'' cocaine until he ``had a client one night offer'' him some. Tr.
47. When the Respondent was prescribed opiates in October 2011 and
ultimately became addicted to them, he blamed a string of doctors who
treated him for various ailments. He testified that he was ``not aware
of the force of opiate addiction'' (Tr. 121) and that he ``had no idea
what it was like until I found out myself.'' Tr. 84. He explained that
he ``trusted the doctors to help'' him, (Tr. 121), and ``maybe [he]
should have told the doctors, please don't give me these opiates.'' Tr.
122. With this detached approach, the Respondent appears to have
abdicated his responsibility to participate in the proper management of
his pain by accounting for his history of drug addiction. Even in his
application, which is the subject of these proceedings, he stated that
he ``BECAME ADDICTED TO OPIATES AFTER 5 STRAIGHT MONS OF DR. PRESCRIBED
OPIATES FOR 2 MAJOR SURGERIES. WHEN THE DRS. FINALLY STOPPED THEM I
WROTE OPIATE PRESCRIPTIONS FOR DOGS AND TOOK SOME FOR MY OWN USE.''
Gov't Ex. 2 at 1 (emphasis in original). Essentially, the Respondent,
despite his status as a medical professional and onetime DEA
registrant, claimed ignorance of the potential for addiction of cocaine
and opiates and instead blamed others for his addiction.
When the Respondent was cross-examined by Government counsel
regarding the ten prescriptions he wrote for which he was convicted of
Illegal Processing of Drug Documents, the Respondent expressed
ambivalence stating that a ``few of the prescriptions were actually for
dogs that were damaged horribly.'' Tr. 102. During this same line of
questioning regarding the ten prescriptions for which he was convicted,
when asked if he issued the prescriptions ``without a legitimate
medical purpose and outside the usual
[[Page 4952]]
course of professional practice,'' the Respondent would only allow that
``[i]n most cases that is exactly correct.'' Tr. 103 (emphasis added).
The Respondent's answers to these pointed questions about the ten
distinct prescriptions for which he was convicted do not exhibit an
unequivocal acceptance of responsibility.
He also appears to have regret mostly for what his actions caused
to his own life and it is evident the Respondent does not fully
comprehend the repercussions of his actions and the effects it had on
the community at large. During his testimony, he stated that his
``actions had harmed [himself] and potentially others.'' \32\ Tr. 83-
84; 102 (emphasis added). He also discussed the fact that he went
through bankruptcy proceedings and ``lost everything that [he] ever
worked for.'' Tr. 108. When questioned regarding the other people who
obtained false prescriptions through him, the Respondent was only able
to ``mainly recall two people [whose] prescriptions were improper,''
one of which he ``found out later . . . was a very big drug dealer in
this area.'' Tr. 112-13. The Respondent's failure to fully grasp how
his diversion adversely impacted his community is a failure to accept
full responsibility for his actions.
---------------------------------------------------------------------------
\32\ It is startling that the Respondent couched his diversion
of Schedule II controlled substances as ``potentially'' harming
others when he also testified that he was diverting to a ``very big
drug dealer,'' thereby implicitly acknowledging the widespread
effect of his diversion. Tr. 112-13. Additionally, when testifying
that, were he to obtain a new DEA registration, he would not divert
drugs from his practice to his son, he also testified that he was
``almost thankful'' his son is ``in jail right now so I don't read
in the morning paper that he's dead.'' Tr. 118. Thus, while the
Respondent is intimately familiar with his own struggles with drug
addiction and that of his son, the fact that he couches his own
diversion as having ``potentially'' harmed others leads this
tribunal to conclude that he has not yet come to terms with his own
role in this country's opioid crisis.
---------------------------------------------------------------------------
Therefore, I do not find that the Respondent has demonstrated an
``unequivocal acceptance of responsibility'' for his actions. Jones
Total Health Care Pharmacy, L.L.C., 81 FR 79,201-02. Due to the fact
that this is the Respondent's second episode of addiction and the fact
that he used his DEA registration to divert controlled substances for a
period spanning several months, I do not have confidence in the
Respondent's statement that he ``can guarantee [he] would never, ever,
ever abuse that authority again.'' Tr. 81.\33\
---------------------------------------------------------------------------
\33\ Where a registrant has not accepted responsibility, it is
not necessary to consider evidence of the registrant's remedial
measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019) (citing
Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, L.L.C.,
81 FR 79,202-03 (2016)). [In this case, even if Respondent had
accepted responsibility, his remedial measures were inadequate.]
Although the Respondent stated he believes he is fully
rehabilitated, the tribunal is not entirely convinced the Respondent
is taking the necessary measures to maintain his sobriety long term.
He attended a few programs while incarcerated and on an outpatient
basis after his release from jail. Although he stated that he
attends NA meetings, by his own admission, he only does so when he
``feel[s] maybe a little stressed.'' Tr. 66. Furthermore, although
he has ``reviewed the standards for record keeping,'' ``purchased
keyed locks, key lockbox,'' and ``will acquire controlled substance
logbooks and keep meticulous records,'' he has not taken any classes
that relate to prescribing controlled substances. Tr. 85, 94.
Finally, the Respondent does not appear to have seriously considered
the Board's suggestions, when he was relicensed, that he attend
counseling and practice under the supervision of another
veterinarian. See supra at 9 n.19. Although the Respondent asserts
that he ``learned through education about addiction that it is a
lifelong condition,'' he does not appear to have in place an
adequate support system (such as participating in the Ohio
Physicians' Health Plan counseling) or an oversight structure (such
as operating his practice under direct supervision by a licensed
veterinarian) such that the tribunal has confidence he can be
entrusted with a registration. Tr. 80.
---------------------------------------------------------------------------
B. Egregiousness, Deterrence, and Lack of Candor
While a registrant must accept responsibility and demonstrate that
he will not engage in future misconduct in order to establish that his
continued registration is consistent with the public interest, DEA has
repeatedly held these are not the only factors that are relevant in
determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR
10,083, 10,094 (2009); Southwood Pharm., Inc., 72 FR 36,487, 36,502-04
(2007). The egregiousness and extent of a registrant's misconduct are
significant factors in determining the appropriate sanction. See Jacobo
Dreszer, 76 FR 19,386, 19,387-88 (2011) (explaining that a respondent
can ``argue that even though the Government has made out a prima facie
case, his conduct was not so egregious as to warrant revocation'');
Paul H. Volkman, 73 FR 30,630, 30,644 n.45 (2008).
Further, in determining whether and to what extent imposing a
sanction is appropriate, besides the egregiousness of the offenses
established by the Government's evidence, consideration must also be
given to the Agency's interest in both specific and general deterrence.
Ruben, M.D., 78 FR 38,385. Here, the egregiousness of the offense
favors denial of the application. The Respondent was convicted of ten
counts of Illegal Processing of Drug Documents. These ten illegal
prescriptions were for Schedule II controlled substances: Eight were
for hydromorphone/Dilaudid and two were for oxycodone/APAP. Gov't Ex. 7
at 14. The Respondent admitted that he diverted to numerous people, a
few of whom he could recall and two of whom he specifically identified
at the hearing. Tr. 112-13. The Respondent described one of these
individuals as someone that he ``found out later . . . was a very big
drug dealer.'' Tr. 112-13.
Considerations of specific and general deterrence in this case
militate in favor of denial of the application.\34\ As to specific
deterrence, this is not the Respondent's first bout with drug
addiction, having suffered from cocaine addiction in the 1990's and
having served a term of incarceration for possession of that drug.\35\
Thus, the Respondent has acknowledged his past history of drug
addiction, even going so far as to state he believes his ability to
become ``highly addicted'' is ``part of [his] personality.'' Tr. 121.
Thus, the interests of specific deterrence, even standing alone,
motivate powerfully in favor of the denial of the Respondent's
application.
---------------------------------------------------------------------------
\34\ I note that the Respondent did not include his 1997
conviction related to cocaine possession or his two-year veterinary
license suspension in the late 1990's in his liability question
responses. Gov't Ex. 2 at 1-2. However, because the Government did
not make any allegations regarding a material falsification of the
Respondent's application and also did not specifically rely on these
events for denial of the instant application, I have not considered
the previous conviction and license discipline except as historical
information to put the Respondent's 2015 conviction and loss of his
veterinary license into the proper context given his past
experience. Presumably, the Agency was aware of these incidents when
it granted the Respondent's previous application for registration in
2008--which the Respondent surrendered for cause in 2015. Gov't Ex.
2 at 1.
\35\ In the Respondent's mind, his cocaine addiction in the
1990's and his opiate addiction years later are unconnected and he
implies he could not have foreseen his later addiction to opiates
because he was ``never addicted to opiates'' and ``didn't go looking
for a new addiction.'' Tr. 121. The Respondent also took issue with
the tribunal's characterization of his opiate addiction as ``a
relapse.'' Tr. 122. The Respondent made similar statements to the
judge at his criminal sentencing in 2015 when the judge stated he
was concerned because the Respondent had a drug addiction earlier in
life and the Respondent replied ``I never had a (sic) opiate
problem.'' Gov't Ex. 8 at 16-17. The judge in the criminal
proceeding did not appear to accept this rationale, stating ``[y]ou
had an addictive problem'' and ``[y]ou know how addictive opiates
are. And you're an addict. Were and are.'' Gov't Ex. 8 at 17.
---------------------------------------------------------------------------
The interests of general deterrence compel a like result. As the
regulator in this field, the Agency bears the responsibility to deter
similar misconduct on the part of others for the protection of the
public at large. Ruben, 78 FR 38,385. Where the record demonstrates
that the Government has borne its burden and established that the
Respondent was convicted of a felony related to controlled substances
and abused his prescriptive privileges to actively divert controlled
substances to himself and others by writing prescriptions in the names
of purported
[[Page 4953]]
animal patients, the unmistakable message to the regulated community
would be that such conduct can be overlooked after a period of non-
registration. Although the Respondent surrendered for cause his
previous DEA registration in 2015,\36\ he was not eligible to reapply
for a new registration until January 2020, when he reacquired his state
veterinary license. The following month, he submitted his application
for a new DEA registration.\37\ At this time, the Respondent has been
without a DEA registration for nearly six years. I find that this is
not an insignificant period of time. However, based on the
egregiousness of the Respondent's behavior discussed above, I find that
the interests of general deterrence support the denial sought by the
Government.
---------------------------------------------------------------------------
\36\ Gov't Ex. 2 at 1.
\37\ The Respondent's COR application was submitted on February
3, 2020. Gov't Ex. 2 at 1.
---------------------------------------------------------------------------
Another factor that weighs significantly in favor of the denial
sanction sought by the Government is lack of candor. In making the
public interest determination, ``this Agency places great weight on [a
respondent's] candor, both during an investigation and in [a]
subsequent proceeding.'' Fred Samimi, M.D., 79 FR 18,698, 18,713 (2014)
(quoting Robert F. Hunt, D.O., 75 FR 49,995, 50,004 (2010)).
Although the Agency did not make any allegations regarding a lack
of candor by the Respondent during the investigation, in making my
credibility determination, as discussed above, I found discrepancies
between the Respondent's prior testimony to the court at his sentencing
hearing and statements made by the Respondent in this proceeding.
During the instant proceeding, the Respondent downplayed the scope and
extent of his drug use, contradicting statements he made at his
sentencing hearing that he was doing crack around the same time he
became addicted to opiates and disavowing his previously acknowledged
``almost daily'' use of marijuana by stating he was not using marijuana
because he ``was after something for [his] pain, not marijuana.'' Tr.
126. Other statements at the hearing that his son was not the recipient
of any of his diverted drugs again conflict with testimony he gave at
his sentencing hearing that his son received drugs that he diverted
from his false prescribing. Finally, I find that the Respondent's
initial testimony that he was not participating in the Ohio Physicians'
Health Plan counseling, due to its cost, exhibits a lack of candor
where the basis for his statement regarding cost was from when he
previously considered the program in the 1990's relating to his cocaine
addiction. I find that the Respondent's statement that the program was
too expensive for him to participate in demonstrated a lack of candor,
inasmuch as he later admitted he had no idea how the program is run
today and that he had not explored options regarding financial
assistance or other accommodations regarding cost. Hence, the
Respondent's lack of candor undermines the confidence that the Agency
can have in the Respondent's ability to be a responsible DEA
registrant.
For the above reasons, I find that the Respondent's misconduct is
egregious and that deterrence considerations and the Respondent's lack
of candor weigh in favor of revocation.
Considering the entire record before me, the conduct of the
hearing, and observation of the testimony of the witnesses presented, I
find that the Government has met its burden of proof and has
established a prima facie case for denial of the Respondent's
application for registration. Furthermore, I find that the Respondent
has failed to meet his burden to overcome the Government's case. While
the Respondent is to be commended for rebuilding his veterinary
practice and while the testimony of his three character witnesses leads
me to conclude that the Respondent is a caring and capable
veterinarian, *\E\ I cannot overlook the egregiousness of his offenses,
his failure to unequivocally accept responsibility, and the need for
specific and general deterrence in this case, each of which, even
standing alone, provides a compelling reason for denial of the
application.
---------------------------------------------------------------------------
*\E\ See Raymond A. Carlson, 53 FR 7425 (1988) (finding that
none of the character ``witnesses was in a position to make an
adequate assessment of [r]espondent's ability to properly handle
controlled substances.'').
---------------------------------------------------------------------------
Therefore, I recommend that the Respondent's application for a DEA
registration, Control No. W20010614C, be Denied and any pending
applications for other DEA registrations likewise be Denied.
[GRAPHIC] [TIFF OMITTED] TN31JA22.000
Respondent's Exceptions
On July 26, 2021, Respondent filed his Exceptions to the
Recommended Decision. DEA regulations require that Exceptions ``include
a statement of supporting reasons for such exceptions, together with
evidence of record (including specific and complete citations of the
pages of the transcript and exhibits) and citations of the authorities
relied upon.'' 21 CFR 1316.66. For the most part, Respondent's
Exceptions not only fail to comply with this regulatory requirement,
but also lack evidentiary support in the Administrative Record.
Additionally, some of Respondent's Exceptions repeat arguments that
were already raised throughout the proceedings and were adequately
addressed in the adopted Recommended Decision. Therefore, I reject
Respondent's Exceptions and adopt the Recommended Decision of the ALJ
as amended above.
Exception 1
In his first Exception, Respondent argues that the ALJ failed to
properly consider Factor One in the public interest analysis under 21
U.S.C. 823(f)(1). Respondent's Exceptions, at 1. Respondent argues that
``by granting [Respondent] a license to practice medicine and surgery
in the State of Ohio after he surrendered it due to the criminal
matter, the Ohio Veterinary Medical Licensing Board has given their
stamp of approval for [Respondent] to
[[Page 4954]]
use [sic] controlled substances in Ohio'' and that ``the Tribunal
should have taken this into consideration.'' Id.
In determining the public interest under Factor One, the
``recommendation of the appropriate State licensing board or
professional disciplinary authority . . . shall be considered.'' 21
U.S.C. 823(f)(1). ``Two forms of recommendations appear in Agency
decisions: (1) A recommendation to DEA directly from a state licensing
board or professional disciplinary authority (hereinafter, appropriate
state entity), which explicitly addresses the granting or retention of
a DEA COR; and (2) the appropriate state entity's action regarding the
licensure under its jurisdiction on the same matter that is the basis
for the DEA OSC.'' John O. Dimowo, M.D., 85 FR 15,800, 15,809 (2020);
see also Vincent J. Scolaro, D.O., 67 FR 42,060, 42,065 (2002) (``While
the State Board did not affirmatively state that the Respondent could
apply for a DEA registration, [the ALJ] found that the State Board by
implication acquiesced to the Respondent's application because the
State Board has given state authority to the Respondent to prescribe
controlled substances.''). It is the Administrator who makes a
determination of whether granting a registration is in the public
interest as defined by the CSA, and the Administrator's purview is
focused on entrusting Respondent with a controlled substances
registration. See Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019).
In Respondent's case, contrary to Respondent's Exception, the ALJ
did consider in his Factor One analysis that the Board was aware of
Respondent's history of drug use and addiction and nonetheless
reinstated Respondent's Ohio veterinary license without restriction.
RD, at 19 n.31. As such, the ALJ found that Factor One leaned in favor
of Respondent. Id.
Ultimately, the ALJ found, and I agree, that Factors Two, Three,
and Four militate strongly in favor of the Government's position that
granting the Respondent a DEA registration is inconsistent with the
public interest. Accordingly, I find Respondent's assertion that the
ALJ did not take the unrestricted reinstatement of Respondent's
veterinary license into consideration in the Factor One analysis to
lack merit.
Exception 2
In his second Exception, Respondent argues that the ALJ improperly
interpreted Respondent's nervous demeanor as a lack of remorse or a
``conditional remorse,'' citing the ALJ's analysis of Respondent's
acceptance of responsibility. Respondent's Exceptions, at 1-2; see RD,
at 23-25. However, in his analysis regarding Respondent's acceptance of
responsibility, the ALJ made no reference whatsoever to Respondent's
demeanor or nervousness. RD, at 23-25. Instead, the ALJ found that
Respondent had not demonstrated an unequivocal acceptance of
responsibility because Respondent's testimony itself demonstrated that
he was ambivalent regarding the extent of his wrongdoing, consistently
placed the blame of his addiction on others, and was primarily
regretful for how his misconduct had affected his own life rather than
the community at large. Id. Accordingly, I find Respondent's argument
that the ALJ improperly interpreted Respondent's demeanor in the
analysis of Respondent's acceptance of responsibility to lack merit. I
credit Respondent's honest acknowledgment of his nerves during the
proceeding. Tr. 81.
In spite of Respondent's commendable sobriety thus far, I have
reason to doubt his claim that he would always be a compliant
registrant. See George R. Smith, M.D., 78 FR 44,972, 44,980 (2013).
Particularly, I remain concerned that if he relapsed, which the record
has demonstrated previously occurred, while entrusted with a controlled
substances registration, he could harm himself and others too quickly
for detection by this Agency or his monitoring. See Robert Wayne
Locklear, M.D., 86 FR 33,745. Ensuring that a registrant is trustworthy
to comply with all relevant aspects of the CSA without constant
oversight is crucial to the Agency's ability to complete its mission of
preventing diversion within such a large regulated population. Jeffrey
Stein, M.D., 84 FR 46,974.
Exception 3
In his third Exception, Respondent argues that ``[t]he Tribunal
gave too much weight to the DI [K.P.]'s opinions about [Respondent's]
work on his addiction.'' Respondent's Exceptions, at 2. Respondent also
argues that ``[t]here was no reason to include this as part of the
Government's case'' and that ``there was no reason for the Tribunal to
challenge [Respondent] about the Ohio Physicians' Health Plan.'' Id.
However, where the Government has met its prima facie burden of showing
that a ground for revocation exists, the burden shifts to the
Respondent to show why he can be entrusted with a registration. See
Jeffrey Stein, M.D., 84 FR 46,968, 46,972 (2019). As such, because the
Respondent presented evidence of his remedial measures in order to meet
this burden, it was entirely relevant to the adjudication of this
matter and appropriate for the Government to present its own evidence
pertaining to Respondent's remedial measures, as well as for the ALJ to
question Respondent regarding these remedial measures.
Moreover, in his third Exception, Respondent again argues the
significance of the Board reinstating his license without restriction.
Respondent's Exceptions, at 2. As already discussed supra, the ALJ
adequately addressed this point in his public interest Factor One
analysis. Accordingly, I find the claims made in Respondent's third
Exception to lack merit.
Exception 4
In his fourth Exception, Respondent argues that rather than an
unrestricted DEA registration, he should instead be granted a limited
DEA registration ``to utilize a limited number of [S]chedule III or
lower substances.'' Respondent's Exceptions, at 2. However, Respondent
does not provide adequate substantiation as to why I should accept this
proposal, nor is there sufficient evidence in the Administrative Record
to support it. Moreover, Respondent has not adequately demonstrated
that he can be entrusted with a controlled substance registration at
any schedule. See Larry C. Daniels, M.D., 86 FR 61,630, 61,664 n.30
(2021). Accordingly, I find Respondent's argument that he should be
granted a limited DEA registration to lack merit.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby deny the pending
application for a Certificate of Registration, Control Number
W20010614C, submitted by Michael E. Smith, D.V.M., as well as any other
pending application of Michael E. Smith, D.V.M., for additional
registration in Ohio. This Order is effective March 2, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022-01840 Filed 1-28-22; 8:45 am]
BILLING CODE 4410-09-P