Trenton F. Horst, D.O.; Decision and Order, 41079-41092 [2015-17309]
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The facts in Volkman pertaining to record
keeping violations involved a doctor who
‘‘rapidly became the largest practitionerpurchaser in the nation of oxycodone’’ which
included ordering ‘‘hundreds of thousands of
dosage units of these drugs’’ over time
periods as short as several months. Id. at
30,643. The facts in Volkman further
reflected that no dispensing logs were
maintained, at times exceeding an entire
year. Id. at 30,645.
Additionally, where a registrant has
committed acts inconsistent with the public
interest, a registrant must accept
responsibility for his or her actions and
demonstrate that he or she will not engage in
future misconduct. Patrick W. Stodola, 74 FR
20,727 (DEA 2009). Also, ‘‘[c]onsideration of
the deterrent effect of a potential sanction is
supported by the CSA’s purpose of protecting
the public interest.’’ Joseph Gaudio, 74 FR
10,083, 10,094 (DEA 2009).
The Respondent testified in substance that
she updated her new registration address
with Texas authorities, made various efforts
to do so with DEA including receiving
correspondence, and therefore thought she
had satisfied her obligation. (Tr. 161–63; ALJ
Ex. 2.) Respondent’s explanation for record
keeping violations is less specific. The
Respondent’s testimony as a whole
demonstrated that she understood the
seriousness and importance of record
keeping requirements, and testified that
while at the temporary Collier street location
‘‘I didn’t have those little DEA 222s, so I
really didn’t purchase any scheduled
medications during that brief period of time.’’
(Tr. 197.) The Respondent also testified that
she believed she ‘‘had very effective
oversight’’ of controlled substances.’’ (Tr.
248.) This belief is contradicted by
Respondent’s own testimony. Respondent
also testified that she relied heavily on her
staff with regard to inventory and
maintenance of controlled substances, and
that Respondent did very little herself. (Tr.
205.) The evidence of record does
demonstrate, however, that Respondent’s
errors were often due to lack of knowledge,
omission or neglect, rather than a deliberate
violation of the record keeping requirements.
The alleged conduct supported by
substantial evidence in this case centers on
Respondent’s record keeping violations,
which have been documented to be deficient
over a relatively short period of time, as well
as a failure to update her registered address,
and improper acceptance and disposal of
returned controlled substances from patients.
The Government argues in its post-hearing
brief that revocation is the appropriate
remedy in this case. An agency’s choice of
sanction will be upheld unless unwarranted
in law or without justification in fact. A
sanction must be rationally related to the
evidence of record and proportionate to the
error committed. See Morall v. DEA, 412 F.3d
165, 181 (D.C. Cir. 2005) (sanction will be
upheld unless unwarranted in law or without
justification in fact).
In support of its recommendation for
revocation, the Government cites Paul H.
Volkman, 73 FR 30,630, 30,644 (DEA 2008),
which is significantly distinguishable from
the facts of this case. Respondent’s conduct
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in this case occurred over a comparatively
short period of time, with substantially fewer
controlled substances, and with no evidence
of actual diversion of any controlled
substances. The Government cites no other
precedent to support a revocation sanction
on facts similar to Respondent’s, nor does
there appear to be any. The Respondent’s
errors and conduct clearly were neglectful
and serious during the relevant time period,
and likely due in part to ongoing issues
including eviction from her registered office,
employee problems, and an office break-in
and theft, among other factors. That said, a
revocation penalty is simply not rationally
related to the evidence of record established
by substantial evidence or proportionate to
Respondent’s misconduct.
I find that Respondent’s testimony as a
whole demonstrates that she has sufficiently
accepted responsibility for her actions and
omissions with regard to a revocation
penalty, but Respondent’s explanation of past
errors and demonstrated plan to avoid future
violations is insufficient to support an
unconditional registration. Accordingly, I
recommend that Respondent’s COR
BC0181999 as a practitioner not be revoked
or a pending application denied, on the
condition that Respondent: a) within a
reasonable period of time as set forth in the
agency’s final order in this matter, satisfy the
appropriate DEA designee that Respondent
has state authority to handle controlled
substances in Texas, the state in which she
is registered with DEA; 65 b) submit to the
nearest Field Division Office of DEA no later
than one (1) year after issuance of a DEA
COR, documentation reflecting successful
completion of accredited training at
Respondent’s expense, in the proper
maintenance, inventory, and record-keeping
requirements for controlled substances, with
such training to take place after the Agency
issues a final order in this matter; and c) for
one (1) year after the issuance of a COR,
Respondent shall submit to the nearest Field
Division Office of DEA, on a quarterly basis,
a log of all controlled substances in
Schedules II, III, IV and V received,
maintained and dispensed by Respondent.
Dated: October 26, 2010
s/ Timothy D. Wing,
Administrative Law Judge
[FR Doc. 2015–17310 Filed 7–13–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 13–24]
Trenton F. Horst, D.O.; Decision and
Order
On March 25, 2014, Administrative
Law Judge Gail A. Randall (ALJ) issued
the attached Recommended Decision.1
U.S.C. 824(a)(3).
citations to the Recommended Decision
(R.D.) are to the ALJ’s slip opinion as originally
issued.
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The Government filed Exceptions to the
Recommended Decision.
Having reviewed the record in its
entirety, I have decided to adopt the
ALJ’s findings of fact and conclusions of
law.2 However, for reasons explained
below, I respectfully amend the ALJ’s
recommended sanction because it is
contrary to precedent and, in my
opinion, gives insufficient weight to the
Agency’s interest in deterring
intentional diversion, both on the part
of Respondent and the community of
registrants. See David A. Ruben, 78 FR
38363, 38386 (2013). A discussion of the
Government’s Exceptions follows.
The Government’s Exceptions
The Government raises two
exceptions to the ALJ’s recommended
decision: First, it takes exception to the
ALJ’s finding that Respondent ‘‘ ‘has
sufficiently accepted responsibility for
his actions and instituted remedial
measures to ensure that the misconduct
will not reoccur.’ ’’ Exceptions, at 2
(quoting R.D. 36). Second, it argues that
the ALJ’s recommended sanction is
inconsistent with agency precedent.
Exceptions, at 5–6.
As for the first exception, the
Government urges that I reject this
finding, contending that Respondent
‘‘continues to[] minimize the nature of
his misconduct.’’ Id. at 4–5. As support
for its contention, the Government cites
Respondent’s testimony regarding his
treatment at a rehabilitation center
which it maintains was inconsistent
with his conduct during his stay. More
specifically, the Government notes
Respondent’s testimony that:
it was a little bit difficult to acclimate myself
for the first few weeks, probably six weeks.
It took me a while to kind of get into the flow
of things. Thereafter, I’d like to think I
became a model participant. I spent seven
months there.
Tr. 210. The Government then notes
that Respondent was subject to a ‘‘no
female contract’’ during the initial four
months of his treatment, and that he
breached the contract when he had
contact with another patient and
engaged in sexual relations with her
2 As ultimate factfinder, I am familiar with my
obligations under the Administrative Procedure Act
and the role of the ALJ’s recommended decision.
See Universal Camera Corp. v. NLRB, 340 U.S. 474,
496 (1951) (‘‘The ‘substantial evidence’ standard is
not modified in any way when the Board and its
examiner disagree . . . . The findings of the
examiner are to be considered along with the
consistency and inherent probability of testimony.
The significance of his report, of course, depends
largely on the importance of credibility in the
particular case.’’) (emphasis added). So too, the
courts are quite familiar with the standard of review
of an Agency decision. Accordingly, I decline to
publish the ALJ’s discussion of the substantial
evidence test and the standard of review.
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approximately two months into his stay.
Exceptions, at 2. The Government
implies that his testimony was
disingenuous because the incident
occurred two weeks later than
Respondent claimed it did. Id. The
Government does not, however, explain
why it matters whether the incident
occurred six weeks or two months into
his stay.
The Government also maintains that
Respondent engaged in a pattern of
minimizing his misconduct, both during
his time in treatment and in his
testimony at the hearing. In support of
this contention, it cites evidence
showing that Respondent admitted his
breach of the no-female contract to the
treatment center staff only upon
learning that he was going to be subject
to a polygraph. As for his testimony, the
Government argues that ‘‘Respondent
did not divulge that he broke [the]
contract . . . on direct examination.’’ Id.
at 3. It then argues that even on crossexamination, Respondent failed to
truthfully answer its questions because
he did not admit to having sexual
relations with the female patient until
he was specifically asked if he had sex
with female patients.3 However, when
the Government specifically asked the
question, he did answer it truthfully.
Most significantly, to the extent the
Government relies on this incident and
Respondent’s testimony regarding it to
contend that he ‘‘has consistently
minimized his misconduct,’’
Exceptions, at 5; its argument is
misplaced. As the Government
acknowledges, the incident and his
testimony ‘‘ha[ve] little or nothing to do
with controlled substances.’’ Id. at 2
(emphasis added). Nor does the
Government cite to any case holding
that an applicant’s breach of the terms
of a treatment contract, which does not
3 The Government initially asked Respondent:
‘‘How did you break that contract?’’ Tr. 263.
Respondent answered that he was ‘‘a friendly
person, and they would approach me, and it’s kind
of hard when people talk to you, to not talk to them,
to completely ignore them.’’ Id. While this may not
have been the answer the Government was seeking,
there is no evidence that Respondent’s answer was
untruthful.
Following this, the Government asked
Respondent: ‘‘Did you do more than speaking with
females?’’ Id. Respondent answered:
I had basically what could be called a girlfriend.
She was very attentive to me, which I was
appreciative of. My marriage was likely in ruins,
and it was something that was—it was nice to have
someone to talk to. And once that was—basically
once that was discovered, I was placed on my nofemale contract, and—well, actually I was on my
no-female contract when that was discovered, and
basically I got reprimanded and eventually I got my
act together.
Id. at 264. Here again, this may not have been the
answer the Government was seeking, but there is no
evidence that it was untruthful.
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involve a violation of the Controlled
Substances Act or applicable state law
(as would failing a drug test), constitutes
conduct which may threaten public
health or safety. Cf. Mark G. Medinnus,
78 FR 62683, 62684 (2013) (rejecting
contention that violation of internal
clinic operating policy, which did not
otherwise violate CSA or state law,
constituted conduct inconsistent with
the public interest.).
Because Respondent’s breach of his
no-female contract does not constitute
actionable misconduct under the public
interest standard, his testimony
regarding the incident is not relevant in
assessing whether he has accepted
responsibility for his misconduct. While
this evidence is arguably relevant in
assessing Respondent’s claim that he
has been rehabilitated, it is undisputed
that he successfully completed inpatient
treatment, that he has been in
compliance with his Oklahoma Health
Professionals Program contract, and that
he passed all of his random drug tests.
RX 2.
There is, however, evidence that
supports the Government’s contention
that Respondent does not fully
acknowledge his misconduct. As
ultimate fact-finder, I am not bound by
the Government’s failure to cite this
evidence which I conclude is properly
considered in reviewing the
Government’s contention that the ALJ’s
recommended sanction is inconsistent
with agency precedent.
The ALJ found that Respondent not
only abused methamphetamine, but that
he also wrote prescriptions for
controlled substances for A.B., his thengirlfriend (and fellow
methamphetamine abuser), as well as
for S.M. and Z.M., who were two of her
friends. With respect to A.B., the
evidence showed that between July 29,
2010 and September 12, 2011,
Respondent issued her 15 prescriptions
for Lortab 7.5mg and 10mg (then a
schedule III controlled substance 4
which combines hydrocodone and
acetaminophen), as well as one
prescription for both Xanax (alprazolam,
a schedule IV drug) and promethazine
with codeine cough syrup (schedule V).
Moreover, the Lortab prescriptions,
which ranged from 40 to 80 tablets,
authorized 28 refills. In total, the
prescriptions, with refills, provided A.B.
with approximately 2,540 tablets of
hydrocodone.
4 Combination hydrocodone products have since
been placed in schedule II of the Controlled
Substances Act. See Schedules of Controlled
Substances: Rescheduling of Hydrocodone
Combination Products from Schedule III to
Schedule II, 79 FR 49661 (2014).
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With respect to S.M., at a minimum,
the evidence showed that Respondent
issued him a prescription for 60 tablets
of hydrocodone/apap with three refills.5
See GX 13. As for Z.M., the evidence
shows that Respondent issued him a
prescription for 40 tablets of Lortab 7.5
with two refills. GX 14.
Respondent did not dispute that he
failed to perform a physical exam on
A.B., S. M., and Z.M., or that the
prescriptions were improper. Indeed, he
testified that: ‘‘[i]mproper, I think, is a
weak word. I think it was stupid. I think
you used the word ‘idiotic’ earlier.’’ Tr.
201 (testimony regarding prescriptions
to A.B.); see also id. at 203 (admitting
that the prescriptions to S.M. and Z.M.
were ‘‘very improper’’).
While Respondent also asserts that he
received no monetary gain from writing
these prescriptions, see Tr. 204, this is
irrelevant. What is relevant is that
Respondent knowingly and improperly
diverted controlled substances to three
individuals, including his girlfriend
A.B., whom he knew was a drug abuser.
Further, while Respondent
acknowledged that the prescriptions
were improper, he then maintained that
he prescribed to A.B. ‘‘out of
compassion’’ because ‘‘[s]he was in
pain.’’ Id. at 252. And he further
asserted that she did not ‘‘use
hydrocodone as a drug of choice, as far
as recreational drugs’’ because ‘‘[s]he
was a methamphetamine addict.’’ Id. at
253.
The ALJ rejected the Government’s
contention that Respondent’s testimony
was an attempt to minimize his
misconduct. According to the ALJ,
‘‘[w]hile the reasons Respondent gave
for prescribing hydrocodone to A.B.
certainly do not justify his improper
methods of prescribing, they also do not
represent an attempt to minimize or
rationalize his behavior.’’ R.D. at 35. In
the ALJ’s view, this was so because
Respondent prefaced this testimony
with ‘‘his statement that ‘it was
improper and I admit that.’’’ Id. (quoting
Tr. 252).
Read more broadly, however, his
testimony most certainly was an attempt
to minimize his misconduct. Indeed, on
further questioning, Respondent
testified that:
5 The record includes three documents from
Walgreens which have the caption: ‘‘Audit/Board of
Pharmacy Inspection Report.’’ While each of the
documents contains a copy of a prescription issued
by Respondent on January 27, 2011, each document
lists a different prescription number, a different
store number, and a different sold date. GX 13.
Thus, it is unclear whether two of the documents
were simply refills of the original prescription or
whether Respondent issued S.M. multiple
prescriptions on the same date.
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. . . . I’m exquisitely sorry that I ever
prescribed these things, these medicines for
these people. You know, I know that I did
it improperly. I know I didn’t have proper
documentation. Deep down, when I was
writing them, I knew better.
Id. at 258 (emphasis added).
Continuing, Respondent testified that:
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Deep down, whenever I was writing them,
I knew better. I let my heart and my empathy
get the best of me, more than my brain. I
know better now. I’ve gone through extensive
counseling, extensive instruction, boundaries
course times two, to understand what my
infractions were.
Id. (emphasis added).
Contrary to Respondent’s assertion,
this was not simply a matter of not
having proper documentation to support
the prescriptions. Notably, while the
ALJ apparently credited his testimony
that A.B. was in pain, noting that this
testimony ‘‘went unrebutted,’’ see R.D.
at 35, the evidence shows that while
Respondent prescribed to A.B for more
than one year, he made no claim that he
ever conducted a physical exam on her
or performed any diagnostic tests to
determine whether she legitimately had
pain or whether her pain warranted the
prescribing of controlled substances.
See Tr. 172–74 (testimony of
Government’s expert that the
hydrocodone prescriptions lacked a
legitimate medical purpose and were
issued outside of the usual course of
professional practice).
As for his assertion that he prescribed
‘‘out of compassion’’ and ‘‘empathy,’’
this too is amply refuted by his failure—
over the course of more than one year—
to take appropriate steps to determine
the source of her purported pain. And
given his acknowledgement that he
knew early in his relationship with A.B.
that she was a meth addict, his claim
that he prescribed to her ‘‘out of
compassion’’ begs the question of why
he did not usher her into treatment.6
Respondent also justified A.B.’s
hydrocodone prescriptions on the
ground that she did not ‘‘use
hydrocodone as a drug of choice, as far
as recreational drugs’’ because ‘‘[s]he
was a methamphetamine addict.’’ Id. at
253. Apparently the possibility that A.B.
could also have been abusing
hydrocodone to bring her down from
the meth she abused or was selling the
drug to support her meth addiction
never dawned on him.
6 Even assuming that the ALJ credited
Respondent’s testimony that A.B. was in pain, see
R.D. at 33, because it was undisputed that he lacked
a legitimate medical purpose and acted outside of
the usual course of professional practice in issuing
the prescriptions to her, I decline to give this
testimony any weight. Indeed, the ALJ later found
that the prescriptions ‘‘clearly constitute intentional
diversion.’’ Id. at 35.
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Finally, Respondent attempted to
rationalize his prescribing to A.B. on the
ground that he did not understand the
boundaries applicable to the practice of
medicine. Id. However, this excuse does
not explain his decision to prescribe
controlled substances to both S.M. and
Z.M. Indeed, it is unclear what his
excuse is for prescribing to S.M. and
Z.M.
Thus, this does not strike me as an
‘‘unequivocal acceptance of
responsibility for his misconduct.’’ R.D.
at 36. I need not, however, reject the
ALJ’s finding that ‘‘Respondent has
sufficiently accepted responsibility for
his actions’’ because as the ALJ properly
noted, ‘‘[e]ven when a respondent is
genuinely remorseful and has instituted
sufficient remedial measures,’’ DEA has
‘‘impose[d] sanctions to deter egregious
violations of the CSA’’ and ‘‘has placed
special emphasis on the need to deter
intentional diversion of controlled
substances.’’ Id. at 36 (citing David A.
Ruben, 78 FR 38363, 38386–87 (2013);
Joseph Gaudio, 74 FR 10083, 10094–95
(2009)).
The ALJ noted that ‘‘Respondent’s
improper prescriptions to A.B., S.M.,
and Z.M. clearly constitute intentional
diversion.’’ R.D. at 37. I agree. So too,
she noted that while his ‘‘improper
prescribing practices were limited to
A.B. and a few of her friends, under
DEA precedent they clearly warrant
sanctions to deter Respondent and
others from repeating the practice.’’ Id.
Again, I agree.
The ALJ also noted ‘‘[w]here the
respondent intentionally diverted
controlled substances, the Agency
required the respondents to periodically
submit logs of all controlled substances
they prescribe and suspended [their]
registrations for a period of time
commensurate with the severity of the
misconduct.’’ Id. at 38 (citing Ruben,
also citing Michael S. Moore, 76 FR
45867, 45868 (2011), and Gregory D.
Owens, 74 FR 36751, 36757–58 (2009))
(emphasis added). Yet notwithstanding
that she found Respondent’s
prescriptions ‘‘troubling to say the
least,’’ id. at 37, the ALJ recommended
no period of suspension.
The ALJ offered no explanation as for
why she believed a period of outright
suspension is unwarranted. To be sure,
earlier in her decision, the ALJ opined
that the Agency ‘‘has granted
registrations with restrictions to
respondents whose misconduct was
more egregious and/or lasted longer
than the misconduct of Respondent
here.’’ Id. (citing Ruben, Owens, Moore,
and Roger D. McAlpin, 62 FR 8038, 8040
(1997)).
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Yet in both Ruben and Moore, the
Agency suspended each respondent’s
registration for a period of one year. As
for the ALJ’s assertion that the
respective registrant’s misconduct in
each of these cases was more egregious
than Respondent’s, that is certainly true
with respect to Ruben. But Respondent’s
misconduct in knowingly diverting
controlled substances to three persons,
including his girlfriend to whom he
provided some 2,540 dosage units of
hydrocodone and did so knowing that
she was meth addict, is itself,
sufficiently egregious to warrant a
suspension for a period of one year. As
for Moore, while the physician’s
misconduct in growing marijuana for
his own and his wife’s use was certainly
egregious, there was inconclusive
evidence as to whether he knowingly
distributed it to others; thus, it is
debatable whether his misconduct was
more egregious than Respondent’s.
As for Owens, the ALJ asserted that
the Agency ‘‘grant[ed] a registration to a
respondent who prescribed controlled
substances for seven years based on an
expired registration.’’ R.D. at 37.
However, the actual decision to grant a
registration to Dr. Owens
notwithstanding the above-described
misconduct had been made in a
proceeding which was resolved seven
years earlier and there was no evidence
that he was diverting controlled
substances. See Gregory D. Owens, 67
FR 50461 (2002). So too, the misconduct
which gave rise to the second Owens
decision did not involve the diversion
of controlled substances and was
comparatively minor.7
Moreover, the 2002 Owens order
predates the Agency’s decision in
Southwood Pharmaceuticals, Inc., 72 FR
36487, 36504 (2007), which held for the
first time that notwithstanding the
remedial nature of proceedings under 21
U.S.C. 823 and 824, the Agency can
consider the need to deter similar acts
on the part of both the individual
registrant/applicant and the community
of registrants. Indeed, this Agency
recently denied a physician’s
application for a new registration based,
in substantial part, on his issuance of
prescriptions after his registration had
expired. See Anthony E. Wicks, 78 FR
7 As for the conduct which gave rise to the second
Owens proceeding, Dr. Owens was found to have
not complied with the 2002 order because he failed
to file a quarterly drug activity log during a fourmonth period between September 3 and December
31, 2002, and failed to report a 2005 state board
action. 74 FR at 36756–58. While Dr. Owens’
misconduct was considerably less egregious than
that involving the intentional diversion of
controlled substances, the Agency nonetheless
suspended his registration outright for a period of
three months. Id. at 36758.
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62676, 62678 (2013); see also Linda Sue
Cheek, 76 FR 66972 (2011) (denying
application based, in part, on
physician’s issuance of prescriptions
without being registered). For the same
reason, I respectfully disagree with the
ALJ’s reliance on McAlpin.
Accordingly, notwithstanding that I
do not reject the ALJ’s finding that
Respondent has ‘‘sufficiently accepted
responsibility for his actions’’ and has
produced evidence of his remedial
efforts, R.D. at 36, I conclude that the
ALJ’s recommended order fails to give
appropriate weight to the Agency’s
substantial interest in deterring the
intentional diversion of controlled
substances. While I will grant
Respondent’s application, consistent
with similar cases, I will order that his
registration be suspended outright for a
period of one year. See Ruben, 78 FR at
38386 (imposing one-year suspension
based on acts of intentional diversion
notwithstanding ALJ’s finding that
registrant accepted responsibility for his
misconduct and undertook remedial
training); Gaudio, 74 FR at 10095
(imposing one-year suspension based on
acts of intentional diversion and
holding renewal application in
abeyance pending registrant’s
acknowledgement of his misconduct);
Jayam Krishna-Iyer, 74 FR 459, 463
(2009) (imposing one-year suspension
based on acts of intentional diversion
where registrant acknowledged her
misconduct).8
Moreover, upon the completion of the
suspension, Respondent’s registration
shall be subject to the following
conditions for a period of two years:
Respondent shall keep a log of all
controlled substances he prescribes on a
monthly basis for each calendar month.
The log shall list each prescription in
chronological order; the patient’s name
and address; the name, quantity,
strength and dosing instructions for
each drug prescribed; and the number of
refills authorized. Respondent shall
submit a copy of the log to the local
DEA Field Office no later than five
business days following the last day of
each month.
In the event Respondent opens his
own practice, he shall consent to
unannounced inspections of his
registered location and waive his right
8 The scope of Respondent’s unlawful
prescribings far exceeds those of Dr. Krishna-Iyer,
who wrote unlawful prescriptions during three
undercover visits. See Jayam Krishna-Iyer, 71 FR
52148, 52158 (2006). Moreover, this Agency has
held that proof of a single act of intentional
diversion can support the denial of an application
or the revocation of an existing registration. See
Dewey C. MacKay, 75 FR 49956, 49977 (2010), pet.
for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th
Cir. 2011).
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to require DEA personnel to obtain an
administrative inspection warrant prior
to conducting an inspection.
Respondent shall not prescribe any
controlled substances to himself, a
family member, or any person with
whom he has or had a personal or
romantic relationship.
Respondent shall have no intentional
contact with A.B., S.M., or Z.M.
Respondent shall notify the local DEA
Field Office of the results of any drug
test he fails, no later than three business
days after receiving notification of
having failed any such test. This
condition shall apply whether the test
in conducted by the Oklahoma Board of
Osteopathic Examiners, the Oklahoma
Health Professions Program, any other
licensing authority, any hospital at
which he seeks or obtains privileges, or
any other employer.
Respondent shall further notify the
local DEA Field Office in the event that
the Oklahoma Board of Osteopathic
Examiners or the Oklahoma Bureau of
Narcotics and Dangerous Drug Control
(or any other licensing authority)
initiates any proceeding, or imposes
sanctions against his medical license or
state controlled substance registration
respectively. Respondent shall make
such notification no later than three
business days upon being notified of
any such action, regardless of whether
he has been formally served with either
a complaint or order issued by any such
agency.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b), I order that the application of
Trenton F. Horst, D.O., for a DEA
Certificate of Registration as a
practitioner, be, and it hereby is, granted
subject to the conditions set forth above.
I further order that Respondent’s
Certificate of Registration be, and it
hereby is, suspended for a period of one
year. This Order is effective
immediately.
Dated: July 6, 2015.
Chuck Rosenberg,
Acting Administrator.
Dedra S. Curteman, Esq., for the
Government.
Spencer B. Housley, Esq., for the
Respondent.
RECOMMENDED RULINGS, FINDINGS
OF FACT, CONCLUSIONS OF LAW,
AND DECISION OF THE
ADMINISTRATIVE LAW JUDGE
I. INTRODUCTION
Gail A. Randall, Administrative Law
Judge. This proceeding is an
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adjudication pursuant to the
Administrative Procedure Act, 5 U.S.C.
551 et seq., to determine whether the
Drug Enforcement Administration
(‘‘DEA’’ or ‘‘Government’’) should
deny 1 a physician’s application for a
DEA Certificate of Registration pursuant
to 21 U.S.C. 823(f) (2006). Without his
registration, the physician, Trenton F.
Horst, D.O. (‘‘Respondent’’ or ‘‘Dr.
Horst’’), would be unable to lawfully
prescribe, dispense or otherwise handle
controlled substances in the course of
his medical practice.
II. PROCEDURAL HISTORY
The Deputy Assistant Administrator,
Drug Enforcement Administration
(‘‘DEA’’ or ‘‘Government’’), issued an
Order to Show Cause (‘‘Order’’) dated
February 27, 2013, proposing to revoke 2
the DEA Certificate of Registration, No.
BH9311604, of Respondent, as a
practitioner, pursuant to 21 U.S.C.
824(a)(3)–(4), and deny any pending
applications for renewal or modification
of such registration because Respondent
does not ‘‘have authority to handle
controlled substances in the State of
Oklahoma’’ and because the
Respondent’s continued registration
would be inconsistent with the public
interest, as that term is used in 21 U.S.C.
823(f). [Administrative Law Judge
Exhibit (‘‘ALJ Exh.’’) 1 at 1].
Specifically, the Order alleged that
Respondent was ‘‘registered with the
DEA as a practitioner in Schedules II–
V under DEA registration BH9311604 at
St. Mary’s Physician Associates, LLC,
330 South Fifth Street, Suite 103, Enid,
Oklahoma 73701.’’ [Id.]. The Order
further alleged that Respondent was
without authority to handle controlled
substances in the state of Oklahoma,
which is the state that listed on his DEA
1 DEA regulations and precedent clearly establish
that ‘‘a registrant, who has been served with an
Order to Show Cause, [must] file his renewal
application at least 45 days before the expiration of
his registration, in order for it to continue in effect
past its expiration date and pending the issuance of
a final order by the Agency.’’ Paul Weir Battershell,
N.P., 76 FR 44359, 44361 (DEA 2011) (citing Paul
Volkman, 73 FR 30,630, 30,641 (DEA 2008)); 21
CFR 1301.36(i). Respondent’s Certificate of
Registration, Number BH9311604, expired by its
own terms on October 31, 2013, about eight months
after the Order to Show Cause was served, and
Respondent did not apply for renewal until October
31, 2013. [ALJ Exh. 14]. Thus, Respondent’s
application for renewal will be considered an
application for registration. See Battershell, 76 FR
at 44,361 (holding that although the registration had
expired, the renewal application may be
considered). Accordingly, the issue in this case is
whether DEA should grant Respondent’s
application, not whether DEA should revoke his
registration.
2 As explained supra note 1, the issue is whether
the DEA should grant Respondent’s application, not
whether his registration should be revoked, as the
Order to Show Cause suggests.
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Certificate Of Registration (‘‘COR’’),
since his Oklahoma Bureau of Narcotics
(‘‘OBN’’) registration expired on October
31, 2011. [Id.]. The Order further alleged
that Respondent’s state osteopathic
license was suspended 3 on June 21,
2012, for a period of five years, by the
Oklahoma State Board of Osteopathic
Examiners (‘‘Oklahoma State Board’’).
[Id. at 2]. Thus, the Order stated that the
DEA must revoke Respondent’s DEA
registration because he lacks authority
to handle controlled substances in the
state of Oklahoma. [Id. at 1].
On March 27, 2013, the Respondent,
through counsel, timely filed a request
for a hearing. [ALJ Exh. 2].
On April 3, 2013, the Government
filed its Motion for Summary
Disposition [ALJ Exh. 3]. On April 18,
2013, the Respondent, through his
attorney, filed a timely Response to
Motion for Summary Disposition. [ALJ
Exh. 4]. On April 29, 2013, the
Government filed a reply to the
Respondent’s Response to Motion for
Summary Disposition, [ALJ Exh. 5], and
on May 7, 2013, the Government filed
a Renewed Motion for Summary
Disposition, [ALJ Exh. 6].
On May 10, 2013, I issued my
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
(‘‘Summary Disposition’’),
recommending that the Administrator
summarily revoke Respondent’s DEA
registration because Respondent was
without state authority to dispense
controlled substances and thus was
ineligible for a DEA registration as a
practitioner. [ALJ Exh. 7 at 9–12].
On July 30, 2013, after my Summary
Disposition was delivered to the
Administrator, but before a final
decision was rendered by the
Administrator, Respondent filed a
Notice to Court and Amended Motion to
Reconsider. [See ALJ Exh. 8 at 1].
Therein, Respondent informed DEA that
he had obtained an Oklahoma Board of
Narcotics license which gave
Respondent authority to handle
controlled substances, so ‘‘the
fundamental facts of the case have now
changed.’’ [Id.]. Consequently, the
Deputy Administrator ruled that ‘‘the
finding necessary to support the
revocation of Respondent’s registration
under section 824(a)(3) can no longer be
made.’’ [Id.]. Noting that the Order to
Show Cause also alleged that
Respondent’s continued DEA
registration would be ‘‘inconsistent with
3 I note here that the Oklahoma State Board of
Osteopathic Examiners did not, in fact, suspend
Respondent’s license; rather, it placed the license
on probation for five years. [Gov’t Exh. 6 at 4].
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the public interest,’’ the Deputy
Administrator ordered the Government
to notify his office as to whether the
Government will seek a remand of the
case to adjudicate that matter. [ALJ Exh.
10 at 2]. The Government requested a
remand on August 6, 2013, [ALJ Exh. 9],
which the Deputy Administrator
granted on August 23, 2013, [ALJ Exh.
8].
The hearing in this case took place on
December 17 through December 18,
2013, at the U.S. Tax Court in Oklahoma
City, Oklahoma. [ALJ Exh. 13].
Respondent and the Government were
each represented by counsel. At the
hearing, the Government introduced
documentary evidence and called six
witnesses and Respondent introduced
documentary evidence and called five
witnesses, including himself.
After the hearing, the Government
and the Respondent submitted proposed
findings of fact, conclusions of law and
argument.
III. ISSUE
The issue in this proceeding is
whether the record as a whole
establishes by a preponderance of the
evidence that the Drug Enforcement
Administration (‘‘DEA’’ or
‘‘Government’’) should deny the
application 4 of Trenton F. Horst, D.O.
(‘‘Respondent’’), as a practitioner,
pursuant to 21 U.S.C. 824(a)(4), and
deny any pending applications for
renewal or modification of such
registration, pursuant to 21 U.S.C.
823(f), because his continued
registration would be inconsistent with
the public interest, as that term is
defined in 21 U.S.C. 823(f).
IV. FINDINGS OF FACT
A. Stipulated Facts
The parties have stipulated to the
following facts:
1. Respondent’s DEA registration
BH9311604, which authorized
Respondent to handle controlled
substances in Schedules II–V at St.
Mary’s Physician Associates, LLC,
330 South Fifth Street, Suite 103,
Enid, Oklahoma 73701, expired by
its terms on October 31, 2013.
2. Respondent submitted a renewal
application for a DEA registration
on October 31, 2013.
3. Respondent has an active and valid
license to practice medicine in the
State of Oklahoma.
4. Respondent has an active and valid
license to handle controlled
4 As explained supra note 1, the issue is whether
the DEA should grant Respondent’s application, not
whether his registration should be revoked, as the
Order to Show Cause suggests.
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41083
dangerous substances from the
Oklahoma Bureau of Narcotics.
5. Respondent has not been charged
with or convicted of any federal or
state crimes relating to the
manufacture, distribution, or
dispensing of controlled substances.
[ALJ Exh. 14].
B. Respondent’s Background,
Employment, Registration, and
Licensure
Respondent testified credibly
regarding his medical background,
employment, and training, facts which
were undisputed at the hearing. [Tr.
182–192]. Respondent graduated from
Oklahoma State University College of
Osteopathic Medicine with honors in
1999. [Tr. 183]. Shortly thereafter,
Respondent completed both an
internship and residency at the Tulsa
Regional Medical Center. [Tr. 184–85].
Upon completion of his internship and
residency, Respondent was awarded a
fellowship at the Scott & White Clinic
and Memorial Hospital in Temple,
Texas, where he learned the specialty of
gastroenterology from 2002 to 2005. [Tr.
185–86]. In 2005, Respondent began
working in a private ‘‘single-specialty
group’’ called Digestive Disease
Specialists, Incorporated. [Tr. 187].
By 2007, Respondent was boardcertified in both internal medicine and
gastroenterology. [Tr. 186–87]. He began
working for St. Mary’s Hospital in Enid,
Oklahoma ‘‘on or about June 1, 2010’’ in
a hospital-owned clinic named Red
Carpet Gastroenterology.5 [Gov’t Exh. 6
at 2; Tr. 192]. As explained in further
detail below, during his employment at
St. Mary’s, Respondent abused
controlled substances, resulting in St.
Mary’s terminating his employment and
the DEA issuing the Order to Show
Cause. After completing therapy at an
in-patient substance abuse rehabilitation
facility, Respondent obtained
employment as a delivery driver for
Pizza Hut while he searched for
employment as a physician. [Tr. 229;
see also Tr. 33, 60–61]. Respondent later
worked as a ‘‘patient liaison’’ at New
Beginning Women’s Healthcare from the
fall of 2012 until April 2013, and then
as a ‘‘chart reviewer’’ for Prairie View
Hospice. [Tr. 230–31]. Since May 2013,
Respondent has been employed as a
5 While Respondent was technically an employee
of St. Mary’s, he principally worked at Red Carpet,
a clinic across the street from the hospital that at
least one witness described as ‘‘a private practice.’’
[Tr. 78, 100, 130, 131, 150]. Respondent was the
only physician working at Red Carpet, and he
designed the clinic’s name and logo. [Tr. 78, 130,
135–136, 150].
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physician at Accident Care and
Treatment Center (‘‘ACTC’’). [Tr. 231].
On June 29, 2005, Respondent was
issued DEA Certificate of Registration
(‘‘COR’’) Number BH9311604, which is
the COR at issue in this case. [Gov’t Exh.
22 at 3]. That COR expired by its terms
on October 31, 2013. [Tr. 27, ALJ Exh.
14]. Respondent also holds an active,
valid license to practice medicine in the
State of Oklahoma and an active, valid
license from the Oklahoma Bureau of
Narcotics to handle controlled
substances. [ALJ Exh. 14].
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C. Respondent’s Substance Abuse
In 2009, while Respondent was
employed at Digestive Disease
Specialists, Respondent met and began
an extra-marital relationship 6 with
A.B.,7 a medical assistant employed at
the same location. [Tr. 78–79, 194–95,
250]. Respondent first became aware
that A.B. was abusing controlled
substances in November of 2010, when
she called him and asked him to bail her
out of jail after she was charged with
possession of marijuana, a controlled
substance. [Tr. 195–96]. Soon after that,
in December 2010, Respondent began
using illegal substances with A.B. and
eventually moved in with A.B. on July
4th or 5th, 2011. [Tr. 195, 196, 198,
199].
Respondent credibly testified, and the
Government did not refute, that before
moving in with A.B., Respondent had
never taken amphetamines or
methamphetamine. [Tr. 194–95]. Also,
Respondent credibly testified, and the
Government did not refute, that he has
never been charged with or convicted of
any crimes involving illegal substances.
[Tr. 195; ALJ Exh. 14].
Several St. Mary’s employees testified
that they noticed ‘‘red spots,’’ ‘‘boils,’’
or ‘‘lesions’’ on Respondent’s neck and
elbow on at least two occasions. [Tr. 86;
119–122]. Although the reason for the
Government soliciting testimony about
the red spots is unclear, the insinuation
seemed to be that the red spots were an
indication of drug use. [Tr. 119. 121–22
(Government witness describing marks
6 Despite the Government’s argument that
Respondent speaking with co-workers about his
relationship with A.B. is probative of Factor Five,
I ruled at the hearing that the details of
Respondent’s romantic relationship with A.B. are
not relevant to these proceedings. [Tr. 81, 86–87].
I now reaffirm that ruling, and only mention
Respondent’s relationship to give factual context to
the events that led to Respondent’s drug abuse and
improper prescribing, which are, of course,
relevant. In making my determinations about
whether Respondent’s registration is in the public
interest, I assign no weight to Respondent’s marital
indiscretions.
7 Before the hearing, I issued a Protective Order
which protects the identities of third parties in
these proceedings. [ALJ Exh. 12].
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on the fleshy area of the elbow)]; 199
(Respondent counsel stating that
‘‘[t]here’s been insinuations at least by
the Government that [Respondent was]
IV drug-using’’)]. Respondent denied
ever using IV drugs, [Tr. 199], and, other
than the red spots, the Government
offered no evidence to the contrary.
Indeed, a drug screen taken by
Respondent in July of 2011 did not
indicate any such use, and the witnesses
who testified about the spots never
explicitly linked the spots to drug use.
In fact, the witness the Government
used as an expert linked the spots to a
bacteria, not to drug use. [Tr. 120–21].
While cross examining this expert,
Respondent’s attorney suggested that
the explanation for the red spots was
Respondent’s cycstic acne. [Tr. 124–25].
At that time, the Government’s witness
admitted that it was beyond the scope
of her expertise to testify about such
conditions. [Tr. 125]. The Government’s
witness also testified that the red spots
‘‘appeared to be a boil, a bite,’’ [Tr. 121],
which is consistent with what
Respondent told his receptionist when
she inquired about the spots, [Tr. 86].
Given the thin evidence offered by the
Government regarding the source of the
red spots on Respondent’s skin and
Respondent’s several explanations for
the spots, I find that the Government
failed to meet its burden of proof to
show that Respondent used IV drugs or
that the red spots on Respondent’s
elbow and neck were related to illicit
drug use.
Respondent’s receptionist at Red
Carpet, Brenda Martin, testified that
Respondent told her that he had been
present on at least one occasion while
A.B. made a ‘‘drug run.’’ [Tr. 81–82; see
also Gov’t Exh. 19]. Ms. Martin noted,
however, that Respondent pointed out
he did not participate in the drug
transactions; he stayed in the back seat
of the car while the transaction was
completed. [Tr. 81–82]. Ms. Martin also
testified that in conversations she had
with Respondent, he admitted to being
present while A.B. and her associates
were ‘‘in the garage making meth,’’
although Respondent also told Martin
that he ‘‘didn’t have anything to do with
it.’’ [Tr. 85].
Several witnesses testified that at
some point during his employment at
St. Mary’s, Respondent began coming to
work tired and tardy on a regular basis.8
8 The witnesses at the hearing did not all agree
on the longevity of Respondent’s fatigue and
tardiness. Ms. Martin testified that for the first few
months she worked for Respondent, Respondent
was ‘‘very efficient and punctual’’ and that
Respondent’s fatigue began approximately one
month before his termination. [Tr. 91, 93; Gov’t
Exh. 9]. Respondent himself also testified that
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[Tr. 85, 94 (testimony of Brenda Martin);
104 (testimony of Michelle Lee Bays);
139 (testimony of Krista Ann Roberts);
241–44 (testimony of Respondent)]. Ms.
Martin testified that Respondent’s
fatigue got so bad that he would take
‘‘catnap[s]’’ in his office between patient
visits and had to reschedule several
appointments after being late to work.
[Tr. 83–84]. Staff members took special
notice of Respondent’s fatigue when
they saw an incoherent notation written
by Respondent on a patient’s progress
note that referenced the patient ‘‘still
having pain from right pink chair.’’ [Tr.
85–86, 139; Gov’t Exh. 17]. Respondent
corrected the error by creating a new
note from memory of the patient visit,
and he admitted that he had trouble
focusing the day he wrote the original
note. [Tr. 136–140; Gov’t Exh. 17].
Respondent’s staff at Red Carpet
expressed their concerns about
Respondent’s tardiness, fatigue, and
personal life to Michelle Bays, the
practice administrator at St. Mary’s. [Tr.
100, 104–105]. As a result of these
reports, St. Mary’s solicited a signed
statement from Ms. Martin about her
conversations with and observations of
Respondent while at work. [Tr. 102–05;
Gov’t Exh. 19]. Respondent voluntarily
submitted to a drug test, apparently
requested by St. Mary’s,9 on July 18,
2011. [Tr. 115–116, 205; Gov’t Exh. 8].
The drug test came back positive for
marijuana, methamphetamine, and
amphetamines, and resulted in
Respondent’s termination from St.
Mary’s in August, 2011. [Tr. 118, 120,
131, 206, 245; Gov’t Exh. 8]. Respondent
admits to using methamphetamine, but
at the hearing he offered explanations
‘‘[m]ost of my, quote, tiredness came during the
month of July.’’ [Tr. 243]. Michelle Bays, the St.
Mary’s employee in charge of overseeing day-to-day
operations at hospital clinics, is the only witness
who testified that Respondent’s fatigue and
tardiness lasted longer than a month. She testified
that the fatigue and tardiness occurred for ‘‘more
than a month and a half’’ and that ‘‘[i]t was an issue
for the time I—my whole time when I worked with
him.’’ [Tr. 100, 106]. Ms. Bays’s recollection of the
chronology of events, however, is not reliable for
several reasons. First, as noted above, her testimony
regarding the timing of Respondent’s fatigue and
tardiness conflicts with the testimony of two other
witnesses. Second, she testified that she began
overseeing Red Carpet in September 2009 and that
Respondent ‘‘was already there’’ at that time, [Tr.
100], but it is clear from the record that Respondent
did not begin working at Red Carpet until June 2010
[Gov’t Exh. 6 at 2; Tr. 131]. Thus, while I find Ms.
Bays to be generally credible, I find that her
testimony regarding the timing of events in this case
not credible. I also find that Respondent’s tiredness
and tardiness at work occurred approximately
during the month immediately preceding his
termination from St. Mary’s.
9 The Government’s witnesses did not explain
who requested the drug test, but Respondent, when
asked who initiated the test, testified that Michelle
Bays ‘‘escorted me to the facility where [the drug
test] was done.’’ [Tr. 205].
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for why marijuana and amphetamines
were in his system. [Tr. 245].
Regarding Respondent’s
methamphetamine use, Respondent
credibly testified that he began using it
in December 2010 and stopped around
August of 2011. [Tr. 196–97].
Respondent testified that he used
methamphetamine ‘‘maybe twice a
month’’ before moving in with A.B. in
July of 2011, and ‘‘maybe once or twice
a week at most’’ after moving in with
A.B. [Tr. 197]. Respondent also credibly
testified that before becoming involved
with A.B., he had never used
methamphetamine or any other illicit
drug. [Tr. 196]. The Government offered
no evidence rebutting this testimony.
With respect to the positive result for
marijuana on the drug test, Respondent
credibly testified that marijuana was in
his system at the time of the drug screen
because he was ‘‘exposed’’ to it while
living with A.B., who regularly smoked
marijuana with her associates. [Tr. 245].
Dr. Westcott, whom I certified at the
hearing as an expert in addiction
management, testified that second-hand
marijuana smoke could cause a positive
result on a drug screen if the subject
were exposed to a concentrated amount,
but also testified that positive results for
marijuana on a drug screen normally
mean the subject used the drug. [Tr.
379–82]. The Government, on the other
hand, presented no evidence to rebut
Respondent’s explanation for the drug
test’s positive result for marijuana,
opting instead to simply argue that
Respondent’s explanation was an
‘‘attempt[] to minimize the significance
of his failed drug screen.’’ [Government
Brief (‘‘Gov’t Br.’’) at 33].
To be sure, Respondent has used
marijuana in the past. At the Board
hearing, Respondent testified that he
had used marijuana with friends on a
‘‘sporadic, recreational’’ basis. [Gov’t
Exh. 21 at 11]. Furthermore,
Respondent’s discharge summary from
´
Sante, appended to the Board hearing
transcript, notes that Respondent had
‘‘secondary’’ issues with ‘‘cannabis
abuse.’’ [Gov’t Exh. 21, Attach. 1]. But
none of this evidence contradicts
Respondent’s testimony at the hearing
in these proceedings regarding his
marijuana use. In these proceedings,
Respondent never testified that he had
never used marijuana; Respondent
merely testified that the particular drug
screen he failed was the result of
exposure to marijuana rather than his
personal use. [Tr. 245]. Indeed, the
Government never asked Respondent
generally whether he had ever used
marijuana; it only asked whether the
failed drug screen was the result of
marijuana use. [Tr. 245]. In context, this
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testimony cannot be construed as a
general denial by Respondent of any
and all allegations of marijuana use.
Thus, Respondent’s testimony is not
inconsistent with other evidence that
proves Respondent has used marijuana
in the past.
I therefore find that Respondent’s
explanation for the positive marijuana
result on the drug screen, which was
corroborated by Dr. Westcott’s
testimony on cross examination and
unrebutted by the Government, is
credible. I also find that Respondent has
used marijuana in the past, but that the
frequency of such use is unclear from
the record. In the absence of any
evidence to rebut Respondent’s credible
testimony regarding the drug test,
however, I find that the Government
failed to establish that the positive
result for marijuana on the drug test was
the result of Respondent’s personal use.
With respect to the drug screen’s
positive result for amphetamines,
Respondent testified that amphetamines
were in his system due to a prescription
drug he was taking called Vyvanse.
Respondent and Dr. Westcott both
testified that Vyvanse is a medication
used to treat Attention Deficit Disorder
(‘‘ADD’’), and that it is ‘‘in the
amphetamine class.’’ [Tr. 246–48, 382–
83]. Respondent testified that he was
issued a valid prescription for Vyvanse
in 2009, and began taking pills leftover
from that prescription every day when
ADD symptoms began to reoccur about
a week and a half before he failed the
drug screen at St. Mary’s. [Tr. 246, 248–
49]. This explanation is corroborated by
two exhibits the Government itself
introduced. First, the Board Order found
that Respondent ‘‘contacted the Board
and confirmed that he had tested
positive for . . . Vyvanse.’’ [Gov’t Exh.
6 at 2]. Second, at the Board hearing,
Respondent testified to the same facts
regarding his Vyvanse use as he did at
the hearing in these proceedings. [Gov’t
Exh. 21 at 14–15]. Respondent and Dr.
Westcott also testified that Vyvanse
stays in the system for at least two days,
and that in a drug test it would likely
result in a positive result for
amphetamines. [Tr. 248, 383]. Similar to
its approach to the marijuana issue, the
Government opted to not offer any
evidence to rebut Respondent’s
explanation of the positive
amphetamine result, instead arguing
that ‘‘Respondent would have the Court
believe [his] less than plausible
explanation in the face of unrefuted
evidence that he tested positive at a
time when he was dating a
methamphetamine addict and living at
her house where methamphetamine was
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41085
manufactured.’’ 10 [Gov’t Br. at 33]. This
circumstantial evidence is not
convincing in light of the credible
testimony Respondent gave at the
hearing in these proceedings, which was
nearly identical to the testimony he gave
at the Board hearing. I therefore find
that the Government has failed to
establish that Respondent improperly
used amphetamines.
Respondent further testified that he
never possessed or used illicit drugs
while at work, and St. Mary’s employees
testified that they never concluded
otherwise. [Tr. 123, 149, 200–01]. The
Government refutes Respondent’s
assertion, arguing that Respondent’s use
of illicit drugs at work is evidenced by
the fact that ‘‘he tested positive for these
drugs while on the job and commuted
a great distance to his job.’’ [Gov’t Br. at
29–30]. Yet, Respondent’s expert
witness testified on cross examination
that methamphetamine and
amphetamines stay in the system for
two to four days, and Respondent
testified that it was ‘‘widely known’’
that marijuana can stay in your system
for up to thirty days. [Tr. at 254, 382].
The Government failed to introduce any
evidence to rebut this testimony,
making considerably less plausible the
suggestion that Respondent’s drug use at
home would wear off during his long
commute. I therefore find that the
Government failed to establish that
Respondent used or possessed illicit
drugs while at work.
Within hours of his termination,
which immediately followed his failed
drug test, Respondent voluntarily
reported himself to the State Board of
Osteopathic Examiners (‘‘State Board’’
or ‘‘Board’’) and the Oklahoma Health
Professional Program (‘‘OHPP’’). [Tr.
206–07; Gov’t Exh. 6 at 2]. However,
Respondent did not report himself to
the DEA. [Tr. 273]. In fact, Respondent
did not communicate with the DEA
about his drug abuse until about a year
later. [Tr. 274].
As a result of Respondent contacting
the Board, the Board conducted an
investigation and held a hearing on June
21, 2012, after Respondent returned
10 The Government also suggested, without
overtly accusing, that Respondent acted improperly
by taking ‘‘a two year-old prescription for which he
did not seek the care of a doctor in a recent visit.’’
[Gov’t Br. at 33 (emphasis in original); Tr. at 246
(Government counsel asking Respondent, ‘‘So you
took it outside the usual course of professional
practice[?]’’)]. The Government, however, cites no
regulation, and I can find none, that forbids the use
of ‘‘leftover’’ prescription drugs. Further, the
Government has offered no evidence to establish
that the Respondent’s prescription for Vyvanse
restricted his use of the drug two years after the
issuance of the prescription. I therefore find that the
Government failed to establish any wrongdoing by
Respondent regarding his consumption of Vyvanse.
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home from in-patient therapy.11 [Gov’t
Exh. 6 at 1; Tr. 207–208]. The same day
as the hearing, the Board issued a
Findings of Fact, Conclusions of Law,
and Agreed Order of Probation (‘‘Board
Order’’), which is pertinent to these
proceedings and binding on this Court
under the principles of collateral
estoppel. [Gov’t Exh. 6; Tr. 30]; David A.
Ruben, 78 FR 38,363, 38,365 (DEA
2013); Robert L. Dougherty, M.D., 76 FR
16,823, 16,830 (DEA 2011). Specifically,
in relation to Respondent’s drug abuse,
the Board found the following:
3. On or about August 2, 2011, St.
Mary’s Regional Medical Center
(‘‘Hospital’’) in Enid, Oklahoma
terminated Dr. Horst’s employment at
the Hospital. Dr. Horst had failed a drug
screen and tested positive for marijuana,
methamphetamine and another drug.
4. Dr. Horst contacted the Board and
confirmed that he had tested positive for
marijuana and a C–II medication
Vyvanse for ADHD. Dr. Horst also
confirmed that the Hospital had
terminated his employment.
[Gov’t Exh. 6 at 2]. Respondent
stipulated to and ‘‘[did] not contest any
of the factual allegations raised by the
Board.’’ [Gov’t Exh. 6 at 2]. Respondent
also testified at the hearing in the
present proceedings that he agreed with
the Board’s findings. [Tr. 217].
D. Improper Prescriptions
In addition to Respondent’s illicit
drug use, the Government proved, and
Respondent admitted, that Respondent
issued illegitimate prescriptions for
purposes other than legitimate medical
purposes. [Tr. 170–172, 201–04; Gov’t
Exhs. 9–14, 16]. Respondent wrote the
prescriptions in question for three
patients: A.B., Z.M., and S.M. [Tr. 170–
172, 201–04; Gov’t Exhs. 9–14, 16].
Patient A.B. was the same A.B. with
which Respondent was romantically
involved, and the other two were A.B.’s
friends. [Tr. 201, 203]. Respondent
admitted that he knew A.B. abused
controlled substances when he issued
her the improper prescriptions. [Tr.
196–97, 251–52].
To prove Respondent illegitimately
issued the prescriptions in question, the
Government offered Dr. Arthur Douglas
Beacham, III as an expert witness in the
area of osteopathic medicine with an
emphasis in pain management. [Tr. 164;
Gov’t Exh. 15]. Dr. Beacham reviewed
patient files and prescriptions written
by Respondent for A.B., Z.M., and S.M.,
11 As explained below, the hearing took place so
long after Respondent’s termination from St. Mary’s
because Respondent had checked into an in-patient
rehabilitation center and his hearing was continued.
[See Gov’t Exh. 5].
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and testified that he could ‘‘find no
documentation that would support the
legitimate medical purpose of controlled
medications.’’ [Tr. 170–172; Gov’t Exhs.
9–14, 16]. Specifically, Dr. Beacham
testified that there was ‘‘no
documentation to support history or
present illness or a physical exam or an
assessment nor a plan.’’ [Tr. 172–73].
Thus, Dr. Beacham concluded that, in
his expert opinion, ‘‘the prescriptions
were written for a matter outside
medical necessity.’’ [Tr. 173–74]. Dr.
Beacham also prepared a report
containing these same conclusions,
which was also admitted into evidence
without objection. [Tr. 171; Gov’t Exh.
16]. Respondent admitted to issuing the
improper prescriptions and did not
refute the testimony of the
Government’s expert witness. [Tr. 201–
04].
Respondent filed the patients’ records
of A.B., S.M., and Z.M. in his own desk
rather than with Red Carpet’s other
patient files. The records were found by
a St. Mary’s employee 12 in
Respondent’s desk drawer after
Respondent’s termination from St.
Mary’s, and Respondent admits that he
should have filed those files with the
rest of the clinic’s records. [Tr. 131–36,
203; Gov’t Exhs. 9–11].
The Board Order included factual
findings regarding Respondent’s
illegitimate prescriptions. These
findings, as noted above, are binding on
this court. Ruben, 78 FR at, 38,365;
Dougherty, 76 FR at 16,830. Specifically,
the Board found the following:
6. Upon Dr. Horst’s termination of
employment by [St. Mary’s], staff at the
[Red Carpet] Clinic discovered patient
charts in Dr. Horst’s office that were
kept separate and apart from the Clinic’s
patient records. These separate charts
represented patients never scheduled or
seen by Clinic staff. They represent
patients AB, SM, and ZM.
7. Patient AB’s chart includes a
patient registration and medical history,
but no physical examination. Chart is on
the Clinic’s patient record forms. There
are no prescribed medications or exam
notes recorded. Beginning July 29, 2010
Dr. Horst issued to patient AB sixteen
(16) prescriptions of controlled
dangerous substances (CDS) with
seventeen refills up until his
termination by the Hospital. None of
these prescriptions are charted. They
12 There are no allegations of privacy invasions
regarding the St. Mary’s employee finding the files
in Respondent’s desk drawer. The St. Mary’s
employee who found the patient files in
Respondent’s desk, Krista Roberts, testified that she
found the files after she offered to help Respondent
clean out his desk and that Respondent consented
to her help. [Tr. 132–33].
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include Hydrocodone, Promethazine
with Codeine syrup, and Alprazolam.
Dr. Horst admitted that he had an
extramarital affair with patient AB.
8. Patient SM’s chart includes a
patient registration and medical history,
but no physical examination. Chart is on
the Clinic’s patient record forms. There
are no prescribed medications or exam
notes recorded. Beginning January 27,
2011 Dr. Horst issued patient SM two
(2) CDS prescriptions of Hydrocodone
with one (1) refill. None of these
prescriptions are charted.
9. Patient ZM’s chart includes a
medical history, but no patient
registration and no physical
examination. Chart is on the Clinic’s
patient record forms. There are no
prescribed medications or exam notes.
On November 29, 2010 Dr. Horst issued
patient ZM one (1) CDS prescription of
Hydrocodone with two (2) refills. This
prescription is not charted.
[Gov’t Exh. 6 at 2–3]. As noted above,
Respondent stipulated to all of these
facts at the Board hearing and testified
at the hearing in the present
proceedings that he agreed with the
Board’s findings. [Gov’t Exh. 6 at 2; Tr.
217]. Additionally, the Board concluded
that Respondent’s actions constituted ‘‘a
violation of the Oklahoma Osteopathic
Medicine Act, 59 O.S. §§ 620 et seq.,
and specifically . . .
§ 637(A)(2)(f)(g)(12) and (13).’’ [Gov’t
Exh. 6 at 4].
E. Respondent’s Remedial Actions and
Oversight of Respondent
Upon suggestion by the former OHPP
president, Respondent checked himself
into an in-patient rehabilitation facility
´
in Argyle, Texas, called Sante Center for
´
Healing (‘‘Sante’’) on October 12, 2011.
[Tr. 208–09]. Respondent testified that
´
he paid for his time at Sante by
‘‘cash[ing] in everything we had as far
as IRAs, 401(k)s, profit-sharing,
anything that we’d saved up over the
years.’’ [Tr. 210]. Half of the money
´
Respondent gathered went to Sante, and
the other half ‘‘went to sustaining [his]
family while [he] was gone.’’ [Tr. 210].
Respondent also testified that even after
‘‘cashing out’’ many of his assets,
´
Respondent still owes Sante $87,000.
[Tr. 210].
Respondent described his experience
´
at Sante as ‘‘intensive,’’ especially in the
beginning. [Tr. 209–210]. The staff there
did various tests and evaluations on
Respondent when he arrived, and the
daily therapy regimen started early in
the morning and lasted until 7:00 p.m.,
utilizing several different techniques
such as group and one-on-one therapy.
´
[Tr. 209–210]. While at Sante,
Respondent was required to isolate
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himself from those outside the treatment
facility, and was not even permitted to
discuss medical issues with other
patients. [Tr. 214–15]. Respondent
candidly admitted during direct
examination that ‘‘it was a little bit
difficult to acclimate myself for the first
few weeks, probably six weeks,’’ but
after the initial acclamation phase, he
‘‘became a model participant.’’ [Tr. 210;
see also Tr. 258–260; but see Tr. 408;
Gov’t Exh. 21, Attach. 1]. On cross
examination, Respondent also admitted
that he broke a ‘‘no female contract’’ at
´
Sante by having a sexual relationship
with a female patient.13 [Tr. 260–64].
In addition to his drug abuse therapy,
Respondent completed a program at
´
Sante entitled ‘‘Maintaining Proper
Boundaries,’’ which, according to a
´
letter from the medical director at Sante,
is a comprehensive educational and
experiential course designed to address
the factors that lead to boundary
violations, result from boundary
violations and are required in the
reparation and prevention of any further
boundary issues. The course focuses
particularly on sexual boundary issues:
including sexual boundary
transgressions and interpersonal sexual
boundary violations, however also
recognizes verbal, ethical, moral and
legal boundary violations.
[Resp’t Exh.. 3; Tr. 212–13].
Respondent completed his time at
´
Sante on May 25, 2012, whereupon he
received a ‘‘certificate of sobriety.’’
[Resp’t Exh. 2; Tr. 213–14, 224].
Respondent testified that his ‘‘sobriety
date’’ is October 12, 2011. [Tr. 208–09].
Respondent testified that in June
2012, after returning from seven months
´
of therapy at Sante, he met with State
Board members and investigators to
discuss how he can ‘‘make things right
and get on with my life, and hopefully
piece my career and life back together.’’
[Tr. 217–18]. On June 21, 2012, the
Board held a hearing for Respondent’s
case, which was attended by
Respondent without counsel, and issued
the Board Order the same day. [Gov’t
Exh. 6]. The Board Order, to which
Respondent had previously agreed in
his meeting with the Board members,
placed Respondent’s medical license on
five years’ probation and required that
Respondent (1) enter into and comply
with a contract with OHPP; (2) regularly
attend counseling sessions with ‘‘A
Chance to Change’’ and report to the
Board on his progress in counseling; (3)
have no contact with A.B.; (4) appear at
the next regularly scheduled Board
meeting and, when requested, at
13 I
admitted evidence of this relationship for
impeachment purposes only. [Tr. 292–93].
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subsequent Board meetings; and (5)
reimburse the Board for the costs it
incurred in conducting its proceedings.
[Gov’t 6 at 4; Tr. 217–20].
Respondent’s agreement with the
OHPP required Respondent to submit to
random bimonthly drug tests and attend
at least 75 percent of the weekly
‘‘Caduceus meetings’’ conducted by
OHPP. [Tr. 218–19; Resp’t Exh. 1].
Caduceus meetings are similar to
Alcoholics Anonymous meetings, but
tailored specifically for physicians. [Tr.
351–52]. Dr. Robert Westcott, the
president of the OHPP, testified that
Caduceus meetings are a place where
physicians can ‘‘discuss issues about
being in recovery and being a physician
that you really can’t talk about in just a
regular open AA meeting.’’ [Tr. 352].
Respondent testified that since entering
into an agreement with OHPP, he has
not failed any of his required drug tests
and has 100 percent attendance at the
weekly Caduceus meetings.14 [Tr. 219–
21]. Respondent testified that the OHPP
has also asked him to ‘‘attend other 12step type meetings,’’ and that he
normally attends those meetings two or
three times per week. [Tr. 219].
Respondent also offered into evidence
an attendance log which showed that
between June 16, 2012, and September
12, 2013, Respondent attended
Alcoholics Anonymous meetings almost
every week, usually attending more than
one meeting per week.15 [Resp’t Exh. 4;
Tr. 221–23].
Dr. Westcott, the president of the
OHPP, testified that Respondent has
fully cooperated with his OHPP
contract, that Respondent has ‘‘done
very well’’ in his recovery, and that he
has ‘‘every reason to believe that
[Respondent will] continue to do so.’’
[Tr. 372, 377]. He also testified that
under OHPP supervision, ‘‘it would (be)
very, very unusual for a person to be
able to use and continue to use without
being caught.’’ [Tr. 369]. In fact, Dr.
14 Although the letter from OHPP offered into
evidence by Respondent reports slightly less than
100 percent attendance, [Resp’t Exh. 1], Respondent
credibly testified on direct examination that the
reason for the discrepancy is that he was not aware
of the sign-in procedures during the first few weeks
he attended the meetings. [Tr. 219]. In any case,
both the letter from the OHPP and Respondent’s
testimony verify that Respondent has been faithful
to his contract with the OHPP regarding meeting
attendance.
15 The attendance logs indicated that Respondent
did not attend OHPP meetings for the weeks of July
8–14, 2012, September 16–22, 2012, October 21–27,
2012, October 28–November 3, 2012, January 13–
19, 2013, and April 7–13, 2013. [Resp’t Exh. 4].
However, the logs do not indicate whether meetings
were scheduled during those weeks; they only list
the meetings Respondent actually attended. Thus,
it is impossible to tell from the logs alone what
percentage of scheduled meetings Respondent
attended.
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Westcott testified that the OHPP has a
90% success rate of helping physicians
stay sober. [Tr. 367–68]. The
Government offered no evidence to
refute that Respondent has been diligent
in abiding by the terms of his probation.
In addition to the conditions of
Respondent’s probation, the Board itself
conducts a certain amount of oversight
over physicians who have been
disciplined. Most notably, at least every
quarter, the Board uses the Prescription
Monitoring Program (‘‘PMP’’) 16 to
review the prescriptions issued by
disciplined physicians. [Tr. 370–71].
DEA investigators also have access to
the PMP, and use it to monitor
registrants suspected of misconduct.
[See Tr. 39–40].
Respondent is also subject to
oversight at his current place of
employment, ACTC. [Tr. 422]. Dr.
Richard Swenson, the medical director
in charge of supervising the physicians
at ACTC, testified that the ‘‘locked
cabinet or closet’’ in which the
controlled substances are stored at
ACTC is ‘‘under constant video
surveillance’’ and the drugs themselves
are not dispensed by the physicians. [Tr.
418, 438]. Respondent is not permitted
to issue prescriptions for controlled
substances; he must obtain approval
from a doctor with an unfettered license
who personally meets and examines the
patient before issuing the prescription.
[Tr. 419, 437–38].
Although no formal procedures are in
place for licensed physicians to review
Respondent’s charts, Dr. Swenson
testified that almost all of the clinic’s
patients come in for multiple visits and
see multiple doctors throughout the
course of their treatment. As such, the
charts for each patient are normally
reviewed by multiple doctors. [Tr. 423–
24, 433]. Dr. Swenson also testified that
ACTC has a ‘‘no tolerance’’ policy
regarding diversion of controlled
substances, meaning he would
immediately report any concerns of
diversion. [Tr. 424–25]. On cross
examination, Dr. Swenson testified that
ACTC does not conduct drug screens or
enter into pain contracts before
prescribing controlled substances
known to be abused. [Tr. 433–36].
However, Dr. Swenson explained that
such precautions are normally used
only at ‘‘chronic pain management
clinics.’’ [Tr. 434]. Even Group
Supervisor John Kushnir, the
Government’s representative at counsel
table at the hearing, testified that while
ACTC had some minor bookkeeping
16 DI Survovec described the PMP as ‘‘a real-time
recording of controlled substance prescriptions that
are issued.’’ [Tr. 40]
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issues, the oversight ACTC conducts
over controlled substances dispensing is
‘‘good.’’ [Tr. 335].
Notably, ACTC has experience with
disciplined physicians because it works
with the State Board to employ
disciplined physicians. [Tr. 420–21].
This practice began under the clinic’s
former medical director, who had
himself experienced substance abuse
problems and was ‘‘interested in seeing
what he could do to help other
providers that found themselves in that
same circumstance.’’ [Tr. 421]. Other
than Respondent, ACTC currently
employs one other physician and one
medical assistant with restricted
licenses. [Tr. 420, 421]. Dr. Swenson
testified that ACTC has a good track
record of helping physicians remain
sober and reestablish their professional
careers. [Tr. 421–22].
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F. DEA Investigations of Respondent
DEA first interviewed Respondent in
August of 2012, after learning that Dr.
Horst’s medical license had been put on
probation by the State Board. [Tr. 26,
32]. In attendance at that interview were
Diversion Investigator Mary Surovec,
Group Supervisor John Kushnir,
Respondent, and Dr. Robert Westcott.
[Tr. 32]. Dr. Westcott attended the
meeting at the request of Respondent.
[Tr. 32, 275, 387]. Notably, DI Surovec
testified that when asked about the
allegations in the Board Order,
Respondent ‘‘didn’t really deny
anything.’’ [Tr. 33]. DI Surovec and GS
Kushnir also asked Respondent to
surrender his DEA registration. [Tr. 32,
55, 226, 318]. Respondent asked what
his options were, and he was told that
he could either surrender his license or
be served with an order to show cause.
[Tr. 56, 227, 320]. Respondent told DI
Surovec and GS Kushnir that ‘‘he was
going to think about surrendering.’’ [Tr.
33; 227]. Respondent testified that he
was hesitant to surrender his COR
because other physicians had told him
that after surrendering a DEA
registration, ‘‘you never get it back.’’ [Tr.
276].17 Indeed, both DI Surovec and GS
Kushnir testified that they did not recall
making any indications to Respondent
that he would be able to regain a
surrendered COR through demonstrated
compliance and rehabilitation. [Tr. 61–
62].
17 The Government sought testimony from Dr.
Westcott that, in fact, he was the one who advised
Respondent to not surrender his registration, but Dr.
Westcott credibly denied doing such. [Tr. 391–392].
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V. STATEMENT OF LAW AND
DISCUSSION
A. Positions of the Parties
1. Government’s Position
The Government timely filed
Government’s Proposed Findings of Fact
and Conclusions of Law (‘‘Government’s
Brief’’) with this Court on January 31,
2014. In its brief, the Government set
forth proposed findings of fact,
conclusions of law, and arguments in
favor of denying Respondent’s COR. The
Government argues that it met its
burden of proving a prima facie case,
primarily focusing on factors two, four,
and five of the public interest analysis
set forth in 21 U.S.C. 823(f). [Gov’t Br.
at 24, 28].
With respect to factors two and four,
the Government points out that
Respondent stipulated to the factual
allegations in the Board Order regarding
his positive drug test and improper
issuing of prescriptions. [Id. at 25].
Moreover, the Government relies on its
expert witness, who testified that
Respondent’s prescribing of controlled
substances to A.B., S.M., and Z.M. were
without a legitimate medical purpose.
[Id. at 25–27].
Regarding factor five, the Government
argues that Respondent’s actions of
prescribing controlled substances to
A.B., someone he knew to be a drug
abuser, were particularly harmful to the
public health and safety given
Respondent’s ‘‘practic[e] as a solo
gastroenterologist in a small
community.’’ [Gov’t Br. at 28–29]. The
Government also argues that
Respondent’s admitted abuse of illicit
and controlled substances also posed a
threat to public health and safety. [Id. at
29]. Although Respondent insists that
he never used or possessed illicit drugs
at work, the Government argues that
‘‘the sheer fact that he tested positive for
these drugs while on the job and
commuted a great distance to his job
demonstrates that Respondent’s
behavior while he was employed as a
physician caused a threat to the public
health and safety.’’ [Id. at 29–30].
The Government also argues that
Respondent’s remedial actions are not
sufficient to entrust him with a DEA
COR because Respondent has
demonstrated a lack of candor with the
DEA. The Government points out that
(1) Respondent did not report to DEA
the positive results of the drug test he
took while working for St. Mary’s, (2)
Respondent ‘‘could not admit that his
self-abuse . . . contributed to his
inability to perform as a doctor,’’ (3)
Respondent’s testimony was ‘‘rife with
inconsistencies,’’ and (4) Respondent
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was not forthright in his testimony
´
about his experience at Sante. [Gov’t Br.
at 32–33].
Finally, the Government argues that
even if Respondent has shown sufficient
remorse and instituted remedial
measures, his actions were too egregious
to warrant his registration. [Gov’t Br. at
34–36]. Further, the Government argues
that in light of the current prescription
drug abuse epidemic, the need to deter
improper prescribing weighs in favor of
denying Respondent’s registration. [Id.
at 36].
2. Respondent’s Position
Respondent timely filed Respondent’s
Proposed Findings of Fact, Conclusions
of Law, and Argument (‘‘Respondent’s
Brief’’) on January 30, 2014. Therein,
Respondent ‘‘fully admits to writing
improper prescriptions to three
individuals’’ and ‘‘further admits to
using methamphetamine, sometimes as
often as twice a week.’’ [Resp’t Br. at 7].
Respondent also notes that the entirety
of his impropriety was during a six
month time period, but does not dispute
that the Government has proved its
prima facie case. [Id.].
Rather, Respondent argues that it has
rebutted the case against him with
evidence that he takes responsibility for
his actions and has instituted sufficient
remedial actions to justify his
registration. Respondent argues that he
has made ‘‘significant, dramatic, and
substantial efforts at rehabilitation and
[has] demonstrated commitment to fully
comply with any and all regulations
placed upon him by state licensure
boards.’’ [Id. at 7]. In particular, he
argues that his participation in (1) a
seven-month inpatient substance abuse
program, (2) boundaries training, (3)
OHPP programs, (4) random drug
testing, and (5) support groups
demonstrate his commitment both to
recovery from substance abuse and
compliance with the Board’s conditions
of licensure. [Id.]. Respondent also
argues that his substance abuse was
short-lived, and that he has now been
sober for over two years. [Id.]. Moreover,
Respondent argues that his
circumstances have ‘‘changed
drastically since the time of his
misconduct’’; he has reconciled with his
wife, attended family counseling, ended
his relationship with A.B., and even
shortened his commute to work. [Id. at
9].
B. Statement of Law and Analysis
Pursuant to 21 U.S.C. 823(f) (2011),
the Deputy Administrator may deny an
application for a DEA COR if he
determines that such registration would
be inconsistent with the public
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interest.18 Similarly, pursuant to 21
U.S.C. 824(a)(4), the Deputy
Administrator may revoke a DEA COR,
if he determines that such registration
would be inconsistent with the public
interest. In determining the public
interest, the following factors are
considered:
(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) (2011).
These factors are to be considered in
the disjunctive; the Deputy
Administrator may rely on any one or a
combination of factors and may give
each factor the weight he deems
appropriate in determining whether a
registration should be revoked or an
application for registration be denied.
See Robert A. Leslie, M.D., 68 FR 15,227,
15,230 (DEA 2003) (citing Henry J.
Schwartz, Jr. M.D., 54 FR 16,422, 16,424
(DEA 1989)). Moreover, the Deputy
Administrator is ‘‘not required to make
findings as to all of the factors.’’ Hoxie
v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d
165, 173–74 (D.C. Cir. 2005). Thus, ‘‘this
is not a contest in which score is kept;
the Agency is not required to
mechanically count up the factors and
determine how many favor’’ each party.
Jayam Krishna-Iyer, M.D., 74 FR 459,
462 (DEA 2009). ‘‘Rather, it is an inquiry
which focuses on protecting the public
interest[.]’’ Id.
The Government bears the ultimate
burden of proving that the requirements
for registration are not satisfied. 21
CFR 1301.44(d) (2014). Specifically, the
Government must show that
Respondent has committed acts that are
inconsistent with the public interest. 21
U.S.C. 823(f); Jeri Hassman, M.D., 75 FR
8,194, 8,227 (DEA 2010). However,
where the Government has made out a
prima facie case that Respondent’s
application would be ‘‘inconsistent with
the public interest,’’ the burden of
production shifts to the applicant to
18 The Deputy Administrator has the authority to
make such a determination pursuant to 28 CFR
0.100(b), 0.104 (2013).
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‘‘present[ ] sufficient mitigating
evidence’’ to show why he can be
trusted with a new registration. See
Medicine Shoppe—Jonesborough, 73 FR
364, 387 (DEA 2008). To this point, the
Agency has repeatedly held that the
‘‘registrant must accept responsibility
for [his] actions and demonstrate that
[he] will not engage in future
misconduct.’’ Id.; see also Samuel S.
Jackson, D.D.S., 72 FR 23,848, 23,853
(DEA 2007). The Respondent must
produce sufficient evidence that he can
be trusted with the authority that a
registration provides by demonstrating
that he accepts responsibility for his
misconduct and that the misconduct
will not reoccur. See id.; see also
Samuel S. Jackson, D.D.S., 72 FR at
23,853. The DEA has consistently held
the view that ‘‘past performance is the
best predictor of future performance.’’
Alra Laboratories, 59 FR 50,620 (DEA
1994), aff’d Alra Laboratories, Inc. v.
DEA, 54 F.3d 450, 451 (7th Cir 1995).
Factor One: Recommendation of
Appropriate State Licensing Board
Recommendations of state licensing
boards are relevant, but not dispositive,
in determining whether a respondent
should be permitted to maintain a
registration. See Gregory D. Owens,
D.D.S., 74 FR 36,751, 36,755 (DEA
2009); see also Martha Hernandez, M.D.,
62 FR 61,145, 61,147 (DEA 1997).
According to clear agency precedent, a
‘‘state license is a necessary, but not a
sufficient condition for registration.’’
Robert A. Leslie, M.D., 68 FR at 15,230;
John H. Kennedy, M.D., 71 FR 35,705,
35,708 (DEA 2006).
DEA possesses ‘‘a separate oversight
responsibility with respect to the
handling of controlled substances,’’
which requires the Agency to make an
‘‘independent determination as to
whether the granting of [a registration]
would be in the public interest.’’
Mortimer B. Levin D.O., 55 FR 8,209,
8,210 (DEA 1990); see also Jayam
Krishna-Iyer, M.D., 74 FR at 461. Even
the reinstatement of a state medical
license does not affect this Agency’s
independent responsibility to determine
whether a DEA registration is in the
public interest. Levin, 55 FR at 8,210.
The ultimate responsibility to determine
whether a registration is consistent with
the public interest has been delegated
exclusively to the DEA, not to entities
within a state government. Edmund
Chein, M.D., 72 FR 6,580, 6,590 (DEA
2007), aff’d Chein v. DEA, 533 F.3d 828
(D.C. Cir. 2008).
Here, it is undisputed that
Respondent holds a valid license to
practice medicine in the state of
Oklahoma. [Gov’t Br. at 21; ALJ Exh.
PO 00000
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14]. Because his licensure does not
constitute a recommendation from the
Board, however, I find that factor one
weighs neither for nor against
Respondent’s registration.
Factors Two and Four: Registrant’s
Experience with Controlled Substances
and Registrant’s Compliance with
Applicable State, Federal, or Local
Laws Relating to Controlled Substances
Respondent’s experiences with
handling controlled substances, as well
as his compliance with laws related to
controlled substances, are relevant
considerations under the public interest
analysis. Pursuant to the Controlled
Substances Act, ‘‘[p]ersons registered by
the Attorney General under this
subchapter to . . . dispense controlled
substances . . . are authorized to
possess . . . or dispense such
substances . . . to the extent authorized
by their registration and in conformity
with the other provisions of this
subchapter.’’ 21 U.S.C. 822(b); Leonard
E. Reaves, III, M.D., 63 FR 44,471,
44,473 (DEA 1998); see also 21
CFR 1301.13(a) (providing that ‘‘[n]o
person required to be registered shall
engage in any activity for which
registration is required until the
application for registration is granted
and a Certificate of Registration is
issued by the Administrator to such
person.’’). As such, the DEA properly
considers practitioners’ past compliance
with CSA requirements and DEA
regulations in determining whether
registering such a practitioner would be
in the public interest.
The regulation applicable here is
DEA’s long-standing requirement that a
prescription be issued for ‘‘a legitimate
medical purpose by an individual
practitioner acting in the usual course of
his professional practice.’’ Ralph J.
Chambers, M.D., 79 FR 4,962, 4,970
(DEA 2014) (quoting 21 CFR 1306.04(a)).
DEA precedent further establishes that
‘‘a practitioner must establish and
maintain a bona-fide doctor-patient
relationship in order to be acting ‘in the
usual course of . . . professional
practice’ and to issue a prescription for
a ‘legitimate medical purpose.’ ’’ Paul H.
Volkman, 73 FR 30,630, 30,642 (DEA
2008). Whether a valid doctor-patient
relationship was established is
determined by looking to state law. Id.
Here, Respondent issued
prescriptions to A.B., S.M., and A.M.
outside the usual course of his
professional practice. The Government’s
expert credibly testified at the hearing
that after reviewing the prescriptions
and the patient files, he could ‘‘find no
documentation that would support the
legitimate medical purpose of controlled
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medications’’ because there was ‘‘no
documentation to support history or
present illness or a physical exam or an
assessment nor a plan.’’ [Tr. 170–173;
Gov’t Exhs. 9–14, 16]. Dr. Beacham’s
written report credibly reached these
same conclusions. [Tr. 171; Gov’t Exh.
16]. Respondent admitted to issuing the
prescriptions improperly and did not
refute the testimony of the
Government’s expert witness. [Tr. 201–
04].19
In addition to his issuing of improper
prescriptions, Respondent’s
possession 20 of methamphetamine
violated federal law. Under the CSA, it
is ‘‘unlawful for any person knowingly
or intentionally to possess a controlled
substance unless such substance was
obtained directly, or pursuant to a valid
prescription or order, from a
practitioner, while acting in the course
of his professional practice.’’ 21 U.S.C.
844(a). It is undisputed that Respondent
possessed methamphetamine, which is
a Schedule III controlled substance
under 21 U.S.C. 812, without a
prescription. [See Tr. 200; Resp’t Br. at
3].
I find that Respondent’s possession of
a controlled substance without a
prescription, combined with his
improper issuing of prescriptions to
A.B., S.M., and Z.M., clearly weigh
against Respondent’s registration under
factors two and four of the public
interest analysis.
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Factor Three: Registrant’s Conviction
Record Relating to Controlled
Substances
Pursuant to 21 U.S.C. § 823(f)(3), the
Deputy Administrator may deny a
pending application for a certificate of
registration upon a finding that the
applicant has been convicted 21 of a
felony related to controlled substances
19 The Government also produced evidence, and
Respondent admitted, that Respondent stored
A.B.’s, S.M.’s, and Z.M.’s patient files in his own
desk rather than with Red Carpet’s other patient
files. [Tr. 132–36, 203; Gov’t Exhs. 9–11]. While this
was certainly suspicious and Respondent admitted
it was improper, I can find no regulation
Respondent violated by storing the files in his desk,
and the Government cites none. Indeed, the
Government’s argument section in its brief makes
no mention of the location of the files.
20 In order to follow agency precedent, I will take
into consideration evidence of Respondent’s selfabuse of illicit drugs under the fifth public interest
factor. Tony T. Bui, M.D., 75 FR 49,979, 49,989
(DEA 2010). Thus, under factor four I only consider
Respondent’s possession of methamphetamine and
not his use.
21 The Administrator interprets the term
‘‘conviction’’ by affording it the ‘‘broadest possible
meaning.’’ Donald Patsy Rocco, D.D.S., 50 FR
34,210, 34,211 (DEA 1985). Thus, evidence of a
guilty plea is probative under the third factor of the
public interest analysis. See e.g., Farmacia Ortiz, 61
FR 726, 728 (DEA 1996); Roger Pharmacy, 61 FR
65,079, 65,080 (DEA 1996).
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under state or federal law. See Thomas
G. Easter II, M.D., 69 FR 5,579, 5,580
(DEA 2004); Barry H. Brooks, M.D., 66
FR 18,305, 18,307 (DEA 2001); John S.
Noell, M.D., 56 FR 12,038, 12,039 (DEA
1991).
Here, the Government concedes that it
‘‘did not introduce any evidence during
this proceeding regarding a Federal or
State conviction for Respondent relating
to controlled substances.’’ [Gov’t Br. at
23]. Indeed, the parties stipulated that
‘‘Respondent has not been charged with
or convicted of any federal or state
crimes relating to the manufacture,
distribution, or dispensing of controlled
substances.’’ [ALJ Exh. 14]. However,
the Government also correctly points
out that under DEA precedent, factor
three is not dispositive and ‘‘is of
considerably less consequence in the
public interest inquiry.’’ [Gov’t Br. at 23
(quoting Ruben, 78 FR at 38,379 n.35].
I therefore find that this factor weighs
neither for nor against Respondent’s
registration.
Factor Five: Such Other Conduct Which
May Threaten the Public Health and
Safety
Under the fifth public interest factor,
the Agency considers ‘‘[s]uch other
conduct which may threaten the public
health and safety.’’ 21 U.S.C. 823(f)(5).
The Administrator has clarified this
language by reasoning that since
Congress used the word ‘‘may,’’ factor
five includes consideration of conduct
‘‘which creates a probable or possible
threat (and not an actual) threat [sic] to
public health and safety.’’ Roni Dreszer,
M.D., 76 FR at 19,434; Michael J. Aruta,
76 FR 19,420, 19,420 (DEA 2011); Beau
Boshers, M.D., 76 FR 19,401, 19,402 n.4
(DEA 2011); Jacobo Dreszer, M.D., 76 FR
19,386, 19,386 n.3 (DEA 2011).
Taking into consideration Congress’s
clear statutory language and legislative
intent under the CSA, misconduct
considered under factor five also ‘‘must
be related to controlled substances.’’
Terese, Inc. D/B/A Peach Orchard
Drugs, 76 FR 46,843, 46,848 n.11 (DEA
2011); Tony T. Bui, M.D., 75 FR at
49,989 (‘‘In short, DEA has never held
that a practitioner’s prescribing
practices with respect to non-controlled
substances provide an independent
basis for concluding that the
practitioner has engaged in conduct
which may threaten public health and
safety and has thus committed acts
inconsistent with the public interest.’’).
Long-standing agency precedent
indicates that a ‘‘practitioner’s selfabuse of a controlled substance is a
relevant consideration under factor
five.’’ Tony T. Bui, M.D., 75 FR at
49,989; Allan L. Gant, D.O., 59 FR
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10,826, 10,827 (DEA 1994); David E.
Trawick, D.D.S, 53 FR 5,326 (DEA
1988). This Agency has upheld such a
position, ‘‘even when there [was] no
evidence that the registrant abused his
prescription writing authority’’ or when
there was ‘‘no evidence that the
practitioner committed acts involving
unlawful distribution to others.’’ Tony
T. Bui, M.D., 75 FR at 49,989. In
determining the likelihood that a
respondent’s self-abuse would impair
the public interest, the DEA may look to
the duration of the drug abuse. See
Roger D. McAlpin, D.M.D., 62 FR 8,038,
8,040 (DEA 1997) (finding ‘‘serious
questions regarding Respondent’s
fitness to possess a DEA registration’’
because of ‘‘his self-abuse of controlled
substances from at least 1974 to 1990’’).
Here, it is undisputed that
Respondent self-abused controlled
substances. Respondent admitted at the
hearing that he used methamphetamine
with A.B. for about eight months and
admitted at the Board hearing that he
has sporadically used marijuana in the
past. Under factor five of the public
interest analysis, this self-abuse weighs
against Respondent’s registration.
In addition to his self-abuse of drugs,
other aspects of Respondent’s behavior
are also troubling under factor five. For
example, Respondent continued
prescribing hydrocodone, a highly
abused drug, to A.B. despite knowing
that A.B. regularly abused controlled
substances such as methamphetamine
and marijuana. Also, while Respondent
did not personally take part in the sale
or manufacturing of any illegal drugs, he
was present or nearby while an illegal
transaction took place and while
methamphetamine was being
manufactured. Taking into
consideration these facts, combined
with Respondent’s self-abuse of
controlled substances, I find that factor
five weighs against Respondent’s
registration.
Having found that factors two, four,
and five weigh against Respondent, I
find that the Government has met its
burden to prove a prima facie case that
Respondent’s registration would not be
in the public interest. I now turn to
whether remedial measures instituted
by Respondent show that he can be
trusted with a DEA registration.
Remedial Measures
Where the Government has made out
a prima facie case that Respondent’s
registration would be inconsistent with
the public interest, the burden of
production shifts to the applicant to
‘‘present[ ] sufficient mitigating
evidence’’ to show why he can be
trusted with a new registration. See
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Medicine Shoppe—Jonesborough, 73 FR
at 387. To this point, the Agency has
repeatedly held that the registrant must
‘‘accept responsibility for [his] actions
and demonstrate that [he] will not
engage in future misconduct. Id.; see
also Samuel S. Jackson, D.D.S., 72 FR
23,848, 23,853 (DEA 2007). Specifically,
to rebut the Government’s prima facie
case, the respondent is required ‘‘to
accept responsibility for [the
established] misconduct, [and] also to
demonstrate what corrective measures
[have been] undertaken to prevent the
re-occurrence of similar acts.’’ Jeri
Hassman, M.D., 75 FR 8,194, 8,236
(DEA 2010) (citing Jayam Krishna-Iyer,
M.D., 74 FR 459, 464 n.8 (DEA 2009)).
In determining whether a respondent
has accepted responsibility and whether
misconduct will reoccur, the Agency
has historically looked to a number of
considerations, including genuine
remorse and admission of wrongdoing,
Lawrence C. Hill, M.D., 64 FR 30,060,
30,062 (DEA 1999), lapse of time since
the wrongdoing, Norman Alpert, M.D.,
58 FR 67,420, 67,421 (DEA 1993),
candor with the court and DEA
investigators, Jeri Hassman, M.D., 75 FR
8,194, 8,236 (DEA 2010), and attempts
to minimize misconduct, Ronald Lynch,
M.D., 75 FR 78,745, 78,754 (DEA 2010).
In self-abuse cases, the Agency has
acknowledged that successful
rehabilitation efforts are an important
consideration in determining whether a
respondent can be trusted with a
registration. Steven M. Abbadessa, D.O.,
74 FR 10,077, 10,082 (DEA 2009); Tony
T. Bui, M.D., 75 FR 49,979, 49,990 (DEA
2010).
At the hearing, Respondent stated
several times that ‘‘ ‘regret’ is not even
a strong enough word. I’m very
remorseful for my ever going down that
pathway.’’ [Tr. 197, 238]. He
unequivocally stated that he accepts
‘‘full responsibility’’ for his misconduct
and that he is ‘‘appalled at [his]
behavior.’’ [Tr. 196, 238, 256, 257].
Respondent also testified, and the
Government did not rebut, that he has
been sober since October of 2011,
confirming the effectiveness of his
treatment and his commitment to
remaining sober. [Tr. 259]. Most
importantly, Respondent provided
unrebutted evidence of his successful
rehabilitation at an inpatient facility,
where he received intensive therapy for
about seven months. [Tr. 210 ; Resp’t
Exh. 2;]. Notably, Respondent displayed
his genuine intent to become and
remain sober by spending his own
money—including retirement
investments—to pay for his
rehabilitation. [Tr. 210]. Moreover,
Respondent provided evidence, largely
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unrebutted by the Government, that he
faithfully attended support group
meetings, passed random drug tests, and
was otherwise successful in abiding by
the terms of his probation.
The Government argues that
Respondent cannot be trusted with a
COR because he was not candid with
DEA investigators or this Court and that
his testimony was ‘‘rife with
inconsistencies.’’ [Gov’t Br. at 33]. I
disagree. The Government’s first
argument to this effect is that
Respondent failed to self-report his
failed drug screen to DEA, and that
when Respondent first met with DEA
investigators, he ‘‘failed to admit . . . the
fact that he issued illegal prescriptions
to A.B., S.M., or Z.M., and did not admit
his self-abuse of marijuana.’’ [Gov’t Br.
at 32]. DI Surovec, however, testified
that in her first meeting with
Respondent, ‘‘[w]e asked him about the
allegation in the board order, and he
really didn’t deny anything.’’ [Tr. 33].
The Board Order mentioned
Respondent’s improper prescribing and
the positive result for marijuana on the
drug screen. [Gov’t Exh. 6 at 2, 3]. In
that context, it can hardly be said that
Respondent was attempting to conceal
facts from the DEA that were contained
in the very document about which the
DEA was questioning him. Furthermore,
Respondent’s failure to self-report to the
DEA does not show a lack of candor,
given that he had already self-reported
to the Board. [Tr. at 273–74]. Rather,
Respondent’s explanation that he did
not know he needed to self-report is the
more plausible explanation. [Tr. 273–
74].
The Government also argues that
Respondent was not candid because he
‘‘could not admit that his self-abuse . . .
contributed to his inability to perform as
a doctor.’’ [Gov’t Br. at 32]. Respondent
testified that he was tired at work
because of his commute, heavy
workload, and lack of sleep at A.B.’s
house and that using
methamphetamine, which is a
stimulant, did not contribute to his
fatigue. [Tr. 243–44, 249]. While this
may seem like Respondent was trying to
minimize the effects of his drug use, I
find that this was merely Respondent’s
honest assessment of his situation at the
time. Indeed, the Government elicited
this testimony itself. [Tr. 243–44].
The Government similarly argues that
Respondent minimized his misconduct
by testifying that he prescribed
hydrocodone to A.B., a known drug
abuser, ‘‘out of compassion [because]
[s]he was in pain,’’ and that
‘‘hydrocodone was not her drug of
choice.’’ [Gov’t Br. at 33]. Again, this
testimony was specifically elicited by
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41091
Government counsel and went
unrebutted. While the reasons
Respondent gave for prescribing
hydrocodone to A.B. certainly do not
justify his improper methods of
prescribing, they also do not represent
an attempt to minimize or rationalize
his behavior. Indeed, Respondent’s
explanation for prescribing to A.B. was
preceded by his statement that ‘‘it was
improper and I admit that.’’ [Tr. 252]
Additionally, the Government argues
that Respondent’s testimony was ‘‘rife
with inconsistencies.’’ [Gov’t Br. at 33].
For example, the Government points to
Respondent’s explanations as to why he
tested positive for marijuana and
amphetamine. As explained above,
however, Respondent’s explanation
about these drug test results were
credible and went unrebutted by the
Government.
The Government also argues that
Respondent was not ‘‘forthright
´
regarding his treatment at Sante’’
because he failed on direct examination
to disclose that he broke his ‘‘no female
contract’’ at the treatment center. [Gov’t
Br. at 33]. The Government points out
that on direct examination Respondent
testified that he was a ‘‘model patient,’’
but that his breaking of the no-female
contract contradicts that statement.
[Gov’t Br. at 33].22 The Government,
however, ignores Respondent’s
testimony that directly precedes his
‘‘model patient’’ statement: ‘‘[I]t was a
little bit difficult to acclimate myself for
the first few weeks, probably six weeks.
It took me a while to kind of get into the
flow of things. Thereafter, I’d like to
think I became a model participant.’’
[Tr. 210]. While Respondent did not
divulge on direct examination every
detail about his struggles in
rehabilitation, his statement that he
became a ‘‘model participant’’ was not
an attempt to conceal anything.
I therefore find that Respondent has
sufficiently accepted responsibility for
his actions and instituted remedial
measures to ensure that the misconduct
will not reoccur. At the hearing,
Respondent was consistent, sincere, and
unequivocal in his acceptance of
responsibility for his misconduct. The
success of Respondent’s rehabilitation is
evidenced by his more than two years
of sobriety and his faithful attendance at
support group meetings since being
discharged from therapy. His separation
from A.B., the epicenter of most of his
22 Over Respondent counsel’s vehement objection
at the hearing, I allowed the Government to
introduce evidence of Respondent’s relationship
´
with a woman at Sante. [Tr. 261–263]. However,
because this subject was not disclosed prior to the
hearing, I admitted the evidence for impeachment
purposes only. [Tr. 293].
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problems, displays his commitment to
avoiding influences that could lead to a
relapse into abusing controlled
substances or improperly issuing
prescriptions.
Even when a respondent is genuinely
remorseful and has instituted sufficient
remedial measures, however, the
Agency sometimes imposes sanctions to
deter egregious violations of the CSA.
David A. Ruben, M.D., 78 FR 38,363,
38,386 (DEA 2013); Joseph Gaudio,
M.D., 74 FR 10,083, 10,094–95 (DEA
2009). In light of the prescription drug
epidemic, the Agency has placed special
emphasis on the need to deter
intentional diversion of controlled
substances, which includes issuing
prescriptions ‘‘outside of the usual
course of professional practice and
[without] a legitimate medical purpose.’’
David A. Ruben, M.D., 78 FR at 38,386–
87; but see Tyson D. Quy, M.D., 78 FR
47,412, 47,412 n.2 (DEA 2013)
(‘‘Because there is no evidence that
Respondent diverted controlled
substances to others and this is a first
offense, I conclude that consideration of
the Agency’s deterrence interests is not
warranted.’’). ‘‘Indeed, this Agency has
revoked a practitioner’s registration
upon proof of as few as two acts of
intentional diversion and has further
explained that proof of a single act of
intentional diversion is sufficient to
support the revocation of a registration.’’
David A. Ruben, M.D., 78 FR at 38,386
(citing Dewey C. MacKay, M.D., 75 FR
49,956, 49,977 (DEA 2010)).
Respondent’s improper prescriptions
to A.B., S.M., and Z.M. clearly
constitute intentional diversion. He
admits to improperly prescribing a
highly abused drug, hydrocodone, to a
known drug addict, A.B., and two of her
friends, S.M. and Z.M.. While he only
wrote one prescription each to S.M. and
Z.M., he continued to prescribe
controlled substances to A.B. for over a
year, totaling fifty-four distributions of
controlled substances, including refills.
[Gov’t Exhs. 12–14]. Thus, although
Respondent’s improper prescribing
practices were limited to A.B. and a few
of her friends, under DEA precedent
they clearly warrant sanctions to deter
Respondent and others from repeating
the practice.
I will not recommend, however, that
the Agency deny Respondent’s
registration altogether. While
Respondent’s improper prescriptions
are troubling to say the least, the DEA
has granted registrations with
restrictions to respondents whose
misconduct was more egregious and/or
lasted longer than the misconduct of
Respondent here. David A. Ruben, M.D.,
78 FR at 38,386 (granting a registration
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to a respondent who improperly
prescribed drugs after being placed on
probation by state board); Gregory D.
Owens, D.D.S., 74 FR 36,751, 36,755,
36,757–58 (DEA 2009) (granting a
registration to a respondent who
prescribed controlled substances for
seven years based on an expired
registration); Michael S. Moore, M.D., 76
FR 45,867, 45,868 (DEA 2011) (granting
a registration to a respondent who was
convicted of growing and distributing
marijuana); Roger D. McAlpin, D.M.D.,
62 FR 8,038, 8,040 (DEA 1997) (granting
a registration to a respondent who selfabused controlled substances for sixteen
years and forged a prescription to obtain
controlled substances).
In each of these cases, the DEA
granted the respondents’ registrations
but also imposed restrictions,
suspensions, or conditions. Where the
respondent intentionally diverted
controlled substances, the Agency
required the respondents to periodically
submit logs of all controlled substances
they prescribe and suspended the
respondents’ registrations for periods of
time commensurate with the severity of
the misconduct. See Ruben, M.D., 78 FR
at 38,387–88; Gregory D. Owens, D.D.S.,
74 FR at 36,757–58; Moore, 76 FR at
45,869. Where the respondent selfabused controlled substances, the
Agency required the respondent to
submit to random drug tests. See Moore,
76 FR at 45,869; McAlpin, 62 FR at
8,040–41. Given that Respondent has a
history of self-abuse and improper
prescriptions, similar conditions are
appropriate here.
I also note that some of the oversight
currently placed over Respondent may
not be present if he is granted a DEA
registration. Specifically, it is not clear
from the record how much of the
oversight of Respondent by ACTC
would be conducted if Respondent had
an unfettered DEA registration. Indeed,
some of the oversight conducted by
ACTC, such as approval from other
doctors for prescriptions of controlled
substances, is done precisely because
Respondent has no DEA registration and
thus is not authorized to dispense
controlled substances. This part of
oversight would presumably—though
not necessarily—be lifted if Respondent
were granted a DEA registration.
Moreover, Respondent expressed at the
hearing his desire to work as a
gastroenterologist, so he may not be
under ACTC supervision much longer.
[Tr. 233]. Given Respondent’s history of
improper prescribing, DEA is justified
in placing certain restrictions on
Respondent’s COR to ensure precise
compliance with the CSA and DEA
regulations in the event that ACTC no
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Sfmt 9990
longer supervises Respondent’s
prescribing practices.
VI. CONCLUSION AND
RECOMMENDATION
Therefore, given that Respondent has
a history of both self-abuse and
intentional diversion but has
demonstrated genuine remorse and
instituted significant remedial
measures, I recommend that
Respondent’s registration be granted
with the following conditions:
(1) For six months following the
publication of the Deputy
Administrator’s final order in this
case, Respondent shall keep a log of
all controlled substance
prescriptions he issues. Said log
shall be maintained in
chronological order, and shall list
each patient by name, and include
the name of the drug prescribed, the
number of refills authorized, the
strength of the dosage unit, the
quantity, and the dosing
instruction. Not later than ten days
following the end of each calendar
month, Respondent shall provide
the local DEA field office with a
complete copy of the log for the
preceding month. If during any
month Respondent is required to
maintain said logs he prescribes no
controlled substances, he shall
submit a letter declaring such to the
local DEA field office no later than
ten days following the end of that
month.
(2) Respondent shall agree to have no
intentional contact with A.B., S.M.,
Z.M., or any other person with
whom Respondent abused
controlled substances.
(3) Respondent shall comply with the
terms of his probation instituted by
the Board and shall comply with
any other conditions the Board
shall see fit to impose on his license
or registration.
(4) Respondent shall notify the local
DEA field office if he fails any drug
screen administered by any entity.
I further recommend that
Respondent’s registration be suspended
for six months following the effective
date of his registration.
Dated: March 25, 2014.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2015–17309 Filed 7–13–15; 8:45 am]
BILLING CODE 4410–09–P
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Agencies
[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Notices]
[Pages 41079-41092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17309]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 13-24]
Trenton F. Horst, D.O.; Decision and Order
On March 25, 2014, Administrative Law Judge Gail A. Randall (ALJ)
issued the attached Recommended Decision.\1\ The Government filed
Exceptions to the Recommended Decision.
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\1\ All citations to the Recommended Decision (R.D.) are to the
ALJ's slip opinion as originally issued.
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Having reviewed the record in its entirety, I have decided to adopt
the ALJ's findings of fact and conclusions of law.\2\ However, for
reasons explained below, I respectfully amend the ALJ's recommended
sanction because it is contrary to precedent and, in my opinion, gives
insufficient weight to the Agency's interest in deterring intentional
diversion, both on the part of Respondent and the community of
registrants. See David A. Ruben, 78 FR 38363, 38386 (2013). A
discussion of the Government's Exceptions follows.
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\2\ As ultimate factfinder, I am familiar with my obligations
under the Administrative Procedure Act and the role of the ALJ's
recommended decision. See Universal Camera Corp. v. NLRB, 340 U.S.
474, 496 (1951) (``The `substantial evidence' standard is not
modified in any way when the Board and its examiner disagree . . . .
The findings of the examiner are to be considered along with the
consistency and inherent probability of testimony. The significance
of his report, of course, depends largely on the importance of
credibility in the particular case.'') (emphasis added). So too, the
courts are quite familiar with the standard of review of an Agency
decision. Accordingly, I decline to publish the ALJ's discussion of
the substantial evidence test and the standard of review.
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The Government's Exceptions
The Government raises two exceptions to the ALJ's recommended
decision: First, it takes exception to the ALJ's finding that
Respondent `` `has sufficiently accepted responsibility for his actions
and instituted remedial measures to ensure that the misconduct will not
reoccur.' '' Exceptions, at 2 (quoting R.D. 36). Second, it argues that
the ALJ's recommended sanction is inconsistent with agency precedent.
Exceptions, at 5-6.
As for the first exception, the Government urges that I reject this
finding, contending that Respondent ``continues to[] minimize the
nature of his misconduct.'' Id. at 4-5. As support for its contention,
the Government cites Respondent's testimony regarding his treatment at
a rehabilitation center which it maintains was inconsistent with his
conduct during his stay. More specifically, the Government notes
Respondent's testimony that:
it was a little bit difficult to acclimate myself for the first few
weeks, probably six weeks. It took me a while to kind of get into
the flow of things. Thereafter, I'd like to think I became a model
participant. I spent seven months there.
Tr. 210. The Government then notes that Respondent was subject to a
``no female contract'' during the initial four months of his treatment,
and that he breached the contract when he had contact with another
patient and engaged in sexual relations with her
[[Page 41080]]
approximately two months into his stay. Exceptions, at 2. The
Government implies that his testimony was disingenuous because the
incident occurred two weeks later than Respondent claimed it did. Id.
The Government does not, however, explain why it matters whether the
incident occurred six weeks or two months into his stay.
The Government also maintains that Respondent engaged in a pattern
of minimizing his misconduct, both during his time in treatment and in
his testimony at the hearing. In support of this contention, it cites
evidence showing that Respondent admitted his breach of the no-female
contract to the treatment center staff only upon learning that he was
going to be subject to a polygraph. As for his testimony, the
Government argues that ``Respondent did not divulge that he broke [the]
contract . . . on direct examination.'' Id. at 3. It then argues that
even on cross-examination, Respondent failed to truthfully answer its
questions because he did not admit to having sexual relations with the
female patient until he was specifically asked if he had sex with
female patients.\3\ However, when the Government specifically asked the
question, he did answer it truthfully.
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\3\ The Government initially asked Respondent: ``How did you
break that contract?'' Tr. 263. Respondent answered that he was ``a
friendly person, and they would approach me, and it's kind of hard
when people talk to you, to not talk to them, to completely ignore
them.'' Id. While this may not have been the answer the Government
was seeking, there is no evidence that Respondent's answer was
untruthful.
Following this, the Government asked Respondent: ``Did you do
more than speaking with females?'' Id. Respondent answered:
I had basically what could be called a girlfriend. She was very
attentive to me, which I was appreciative of. My marriage was likely
in ruins, and it was something that was--it was nice to have someone
to talk to. And once that was--basically once that was discovered, I
was placed on my no-female contract, and--well, actually I was on my
no-female contract when that was discovered, and basically I got
reprimanded and eventually I got my act together.
Id. at 264. Here again, this may not have been the answer the
Government was seeking, but there is no evidence that it was
untruthful.
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Most significantly, to the extent the Government relies on this
incident and Respondent's testimony regarding it to contend that he
``has consistently minimized his misconduct,'' Exceptions, at 5; its
argument is misplaced. As the Government acknowledges, the incident and
his testimony ``ha[ve] little or nothing to do with controlled
substances.'' Id. at 2 (emphasis added). Nor does the Government cite
to any case holding that an applicant's breach of the terms of a
treatment contract, which does not involve a violation of the
Controlled Substances Act or applicable state law (as would failing a
drug test), constitutes conduct which may threaten public health or
safety. Cf. Mark G. Medinnus, 78 FR 62683, 62684 (2013) (rejecting
contention that violation of internal clinic operating policy, which
did not otherwise violate CSA or state law, constituted conduct
inconsistent with the public interest.).
Because Respondent's breach of his no-female contract does not
constitute actionable misconduct under the public interest standard,
his testimony regarding the incident is not relevant in assessing
whether he has accepted responsibility for his misconduct. While this
evidence is arguably relevant in assessing Respondent's claim that he
has been rehabilitated, it is undisputed that he successfully completed
inpatient treatment, that he has been in compliance with his Oklahoma
Health Professionals Program contract, and that he passed all of his
random drug tests. RX 2.
There is, however, evidence that supports the Government's
contention that Respondent does not fully acknowledge his misconduct.
As ultimate fact-finder, I am not bound by the Government's failure to
cite this evidence which I conclude is properly considered in reviewing
the Government's contention that the ALJ's recommended sanction is
inconsistent with agency precedent.
The ALJ found that Respondent not only abused methamphetamine, but
that he also wrote prescriptions for controlled substances for A.B.,
his then-girlfriend (and fellow methamphetamine abuser), as well as for
S.M. and Z.M., who were two of her friends. With respect to A.B., the
evidence showed that between July 29, 2010 and September 12, 2011,
Respondent issued her 15 prescriptions for Lortab 7.5mg and 10mg (then
a schedule III controlled substance \4\ which combines hydrocodone and
acetaminophen), as well as one prescription for both Xanax (alprazolam,
a schedule IV drug) and promethazine with codeine cough syrup (schedule
V). Moreover, the Lortab prescriptions, which ranged from 40 to 80
tablets, authorized 28 refills. In total, the prescriptions, with
refills, provided A.B. with approximately 2,540 tablets of hydrocodone.
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\4\ Combination hydrocodone products have since been placed in
schedule II of the Controlled Substances Act. See Schedules of
Controlled Substances: Rescheduling of Hydrocodone Combination
Products from Schedule III to Schedule II, 79 FR 49661 (2014).
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With respect to S.M., at a minimum, the evidence showed that
Respondent issued him a prescription for 60 tablets of hydrocodone/apap
with three refills.\5\ See GX 13. As for Z.M., the evidence shows that
Respondent issued him a prescription for 40 tablets of Lortab 7.5 with
two refills. GX 14.
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\5\ The record includes three documents from Walgreens which
have the caption: ``Audit/Board of Pharmacy Inspection Report.''
While each of the documents contains a copy of a prescription issued
by Respondent on January 27, 2011, each document lists a different
prescription number, a different store number, and a different sold
date. GX 13. Thus, it is unclear whether two of the documents were
simply refills of the original prescription or whether Respondent
issued S.M. multiple prescriptions on the same date.
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Respondent did not dispute that he failed to perform a physical
exam on A.B., S. M., and Z.M., or that the prescriptions were improper.
Indeed, he testified that: ``[i]mproper, I think, is a weak word. I
think it was stupid. I think you used the word `idiotic' earlier.'' Tr.
201 (testimony regarding prescriptions to A.B.); see also id. at 203
(admitting that the prescriptions to S.M. and Z.M. were ``very
improper'').
While Respondent also asserts that he received no monetary gain
from writing these prescriptions, see Tr. 204, this is irrelevant. What
is relevant is that Respondent knowingly and improperly diverted
controlled substances to three individuals, including his girlfriend
A.B., whom he knew was a drug abuser.
Further, while Respondent acknowledged that the prescriptions were
improper, he then maintained that he prescribed to A.B. ``out of
compassion'' because ``[s]he was in pain.'' Id. at 252. And he further
asserted that she did not ``use hydrocodone as a drug of choice, as far
as recreational drugs'' because ``[s]he was a methamphetamine addict.''
Id. at 253.
The ALJ rejected the Government's contention that Respondent's
testimony was an attempt to minimize his misconduct. According to the
ALJ, ``[w]hile the reasons Respondent gave for prescribing hydrocodone
to A.B. certainly do not justify his improper methods of prescribing,
they also do not represent an attempt to minimize or rationalize his
behavior.'' R.D. at 35. In the ALJ's view, this was so because
Respondent prefaced this testimony with ``his statement that `it was
improper and I admit that.''' Id. (quoting Tr. 252).
Read more broadly, however, his testimony most certainly was an
attempt to minimize his misconduct. Indeed, on further questioning,
Respondent testified that:
[[Page 41081]]
. . . . I'm exquisitely sorry that I ever prescribed these things,
these medicines for these people. You know, I know that I did it
improperly. I know I didn't have proper documentation. Deep down,
when I was writing them, I knew better.
Id. at 258 (emphasis added). Continuing, Respondent testified that:
Deep down, whenever I was writing them, I knew better. I let my
heart and my empathy get the best of me, more than my brain. I know
better now. I've gone through extensive counseling, extensive
instruction, boundaries course times two, to understand what my
infractions were.
Id. (emphasis added).
Contrary to Respondent's assertion, this was not simply a matter of
not having proper documentation to support the prescriptions. Notably,
while the ALJ apparently credited his testimony that A.B. was in pain,
noting that this testimony ``went unrebutted,'' see R.D. at 35, the
evidence shows that while Respondent prescribed to A.B for more than
one year, he made no claim that he ever conducted a physical exam on
her or performed any diagnostic tests to determine whether she
legitimately had pain or whether her pain warranted the prescribing of
controlled substances. See Tr. 172-74 (testimony of Government's expert
that the hydrocodone prescriptions lacked a legitimate medical purpose
and were issued outside of the usual course of professional practice).
As for his assertion that he prescribed ``out of compassion'' and
``empathy,'' this too is amply refuted by his failure--over the course
of more than one year--to take appropriate steps to determine the
source of her purported pain. And given his acknowledgement that he
knew early in his relationship with A.B. that she was a meth addict,
his claim that he prescribed to her ``out of compassion'' begs the
question of why he did not usher her into treatment.\6\
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\6\ Even assuming that the ALJ credited Respondent's testimony
that A.B. was in pain, see R.D. at 33, because it was undisputed
that he lacked a legitimate medical purpose and acted outside of the
usual course of professional practice in issuing the prescriptions
to her, I decline to give this testimony any weight. Indeed, the ALJ
later found that the prescriptions ``clearly constitute intentional
diversion.'' Id. at 35.
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Respondent also justified A.B.'s hydrocodone prescriptions on the
ground that she did not ``use hydrocodone as a drug of choice, as far
as recreational drugs'' because ``[s]he was a methamphetamine addict.''
Id. at 253. Apparently the possibility that A.B. could also have been
abusing hydrocodone to bring her down from the meth she abused or was
selling the drug to support her meth addiction never dawned on him.
Finally, Respondent attempted to rationalize his prescribing to
A.B. on the ground that he did not understand the boundaries applicable
to the practice of medicine. Id. However, this excuse does not explain
his decision to prescribe controlled substances to both S.M. and Z.M.
Indeed, it is unclear what his excuse is for prescribing to S.M. and
Z.M.
Thus, this does not strike me as an ``unequivocal acceptance of
responsibility for his misconduct.'' R.D. at 36. I need not, however,
reject the ALJ's finding that ``Respondent has sufficiently accepted
responsibility for his actions'' because as the ALJ properly noted,
``[e]ven when a respondent is genuinely remorseful and has instituted
sufficient remedial measures,'' DEA has ``impose[d] sanctions to deter
egregious violations of the CSA'' and ``has placed special emphasis on
the need to deter intentional diversion of controlled substances.'' Id.
at 36 (citing David A. Ruben, 78 FR 38363, 38386-87 (2013); Joseph
Gaudio, 74 FR 10083, 10094-95 (2009)).
The ALJ noted that ``Respondent's improper prescriptions to A.B.,
S.M., and Z.M. clearly constitute intentional diversion.'' R.D. at 37.
I agree. So too, she noted that while his ``improper prescribing
practices were limited to A.B. and a few of her friends, under DEA
precedent they clearly warrant sanctions to deter Respondent and others
from repeating the practice.'' Id. Again, I agree.
The ALJ also noted ``[w]here the respondent intentionally diverted
controlled substances, the Agency required the respondents to
periodically submit logs of all controlled substances they prescribe
and suspended [their] registrations for a period of time commensurate
with the severity of the misconduct.'' Id. at 38 (citing Ruben, also
citing Michael S. Moore, 76 FR 45867, 45868 (2011), and Gregory D.
Owens, 74 FR 36751, 36757-58 (2009)) (emphasis added). Yet
notwithstanding that she found Respondent's prescriptions ``troubling
to say the least,'' id. at 37, the ALJ recommended no period of
suspension.
The ALJ offered no explanation as for why she believed a period of
outright suspension is unwarranted. To be sure, earlier in her
decision, the ALJ opined that the Agency ``has granted registrations
with restrictions to respondents whose misconduct was more egregious
and/or lasted longer than the misconduct of Respondent here.'' Id.
(citing Ruben, Owens, Moore, and Roger D. McAlpin, 62 FR 8038, 8040
(1997)).
Yet in both Ruben and Moore, the Agency suspended each respondent's
registration for a period of one year. As for the ALJ's assertion that
the respective registrant's misconduct in each of these cases was more
egregious than Respondent's, that is certainly true with respect to
Ruben. But Respondent's misconduct in knowingly diverting controlled
substances to three persons, including his girlfriend to whom he
provided some 2,540 dosage units of hydrocodone and did so knowing that
she was meth addict, is itself, sufficiently egregious to warrant a
suspension for a period of one year. As for Moore, while the
physician's misconduct in growing marijuana for his own and his wife's
use was certainly egregious, there was inconclusive evidence as to
whether he knowingly distributed it to others; thus, it is debatable
whether his misconduct was more egregious than Respondent's.
As for Owens, the ALJ asserted that the Agency ``grant[ed] a
registration to a respondent who prescribed controlled substances for
seven years based on an expired registration.'' R.D. at 37. However,
the actual decision to grant a registration to Dr. Owens
notwithstanding the above-described misconduct had been made in a
proceeding which was resolved seven years earlier and there was no
evidence that he was diverting controlled substances. See Gregory D.
Owens, 67 FR 50461 (2002). So too, the misconduct which gave rise to
the second Owens decision did not involve the diversion of controlled
substances and was comparatively minor.\7\
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\7\ As for the conduct which gave rise to the second Owens
proceeding, Dr. Owens was found to have not complied with the 2002
order because he failed to file a quarterly drug activity log during
a four-month period between September 3 and December 31, 2002, and
failed to report a 2005 state board action. 74 FR at 36756-58. While
Dr. Owens' misconduct was considerably less egregious than that
involving the intentional diversion of controlled substances, the
Agency nonetheless suspended his registration outright for a period
of three months. Id. at 36758.
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Moreover, the 2002 Owens order predates the Agency's decision in
Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007), which held
for the first time that notwithstanding the remedial nature of
proceedings under 21 U.S.C. 823 and 824, the Agency can consider the
need to deter similar acts on the part of both the individual
registrant/applicant and the community of registrants. Indeed, this
Agency recently denied a physician's application for a new registration
based, in substantial part, on his issuance of prescriptions after his
registration had expired. See Anthony E. Wicks, 78 FR
[[Page 41082]]
62676, 62678 (2013); see also Linda Sue Cheek, 76 FR 66972 (2011)
(denying application based, in part, on physician's issuance of
prescriptions without being registered). For the same reason, I
respectfully disagree with the ALJ's reliance on McAlpin.
Accordingly, notwithstanding that I do not reject the ALJ's finding
that Respondent has ``sufficiently accepted responsibility for his
actions'' and has produced evidence of his remedial efforts, R.D. at
36, I conclude that the ALJ's recommended order fails to give
appropriate weight to the Agency's substantial interest in deterring
the intentional diversion of controlled substances. While I will grant
Respondent's application, consistent with similar cases, I will order
that his registration be suspended outright for a period of one year.
See Ruben, 78 FR at 38386 (imposing one-year suspension based on acts
of intentional diversion notwithstanding ALJ's finding that registrant
accepted responsibility for his misconduct and undertook remedial
training); Gaudio, 74 FR at 10095 (imposing one-year suspension based
on acts of intentional diversion and holding renewal application in
abeyance pending registrant's acknowledgement of his misconduct); Jayam
Krishna-Iyer, 74 FR 459, 463 (2009) (imposing one-year suspension based
on acts of intentional diversion where registrant acknowledged her
misconduct).\8\
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\8\ The scope of Respondent's unlawful prescribings far exceeds
those of Dr. Krishna-Iyer, who wrote unlawful prescriptions during
three undercover visits. See Jayam Krishna-Iyer, 71 FR 52148, 52158
(2006). Moreover, this Agency has held that proof of a single act of
intentional diversion can support the denial of an application or
the revocation of an existing registration. See Dewey C. MacKay, 75
FR 49956, 49977 (2010), pet. for rev. denied, MacKay v. DEA, 664
F.3d 808 (10th Cir. 2011).
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Moreover, upon the completion of the suspension, Respondent's
registration shall be subject to the following conditions for a period
of two years:
Respondent shall keep a log of all controlled substances he
prescribes on a monthly basis for each calendar month. The log shall
list each prescription in chronological order; the patient's name and
address; the name, quantity, strength and dosing instructions for each
drug prescribed; and the number of refills authorized. Respondent shall
submit a copy of the log to the local DEA Field Office no later than
five business days following the last day of each month.
In the event Respondent opens his own practice, he shall consent to
unannounced inspections of his registered location and waive his right
to require DEA personnel to obtain an administrative inspection warrant
prior to conducting an inspection.
Respondent shall not prescribe any controlled substances to
himself, a family member, or any person with whom he has or had a
personal or romantic relationship.
Respondent shall have no intentional contact with A.B., S.M., or
Z.M.
Respondent shall notify the local DEA Field Office of the results
of any drug test he fails, no later than three business days after
receiving notification of having failed any such test. This condition
shall apply whether the test in conducted by the Oklahoma Board of
Osteopathic Examiners, the Oklahoma Health Professions Program, any
other licensing authority, any hospital at which he seeks or obtains
privileges, or any other employer.
Respondent shall further notify the local DEA Field Office in the
event that the Oklahoma Board of Osteopathic Examiners or the Oklahoma
Bureau of Narcotics and Dangerous Drug Control (or any other licensing
authority) initiates any proceeding, or imposes sanctions against his
medical license or state controlled substance registration
respectively. Respondent shall make such notification no later than
three business days upon being notified of any such action, regardless
of whether he has been formally served with either a complaint or order
issued by any such agency.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b), I order that the application of Trenton F. Horst,
D.O., for a DEA Certificate of Registration as a practitioner, be, and
it hereby is, granted subject to the conditions set forth above. I
further order that Respondent's Certificate of Registration be, and it
hereby is, suspended for a period of one year. This Order is effective
immediately.
Dated: July 6, 2015.
Chuck Rosenberg,
Acting Administrator.
Dedra S. Curteman, Esq., for the Government.
Spencer B. Housley, Esq., for the Respondent.
RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION
OF THE ADMINISTRATIVE LAW JUDGE
I. INTRODUCTION
Gail A. Randall, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. 551
et seq., to determine whether the Drug Enforcement Administration
(``DEA'' or ``Government'') should deny \1\ a physician's application
for a DEA Certificate of Registration pursuant to 21 U.S.C. 823(f)
(2006). Without his registration, the physician, Trenton F. Horst, D.O.
(``Respondent'' or ``Dr. Horst''), would be unable to lawfully
prescribe, dispense or otherwise handle controlled substances in the
course of his medical practice.
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\1\ DEA regulations and precedent clearly establish that ``a
registrant, who has been served with an Order to Show Cause, [must]
file his renewal application at least 45 days before the expiration
of his registration, in order for it to continue in effect past its
expiration date and pending the issuance of a final order by the
Agency.'' Paul Weir Battershell, N.P., 76 FR 44359, 44361 (DEA 2011)
(citing Paul Volkman, 73 FR 30,630, 30,641 (DEA 2008)); 21 CFR
1301.36(i). Respondent's Certificate of Registration, Number
BH9311604, expired by its own terms on October 31, 2013, about eight
months after the Order to Show Cause was served, and Respondent did
not apply for renewal until October 31, 2013. [ALJ Exh. 14]. Thus,
Respondent's application for renewal will be considered an
application for registration. See Battershell, 76 FR at 44,361
(holding that although the registration had expired, the renewal
application may be considered). Accordingly, the issue in this case
is whether DEA should grant Respondent's application, not whether
DEA should revoke his registration.
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II. PROCEDURAL HISTORY
The Deputy Assistant Administrator, Drug Enforcement Administration
(``DEA'' or ``Government''), issued an Order to Show Cause (``Order'')
dated February 27, 2013, proposing to revoke \2\ the DEA Certificate of
Registration, No. BH9311604, of Respondent, as a practitioner, pursuant
to 21 U.S.C. 824(a)(3)-(4), and deny any pending applications for
renewal or modification of such registration because Respondent does
not ``have authority to handle controlled substances in the State of
Oklahoma'' and because the Respondent's continued registration would be
inconsistent with the public interest, as that term is used in 21
U.S.C. 823(f). [Administrative Law Judge Exhibit (``ALJ Exh.'') 1 at
1].
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\2\ As explained supra note 1, the issue is whether the DEA
should grant Respondent's application, not whether his registration
should be revoked, as the Order to Show Cause suggests.
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Specifically, the Order alleged that Respondent was ``registered
with the DEA as a practitioner in Schedules II-V under DEA registration
BH9311604 at St. Mary's Physician Associates, LLC, 330 South Fifth
Street, Suite 103, Enid, Oklahoma 73701.'' [Id.]. The Order further
alleged that Respondent was without authority to handle controlled
substances in the state of Oklahoma, which is the state that listed on
his DEA
[[Page 41083]]
Certificate Of Registration (``COR''), since his Oklahoma Bureau of
Narcotics (``OBN'') registration expired on October 31, 2011. [Id.].
The Order further alleged that Respondent's state osteopathic license
was suspended \3\ on June 21, 2012, for a period of five years, by the
Oklahoma State Board of Osteopathic Examiners (``Oklahoma State
Board''). [Id. at 2]. Thus, the Order stated that the DEA must revoke
Respondent's DEA registration because he lacks authority to handle
controlled substances in the state of Oklahoma. [Id. at 1].
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\3\ I note here that the Oklahoma State Board of Osteopathic
Examiners did not, in fact, suspend Respondent's license; rather, it
placed the license on probation for five years. [Gov't Exh. 6 at 4].
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On March 27, 2013, the Respondent, through counsel, timely filed a
request for a hearing. [ALJ Exh. 2].
On April 3, 2013, the Government filed its Motion for Summary
Disposition [ALJ Exh. 3]. On April 18, 2013, the Respondent, through
his attorney, filed a timely Response to Motion for Summary
Disposition. [ALJ Exh. 4]. On April 29, 2013, the Government filed a
reply to the Respondent's Response to Motion for Summary Disposition,
[ALJ Exh. 5], and on May 7, 2013, the Government filed a Renewed Motion
for Summary Disposition, [ALJ Exh. 6].
On May 10, 2013, I issued my Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision of the Administrative Law Judge
(``Summary Disposition''), recommending that the Administrator
summarily revoke Respondent's DEA registration because Respondent was
without state authority to dispense controlled substances and thus was
ineligible for a DEA registration as a practitioner. [ALJ Exh. 7 at 9-
12].
On July 30, 2013, after my Summary Disposition was delivered to the
Administrator, but before a final decision was rendered by the
Administrator, Respondent filed a Notice to Court and Amended Motion to
Reconsider. [See ALJ Exh. 8 at 1]. Therein, Respondent informed DEA
that he had obtained an Oklahoma Board of Narcotics license which gave
Respondent authority to handle controlled substances, so ``the
fundamental facts of the case have now changed.'' [Id.]. Consequently,
the Deputy Administrator ruled that ``the finding necessary to support
the revocation of Respondent's registration under section 824(a)(3) can
no longer be made.'' [Id.]. Noting that the Order to Show Cause also
alleged that Respondent's continued DEA registration would be
``inconsistent with the public interest,'' the Deputy Administrator
ordered the Government to notify his office as to whether the
Government will seek a remand of the case to adjudicate that matter.
[ALJ Exh. 10 at 2]. The Government requested a remand on August 6,
2013, [ALJ Exh. 9], which the Deputy Administrator granted on August
23, 2013, [ALJ Exh. 8].
The hearing in this case took place on December 17 through December
18, 2013, at the U.S. Tax Court in Oklahoma City, Oklahoma. [ALJ Exh.
13]. Respondent and the Government were each represented by counsel. At
the hearing, the Government introduced documentary evidence and called
six witnesses and Respondent introduced documentary evidence and called
five witnesses, including himself.
After the hearing, the Government and the Respondent submitted
proposed findings of fact, conclusions of law and argument.
III. ISSUE
The issue in this proceeding is whether the record as a whole
establishes by a preponderance of the evidence that the Drug
Enforcement Administration (``DEA'' or ``Government'') should deny the
application \4\ of Trenton F. Horst, D.O. (``Respondent''), as a
practitioner, pursuant to 21 U.S.C. 824(a)(4), and deny any pending
applications for renewal or modification of such registration, pursuant
to 21 U.S.C. 823(f), because his continued registration would be
inconsistent with the public interest, as that term is defined in 21
U.S.C. 823(f).
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\4\ As explained supra note 1, the issue is whether the DEA
should grant Respondent's application, not whether his registration
should be revoked, as the Order to Show Cause suggests.
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IV. FINDINGS OF FACT
A. Stipulated Facts
The parties have stipulated to the following facts:
1. Respondent's DEA registration BH9311604, which authorized Respondent
to handle controlled substances in Schedules II-V at St. Mary's
Physician Associates, LLC, 330 South Fifth Street, Suite 103, Enid,
Oklahoma 73701, expired by its terms on October 31, 2013.
2. Respondent submitted a renewal application for a DEA registration on
October 31, 2013.
3. Respondent has an active and valid license to practice medicine in
the State of Oklahoma.
4. Respondent has an active and valid license to handle controlled
dangerous substances from the Oklahoma Bureau of Narcotics.
5. Respondent has not been charged with or convicted of any federal or
state crimes relating to the manufacture, distribution, or dispensing
of controlled substances.
[ALJ Exh. 14].
B. Respondent's Background, Employment, Registration, and Licensure
Respondent testified credibly regarding his medical background,
employment, and training, facts which were undisputed at the hearing.
[Tr. 182-192]. Respondent graduated from Oklahoma State University
College of Osteopathic Medicine with honors in 1999. [Tr. 183]. Shortly
thereafter, Respondent completed both an internship and residency at
the Tulsa Regional Medical Center. [Tr. 184-85]. Upon completion of his
internship and residency, Respondent was awarded a fellowship at the
Scott & White Clinic and Memorial Hospital in Temple, Texas, where he
learned the specialty of gastroenterology from 2002 to 2005. [Tr. 185-
86]. In 2005, Respondent began working in a private ``single-specialty
group'' called Digestive Disease Specialists, Incorporated. [Tr. 187].
By 2007, Respondent was board-certified in both internal medicine
and gastroenterology. [Tr. 186-87]. He began working for St. Mary's
Hospital in Enid, Oklahoma ``on or about June 1, 2010'' in a hospital-
owned clinic named Red Carpet Gastroenterology.\5\ [Gov't Exh. 6 at 2;
Tr. 192]. As explained in further detail below, during his employment
at St. Mary's, Respondent abused controlled substances, resulting in
St. Mary's terminating his employment and the DEA issuing the Order to
Show Cause. After completing therapy at an in-patient substance abuse
rehabilitation facility, Respondent obtained employment as a delivery
driver for Pizza Hut while he searched for employment as a physician.
[Tr. 229; see also Tr. 33, 60-61]. Respondent later worked as a
``patient liaison'' at New Beginning Women's Healthcare from the fall
of 2012 until April 2013, and then as a ``chart reviewer'' for Prairie
View Hospice. [Tr. 230-31]. Since May 2013, Respondent has been
employed as a
[[Page 41084]]
physician at Accident Care and Treatment Center (``ACTC''). [Tr. 231].
---------------------------------------------------------------------------
\5\ While Respondent was technically an employee of St. Mary's,
he principally worked at Red Carpet, a clinic across the street from
the hospital that at least one witness described as ``a private
practice.'' [Tr. 78, 100, 130, 131, 150]. Respondent was the only
physician working at Red Carpet, and he designed the clinic's name
and logo. [Tr. 78, 130, 135-136, 150].
---------------------------------------------------------------------------
On June 29, 2005, Respondent was issued DEA Certificate of
Registration (``COR'') Number BH9311604, which is the COR at issue in
this case. [Gov't Exh. 22 at 3]. That COR expired by its terms on
October 31, 2013. [Tr. 27, ALJ Exh. 14]. Respondent also holds an
active, valid license to practice medicine in the State of Oklahoma and
an active, valid license from the Oklahoma Bureau of Narcotics to
handle controlled substances. [ALJ Exh. 14].
C. Respondent's Substance Abuse
In 2009, while Respondent was employed at Digestive Disease
Specialists, Respondent met and began an extra-marital relationship \6\
with A.B.,\7\ a medical assistant employed at the same location. [Tr.
78-79, 194-95, 250]. Respondent first became aware that A.B. was
abusing controlled substances in November of 2010, when she called him
and asked him to bail her out of jail after she was charged with
possession of marijuana, a controlled substance. [Tr. 195-96]. Soon
after that, in December 2010, Respondent began using illegal substances
with A.B. and eventually moved in with A.B. on July 4th or 5th, 2011.
[Tr. 195, 196, 198, 199].
---------------------------------------------------------------------------
\6\ Despite the Government's argument that Respondent speaking
with co-workers about his relationship with A.B. is probative of
Factor Five, I ruled at the hearing that the details of Respondent's
romantic relationship with A.B. are not relevant to these
proceedings. [Tr. 81, 86-87]. I now reaffirm that ruling, and only
mention Respondent's relationship to give factual context to the
events that led to Respondent's drug abuse and improper prescribing,
which are, of course, relevant. In making my determinations about
whether Respondent's registration is in the public interest, I
assign no weight to Respondent's marital indiscretions.
\7\ Before the hearing, I issued a Protective Order which
protects the identities of third parties in these proceedings. [ALJ
Exh. 12].
---------------------------------------------------------------------------
Respondent credibly testified, and the Government did not refute,
that before moving in with A.B., Respondent had never taken
amphetamines or methamphetamine. [Tr. 194-95]. Also, Respondent
credibly testified, and the Government did not refute, that he has
never been charged with or convicted of any crimes involving illegal
substances. [Tr. 195; ALJ Exh. 14].
Several St. Mary's employees testified that they noticed ``red
spots,'' ``boils,'' or ``lesions'' on Respondent's neck and elbow on at
least two occasions. [Tr. 86; 119-122]. Although the reason for the
Government soliciting testimony about the red spots is unclear, the
insinuation seemed to be that the red spots were an indication of drug
use. [Tr. 119. 121-22 (Government witness describing marks on the
fleshy area of the elbow)]; 199 (Respondent counsel stating that
``[t]here's been insinuations at least by the Government that
[Respondent was] IV drug-using'')]. Respondent denied ever using IV
drugs, [Tr. 199], and, other than the red spots, the Government offered
no evidence to the contrary. Indeed, a drug screen taken by Respondent
in July of 2011 did not indicate any such use, and the witnesses who
testified about the spots never explicitly linked the spots to drug
use. In fact, the witness the Government used as an expert linked the
spots to a bacteria, not to drug use. [Tr. 120-21]. While cross
examining this expert, Respondent's attorney suggested that the
explanation for the red spots was Respondent's cycstic acne. [Tr. 124-
25]. At that time, the Government's witness admitted that it was beyond
the scope of her expertise to testify about such conditions. [Tr. 125].
The Government's witness also testified that the red spots ``appeared
to be a boil, a bite,'' [Tr. 121], which is consistent with what
Respondent told his receptionist when she inquired about the spots,
[Tr. 86]. Given the thin evidence offered by the Government regarding
the source of the red spots on Respondent's skin and Respondent's
several explanations for the spots, I find that the Government failed
to meet its burden of proof to show that Respondent used IV drugs or
that the red spots on Respondent's elbow and neck were related to
illicit drug use.
Respondent's receptionist at Red Carpet, Brenda Martin, testified
that Respondent told her that he had been present on at least one
occasion while A.B. made a ``drug run.'' [Tr. 81-82; see also Gov't
Exh. 19]. Ms. Martin noted, however, that Respondent pointed out he did
not participate in the drug transactions; he stayed in the back seat of
the car while the transaction was completed. [Tr. 81-82]. Ms. Martin
also testified that in conversations she had with Respondent, he
admitted to being present while A.B. and her associates were ``in the
garage making meth,'' although Respondent also told Martin that he
``didn't have anything to do with it.'' [Tr. 85].
Several witnesses testified that at some point during his
employment at St. Mary's, Respondent began coming to work tired and
tardy on a regular basis.\8\ [Tr. 85, 94 (testimony of Brenda Martin);
104 (testimony of Michelle Lee Bays); 139 (testimony of Krista Ann
Roberts); 241-44 (testimony of Respondent)]. Ms. Martin testified that
Respondent's fatigue got so bad that he would take ``catnap[s]'' in his
office between patient visits and had to reschedule several
appointments after being late to work. [Tr. 83-84]. Staff members took
special notice of Respondent's fatigue when they saw an incoherent
notation written by Respondent on a patient's progress note that
referenced the patient ``still having pain from right pink chair.''
[Tr. 85-86, 139; Gov't Exh. 17]. Respondent corrected the error by
creating a new note from memory of the patient visit, and he admitted
that he had trouble focusing the day he wrote the original note. [Tr.
136-140; Gov't Exh. 17].
---------------------------------------------------------------------------
\8\ The witnesses at the hearing did not all agree on the
longevity of Respondent's fatigue and tardiness. Ms. Martin
testified that for the first few months she worked for Respondent,
Respondent was ``very efficient and punctual'' and that Respondent's
fatigue began approximately one month before his termination. [Tr.
91, 93; Gov't Exh. 9]. Respondent himself also testified that
``[m]ost of my, quote, tiredness came during the month of July.''
[Tr. 243]. Michelle Bays, the St. Mary's employee in charge of
overseeing day-to-day operations at hospital clinics, is the only
witness who testified that Respondent's fatigue and tardiness lasted
longer than a month. She testified that the fatigue and tardiness
occurred for ``more than a month and a half'' and that ``[i]t was an
issue for the time I--my whole time when I worked with him.'' [Tr.
100, 106]. Ms. Bays's recollection of the chronology of events,
however, is not reliable for several reasons. First, as noted above,
her testimony regarding the timing of Respondent's fatigue and
tardiness conflicts with the testimony of two other witnesses.
Second, she testified that she began overseeing Red Carpet in
September 2009 and that Respondent ``was already there'' at that
time, [Tr. 100], but it is clear from the record that Respondent did
not begin working at Red Carpet until June 2010 [Gov't Exh. 6 at 2;
Tr. 131]. Thus, while I find Ms. Bays to be generally credible, I
find that her testimony regarding the timing of events in this case
not credible. I also find that Respondent's tiredness and tardiness
at work occurred approximately during the month immediately
preceding his termination from St. Mary's.
---------------------------------------------------------------------------
Respondent's staff at Red Carpet expressed their concerns about
Respondent's tardiness, fatigue, and personal life to Michelle Bays,
the practice administrator at St. Mary's. [Tr. 100, 104-105]. As a
result of these reports, St. Mary's solicited a signed statement from
Ms. Martin about her conversations with and observations of Respondent
while at work. [Tr. 102-05; Gov't Exh. 19]. Respondent voluntarily
submitted to a drug test, apparently requested by St. Mary's,\9\ on
July 18, 2011. [Tr. 115-116, 205; Gov't Exh. 8]. The drug test came
back positive for marijuana, methamphetamine, and amphetamines, and
resulted in Respondent's termination from St. Mary's in August, 2011.
[Tr. 118, 120, 131, 206, 245; Gov't Exh. 8]. Respondent admits to using
methamphetamine, but at the hearing he offered explanations
[[Page 41085]]
for why marijuana and amphetamines were in his system. [Tr. 245].
---------------------------------------------------------------------------
\9\ The Government's witnesses did not explain who requested the
drug test, but Respondent, when asked who initiated the test,
testified that Michelle Bays ``escorted me to the facility where
[the drug test] was done.'' [Tr. 205].
---------------------------------------------------------------------------
Regarding Respondent's methamphetamine use, Respondent credibly
testified that he began using it in December 2010 and stopped around
August of 2011. [Tr. 196-97]. Respondent testified that he used
methamphetamine ``maybe twice a month'' before moving in with A.B. in
July of 2011, and ``maybe once or twice a week at most'' after moving
in with A.B. [Tr. 197]. Respondent also credibly testified that before
becoming involved with A.B., he had never used methamphetamine or any
other illicit drug. [Tr. 196]. The Government offered no evidence
rebutting this testimony.
With respect to the positive result for marijuana on the drug test,
Respondent credibly testified that marijuana was in his system at the
time of the drug screen because he was ``exposed'' to it while living
with A.B., who regularly smoked marijuana with her associates. [Tr.
245]. Dr. Westcott, whom I certified at the hearing as an expert in
addiction management, testified that second-hand marijuana smoke could
cause a positive result on a drug screen if the subject were exposed to
a concentrated amount, but also testified that positive results for
marijuana on a drug screen normally mean the subject used the drug.
[Tr. 379-82]. The Government, on the other hand, presented no evidence
to rebut Respondent's explanation for the drug test's positive result
for marijuana, opting instead to simply argue that Respondent's
explanation was an ``attempt[] to minimize the significance of his
failed drug screen.'' [Government Brief (``Gov't Br.'') at 33].
To be sure, Respondent has used marijuana in the past. At the Board
hearing, Respondent testified that he had used marijuana with friends
on a ``sporadic, recreational'' basis. [Gov't Exh. 21 at 11].
Furthermore, Respondent's discharge summary from Sant[eacute], appended
to the Board hearing transcript, notes that Respondent had
``secondary'' issues with ``cannabis abuse.'' [Gov't Exh. 21, Attach.
1]. But none of this evidence contradicts Respondent's testimony at the
hearing in these proceedings regarding his marijuana use. In these
proceedings, Respondent never testified that he had never used
marijuana; Respondent merely testified that the particular drug screen
he failed was the result of exposure to marijuana rather than his
personal use. [Tr. 245]. Indeed, the Government never asked Respondent
generally whether he had ever used marijuana; it only asked whether the
failed drug screen was the result of marijuana use. [Tr. 245]. In
context, this testimony cannot be construed as a general denial by
Respondent of any and all allegations of marijuana use. Thus,
Respondent's testimony is not inconsistent with other evidence that
proves Respondent has used marijuana in the past.
I therefore find that Respondent's explanation for the positive
marijuana result on the drug screen, which was corroborated by Dr.
Westcott's testimony on cross examination and unrebutted by the
Government, is credible. I also find that Respondent has used marijuana
in the past, but that the frequency of such use is unclear from the
record. In the absence of any evidence to rebut Respondent's credible
testimony regarding the drug test, however, I find that the Government
failed to establish that the positive result for marijuana on the drug
test was the result of Respondent's personal use.
With respect to the drug screen's positive result for amphetamines,
Respondent testified that amphetamines were in his system due to a
prescription drug he was taking called Vyvanse. Respondent and Dr.
Westcott both testified that Vyvanse is a medication used to treat
Attention Deficit Disorder (``ADD''), and that it is ``in the
amphetamine class.'' [Tr. 246-48, 382-83]. Respondent testified that he
was issued a valid prescription for Vyvanse in 2009, and began taking
pills leftover from that prescription every day when ADD symptoms began
to reoccur about a week and a half before he failed the drug screen at
St. Mary's. [Tr. 246, 248-49]. This explanation is corroborated by two
exhibits the Government itself introduced. First, the Board Order found
that Respondent ``contacted the Board and confirmed that he had tested
positive for . . . Vyvanse.'' [Gov't Exh. 6 at 2]. Second, at the Board
hearing, Respondent testified to the same facts regarding his Vyvanse
use as he did at the hearing in these proceedings. [Gov't Exh. 21 at
14-15]. Respondent and Dr. Westcott also testified that Vyvanse stays
in the system for at least two days, and that in a drug test it would
likely result in a positive result for amphetamines. [Tr. 248, 383].
Similar to its approach to the marijuana issue, the Government opted to
not offer any evidence to rebut Respondent's explanation of the
positive amphetamine result, instead arguing that ``Respondent would
have the Court believe [his] less than plausible explanation in the
face of unrefuted evidence that he tested positive at a time when he
was dating a methamphetamine addict and living at her house where
methamphetamine was manufactured.'' \10\ [Gov't Br. at 33]. This
circumstantial evidence is not convincing in light of the credible
testimony Respondent gave at the hearing in these proceedings, which
was nearly identical to the testimony he gave at the Board hearing. I
therefore find that the Government has failed to establish that
Respondent improperly used amphetamines.
---------------------------------------------------------------------------
\10\ The Government also suggested, without overtly accusing,
that Respondent acted improperly by taking ``a two year-old
prescription for which he did not seek the care of a doctor in a
recent visit.'' [Gov't Br. at 33 (emphasis in original); Tr. at 246
(Government counsel asking Respondent, ``So you took it outside the
usual course of professional practice[?]'')]. The Government,
however, cites no regulation, and I can find none, that forbids the
use of ``leftover'' prescription drugs. Further, the Government has
offered no evidence to establish that the Respondent's prescription
for Vyvanse restricted his use of the drug two years after the
issuance of the prescription. I therefore find that the Government
failed to establish any wrongdoing by Respondent regarding his
consumption of Vyvanse.
---------------------------------------------------------------------------
Respondent further testified that he never possessed or used
illicit drugs while at work, and St. Mary's employees testified that
they never concluded otherwise. [Tr. 123, 149, 200-01]. The Government
refutes Respondent's assertion, arguing that Respondent's use of
illicit drugs at work is evidenced by the fact that ``he tested
positive for these drugs while on the job and commuted a great distance
to his job.'' [Gov't Br. at 29-30]. Yet, Respondent's expert witness
testified on cross examination that methamphetamine and amphetamines
stay in the system for two to four days, and Respondent testified that
it was ``widely known'' that marijuana can stay in your system for up
to thirty days. [Tr. at 254, 382]. The Government failed to introduce
any evidence to rebut this testimony, making considerably less
plausible the suggestion that Respondent's drug use at home would wear
off during his long commute. I therefore find that the Government
failed to establish that Respondent used or possessed illicit drugs
while at work.
Within hours of his termination, which immediately followed his
failed drug test, Respondent voluntarily reported himself to the State
Board of Osteopathic Examiners (``State Board'' or ``Board'') and the
Oklahoma Health Professional Program (``OHPP''). [Tr. 206-07; Gov't
Exh. 6 at 2]. However, Respondent did not report himself to the DEA.
[Tr. 273]. In fact, Respondent did not communicate with the DEA about
his drug abuse until about a year later. [Tr. 274].
As a result of Respondent contacting the Board, the Board conducted
an investigation and held a hearing on June 21, 2012, after Respondent
returned
[[Page 41086]]
home from in-patient therapy.\11\ [Gov't Exh. 6 at 1; Tr. 207-208]. The
same day as the hearing, the Board issued a Findings of Fact,
Conclusions of Law, and Agreed Order of Probation (``Board Order''),
which is pertinent to these proceedings and binding on this Court under
the principles of collateral estoppel. [Gov't Exh. 6; Tr. 30]; David A.
Ruben, 78 FR 38,363, 38,365 (DEA 2013); Robert L. Dougherty, M.D., 76
FR 16,823, 16,830 (DEA 2011). Specifically, in relation to Respondent's
drug abuse, the Board found the following:
---------------------------------------------------------------------------
\11\ As explained below, the hearing took place so long after
Respondent's termination from St. Mary's because Respondent had
checked into an in-patient rehabilitation center and his hearing was
continued. [See Gov't Exh. 5].
3. On or about August 2, 2011, St. Mary's Regional Medical Center
(``Hospital'') in Enid, Oklahoma terminated Dr. Horst's employment at
the Hospital. Dr. Horst had failed a drug screen and tested positive
for marijuana, methamphetamine and another drug.
4. Dr. Horst contacted the Board and confirmed that he had tested
positive for marijuana and a C-II medication Vyvanse for ADHD. Dr.
Horst also confirmed that the Hospital had terminated his employment.
[Gov't Exh. 6 at 2]. Respondent stipulated to and ``[did] not contest
any of the factual allegations raised by the Board.'' [Gov't Exh. 6 at
2]. Respondent also testified at the hearing in the present proceedings
that he agreed with the Board's findings. [Tr. 217].
D. Improper Prescriptions
In addition to Respondent's illicit drug use, the Government
proved, and Respondent admitted, that Respondent issued illegitimate
prescriptions for purposes other than legitimate medical purposes. [Tr.
170-172, 201-04; Gov't Exhs. 9-14, 16]. Respondent wrote the
prescriptions in question for three patients: A.B., Z.M., and S.M. [Tr.
170-172, 201-04; Gov't Exhs. 9-14, 16]. Patient A.B. was the same A.B.
with which Respondent was romantically involved, and the other two were
A.B.'s friends. [Tr. 201, 203]. Respondent admitted that he knew A.B.
abused controlled substances when he issued her the improper
prescriptions. [Tr. 196-97, 251-52].
To prove Respondent illegitimately issued the prescriptions in
question, the Government offered Dr. Arthur Douglas Beacham, III as an
expert witness in the area of osteopathic medicine with an emphasis in
pain management. [Tr. 164; Gov't Exh. 15]. Dr. Beacham reviewed patient
files and prescriptions written by Respondent for A.B., Z.M., and S.M.,
and testified that he could ``find no documentation that would support
the legitimate medical purpose of controlled medications.'' [Tr. 170-
172; Gov't Exhs. 9-14, 16]. Specifically, Dr. Beacham testified that
there was ``no documentation to support history or present illness or a
physical exam or an assessment nor a plan.'' [Tr. 172-73]. Thus, Dr.
Beacham concluded that, in his expert opinion, ``the prescriptions were
written for a matter outside medical necessity.'' [Tr. 173-74]. Dr.
Beacham also prepared a report containing these same conclusions, which
was also admitted into evidence without objection. [Tr. 171; Gov't Exh.
16]. Respondent admitted to issuing the improper prescriptions and did
not refute the testimony of the Government's expert witness. [Tr. 201-
04].
Respondent filed the patients' records of A.B., S.M., and Z.M. in
his own desk rather than with Red Carpet's other patient files. The
records were found by a St. Mary's employee \12\ in Respondent's desk
drawer after Respondent's termination from St. Mary's, and Respondent
admits that he should have filed those files with the rest of the
clinic's records. [Tr. 131-36, 203; Gov't Exhs. 9-11].
---------------------------------------------------------------------------
\12\ There are no allegations of privacy invasions regarding the
St. Mary's employee finding the files in Respondent's desk drawer.
The St. Mary's employee who found the patient files in Respondent's
desk, Krista Roberts, testified that she found the files after she
offered to help Respondent clean out his desk and that Respondent
consented to her help. [Tr. 132-33].
---------------------------------------------------------------------------
The Board Order included factual findings regarding Respondent's
illegitimate prescriptions. These findings, as noted above, are binding
on this court. Ruben, 78 FR at, 38,365; Dougherty, 76 FR at 16,830.
Specifically, the Board found the following:
6. Upon Dr. Horst's termination of employment by [St. Mary's],
staff at the [Red Carpet] Clinic discovered patient charts in Dr.
Horst's office that were kept separate and apart from the Clinic's
patient records. These separate charts represented patients never
scheduled or seen by Clinic staff. They represent patients AB, SM, and
ZM.
7. Patient AB's chart includes a patient registration and medical
history, but no physical examination. Chart is on the Clinic's patient
record forms. There are no prescribed medications or exam notes
recorded. Beginning July 29, 2010 Dr. Horst issued to patient AB
sixteen (16) prescriptions of controlled dangerous substances (CDS)
with seventeen refills up until his termination by the Hospital. None
of these prescriptions are charted. They include Hydrocodone,
Promethazine with Codeine syrup, and Alprazolam. Dr. Horst admitted
that he had an extramarital affair with patient AB.
8. Patient SM's chart includes a patient registration and medical
history, but no physical examination. Chart is on the Clinic's patient
record forms. There are no prescribed medications or exam notes
recorded. Beginning January 27, 2011 Dr. Horst issued patient SM two
(2) CDS prescriptions of Hydrocodone with one (1) refill. None of these
prescriptions are charted.
9. Patient ZM's chart includes a medical history, but no patient
registration and no physical examination. Chart is on the Clinic's
patient record forms. There are no prescribed medications or exam
notes. On November 29, 2010 Dr. Horst issued patient ZM one (1) CDS
prescription of Hydrocodone with two (2) refills. This prescription is
not charted.
[Gov't Exh. 6 at 2-3]. As noted above, Respondent stipulated to all of
these facts at the Board hearing and testified at the hearing in the
present proceedings that he agreed with the Board's findings. [Gov't
Exh. 6 at 2; Tr. 217]. Additionally, the Board concluded that
Respondent's actions constituted ``a violation of the Oklahoma
Osteopathic Medicine Act, 59 O.S. Sec. Sec. 620 et seq., and
specifically . . . Sec. 637(A)(2)(f)(g)(12) and (13).'' [Gov't Exh. 6
at 4].
E. Respondent's Remedial Actions and Oversight of Respondent
Upon suggestion by the former OHPP president, Respondent checked
himself into an in-patient rehabilitation facility in Argyle, Texas,
called Sant[eacute] Center for Healing (``Sant[eacute]'') on October
12, 2011. [Tr. 208-09]. Respondent testified that he paid for his time
at Sant[eacute] by ``cash[ing] in everything we had as far as IRAs,
401(k)s, profit-sharing, anything that we'd saved up over the years.''
[Tr. 210]. Half of the money Respondent gathered went to Sant[eacute],
and the other half ``went to sustaining [his] family while [he] was
gone.'' [Tr. 210]. Respondent also testified that even after ``cashing
out'' many of his assets, Respondent still owes Sant[eacute] $87,000.
[Tr. 210].
Respondent described his experience at Sant[eacute] as
``intensive,'' especially in the beginning. [Tr. 209-210]. The staff
there did various tests and evaluations on Respondent when he arrived,
and the daily therapy regimen started early in the morning and lasted
until 7:00 p.m., utilizing several different techniques such as group
and one-on-one therapy. [Tr. 209-210]. While at Sant[eacute],
Respondent was required to isolate
[[Page 41087]]
himself from those outside the treatment facility, and was not even
permitted to discuss medical issues with other patients. [Tr. 214-15].
Respondent candidly admitted during direct examination that ``it was a
little bit difficult to acclimate myself for the first few weeks,
probably six weeks,'' but after the initial acclamation phase, he
``became a model participant.'' [Tr. 210; see also Tr. 258-260; but see
Tr. 408; Gov't Exh. 21, Attach. 1]. On cross examination, Respondent
also admitted that he broke a ``no female contract'' at Sant[eacute] by
having a sexual relationship with a female patient.\13\ [Tr. 260-64].
---------------------------------------------------------------------------
\13\ I admitted evidence of this relationship for impeachment
purposes only. [Tr. 292-93].
---------------------------------------------------------------------------
In addition to his drug abuse therapy, Respondent completed a
program at Sant[eacute] entitled ``Maintaining Proper Boundaries,''
which, according to a letter from the medical director at Sant[eacute],
is a comprehensive educational and experiential course designed to
address the factors that lead to boundary violations, result from
boundary violations and are required in the reparation and prevention
of any further boundary issues. The course focuses particularly on
sexual boundary issues: including sexual boundary transgressions and
interpersonal sexual boundary violations, however also recognizes
verbal, ethical, moral and legal boundary violations.
[Resp't Exh.. 3; Tr. 212-13].
Respondent completed his time at Sant[eacute] on May 25, 2012,
whereupon he received a ``certificate of sobriety.'' [Resp't Exh. 2;
Tr. 213-14, 224]. Respondent testified that his ``sobriety date'' is
October 12, 2011. [Tr. 208-09].
Respondent testified that in June 2012, after returning from seven
months of therapy at Sant[eacute], he met with State Board members and
investigators to discuss how he can ``make things right and get on with
my life, and hopefully piece my career and life back together.'' [Tr.
217-18]. On June 21, 2012, the Board held a hearing for Respondent's
case, which was attended by Respondent without counsel, and issued the
Board Order the same day. [Gov't Exh. 6]. The Board Order, to which
Respondent had previously agreed in his meeting with the Board members,
placed Respondent's medical license on five years' probation and
required that Respondent (1) enter into and comply with a contract with
OHPP; (2) regularly attend counseling sessions with ``A Chance to
Change'' and report to the Board on his progress in counseling; (3)
have no contact with A.B.; (4) appear at the next regularly scheduled
Board meeting and, when requested, at subsequent Board meetings; and
(5) reimburse the Board for the costs it incurred in conducting its
proceedings. [Gov't 6 at 4; Tr. 217-20].
Respondent's agreement with the OHPP required Respondent to submit
to random bimonthly drug tests and attend at least 75 percent of the
weekly ``Caduceus meetings'' conducted by OHPP. [Tr. 218-19; Resp't
Exh. 1]. Caduceus meetings are similar to Alcoholics Anonymous
meetings, but tailored specifically for physicians. [Tr. 351-52]. Dr.
Robert Westcott, the president of the OHPP, testified that Caduceus
meetings are a place where physicians can ``discuss issues about being
in recovery and being a physician that you really can't talk about in
just a regular open AA meeting.'' [Tr. 352]. Respondent testified that
since entering into an agreement with OHPP, he has not failed any of
his required drug tests and has 100 percent attendance at the weekly
Caduceus meetings.\14\ [Tr. 219-21]. Respondent testified that the OHPP
has also asked him to ``attend other 12-step type meetings,'' and that
he normally attends those meetings two or three times per week. [Tr.
219]. Respondent also offered into evidence an attendance log which
showed that between June 16, 2012, and September 12, 2013, Respondent
attended Alcoholics Anonymous meetings almost every week, usually
attending more than one meeting per week.\15\ [Resp't Exh. 4; Tr. 221-
23].
---------------------------------------------------------------------------
\14\ Although the letter from OHPP offered into evidence by
Respondent reports slightly less than 100 percent attendance,
[Resp't Exh. 1], Respondent credibly testified on direct examination
that the reason for the discrepancy is that he was not aware of the
sign-in procedures during the first few weeks he attended the
meetings. [Tr. 219]. In any case, both the letter from the OHPP and
Respondent's testimony verify that Respondent has been faithful to
his contract with the OHPP regarding meeting attendance.
\15\ The attendance logs indicated that Respondent did not
attend OHPP meetings for the weeks of July 8-14, 2012, September 16-
22, 2012, October 21-27, 2012, October 28-November 3, 2012, January
13-19, 2013, and April 7-13, 2013. [Resp't Exh. 4]. However, the
logs do not indicate whether meetings were scheduled during those
weeks; they only list the meetings Respondent actually attended.
Thus, it is impossible to tell from the logs alone what percentage
of scheduled meetings Respondent attended.
---------------------------------------------------------------------------
Dr. Westcott, the president of the OHPP, testified that Respondent
has fully cooperated with his OHPP contract, that Respondent has ``done
very well'' in his recovery, and that he has ``every reason to believe
that [Respondent will] continue to do so.'' [Tr. 372, 377]. He also
testified that under OHPP supervision, ``it would (be) very, very
unusual for a person to be able to use and continue to use without
being caught.'' [Tr. 369]. In fact, Dr. Westcott testified that the
OHPP has a 90% success rate of helping physicians stay sober. [Tr. 367-
68]. The Government offered no evidence to refute that Respondent has
been diligent in abiding by the terms of his probation.
In addition to the conditions of Respondent's probation, the Board
itself conducts a certain amount of oversight over physicians who have
been disciplined. Most notably, at least every quarter, the Board uses
the Prescription Monitoring Program (``PMP'') \16\ to review the
prescriptions issued by disciplined physicians. [Tr. 370-71]. DEA
investigators also have access to the PMP, and use it to monitor
registrants suspected of misconduct. [See Tr. 39-40].
---------------------------------------------------------------------------
\16\ DI Survovec described the PMP as ``a real-time recording of
controlled substance prescriptions that are issued.'' [Tr. 40]
---------------------------------------------------------------------------
Respondent is also subject to oversight at his current place of
employment, ACTC. [Tr. 422]. Dr. Richard Swenson, the medical director
in charge of supervising the physicians at ACTC, testified that the
``locked cabinet or closet'' in which the controlled substances are
stored at ACTC is ``under constant video surveillance'' and the drugs
themselves are not dispensed by the physicians. [Tr. 418, 438].
Respondent is not permitted to issue prescriptions for controlled
substances; he must obtain approval from a doctor with an unfettered
license who personally meets and examines the patient before issuing
the prescription. [Tr. 419, 437-38].
Although no formal procedures are in place for licensed physicians
to review Respondent's charts, Dr. Swenson testified that almost all of
the clinic's patients come in for multiple visits and see multiple
doctors throughout the course of their treatment. As such, the charts
for each patient are normally reviewed by multiple doctors. [Tr. 423-
24, 433]. Dr. Swenson also testified that ACTC has a ``no tolerance''
policy regarding diversion of controlled substances, meaning he would
immediately report any concerns of diversion. [Tr. 424-25]. On cross
examination, Dr. Swenson testified that ACTC does not conduct drug
screens or enter into pain contracts before prescribing controlled
substances known to be abused. [Tr. 433-36]. However, Dr. Swenson
explained that such precautions are normally used only at ``chronic
pain management clinics.'' [Tr. 434]. Even Group Supervisor John
Kushnir, the Government's representative at counsel table at the
hearing, testified that while ACTC had some minor bookkeeping
[[Page 41088]]
issues, the oversight ACTC conducts over controlled substances
dispensing is ``good.'' [Tr. 335].
Notably, ACTC has experience with disciplined physicians because it
works with the State Board to employ disciplined physicians. [Tr. 420-
21]. This practice began under the clinic's former medical director,
who had himself experienced substance abuse problems and was
``interested in seeing what he could do to help other providers that
found themselves in that same circumstance.'' [Tr. 421]. Other than
Respondent, ACTC currently employs one other physician and one medical
assistant with restricted licenses. [Tr. 420, 421]. Dr. Swenson
testified that ACTC has a good track record of helping physicians
remain sober and reestablish their professional careers. [Tr. 421-22].
F. DEA Investigations of Respondent
DEA first interviewed Respondent in August of 2012, after learning
that Dr. Horst's medical license had been put on probation by the State
Board. [Tr. 26, 32]. In attendance at that interview were Diversion
Investigator Mary Surovec, Group Supervisor John Kushnir, Respondent,
and Dr. Robert Westcott. [Tr. 32]. Dr. Westcott attended the meeting at
the request of Respondent. [Tr. 32, 275, 387]. Notably, DI Surovec
testified that when asked about the allegations in the Board Order,
Respondent ``didn't really deny anything.'' [Tr. 33]. DI Surovec and GS
Kushnir also asked Respondent to surrender his DEA registration. [Tr.
32, 55, 226, 318]. Respondent asked what his options were, and he was
told that he could either surrender his license or be served with an
order to show cause. [Tr. 56, 227, 320]. Respondent told DI Surovec and
GS Kushnir that ``he was going to think about surrendering.'' [Tr. 33;
227]. Respondent testified that he was hesitant to surrender his COR
because other physicians had told him that after surrendering a DEA
registration, ``you never get it back.'' [Tr. 276].\17\ Indeed, both DI
Surovec and GS Kushnir testified that they did not recall making any
indications to Respondent that he would be able to regain a surrendered
COR through demonstrated compliance and rehabilitation. [Tr. 61-62].
---------------------------------------------------------------------------
\17\ The Government sought testimony from Dr. Westcott that, in
fact, he was the one who advised Respondent to not surrender his
registration, but Dr. Westcott credibly denied doing such. [Tr. 391-
392].
---------------------------------------------------------------------------
V. STATEMENT OF LAW AND DISCUSSION
A. Positions of the Parties
1. Government's Position
The Government timely filed Government's Proposed Findings of Fact
and Conclusions of Law (``Government's Brief'') with this Court on
January 31, 2014. In its brief, the Government set forth proposed
findings of fact, conclusions of law, and arguments in favor of denying
Respondent's COR. The Government argues that it met its burden of
proving a prima facie case, primarily focusing on factors two, four,
and five of the public interest analysis set forth in 21 U.S.C. 823(f).
[Gov't Br. at 24, 28].
With respect to factors two and four, the Government points out
that Respondent stipulated to the factual allegations in the Board
Order regarding his positive drug test and improper issuing of
prescriptions. [Id. at 25]. Moreover, the Government relies on its
expert witness, who testified that Respondent's prescribing of
controlled substances to A.B., S.M., and Z.M. were without a legitimate
medical purpose. [Id. at 25-27].
Regarding factor five, the Government argues that Respondent's
actions of prescribing controlled substances to A.B., someone he knew
to be a drug abuser, were particularly harmful to the public health and
safety given Respondent's ``practic[e] as a solo gastroenterologist in
a small community.'' [Gov't Br. at 28-29]. The Government also argues
that Respondent's admitted abuse of illicit and controlled substances
also posed a threat to public health and safety. [Id. at 29]. Although
Respondent insists that he never used or possessed illicit drugs at
work, the Government argues that ``the sheer fact that he tested
positive for these drugs while on the job and commuted a great distance
to his job demonstrates that Respondent's behavior while he was
employed as a physician caused a threat to the public health and
safety.'' [Id. at 29-30].
The Government also argues that Respondent's remedial actions are
not sufficient to entrust him with a DEA COR because Respondent has
demonstrated a lack of candor with the DEA. The Government points out
that (1) Respondent did not report to DEA the positive results of the
drug test he took while working for St. Mary's, (2) Respondent ``could
not admit that his self-abuse . . . contributed to his inability to
perform as a doctor,'' (3) Respondent's testimony was ``rife with
inconsistencies,'' and (4) Respondent was not forthright in his
testimony about his experience at Sant[eacute]. [Gov't Br. at 32-33].
Finally, the Government argues that even if Respondent has shown
sufficient remorse and instituted remedial measures, his actions were
too egregious to warrant his registration. [Gov't Br. at 34-36].
Further, the Government argues that in light of the current
prescription drug abuse epidemic, the need to deter improper
prescribing weighs in favor of denying Respondent's registration. [Id.
at 36].
2. Respondent's Position
Respondent timely filed Respondent's Proposed Findings of Fact,
Conclusions of Law, and Argument (``Respondent's Brief'') on January
30, 2014. Therein, Respondent ``fully admits to writing improper
prescriptions to three individuals'' and ``further admits to using
methamphetamine, sometimes as often as twice a week.'' [Resp't Br. at
7]. Respondent also notes that the entirety of his impropriety was
during a six month time period, but does not dispute that the
Government has proved its prima facie case. [Id.].
Rather, Respondent argues that it has rebutted the case against him
with evidence that he takes responsibility for his actions and has
instituted sufficient remedial actions to justify his registration.
Respondent argues that he has made ``significant, dramatic, and
substantial efforts at rehabilitation and [has] demonstrated commitment
to fully comply with any and all regulations placed upon him by state
licensure boards.'' [Id. at 7]. In particular, he argues that his
participation in (1) a seven-month inpatient substance abuse program,
(2) boundaries training, (3) OHPP programs, (4) random drug testing,
and (5) support groups demonstrate his commitment both to recovery from
substance abuse and compliance with the Board's conditions of
licensure. [Id.]. Respondent also argues that his substance abuse was
short-lived, and that he has now been sober for over two years. [Id.].
Moreover, Respondent argues that his circumstances have ``changed
drastically since the time of his misconduct''; he has reconciled with
his wife, attended family counseling, ended his relationship with A.B.,
and even shortened his commute to work. [Id. at 9].
B. Statement of Law and Analysis
Pursuant to 21 U.S.C. 823(f) (2011), the Deputy Administrator may
deny an application for a DEA COR if he determines that such
registration would be inconsistent with the public
[[Page 41089]]
interest.\18\ Similarly, pursuant to 21 U.S.C. 824(a)(4), the Deputy
Administrator may revoke a DEA COR, if he determines that such
registration would be inconsistent with the public interest. In
determining the public interest, the following factors are considered:
---------------------------------------------------------------------------
\18\ The Deputy Administrator has the authority to make such a
determination pursuant to 28 CFR 0.100(b), 0.104 (2013).
(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) (2011).
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
a registration should be revoked or an application for registration be
denied. See Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (DEA 2003)
(citing Henry J. Schwartz, Jr. M.D., 54 FR 16,422, 16,424 (DEA 1989)).
Moreover, the Deputy Administrator is ``not required to make findings
as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
Thus, ``this is not a contest in which score is kept; the Agency is not
required to mechanically count up the factors and determine how many
favor'' each party. Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (DEA
2009). ``Rather, it is an inquiry which focuses on protecting the
public interest[.]'' Id.
The Government bears the ultimate burden of proving that the
requirements for registration are not satisfied. 21 CFR 1301.44(d)
(2014). Specifically, the Government must show that Respondent has
committed acts that are inconsistent with the public interest. 21
U.S.C. 823(f); Jeri Hassman, M.D., 75 FR 8,194, 8,227 (DEA 2010).
However, where the Government has made out a prima facie case that
Respondent's application would be ``inconsistent with the public
interest,'' the burden of production shifts to the applicant to
``present[ ] sufficient mitigating evidence'' to show why he can be
trusted with a new registration. See Medicine Shoppe--Jonesborough, 73
FR 364, 387 (DEA 2008). To this point, the Agency has repeatedly held
that the ``registrant must accept responsibility for [his] actions and
demonstrate that [he] will not engage in future misconduct.'' Id.; see
also Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (DEA 2007). The
Respondent must produce sufficient evidence that he can be trusted with
the authority that a registration provides by demonstrating that he
accepts responsibility for his misconduct and that the misconduct will
not reoccur. See id.; see also Samuel S. Jackson, D.D.S., 72 FR at
23,853. The DEA has consistently held the view that ``past performance
is the best predictor of future performance.'' Alra Laboratories, 59 FR
50,620 (DEA 1994), aff'd Alra Laboratories, Inc. v. DEA, 54 F.3d 450,
451 (7th Cir 1995).
Factor One: Recommendation of Appropriate State Licensing Board
Recommendations of state licensing boards are relevant, but not
dispositive, in determining whether a respondent should be permitted to
maintain a registration. See Gregory D. Owens, D.D.S., 74 FR 36,751,
36,755 (DEA 2009); see also Martha Hernandez, M.D., 62 FR 61,145,
61,147 (DEA 1997). According to clear agency precedent, a ``state
license is a necessary, but not a sufficient condition for
registration.'' Robert A. Leslie, M.D., 68 FR at 15,230; John H.
Kennedy, M.D., 71 FR 35,705, 35,708 (DEA 2006).
DEA possesses ``a separate oversight responsibility with respect to
the handling of controlled substances,'' which requires the Agency to
make an ``independent determination as to whether the granting of [a
registration] would be in the public interest.'' Mortimer B. Levin
D.O., 55 FR 8,209, 8,210 (DEA 1990); see also Jayam Krishna-Iyer, M.D.,
74 FR at 461. Even the reinstatement of a state medical license does
not affect this Agency's independent responsibility to determine
whether a DEA registration is in the public interest. Levin, 55 FR at
8,210. The ultimate responsibility to determine whether a registration
is consistent with the public interest has been delegated exclusively
to the DEA, not to entities within a state government. Edmund Chein,
M.D., 72 FR 6,580, 6,590 (DEA 2007), aff'd Chein v. DEA, 533 F.3d 828
(D.C. Cir. 2008).
Here, it is undisputed that Respondent holds a valid license to
practice medicine in the state of Oklahoma. [Gov't Br. at 21; ALJ Exh.
14]. Because his licensure does not constitute a recommendation from
the Board, however, I find that factor one weighs neither for nor
against Respondent's registration.
Factors Two and Four: Registrant's Experience with Controlled
Substances and Registrant's Compliance with Applicable State, Federal,
or Local Laws Relating to Controlled Substances
Respondent's experiences with handling controlled substances, as
well as his compliance with laws related to controlled substances, are
relevant considerations under the public interest analysis. Pursuant to
the Controlled Substances Act, ``[p]ersons registered by the Attorney
General under this subchapter to . . . dispense controlled substances .
. . are authorized to possess . . . or dispense such substances . . .
to the extent authorized by their registration and in conformity with
the other provisions of this subchapter.'' 21 U.S.C. 822(b); Leonard E.
Reaves, III, M.D., 63 FR 44,471, 44,473 (DEA 1998); see also 21 CFR
1301.13(a) (providing that ``[n]o person required to be registered
shall engage in any activity for which registration is required until
the application for registration is granted and a Certificate of
Registration is issued by the Administrator to such person.''). As
such, the DEA properly considers practitioners' past compliance with
CSA requirements and DEA regulations in determining whether registering
such a practitioner would be in the public interest.
The regulation applicable here is DEA's long-standing requirement
that a prescription be issued for ``a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'' Ralph J. Chambers, M.D., 79 FR 4,962, 4,970 (DEA 2014)
(quoting 21 CFR 1306.04(a)). DEA precedent further establishes that ``a
practitioner must establish and maintain a bona-fide doctor-patient
relationship in order to be acting `in the usual course of . . .
professional practice' and to issue a prescription for a `legitimate
medical purpose.' '' Paul H. Volkman, 73 FR 30,630, 30,642 (DEA 2008).
Whether a valid doctor-patient relationship was established is
determined by looking to state law. Id.
Here, Respondent issued prescriptions to A.B., S.M., and A.M.
outside the usual course of his professional practice. The Government's
expert credibly testified at the hearing that after reviewing the
prescriptions and the patient files, he could ``find no documentation
that would support the legitimate medical purpose of controlled
[[Page 41090]]
medications'' because there was ``no documentation to support history
or present illness or a physical exam or an assessment nor a plan.''
[Tr. 170-173; Gov't Exhs. 9-14, 16]. Dr. Beacham's written report
credibly reached these same conclusions. [Tr. 171; Gov't Exh. 16].
Respondent admitted to issuing the prescriptions improperly and did not
refute the testimony of the Government's expert witness. [Tr. 201-
04].\19\
---------------------------------------------------------------------------
\19\ The Government also produced evidence, and Respondent
admitted, that Respondent stored A.B.'s, S.M.'s, and Z.M.'s patient
files in his own desk rather than with Red Carpet's other patient
files. [Tr. 132-36, 203; Gov't Exhs. 9-11]. While this was certainly
suspicious and Respondent admitted it was improper, I can find no
regulation Respondent violated by storing the files in his desk, and
the Government cites none. Indeed, the Government's argument section
in its brief makes no mention of the location of the files.
---------------------------------------------------------------------------
In addition to his issuing of improper prescriptions, Respondent's
possession \20\ of methamphetamine violated federal law. Under the CSA,
it is ``unlawful for any person knowingly or intentionally to possess a
controlled substance unless such substance was obtained directly, or
pursuant to a valid prescription or order, from a practitioner, while
acting in the course of his professional practice.'' 21 U.S.C. 844(a).
It is undisputed that Respondent possessed methamphetamine, which is a
Schedule III controlled substance under 21 U.S.C. 812, without a
prescription. [See Tr. 200; Resp't Br. at 3].
---------------------------------------------------------------------------
\20\ In order to follow agency precedent, I will take into
consideration evidence of Respondent's self- abuse of illicit drugs
under the fifth public interest factor. Tony T. Bui, M.D., 75 FR
49,979, 49,989 (DEA 2010). Thus, under factor four I only consider
Respondent's possession of methamphetamine and not his use.
---------------------------------------------------------------------------
I find that Respondent's possession of a controlled substance
without a prescription, combined with his improper issuing of
prescriptions to A.B., S.M., and Z.M., clearly weigh against
Respondent's registration under factors two and four of the public
interest analysis.
Factor Three: Registrant's Conviction Record Relating to Controlled
Substances
Pursuant to 21 U.S.C. Sec. 823(f)(3), the Deputy Administrator may
deny a pending application for a certificate of registration upon a
finding that the applicant has been convicted \21\ of a felony related
to controlled substances under state or federal law. See Thomas G.
Easter II, M.D., 69 FR 5,579, 5,580 (DEA 2004); Barry H. Brooks, M.D.,
66 FR 18,305, 18,307 (DEA 2001); John S. Noell, M.D., 56 FR 12,038,
12,039 (DEA 1991).
---------------------------------------------------------------------------
\21\ The Administrator interprets the term ``conviction'' by
affording it the ``broadest possible meaning.'' Donald Patsy Rocco,
D.D.S., 50 FR 34,210, 34,211 (DEA 1985). Thus, evidence of a guilty
plea is probative under the third factor of the public interest
analysis. See e.g., Farmacia Ortiz, 61 FR 726, 728 (DEA 1996); Roger
Pharmacy, 61 FR 65,079, 65,080 (DEA 1996).
---------------------------------------------------------------------------
Here, the Government concedes that it ``did not introduce any
evidence during this proceeding regarding a Federal or State conviction
for Respondent relating to controlled substances.'' [Gov't Br. at 23].
Indeed, the parties stipulated that ``Respondent has not been charged
with or convicted of any federal or state crimes relating to the
manufacture, distribution, or dispensing of controlled substances.''
[ALJ Exh. 14]. However, the Government also correctly points out that
under DEA precedent, factor three is not dispositive and ``is of
considerably less consequence in the public interest inquiry.'' [Gov't
Br. at 23 (quoting Ruben, 78 FR at 38,379 n.35]. I therefore find that
this factor weighs neither for nor against Respondent's registration.
Factor Five: Such Other Conduct Which May Threaten the Public Health
and Safety
Under the fifth public interest factor, the Agency considers
``[s]uch other conduct which may threaten the public health and
safety.'' 21 U.S.C. 823(f)(5). The Administrator has clarified this
language by reasoning that since Congress used the word ``may,'' factor
five includes consideration of conduct ``which creates a probable or
possible threat (and not an actual) threat [sic] to public health and
safety.'' Roni Dreszer, M.D., 76 FR at 19,434; Michael J. Aruta, 76 FR
19,420, 19,420 (DEA 2011); Beau Boshers, M.D., 76 FR 19,401, 19,402 n.4
(DEA 2011); Jacobo Dreszer, M.D., 76 FR 19,386, 19,386 n.3 (DEA 2011).
Taking into consideration Congress's clear statutory language and
legislative intent under the CSA, misconduct considered under factor
five also ``must be related to controlled substances.'' Terese, Inc. D/
B/A Peach Orchard Drugs, 76 FR 46,843, 46,848 n.11 (DEA 2011); Tony T.
Bui, M.D., 75 FR at 49,989 (``In short, DEA has never held that a
practitioner's prescribing practices with respect to non-controlled
substances provide an independent basis for concluding that the
practitioner has engaged in conduct which may threaten public health
and safety and has thus committed acts inconsistent with the public
interest.'').
Long-standing agency precedent indicates that a ``practitioner's
self-abuse of a controlled substance is a relevant consideration under
factor five.'' Tony T. Bui, M.D., 75 FR at 49,989; Allan L. Gant, D.O.,
59 FR 10,826, 10,827 (DEA 1994); David E. Trawick, D.D.S, 53 FR 5,326
(DEA 1988). This Agency has upheld such a position, ``even when there
[was] no evidence that the registrant abused his prescription writing
authority'' or when there was ``no evidence that the practitioner
committed acts involving unlawful distribution to others.'' Tony T.
Bui, M.D., 75 FR at 49,989. In determining the likelihood that a
respondent's self-abuse would impair the public interest, the DEA may
look to the duration of the drug abuse. See Roger D. McAlpin, D.M.D.,
62 FR 8,038, 8,040 (DEA 1997) (finding ``serious questions regarding
Respondent's fitness to possess a DEA registration'' because of ``his
self-abuse of controlled substances from at least 1974 to 1990'').
Here, it is undisputed that Respondent self-abused controlled
substances. Respondent admitted at the hearing that he used
methamphetamine with A.B. for about eight months and admitted at the
Board hearing that he has sporadically used marijuana in the past.
Under factor five of the public interest analysis, this self-abuse
weighs against Respondent's registration.
In addition to his self-abuse of drugs, other aspects of
Respondent's behavior are also troubling under factor five. For
example, Respondent continued prescribing hydrocodone, a highly abused
drug, to A.B. despite knowing that A.B. regularly abused controlled
substances such as methamphetamine and marijuana. Also, while
Respondent did not personally take part in the sale or manufacturing of
any illegal drugs, he was present or nearby while an illegal
transaction took place and while methamphetamine was being
manufactured. Taking into consideration these facts, combined with
Respondent's self-abuse of controlled substances, I find that factor
five weighs against Respondent's registration.
Having found that factors two, four, and five weigh against
Respondent, I find that the Government has met its burden to prove a
prima facie case that Respondent's registration would not be in the
public interest. I now turn to whether remedial measures instituted by
Respondent show that he can be trusted with a DEA registration.
Remedial Measures
Where the Government has made out a prima facie case that
Respondent's registration would be inconsistent with the public
interest, the burden of production shifts to the applicant to
``present[ ] sufficient mitigating evidence'' to show why he can be
trusted with a new registration. See
[[Page 41091]]
Medicine Shoppe--Jonesborough, 73 FR at 387. To this point, the Agency
has repeatedly held that the registrant must ``accept responsibility
for [his] actions and demonstrate that [he] will not engage in future
misconduct. Id.; see also Samuel S. Jackson, D.D.S., 72 FR 23,848,
23,853 (DEA 2007). Specifically, to rebut the Government's prima facie
case, the respondent is required ``to accept responsibility for [the
established] misconduct, [and] also to demonstrate what corrective
measures [have been] undertaken to prevent the re-occurrence of similar
acts.'' Jeri Hassman, M.D., 75 FR 8,194, 8,236 (DEA 2010) (citing Jayam
Krishna-Iyer, M.D., 74 FR 459, 464 n.8 (DEA 2009)).
In determining whether a respondent has accepted responsibility and
whether misconduct will reoccur, the Agency has historically looked to
a number of considerations, including genuine remorse and admission of
wrongdoing, Lawrence C. Hill, M.D., 64 FR 30,060, 30,062 (DEA 1999),
lapse of time since the wrongdoing, Norman Alpert, M.D., 58 FR 67,420,
67,421 (DEA 1993), candor with the court and DEA investigators, Jeri
Hassman, M.D., 75 FR 8,194, 8,236 (DEA 2010), and attempts to minimize
misconduct, Ronald Lynch, M.D., 75 FR 78,745, 78,754 (DEA 2010). In
self-abuse cases, the Agency has acknowledged that successful
rehabilitation efforts are an important consideration in determining
whether a respondent can be trusted with a registration. Steven M.
Abbadessa, D.O., 74 FR 10,077, 10,082 (DEA 2009); Tony T. Bui, M.D., 75
FR 49,979, 49,990 (DEA 2010).
At the hearing, Respondent stated several times that `` `regret' is
not even a strong enough word. I'm very remorseful for my ever going
down that pathway.'' [Tr. 197, 238]. He unequivocally stated that he
accepts ``full responsibility'' for his misconduct and that he is
``appalled at [his] behavior.'' [Tr. 196, 238, 256, 257]. Respondent
also testified, and the Government did not rebut, that he has been
sober since October of 2011, confirming the effectiveness of his
treatment and his commitment to remaining sober. [Tr. 259]. Most
importantly, Respondent provided unrebutted evidence of his successful
rehabilitation at an inpatient facility, where he received intensive
therapy for about seven months. [Tr. 210 ; Resp't Exh. 2;]. Notably,
Respondent displayed his genuine intent to become and remain sober by
spending his own money--including retirement investments--to pay for
his rehabilitation. [Tr. 210]. Moreover, Respondent provided evidence,
largely unrebutted by the Government, that he faithfully attended
support group meetings, passed random drug tests, and was otherwise
successful in abiding by the terms of his probation.
The Government argues that Respondent cannot be trusted with a COR
because he was not candid with DEA investigators or this Court and that
his testimony was ``rife with inconsistencies.'' [Gov't Br. at 33]. I
disagree. The Government's first argument to this effect is that
Respondent failed to self-report his failed drug screen to DEA, and
that when Respondent first met with DEA investigators, he ``failed to
admit . . . the fact that he issued illegal prescriptions to A.B.,
S.M., or Z.M., and did not admit his self-abuse of marijuana.'' [Gov't
Br. at 32]. DI Surovec, however, testified that in her first meeting
with Respondent, ``[w]e asked him about the allegation in the board
order, and he really didn't deny anything.'' [Tr. 33]. The Board Order
mentioned Respondent's improper prescribing and the positive result for
marijuana on the drug screen. [Gov't Exh. 6 at 2, 3]. In that context,
it can hardly be said that Respondent was attempting to conceal facts
from the DEA that were contained in the very document about which the
DEA was questioning him. Furthermore, Respondent's failure to self-
report to the DEA does not show a lack of candor, given that he had
already self-reported to the Board. [Tr. at 273-74]. Rather,
Respondent's explanation that he did not know he needed to self-report
is the more plausible explanation. [Tr. 273-74].
The Government also argues that Respondent was not candid because
he ``could not admit that his self-abuse . . . contributed to his
inability to perform as a doctor.'' [Gov't Br. at 32]. Respondent
testified that he was tired at work because of his commute, heavy
workload, and lack of sleep at A.B.'s house and that using
methamphetamine, which is a stimulant, did not contribute to his
fatigue. [Tr. 243-44, 249]. While this may seem like Respondent was
trying to minimize the effects of his drug use, I find that this was
merely Respondent's honest assessment of his situation at the time.
Indeed, the Government elicited this testimony itself. [Tr. 243-44].
The Government similarly argues that Respondent minimized his
misconduct by testifying that he prescribed hydrocodone to A.B., a
known drug abuser, ``out of compassion [because] [s]he was in pain,''
and that ``hydrocodone was not her drug of choice.'' [Gov't Br. at 33].
Again, this testimony was specifically elicited by Government counsel
and went unrebutted. While the reasons Respondent gave for prescribing
hydrocodone to A.B. certainly do not justify his improper methods of
prescribing, they also do not represent an attempt to minimize or
rationalize his behavior. Indeed, Respondent's explanation for
prescribing to A.B. was preceded by his statement that ``it was
improper and I admit that.'' [Tr. 252]
Additionally, the Government argues that Respondent's testimony was
``rife with inconsistencies.'' [Gov't Br. at 33]. For example, the
Government points to Respondent's explanations as to why he tested
positive for marijuana and amphetamine. As explained above, however,
Respondent's explanation about these drug test results were credible
and went unrebutted by the Government.
The Government also argues that Respondent was not ``forthright
regarding his treatment at Sant[eacute]'' because he failed on direct
examination to disclose that he broke his ``no female contract'' at the
treatment center. [Gov't Br. at 33]. The Government points out that on
direct examination Respondent testified that he was a ``model
patient,'' but that his breaking of the no-female contract contradicts
that statement. [Gov't Br. at 33].\22\ The Government, however, ignores
Respondent's testimony that directly precedes his ``model patient''
statement: ``[I]t was a little bit difficult to acclimate myself for
the first few weeks, probably six weeks. It took me a while to kind of
get into the flow of things. Thereafter, I'd like to think I became a
model participant.'' [Tr. 210]. While Respondent did not divulge on
direct examination every detail about his struggles in rehabilitation,
his statement that he became a ``model participant'' was not an attempt
to conceal anything.
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\22\ Over Respondent counsel's vehement objection at the
hearing, I allowed the Government to introduce evidence of
Respondent's relationship with a woman at Sant[eacute]. [Tr. 261-
263]. However, because this subject was not disclosed prior to the
hearing, I admitted the evidence for impeachment purposes only. [Tr.
293].
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I therefore find that Respondent has sufficiently accepted
responsibility for his actions and instituted remedial measures to
ensure that the misconduct will not reoccur. At the hearing, Respondent
was consistent, sincere, and unequivocal in his acceptance of
responsibility for his misconduct. The success of Respondent's
rehabilitation is evidenced by his more than two years of sobriety and
his faithful attendance at support group meetings since being
discharged from therapy. His separation from A.B., the epicenter of
most of his
[[Page 41092]]
problems, displays his commitment to avoiding influences that could
lead to a relapse into abusing controlled substances or improperly
issuing prescriptions.
Even when a respondent is genuinely remorseful and has instituted
sufficient remedial measures, however, the Agency sometimes imposes
sanctions to deter egregious violations of the CSA. David A. Ruben,
M.D., 78 FR 38,363, 38,386 (DEA 2013); Joseph Gaudio, M.D., 74 FR
10,083, 10,094-95 (DEA 2009). In light of the prescription drug
epidemic, the Agency has placed special emphasis on the need to deter
intentional diversion of controlled substances, which includes issuing
prescriptions ``outside of the usual course of professional practice
and [without] a legitimate medical purpose.'' David A. Ruben, M.D., 78
FR at 38,386-87; but see Tyson D. Quy, M.D., 78 FR 47,412, 47,412 n.2
(DEA 2013) (``Because there is no evidence that Respondent diverted
controlled substances to others and this is a first offense, I conclude
that consideration of the Agency's deterrence interests is not
warranted.''). ``Indeed, this Agency has revoked a practitioner's
registration upon proof of as few as two acts of intentional diversion
and has further explained that proof of a single act of intentional
diversion is sufficient to support the revocation of a registration.''
David A. Ruben, M.D., 78 FR at 38,386 (citing Dewey C. MacKay, M.D., 75
FR 49,956, 49,977 (DEA 2010)).
Respondent's improper prescriptions to A.B., S.M., and Z.M. clearly
constitute intentional diversion. He admits to improperly prescribing a
highly abused drug, hydrocodone, to a known drug addict, A.B., and two
of her friends, S.M. and Z.M.. While he only wrote one prescription
each to S.M. and Z.M., he continued to prescribe controlled substances
to A.B. for over a year, totaling fifty-four distributions of
controlled substances, including refills. [Gov't Exhs. 12-14]. Thus,
although Respondent's improper prescribing practices were limited to
A.B. and a few of her friends, under DEA precedent they clearly warrant
sanctions to deter Respondent and others from repeating the practice.
I will not recommend, however, that the Agency deny Respondent's
registration altogether. While Respondent's improper prescriptions are
troubling to say the least, the DEA has granted registrations with
restrictions to respondents whose misconduct was more egregious and/or
lasted longer than the misconduct of Respondent here. David A. Ruben,
M.D., 78 FR at 38,386 (granting a registration to a respondent who
improperly prescribed drugs after being placed on probation by state
board); Gregory D. Owens, D.D.S., 74 FR 36,751, 36,755, 36,757-58 (DEA
2009) (granting a registration to a respondent who prescribed
controlled substances for seven years based on an expired
registration); Michael S. Moore, M.D., 76 FR 45,867, 45,868 (DEA 2011)
(granting a registration to a respondent who was convicted of growing
and distributing marijuana); Roger D. McAlpin, D.M.D., 62 FR 8,038,
8,040 (DEA 1997) (granting a registration to a respondent who self-
abused controlled substances for sixteen years and forged a
prescription to obtain controlled substances).
In each of these cases, the DEA granted the respondents'
registrations but also imposed restrictions, suspensions, or
conditions. Where the respondent intentionally diverted controlled
substances, the Agency required the respondents to periodically submit
logs of all controlled substances they prescribe and suspended the
respondents' registrations for periods of time commensurate with the
severity of the misconduct. See Ruben, M.D., 78 FR at 38,387-88;
Gregory D. Owens, D.D.S., 74 FR at 36,757-58; Moore, 76 FR at 45,869.
Where the respondent self-abused controlled substances, the Agency
required the respondent to submit to random drug tests. See Moore, 76
FR at 45,869; McAlpin, 62 FR at 8,040-41. Given that Respondent has a
history of self-abuse and improper prescriptions, similar conditions
are appropriate here.
I also note that some of the oversight currently placed over
Respondent may not be present if he is granted a DEA registration.
Specifically, it is not clear from the record how much of the oversight
of Respondent by ACTC would be conducted if Respondent had an
unfettered DEA registration. Indeed, some of the oversight conducted by
ACTC, such as approval from other doctors for prescriptions of
controlled substances, is done precisely because Respondent has no DEA
registration and thus is not authorized to dispense controlled
substances. This part of oversight would presumably--though not
necessarily--be lifted if Respondent were granted a DEA registration.
Moreover, Respondent expressed at the hearing his desire to work as a
gastroenterologist, so he may not be under ACTC supervision much
longer. [Tr. 233]. Given Respondent's history of improper prescribing,
DEA is justified in placing certain restrictions on Respondent's COR to
ensure precise compliance with the CSA and DEA regulations in the event
that ACTC no longer supervises Respondent's prescribing practices.
VI. CONCLUSION AND RECOMMENDATION
Therefore, given that Respondent has a history of both self-abuse
and intentional diversion but has demonstrated genuine remorse and
instituted significant remedial measures, I recommend that Respondent's
registration be granted with the following conditions:
(1) For six months following the publication of the Deputy
Administrator's final order in this case, Respondent shall keep a log
of all controlled substance prescriptions he issues. Said log shall be
maintained in chronological order, and shall list each patient by name,
and include the name of the drug prescribed, the number of refills
authorized, the strength of the dosage unit, the quantity, and the
dosing instruction. Not later than ten days following the end of each
calendar month, Respondent shall provide the local DEA field office
with a complete copy of the log for the preceding month. If during any
month Respondent is required to maintain said logs he prescribes no
controlled substances, he shall submit a letter declaring such to the
local DEA field office no later than ten days following the end of that
month.
(2) Respondent shall agree to have no intentional contact with A.B.,
S.M., Z.M., or any other person with whom Respondent abused controlled
substances.
(3) Respondent shall comply with the terms of his probation instituted
by the Board and shall comply with any other conditions the Board shall
see fit to impose on his license or registration.
(4) Respondent shall notify the local DEA field office if he fails any
drug screen administered by any entity.
I further recommend that Respondent's registration be suspended for
six months following the effective date of his registration.
Dated: March 25, 2014.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2015-17309 Filed 7-13-15; 8:45 am]
BILLING CODE 4410-09-P