[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49995-50004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20243]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-22]
Robert F. Hunt, D.O. Revocation of Registration
On November 25, 2008, I, the Deputy Administrator of the Drug
Enforcement Administration (DEA), issued an Order to Show Cause and
Immediate Suspension of Registration to Robert F. Hunt, D.O.
(Respondent), of Fort Lauderdale, Florida. The Show Cause Order
proposed the revocation of Respondent's Certificate of Registration,
BH1292642, which authorizes him to dispense schedule II through V
controlled substances as a practitioner, on the ground that his
``continued registration is inconsistent with the public interest, as
that term is defined in 21 U.S.C. 823(f).'' Order to Show Cause at 1.
The Order immediately suspended Respondent's registration based on my
conclusion that his continued registration during the pendency of the
proceeding would ``constitute[] an imminent danger to the public health
and safety.'' Id. at 2 (citing 21 U.S.C. 824(d)).
More specifically, the Show Cause Order alleged that on April 10,
2008, Respondent ``issued a prescription for an anabolic steroid, a
Schedule III controlled substance,'' to a patient without referring
``to the patient's medical file or conduct[ing] a medical examination
of this patient.'' Id. at 1. The Order further alleged that Respondent
``issued the prescription solely because [this] patient requested
anabolic steroids,'' that he had ``previously issued numerous
prescriptions for controlled substances to this patient,'' and that
``in some instances,'' he had ``accepted illicit drugs as payment for
these prescriptions.'' Id. at 1-2. The Order thus alleged that
Respondent's conduct violated 21 U.S.C. 841(a)(1) and 844. Id. at 2.
Next, the Show Cause Order alleged that, on April 24, 2008,
Respondent ``issued two prescriptions for two brands of anabolic
steroids to another patient,'' who was ``a police detective acting in
an undercover capacity,'' and who ``presented no legitimate medical
reason to justify the * * * prescriptions.'' Id. at 2. The Order
alleged that neither Respondent, nor his staff, ``perform[ed] any
medical tests or exams on this patient'' and that Respondent ``stated
that [he] would list a fictitious ailment in [the patient's] medical
record to justify [his] prescribing of anabolic steroids.'' Id. The
Order alleged that ``[t]hese prescriptions were not for a legitimate
medical purpose in the usual course of professional practice'' and that
in issuing them, Respondent violated Florida Statute Sec.
893.13(8)(a)(1), which ``prohibits a prescribing practitioner from
knowingly assisting a patient in obtaining a controlled substance
through deceptive, untrue, or fraudulent representations in or related
to the
[[Page 49996]]
practice of the prescribing practitioner's professional practice,'' as
well as 21 U.S.C. 841(a)(1). Id.
Additionally, the Show Cause Order alleged that at the same visit,
Respondent also prescribed hydrocodone to this undercover detective
again without ``obtain[ing] a medical history, conduct[ing] a physical
examination, or otherwise conduct[ing] an evaluation of the patient in
violation of Florida Administrative Code Sec. Sec. 64B15-14.005(3)(a)
and (f).'' Id. The Order further alleged that the hydrocodone
prescription ``was not for a legitimate medical purpose'' and was not
issued ``in the usual course of professional practice,'' and thus
violated both Federal law and Florida Statute Sec. 458.33(1)(q) & (t).
Id.
Finally, the Show Cause Order alleged that on July 24, 2008, the
Broward County Sheriff's Office arrested Respondent on two felony
counts of assisting persons in obtaining controlled substances through
deceptive, untrue, or fraudulent representations, a violation of
Florida Statute Sec. 893.13-8(a)(1), and one felony count of
trafficking by issuing prescriptions in excessive quantities, a
violation of Florida Statute Sec. 893.13(8)(d). Id. The Order further
alleged that Respondent is ``currently on pre-trial release.'' Id.
By letter of December 15, 2008, Respondent, through his counsel,
requested a hearing on the allegations. ALJ Ex. 3. The matter was
placed on the docket of the Agency's Administrative Law Judges (ALJ)
and set for a hearing on January 6, 2009. Id. Thereafter, Respondent's
counsel sought and was granted several continuances; \1\ the hearing
was finally held on April 28 and 29, 2009, in Fort Lauderdale, Florida.
ALJ Exs. 4-6; ALJ at 4.
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\1\ In his letter which requested a hearing, Respondent's
counsel also requested a continuance from the scheduled date of the
hearing of January 6, 2009. ALJ Ex. 3, at 1. The hearing was then
rescheduled for February 23, 2009. See ALJ Ex. 4, at 2. On January
28, 2009, Respondent's counsel requested a second continuance on the
grounds that he sought the actual recordings of the transcribed
undercover visits at issue, that he sought to depose the
confidential informant, and that he was ``interviewing prospective
expert witnesses to testify on the doctor's behalf.'' Id. at 1-2. In
ruling on the second request for continuance, the ALJ noted that
``Respondent argued that any prejudice stemming from an additional
continuance is suffered only by the Respondent.'' ALJ Ex. 6, at 2.
The ALJ therein canceled the February 23, 2009 hearing. Id. at 3. In
her Prehearing Ruling of February 27, 2009, the ALJ rescheduled the
hearing for April 28 and 29, 2009. ALJ Ex. 7, at 4; see also ALJ Ex.
8 (Notice of Hearing; Instructions (April 8, 2009)).
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At the hearing, both parties called witnesses to testify and
introduced documentary evidence. Thereafter, both parties filed
proposed findings of facts, conclusions of law, and argument.
On July 2, 2009, the ALJ issued her Recommended Decision (also
ALJ). Therein, the ALJ, upon analyzing the public interest factors, see
21 U.S.C. 823(f), concluded that the ``continuation of [Respondent's]
registration would not be in the public interest,'' and ``that the
preponderance of the evidence * * * favors revocation.'' ALJ at 33.
With respect to the first factor--the recommendation of the
appropriate state licensing board--the ALJ found that the record
contained ``no information of any action being taken by the Florida
Medical Board * * * against the Respondent's medical license'' or ``any
recommendation from the [Florida Medical] Board regarding the outcome
of this proceeding.'' Id. at 27. Likewise, with respect to the third
factor--Respondent's record of convictions for offenses related to
controlled substances--the ALJ found that the ``record contains no
evidence that the Respondent has a conviction record related to his
handling of controlled substances.'' Id. at 30.
As to the second and fourth factors--Respondent's experience in
dispensing controlled substances and his compliance with applicable
laws--the ALJ made several findings. First, she found that Respondent
``prescribed controlled substances to [the undercover detective (UC)]
to assist in pain management for his joint pain,'' but that his
``[medical] records fail to identify this diagnosis, and do not include
the amount, strength, and number of refills of the controlled
substances he prescribed,'' in violation of Florida Statute Sec.
458.331(1)(m).\2\ Id. at 27.
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\2\ This statute provides for disciplinary action against a
medical doctor for ``[f]ailing to keep legible * * * medical records
that * * * justify the course of the treatment of the patient,
including, but not limited to, patient histories; examination
results; test results; records of drugs prescribed, dispensed, or
administered; and reports of consultations and hospitalizations.''
Fla. Stat. Sec. 458.331(1)(m). However, as discussed below,
Respondent is a doctor of osteopathy; his license is subject to the
provisions of Florida Statutes Chapter 459, which provide grounds
for disciplinary action against an osteopath's license in Fla. Stat.
Sec. 459.015.
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Next, the ALJ found that Respondent's ``medical record for [the UC]
fails to have any of [the] elements,'' such as ``[a] complete medical
history and physical examination * * * [and documentation of] the
nature and intensity of the pain,'' as required by Florida
Administrative Code r. 64B15-14.005(3)(a). Id. at 27-28. The ALJ
reasoned that even if this provision, which is part of Florida Board of
Osteopathic Medicine's [hereinafter, the Board] guidelines for the
treatment of pain with controlled substances, does ``not have the force
of law in Florida, the fact that the Respondent's medical record for
[the UC] fails to have any of these elements to justify the prescribing
of controlled substances for pain supports a finding that * * *
Respondent is not handling controlled substance prescriptions and
records in a responsible manner.'' Id. at 28. The ALJ also noted that
the transcript of the UC's ``April 24, 2008 visit does not contain any
conversation between * * * Respondent and [the UC] that would support a
finding that [he] attempted to ascertain the `nature and intensity of
the pain,' or any other factor listed in Section 64B15-14.005(3)(a), in
order to justify the prescribing of 100 dosage units of Vicodin with
three refills.'' Id.
The ALJ further found that ``Respondent recorded a history of
osteoporosis in [the UC's] medical record, while simultaneously stating
that it was not true,'' and that ``[t]his chart notation was used to
justify issuing prescriptions for two anabolic steroids to'' the UC.
Id. Based on this finding, the ALJ concluded that Respondent violated
Florida Statute Sec. 893.13(8)(a)(1), which prohibits ``a prescribing
practitioner'' from ``knowingly assist[ing] a patient * * * in
obtaining a controlled substance through deceptive, untrue, or
fraudulent representations in or related to the practice of the
prescribing practitioner's professional practice.'' Id.
Having found that ``Respondent's asserted belief that [the UC] had
HIV and osteoporosis is not credible, and his purported diagnoses
false,'' the ALJ further concluded that Respondent ``knew or should
have known that [the UC] was seeing him to obtain anabolic steroids for
the purpose of body building,'' and thus, in issuing the steroid
prescriptions to the UC, he also violated the prescription requirement
of 21 CFR 1306.04(a). Id. (citing Edmund Chein, M.D., 72 FR 6580, 6590
(2007) (``prescribing anabolic steroids for body building or strength
enhancement under a false diagnosis is not [prescribing] for a
legitimate medical purpose'')).
The ALJ further found that Respondent ``prescribed Subutex''
(buprenorphine), ``a Schedule III controlled substance * * * approved
by the FDA for use by authorized practitioners for detoxification or
maintenance treatment,'' \3\ to a patient ``on multiple occasions to
treat him for the effects of the other controlled substances [the
patient] was consuming.'' Id. at 28-29. Because Respondent did not hold
a separate registration to prescribe ``this drug for narcotic abuse
treatment'' as required by
[[Page 49997]]
21 U.S.C. 823(g), and ``was admittedly not authorized by the DEA to
prescribe this substance for this purpose,'' the ALJ concluded that
Respondent ``clearly violated the Controlled Substances Act.'' Id. at
29. Ultimately, the ALJ concluded that under these two factors, ``the
preponderance of the evidence weighs against allowing Respondent to
maintain his DEA registration.'' Id. at 29-30.
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\3\ See 21 CFR 1308.13(c)(2)(i).
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As to the final factor--such other conduct which may threaten the
public health and safety--the ALJ explained that ``[t]he gravamen of
this case is the Respondent's lack of candor, in both his recordkeeping
and in his testimony before this tribunal, as well as his apparent lack
of appreciation for the serious responsibilities of a DEA registrant.''
Id. at 30. Noting that ``Respondent falsely entered `osteoporosis' as a
diagnosis in [the UC's] medical record,'' and ``then testified under
oath that he genuinely believed his diagnosis to be true,'' the ALJ
found--based on the transcript of the April 24 undercover visit--that
``this testimony lacked credibility.'' Id. The ALJ thus concluded that
this ``lack of candor further supports [the] conclusion that revocation
of Respondent's registration is appropriate.'' Id.
The ALJ further noted that Respondent had ``issued the
prescriptions for anabolic steroids notwithstanding the fact that he
had no test results to support his purported diagnosis of osteoporosis,
and despite his admission that such test results would determine
whether or not his basis for issuing the prescriptions was valid.'' Id.
at 31. The ALJ thus concluded that ``Respondent's attitude toward
prescribing controlled substances under these circumstances * * * was
so cavalier as to create a substantial risk of diversion'' and that
``Respondent's conduct therefore falls below the level of
responsibility expected of a DEA registrant.'' Id. Thus, under the
fifth factor, the ALJ found that ``the preponderance of the evidence *
* * supports a conclusion that continuation of [Respondent's] DEA
registration would not be in the public interest.'' Id.
Having concluded that the Government had made out a prima facie
case for revocation, the ALJ turned to whether Respondent had
``accept[ed] responsibility for his misconduct'' and demonstrated that
his misconduct would not recur. Id. at 32. The ALJ noted that
Respondent had refused the UC's request for a prescription for HGH and
had declined the UC's request to refer other persons, stating that he
would not ``usually'' prescribe to men who were seeking anabolic
steroids for body building. Id. However, the ALJ also found that
``[i]nstead of admitting his mistake in prescribing steroids for [the
UC] and presenting evidence to reassure [the Agency] that he would
cease this practice, * * * Respondent chose to build upon the
falsifications.'' Id. at 33. Concluding that Respondent had failed ``to
take responsibility for his past misconduct, and [had] fail[ed] to
provide assurances regarding his future conduct,'' the ALJ concluded
that Respondent's registration should be revoked. Id.
Neither party timely filed exceptions to the ALJ's decision, which
were due no later than July 27, 2009. On July 30, 2009, the ALJ
forwarded the record to me for final agency action. Thereafter, on
September 3, 2009, Respondent filed exceptions. However, because
Respondent's exceptions were filed out-of-time, I have not considered
them.
However, I have considered the rest of the record in its entirety
including Respondent's brief containing his proposed findings of fact
and conclusions of law. Having done so, I adopt the ALJ's findings of
fact and conclusions of law except as specifically noted herein. I
further adopt both her ultimate conclusion that Respondent's continued
registration is inconsistent with the public interest and her
recommendation that Respondent's registration be revoked. I make the
following findings.
Findings of Fact
Respondent is a doctor of osteopathic medicine, and is board-
certified in family practice. Tr. 408-09. At the time of the hearing,
Respondent had practiced as a general practitioner in Broward County,
Florida for approximately 21\1/2\; years.\4\ Tr. 408-09.
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\4\ Respondent has been ``involved with'' two organizations,
Community Healthcare Center One and Broward House, which are
community resource centers for patients with HIV in Broward County.
Id.f at 413, 417-18. At the Children's Medical Services Program, he
helped create Broward County's clinic for infectious diseases for
the pediatric HIV population; at the Children's Diagnostic and
Treatment Center, he has volunteered one afternoon a week seeing HIV
patients and waiving payment. Id. at 421. He has also been
``involved with'' the Gay and Lesbian Community Center, where he has
given free lectures on topics ``related to living with HIV.'' Id. at
416.
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Respondent is also the holder of DEA Certificate of Registration,
BH1292642, which authorizes him to dispense controlled substances as a
practitioner in schedules II through V. GX 1. According to the
certificate, Respondent's registration was to expire on October 31,
2008. Id. However, on September 18, 2008, Respondent filed a renewal
application. GX 2. In accordance with the Administrative Procedure Act
and DEA regulations, I find that Respondent's registration remains in
effect (albeit in suspended status) pending the issuance of the Final
Order in this matter. See 5 U.S.C. 558(c); 21 CFR 1301.36(i).
In February of either 2006 or 2007, one of Respondent's patients
was arrested by an officer with the Hollywood, Florida police
department and charged with the state law offense of trafficking in
hydrocodone. Tr. 123. At the time of his arrest, the patient had in his
possession 150 tablets of a controlled substance containing
hydrocodone, which he had obtained through a prescription issued by
Respondent.\5\ Id. at 23, 25, 75. In either December 2007 or January
2008, the patient, who was facing a lengthy prison sentence, accepted a
plea bargain under which he entered into a ``substantial assistance
agreement'' with the Broward County, Florida Sheriff's Office and
became a confidential informant (CI). Id. 23, 27, 87, 364.
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\5\ The patient had been treated by Respondent since at least
January 2002, GX 7A, at 70; and initially saw Respondent for anxiety
and a heart palpitations and explained that he was concerned that
his heart problems were caused by his prior use of steroids. Tr. 31.
The CI maintained that Respondent had told him that ``if I wanted to
do it the right way under [a] doctor's care[,] to come see him. Id.
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Thereafter, the CI told the authorities that Respondent had
prescribed hydrocodone,\6\ testosterone,\7\ Deca-Durabolin,\8\ and
Xanax \9\ for him. Id. at 27. While the CI testified that Respondent
had legitimately treated him for anxiety and had referred him to
several specialists for heart and joint issues, Respondent also gave
him prescriptions for anabolic steroids. Id. at 28-29. According to the
CI, he initially obtained the steroid prescriptions ``just because I
asked him for them,'' id. at 29, and did so at either the second or
third visit after his initial visit. Id. at 31. However, ``after awhile
[the CI's] body was [not] producing enough testosterone'' and ``it
became medically necessary to have some testosterone.'' Id.
[[Page 49998]]
at 29. According to the CI, when he asked for the steroid
prescriptions, Respondent did not hesitate to prescribe them. Id. at
30.
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\6\ Hydrocodone in combination with another active
pharmaceutical ingredient is a Schedule III narcotic controlled
substance. 21 CFR 1308.13(e)(iv). Stipulated Facts, ALJ at 5.
\7\ Androgen 1% is an injectable brand of testosterone, an
anabolic steroid, a Schedule III controlled substance. 21 CFR
1300.01(b)(4)(lvii), 21 CFR 1308.13(f); Stipulated Facts, ALJ at 5.
Delatestryl is a brand of testosterone, and Testim 1% is a brand of
testosterone gel. ALJ at 5.
\8\ A brand of nandrolone decanoate, an anabolic steroid. Tr.
170; 21 CFR 1300.01(b)(4)(xl); 21 CFR 1308.13(f).
\9\ Xanax, or alprazolam, which is a Schedule IV depressant
controlled substance. 21 CFR 1308.14(c)(1); Stipulated Facts, ALJ at
5.
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According to the CI, Respondent prescribed the anabolic steroids
``off and on,'' and the CI made the decision as to when to cycle on,
and off of, the drugs. Id. at 32, 34. The CI also testified that
Respondent wrote him a prescription for Human Growth Hormone (HGH)
because he asked for it, id. at 35, as well as prescriptions for
Percocet \10\ for his knees; Respondent subsequently referred the CI to
an orthopedist who diagnosed him as having ``a slight torn meniscus.''
Id. at 34-35. Finally, the record also establishes that Respondent
wrote the CI at least twenty-six prescriptions for Subutex
(buprenorphine), a schedule III controlled substance, as well as
prescriptions for both Testim and Androgel, which are gel forms of
testosterone and also a schedule III controlled substance. See GX 7C,
at 1-3, 5-6, 9-10, 14-15, 18-19, 22-23, 30-32, 37, 61-62, 64, 66, 71,
78, 83-84, 87-90, 95-96, 105-06 (Subutex Rxs); id. at 2, 24, 31, 33,
62, 67, 81, 82 (Testim and Androgel Rxs).
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\10\ Percocet is a combination oxycodone product. Oxycodone is a
Schedule II narcotic controlled substance. 21 CFR
1308.12(b)(1)(xiii); Stipulated Facts, ALJ at 5.
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The CI's medical record (GXs 7A & 7D) contains various documents
including blood tests, radiology reports, as well as evaluations by
specialists including an orthopedist, cardiologist, and
endocrinologist. See GX 7A, at 60 (orthopedist's report); 65-69
(cardiologist's report); GX 7D, at 13-14 (endocrinologist's report).
The medical record contains ample evidence (including blood tests and
endocrinologist's report) establishing that the CI had low testosterone
levels and had been diagnosed with hypogonadism, which was caused by
the presence of a small tumor (adenoma) on his pituitary gland. Id. at
444-455; GX 7A, at 9, 13-14; GX 7D, at 1, 3-4, 7-12, 16-18, 21, 25, 39-
41, 43-49, 54-57; GX 7D, at 13-14. In its brief, the Government does
not challenge the medical appropriateness of any of the controlled
substance prescriptions Respondent wrote for the CI with the exception
of an April 10, 2008 prescription for Testim, and his prescribing of
Subutex. See Gov. Br. at 8-9; 31-35.
As for the Subutex prescriptions, Respondent testified that after
the CI told him that he had also been going to a pain clinic (run by a
Dr. Weed) to obtain additional quantities of narcotics and ``had
actually been taking much higher quantities of narcotics that I had
suspected [and] had been doing this for quite some time,'' he
recommended that the CI ``see a psychiatrist who specializes in detox
patients.'' Tr. 486. While Respondent was ``not sure'' as to whether
the CI went to this doctor ``or another detox specialist,'' the CI went
back to Respondent, showed him the Subutex prescription and apparently
other documents showing that he had seen the detox specialist ``a
couple of times.'' Tr. 486, 488. The CI told Respondent said that the
Subutex ``was working well for him,'' but complained that the detox
specialist charged ``$250 or $275 a visit, insisted on seeing [the CI]
every month, and would not accept his'' insurance. Id. at 488.
Respondent then agreed to write Subutex prescriptions for the CI. Id.
As found above, the CI's patient file indicates that between November
16, 2004, and April 10, 2008, Respondent authorized at least twenty six
prescriptions for Subutex. See generally GX 7C, at 1-3, 5-6, 9-10, 14-
15, 18-19, 22-23, 30-33, 37, 61-62, 64, 66, 71, 78, 83-84, 87-90, 95-
96, 105-06; GX 7D, at 19 & 33.
In his testimony, Respondent maintained that he was unaware until
``only recently'' that there was a special course that he had to take
to prescribe Subutex, that he did know exactly when this requirement
``went into effect,'' and that he was unsure as to whether the course
was required at the time he wrote the CI's prescriptions. Id. at 488-
89. He also maintained that no pharmacist had told him that he needed a
special registration to prescribe Subutex for detoxification. Id. at
488-89.
The ALJ observed that ``the Government presented no expert medical
testimony to suggest that the Respondent's treatment of [the CI] was
inappropriate.'' ALJ at 9. She therefore ``decline[d] to make any
specific findings concerning the legitimacy of Respondent's treatment
decisions in [the CI's] case.'' Id. at 9 n. 5. As noted above, the ALJ
did, however, find that Respondent violated Federal law by prescribing
Subutex to the CI. ALJ at 28-29.
Pursuant to his substantial assistance agreement, the CI agreed to
introduce a Detective from the Broward County Sheriff's Office to
Respondent. Tr. 39. Accordingly, the CI phoned Respondent and left a
message in the latter's personal voicemail indicating that he would be
dropping by Respondent's office and bringing a friend that he wanted to
refer to him. Id. at 38, 39, 40. The CI testified that he did not make
any further phone calls to Respondent. Id. at 40. Furthermore,
according to the Detective, the CI was required to report any contact
he had with Respondent, and the Detective stated that he believed the
CI would have reported any such contact. Tr. 374. Moreover, had the CI
otherwise contacted Respondent and not reported it, the CI would have
violated the substantial assistance agreement. Id. at 371.
In his testimony, Respondent asserted that either ``a few days,''
or ``a few weeks'' before April 10, 2008, Respondent and the CI talked
on the phone for some five to ten minutes regarding the friend's
alleged medical issues. Id. at 493-94, 531. However, on cross-
examination, Respondent testified that the call could have taken place
on April 10, 2008. Tr. 530. Respondent's recollection was that the
conversation occurred when he answered the CI's phone call. Id. at 531.
Respondent maintained that during this conversation, the CI told
him that his friend experienced problems with fatigue and that he had a
``history of * * * joint pain, shoulder problems with surgery,
fractures in his back, etc., and that he was, his workout partner * * *
and that he felt he would benefit from the same testosterone therapy
and the steroids that he was taking.'' Id. at 494.
In his testimony, Respondent claimed that he told the CI that there
was a ``difference'' between him and his friend because ``You [the CI]
have a medical reason * * * to be on testosterone replacement therapy
[and] I can't just prescribe this for a patient who wants it.'' Id. at
494-95. According to Respondent, the CI ``continued to badger me,'' and
asked: ``Well, couldn't we put down something else as a diagnosis?''
Id. Respondent maintained that he answered: ``No, that's not the way
this works. This is a controlled substance and I need to document why
it's being used.'' Id.
Respondent asserted that the CI then told him that his friend was
HIV positive, that he ``had a serious problem maintaining [his] weight
[and] with fatigue and weakness,'' and that he was in paramedic
training and needed to ``beef up'' to complete it. Id. Respondent
testified that he thought it ``was admirable'' that the CI's friend had
decided not to go on disability and collect Medicaid or work under the
table. Id. at 495-96. On cross-examination, however, Respondent
acknowledged that the CI had not said when his friend was diagnosed
with HIV or by whom. Id. at 532. Nor did he discuss what treatment the
CI's friend was receiving for HIV. Id. at 533.
According to Respondent, he ``felt a little bit of compassion'' on
hearing that
[[Page 49999]]
the CI's friend ``was HIV positive,'' but he ``reiterated'' that
``[a]nabolic steroids are out of the question unless there is a medical
reason.'' Id. at 496. Respondent further claimed that the CI told him
that his friend was ``really touchy about'' his being HIV positive and
did not want anyone to know because they would think that he was either
gay or an ``IV drug addict.'' Id. Respondent next asserted that the CI
had said that he [Respondent] could not tell his friend that the CI had
told him about the friend's HIV positive status. Id.
Respondent then testified that he asked the CI to ``tell [him] more
about these fractures [the friend] had'' and that the CI related that
his friend had fractured his shoulder and two vertebrae. Id. at 497.
Respondent maintained that based on this information he concluded that
the CI's friend ``may have some bone loss'' and ``some osteoporosis.''
Id. Respondent then asserted that he told the CI that if he could
``establish that as a diagnosis, then I can at least justify giving him
a prescription and then when he comes back to see me for [a] follow
up[,] I will try to get him to admit that he knows that he's HIV
positive and proceed with the appropriate testing.'' Id. Finally,
Respondent asserted that he discussed with the CI that the latter's
friend did not have insurance and that there would be ``cost issues''
as to whether he ``could do all the testing on him like the bone
density study to show that he had osteoporosis.'' Id.
The ALJ found it unnecessary to make a specific finding as to
whether the phone conversation--as testified to by Respondent--took
place. ALJ at 12 n.12. However, as ultimate factfinder, I reject
Respondent's testimony pertaining to the conversation in its entirety.
See 5 U.S.C. 557(b); Reckitt & Colman, Ltd., v. DEA, 788 F.2d 22, 26
(DC Cir. 1986). I do so for the following reasons: (1) I accept the
CI's testimony that the only call he made involved his leaving a voice
mail message noting that the Detectives testified that the CI made only
one call and that if the CI had made another a call and had not
notified the Detectives, he would have violated the assistance
agreement and could have received substantial prison time; (2) in his
testimony, Respondent gave three possible dates (or ranges of) for when
the conversation took place including a few weeks before, a few days
before, or on the day that the visit actually occurred; (3) other
evidence in the case (which is discussed below) showed that Respondent
falsified medical records, thus casting serious doubt on his
truthfulness as a witness; (4) much of Respondent's testimony regarding
the phone call is patently self-serving and implausible;\11\ and (5)
during the Detective's two visits, Respondent never questioned the
Detective (despite his elaborate story regarding his reason for
diagnosing the Detective as having osteoporosis) about the purported
fractures of the Detective's shoulder and two back vertebrae.\12\ See
ALJ at 31; see also GXs 9 & 10.
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\11\ See, e.g., Tr. 495 (``I can't just prescribe this
[testosterone] for a patient who wants it.''); (``This is a
controlled substance and I need to document why it's being used.'')
\12\ At the second visit, Respondent, after looking at charts
filled out by the Detective, asked: ``what was the shoulder, rotator
cuff?'' GX 10, at 8. He then asked the Detective: ``Any other
problems other than the shoulder?'' Id. at 10. Notably, he did not
ask the Detective any questions about the purported fractures.
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On April 10, 2008, the CI and the Detective, who used the name
``Bill Rix,'' [hereinafter, either ``Rix'' or ``UC''] went to
Respondent's office; the UC wore a wire, and the entire visit was tape-
recorded and transcribed. Id. at 132; see GX 9. The CI introduced Bill
Rix to Respondent, and indicated that Rix was looking for a doctor. Tr.
39, 125.
At the visit, the CI complained of a swollen gland. GX 9, at 2.
Respondent examined his neck and wrote him a prescription for an
antibiotic, Augmentin. Id. at 2-3; GX 5, at 1. The CI then asked
whether Respondent had ``any more samples * * * of Andro Gel.'' GX 9,
at 4. Respondent asked the CI ``[w]hich one'' he took? The CI
responded: ``Testim.'' Id. at 4. Respondent then gave the CI a coupon
for a debit card that gave a $40 discount off of each monthly co-pay
for the drug for a year, id. at 4-5, and wrote him a prescription for
Testim 1%, a brand of testosterone gel, which is an anabolic steroid
and schedule III controlled substance. GX 5, at 2; Stipulated Facts,
ALJ at 5. Respondent did not document the April 10, 2008 visit in the
CI's medical record.\13\ Tr. 181-82; GX 7A-D.
---------------------------------------------------------------------------
\13\ On July 24, 2008, the Broward County Sheriff's Office
executed a search warrant at Respondent's office and seized the
medical records. Tr. 321-22.
---------------------------------------------------------------------------
At the April 10 visit, the UC (after indicating that he did not
have insurance) stated that he had ``had shoulder surgery,'' that his
joints were ``shot,'' that ``everything'' hurt, that he was ``just
losing strength and * * * getting older,'' and that he wanted to ``get
the physical done * * * and just see what [his] body's doing.'' GX 9,
at 9-10. When Respondent mentioned getting blood tests done, the UC
indicated that he did not want blood work done, asked if it ``that
[was] necessary,'' and stated that he was ``just worried about [his]
joints.'' Id. at 10. Respondent then asked the UC if he thought
``anything is bad like you're going to need x-rays or an MRI scan or
anything like that?'' Id. The UC answered ``no,'' and that he did not
``think so.'' Id.
In his testimony regarding the April 10 visit, Respondent alleged
that he made his diagnosis in part that day because Bill Rix had ``a
slight figure'' and ``ha[d] very deep lines on either side of his face.
That to me is a sign of lipodystrophy * * * when he smiled and I saw
these deep indentations in either side of his face, it just
corroborated for me that this guy * * * not only is * * * definitely
HIV positive but that he's had some problems with muscle wasting and
fat loss and muscle loss.'' \14\ Tr. 499, 571.
---------------------------------------------------------------------------
\14\ The ALJ found credible Respondent's testimony that
lipodystrophy is a sign of HIV status. ALJ at 16. However, the
record contains no evidence establishing whether the UC actually has
deep lines on his face. Moreover, according to the UC's patient
file, on April 24, 2008, the UC was measured as being 5 feet, 10
inches tall and weighing 182 pounds. The UC's height and weight do
not appear consistent with that of a person who has a slight build.
---------------------------------------------------------------------------
Regarding the April 10 visit, Respondent also testified that the
fatigue and joint pain of which the UC complained would be consistent
with osteoporosis. Tr. 510; RX 13. While Respondent testified that in
normally evaluating a patient's complaint of fatigue he would conduct
blood tests to check a patient's testosterone level, Tr. 510, at
neither of the UC's visits did Respondent require the UC to undergo a
blood test. See GXs 9 & 10. According to Respondent, this was because
the UC had indicated he did not want them. Tr. 510.
At the April 24th visit, the UC first completed several forms for
the patient file, including one in which he provided his ``Patient
Information,'' one for his ``Adult Health History,'' and one in which
he provided his consent ``to undergo all necessary tests * * * and any
other procedure required in the course of study, diagnosis, and
treatment of'' his condition. GX 8, at 6-7, 9-11, 13-14; GX 10, at 1;
Tr. 184-188. On the ``Patient Information'' form, the UC indicated that
he was ``self-employed'' and not that he was training to become a
paramedic. GX 8, at 6. On the medical history form, the UC indicated
that he was sexually active with more than one female partner, that he
drank four to five times per week, and that he smoked marijuana
``socially.'' GX 8, at 11. He also indicated that the purpose of his
visit was ``Fatigue/Muscle Loss,'' and that he had undergone shoulder
surgery in ``02.'' Id. at 10. The UC did not, however, indicate that he
had a history of any other
[[Page 50000]]
conditions such as the purported fractures of his shoulder or
vertebrae. Id.
On cross-examination, Respondent testified that he does not usually
read the ``demographic'' portion of the forms his patients complete
(where the UC had indicated that he was self-employed), and that he
reads only the medical history. Tr. 560. Respondent further maintained
that he was ``operating on the assumption that this man w[i]ll be
trying to use my medical records to reflect a normal physical within
reason so that he could get a job as a paramedic,'' notwithstanding
that at no time during the visit did the UC indicate that he was in
training for a paramedic position. Id. at 559, 564-65. He also
maintained that he believed that Bill Rix had been infected with HIV
since 2002. Id. at 561-62.
Upon entering the exam room, Respondent recognized the UC and asked
him if he had been with the CI ``the other week, right?'' GX 10, at 8.
After the UC answered affirmatively, Respondent asked him: ``What was
the shoulder, rotator cuff?'' Id. The UC mentioned ``Mumford,'' an
apparent reference to a surgical procedure, but then stated that he had
no problems other than aging, losing strength, and aching joints. Id.
at 9-10.
The UC then complained that things were different when he could get
Winstrol and Testosterone Enthanate, which are both anabolic steroids,
through Powermedica, a pharmacy which arranged for persons to get
prescriptions which were written by doctors who never saw the persons
for whom they prescribed.\15\ Id. The UC also related that he had gone
to Powermedica ``one day to pick up my order and there were cops
everywhere.'' Id.
---------------------------------------------------------------------------
\15\ On June 20, 2005, the Florida Department of Health ordered
the emergency suspension of Powermedica's state pharmacy permit
following a joint investigation by the Food and Drug Administration
and the Broward County Sheriff's Office. Powermedica eventually
surrendered its state permit and DEA registration. See Wonderyears,
Inc., 74 FR 457458 (2008).
---------------------------------------------------------------------------
After discussing the side effects of HGH, the UC told Respondent
that he had used Deca Durabolin ``back in college'' when he ``played
college baseball.'' Id. at 12. Respondent stated it was ``too bad they
stopped making'' Deca. Id. When the UC expressed surprise at this,
Respondent indicated that ``we can still get [Deca] at Comcare
Pharmacy[.] [T]hey're compounding their own.'' Id.
After discussing some of the side effects of using anabolic
steroids and how these substances are metabolized, Respondent noted
that Deca provided ``more bang for your buck'' than other steroids. Id.
at 12-14. Respondent advised the UC that while there was an
``association'' between Deca and necrosis of the hip, he ``would have
no problem prescribing it for anybody'' and that necrosis was caused by
using too much. Id. at 14.
Respondent then advised the CI that Deca was the ``safest one as
far as your liver is concerned,'' and ``you get good results with it
especially when you combine it with testosterone,'' but that ``you just
have to combine it with testosterone cause if you just start using the
Deca[,] [its] chemical structure is very similar to testosterone so
your body sees it as testosterone.'' Id. ``So if you start injecting
all that extra Deca[,] your own testosterone production is going to
drop.'' Id. at 15. Respondent then told the CI that ``you really have
to combine the two together,'' (Deca and testosterone) and ``that's not
a problem cause'' ``injectable testosterone is cheap and they're both
oil base[d] so you can put it in the same syringe and you're done.''
Id. Respondent did advise the UC that he would need to get a liver
function test ``every two to three months'' that he took the steroids.
Id.
The CI then told Respondent that ``all I'm concerned with'' is ``I
need to get strong again.'' Id. at 16. Respondent then asked the CI:
``What was the blood work that you last had done or anything?'' Id. The
CI answered: ``it was about two years ago.'' Id. Upon being asked by
Respondent if he ever ``had any liver enzyme problems?,'' the CI
answered ``No,'' and added that ``actually,'' his ``testosterone levels
[were] high.'' Id.
After discussing the relative effects of testosterone (which would
improve his strength) and Deca (which would give him more size),
Respondent declared: ``Just to cover my ass I'm going to put down you
got a history of osteoporosis.'' Id. at 17. Respondent then explained
that ``[i]t's just brittle bones, it's common actually * * * in women
after menopause but men do get it who have low testosterone levels.''
Id. The UC then asked Respondent: ``Do you want me to say my Mom or Dad
had it?'' Id. Respondent answered ``No,'' and the UC stated: ``Okay.''
Id.
Respondent then stated: ``Just so that you know when I write
osteoporosis it has nothing to do with you[,] it just has to do if the
State ever comes in to monitor my charts that I have a reason for
prescribing you testosterone and Deca.'' \16\ Id. at 18. After
discussing osteoporosis, Respondent advised the UC that ``at some point
down the road you should get your liver enzymes checked[,] not now
because you know you haven't been on anything.'' Id. Respondent then
advised the UC how often he should get his liver enzymes tested, how to
cycle on and off of the testosterone, and how to come off of it without
losing his strength gains. Id. at 19-20. Respondent added: ``we're
looking to get you to the upper limits of normal[,] not Lyle Alzado[']s
brain tumor.'' Id. at 21.
---------------------------------------------------------------------------
\16\ In his testimony, Respondent asserted that his comment that
he was ``using this diagnosis [of osteoporosis] to cover my ass''
was just a flippant and stupid comment which he made to try to get
the UC to trust him so that he would admit that he had HIV. Tr. 515.
The ALJ did not find Respondent's story persuasive. See ALJ at 17.
Nor do I given that the comment was not some offhand remark but a
prelude to Respondent's further explanation that he was going to
write down the osteoporosis diagnosis in the UC's chart so that if
``the State ever comes in to monitor my charts * * * I have a reason
for prescribing you testosterone and Deca.'' GX 10, at 18. Moreover,
while the comment may have been flippant and stupid, in that it was
made to an undercover officer who was wearing a wire, it is
nonetheless probative of Respondent's intent.
---------------------------------------------------------------------------
Respondent and the UC next discussed what drug he could take for
joint pain. Id. at 21-23. Respondent recommended several drugs
including anti-inflammatories such as Ibuprofen and Naproxen, narcotics
such as Vicodin or Percocet, and Celebrex (if he had a sensitive
stomach, but which cost $240 for thirty pills). Id. at 24. The UC then
noted that a Vicodin prescription cost only $13 dollars at a local
pharmacy while ``everyone [is] talking about how much OxyContin is.''
Id.
Respondent then apparently wrote out various prescriptions as the
UC asked if there was ``[a]ny particular place you want me to give
these to?'' Id. at 25. Respondent recommended Comcare, the same
pharmacy he had referred to earlier as compounding Deca Durabolin, and
indicated that they had three offices. Id. at 25-26. Respondent further
noted that ``most of the pharmacists'' at Comcare knew him, and added:
``they're nice guys so you won't have a problem.'' Id. at 27.\17\
---------------------------------------------------------------------------
\17\ Following a discussion of the counterfeiting of
prescription drugs and the implementation of a drug tracking system
to protect consumers, Respondent started discussing the ordering of
drugs from Canada. GX 10, at 32. Respondent stated that he did not
``know how that works,'' and ``that's why I ask whoever comes [in]
how did you get the stuff you're getting before without a
prescription.'' Id. Respondent then noted that a patient ``had a
doctor who was pulling a little scam.'' Id. at 33. After the UC
interjected: ``Oh, I don't know where it's coming from,'' Respondent
stated: ``He [the doctor] was treating you and giving it to you
without ever actually meeting you or examining you.'' Id. Respondent
then added: ``Which is not really appropriate[.] I'm sure he lost
his license in the process.'' Id.
---------------------------------------------------------------------------
Later, the UC asked whether he could refer ``a couple close
friends.'' Id. at 34. Respondent initially responded that he
[[Page 50001]]
didn't ``normally'' take on such persons, and while he would ``do
this'' for the CI, ``this is not my thing.'' Id. Respondent stated that
he knew ``a lot about steroids cause [he] did them in college'' and had
``learned the hard way how to do them.'' Id. at 34-35. Respondent then
added that the CI ``has a deficiency where he doesn't make enough * * *
of a certain hormone'' and thus had a ``medical reasons for doing it.''
Id. at 35. After the UC stated, ``That's why I asked you,'' Respondent
replied: ``That's not a problem but it's not my thing to do this.'' Id.
Respondent then said that he would be willing to prescribe to the UC's
friends if they were HIV positive because ``three quarters of men with
HIV disease are low in testosterone'' and there is research showing
that ``normal or elevated testosterone levels actually help the immune
system.'' Id. at 36. Respondent added that while he was willing to help
HIV patients, ``for guys who are just looking for body building and
stuff like that I don't usually do.'' Id. at 36.
The record shows that during the visit, Respondent wrote Bill Rix
five prescriptions, including three for controlled substances.
Specifically, Respondent wrote for: 100 tablets of Vicodin ES, with
three refills; \18\ 5 cc's of nandrolone decanoate, with three refills;
and 10 cc's of testosterone cipionate, with three refills. GX 6.
Respondent also wrote Rix a prescription for 30 syringes with five
refills and one for ibuprofen. GX 6; Stipulated Facts, ALJ at 5.
---------------------------------------------------------------------------
\18\ The ALJ reasoned that because ``the record contains no
expert medical testimony or any other evidence which demonstrates
that the Respondent's treatment of [the UC] in this area was not for
a legitimate medical reason or outside the course of professional
practice,'' the preponderance of the evidence did not indicate that
this prescription was invalid. ALJ at 22. For reasons explained in
the discussion section of this decision, I conclude otherwise.
---------------------------------------------------------------------------
As the ALJ noted, ``[t]he assessment notes in [the UC's] medical
chart were incomplete, and did not include the specific prescriptions
the Respondent issued to [the UC].'' ALJ at 14; see also GX 8, at 5
(sheet for listing prescriptions for both legend and over-the-counter
drugs which is blank). More specifically, while the form Respondent
used to indicate the patient's complaint, history, physical exam,
assessment and treatment plan, indicates that he diagnosed Rix with
``osteoporosis''; consistent with the transcript of the visit, there
are no findings to support the diagnosis. Likewise, there are no
findings to support a diagnosis of joint pain or low testosterone and
neither condition is documented in the ``assessment'' section of the
form.
The ALJ also noted that Respondent did not ask ``for a copy of the
results of any of [the UC's] prior blood tests or order[] new blood
tests prior to prescribing testosterone.'' ALJ at 15. And, as the
transcript of the visit make clear, at no point did the UC indicate
that he had a history of shoulder and vertebral fractures, and
Respondent did not question the UC regarding the purported condition.
See id. at 18-19.
In his testimony, Respondent nonetheless maintained that he did a
full physical exam on the UC (except for checking his prostate), Tr.
570, and that he had actually ``found signs of lipodystrophy'' even
though there is no such documentation in UC's chart. Id. at 580. In his
testimony, Respondent stated that the form was incomplete because his
nurse came in to the exam room and said ``that a patient was about to
leave if I didn't get in there right away.'' Id. However, he intended
to write down ``history of osteoporosis second to hypogonadism [low
testosterone]'' at the ``little pound sign [which] is [his] indication
for a diagnosis.'' Id.
Respondent may well have intended to write this down. However,
given that: (1) The transcript of the visit clearly shows that
Respondent told the UC that he was writing down osteoporosis simply to
``cover my ass'' in the event the State inspected his records; (2) he
never questioned the UC about any of the purported fractures; (3) he
had been told by the UC that when he was last tested he had high
testosterone levels; and (4) he had been told by the UC that he had
previously obtained steroids illegally, writing down the additional
information would not make the diagnosis any less fraudulent.
Regarding his ``diagnosis'' of the UC, Respondent testified that
``[i]n [his] mind, Bill Rix had osteoporosis.'' Id. at 597. Thus, ``in
[his] mind, that was not a false diagnosis.'' Id. at 593. On cross-
examination, Respondent admitted, however, that he would not ``find out
whether this [sic] testosterone prescriptions that [he] issued were
medically valid'' until three months later, after the UC underwent a
blood test. Id. at 604. Moreover, the ALJ specifically found incredible
Respondent's testimony that he genuinely believed that the UC had
osteoporosis, noting his statement during the UC's April 24 visit. ALJ
at 19 (quoting GX 10, at 17-18) (``Just to cover my ass I'm going to
put down you got a history of osteoporosis. * * * [W]hen I write
osteoporosis it has nothing to do with you[.] [I]t just has to do if
the State ever comes in to monitor my charts that I have a reason for
prescribing you testosterone and * * * [Deca].'') I agree with the
ALJ's credibility determination.
Finally, in his testimony, Respondent stated that ``[i]n [his]
mind, everything [the UC] said was legitimate because I had already the
knowledge that he was HIV and he did show signs of it.'' Tr. 503.
Furthermore, he was ``trying to develop a rapport with this man. I was
trying to get him to trust me * * * to get him to eventually admit to
me that he knew he was HIV positive.'' Id. at 505. Respondent
maintained that he had lied to the UC about having used steroids in
college because he ``wanted to develop a rapport that `Hey, he's a cool
guy.' [The UC] was telling me he used steroids in the past, I wanted
him to think I was a sympathetic ear.'' Id. at 511.
The ALJ did not address whether she found this testimony credible.
However, I note that this testimony flows from Respondent's claim,
which I find is not credible, that the CI had told him in a telephone
call prior to the UC's visit that the UC was HIV positive. Moreover, at
no point did Respondent order a blood test to verify the UC's purported
condition. Finally, while Respondent testified that he believed that
the UC had been infected with HIV since 2002, id. at 562, Respondent
did not discuss with the UC what doctors he had previously seen and
offered no evidence that he had attempted to obtain the UC's medical
records. In short, he did nothing to verify whether the UC was HIV
positive. Thus, I find this testimony disingenuous.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In making the public interest determination, the CSA
requires that the following factors be considered:
(1) The recommendation of the appropriate state licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
[[Page 50002]]
21 U.S.C. 823(f).
These factors are considered in the disjunctive. Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a combination
of factors, and I may give each factor the weight I deem appropriate in
determining whether to revoke an existing registration. Id. Moreover, I
am ``not required to make findings as to all the factors.'' Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412
F.3d 165, 173-74 (DC Cir. 2005).
The Government bears the burden of proof. 21 CFR 1316.56. However,
where the Government makes out a prima facie case that a registrant's
continued registration is inconsistent with the public interest, the
burden shifts to the registrant to demonstrate why he can be entrusted
with a registration.
Having considered all of the factors, I acknowledge that the record
contains no evidence that the State of Florida has taken action against
Respondent's medical license (factor one) or that Respondent has been
convicted of an offense related to controlled substances (factor
three).\19\ However, with respect to Respondent's experience in
dispensing controlled substances (factor two) and his record of
compliance with applicable Federal and state laws (factor four), the
record establishes that Respondent violated the CSA's prescription
requirement, see 21 CFR 1306.04(a), and Federal law when he prescribed
anabolic steroids and narcotics to the UC in that he acted outside of
the usual course of professional practice and/or lacked a legitimate
medical purpose. See 21 U.S.C. 841; 21 CFR 1306.04(a). The record also
demonstrates that Respondent violated the prescription requirement and
Federal law on numerous occasions by prescribing Subutex to the CI for
detoxification purposes when he was not qualified to treat and manage
opiate-dependent patients. 21 U.S.C. 823(g); 21 CFR 1306.04(c).
Finally, I agree with the ALJ that Respondent has failed to rebut the
Government's prima facie case. Accordingly, Respondent's registration
will be revoked and his pending application to renew his registration
will be denied.
---------------------------------------------------------------------------
\19\ This Agency has long held that a State's failure to take
action against a practitioner's authority to dispense controlled
substances is not dispositive in determining whether the
continuation of a registration would be consistent with the public
interest. See Mortimer B. Levin, 55 FR 8209, 8210 (1990). Likewise,
the absence of a criminal conviction is not dispositive of the
public interest inquiry. See, e.g., Edmund Chein, 72 FR 6580, 6593
n.22 (2007).
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws.
Under a longstanding DEA regulation, a prescription for a
controlled substance is not ``effective'' unless it is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``an order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
829] and * * * the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances.'' Id. See also 21 U.S.C. 802(10) (defining the term
``dispense'' as meaning ``to deliver a controlled substance to an
ultimate user by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled
substance'') (emphasis added).
As the Supreme Court recently explained, ``the prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135, 143 (1975)). Under the CSA, it is fundamental that a practitioner
must establish and maintain a bonafide doctor-patient relationship in
order to act ``in the usual course of * * * professional practice'' and
to issue a prescription for a ``legitimate medical purpose.'' Laurence
T. McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S.
at 142-43 (noting that evidence established that physician ``exceeded
the bounds of `professional practice,' '' when ``he gave inadequate
physical examinations or none at all,'' ``ignored the results of the
tests he did make,'' and ``took no precautions against * * * misuse and
diversion''). The CSA, however, generally looks to state law to
determine whether a doctor and patient have established a bonafide
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931,
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407-08
(2007).
Under the standards adopted by the Florida Board of Osteopathic
Medicine, to evaluate a patient:
[a] complete medical history and physical examination must be
conducted and documented in the medical record. The medical record
should document the nature and intensity of the pain, current and
past treatments for pain, underlying or coexisting diseases or
conditions, the effect of the pain on physical and psychological
function, and history of substance abuse. The medical record also
should document the presence of one or more recognized medical
indications for the use of a controlled substance.
Fla. Admin Code Ann. r. 64B15-14.005(3)(a). The Board's standard
further states that ``[t]he osteopathic physician should discuss the
risks and benefits of the use of controlled substances with the
patient.'' Id. para. (3)(c). Moreover, as relevant here, an
ostheopathic physician is required to keep accurate and complete
records to include, but not be limited to:
1. The medical history and physical examination;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments; [and]
7. Medications (including date, type, dosage, and quantity
prescribed)[.]
Id. para (3)(f).
As found above, during the UC's April 24 visit, Respondent issued
him a prescription for 100 tablets of Vicodin ES, with three refills, a
schedule III controlled substance which contains hydrocodone. ALJ at 5
(stipulated facts). While the prescription was purportedly issued to
address the UC's joint pain, Respondent did not physically examine the
UC. Moreover, although the UC made an oblique reference to pain in his
knees while performing squats, Respondent did not further question the
UC as to the nature and intensity of the pain or the pain's effect on
the UC's physical and psychological function. Furthermore, Respondent
did not discuss the risks and benefits of using controlled substances.
Finally, Respondent did not document any past or current treatments for
the purported pain and did not document the presence of a medical
condition for which the use of controlled substances was indicated.
Therefore, in accordance with the standards of the Florida Board, I
conclude that Respondent acted outside of the usual course of
professional practice and lacked a legitimate medical purpose in
issuing the Vicodin prescription (with three refills) to the UC and
violated Federal law. See 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a).
I further conclude that Respondent violated both state and Federal
law when he prescribed to the UC two anabolic steroids, which are
schedule III
[[Page 50003]]
controlled substances: 15 cc's of nandralone decanoate (with three
refills), and 10 cc's of testosterone cipionate (also with three
refills). Under Florida law, ``prescribing * * * testosterone or its
analogs * * * for the purpose of muscle building or to enhance athletic
performance'' is unlawful.\20\ See Fla. Stat. Ann. Sec.
458.331(1)(ee). As found above, during the April 24 visit, the UC was
clearly seeking the anabolic steroid prescriptions for muscle building
purposes, which is not a legitimate medical purpose under Florida law
(and therefore Federal law as well).
---------------------------------------------------------------------------
\20\ It is acknowledged that for the purpose of this provision,
``the term `muscle building' does not include the treatment of
injured muscle.'' Fla. Stat. Ann. Sec. 458.331(ee).
---------------------------------------------------------------------------
Moreover, the transcript of the visit further establishes that
Respondent clearly knew that the UC was seeking the steroids for this
purpose. Specifically, the UC did not complain of any problem other
than that he was aging and losing strength; related that he had
obtained steroids through a pharmacy, which arranged for doctors, who
never saw patients, to write the prescriptions lawfully required to
dispense the steroids; that he had gone to the pharmacy one day only to
find that it had been raided by the police; and that when he had last
undergone a blood test, his testosterone levels were high.
Respondent's statements during the undercover visit further support
the conclusion that he knew the UC was seeking the steroids for other
than a legitimate medical purpose. As found above, Respondent stated
that ``just to cover my ass,'' he was going to ``put down'' in the UC's
chart that he had ``a history of osteoporosis,'' and that ``when I
write osteoporosis it has nothing to do with you[,] it just has to do
if the State ever comes in to monitor my charts that I have a reason
for prescribing you testosterone and Deca.'' GX 10, at 17-18. Thus, it
is clear that Respondent knew that he lacked a legitimate medical
purpose for prescribing steroids to the UC.\21\
---------------------------------------------------------------------------
\21\ To similar effect, upon being asked by the UC whether he
would accept referrals of ``a couple [of] close friends,''
Respondent answered that while he was willing to prescribe steroids
to the UC as a favor to Jimmy (the CI), ``this is not my thing'' and
that I ``know a lot about steroids cause I did them in college.'' GX
10, at 34. He then added that Jimmy (unlike the UC) ``actually has a
deficiency where he doesn't make enough of a certain hormone so * *
* he has medical reasons for doing'' steroids. Id. at 35. Respondent
then told the UC that ``it's not my thing to do this.'' Id.
---------------------------------------------------------------------------
Respondent therefore violated the prescription requirement of
Federal law when he wrote the UC prescriptions for nandralone and
testosterone. I further hold that Respondent's issuance of the Vicodin
and anabolic steroid prescriptions to the UC each provide an
independent and adequate basis to satisfy the Government's prima facie
case that Respondent's continued registration is inconsistent with the
public interest.
Respondent also repeatedly violated Federal law by prescribing
Subutex to the CI. According to the record, Respondent had initially
referred the CI to a psychiatrist who specialized in detoxification of
opiate-dependent patients and from whom the CI received prescriptions
of Subutex for this purpose. When, however, the CI complained that the
detox specialist charged too much and insisted on seeing him every
month, Respondent agreed to write Subutex prescriptions for the CI and
wrote him numerous prescriptions (as well as authorized refills) over
the course of nearly three and a half years. Respondent did not dispute
that the Subutex prescriptions were written for this purpose.
Under Federal law, a physician who dispenses (which includes
prescribing) narcotic drugs in schedules III through V to a person for
maintenance or detoxification treatment need not necessarily obtain a
separate registration for this purpose. However, the physician must
satisfy extensive conditions to prescribe these drugs for these
purposes. See 21 U.S.C. 823(g)(2)(A) & (B). These conditions include
that the practitioner must, ``before the initial dispensing of narcotic
drugs in schedule III, IV or V'' for these purposes, notify the
Secretary of the Department of Health and Human Services (HHS) of his
intent ``to begin dispensing the drugs * * * for such purpose.'' Id.
Sec. 823(g)(2)(B). And as part of the notification, the physician must
make three certifications.
More specifically, the practitioner must certify that: (1) He ``is
a qualifying physician''; (2) he ``has the capacity to refer the
patients for appropriate counseling and other appropriate ancillary
services''; and (3) ``[t]he total number of patient of the practitioner
at any one time will not exceed the applicable number.''\22\ Id. With
respect to the first requirement, a physician must hold (in addition to
a state license) either board certification in addiction, addiction
medicine, or addiction psychiatry; or have completed ``not less than
eight hours of training'' in the ``treatment and management of opiate-
dependent patients'' provided by various professional
organizations,\23\ or have other training or experience as either the
Secretary of HHS or a State medical board has determined
``demonstrate[s] the ability of the physician to treat and manage
opiate-dependent patients.'' Id. Sec. 823(g)(2)(G).
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\22\ Initially, a practitioner may only treat thirty patients.
21 U.S.C. 823(g)(2)(B)(iii).
\23\ The organizations include ``the American Society of
Addiction Medicine, the American Academy of Addiction Psychiatry,
the American Medical Associations, the American Ostheopathic
Association, and the American Psychiatric Association.'' 21 U.S.C.
823(g)(2)(G)(IV).
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Although Respondent holds a valid state license, he did not meet
any of the conditions necessary to demonstrate that he is qualified as
a physician to treat and manage opiate-dependent patients such as the
CI. Nor did he satisfy any of the statute's other requirements for
dispensing narcotics drugs for the purpose of maintenance or
detoxification treatment.
While Respondent asserted that he did not know when these
requirements went into effect and was unsure as to whether ``the
course'' was required at the time he wrote the prescriptions, they have
been in effect since the year 2000.\24\ See Drug Addiction Treatment
Act of 2000, Public Law 106-310, Sec. 3502, 114 Stat. 1222, 1225
(2000). As for his contention that no pharmacist ever told him he
needed a special registration to prescribe narcotics for this purpose,
Respondent is responsible for knowing the law. Cf. Patrick W. Stodola,
M.D., 74 FR 20727 20734 (2009) (quoting Hageseth v. Superior Court, 59
Cal. Rptr.3d 385, 403 (Ct. App. 2007) (``[T]he proscription of the
unlicensed practice of medicine is neither an obscure nor an unusual
state prohibition of which ignorance can reasonably be claimed, and
certainly not by persons * * * who are licensed health care
providers.'').
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\24\ Since 1974, Federal law has required that a practitioner
obtain a separate registration and meet various standards imposed by
the Secretary to dispense narcotic drugs for maintenance or
detoxification treatment. See Narcotic Treatment Act of 1974, Public
Law 93-281, 88 Stat. 137-38 (1974). While a practitioner who seeks
to dispense schedule III through V controlled substances for
maintenance or detoxification treatment may obtain a waiver of the
registration requirement, as explained above, he must still meet
various requirements including having either board- certification or
suitable experience and/or training in treating and managing opiate-
dependent patients.
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These are serious violations of Federal law. Congress made this
clear in the Drug Addiction Treatment Act, where it specifically
provided that if a practitioner, ``in violation of the conditions
specified in subparagraph[] B * * * dispenses narcotic drugs in
schedule III, IV, or V * * * for maintenance treatment or
detoxification treatment, the Attorney General may, for
[[Page 50004]]
purposes of [21 U.S.C. 824(a)(4)], consider the practitioner to have
committed an act that renders the registration of the practitioner
pursuant to subsection (f) to be inconsistent with the public
interest.'' 21 U.S.C. 823(g)(2)(E)(i). Accordingly, I further hold that
Respondent's prescribing of Subutex to the CI for detoxification
purposes provides an additional and independent basis to support the
Government's prima facie case.
Sanction
Under Agency precedent, where, as here, ``the Government has proved
that a registrant has committed acts inconsistent with the public
interest, a registrant must `present[] sufficient mitigating evidence
to assure the Administrator that [he] can be entrusted with the
responsibility carried by such a registration.' '' Medicine Shoppe-
Jonesborough, 73 FR 363, 387 (2008) (quoting Samuel S. Jackson, 72 FR
23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)).
Moreover, because ``past performance is the best predictor of future
performance, ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995),
[DEA] has repeatedly held that where a registrant has committed acts
inconsistent with the public interest, the registrant must accept
responsibility for [his] actions and demonstrate that [he] will not
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006);
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v.
DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]''
by DEA to be an ``important factor[]'' in the public interest
determination).
As part of this determination, this Agency also places great weight
on a registrant's candor, both during an investigation and in any
subsequent proceeding. See, e.g., The Lawsons, Inc., t/a The Medicine
Shoppe Pharmacy, 72 FR 74334, 74338 (2007) (quoting Hoxie, 419 F.3d at
483) (``Candor during DEA investigations properly is considered by the
DEA to be an important factor when assessing whether a * * *
registration is consistent with the public interest.''). See also Rose
Mary Jacinta Lewis, M.D., 72 FR 4035, 4042 (2007) (holding that lying
under oath in proceeding to downplay responsibility supports conclusion
that physician ``cannot be entrusted with a registration'').
Here, as the ALJ found, the evidence supports the conclusions that
Respondent has failed to accept responsibility for his misconduct and
gave false testimony in the proceeding. ALJ at 30. More specifically,
based on the transcript of the April 24 visit, which clearly shows that
Respondent falsely documented that the UC had osteoporosis, the ALJ
found not credible Respondent's testimony that he genuinely believed
the UC had osteoporosis. I agree.
Moreover, while the ALJ expressly declined to make any findings as
to whether she found credible Respondent's testimony that the CI had
phoned him and related that the UC had various conditions such as HIV
and a history of bone fractures (which was offered to provide some
medical justification for the steroid prescriptions), as explained
above, as ultimate factfinder, I have rejected his testimony as not
credible for multiple reasons. In short, the entirety of the evidence
convincingly demonstrates that Respondent's testimony regarding the
purported phone call was patently self-serving and disingenuous.
Respondent further argues that he refused to prescribe HGH to the
UC and also refused the UC's request to accept the latter's friends as
``patients.'' As for Respondent's refusal to prescribe HGH (which is
not a controlled substance), it is far from clear that the UC was
seeking HGH as he noted that it's ``the most expensive stuff on earth''
and that it had caused an acquaintance's head to swell.\26\ GX 10, at
11. While it is true that Respondent told the UC of other serious side
effects caused by HGH, this no more mitigates his misconduct in issuing
the steroid prescriptions than would an argument that one had
prescribed a slightly less dangerous narcotic rather than a more
dangerous one sought by a drug abuser (for example OxyContin instead of
Fentanyl), when there was no legitimate medical purpose for any such
prescription. Put another way, the fact that a controlled substance
causes less dangerous side effects than another drug which a drug
abuser may have sought does not make a prescription for a controlled
substance, which lacks a legitimate medical purpose, any less illegal.
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\26\ In her opinion, the ALJ found that the UC had ``hinted that
he would like a prescription for'' HGH. ALJ at 22. This does not
seem to be an accurate reading of the evidence in light of the UC's
complaint that HGH is ``the most expensive stuff on earth.'' GX 10,
at 39.
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As for Respondent's declining the UC's offer to refer his friends
because he ``usually'' did not do ``guys who are just looking for
bodybuilding and stuff like that,'' he nonetheless was willing to issue
illegal prescriptions to the UC. Moreover, that Respondent did not
``usually'' write steroid prescriptions for those into bodybuilding
implies that, in some other instances, he did. See ALJ at 32.
In short, even were I to view the evidence as supporting both
Respondent's contention that the UC sought HGH but he refused to
prescribe it and that he declined the UC's offer to refer his friends,
these circumstances are not sufficient to rebut the Government's prima
facie case and demonstrate that he can be entrusted with a
registration. Moreover, regarding his extensive violations of Federal
law in prescribing Subutex for detoxification treatment, Respondent did
not accept responsibility, but rather blamed his misconduct on the fact
that no pharmacist told him that he needed a separate registration to
do so.\27\
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\27\ I have also considered Respondent's evidence regarding his
volunteer activities related to persons with HIV. While his
activities are laudable, they do not negate the fact that Respondent
knowingly diverted steroids and repeatedly violated Federal law in
prescribing Subutex. Nor are his activities relevant in determining
whether Respondent has accepted responsibility for his misconduct.
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In conclusion, because Respondent has failed to accept
responsibility for his misconduct and provided less than candid
testimony in the proceeding, it is clear that his continued
registration ``would be inconsistent with the public interest.'' 21
U.S.C. 823(f). Accordingly, Respondent's registration will be revoked
and his pending application to renew his registration will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate of Registration, BH1292642, issued to Robert F. Hunt, D.O.,
be, and it hereby is, revoked. I further order that Respondent's
pending application to renew his registration be, and it hereby is,
denied. This Order is effective immediately.
Dated: July 30, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-20243 Filed 8-13-10; 8:45 am]
BILLING CODE 4410-09-P