[Federal Register Volume 79, Number 203 (Tuesday, October 21, 2014)]
[Notices]
[Pages 62957-62968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25025]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 13-16]
Michael A. White, M.D.; Decision and Order
On April 16, 2014, Administrative Law Judge (ALJ) Gail A. Randall
issued the attached Recommended Decision (R.D.).\1\ Respondent filed
Exceptions to the Recommended Decision. Having reviewed the entire
record including Respondent's Exceptions, I have decided to adopt the
ALJ's findings of fact, conclusions of law, and recommended sanction
except as explained below.\2\ A discussion of Respondent's Exceptions
follows.
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\1\ All citations to the Recommended Decision are to the slip
opinion as issued by the ALJ.
\2\ I decline to publish the ALJ's discussion of the substantial
evidence standard. It suffices to say that in reviewing the factual
findings of a recommended decision, this Agency adheres to the
principles set forth in Universal Camera Corp. v. NLRB, 340 U.S.
474, 496 (1951).
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Respondent's Exceptions
In his Exceptions, Respondent raises five different contentions.
Notably, however, Respondent does not challenge any of the ALJ's
factual findings (including her findings that were based on the
testimony of the Government's Expert) regarding his prescribing of
phentermine to the sixteen patients at issue in this proceeding. See
generally Exceptions, at 1-4. Nor does he challenge the ALJ's legal
conclusion ``that Respondent failed to establish a bona-fide doctor-
patient relationship before prescribing [p]hentermine to the sixteen
patients at issue here, thus violating 21 CFR 1306.04(a).'' R.D. at 33;
see also Exceptions, at 1-4.
The ALJ also made extensive findings based on the results of a
January 19, 2012 hearing conducted by the Mississippi State Board of
Medical Licensure regarding Respondent's prescribing of phentermine to
five other persons. GX 5. Following the hearing, at which Respondent
was represented by counsel, the Board found him guilty of violating
various provisions of both state law and the Board's rules.
More specifically, with respect to each of the five persons, the
Board found that Respondent failed to obtain a thorough history or
complete a thorough physical examination prior to initiating treatment
utilizing a Schedule IV controlled substance.\3\ Id. at 49 (citing
Miss. Code Ann. Sec. 73-25-29(13); 25 Miss. Code R. Sec. 501(2)). The
Board further found that Respondent had violated its rule prohibiting
the continued prescribing of controlled substances classified as
amphetamine like anorectics and/or central nervous system stimulants to
a patient who had failed to lose weight after taking the controlled
substances over a period of thirty days. Id. (citing Miss. Code Ann.
Sec. 73-25-29(13)).
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\3\ The Board also found that he had ``initiated treatment
utilizing a Schedule IV controlled substance without having
performed a review of the patient's prior medical and weight-loss
program records to determine that the patient had made a substantial
good-faith effort to lose weight in a treatment program utilizing a
regimen of weight reduction based on caloric restriction,
nutritional counseling, behavior modification and exercise, without
the utilization of controlled substances, and that said treatment
had been ineffective, all in violation of Miss. Code Ann. Sec. 73-
25-29(13).'' GX 5, at 49 (citing 25 Miss. Code R. Sec. 501(1)).
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Most significantly, with respect to each of the five patients at
issue in the proceeding, the Board found Respondent ``guilty of
dispensing drugs having addiction-forming or addiction-sustaining
liability otherwise than in the course of legitimate professional
practice.'' Id. at 16 (citing Miss. Code Ann. Sec. 73-25-29(3)). This
finding is equivalent to a finding that Respondent violated 21 CFR
1306.04(a), which requires that a controlled-substance prescription
``be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional practice.''
Here again, Respondent did not challenge the ALJ's findings of fact
and conclusions of law which were based on the Board's findings.
Indeed, nowhere in his Exceptions does he dispute the ALJ's legal
conclusions that he violated the Controlled Substance Act's
prescription requirement with respect to some twenty-one patients.
Instead, he argues that the denial of his application is
unwarranted because there is no evidence that any person he prescribed
to has been injured or died as a result of his unlawful prescribing of
controlled substances. Exceptions, at 1-2. The short answer to
Respondent's contention is that proving injury is not an element of an
allegation that a physician violated 21 CFR 1306.04(a). Rather, proof
of such a violation is established by showing that in issuing the
prescription, the physician acted outside of the usual course of
professional practice and lacked a legitimate medical purpose, and such
proof establishes that a physician knowingly or intentionally diverted
a controlled substance.
Respondent also argues that the ALJ's findings and recommendation
are erroneous because he was found not guilty in a criminal proceeding
``after the exact evidence was presented and the same witness
testimony[ ] that was presented'' at the DEA hearing. Exceptions, at 2.
Putting aside whether the exact same evidence was presented at both his
criminal trial and the DEA proceeding (the latter appearing to include
evidence of his misconduct in prescribing to far more patients than
were at issue in the former), Respondent ignores that the State Board
also found him guilty of dispensing controlled substances other than in
the course of legitimate professional practice (i.e., without a
legitimate medical purpose). See GX 5, at 50.
As for his related argument that ``[t]he irony is overwhelming that
the public who he could potentially harm did not buy the DEA's
assertions while sitting in the jury box,'' Exceptions, at 2-3;
Respondent ignores that because of the greater consequences that attach
upon a criminal conviction, a higher standard of proof applies in a
criminal trial than in an administrative proceeding. Indeed, given that
Respondent does not challenge any of the ALJ's findings with respect to
whether he violated the CSA's prescription requirement and diverted
controlled substances, there is more than ample evidence to support the
conclusion that he poses a potential danger to the public. See Gonzales
v. Oregon, 546 U.S. 243, 274 (2006) (``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
[[Page 62958]]
crave the drugs for those prohibited uses'') (citing United States v.
Moore, 423 U.S. 122, 135, 143 (1975)).
As further support for his contention that he ``poses no threat or
risk'' to the public, Respondent points to the fact that the State
Board has allowed him to continue to practice medicine.\4\ Exceptions,
at 3. Contrary to Respondent's understanding, the denial of his
application for a DEA registration does not prevent him from practicing
medicine. It only prevents him from dispensing controlled substances, a
remedy which is more than warranted considering the extensiveness of
his misconduct and his failure to accept responsibility for it. See
R.D. at 37 (noting that Respondent's ``acceptance of responsibility was
tenuous at best,'' that ``not once during the hearing did Respondent
unequivocally admit fault for his improper [p]hentermine
prescriptions,'' and that his ``purported admission of guilt was also
undermined by his tendency to blame others and make excuses for his
misconduct'').
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\4\ While in exercising its sovereign power to regulate the
medical profession within the State, the Mississippi Board may have
chosen to allow Respondent to continue to practice medicine, this
``Agency has long held that `the Controlled Substances Act requires
that the Administrator . . . make an independent determination [from
that made by state officials] as to whether the granting of
controlled substance privileges would be in the public interest.' ''
David A. Ruben, 78 FR 38363, 38379 n.35 (2013) (quoting Mortimer
Levin, 57 FR 8680, 8681 (1992)).
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As the Tenth Circuit has recognized:
The DEA may properly consider whether a physician admits fault
in determining if the physician's registration should be revoked.
When faced with evidence that a doctor has a history of distributing
controlled substances unlawfully, it is reasonable for the [Agency]
to consider whether that doctor will change his or her behavior in
the future. And that consideration is vital to whether continued
registration is in the public interest.
MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (citing Hoxie v. DEA,
419 F.3d 477, 483 (6th Cir. 2005)); see also Jayam Krishna-Iyer, 74 FR
459, 462 (2009) (holding that even where the evidence shows that an
applicant or registrant has committed only a few acts of intentional
diversion, ``this Agency will not grant or continue the practitioner's
registration unless he accepts responsibility for his misconduct'').
As for his contention that this proceeding ``is nothing more than a
vindictive act by'' the Agency because he was acquitted in his criminal
case, Exceptions at 3, here again, Respondent ignores that two separate
bodies have found that he knowingly diverted controlled substances, and
the ALJ's findings, which he does not challenge, establish that he
diverted controlled substances to more than twenty patients. Because
his misconduct is egregious and Respondent has failed to accept
responsibility for it, I reject his exceptions and will adopt the ALJ's
recommended order that I deny his application.\5\
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\5\ I have also considered his final contention, which takes
issue with the ALJ's finding that Respondent took a ``hostile tone''
during the hearing and argues that this finding establishes that the
ALJ was not impartial. R.D. at 38; Exceptions, at 3-4. He cites no
authority for the contention that a trier of fact cannot consider a
witness's tone in assessing his credibility, and because the ALJ was
in the best position to observe Respondent's demeanor during the
hearing, I reject the contention.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) and 0.104, I order that the application of Michael
A. White, M.D., for a DEA Certificate of Registration as a practitioner
be, and it hereby is, denied. This Order is effective immediately.
Dated: October 10, 2014.
Thomas M. Harrigan,
Deputy Administrator.
Michelle F. Gillice, Esq., and
Frank W. Mann, Esq., for the Government
Rodney A. Ray, Esq., for the Respondent
RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION
OF THE ADMINISTRATIVE LAW JUDGE
Gail A. Randal, Administrative Law Judge.
I. INTRODUCTION
This proceeding is an adjudication pursuant to the Administrative
Procedure Act, 5 U.S.C. Sec. 551 et seq., to determine whether the
Drug Enforcement Administration (``DEA'' or ``Government'') should deny
a physician's application for a DEA Certificate of Registration
pursuant to 21 U.S.C. Sec. 823(f) (2006). Without his registration,
the physician, Michael A. White, M.D. (``Respondent'' or ``Dr.
White''), 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 (``OTSC'')
dated July 2, 2013, proposing to deny the Respondent's application for
a DEA Certificate of Registration, as a practitioner, pursuant to 21
U.S.C. Sec. Sec. 824(a)(4) and 823(f) because the Respondent's
registration would be inconsistent with the public interest, as that
term is defined in 21 U.S.C. Sec. 823(f). [Administrative Law Judge
Exhibit (``ALJ Exh.'') 1 at 1].
Specifically, the OTSC stated that according to a January 19, 2012
order (``Board Order'' or ``Order'') from the Mississippi State Board
of Medical Licensure (``Board''), Respondent violated several state
laws relating to controlled substances. [Id. at 2]. First, the OTSC
alleged that, according to the Board Order, Respondent violated title
73, chapter 25, section 29(3) of the Mississippi Code by dispensing
drugs having addiction-forming or addiction-sustaining liability
outside of the course of legitimate professional practice. [Id.].
Second, the OTSC alleged that, according to the Board Order, Respondent
violated Chapter 25, Section 501 of the Board's Rules and Regulations
by prescribing a Schedule IV controlled substance without first
reviewing the patient's records to determine if the patient had made a
good-faith effort to lose weight using caloric restriction, nutritional
counseling, behavior modification, and exercise. [Id.]. Third, the OTSC
alleged that, according to the Board Order, Respondent violated Chapter
25, Section 501(2) of the Board's Rules and Regulations by prescribing
a Schedule IV controlled substance without first obtaining a thorough
history or completing a thorough physical examination of the patient.
[Id.]. Fourth, the OTSC alleged that, according to the Board Order,
Respondent violated Chapter 25, Section 501(5)(a) of the Board's Rules
and Regulations by continuing to prescribe a Schedule IV controlled
substance to patients who failed to lose weight over a thirty day
period. [Id.]. Finally, the OTSC alleged that, according to the Board
Order, Respondent's improper prescribing of a Schedule IV controlled
substance constituted unprofessional conduct under Mississippi Code
Ann. 73-24-83(a). Additionally, the Order alleged that Respondent
failed to obey the Board Order's requirement that Respondent submit
proof that he completed 40 hours of continuing medical education
(``CME''). [Id. at 2-3]. The OTSC alleged that as a result of these
violations, the Board suspended Respondent's medical license for six
months and permanently prohibited Respondent from treating patients for
[[Page 62959]]
weight loss with controlled substances. [Id.at 2].
The OTSC further alleged that Respondent's issuing of prescriptions
for Schedule IV controlled substances without a legitimate medical
purpose and outside the usual course of business violated 21 C.F.R.
Sec. 1306.04(a). [Id.].
On July 31, 2013, the Respondent, through counsel, timely filed a
request for a hearing. [ALJ Exh. 2].
The hearing in this case took place on January 29, 2014 in Oxford,
Mississippi. [ALJ Exh. 7; Transcript (``Tr.'') 1]. Respondent and the
Government were each represented by counsel. At the hearing, the
Government introduced documentary evidence and called three witnesses
and Respondent called one witness, himself. [Tr. 3].
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 or not the record as a
whole establishes by a preponderance of the evidence that the Drug
Enforcement Administration should deny the application for a DEA
Certificate of Registration (``COR'') of Dr. Michael A. White, as a
practitioner, pursuant to 21 U.S.C. Sec. 823(f), because to grant his
application would be inconsistent with the public interest, as that
term is defined in 21 U.S.C. Sec. 823(f). [Tr. 6; ALJ Exh. 4 at 1].
IV. FINDINGS OF FACT
A. Stipulated Facts
The parties have stipulated to the following facts:
1. Respondent applied for a DEA COR as a practitioner in Schedules
II-V at the Pain Clinic LLC, 3499 Bluecutt Road, Suite 1, Columbus,
Mississippi, 39701 on March 21, 2012.
2. Respondent was previously registered with DEA as a practitioner
in Schedules II-V under DEA COR number BW3923009 at 3499 Bluecutt Road,
Suite 1, P.O. Box 7757, Columbus, Mississippi, 39705.
3. On September 22, 2011, DEA issued an Order to Show Cause to
Respondent seeking revocation of his DEA COR BW3923009.
4. Phentermine is a Schedule IV controlled substance pursuant to 21
C.F.R. Sec. 1308.14(e)(9).
5. Respondent voluntarily surrendered his COR BW3923009 on March
16, 2012.
6. On June 21, 2011, DEA and other law enforcement officials
executed a search warrant at Respondent's medical practice which was
also his registered address and seized among other items, Respondent's
patient files.
7. Government Exhibit #12 is a true and accurate copy of the
Respondent's patient file of patient [C.H.] \6\ seized during the
execution of a search warrant at Respondent's registered address on
June 21, 2011.
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\6\ Before the hearing, I issued a Protective Order which
protects the identities of third parties in these proceedings. [ALJ
Exh. 3]. Thus, in this recommended decision, I will refer to all
parties protected by the Protective Order by their initials.
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8. Government Exhibit #13 is a true and accurate copy of the
Respondent's patient file of patient [R.G.] seized during the execution
of a search warrant at Respondent's registered address on June 21,
2011.
9. Government Exhibit #14 is a true and accurate copy of the
Respondent's patient file of patient [C.B.] seized during the execution
of a search warrant at Respondent's registered address on June 21,
2011.
10. Government Exhibit #15 is a true and accurate copy of the
Respondent's patient file of patient [A.G.] seized during the execution
of a search warrant at Respondent's registered address on June 21,
2011.
11. Government Exhibit #16 is a true and accurate copy of the
Respondent's patient file of patient [J.H.] seized during the execution
of a search warrant at Respondent's registered address on June 21,
2011.
12. Government Exhibit #17 is a true and accurate copy of the
Respondent's patient file of patient [T.H.] seized during the execution
of a search warrant at Respondent's registered address on June 21,
2011.
13. Government Exhibit #18 is a true and accurate copy of the
Respondent's patient file of patient [K.H.] seized during the execution
of a search warrant at Respondent's registered address on June 21,
2011.
[ALJ Exh. 4 at 1-2; ALJ Exh. 5].
B. Respondent's Background
Respondent earned his undergraduate degree in Chemistry and Biology
from the University of California, Irvine. [Tr. 186]. Thereafter, he
earned his medical degree from the California College of Medicine at
Irvine in 1981 and later completed his residency in anesthesiology at
Emory University in Atlanta, Georgia. [Tr. 186-87]. He obtained DEA COR
BW3923009 on March 4, 1994. [Gov't Exh. 1 at 1]. On March 20, 2012, the
Respondent surrendered this registration for cause. [Id.].
Respondent practiced anesthesiology in Mississippi until 2008 when,
due to his hearing beginning to deteriorate, he felt he could not
properly perform his job function and might pose a danger in the
surgery room. [Tr. 187]. Drawing on his experience in pain management
as an anesthesiologist, Respondent then opened a pain management clinic
in Columbus, Mississippi. [Tr. 188]. Respondent started the practice
``from scratch,'' and most of his patients sought relief from neck or
back pain and were referred by another physician. [Tr. 188-89].
In the Fall of 2008, Respondent agreed to treat the patients of a
weight loss physician, ``Dr. Burtman,'' who, in Respondent's words,
``was shut down by . . . the DEA and the Medical Board.'' [Tr. 189].
Respondent testified that he did not intend his weight loss practice to
be permanent, but that he maintained the weight loss patients because
it was a financial buoy for his developing pain management practice.
[Tr. 190].
C. Law Enforcement's Investigation of Respondent
The DEA investigation into Respondents' weight loss practice began
when the Lowndes County Narcotics Task Force notified DEA that
Respondent and another doctor may be ``running pill mills'' and that
``there were some concerns about some overdose deaths.'' \7\ [Tr. 15-
16]. DEA investigators worked together with the Lowndes County
Narcotics Task Force, Mississippi Bureau of Narcotics, and the
Mississippi State Board of Medical Licensure to conduct the
investigation of Respondent's practice. [Tr. 15].
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\7\ On cross examination, Diversion Investigator Sean Baudier
admitted that although the investigation began because of ``initial
complaints'' about overdose deaths, no such overdoses were ever
substantiated during the investigation. [Tr. 26-27]. In fact, DI
Baudier testified that DEA did not even seriously investigate the
reported drug overdose deaths because ``a lot of times in overdose
deaths, there are--there are poly drugs or alcohol involved.'' [Tr.
26]. Moreover, the president of the Board testified that he is not
aware of any injuries or deaths resulting from Respondent's
practice. [Tr. 70]. Therefore, because the Government did not
establish that any deaths occurred due to misconduct by Respondent,
my recommendation to the Administrator does not take into account DI
Baudier's mention of deaths by overdose.
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During the course of the investigation, law enforcement officers
interviewed Respondent's patients and sent undercover informants to
book appointments with Respondent's practice. [Gov't Exh. 5 at 36; Tr.
17]. The informants first attempted to book appointments with
Respondent for pain management, but were turned away.\8\
[[Page 62960]]
[Tr. 16-17; 41-42]. When the informants were able to get appointments
with Respondent for weight loss, DEA centered its investigation on the
weight loss side of Respondent's practice. [Tr. 17, 48]. Diversion
Investigator Sean Baudier testified that the informants obtained
Phentermine from Respondent ``[e]very time'' they visited Respondent's
practice. [Tr. 17]. Phentermine, also called Adipex, is a Schedule IV
controlled substance. [Tr. 52; ALJ Exh. 4 at 2]; 21 C.F.R. Sec.
1308.14(e)(9).
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\8\ There is some dispute as to why Respondent turned away the
informants on the pain management side of his practice. On direct
examination, DI Baudier testified that the informants were turned
away on the pain management side because Respondent was ``not taking
any patients.'' [Tr. 16-17]. He clarified this testimony on cross
examination, testifying that Respondent turned the informants away
because he ``[w]asn't accepting new patients.'' [Tr. 41].
Respondent's counsel suggested while cross examining DI Baudier that
the informants were turned away because Respondent only accepted new
patients with referrals, not because Respondent was not taking new
patients. [Tr. 41-42]. DI Baudier responded that because he did not
personally make the phone calls to book the appointments, he could
not dispute Respondent's explanation. [Tr. 41, 42]. Respondent
himself testified that all of his pain management patients were
referred by physicians and that ``[y]ou couldn't walk off the street
into my clinic.'' [Tr. 188-89]. To the extent that it is relevant, I
find that the Government has failed to establish that Respondent
turned the informants away because he was not accepting new pain
patients.
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DEA executed a warrant to search and seize evidence from
Respondent's practice on June 21, 2011 and obtained all patient files
kept by Respondent. [Tr. 17-18, 191; ALJ Exh. 5 at 1; Gov't Exhs. 12-
27]. Respondent credibly testified, and the Government did not refute,
that he ceased treating weight loss patients on the day the warrant was
executed. [Tr. 192].
D. The Board Hearings and Board Order
The investigation of Respondent resulted in the Board issuing a
Summons and Affidavit in November of 2011, formally charging Respondent
with twenty three counts of misconduct. [Gov't Exh. 5 at 1-33].
Respondent, represented by counsel, attended a hearing before the Board
on January 19, 2012. [Gov't Exh. 5 at 35; Gov't Exh. 6 at 1-2; Tr. 51,
58-59]. Respondent did not testify at that hearing because criminal
charges related to the same facts were pending. [Tr. 66-67]. The Board
issued its decision orally and in writing on the day of the hearing.
[Gov't Exh. 5 at 35-52; Gov't Exh. 6 at 215-218].
The Board considered Respondent's misconduct with respect to five
patients, J.B., A.S., T.S., C.R., and T.S., three of whom were
confidential informants employed by law enforcement. [Gov't Exh. 5 at
36-48]. Regarding those patients, the Board made the following factual
and legal findings, which are binding on this Court under the
principles of collateral estoppel. See David A. Ruben, 78 Fed. Reg.
38,363, 38,365 (DEA 2013); Robert L. Dougherty, M.D., 76 Fed. Reg.
16,823, 16,830 (DEA 2011).
1. J.B.
J.B., referred to in the Board Order as ``Patient #1,'' was one of
Respondent's patients who was interviewed by law enforcement during the
course of its investigation. [Gov't Exh. 5 at 36-37]. At the time she
first came to see Respondent for weight loss on February 2, 2009, J.B.
was 5'7'' tall and weighed 148 pounds, ``which the Board determine[d]
is not obese.'' [Gov't Exh. 5 at 37]. On the initial visit, Respondent
issued a prescription for 30 doses of Phentermine and subsequently
issued eight more prescriptions for 30 doses of Phentermine between
March 9, 2009 and September 27, 2010. [Gov't Exh. 5 at 37].
Additionally, Respondent prescribed to J.B. 90 doses of Sibutramine, a
Schedule IV controlled substance. [Gov't Exh. 5 at 37].
Respondent issued these prescriptions without performing a physical
examination, properly documenting J.B.'s medical history, recording
adiposity measurements such as BMI or waist circumference, conducting
an EKG, conducting any laboratory testing, or verifying that J.B. had
made good-faith efforts to lose weight without the aid of controlled
substances. [Gov't Exh. 5 at 37-38]. Furthermore, Respondent continued
to prescribe controlled substances to J.B. despite the patient's
failure to lose weight after six months of treatment. [Gov't Exh. 5 at
39]. In fact, after the nineteen month-long treatment, J.B. actually
gained twenty pounds. [Gov't Exh. 5 at 39].
2. A.S.
A.S., referred to in the Board Order as ``Patient #2,'' was also
one of Respondent's patients who cooperated with the law enforcement
investigation. [Gov't Exh. 5 at 39]. A.S. was 5'6'' tall and weighed
180 pounds when she first saw Respondent for weight loss. [Gov't Exh. 5
at 39]. She told Respondent that she had previously received ``diet
medication'' from another doctor, Dr. Burtman, but Respondent did not
include Dr. Burtman's charts in A.S.'s file. [Gov't Exh. 5 at 40].
Respondent prescribed controlled substances to A.S. without
performing an adequate physical examination, properly documenting her
medical history, recording adiposity measurements such as BMI or waist
circumference, conducting any laboratory testing, or verifying that
J.B. had made good-faith efforts to lose weight without the aid of
controlled substances. [Gov't Exh. 5 at 39-41]. In total, Respondent
prescribed 150 doses of Phentermine to A.S. [Gov't Exh. 5 at 39].
3. T.S.
T.S., referred to in the Board Order as ``Patient #3,'' was a
confidential informant employed by law enforcement to gather
information about Respondent's practice. [Gov't Exh. 5 at 41]. She was
thirty four years old, 5'4'' tall, and weighed 225 pounds at the time
of her initial visit to Respondent's practice. [Gov't Exh. 5 at 41-42].
Law enforcement chose her to participate in the investigation because
she is not only obese, but has a number of other medical conditions as
well. [Gov't Exh. 5 at 41].
As with the other patients, Respondent prescribed controlled
substances to T.S. without performing an adequate physical examination,
properly documenting her medical history, recording adiposity
measurements such as BMI or waist circumference, conducting any
laboratory testing, or verifying that T.S had made good faith efforts
to lose weight without the aid of controlled substances. [Gov't Exh. 5
at 42-43]. In total, Respondent prescribed 150 doses of Phentermine to
T.S. [Gov't Exh. 5 at 41].
4. C.R.
C.R., referred to in the Board Order as ``Patient #4,'' was another
confidential law enforcement informant. [Gov't Exh. 5 at 43]. At the
time of her initial visit with Respondent, she was twenty two years
old, 5'3'' tall, and weighed 139 pounds. [Gov't Exh. 5 at 43-44]. The
Board found that although she was not obese, Respondent noted in C.R.'s
chart that she was ``overweight.'' [Gov't Exh. 5 at 44].
As with the other patients, Respondent prescribed controlled
substances to C.R. without performing an adequate physical examination,
properly documenting her medical history, recording adiposity
measurements such as BMI or waist circumference, conducting any
laboratory testing, or verifying that C.R. had made good faith efforts
to lose weight without the aid of controlled substances. [Gov't Exh. 5
at 43-45]. Additionally, Respondent did not document an individualized
treatment plan for C.R. Rather, under ``Plan of Care'' in the chart,
Respondent merely
[[Page 62961]]
wrote ``Weight Loss Program Month #1,'' which apparently included
prescriptions for Phentermine and a ``Low carb Diet.'' [Gov't Exh. 5 at
45]. Respondent prescribed C.R. a total of 120 doses of Phentermine.
[Gov't Exh. 5 at 43].
5. T.S.1
T.S.1, referred to in the Board Order as ``Patient #5,'' was
another confidential informant who visited Respondent for weight loss.
[Gov't Exh. 5 at 46]. At the time of her initial visit, she was twenty
nine years old, 5'8'' tall, and weighed 125 pounds. [Gov't Exh. 5 at
46]. The Board found that she was not obese. [Gov't Exh. 5 at 46].
As with the other patients, Respondent prescribed controlled
substances to T.S.1 without performing an adequate physical
examination, properly documenting her medical history, recording
adiposity measurements such as BMI or waist circumference, conducting
any laboratory testing, or verifying that T.S.1 had made good faith
efforts to lose weight without the aid of controlled substances. [Gov't
Exh. 5 at 46-47]. Additionally, Respondent continued to prescribe
Phentermine to T.S.1 even though she actually gained nine pounds while
being on the weight loss program. [Gov't Exh. 5 at 48]. In total,
Respondent prescribed 120 doses of Phentermine to T.S.1. [Gov't Exh 5
at 46].
6. The Board's Conclusions of Law
Based on these factual findings, the Board concluded that
Respondent violated a number of rules and regulations. First, it found
that Respondent's failure to verify that these five patients made a
good-faith effort to lose weight without the aid of controlled
substances violated Chapter 25, Section 501(1) of the Rules and
Regulations of the Board, as well as title 73, Chapter 25, section
29(13) of the Mississippi Code. [Gov't Exh. 5 at 49].
Second, the Board found that Respondent's failure to obtain full
medical histories and perform adequate physical examinations of the
five patients violated Chapter 25, Section 501(2) of the Rules and
Regulations of the Board, as well as title 73, Chapter 25, section
29(13) of the Mississippi Code. [Gov't Exh. 5 at 49].
Third, the Board found that Respondent's continued prescribing of
controlled substances to patients who failed to lose weight after
thirty days of taking the controlled substances violated Chapter 25,
Section 501(5)(a) of the Rules and Regulations of the Board, as well as
title 73, Chapter 25, section 29(13) of the Mississippi Code. [Gov't
Exh. 5 at 49].
Fourth, the Board found that Respondent dispensed ``drugs having
addition-forming or addition-sustaining liability otherwise than in the
course of legitimate professional practice, all in violation of Miss.
Code Ann. 73-25-29(3).'' [Gov't Exh. 5 at 50].
Finally, the Board found that Respondent's actions constituted
``dishonorable or unethical conduct likely to deceive, defraud, or harm
the public in violation of Miss. Code Ann. 73-25-29(8)(d) and 73-24-
83(a).'' [Gov't Exh. 5 at 50].
Having made these findings, the Board suspended Respondent's
medical license for six months, but stayed the suspension contingent on
certain conditions. [Gov't Exh. 5 at 50-51]. Namely, the Board ordered
Respondent to complete certain continuing medical education courses
within six months of the Board Order and to report such completion to
the Board. [Gov't Exh. 5 at 50-51]. The Board also permanently
prohibited Respondent from treating patients for weight loss and
ordered Respondent to reimburse the Board for its costs in adjudicating
the matter. [Gov't Exh. 5 at 51]. Additionally, the Board stated that
it would monitor Respondent's compliance with the Board Order by
periodically reviewing Respondent's patient charts. [Gov't Exh. 5 at
51].
7. The Second Board Hearing
In November of 2013, the Board held another hearing to determine
why Respondent had not complied with the Board Order. [Tr. 60; Gov't
Exh. 32]. At that hearing, Respondent testified that he had not taken
the CME courses because he could not afford them.\9\ [Tr. 60]. The
Board found that Respondent ``failed to comply with the . . .
conditions as set forth in the January 19, 2012 Determination Order.
Specifically, [Respondent] failed to submit proof of successful
completion of Continuing Medical Education (CME) hours; failed to
communicate with the Board as to the status of same; and failed to
reimburse the Board for all costs. . . .'' [Gov't Exh. 32 at 5].
---------------------------------------------------------------------------
\9\ The transcripts for the second Board hearing were not
entered into the record, but Dr. Van Craig testified that Respondent
told the Board at the hearing that he could not afford the CME
courses. [Tr. 60]. This testimony is corroborated by Respondent's
own testimony in these proceedings. [Tr. 205-06].
---------------------------------------------------------------------------
Thereafter, the Board allowed Respondent more time to complete the
CME courses and reimburse the Board for its expenses. Specifically, the
Board ordered Respondent to complete the courses and pay the Board
within six months of this DEA hearing. [Gov't Exh. 32 at 5]. The Board
also ordered Respondent to notify the Board ``when the DEA hearing is
scheduled and conducted.'' [Gov't Exh. 32 at 5].
At the hearing in these proceedings, the Board's executive
director, Dr. Harris Van Craig, testified that Respondent, to date, had
not notified the Board of the scheduled date for the DEA hearing. [Tr.
63]. He also testified regarding Respondent's ``demeanor'' in the
second Board hearing. [Tr. 60-61]. Specifically, Dr. Van Craig
testified that Respondent appeared ``angry with the Board for . . .
disciplining him'' and that Respondent thought he had received ``rather
harsh treatment from the Board because of what he was doing.'' [Tr. 60,
61; see also Tr. 66]. Dr. Van Craig also testified that Respondent felt
he was being ``singled out'' by law enforcement because ``other
practitioners in his area were doing the same thing as he was.'' [Tr.
60; see also Tr. 61].
E. Respondent's Criminal Charges
A month or two \10\ after the Board handed down its Order, federal
criminal charges were brought against Respondent for ``knowingly and
intentionally dispensing and distributing phentermine, which is a
Schedule IV controlled substance[,] without a legitimate medical
purpose and outside the usual course of medical practice.'' [Gov't Exh.
10 at 6; see also Tr. 21, 192]. A jury trial was conducted on October
22 and October 23, 2012, resulting in Respondent being acquitted of all
charges. [Gov't Exh. 10 at 1; Gov't Exh. 11 at 1, 224; Tr. 33].
Respondent credibly testified, and the Government did not refute, that
he stopped practicing medicine altogether on the day he was indicted.
[Tr. 192].
---------------------------------------------------------------------------
\10\ The record is not clear as to exactly when Respondent was
indicted. Respondent testified that he was indicted four to six
weeks after the Board issued its Order on January 19, 2012, [Tr.
192], but the indictment itself is not in evidence.
---------------------------------------------------------------------------
F. The Standard of Care for Prescribing Phentermine
At the hearing in these proceedings, the Government offered, and I
certified, Dr. Stephen Sudderth as an expert in weight loss medicine
and the medical use of Phentermine for weight loss. [Tr. 77-78]. Dr.
Sudderth is a general surgeon, a bariatric surgeon, and a bariatric
physician, licensed to practice in Mississippi. [Tr. 72, 73]. His
bariatric specialty means he ``specializes in the field of metabolic
and obesity disease.'' [See Tr. 72-73]. He has been practicing weight-
loss medicine for twelve years.
[[Page 62962]]
[Tr. 73]. He attended medical school at Louisiana State University
Medical School, completed his internship at Yale University-affiliated
hospitals in New Haven, Connecticut, and completed his general surgery
residency at the University of Nevada, Las Vegas. [Tr. 74-75; Gov't
Exh. 28]. He is board-certified in bariatric medicine and general
surgery. [Tr. 75]. He is a fellow of the American College of Surgeons
and a diplomat to the American Board of Bariatric Medicine, which is an
honor denoting ``that you are at the top of your field.'' [Tr. 75]. Dr.
Sudderth testified that he has treated ``[t]housands'' of patients for
weight loss in his career and regularly prescribes Phentermine. [Tr.
76]. In fact, he helped draft the recent changes to the regulations
regarding the prescription of Phentermine for weight loss. [Tr. 76]. As
such, he is familiar with the regulations and standards both as they
are now and as they were when Respondent's misconduct occurred. [Tr.
76-77].
Dr. Sudderth credibly testified regarding the standard of care when
prescribing Phentermine. He testified that physicians should document
the patient's history of diet, weight, exercise, and controlled
substance use ``to determine if they had gone through other programs or
used drugs for the purpose of weight loss by a prescription.'' [Tr. 83,
84]. Dr. Sudderth also testified that the patient's medical history
should be noted in the chart, including allergies and other medical
conditions the patient may have. [Tr. 85]. The physician should also
note any medications the patient is taking, the patient's primary care
physician, the patient's gynecological history, and the patient's
family medical history. [Tr. 85]. This information should all be noted
in the patient's chart. [Tr. 84]. According to Dr. Sudderth,
documenting this information is necessary for a physician to meet the
standard of care when prescribing Phentermine. [Tr. 87].
Dr. Sudderth testified that a physical examination is also
necessary to meet the standard of care. [Tr. 87, 103]. This means that
before prescribing Phentermine, the physician should measure and
document the patient's vital signs, including temperature, pulse, blood
pressure, height, and weight. [Tr. 87]. In addition, the physician
should measure the patient's body mass index (``BMI''), waist
circumferences, or body fat percentage, each of which give ``some
indication of the patient's fat content.'' [Tr. 87, 93].
BMI, which is a ``common standard used in most states and certainly
in Mississippi'' to measure adiposity, is calculated by dividing the
patient's weight by the patient's height squared. [Tr. 88-90]. A BMI of
18 to 24 is considered ``normal weight,'' 25 to 29.9 is considered
``overweight,'' 30 to 39 is considered ``obese,'' 40 to 49 is
considered ``morbidly obese,'' and anything over 50 is considered
``super morbid obese.'' [Tr. 90]. To be prescribed Phentermine for
weight loss, a patient must have a BMI of 27 or greater and have at
least one ``comorbid medical problem,'' which Dr. Sudderth testified is
``[a]nother medical problem that's related directly to the weight.''
[Tr. 91]. Common comorbid conditions include high blood pressure,
diabetes, sleep apnea, arthritis, lower back pain, heartburn, urinary
incontinence, breast cancer, and prostate cancer. [Tr. 91]. A patient
without a comorbid condition must have a BMI of at least 30 to be
prescribed Phentermine for weight loss. [Tr. 91]. Dr. Sudderth also
testified that although these are the customary standards, a physician
has some ``latitude'' to prescribe Phentermine to a patient with a
slightly lower BMI if the physician believes the patient's weight is
significantly aggravating a medical condition. [Tr. 92-93].
Measuring vital signs and adiposity, however, is not the only
important part of the physical exam. Dr. Sudderth testified that
various observations made during a routine physical exam might indicate
the patient has medical conditions that are contributing to the
patient's weight or would make controlled substances unsafe to
prescribe. [Tr. 94-98].
Dr. Sudderth also testified that lab work is ``essential'' in
determining whether to prescribe Phentermine because it uncovers things
that a physical examination typically does not. [Tr. 99]. Specifically,
lab work can identify conditions that may hinder weight loss or make
prescribing certain controlled substances improper, such as anemia,
liver disease, hypothyroidism, and high cholesterol. [Tr. 99-101]. Dr.
Sudderth testified that in Mississippi, the standard of care is to
perform blood work and to document the results before or at the visit
when prescribing Phentermine for weight loss occurs.\11\ [Tr. 101-02].
---------------------------------------------------------------------------
\11\ On cross examination, counsel for Respondent suggested that
cost sometimes prohibits lab work. [Tr. 170-71]. However, Respondent
offered no evidence, expert or otherwise, to contradict Dr.
Sudderth's credible testimony that lab work is essential before
prescribing Phentermine. Therefore, I find that lab work is required
before prescribing Phentermine under the standard of care in
Mississippi, regardless of the cost.
---------------------------------------------------------------------------
G. The Sixteen Additional Patient Files
Dr. Sudderth also testified that he reviewed the patient files of
sixteen of Respondent's patients not included in the Board Order and
concluded that Respondent did not meet the standard of care when he
prescribed Phentermine to all sixteen patients. [Tr. 80; Gov't Exhs.
12-27; Tr. 79-80, 106, 117, 123, 127, 128, 133, 138, 140-41, 145, 146,
150, 151, 152, 153]. The Government questioned Dr. Sudderth on only six
of the sixteen patients whose files were entered into evidence: C.H.,
R.G., A.G., J.G., K.C., and P.H.
1. C.H.
C.H.'s height and weight at the initial visit were recorded in the
chart as 5'6'', 150 pounds. [Gov't Exh. 12 at 13; Tr. 107-08]. No BMI
was recorded, however, and Dr. Sudderth testified that he calculated
C.H.'s BMI to be 24.2 using the patient's recorded height and weight.
[Tr. 109, 111; Gov't Exh. 31]. Based on this BMI calculation, Dr.
Sudderth testified that C.H. did not qualify for Phentermine
prescriptions. [Tr. 111]. Dr. Sudderth further testified that
Respondent's ``impression'' that C.H. is ``overweight,'' recorded in
the chart, is an incorrect diagnosis, and that there are no co-morbid
conditions recorded in C.H.'s chart that would justify prescribing
Phentermine. [Tr. 115]. As such, Dr. Sudderth testified that, in his
opinion, Respondent did not ``take a thorough history of [C.H.] as
contemplated by the State regulations.'' [Tr. 115].
Dr. Sudderth further testified that while Respondent recorded
C.H.'s blood pressure and heart rate in the chart, he failed to record
C.H.'s weight, diet, and gynecological history. [Tr. 111-12].
Additionally, on the chart, Respondent had drawn ``squiggly lines''
through all of the spaces designed to notate that the various organs
were ``normal.'' [Tr. 112-13; Gov't Exh. 12 at 14]. The chart also had
no indication that any lab work was conducted on C.H. [Tr. 114]. Thus,
Dr. Sudderth testified that Respondent did not conduct a ``thorough
physical examination as contemplated under the regulations.'' [Tr. 115-
16].
Dr. Sudderth concluded that Respondent did not meet the standard of
care when he prescribed C.H. Phentermine on her initial visit. [Tr.
117]. He noted that the chart does not reflect any legitimate medical
justification for prescribing Phentermine to C.H. [Tr. 123-24].
Additionally, Dr. Sudderth testified that Respondent failed to meet
the standard of care for prescribing Phentermine at each of C.H.'s
follow-up
[[Page 62963]]
visits. [Tr. at 123]. He reached this conclusion partly because in each
of the seven follow-up visits notated in the chart, neither Respondent
nor C.H. had any questions or concerns about the weight loss plan. [Tr.
120-23; Gov't Exh. 12 at 11]. Dr. Sudderth testified that this is
``very significant because I haven't seen that in my 12-year career of
doing weight loss, that there are no problems at any follow-up visit
ever.'' [Tr. 122].
2. R.G.
R.G.'s initial height and weight were recorded in the chart as
5'4'', 141 pounds. [Tr. 125; Gov't Exh. 13 at 13]. R.G.'s body fat and
BMI were not measured, however, but Dr. Sudderth calculated R.G.'s BMI
to be approximately 24, which is ``normal.'' [Tr. 125; Gov't Exh. 31].
Thus, Dr. Sudderth testified that R.G. did not qualify for weight loss
treatment with Phentermine. [Tr. 125].
Dr. Sudderth testified that R.G.'s weight, diet, exercise, and
gynecological history were not recorded in the chart, except to note
that R.G. is not pregnant.\12\ [Tr. 125; Gov't Exh. 13 at 13-14]. Like
in C.H.'s chart, the ``Physical Examination'' section of R.G.'s chart
contained ``squiggly lines'' through all of the spaces designed to
notate that the various organs were ``normal.'' [Tr. 126; Gov't Exh. 13
at 14]. Because the chart contained a line through the part marked
``Laboratory Findings,'' Dr. Sudderth testified that he assumed no labs
were conducted. [Tr. 126; Gov't Exh. 13 at 14].
---------------------------------------------------------------------------
\12\ Dr. Sudderth testified that simply noting the pregnancy
status of a female patient does not constitute an adequate
gynecological history report. [Tr. 136].
---------------------------------------------------------------------------
Dr. Sudderth testified that because R.G. has no co-morbid
conditions and a BMI of 24, it was not appropriate to prescribe
Phentermine to the patient. [Tr. 126, 127]. Also, similar to C.H.'s
chart, Dr. Sudderth noted that the follow-up visits uncovered no
questions or concerns about the weight loss program. [Tr. 127-28; Gov't
Exh 13 at 11]. Thus, Dr. Sudderth concluded that Respondent did not
meet the standard of care in prescribing R.G. Phentermine during the
seven follow-up visits. [Tr. 128; Gov't Exh. 13 at 4-10]. In sum, Dr.
Sudderth testified that ``[t]here is no justification'' for prescribing
Phentermine to R.G. [Tr. 128].
3. A.G.
A.G.'s height and weight at the initial visit were 5'1'', 141
pounds. [Tr. 129, Gov't Exh. 15 at 8]. A.G.'s BMI was not in the chart,
but Dr. Sudderth calculated it to be 26.6. [Tr. 129; Gov't Exh 31].
Respondent recorded his ``impression'' of A.G. as ``obesity.'' [Tr.
129; Gov't Exh 15 at 9]. Dr. Sudderth testified, however, that A.G. was
not ``obese,'' but ``overweight'' according to the standard in
Mississippi. [Tr. 129-30].
Dr. Sudderth further testified that A.G.'s diet, weight, exercise,
and gynecological history were not noted in the file except that A.G.
is not pregnant and that ``she is on a Depo shot for birth control.''
[Tr. 130; Gov't Exh. 15 at 8]. In physical examination section of the
chart, there were lines through all of the spaces designed to notate
that the various organs were ``normal.'' [Tr. 130-31; Gov't Exh. 15 at
9]. The only organ with a notation other than the line was the abdomen,
which had ``obese'' written in the ``normal'' column.\13\ [Tr. 130-31;
Gov't Exh. 15 at 9]. No lab work or co-morbid conditions were indicated
on the chart. [Tr. 131; Gov't Exh. 15 at 9]. Thus, Dr. Sudderth
ultimately concluded that Respondent did not meet the standard of care
when he prescribed A.G. Phentermine. [Tr. 133; Gov't Exh. 15 at 4-5,
7].
---------------------------------------------------------------------------
\13\ Dr. Sudderth noted that describing an abdomen as ``obese''
is inaccurate. ``You may characterize it as protuberant, large. It
may be described in many different ways, but you wouldn't describe
an abdomen as obese. You may describe a person as obese but not an
abdomen.'' [Tr. 131].
---------------------------------------------------------------------------
4. J.G.
According to the chart, J.G. weighed 282 pounds and was 5'4'' tall
when she first visited Respondent for weight loss. [Tr. 134; Gov't Exh
20 at 12]. Her BMI was not included in the chart, but Dr. Sudderth
calculated it to be approximately 48, which is high enough to qualify
for a Phentermine prescription. [Tr. 134; Gov't Exh. 31].
Respondent recorded three co-morbid conditions for J.G.: High blood
pressure, high cholesterol, and diabetes. [Tr. 134-35; Gov't Exh. 20 at
12]. Dr. Sudderth testified that he would have ``done a thorough
history and physical'' and ``gotten labs on this patient and an EKG''
before prescribing Phentermine, which can aggravate the co-morbid
conditions reported by J.G. [Tr. 135]. J.G.'s chart had no lab findings
recorded. [Tr. 136-37; Gov't Exh. 20 at 13].
No weight, diet, exercise, or gynecological history was recorded on
the chart except that J.G. is not pregnant. [Tr. 135-36; Gov't Exh. 20
at 12]. J.G.'s chart included heart rate and blood pressure
measurements, but the section for organ examinations, like in the other
charts, had a ``squiggly line'' through the ``normal'' boxes. [Tr. 136;
Gov't Exh. 20 at 13]. Respondent recorded his ``impression'' of J.G. as
``overweight,'' which Dr. Sudderth testified is an inappropriate
diagnosis--Respondent should have diagnosed J.G. as ``morbidly obese.''
[Tr. 137; Gov't Exh. 20 at 13].
Dr. Sudderth testified that Respondent did not meet the standard of
care when he prescribed Phentermine to J.G. on her first visit because
Respondent did not conduct and record an adequately thorough physical
examination and history. [Tr. 138].
Respondent prescribed J.G. Phentermine in each of six follow-up
visits. [Tr. 139, 140; Gov't Exh 20 at 4-9, 11]. Dr. Sudderth testified
that a visit on August 9, 2010 was particularly troubling, since J.G.'s
blood pressure was especially high that day, apparently because J.G.
had not taken her blood pressure medication. [Tr. 138-39; Gov't Exh. 20
at 10]. Dr. Sudderth testified that, given J.G.'s unregulated blood
pressure, prescribing J.G. Phentermine on that visit fell below the
standard of care. [Tr. 139]. Similarly, J.G.'s blood pressure was even
higher on her next visit, and Respondent once again prescribed
Phentermine. [Tr. 139-40]. Dr. Sudderth thus concluded that Respondent
fell below the standard of care by prescribing Phentermine to J.G. at
each follow-up visit because he failed to perform adequate histories
and physicals, he ignored contraindications such as high blood
pressure, and ``he has no follow-up visit that is of any substance,
whatsoever.'' [Tr. 141].
5. K.C.
K.C. was sixteen years old, weighed 142 pounds, and was 5'4'' tall
when she first visited Respondent for weight loss. [Tr. 141-42; Gov't
Exh 21 at 9]. Her BMI was not recorded in her file, but Dr. Sudderth
calculated it to be approximately 24, which classifies her weight as
``normal.''\14\ [Tr. 142, 144; Gov't Exh. 31]. The patient chart
included no weight, diet, or gynecological history recorded except that
K.C. is not pregnant. [Tr. 143-44; Gov't Exh. 21 at 9]. Notably, K.C.'s
chart did not include any physical examination; in fact, the patient
file did not even include the form Respondent normally used to record
physical examinations. [Tr. 144; Gov't Exh. 21].
---------------------------------------------------------------------------
\14\ Dr. Sudderth explained that there is a slightly different
standard for determining whether Phentermine is appropriate to
prescribe to pediatric patients such as K.C. Specifically, children
must be ``in the 99th percentile or greater'' in relation to ``other
kids their age'' to qualify for a Phentermine prescription. [Tr.
144]. He testified that K.C. is a ``normal 16-year-old girl who
falls in the normal percentile of girls.'' [Tr. 143-44].
---------------------------------------------------------------------------
Dr. Sudderth testified that Respondent fell below the standard of
care by prescribing Phentermine on the
[[Page 62964]]
initial visit. [Tr. 144-45; Gov't Exh. 21 at 8]. He also testified that
Respondent fell below the standard of care by prescribing Phentermine
to K.C. during three follow-up visits, where no problems or concerns
were reported or discussed. [Tr. 145-46]. Dr. Sudderth testified that
nowhere in the file was a legitimate medical reason or justification
for prescribing K.C. Phentermine recorded. [Tr. 146; Gov't Exh. 21].
6. P.H
P.H. weighed 162 pounds and was 5'5'' tall on her initial visit to
Respondent. [Gov't Exh. 27 at 22]. No body fat or BMI were recorded,
but Dr. Sudderth calculated it to be 26.9, which is classified as
``overweight.'' [Tr. 147; Gov't Exh. 31]. No weight, diet, or
gynecological history were recorded except that P.H. is not pregnant.
[Tr. 147-48; Gov't Exh. 27 at 22]. P.H.'s heart rate and blood pressure
were recorded in the chart, and Dr. Sudderth testified that P.H. had
high blood pressure. [Tr. 148; Gov't Exh. 27 at 23]. Dr. Sudderth also
testified that P.H.'s high blood pressure is probably ``controlled''
because ``it's high, but it's not excessively high.'' [Tr. 149]. No lab
work was recorded in the file. [Tr. 148]. Respondent recorded his
``impression'' of P.H. as ``desires weight loss,'' which Dr. Sudderth
testified was an inappropriate diagnosis. [Tr. 149].
Dr. Sudderth noted that P.H.'s BMI, combined with her co-morbid
condition of high blood pressure, qualified her for Phentermine. [Tr.
150]. Dr. Sudderth concluded, however, that the physical examination
and history of P.H. fell below the standard of care for prescribing
Phentermine on the initial visit. [Tr. 150].
Respondent treated P.H. for about three years, prescribing
Phentermine at each of fifteen follow-up visits. [Tr. 150-51, 152;
Gov't Exh. 27 at 4-23]. As with the other patients, Respondent noted no
problems at any of the follow-up visits. [Tr. 151; Gov't Exh 27 at 19-
20]. Dr. Sudderth testified that P.H.'s blood pressure was high at
every follow-up visit, and ``was worsening by the time she finished
with Dr. White.'' [Tr. 151; Gov't Exh. 27 at 19-20]. Notably,
Respondent did not diagnose or record P.H's blood pressure as being
high at any time during her treatment. [Tr. 151; Gov't Exh. 27]. Dr.
Sudderth concluded that Respondent fell below the standard of care each
time he prescribed P.H. Phentermine at a follow-up visit. [Tr. 152].
7. The Sixteen Patient Files Generally
Outside the six patient files about which he specifically
testified, Dr. Sudderth also testified generally that he reviewed all
of the sixteen patient files the Government entered into evidence and
that none of them included adequate histories, physicals, or lab work.
[Tr. 106-07, 120, 152]. He thus concluded that Respondent fell below
the standard of care in prescribing Phentermine to ``[a]ll sixteen'' of
those patients'' both in their initial visits, and in all follow-up
visits. [Tr. 153]. He additionally testified that seven of the sixteen
patients did not qualify for Phentermine based on their BMIs, which Dr.
Sudderth calculated himself since they were not documented in the
charts. [Tr. 110-11; Gov't Exh. 31]. Dr. Sudderth also testified that
in the sixteen patient files he reviewed, ``there was no follow-up
visit to speak of, of any substance that would qualify these patients
to receive more Phentermine.'' [Tr. 106-07].
H. Letters from Respondent's Patients
At the hearing, the Government offered into evidence hundreds of
letters written by Respondent's patients, vouching for the quality of
care Respondent provided them. [Gov't Exh. 30; Tr. 54]. To the extent
that Respondent relies on these letters to prove that denying his
registration would impose a burden on his patients, I find the letters
irrelevant. The Agency has consistently held that so-called ``community
impact evidence'' is not relevant in these proceedings. See Linda Sue
Cheek, M.D., 76 Fed. Reg. 66,972, 66,973 (DEA 2011); Steven M.
Abbadessa, D.O., 74 Fed. Reg. 10,077, 10,078 (DEA 2009); Mark De La
Lama, P.A., 76 Fed. Reg. 20,011, 20,020 n.20 (DEA 2011); Bienvenido
Tan, M.D., 76 Fed. Reg. 17,673, 17,694 n.58 (DEA 2011); Gregory D.
Owens, D.D.S, 74 Fed. Reg. 36,751, 36,757 & n.22 (DEA 2009); Kwan Bo
Jin, M.D., 77 Fed. Reg. 35,021, 35,021 (DEA 2012).
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
April 2, 2014. The bulk of the Government's argument is that Respondent
deviated from the standard of care by performing ``woefully
inadequate'' physical examinations, failing to obtain patient's medical
histories, and failing to measure patients' BMI before prescribing
Phentermine to the sixteen patients at issue in these proceedings and
to the five patients at issue in the Board Order. [Gov't Br. at 36-39].
In addition, the Government argues that Respondent violated the Board's
order to complete certain CME courses within six months of the Order.
[Gov't Br. at 39]. According to the Government, these facts, which are
largely undisputed, prove that Respondent's registration would be
inconsistent with the public interest. [Gov't Br. at 39-40].
The Government also argues that Respondent failed to prove that he
has taken responsibility for his actions and therefore failed to rebut
the Government's prima facie case. [Gov't Br. at 42]. The Government
points out various portions of Respondents' testimony where Respondent
attempted to minimize his misconduct and criticized the laws,
standards, rules, and regulations concerning the prescription of
Phentermine. [Gov't Br. at 42-45]. This testimony, the Government
argues, shows that Respondent has failed to take responsibility for his
actions. [Gov't Br. at 44]. Moreover, the Government argues that
Respondent failed to take responsibility for his actions in the
criminal trial, where he testified that he had done nothing improper.
[Gov't Br. at 44]. Accordingly, the Government argues that Respondent
has failed to rebut the Government's prima facie case because any
acceptance of responsibility--which is minimal--is not credible. [Gov't
Br. at 44-45].
2. Respondent's Position
Respondent timely filed Respondent's Proposed Findings of Fact and
Conclusions of Law (``Respondent's Brief'') on April 2, 2014. Therein,
Respondent makes three arguments. First, Respondent argues that his
registration would be consistent with the public interest because he
has never harmed any of his patients and has never been the subject of
any medical malpractice complaint. [Resp't Br. at 7]. In Respondent's
view, the fact that law enforcement investigated Respondent for months
before taking any action supports the conclusion that Respondent's
misconduct was not seriously harmful or egregious. [Resp't Br. at 8-9].
Second, Respondent argues that he has taken responsibility for his
actions, as evidenced by his voluntary relinquishment of his DEA
registration and his agreement to forego treating patients for weight
loss. [Resp't Br. at 7].
Lastly, Respondent argues that his registration is consistent with
the public interest because, after a criminal trial
[[Page 62965]]
and two hearings before the Board, the Board still saw fit to permit
Respondent to practice medicine. [Resp't Br. at 9-10].
B. Statement of Law and Analysis
Pursuant to 21 U.S.C. Sec. 823(f), the Deputy Administrator may
deny an application for a DEA COR if he determines that such
registration would be inconsistent with the public interest.\15\ In
determining the public interest, the following factors are considered:
---------------------------------------------------------------------------
\15\ The Deputy Administrator has the authority to make such a
determination pursuant to 28 C.F.R. Sec. Sec. 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. Sec. 823(f).
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 Fed. Reg. 15,227, 15,230 (DEA
2003) (citing Henry J. Schwartz, Jr. M.D., 54 Fed. Reg. 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
Fed. Reg. 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 C.F.R. Sec.
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. Sec. 823(f); Jeri Hassman, M.D., 75 Fed. Reg.
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 Fed. Reg. 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 Fed. Reg. 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 Fed. Reg. at 23,853. The DEA has
consistently held the view that ``past performance is the best
predictor of future performance.'' Alra Laboratories, 59 Fed. Reg.
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 Fed. Reg.
36,751, 36,755 (DEA 2009); see also Martha Hernandez, M.D., 62 Fed.
Reg. 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 Fed. Reg. at 15,230; John H.
Kennedy, M.D., 71 Fed. Reg. 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 Fed. Reg. 8,209, 8,210 (DEA 1990); see also Jayam Krishna-
Iyer, 74 Fed. Reg. 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 Fed. Reg. 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 state
government. Edmund Chein, M.D., 72 Fed. Reg. 6,580, 6,590 (DEA 2007),
aff'd Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008). Thus, Agency
precedent holds that even where a respondent is licensed to practice
medicine by a state licensing agency, factor one weighs neither for nor
against registration unless the state licensing agency makes a direct
recommendation regarding the respondent's DEA registration. Mark G.
Medinnus, D.D.S., 78 Fed. Reg. 62,683, 62,692-93 (DEA 2013); George R.
Smith, M.D., 78 Fed. Reg. 44,972, 44,979 (DEA 2013); Robert M. Brodkin,
D.P.M., 77 Fed. Reg. 73,678, 73,681 n.5 (DEA 2012); Jeffrey J. Becker,
D.D.S., 77 Fed. Reg. 72,387, 72,403 (DEA 2012); Scott D. Fedosky, M.D.,
76 Fed. Reg. 71,375, 71,377 (DEA 2011); Paul W. Battershell, 76 Fed.
Reg. 44,359, 44,365 (DEA 2011); Robert L. Dougherty, 76 Fed. Reg.
16,823, 16,833 n.13 (DEA 2011); Gilbert Eugene Johnson, 75 Fed. Reg.
65,663, 65,666 n.3 (DEA 2010).
Although it is undisputed in this case that Respondent's state
license is valid, [ALJ Exh. 4 at 4], the Board has not given a
recommendation on whether Respondent's application for a DEA
registration should be granted. Therefore, factor one weighs neither
for nor against Respondent's registration.\16\
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\16\ The Government argues that because Mississippi law
prohibits physicians who have been the subject of a disciplinary
action for improper prescribing practices from operating pain
management clinics, the Board's prohibition against Respondent
operating a weight loss clinic ``is the equivalent to a Board
recommendation against Respondent handling controlled substances for
pain management.'' [Gov't Br. at 31]. This argument, however, does
not square with the Board Order, which allowed Respondent to
practice medicine with full knowledge that Respondent owned a pain
management clinic. Had the Board wished to restrict Respondent's
ability to practice pain management, it could have done so.
Moreover, Agency precedent strongly suggests that anything less than
a specific, direct recommendation from a state board to DEA
regarding respondent's suitability for DEA registration does not
constitute a ``recommendation'' under factor one of the public
interest analysis. See Mark G. Medinnus, D.D.S., 78 Fed. Reg.
62,683, 62,692-93 (DEA 2013) (holding that factor one weighed
neither for nor against granting a registration because the state
board ``has not made a specific recommendation concerning the
granting of a DEA registration to the Respondent''); George R.
Smith, M.D., 78 Fed. Reg. 44,972, 44,979 (DEA 2013) (holding that
factor one weighed neither for nor against granting a registration
because the state board ``did not directly recommend that the
Respondent's DEA application for registration should be granted'').
I therefore decline to construe the Board's findings as a
recommendation by the Board that Respondent's registration should be
denied.
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[[Page 62966]]
Factors Two and Four: Applicant's Experience with Controlled Substances
and Applicant'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. Sec. 822(b);
Leonard E. Reaves, III, M.D., 63 Fed. Reg. 44,471, 44,473 (DEA 1998);
see also 21 C.F.R. Sec. 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 first 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.'' 21 C.F.R. Sec. 1306.04(a). DEA precedent
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 Fed. Reg.
30,630, 30,642 (DEA 2008). Whether a valid doctor-patient relationship
was established is determined by looking to state law.
Id.
Here, Dr. Sudderth credibly testified regarding the steps
physicians must take to create a doctor-patient relationship before
legitimately prescribing Phentermine. Specifically, he testified that
in Mississippi, before prescribing Phentermine, a physician must (1)
document the patient's history of diet, weight, exercise, and use of
controlled substances for weight loss [Tr. 83-84]; (2) document the
patient's medical and family history [Tr. 85]; (3) perform and document
a physical examination of the patient, including vital signs and some
form or adiposity measurement (BMI, waist circumference, or body fat)
[Tr. 87-98]; and (4) perform lab work such as blood tests and an EKG
[Tr. 99-102]. Dr. Sudderth further testified that to be prescribed
Phentermine for weight loss, a patient must either (1) have a BMI of at
least 30; or (2) have a BMI of at least 27 and have at least one
comorbid condition. [Tr. 91, 105]. Some of these standards, including
the requirement to perform physicals, document histories, and
investigate prior weight loss efforts, are found in Chapter 25, Section
501(1) and (2) of the Rules and Regulations of the Board.\17\ [Gov't
Exh. 29].
---------------------------------------------------------------------------
\17\ The standards set forth in the Rules and Regulations of the
Board for prescribing anorectics were revised in 2012. [Tr. 76]. The
Government entered into evidence the version of the regulations that
was in place during the time in question. [Tr. 81-82; Gov't Exh.
29].
---------------------------------------------------------------------------
Dr. Sudderth testified that Respondent fell below this standard of
care for each of the sixteen patient files he reviewed. [Tr. 80, 106].
Specifically, Dr. Sudderth testified that Respondent failed to document
the patients' histories, conduct or document adequate physical exams,
measure patients' BMI, or do any lab work on the patients. [Tr. 114,
115-16, 120, 125, 126, 129, 130, 131, 137, 138, 142, 147, 148].
Additionally, Dr. Sudderth testified that seven of the sixteen patients
had BMIs too low to justify prescribing Phentermine. [Tr. 110-11; see
also Gov't Exh. 31]. Further, Dr. Sudderth testified that Respondent
failed to conduct any follow-up visit ``of substance'' that would
justify the continued prescription of Phentermine to the patients. [Tr.
106-07].
I find Dr. Sudderth's testimony credible because his credentials
are impeccable, his testimony was internally and externally consistent,
and the testimony itself was largely unrebutted by Respondent. Indeed,
when asked at the hearing if he disputes Dr. Sudderth's testimony,
Respondent replied, ``Why would I dispute his testimony? He's an
expert.'' [Tr. 219]. Accordingly, I find that Respondent failed to
establish a bona-fide doctor-patient relationship before prescribing
Phentermine to the sixteen patients at issue here, thus violating 21
C.F.R. Sec. 1306.04(a).\18\
---------------------------------------------------------------------------
\18\ 21 C.F.R. Sec. 1306.04(a) provides, in relevant part, ``A
prescription for a controlled substance to be effective must be
issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice.''
---------------------------------------------------------------------------
I also find that Respondent's improper prescriptions of Phentermine
to the sixteen patients at issue in these proceedings violated Chapter
25, Section 501(1) and (2) of the Rules and Regulations of the Board,
which requires documentation of a thorough physical examination,
medical history, and a good-faith effort by the patient to lose weight
without controlled substances before prescribing anorectics. [Gov't
Exh. 29 at 1-2].
Moreover, as noted supra, the Board found that Respondent violated
multiple rules, regulations, and statutes by improperly prescribing
Phentermine to five additional patients. Specifically, the Board found
that Respondent violated Chapter 25, Section 501 of the Rules and
Regulations of the Board by (1) failing to verify that the five
patients made a good-faith effort to lose weight without the aid of
controlled substances; (2) failing to obtain full medical histories and
perform adequate physical examinations of the five patients; and (3)
continuing to prescribe controlled substances to patients who failed to
lose weight after thirty days of taking the controlled substances.
[Gov't Exh. 5 at 49-50]. Additionally, the Board found that Respondent
violated title 73, chapter 25, section 29(3) of the Mississippi Code by
dispensing ``drugs having addiction-forming or addiction-sustaining
liability otherwise than in the course of legitimate professional
practice.'' [Gov't Exh. 5 at 50]. Finally, the Board found that
Respondent's actions constituted ``dishonorable or unethical conduct
likely to deceive, defraud, or harm the public, in violation of Miss.
Code Ann. 73-25-29(8)(d) and 73-24-83(a).'' [Gov't Exh. 5 at 50]. These
findings of fact and law are binding on the Agency. David A. Ruben,
M.D., 78 Fed. Reg. at 38,365-66; Dougherty, 76 Fed. Reg. at16,830-31.
Respondent also failed to attend the CME courses required by the
Board Order. Although Respondent offered an explanation for this
failure--that he could not afford the courses \19\--such explanations
do not alter the fact that failing to attend the courses within six
month of the Board Order constituted a violation of the Order.
---------------------------------------------------------------------------
\19\ I find this reason incredible, since the Respondent also
testified that he has a monthly income of $15,000. [Tr. 207].
---------------------------------------------------------------------------
Therefore, because Respondent violated multiple rules, regulations,
and statutes by prescribing Phentermine to twenty-one patients without
a legitimate medical purpose and outside the usual course of
professional practice, and because Respondent violated the Board Order
by failing to attend the required CME courses, I find that factors two
and four clearly weigh against Respondent's registration.
[[Page 62967]]
Factor Three: Applicant'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 \20\ of a felony related
to controlled substances under state or federal law. See Thomas G.
Easter II, M.D., 69 Fed. Reg. 5,579, 5,580 (DEA 2004); Barry H. Brooks,
M.D., 66 Fed. Reg. 18,305, 18,307 (DEA 2001); John S. Noell, M.D., 56
Fed. Reg. 12,038, 12,039 (DEA 1991).
---------------------------------------------------------------------------
\20\ The Administrator interprets the term ``conviction'' by
affording it the ``broadest possible meaning.'' Donald Patsy Rocco,
D.D.S., 50 Fed. Reg. 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 Fed. Reg. 726, 728
(DEA 1996); Roger Pharmacy, 61 Fed. Reg. 65,079, 65,080 (DEA 1996).
---------------------------------------------------------------------------
Here, it is undisputed that Respondent has not been convicted of
any crimes relating to controlled substances. However, DEA precedent
clearly holds that because there are ``a number of reasons why a person
may never be convicted of an offense falling under this factor, let
alone be prosecuted for one, the absence of such a conviction is of
considerably less consequence in the public interest inquiry.'' Ruben,
78 Fed. Reg. at 38,379 n.35 (quoting Dewey C. MacKay, M.D., 75 Fed.
Reg. 49,956, 49,973 (DEA 2010), pet. for rev. denied, MacKay v. DEA,
664 F.3d 808 (10th Cir. 2011)). I therefore find that factor three
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. Sec. 823(f)(5). Because the facts of this case do
not implicate this factor,\21\ I find that factor five weighs neither
for nor against Respondent's registration.
---------------------------------------------------------------------------
\21\ Under the heading of factor five, the Government's Brief
makes a host of arguments about Respondent's credibility and his
failure to accept responsibility. [Gov't Br. at 40-45]. These
arguments, however, are more properly asserted in the context of
Respondent's rebuttal case. See, e.g., Jeri Hassman, M.D., 75 Fed.
Reg. 8,194, 8,235-36 (DEA 2010). I therefore address these arguments
infra in the ``Sanction'' discussion.
---------------------------------------------------------------------------
Therefore, because the Government proved by a preponderance of the
evidence that Respondent violated multiple statutes, rules, and
regulations relating to dispensing controlled substances, I find that
the Government met its burden to prove its prima facie case that
Respondent's registration would be inconsistent with the public
interest.
Sanction
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 Medicine Shoppe--Jonesborough, 73
Fed. Reg. 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 Fed. Reg. 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 Fed. Reg. 8,194, 8,236 (DEA 2010) (citing Jayam
Krishna-Iyer, M.D., 74 Fed. Reg. 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 Fed. Reg. 30,060, 30,062 (DEA
1999), lapse of time since the wrongdoing, Norman Alpert, M.D., 58 Fed.
Reg. 67,420, 67,421 (DEA 1993), candor with the court and DEA
investigators, Jeri Hassman, M.D., 75 Fed. Reg. 8,194, 8,236 (DEA
2010), and attempts to minimize misconduct, Ronald Lynch, M.D., 75 Fed.
Reg. 78,745, 78,754 (DEA 2010).
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
Fed. Reg. at 38,386-87; see also Joseph Gaudio, M.D., 74 Fed. Reg.
10,083, 10,094-95 (DEA 2009). ``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 Fed. Reg. at 38,386 (citing
Dewey C. MacKay, M.D., 75 Fed. Reg. 49,956, 49,977 (DEA 2010)).
Here, Respondent's improper prescribing methods clearly constituted
intentional diversion. See David A. Ruben, M.D., 78 Fed. Reg. at
38,386-87 (defining intentional diversion as prescribing controlled
substances ``outside of the usual course of professional practice and
[without] a legitimate medical purpose''). The Agency thus has an
interest in deterring Respondent and others from engaging in similar
egregious behavior. That no one was injured as a result of Respondent's
misconduct is irrelevant; Agency precedent is clear that in light of
the prescription drug abuse epidemic, even a single act of intentional
diversion justifies revocation. David A. Ruben, M.D., 78 Fed. Reg. at
38,386.
Moreover, Respondent's purported acceptance of responsibility was
tenuous at best. When asked on direct examination whether his weight
loss prescribing practices were improper, he responded equivocally:
``When I got busted, I realized it, yeah. I didn't know--I had no idea
that there was a strict rule on BMI.'' [Tr. 193]. When asked on cross-
examination whether he admits to prescribing controlled substances
without medical justification, Respondent responded that he had ``never
given anything to somebody without a medical justification, in my
opinion.'' [Tr. 214]. But when pressed on the same question, Respondent
quickly changed his tune and answered, ``According to the rules, I
guess, yes.'' [Tr. 214]. Similarly, when asked whether his weight-loss
practice was ``improperly run,'' Respondent replied, ``I said I broke
some rules and regulations. I didn't say it was anything improper.''
[Tr. 221-22]. Indeed, not once during the hearing did Respondent
unequivocally admit fault for his improper Phentermine prescriptions.
Respondent's purported admission of guilt was also undermined by
his tendency to blame others and make excuses for his misconduct. For
example, he testified several times that in his weight loss practice he
was ``just doing the same practice that I know other physicians do.''
[Tr. 217; see also Tr. 190 (``. . . there were a lot of doctors doing
it in town, and I followed what they did.'')]. Indeed, when Respondent
was asked on cross examination whether he believed he was ``picked on
by the DEA,'' he responded, ``I don't believe it. I know it.'' [Tr.
222]. In addition, Respondent admitted that his practices were ``less
than desirable,'' and then, practically in the same breath, blamed the
undesirable practices on his staff: ``I didn't know that [my histories
and physicals] were that less than desirable because they were all done
by
[[Page 62968]]
my nurse practitioners.'' \22\ [Tr. 197]. In short, Respondent blamed
other physicians, the DEA, and his own staff for his current
predicament rather than take the responsibility himself.
---------------------------------------------------------------------------
\22\ I note that immediately following this remark, Respondent
purported to take responsibility by saying, ``Although, I'm
responsible, so I take the cold blame for them myself.'' [Tr. 197].
In context, however, I find this acceptance of responsibility to be
disingenuous; he made this statement only after clearly placing
blame on someone else.
---------------------------------------------------------------------------
Respondent also minimized the severity of his misconduct by
suggesting that he thinks the requirements for prescribing Phentermine
are too strict. For example, Respondent testified in these proceedings
and at his criminal trial, ``I mean, you can get a tummy tuck, a
facelift, whatever you want, but you can't get a--you can't get a diet
pill. Come on.'' [Tr. 193; see also Tr. 198-99; Gov't Exh. 11 at 115].
In his criminal trial, Respondent testified, ``You can get phentermine
over the internet from Canada. Nurses can write for it. It's a Schedule
IV drug like cough syrup. I mean, it's so safe. The addiction potential
is so low.'' [Gov't Exh. 11 at 119]. Additionally, Respondent testified
in his criminal trial that BMI measurements are ``worthless.'' [Tr.
216; Gov't Exh. 11 at 117]. In other words, rather than acknowledging
his faults, Respondent opted to criticize the standards put in place by
the medical community, the Board, and the DEA.
I also find it significant that Dr. Van Craig, the executive
director of the Board, remembered Respondent as being ``angry with the
Board for disciplining him'' and felt that Respondent believed he had
received ``rather harsh treatment from the Board because of what he was
doing.'' [Tr. 60, 61; see also Tr. 66]. Indeed, Respondent's demeanor
described by Dr. Van Craig is consistent with the hostile tone
Respondent took during the hearings in these proceedings.\23\
---------------------------------------------------------------------------
\23\ Respondent's counsel, at the hearing, suggested that
Respondent's ``loud and obnoxious'' tone is a result of his hearing
impairment rather than his lack of remorse or hostility toward the
Board or the DEA. [Tr. 66]. During the hearing in these proceedings,
I certainly noticed that Respondent's hearing disability affected
him. [E.g., Tr. 225, 226]. But Respondent's hearing did not appear
to be what motivated his tone or his statements, discussed supra,
which gave cause for concern regarding his remorse and acceptance of
responsibility.
---------------------------------------------------------------------------
The above-noted examples do not reflect someone who feels remorse
for his misconduct or understands the gravity of his mistakes. Rather,
they illustrate that Respondent takes no responsibility for his
actions, blames others for his improper prescribing methods, and
disagrees with the rules regarding the dispensing of Phentermine.
Additionally, other than a promise to comply with the Board's order to
refrain from treating weight loss patients, Respondent has offered no
evidence of remedial measures he has taken to ensure that future
violations will not occur. As such, I find that Respondent has not
taken responsibility for his misconduct and therefore has failed to
rebut the Government's prima facie case.
VI. CONCLUSION AND RECOMMENDATION
Because the Government met its burden to prove that Respondent's
registration would be inconsistent with the public interest, and
because Respondent failed to rebut the Government's case, I recommend
that the Deputy Administrator deny Respondent's application.
Dated: April 16, 2014
s/Gail A. Randall,
Administrative Law Judge
CERTIFICATE OF SERVICE
This is to certify that the undersigned, on _____--, 2013, caused a
copy of the foregoing to be faxed and placed in the interoffice mail
addressed to DEA Headquarters, Attn: Office of Chief Counsel/Michelle
Gillice, Esq., 8701 Morrissette Drive, Springfield, VA 22152, Fax:
(202) 307-4946, and a copy to be faxed and mailed to Respondent's
Counsel, Rodney A. Ray, Esq., P. O. Box 1018, Columbus, MS 39703, Fax:
(662) 329-3522.
Carlene R. Thomas,
Secretary to The Honorable Gail A. Randall
[FR Doc. 2014-25025 Filed 10-20-14; 8:45 am]
BILLING CODE 4410-09-P