Robert Wayne Locklear, M.D.; Decision and Order, 33738-33748 [2021-13525]
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certain lithium ion batteries, battery
cells, battery modules, battery packs,
components thereof, and processes
therefor by reason of misappropriation
of trade secrets, the threat or effect of
which is to destroy or substantially
injure an industry in the United States,
under subsection (a)(1)(A) of section
337. The complaint, as supplemented,
names SK Innovation Co., Ltd. of Seoul,
Republic of Korea and SK Battery
America, Inc. of Atlanta, Georgia as the
respondents (collectively,
‘‘respondents’’ or ‘‘SK’’). The Office of
Unfair Import Investigations (‘‘OUII’’)
was also named as a party in this
investigation.
On February 14, 2020, the
administrative law judge issued an
initial determination (‘‘ID’’) (Order No.
34) finding that the respondents
spoliated evidence, and that the
appropriate remedy is to find the
respondents in default.
On April 17, 2020, the Commission
determined to review the ID in its
entirety. 85 FR 22,753 (Apr. 23, 2020)
(‘‘Notice of Review’’). The Notice of
Review requested that the parties brief
certain issues and sought briefing from
the parties, interested government
agencies, and any other interested
parties on remedy, the public interest,
and bonding.
On February 10, 2021, the
Commission affirmed the ID’s finding of
default, thus finding a violation of
section 337. The Commission issued an
LEO and two CDOs, all of which were
tailored to accommodate public interest
considerations raised by the parties to
the investigation and by non-parties.
On May 24, 2021, SK filed a petition
to rescind the LEO and CDOs on the
basis of settlement. LG did not oppose
the petition, and on June 3, 2021, OUII
filed a response in support of the
petition. Also, on June 3, 2021, SK filed
a supplemental submission that
provided a modified public version of
the settlement agreement.
The Commission has determined that
the petition, as supplemented, complies
with Commission rules, see 19 CFR
210.76(a)(3), and that there are no
extraordinary reasons to deny rescission
of the remedial orders. Accordingly, the
Commission has determined to institute
a rescission proceeding and to
permanently rescind the LEO and the
CDOs. The rescission proceeding is
hereby terminated.
The Commission’s vote on this
determination took place on June 21,
2021. The LEO and CDOs are
permanently rescinded.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
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amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: June 22, 2021.
Lisa Barton,
Secretary to the Commission.
INTERNATIONAL TRADE
COMMISSION
[Investigation Nos. 731–TA–753, 754, and
756 (Fourth Review)]
Cut-to-Length Carbon Steel Plate From
China, Russia, and Ukraine
Determinations
On the basis of the record 1 developed
in the subject five-year reviews, the
United States International Trade
Commission (‘‘Commission’’)
determines, pursuant to the Tariff Act of
1930 (‘‘the Act’’), that revocation of the
antidumping duty order on cut-to-length
carbon steel plate from China and the
termination of the suspended
investigations on cut-to-length carbon
steel plate from Russia and Ukraine
would be likely to lead to continuation
or recurrence of material injury to an
industry in the United States within a
reasonably foreseeable time.
Background
The Commission instituted these
reviews on November 2, 2020 (85 FR
69362) and determined on February 5,
2021 that it would conduct expedited
reviews (86 FR 26067, May 12, 2021).
The Commission made these
determinations pursuant to section
751(c) of the Act (19 U.S.C. 1675(c)). It
completed and filed its determinations
in these reviews on June 21, 2021. The
views of the Commission are contained
in USITC Publication 5205 (June 2021),
entitled Cut-to-Length Carbon Steel
Plate from China, Russia, and Ukraine:
Investigation Nos. 731–TA–753, 754,
and 756 (Fourth Review).
By order of the Commission.
Issued: June 21, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–13523 Filed 6–24–21; 8:45 am]
BILLING CODE 7020–02–P
1 The record is defined in § 207.2(f) of the
Commission’s Rules of Practice and Procedure (19
CFR 207.2(f)).
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[Docket No. 19–18]
I. Procedural History
BILLING CODE 7020–02–P
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Drug Enforcement Administration
Robert Wayne Locklear, M.D.; Decision
and Order
[FR Doc. 2021–13574 Filed 6–24–21; 8:45 am]
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DEPARTMENT OF JUSTICE
On March 26, 2019, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Robert
Wayne Locklear, M.D., (hereinafter,
Respondent) of Johnson City,
Tennessee. Administrative Law Judge
(hereinafter, ALJ) Exhibit (hereinafter,
ALJX) 1 (OSC), at 1. The OSC proposed
the denial of Respondent’s application
for a DEA Certificate of Registration,
Application Control No. W18124612C,
‘‘pursuant to 21 U.S.C. 824(a)(2) & (a)(5),
because [Respondent has] been
convicted of a felony related to
controlled substances and because [he
has] been excluded from participation
in a program pursuant to section 1320a–
7(a) of Title 42.’’ Id.
Specifically, the OSC alleged that, on
October 8, 2014, Judgment was entered
against Respondent in the United States
District Court for the Eastern District of
Tennessee (hereinafter, E.D. Tenn.)
‘‘after [Respondent] pled guilty to: one
count of ‘Conspiracy to Distribute a
Quantity of Cocaine Base,’ in violation
of 21 U.S.C. 846 & 841(b)(1)(C); and one
count of ‘Conspiracy to Defraud a
Health Care Benefit Program,’ in
violation of 18 U.S.C. 1347 & 1349.’’ Id.
at 2 (citing U.S. v. Robert Wayne
Locklear, No. 2:14–CR–38 (E.D. Tenn.
Oct. 8, 2014)). The OSC alleged that
Respondent’s conviction of a felony
related to controlled substances
warrants the denial of Respondent’s
application pursuant to 21 U.S.C.
824(a)(2).
The OSC further alleged that ‘‘based
on [such] conviction, the U.S.
Department of Health and Human
Services, Office of Inspector General
(‘HHS/OIG’) mandatorily excluded
[Respondent] from participation in
Medicare, Medicaid, and all Federal
health care programs pursuant to 42
U.S.C. 1320a–7(a).’’ Id. The OSC stated
that this exclusion took effect on June
18, 2015, and ‘‘runs for a period of ten
years,’’ and that such exclusion
‘‘warrants denial of [Respondent’s]
application for DEA registration
pursuant to 21 U.S.C. 824(a)(5).’’ Id.
The Order to Show Cause notified
Respondent of the right to request a
hearing on the allegations or to submit
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a written statement, while waiving the
right to a hearing, the procedures for
electing each option, and the
consequences for failing to elect either
option. Id. at 2–3 (citing 21 CFR
1301.43). The OSC also notified
Respondent of the opportunity to
submit a corrective action plan. Id. at 3–
4 (citing 21 U.S.C. 824(c)(2)(C)).
On April 8, 2019, Respondent timely
filed a request for a hearing, in which
he affirmed his conviction and stated
that he ‘‘developed a severe addiction to
cocaine and alcohol’’ and that he had
been ‘‘clean and sober and active in
Recovery since June 27th, 2013.’’ ALJX
2 (Request for a Hearing, at 2).
The matter was placed on the docket
of the Office of Administrative Law
Judges and assigned to Chief
Administrative Law Judge John J.
Mulrooney II (hereinafter, the Chief
ALJ). On April 10, 2019, the ALJ
established a schedule for the filing of
prehearing statements. ALJX 3
(Amended Order for Prehearing
Statements), at 1–2. The Government
filed a Motion for Summary Disposition
on April 16, 2019, alleging that there
was no genuine issue of material fact
and separately filed a Prehearing
Statement on the same date. ALJX 4
(hereinafter, Govt MSD) and ALJX 5
(hereinafter, Govt Prehearing).
Respondent pro se filed a Motion for
Continuance requesting a delay in the
prehearing while he awaited a response
on his Corrective Action Plan.1 ALJX 7
(Motion for Continuance). The Chief
ALJ denied the Motion for Continuance,
because ‘‘the filing and pendency of a
corrective action plan, standing alone,
presents no impediment to proceeding
as scheduled or any cognizable
justification for a continuance . . . .’’
ALJX 8 (Order Denying Respondent’s
Motion for Continuance). On May 3,
2019, Respondent pro se filed his
Prehearing Statement. ALJX 9
(hereinafter, Resp Prehearing). The
Chief ALJ issued a Prehearing Ruling on
May 10, 2019, which, among other
things, set out six stipulations 2 already
agreed upon and established schedules
for the filing of additional joint
1 Respondent did not introduce the Corrective
Action Plan into the record.
2 The Stipulations included the fact that
Respondent voluntarily surrendered for cause his
previous DEA registration on July 8, 2013; the fact
that Respondent was excluded from participation in
Medicare, Medicaid, and all Federal health care
programs pursuant to 42 U.S.C. 1320a–7(a) effective
June 18, 2015; the fact that on October 8, 2014,
Respondent was convicted in E.D. Tenn. Of one
count of ‘‘Conspiracy to Distribute a Quantity
Cocaine Base’’ and one count of ‘‘Conspiracy to
Defraud a Health Care Benefit Program;’’ and the
fact that Respondent received a conditional medical
license in the State of Tennessee on November 16,
2018. ALJX 10, at 2.
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stipulations and supplemental
prehearing statements. ALJX 10
(Prehearing Ruling). On May 17, 2019,
Respondent filed a Notice of
Appearance of counsel and filed
requests for continuance and extension
of time as a result of obtaining counsel,
which the Chief ALJ considered in
amending his prehearing deadlines.
ALJX 11–15.
On June 13, 2019, Respondent filed a
Response to Government’s Statement of
Undisputed Material Facts and
Statement of Additional Undisputed
Material Fact of Respondent Robert
Wayne Locklear, M.D., in which he
confirmed the previous stipulations, but
clarified that ‘‘on the day he was
arrested by the Drug Task Force that,
although he never sold any, he shared
some illegal substances with others that
same day.’’ ALJX 16, at 2. On that same
date, Respondent also filed a Response
to Motion for Summary Disposition of
Respondent Robert Wayne Locklear,
M.D., in which he argued that material
facts exist related to why Respondent
can be entrusted with his DEA
registration, and that Respondent ‘‘is no
longer a threat to the public . . . .’’
ALJX 17 (Respondent’s Response to
MSD), at 6–7. Further on that same date,
Respondent filed a Second Prehearing
Statement of Respondent Robert Wayne
Locklear, M.D. (hereinafter, Resp Supp
Prehearing). ALJX 18. On June 18, 2019,
the Chief ALJ denied the Government’s
Motion for Summary Disposition,
finding that ‘‘the Agency has established
that where the Government has met its
burden by making a prima facie case for
sanction, the burden of production then
shifts to a respondent to show that,
given the totality of the facts and
circumstances in the record, denial or
revocation [of] the registrant’s
registration would not be appropriate.’’
ALJX 20, at 8 (citations omitted). I have
reviewed and agree with the procedural
rulings of the Chief ALJ during the
administration of the hearing.
The hearing in this matter spanned
one day.3 On August 29, 2019, the
Government filed its Proposed Findings
of Fact and Conclusions of Law and
Respondent filed his Proposed Findings
of Fact and Conclusions of Law of
Respondent Robert Wayne Locklear,
M.D. ALJX 26 (hereinafter, Govt
Posthearing); ALJX 25 (hereinafter, Resp
Posthearing). The Recommended
Rulings, Findings of Fact, Conclusions
of Law and Decision of the
Administrative Law Judge (hereinafter,
RD) is dated September 11, 2019. On
October 8, 2019, the Chief ALJ
3 Hearings were held in Knoxville, Tennessee on
July 30, 2019.
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transmitted his RD, along with the
certified record, to me, and certified that
no exceptions were filed by either party.
ALJ Transmittal Letter, at 1.4
Having considered this matter in the
entirety, I find that Respondent has been
convicted of a felony related to
controlled substances and has been
excluded from participation in a
program pursuant to section 1320a–7(a)
of Title 42, and that therefore, there is
a basis to deny Respondent’s
application. See infra III. I further find
that, given the facts on the record,
Respondent has not established
sufficient mitigating evidence to assure
me that he can be entrusted with a
controlled substances registration.
I issue this Decision and Order based
on the entire record before me. 21 CFR
1301.43(e). I make the following
findings of fact.
II. Findings of Fact
A. Stipulations
1. Respondent’s DEA Registration
On November 21, 2018, Respondent
filed an application (Application
Control No. W18124612C) for a DEA
Certificate of Registration as a
practitioner in schedules II–V, with a
proposed registered location at Recovery
Associates Inc., 401 E Main St., Ste 3,
Johnson City, Tennessee 37601–4891.
Government Exhibit (hereinafter, GX)
(Certificate of Non-Registration) 1, at 1;
see also RD, at 3 (Stipulation
(hereinafter, Stip) 1).
4 Respondent filed a Motion to Reopen the Record
on January 21, 2021 (hereinafter, Resp Mot to
Reopen), which the Chief ALJ denied on January 25,
2021. The Respondent noted in this filing that
Respondent should be allowed to reopen the record
for the submission of new ‘‘material evidence,’’
because the Respondent believed that the Chief ALJ
‘‘took issue with Dr. Locklear’s intention to
imminently petition the Board for removal of the
practice monitoring requirement’’ and asserts that
despite such removal, Respondent maintains the
advocacy of the Tennessee Medical Foundation.
Resp Mot to Reopen, at 2. I found evidence in the
record transmitted to me on October 8, 2019, that
supported the finding that Respondent would be
required to maintain the Tennessee Medical
Foundation’s advocacy in order to maintain his
medical license. See infra n.12. Specifically, in
addition to Respondent’s testimony that he would
continue to have the Tennessee Medical
Foundation’s advocacy for life, Tr. 129, the
conditions on Respondent’s medical license
required the maintenance of the ‘‘advocacy of the
Tennessee Medical Foundation for the duration of
time that [he is] licensed in Tennessee.’’ RX 17, at
1. Therefore, although Respondent’s proposed
evidence may be more current, that finding has
already been included in the record. Further, I do
not find the continuance of this advocacy or the
removal of the practice monitor to ultimately affect
my final decision in the matter. As explained in
infra IV, Respondent has repeatedly evaded
accountability measures in the past, and I cannot
entrust him with the responsibility of a controlled
substances registration.
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On July 8, 2013, Respondent
submitted a Form DEA–104, Voluntary
Surrender of Controlled Substances
Privileges, surrendering his previous
DEA Registration Control No.
BL7274107. GX 2 (DEA–104); see also
RD, at 3 (Stip 2).
2. Respondent’s Conviction
On October 8, 2014, judgment was
entered against Respondent in the
United States District Court for the
Eastern District of Tennessee
(hereinafter, E.D. Tenn.) after the
Respondent pled guilty to one count of
‘‘Conspiracy to Distribute a Quantity of
Cocaine Base,’’ in violation of 21 U.S.C.
841(b)(1)(C) & 846, and one count of
‘‘Conspiracy to Defraud a Health Care
Benefit Program,’’ in violation of 18
U.S.C. 1347 & 1349.’’ U.S. v. Robert
Wayne Locklear, No. 2:14–CR–38 (E.D.
Tenn. Oct. 8, 2014)). RD, at 3 (Stip 3);
see also GX 3 (Plea Agreement) and GX
4 (Judgment in a Criminal Case).
3. Respondent’s Exclusion
Based on the Respondent’s
conviction, HHS/OIG mandatorily
excluded the Respondent from
participation in Medicare, Medicaid,
and all federal health care programs
under 42 U.S.C. 1320a–7(a). RD, at 4
(Stip 4). The exclusion was effective on
June 18, 2015, and runs for a minimum
period of ten years. Id.; see also GX 5
(Exclusion Letter), at 1.
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4. Respondent’s State License
The Respondent received a
conditional medical license in the State
of Tennessee on November 16, 2018.
RD, at 4 (Stip. 6); see also RX 17 (Letter
from the Board of Medical Examiners);
RX 18 (Conditional Medical License).
B. The Government’s Case
The Government’s documentary
evidence consists primarily of records
supporting the stipulated facts. GX 1–6.
The Government called one witness, a
Diversion Investigator (hereinafter, the
DI). RD, at 4; Tr. 17–33. The DI testified
that she has been employed by DEA for
approximately eleven years and as a DI
for over three and a half years. Tr. 18.
The DI testified that she became familiar
with Respondent due to his answers to
the liability questions on the DEA
application and she testified as to the
basis of the Government Exhibits 2–6.
Id. at 18–30. The Chief ALJ found, and
I agree that the DI’s testimony ‘‘was
primarily focused on the noncontroversial introduction of
documentary evidence and her contact
with this case’’ and ‘‘merits full
credibility in these proceedings.’’ RD, at
6.
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The Government’s evidence includes
the Plea Agreement in Respondent’s
criminal case, the stipulated facts of
which describe Respondent’s
conspiracy to defraud a health care
benefit program and his interactions
with law enforcement regarding his
crack/cocaine use, including his
conspiracy to distribute. Regarding
Respondent’s drug charges, the plea
agreement stated:
Between the approximate month of January
2013 and continuing through the month of
July 2013, in the Eastern District of
Tennessee and elsewhere, conservatively, the
defendant did knowingly, intentionally, and
without authority, conspire with at least one
other person to distribute approximately at
least 5.6 but less than 11.2 grams of a mixture
and substance containing a detectable
amount of cocaine base (‘‘crack’’), a Schedule
II controlled substance.
GX 3, at 3.
The plea agreement further detailed
that Respondent had smoked crack
cocaine prior to seeing patients on May
13, 2013. Id. at 5. On June 5, 2013,
police seized crack cocaine from
Respondent, and he admitted that ‘‘he
had a drug problem’’ and that ‘‘he had
been smoking crack a few times a day
(before, during and after work).’’ Id. On
June 11, 2013, Respondent was arrested
and crack cocaine was seized from his
person. Id. He admitted that ‘‘a total of
$2,000 worth of crack cocaine was
purchased that morning and that he and
several others smoked some of it’’ and
that ‘‘he gave the dealer from Knoxville
and her friends approximately $200 to
$300 worth of crack cocaine to help
them out.’’ Id. at 6–7.
In addition to his drug use, the plea
agreement provided details as to
Respondent’s unlawful actions
regarding his conspiracy to defraud a
health care benefit program. Id. ‘‘The
[Respondent] operated two businesses
in the Eastern District of Tennessee:
Trinity Internal Medicine and Sleep
(‘TIMS’) and Trinity Recover Clinic
(‘TRC’). TIMS was a primary care
medical practice . . . TRC was operated
as an office based substance abuse
treatment program . . . .’’ Id. at 3. The
Plea Agreement stated that, ‘‘[d]ue
primarily to his usage of crack cocaine
and alcohol, the defendant was
frequently physically absent from the
medical practices TIMS and TRC during
periods when the medical practices
were open for business and providing
medical services to patients who were
enrolled in health care benefit
programs.’’ Id. at 8. According to the
plea agreement, while Respondent was
absent, he ‘‘told office staff to see
patients and prescribe medications,
including Suboxone in his absence,’’
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even though he ‘‘knew that no
employee/medical assistant at his
practice was properly licensed or
trained to provide these requisite
medical services.’’ Id. Further, the plea
agreement states that Respondent ‘‘often
did not examine, interview or treat the
patients on return visits, was often
absent from the practice when the
patients returned and thus did not
attend to or assess the patients’ medical
conditions.’’ Id. at 9.
The plea agreement concluded that
Respondent’s absence from the office
‘‘caused the pharmacies to submit
claims to health benefits programs and
receive reimbursement for prescriptions
that had been issued outside of the
usual course of professional practice
and without a finding of medical
necessity.’’ Id. Additionally, ‘‘laboratory
service providers [ ] submitted claims to
health care benefits programs . . . when
in fact, the testing had not been
reviewed or directed by [Respondent]
for the purpose of diagnosing or treating
a medical condition.’’ Id. Furthermore,
‘‘[o]n numerous occasions, drug screens
came back positive for the presence of
other scheduled drugs such as
marijuana or heroin, but the patients
continued to have their Suboxone
prescriptions called in anyway.’’ Id. at
9. The plea agreement provided
numerous examples of the claims filed
to health care benefits programs and
found: ‘‘an approximate total of 150
dates of service where a prescription
was issued and [Respondent] was not
present to examine the patient;’’ ‘‘the
total amount of loss to be applied in this
case, conservatively, is more than
$120,000 but less than $200,000;’’ and
that ‘‘this offense involved 10 or more
victims (health care benefit
companies).’’ Id. at 13.
C. The Respondent’s Case
Respondent submitted documentary
evidence including records related to
his conviction, sentencing, probation,
treatment for substance abuse, and
medical license. See Respondent’s
Exhibits (hereinafter, RX). Respondent
also testified on his own behalf and
submitted an affidavit signed by
himself 5 and testimony of character
witnesses, coworkers, and family
members. Tr. 33–167; RX 7.
Respondent testified that he attended
Duke Medical School. Tr. 50–51. He
admitted that ‘‘second year of medical
school, [he] began experimenting with
5 The Chief ALJ noted, and I agree that this
affidavit was allowed into the record with the
caveat that it would be subject to cross-examination
at the hearing. RD, at 15–16 n.43.
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crack, and it took [him] down very fast,
very quickly.’’ Id. at 149.
After medical school, Respondent
testified that he practiced at Takoma
Medical Center from 2002 to 2012 in
‘‘internal medicine.’’ Id. at 51.
Respondent stated, ‘‘I had moved out of
my home [in] approximately 2005
because I wanted to—I wanted to drink,
drug 6 and womanize. And in 2008, my
[wife]—she had had enough . . . and
we divorced in 2008. And then my
drinking continued to get worse. At this
point, I hadn’t started back drugging. I
had done some drugs back when I was
in college, in medical school, but I
hadn’t started back.’’ Id. at 52. In 2012,
he testified that his employer at Takoma
Medical Center ‘‘asked [him] to leave
because of [his] erratic behavior with
[his] drinking. So [he] went and opened
up [his] own practice in 2012, and it
wasn’t a month after [he] was in private
practice that [he] started using drugs
again.’’ Id. Respondent stated that ‘‘a big
part of it was at that point [he] had no
accountability.’’ 7 Id.
Respondent further testified that he
and his wife reconciled in 2012, when
he was ‘‘at the height of [his] drug
addiction,’’ before he was arrested and
that he ‘‘tormented her and put her
through H–E double L.’’ Id. at 55. Since
the arrest, he stated that he turned his
life around. He said, ‘‘I was completely
broken and I wanted to do whatever was
recommended so that I could get better.
I had a baby on the way, and grown
kids, and a—and a woman at this time
who was not my wife again, but who
loved me, and so I did—I followed the
suggestions, went to church, went to
meetings, did whatever was
recommended I do.’’ Id. at 56.
Respondent introduced a letter from
Talbott Recovery Campus in Atlanta,
Georgia (hereinafter, Talbott), which
stated that he had ‘‘successfully
completed all phases of his treatment
program.’’ RX 8. He testified that he
competed a 90-day inpatient program
there, because ‘‘the judge allowed me—
offered me to go to rehab if—to get out
of jail.’’ Tr. 65–66. When asked if there
was bail, Respondent stated, ‘‘I was
initially given bail and initially
6 It is noted that this is inconsistent with what
Respondent said a few sentences later, that he
‘‘hadn’t started back drugging.’’ Tr. 52.
7 It is unclear what Respondent meant by this
statement. The record demonstrates that as a result
of this behavior, he lost his practice, medical
license and was arrested and went to jail.
Additionally, he had previously almost been
removed from medical school, been divorced and
been required to leave his job at Takoma Medical
Center due to his addiction. I disagree with the
statement that he had no accountability—it instead
appears that he did not regard these consequences
as important at the time.
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released, but I ran the first time.’’ Id. at
67. He explained that after his arrest, he
went to rehab in Alabama at Bradford
Health Services (hereinafter, Bradford),
where he was for about ‘‘six days,’’ but
he ‘‘wanted to use drugs,’’ and so he
escaped and was later ‘‘picked up by a
bounty hunter’’ after he had been living
with other drug addicts for a few days.
Id. at 69–70. Then Respondent testified
that he then went to jail 8 for eleven
days and ‘‘unbelievably, the judge
allowed me to go—to leave again and go
to rehab within 11 days.’’ Id. at 71.
When asked why he went to Talbott
instead of Bradford, Respondent stated,
‘‘[w]e didn’t want to go back to
Bradford, and we told the judge that
Bradford wasn’t good for me, when it
really wasn’t Bradford, it was me. But
we—it was an angle to go somewhere
else.’’ Id. at 73. Respondent further
explained that it was ‘‘an excuse to
maybe try something different’’ and he
did not ‘‘know that Bradford would
have even taken [him] back.’’ Id. at 74.
Respondent submitted his first
agreement with the Tennessee Medical
Foundation, which memorialized his
sobriety date as June 27, 2013, and was
signed prior to his admission to
Talbott’s rehabilitation program on
January 26, 2013. Id. at 85; RX 12, at 7.
After he was released from Talbott on
October 6, 2013, Respondent testified
that he ‘‘went home, and it was about
a year and a half before [he] got
sentenced to prison.’’ Id. at 78; RX 7, at
2; RX 8, at 1. After his year in prison,
Respondent was released early and
signed up for a halfway house through
which he completed another
rehabilitation program. Id. at 82–84; RX
13.
Respondent testified that he pled
guilty in federal court, ‘‘because he was
guilty’’ and that he was ‘‘[v]ery. Very
sorry.’’ Id. at 34. He testified that he was
sentenced to two years in a penitentiary,
‘‘but served only one because [he]
completed a drug program in prison.’’
Id. He stated that after prison, he held
various jobs making pizza dough,
working as a secretary and a personal
trainer, and then in 2016, he ‘‘got a job
as a peer counselor in a drug treatment
program,’’ because he ‘‘felt like it was
[his] purpose.’’ Id. at 35. Respondent
stated that he worked at East Tennessee
Recovery and for the past two years, he
has been working at Recovery
Associates. Id. at 36.
8 Respondent testified that he lost his bail, and he
could not remember how much it was, but his wife
could probably remember. Tr. 70–71. Later, when
asked about whether there was bail after his time
at Talbott, he stated, ‘‘It’s fuzzy. I think there might
have been, Judge. Honestly, I don’t know.’’ Id. at 78.
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Respondent stated that he wanted to
get his medical license back because he
‘‘was in recovery and wanted to help
people.’’ Id. at 58. To regain his medical
license, he had to ‘‘do a competency
evaluation,’’ which he passed. Id.
Respondent testified that he is ‘‘closely
monitored’’ through the Tennessee
Medical Foundation and that
monitoring includes: Random drug
screens that began an average of ‘‘once
a week to once every two weeks’’ and
are now ‘‘about once a month;’’
checking in every morning seven days a
week to see if Respondent requires a
screen that day, and ‘‘on occasion, they
ask [him] to do a nail sample;’’ going to
‘‘a Caduceus 9 meeting once a week;’’
and, ‘‘[he has] 10 to go to three—at least
three other 12-step recovery meetings a
week outside of that, so at least four
meetings a week.’’ Id. at 38. Further,
Respondent testified that he ‘‘meet[s]
with a supervisor every three months
who reports to the Tennessee Medical
Foundation. We have to participate in a
retreat once a year.’’ Respondent added
that he has to meet with a counselor and
‘‘licensed addictionologist once a
quarter to be evaluated,’’ and the
addictionologist is a psychiatrist and
also monitors his depression. Id. at 60.
He stated that if he did not meet the
requirements of the Tennessee Medical
Foundation, ‘‘they would report me—
report me immediately to the board and
my license would be revoked.’’ Id. at
60–61. Respondent introduced into
evidence his second agreement 11 with
the Tennessee Medical Foundation,
which was executed on January 11,
2016, and expires 5 years after its date
of execution. RX 16, at 2. Respondent
further submitted a letter, dated October
12, 2018, from the Tennessee Board of
Medical Examiners, which granted him
a conditional medical license, and
among other things, required a practice
monitor for six months and the
maintenance of the ‘‘advocacy of the
Tennessee Medical Foundation for the
duration of time that [he is] licensed in
Tennessee.’’ 12 RX 17, at 1.
9 A Caduceus meeting is ‘‘a meeting for
physicians and other health care professionals in
recovery, a peer support group.’’ Tr. 38.
10 The Chief ALJ asked Respondent if it was
‘‘mandated to go to Caduceus plus the three other
12-step recovery’’ every week, and Respondent
answered affirmatively. Tr. 40
11 This agreement, as well as the first agreement,
included a provision to which Respondent agreed
stating, ‘‘I will not seek employment or work in
pain medicine, addiction medicine, or any
medication assisted treatment (MAT) center for a
minimum of the first 2 (two) years under the [ ]
contract.’’ RX 16, at 6; RX 12, at 6.
12 Respondent testified that when his five years
expired with the Tennessee Medical Foundation, he
would enter a new contract and that he and the
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Respondent also submitted a letter
from the Tennessee Medical
Foundation, which was written at the
request of his malpractice insurance that
states that Respondent is ‘‘in
compliance with all of the requirements
of his monitoring contract.’’ RX 15, at 1;
Tr. 97–101. The purpose of
Respondent’s controlled substances
registration, Respondent testified,
would be to work in addiction medicine
at Recovery Associates, and also to open
up a practice with his wife, based on
direct primary care ‘‘where patients pay
a certain fee a month to get unlimited
access to the physician,’’ because
Respondent is excluded from federal
health care programs. Tr. 103–05.
Respondent testified that his
supervisor at Recovery Associates Dr.
H.13 ‘‘has a terminal illness and that’s
why he’s not able to be here today. And
he’s been very supportive and
encouraging for me.’’ Id. at 47.
Respondent stated that Dr. H. was
scheduled to testify, but he has ‘‘end
stage myeloma, and he is bedridden at
the moment.’’ Id. at 138. When asked on
cross examination how Dr. H. is
‘‘effectively monitoring’’ his practice if
he is ill, Respondent stated that ‘‘he has
been monitoring me up to this point, but
there’s other doctors there that are also
involved’’ and that Dr. H. was onsite
‘‘about a week and a half ago.’’ Id. at
140. Respondent responded
affirmatively to the follow up of
whether the Tennessee Medical Board
knows that Dr. H. is too ill to be on site
monitoring his practice. Id. Then he
said, ‘‘Well, let me—let me rephrase
that. I don’t—I haven’t said anything to
the Tennessee Medical Board, and at
this point I don’t practice.’’ Id. at 141.
Respondent admitted that he is required
to have a practice monitor by the
medical board and Dr. H. is that practice
foundation ‘‘both agreed that [he] need[s] to be on
a lifetime contract.’’ Tr. 129. Although the Chief
ALJ had noted that Respondent’s agreement was
expiring shortly, RD, at 36, I find that the record
supports that even if certain restrictions, such as the
practice monitoring were lifted, Respondent would
likely continue to have some sort of accountability
monitored through the Tennessee Medical
Foundation for the duration of his medical license.
The language in his conditional license was clear
that this would be a requirement for ‘‘the duration
of time that [he is] licensed in Tennessee.’’ RX 17,
at 1. Therefore, I find that the record support that
Respondent will maintain the Tennessee Medical
Foundation’s advocacy for the duration of his
practice of medicine. I also have found below that
even with the full accountability measures in place,
Respondent has not demonstrated that he can be
entrusted with a controlled substances registration.
See supra IV.
13 Respondent also testified that his conditional
medical license ‘‘means that I can only practice for
a certain physician [Dr. H].’’ Tr. 121.
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monitor.14 Id. He then shifted his
position and stated that when Dr. H. is
not there, ‘‘then what I do—I
occasionally see patients individually,
and then I give the patient charts to the
doctor, but then they see the patient
themselves individually.’’ Id. at 142.
The Chief ALJ asked whether Dr. H. was
‘‘not there 50 percent of the time now,
and he’s not going to be there 50 percent
of the time if he has end stage multiple
myeloma, right?’’ Id. at 145. Respondent
answered, ‘‘He has been—he’s been
around for a while. He’s had—he’s had
it for 10 years, 11 years. He’s just not
there to—right now.’’ Id.
Regarding Respondent’s plans for his
controlled substances registration,
Respondent stated that his ‘‘training is
internal medicine, so what [he’d] be
doing . . . [he’d] be treating adults for
medical issues, anything from diabetes,
to COPD, to congestive heart failure to
hypertension.’’ Id. at 48. When asked
how he plans to work with drug addicts,
he stated that he ‘‘feel[s] confident that
[he has] a strong support system in
place.’’ Tr. 128–29.
Respondent testified that he accepts
responsibility and is remorseful for both
the felony and the exclusion. Tr. 134–
35. When asked why he believes he can
be a responsible DEA registrant,
Respondent answered, ‘‘I think that the
same—it’s the same reasons I can be—
I’m responsible with the—with the
things that I’ve been given so far. The
last thing I want to do—I—I’m not the
same person I was. I’ve been
rehabilitated. The last thing I want to do
is hurt someone.’’ Id. at 136. When
asked whether ‘‘working with patients
who are being treated for substance
abuse puts [him] at increased risk for
relapse [him]self,’’ he admitted that
14 Respondent’s conditional medical license
required reporting from his practice monitor every
month for six months, which started on the
effective date of November 14, 2018; therefore, six
months had likely passed before Dr. H. became
bedridden before this hearing on July 30, 2019;
however, the letter from the Board states that
Respondent must ‘‘petition for an Order of
Compliance to have the monitoring requirements
lifted.’’ RX 17, at 1. Respondent testified that he
was going to ask for the conditions on his license
to be removed, ‘‘as soon as [he] can get the
paperwork in’’ and ‘‘imminently.’’ Tr. 133.
Therefore, although the period of six months had
elapsed, the conditions on his medical license leave
open the question of whether Respondent might
have been required to have a practice monitor at the
time that Dr. H. became ill. This raises a concern,
because Respondent testified that he had not
notified the Board or the Tennessee Medical
Foundation about Dr. H.’s inability to monitor him.
Id. at 141. Ultimately, as explained below,
Respondent’s other egregious behavior is more
compelling in deciding a sanction in this case, but
both Respondent’s change in answers regarding this
topic and his lack of communication with the Board
or the Tennessee Medical Foundation certainly
raise concerns about my ability to trust him.
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‘‘[t]here are times it can be a trigger,
yes.’’ Id. at 137. He testified, ‘‘I work in
an environment—I make sure I work in
an environment that’s recoveryoriented, that most 15 of the people there
are in active recovery, so they not
only—I’m not only accountable to my
support system outside of work, I’m
accountable at work.’’ Id.
The Chief ALJ asked Respondent
about his previous rehabilitation efforts
and Respondent admitted that ‘‘second
year of medical school, [he] began
experimenting with crack, and it took
[him] down very fast, very quickly.’’ Id.
at 149. When asked by the Chief ALJ, he
admitted that at the time, he had started
the clinical portion and was ‘‘in and out
of a support role in patient care,’’ while
he was experimenting with crack. Id. at
149–50. Respondent admitted that he
was ‘‘directed to rehab by the faculty at
Duke’’ after he ‘‘went to the emergency
room’’ and he had to go to inpatient
rehab for 30 days and then was sober for
five years. Id. at 151. Respondent
testified
I was being monitored by the medical
school and the residency program, so as soon
as that monitoring was lifted—but all along,
I had it in the back of my head that I could
drink. I still thought I could drink. I knew I
couldn’t do drugs, but I thought I could drink
successfully. But I couldn’t drink while I was
being monitored, so as soon as the five years
was up and I no longer had any supervision,
I had it in my head I was going to drink, and
I did.’’
Id. at 152.
He then stated that he had to leave
Takoma Hospital because of a
‘‘culmination of events related to [his]
drinking,’’ including ‘‘not showing up
for work, being erratic, outbursts’’ and
he was sent to the Tennessee Medical
Foundation for an evaluation, during
which he ‘‘lied, and Tennessee Medical
Foundation recommended some
inpatient programs or some retreats for
[his] depression and trauma issues, but
[he] never followed through.’’ Id. at 154.
He stated that he was asked to leave
Takoma because of the refusal to
complete rehabilitation and
‘‘inappropriate behavior’’ and he
sometimes showed up to work in an
‘‘incapacitated status.’’ Id. at 155. But
then he retracted and clarified that he
was not under the influence at Takoma
and that it was really the inappropriate
behavior in texting a colleague that
15 Respondent noted that 100 percent of the
patients are being treated with buprenorphine and
that the typical course of treatment time is ‘‘at least
two years’’ and that when someone gets off
buprenorphine, ‘‘[t]hey usually just don’t show
back up.’’ Tr. 125–26. Later, he stated, ‘‘They don’t
come back, so they’re discharged, but we don’t
know why they’re not coming back, oftentimes.’’ Id.
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precipitated his departure from Takoma.
Id. at 156.
Respondent admitted that during the
time leading up to his arrest, he was not
showing up to work, and that as a result,
‘‘there were other people making
decisions about controlled substances
who weren’t qualified to do that’’ and
doing so was ‘‘extremely’’ dangerous
and ‘‘[he] put them at risk, as well as the
patient.’’ Id. at 160. He said that he
believed that he was successful at
Talbott’s rehabilitation program because
he ‘‘was in jail long enough’’ and
‘‘because [he] had the right mindset by
that point.’’ Id. at 164.
Regarding Respondent’s credibility,
the Chief ALJ found that:
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As the witness with the most at stake at the
hearing, the Respondent is certainly imbued
with the largest motive to embellish and
fabricate. Additionally, it cannot escape
notice that the Respondent has a lengthy
history of convincing responsible,
experienced professionals of his sincerity. He
has convinced medical school
administrators, rehabilitation professionals,
physicians, a judge and family members that
he has periodically been rehabilitated.
RD, at 18. The Chief ALJ further noted
‘‘internal inconsistencies in the
Respondent’s testimony. . . .’’ For
example, he found that Respondent
testified at first that his TMF monitor
was unavailable to testify because he
was bedridden, and when asked
whether he had notified the TMF that
his monitor was unable to monitor him,
Respondent stated that he had not,
‘‘then said (contrary to prior testimony)
that monitoring was unnecessary
because he was not practicing.’’ Id. The
Chief ALJ also noted that Respondent
admitted to lying to Takoma Hospital
and TMF, id. (citing Tr. 154), and lying
so that a District Court Judge would
send him to a different rehabilitation
facility, id. The Chief ALJ concluded
that ‘‘there were biographical elements
and other areas where the Respondent’s
testimony could be credited. However,
where the Respondent’s testimony
conflicts with objective, established
facts of record, other evidence and
testimony in the record, and common
sense, that testimony must be viewed
with robust skepticism.’’ Id. at 18–19. I
agree with the Chief ALJ, and although
I appreciate Respondent’s honesty about
his previous incidents of lying to a
Judge to get what he wanted, it makes
it very difficult for me to be able to trust
that he is not being honest now as an
angle to manipulate my decision. See
RD, at 18. I also find that there were
additional moments of inconsistency,
such as when he discussed the reasons
for his dismissal from Takoma—at first
he stated that he had erratic behavior,
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such as outbursts and not showing up
to work, Tr. 154, but then he insisted
that he was never impaired at Takoma
and that he was really dismissed
because of his inappropriate texting, id.
at 156. I find it unlikely given the
‘‘erratic’’ behavior and tardiness that he
was never impaired at work.
Respondent’s wife, S.L., testified on
his behalf. Tr. 170–190. She testified
that she has known Respondent since
middle school. Tr. 170–71. S.L. testified
that she is an addiction counselor and
that she and Respondent were divorced
in 2008 and remarried in 2018. Id. S.L.
believes Respondent that he has not
used drugs or alcohol in the last six
years, because she has ‘‘been there, and
also because there’s a lot of things in
place to ensure that he doesn’t.’’ Id. at
172–73. When asked why she trusts
Respondent, she said, ‘‘I didn’t start out,
you know, trusting him, you know,
when he first came out of recovery. But
you know, over the years, I’ve definitely
come to trust him. I wouldn’t have
remarried him if I—if I didn’t.’’ Id. at
173. She testified about his previous
rehabilitation efforts in medical school
and stated, that ‘‘I think it was a
situation where he came out and he did
really well when he had some—you
know, he was going to meetings. He was
doing everything that he needed to do.
From that standpoint—stayed sober. I
can’t remember how many years.’’ Id. at
184. But then she stated, ‘‘When he
stopped going to meetings, when he
stopped doing the things that were the
basis of recovery, I was a little wary, you
know.’’ Id. However, she followed,
‘‘[a]nd that’s why I’m hoping like this
time, for me—you know, there’s a lot of
things that are put in place that—to hold
him accountable, and that’s been good
for me in knowing—you know, it’s not
on me to keep an eye and try to predict,
you know, our behavior, because we
can’t. We can’t.’’ Id. When the Chief ALJ
asked her if the difference is that there
are safeguards in place now, she agreed,
but also added that ‘‘his general wellbeing is better. His mental health is
better.’’ Id. at 186.
The Chief ALJ found, and I agree, that
‘‘[n]otwithstanding the obvious reality
that [S.L.] has a vested interest in the
issuance of a COR to her husband so
that they can bring their joint practice
plans to fruition, she presented as a
generally candid witness whose
testimony bore sufficient detail, internal
consistency, and plausibility to be
afforded credibility in these
proceedings.’’ RD, at 20.
Respondent next presented the
testimony of Dr. G., who is an
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33743
‘‘addiction medicine specialist’’ 16 and
who has known Respondent ‘‘nine
years, probably since 2010.’’ Tr. 191–
211. Dr. G. testified that he knew
Respondent before and after his
recovery, and that before, they were
‘‘colleagues in the sense that
[Respondent] saw some patients that
had some substance use disorders, and
it’s a small-knit group of people in
recovery. . . .’’ Id. at 192. Dr. G.
testified that he took over the care of
some of Respondent’s patients during
his addiction. Id. at 193. Now, Dr. G.
sees Respondent ‘‘once a week, every
week, for the past six years’’ as part of
a recovery meeting for medical
professionals, where they are peers. Id.
at 194. Dr. G. testified that Respondent
has never been impaired at one of those
meetings. Id. at 201, 206. Dr. G. also
described that impression of the
difference between Respondent now
and his previous acquaintance with
Respondent in 2012 as ‘‘day and night.’’
Id. at 206. He further testified that
Respondent has been doing all of the
things that are important for recovery.
Id. at 206–07. He further stated that
‘‘[t]he wonderful thing about [the
Tennessee Medical foundation contract]
is I know [Respondent] every day has to
pick up a phone, and he’s got to punch
in a number and he’s got to see if he’s
being drug screened, seven days a
week.’’ Id. at 208. He further stated, ‘‘It
made me think about that when you
said would I be able to tell if
[Respondent] was doing something.
Well, there’s not only me, there is the
Tennessee Medical Foundation that has
advocated for [Respondent], that—he is
under their monitoring.’’ Id. Dr. G. also
testified that he feels Respondent has
been rehabilitated and when asked if he
would trust his judgment in taking care
of patients, he said, ‘‘Absolutely.’’ Id. at
210.
The Chief ALJ found, and I agree, that
some of Dr. G.’s testimony was ‘‘likely
more broad and optimistic than his
objective bases for those positions
would justify. . . . [it] was sufficiently
detailed, plausible, and internally
consistent to be deemed credible in
these proceedings.’’ RD, at 24.
The next witness to testify on behalf
of Respondent was M.C., who is a
licensed clinical social worker and a
peer 17 colleague of Respondent for
16 Respondent’s attorney moved to qualify Dr. G.
as an expert witness, but the Chief ALJ found, and
I agree, that there had not been adequate notice that
Respondent would call upon Dr. G. as an expert.
Tr. 202–04.
17 Respondent testified initially that M.C. is
charged with monitoring him as he is ‘‘the head
counselor at the program, which is part of
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about six years and sees him ‘‘anywhere
from two to four times a week in
person’’ at work. Tr. 212–13. M.C.
testified that he would be able to tell if
Respondent ever had come into work
impaired, because he is ‘‘a recovering
drug addict [himself], so [he] know[s]
what it looks like, what it smells like,
what it tastes like, what it acts like,’’
and he has never seen Respondent
impaired. Id. at 214–15. M.C. described
Respondent as ‘‘transparent,’’ because as
he stated, ‘‘in recovery, if a person’s
going to get clean, stay clean, they have
to get honest.’’ Id. at 215. He further
stated that he would trust his clinical
judgment, although he has never
observed him with patients, because he
is ‘‘behind closed doors.’’ Id. at 225–26.
The Chief ALJ found, and I agree, that
‘‘[w]hile the depth of his knowledge of
the Respondent’s suitability to discharge
the duties of a DEA registrant is
extremely limited, M.C. presented
testimony that was sufficiently cogent,
detailed, plausible, and internally
consistent to be considered generally
credible.’’ RD, at 25.
Another of Respondent’s co-workers,
W.J., who is a certified peer specialist
and has known Respondent for three
and a half years testified on his behalf.
Tr. 228–30. He testified that Respondent
became his first sponsor, but they
became such close friends that he is no
longer his sponsor. Id. at 233. He said
he has never seen Respondent impaired
and that he trusts Respondent ‘‘with
[his] life.’’ Id. at 230, 233. The Chief ALJ
found, and I agree, that although
Respondent’s assistance to W.J. is
‘‘undoubtedly commendable,’’ ‘‘there
was very little presented through [W.J.]
that can be objectively considered as
helpful in determining whether the
Agency can have confidence that
Respondent can/will discharge his
duties as a DEA registrant.’’ RD, at 26.
Respondent’s son, C.L., also testified
on his father’s behalf. He stated that he
is studying experimental biological
psychology to conduct ‘‘addiction and
pharmacological research.’’ Tr. 237. He
testified that he was interested in the
subject because of his parents’ work and
‘‘the things that we’ve experienced as a
family . . .’’ Id. at 238. When asked
about his relationship with his father,
he stated, ‘‘Today, it’s fantastic.’’ He
further stated that he believes his father
is sober, because ‘‘he was just an
entirely different person, but you know,
it’s—hasn’t been anything like that in a
[Respondent’s] job role.’’ Tr. 145. However, later he
clarified that the ‘‘person who does the direct
monitoring is Dr. H.’’ Id. at 146. It was clear from
M.C.’s testimony that he does not monitor
Respondent’s patient care or ‘‘supervise [him] in
any way.’’ Id. at 226.
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very long time. . . .’’ Id. at 239. He also
testified that he and his father had built
trust and that he trusted his father now,
but there was a time when he did not,
‘‘because there was no—there was no
sort of stability.’’ Id. at 243.
Respondent’s oldest son, R.L., also
testified on his father’s behalf. Id. at
244–55. He testified that he is a youth
minister in North Carolina and working
on a master’s degree in cultural studies.
Id. at 247. When asked if he trusts his
father, he stated, ‘‘I trust that he is—he
is moving in—you know, moving in the
right direction, and so it’s just been, you
know exciting and just encouraging for
me to see, so yeah. Yes, I do, I trust
him.’’ Id. at 248–49. He testified that he
has seen his father mature, and control
his anger. Id. at 249–50. When asked if
he believes his father has been sober for
six years, he said, ‘‘I’ve never seen any
evidence of it, never heard any—of
anything from my parents, or sisters, or
anybody, and continuing to see him
grow, so yeah, I believe him.’’ Id. at 250.
With respect to both of Respondent’s
sons, the Chief ALJ found, and I agree,
that C.L. and R.L. presented as ‘‘loving’’
sons, ‘‘seeking to support [their] father
and family.’’ RD, at 21. He found that
their testimony was ‘‘internally
consistent, plausible, and based on the
questions [they were] asked, adequately
detailed.’’ However, he ultimately
found, and I agree, that ‘‘there was very
little practical value added’’ by these
witnesses as ‘‘to a determination of
whether the issuance of a [registration]
would be in the public interest.’’ Id. at
21–22.
Respondent also presented the
testimony of the Reverend at his church,
where Respondent teaches Sunday
school and has ‘‘a significant role.’’ Tr.
258. He testified that he has known
Respondent for about three years and
that he trusts Respondent and described
him as reliable—‘‘if he says something,
he’s going to do that.’’ Id. at 260. The
Chief ALJ concluded, and I agree, that
in part due to the limitations on the
time and context that the Reverend has
known the Respondent, the Reverend
‘‘presented as a responsible dedicated
pastor whose testimony however
believable, added only minimally to an
objective determination of whether the
Respondent should be entrusted with a
DEA COR.’’ RD, at 27.
III. Discussion
In this matter, as already discussed,
the OSC calls for my adjudication of the
application for registration based on the
charge that Respondent has been
convicted of a felony related to
controlled substances and that he was
excluded from participation in a
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program pursuant to section 1320a–7(a)
of Title 42. OSC, at 1–4; supra sections
II.A and II.D. Both of these are bases for
revocation or suspension or a controlled
substances registration under 21 U.S.C.
824(a)(2) & (a)(5). The OSC does not
allege that granting Respondent’s
application would be inconsistent with
the public interest based on
consideration of the factors in 21 U.S.C.
823(f)(1) through (5) (hereinafter, the
public interest factors). The Government
raised the public interest factors in its
Posthearing Brief; however, the Chief
ALJ found that they were ‘‘unavailable
as a basis for sanction in these
proceedings,’’ due to the late stage in
which they were raised. See RD, at 28
n.65. Accordingly, the OSC’s specific
substantive bases for proposing the
denial of Registrant’s registration
application are his felony conviction
and his mandatory exclusion under 21
U.S.C. 824(a)(2) & (a)(5). OSC, at 1–4.
Prior Agency decisions have
addressed whether it is appropriate to
consider a provision of 21 U.S.C. 824(a)
when determining whether or not to
grant a practitioner registration
application. For over forty-five years,
Agency decisions have concluded that it
is.
In John R. Amato, M.D., 40 FR 22852
(1975), the Agency issued an Order to
Show Cause regarding Dr. Amato’s
application on November 6, 1974. Id.
The Order to Show Cause referenced a
medical license revocation issued by the
New Jersey Board of Medical Examiners.
Id. The Agency’s analysis began by
citing, and agreeing with,
Administrative Law Judge Parker’s
conclusion, ‘‘as a matter of law,’’ that
the state dispensing authority
requirement of section 823(f) ‘‘must
logically give the Administrator the
authority to deny a registration if the
practitioner is not authorized by the
State to dispense controlled
substances.’’ 18 Id. The Administrator
agreed, stating ‘‘[t]o hold otherwise
would mean that all applications would
have to be granted only to be revoked
the next day under 21 U.S.C. 824(a)(3).’’
Id. The Administrator also stated that
‘‘[t]his agency has consistently held that
where a registration can be revoked
under section 824, it can, a fortiori, be
denied under section 823.’’ Id. The
Administrator stated that he accepted
Judge Parker’s recommendation that the
application be denied because Dr.
Amato lacked authority in New Jersey
18 Section 303(f) states that the Attorney General
shall register practitioners if they have authority to
‘‘dispense . . . controlled substances under the
laws of the State in which . . . [they] practice[ ].’’
21 U.S.C. 823(f).
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‘‘to administer, dispense or prescribe
controlled substances.’’ Id.
Other Agency decisions from the
1970s and 1980s similarly concluded
that a provision of section 824 may be
the basis for the denial of a practitioner
registration application. See, e.g., Arthur
R. Black, D.O., 49 FR 33183, 33183
(1984) (denying practitioner registration
application for ‘‘two lawful grounds’’: A
federal felony conviction and material
falsification of the application); Brady
Kortland Fleming, D.O., 46 FR 45841,
45842 (1981) (denying practitioner
registration application due to past
controlled substance-related federal
felony conviction); Thomas W. Moore,
Jr., M.D., 45 FR 40743, 40743–44 (1980)
(denying practitioner registration
application due to past controlled
substance-related federal felony
convictions); Raphael C. Ciliento, M.D.,
44 FR 30466, 30466 (1979) (denying
practitioner registration application due
to past controlled substance-related
state felony conviction and applicant’s
decision not to attend the hearing he
requested and show why denial is not
appropriate).
I agree with the results of all of these
Agency decisions.
An Agency decision from the 1990s,
when the practitioner portions of
sections 823 and 824 looked more like
they do today than when the Agency
decided the above-cited decision,
likewise concluded that a practitioner
registration application may be denied
based on a provision of section 824.
Dinorah Drug Store, Inc., 61 FR 15972
(1996). Dinorah is the adjudication of a
practitioner registration application by a
retail pharmacy. Id. at 15972. The Order
to Show Cause referenced 21 U.S.C.
823(f) as well as 21 U.S.C. 824(a)(5)
(mandatory exclusion from federal
health care programs). Id.
The parties disagreed on whether a
provision of section 824 could be the
basis for the denial of a pharmacy’s
registration application. Id. at 15973.
The Government’s position was that
section 824(a)(5) ‘‘is to be construed as
not only grounds for the suspension or
revocation of a DEA registration, but
also as a basis for the denial of an
application for a DEA registration.’’ Id.
The pharmacy’s position was that
section 824(a)(5) is ‘‘limited to the
revocation or suspension of already
existing registrations.’’ Id.
According to the Agency’s decision in
Dinorah:
To reject 21 U.S.C. 824(a)(5) as a basis for
the denial of DEA registration makes little
sense. The result would be to grant the
application for registration, only to possibly
turn around and propose to revoke or
suspend that registration based on
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registrant’s exclusion from a Medicare
program. A statutory construction which
would impute a useless act to Congress will
be viewed as unsound and rejected. South
Corp. v. United States, 690 F.2d [1369], 1374
(Fed. Cir. 1982).
Id. In other words, the basis for the
decision’s conclusion is statutory
construction as articulated by the
Federal Circuit. Id. The decision thus
concluded that ‘‘21 U.S.C. 824(a)(5) may
serve as a basis for the denial of a DEA
registration.’’ Id.
Dinorah is also instructive for its
analysis of the application and its
conclusion to grant the application
despite the mandatory exclusion. Id. at
15973–74. The decision, citing the ALJ,
agreed that ‘‘[s]ince denial of
registration under Section 824(a)(5) is
discretionary, the factors listed in
Section 823(f) may be considered in
determining whether the granting of
[the] Respondent’s application is
inconsistent with the public interest.’’
Id. at 15973. The decision analyzed each
of the public interest factors, finding
each of them relevant. Id. at 15973–74;
21 U.S.C. 823(f). The Deputy
Administrator’s analysis of the public
interest factors was favorable to the
pharmacy, while he explicitly stated
that he did not ‘‘condone’’ the
fraudulent activity in which the
pharmacy and its owner had engaged.
61 FR at 15974. Accordingly, the Deputy
Administrator approved the pharmacy’s
registration application. Id. I agree with
my predecessor’s conclusion that a
provision of section 824 may be the
basis for the denial of a practitioner
registration application and that
allegations related to section 823 remain
relevant to the adjudication of a
practitioner registration application
when a provision of section 824 is
involved.
Accordingly, when considering an
application for a registration, I will
consider any allegations related to the
grounds for denial of an application
under 823 and will also consider any
allegations that the applicant meets one
of the five grounds for revocation or
suspension of a registration under
section 824. See id. at 15973–74.
i. 21 U.S.C. 823(f): The Five Public
Interest Factors
Pursuant to section 303(f) of the CSA,
‘‘[t]he Attorney General shall register
practitioners . . . to dispense . . .
controlled substances . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Section 303(f) further
provides that an application for a
practitioner’s registration may be denied
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upon a determination that ‘‘the issuance
of such registration . . . would be
inconsistent with the public interest.’’
Id. In making the public interest
determination, the CSA requires
consideration of the following factors:
(1) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(2) The applicant’s experience in
dispensing, or conducting research with
respect to controlled substances.
(3) The applicant’s conviction record
under Federal or State laws relating to
the manufacture, distribution, or
dispensing of controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to
controlled substances.
(5) Such other conduct which may
threaten the public health and safety. 21
U.S.C. 823(f).
In this case, it is undisputed that
Respondent holds a valid state medical
license and is authorized to dispense
controlled substances in the State of
Tennessee where he practices. RX 17,
18. The Government did not allege that
Respondent’s registration would be
inconsistent with the public interest
pursuant to section 823 in the OSC and
did not advance any arguments or
present any evidence under the public
interest factors in its case at hearing. See
OSC; Govt Prehearing. Instead, the
Government based its initial case in
section 824 alleging that Respondent’s
conviction of a felony related to
controlled substances and his
mandatory exclusion from federal
health programs merit the denial of his
registration under 21 U.S.C. 824(a)(2) &
(a)(5). See OSC; Govt Prehearing.
Because the Government has not alleged
that Respondent’s registration is
inconsistent with the public interest
under section 823, I will not deny
Respondent’s application based on
section 823, and although I have
considered 823, I will not analyze
Respondent’s application under the
public interest factors. Therefore, in
accordance with prior agency decisions,
I will move to assess whether the
Government has proven by substantial
evidence that one or more grounds for
revocation exist under 21 U.S.C. 824(a).
ii. 21 U.S.C. 824(a)(2) & (a)(5)
Each subsection of section 824(a)
provides an independent ground to
impose a sanction on a registrant.
Arnold E. Feldman, M.D., 82 FR 39614,
39617 (2017); see also Gilbert L.
Franklin, D.D.S., 57 FR 3441 (1992)
(‘‘[M]andatory exclusion from
participation in the Medicare program
constitutes an independent ground for
revocation pursuant to 21 U.S.C. [§ ]
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824(a)(5).’’). Pursuant to 824(a)(2), the
Attorney General is authorized to
suspend or revoke a registration ‘‘upon
a finding that the registrant . . . has
been convicted of a felony under this
subchapter or subchapter II of this
chapter or any other law of the United
States . . . relating to any substance
defined in this subchapter as a
controlled substance or a list I
chemical.’’ 21 U.S.C. 824(a)(2). The
ground in 21 U.S.C. 824(a)(5) requires
that the registrant ‘‘has been excluded
(or directed to be excluded) from
participation in a program pursuant to
section 1320a–7(a) of Title 42.’’ 42
U.S.C. 1320a–7(a) provides a list of four
predicate offenses for which exclusion
from Medicare, Medicaid, and other
federal health care programs is
mandatory and sets out mandatory
timeframes for such exclusion. Id.
Here, there is no dispute in the record
that Respondent is mandatorily
excluded pursuant to Section 1320a–
7(a) of Title 42 and, therefore, that a
ground for the revocation or suspension
of Registrant’s registration exists. 21
U.S.C. 824(a)(5). There is also no
dispute in the record that Respondent
has been convicted one count of
‘‘Conspiracy to Distribute a Quantity of
Cocaine Base,’’ in violation of 21 U.S.C.
841(b)(1)(C) & 846, which constitutes a
felony conviction ‘‘relating to’’
controlled substances as those terms are
defined in 21 U.S.C. 824(a)(2). William
J. O’Brien, III, D.O., 82 FR 46527, 46529
(2017).
Where, as here, the Government has
met its prima facie burden of showing
that two grounds for revocation exists,
the burden shifts to the Registrant to
show why he can be entrusted with a
registration. See Jeffrey Stein, M.D., 84
FR 46968, 46972 (2019).
IV. Sanction
Where, as in the instant case, the
Government has established grounds to
deny a registration, I will review any
evidence and argument the respondent
submitted to determine whether or not
the respondent has presented ‘‘sufficient
mitigating evidence to assure the
Administrator that [he] can be trusted
with the responsibility carried by such
a registration.’’ Samuel S. Jackson,
D.D.S., 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, M.D., 53 FR
21931, 21932 (1988)). ‘‘ ‘Moreover,
because ‘‘past performance is the best
predictor of future performance,’’ ALRA
Labs, Inc. v. Drug Enf’t Admin., 54 F.3d
450, 452 (7th Cir. 1995), [the Agency]
has repeatedly held that where a
registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
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[the registrant’s] actions and
demonstrate that [registrant] will not
engage in future misconduct.’ ’’ Jayam
Krishna-Iyer, 74 FR 459, 463 (2009)
(quoting Medicine Shoppe, 73 FR 364,
387 (2008)); see also Samuel S. Jackson,
D.D.S., 72 FR at 23853; John H.
Kennnedy, M.D., 71 FR 35705, 35709
(2006); Prince George Daniels, D.D.S., 60
FR 62884, 62887 (1995). The issue of
trust is necessarily a fact-dependent
determination based on the
circumstances presented by the
individual respondent; therefore, the
Agency looks at factors, such as the
acceptance of responsibility and the
credibility of that acceptance as it
relates to the probability of repeat
violations or behavior and the nature of
the misconduct that forms the basis for
sanction, while also considering the
Agency’s interest in deterring similar
acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 (2016).
In evaluating the degree required of a
respondent’s acceptance of
responsibility to entrust him with a
registration, in Mohammed Asgar, M.D.,
the Agency looked for ‘‘unequivocal
acceptance of responsibility when a
respondent has committed knowing or
intentional misconduct.’’ 83 FR 29569,
29572 (2018) (citing Lon F. Alexander,
M.D., 82 FR 49704, 49728). Here,
Respondent pled guilty to one count of
‘‘Conspiracy to Distribute a Quantity of
Cocaine Base,’’ in violation of 21 U.S.C.
841(b)(1)(C) & 846, and one count of
‘‘Conspiracy to Defraud a Health Care
Benefit Program,’’ in violation of 18
U.S.C. 1347 & 1349. U.S. v. Robert
Wayne Locklear, No. 2:14–CR–38 (E.D.
Tenn. Oct. 8, 2014)). I will, therefore,
look for a clear acceptance of
responsibility from Respondent.
Respondent took concrete actions to
accept responsibility for his misconduct
while his criminal case was ongoing. He
did so by pleading guilty to the charges
in Federal Court. Respondent testified
that he pled guilty in federal court
‘‘because he was guilty’’ and that he was
‘‘[v]ery. Very sorry.’’ Tr. at 34. However,
after his arrest, he was given the option
of entering an inpatient rehabilitation
program in lieu of incarceration, and
after only six days, he escaped, because
he ‘‘wanted to use drugs.’’ Id. at 67–68.
By his own admission, it was not until
he had been ‘‘in jail long enough,’’ that
he was fully ready to accept
rehabilitation. Id. at 167. It is difficult to
credit Respondent’s guilty pleas as full
acceptance of responsibility given his
behavior after his arrest.
Regarding Respondent’s acceptance of
responsibility for the health care benefit
fraud, the Chief ALJ found, and I agree
that:
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During his testimony, the Respondent
complacently agreed that allowing
unqualified administrative staff personnel to
hand out controlled substance prescriptions
while he was absent from his office due to
his drug and alcohol abuse was ‘‘[e]xtremely
dangerous.’’ Tr. 160. He even allowed that he
‘‘put [his staff] at risk, as well as the patient,’’
but his demeanor conveyed no indication
that he regretted his actions or even
recognized the monetary and safety
ramifications of those actions. The message
his nonchalant testimonial demeanor
conveyed was that it happened, he got
caught, and his actions merited no further
reflection.
RD, at 32. I defer to the Chief ALJ’s
assessment of Respondent’s demeanor.
Because the Administrative Law Judge
has had the opportunity to observe the
demeanor and conduct of hearing
witnesses, the factual findings regarding
demeanor set forth in his recommended
decision are entitled to significant
deference. Universal Camera Corp. v.
NLRB, 340 U.S. 474, 496 (1951); Jeffery
J. Becker, D.D.S., and Jeffery J. Becker,
D.D.S., Affordable Care, 77 FR 72387,
72403 (2012). I find the Chief ALJ’s
characterization of Respondent’s
reaction in making these statements to
be important in this case, particularly
because the illegal conduct involved the
prescribing of controlled substances—
the very responsibility with which
Respondent now seeks to be entrusted.
Furthermore, the magnitude of the
offense is staggering—the plea
agreement included 150 dates of service
where a prescription was issued and
Respondent was not present to examine
the patient. GX 3, at 13. The offense
therefore, warranted much more
attention and focus from Respondent in
accepting responsibility. This crime did
not just affect federal health care
programs, but also the patients, who
were not receiving adequate medical
care, and Respondent’s staff, who as
Respondent noted, he put at risk for
malpractice and even potential criminal
liability. The plea agreement also noted
that ‘‘[o]n numerous occasions, drug
screens came back positive for the
presence of other scheduled drugs such
as marijuana or heroin, but the patients
continued to have their Suboxone
prescriptions called in anyway.’’ GX 3,
at 9. Additionally, Respondent admitted
that he saw patients after smoking crack
cocaine. Id. at 5. This behavior is
directly related to his controlled
substance registration—and I find that
the magnitude of the harm that he
caused and could have caused merited
more than a ‘‘nonchalant’’ admission.19
19 There is no mention at all of the conduct
related to prescribing in the affidavit Respondent
submitted, see RX 7, and he submitted no testimony
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Regarding Respondent’s acceptance of
responsibility for his felony conviction
for Conspiracy to Distribute a Quantity
of Cocaine Base, he testified that he
accepts responsibility and is remorseful.
Tr. 134–35. Although he made these
overall statements, in the affidavit he
submitted, he stated that he ‘‘admitted
on the day [he] was arrested by the Drug
Task Force that, although [he] never
sold any illegal substances, [he] shared
some crack cocaine with others that
same day.’’ RX 7. Respondent seems to
assume that the act of sharing somehow
would improve my view of his actions,
when in truth the fact that he
distributed an illegal substance to others
is serious misconduct in considering
whether he can be entrusted with a
controlled substance registration,
irrespective of whether he did so as a
gift or for payment. In sharing crack
cocaine, he endangered the lives of
these individuals and brought them
further into the same spiral of addiction
in which he was swirling. This
statement, which qualifies what he did
not do, appears to be aimed at
minimizing the egregiousness of his
conduct, which the Agency has
previously weighed against a finding of
acceptance of full responsibility. See
Ronald Lynch, M.D., 75 FR 78745,
78754 (2010) (Respondent did not
accept responsibility noting that he
‘‘repeatedly attempted to minimize his
[egregious] misconduct’’; see also
Michael White, M.D., 79 FR 62957,
62967 (2014) (finding that Respondent’s
‘‘acceptance of responsibility was
tenuous at best’’ and that he
‘‘minimized the severity of his
misconduct by suggesting that he thinks
the requirements for prescribing
Phentermine are too strict.’’).
As to his demeanor in his acceptance
of responsibility for the felony charge,
the Chief ALJ remarked that Respondent
‘‘cooly related’’ the events leading up to
his arrest. RD, at 33. He further stated
that:
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If the Respondent understands that doling
out crack cocaine in a hotel room,
particularly when committed by one who
had been entrusted with a DEA registration,
was reprehensible, that understanding was
reflected in neither his language nor his tone
during the hearing. In his testimony, he
described his actions with no more emotion
than if he were recounting an uneventful
shopping trip to a local mall.
RD, at 34.
I also find it of significance in
evaluating Respondent’s acceptance of
responsibility that he did not seem to be
on his own about this specific matter. The Chief
ALJ had to ask him about the controlled substances
prescriptions in the plea agreement. Tr. 160.
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aware of the full extent of the harm that
he caused. For example, when the Chief
ALJ asked him what happened to his
bail when he escaped from Bradford,
Respondent testified that it was ‘‘lost,’’
and he could not remember how much
it was, but his ‘‘wife could probably tell
you for sure.’’ Tr. 70–71; supra n.8.
And, again, when asked about whether
he posted bail after Talbott, he answered
that it was ‘‘fuzzy,’’ and ‘‘I think there
might have been.’’ Id. at 78. The fact
that he did not fully understand the
financial impact on his family and left
the responsibility of that knowledge to
his wife, does not demonstrate full
acceptance of responsibility for his
misconduct.
Further, the Chief ALJ noted, and I
agree, that Respondent ‘‘was repeatedly
successful in convincing persons in
authority to afford him the benefit of
rehabilitation.’’ Id. at 35; see Tr. 152–53
(Duke Medical School); Tr. 153–59
(Takoma Medical Center); Tr. 162
(District Court Judge who sent him to
Bradford); Tr. 168–69 (District Court
Judge sent him to Talbott after he
escaped from Bradford); Tr. 78–79
(released after Talbott). Like the Chief
ALJ, I find Respondent’s admission that
he described his statements to a District
Court Judge that he could not go back
to Bradford Rehabilitation as ‘‘an angle
to go somewhere else,’’ id. at 73, to be
of particular concern, see RD, at 36.
Although I credit his retrospective
honesty, in deciding whether I can trust
him, I cannot ignore the fact that he has
successfully angled to obtain trust
repeatedly, and repeatedly abused that
trust.
The Agency has decided that the
egregiousness and extent of the
misconduct are significant factors in
determining the appropriate sanction.
Garrett Howard Smith, M.D., 83 FR at
18910 (collecting cases). The Agency
has also considered the need to deter
similar acts by a respondent and by the
community of registrants. Id. In this
case, there is no doubt that the
Respondent’s felonies and past behavior
are egregious. His acts related to his
controlled substances registration—
instructing unqualified staff to issue
controlled substances prescriptions on
his behalf and without properly
considering contrary urine drug screens,
I find to be particularly egregious.
Further, as the Chief ALJ stated,
‘‘intentionally and volitionally
distributing crack cocaine is a grave
departure from even the most minimal
standard of responsibility to guard
against diversion that is expected of a
DEA registrant. It is not that he just
came up short in preventing drug
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diversion, he intentionally diverted
crack cocaine.’’ RD, at 39.
As the Chief ALJ noted, although the
Agency has permitted registrants to
maintain or obtain registrations based
on demonstrated unequivocal
acceptance of responsibility and
‘‘concrete, sincere efforts at
rehabilitation,’’ many of these cases
involved no harm to anyone beyond the
respondent and no grounds for
revocation under Section 824; whereas,
in this case, the ‘‘record reflects the
distribution of crack to others, the
placement of his patients in extreme
danger, professional (even criminal)
exposure inflicted on his office staff,
and monetary damages to various health
care providers who submitted
reimbursement claims.’’ RD, at 38
(citing Ronald F. Lambert, D.D.S., 78 FR
62662, 62664 (2013); Kimberly Maloney,
N.P., 76 FR 60922, 60927–28 (2011);
John J. Cienki, M.D. 63 FR 52293, 52296
(1998) (parentheticals omitted)).
Generally, I find Respondent’s
recovery to be commendable given his
lengthy and difficult battle with
addiction. Respondent cited the support
of his friends and family numerous
times as being essential to his recovery.
Tr. 128–29, 136, 137. Although the
testimony of his network of family and
friends who support him is important to
understanding their opinions about the
status of his recovery, I find that overall,
their opinions are not the best evidence
for me to use to determine my ability to
be entrust Respondent with a controlled
substances registration. See Raymond A.
Carlson, 53 FR 7425 (1988) (finding that
none of the character ‘‘witnesses was in
a position to make an adequate
assessment of [r]espondent’s ability to
properly handle controlled
substances.’’). Further, I find that the
record evidence of Respondent’s
egregious controlled substance
dispensing-related violations is relevant
to my evaluation and outweighs all of
the record evidence from his family,
friend, colleague, and minister that he
has been generally trustworthy and
reliable since his recovery. See George
Pursley, M.D. 85 FR 80162, 80180
(2020).
In addition to acceptance of
responsibility, the Agency also gives
consideration to both specific and
general deterrence when determining an
appropriate sanction. Daniel A. Glick,
D.D.S., 80 FR 74800, 74810 (2015).
Specific deterrence is the DEA’s interest
in ensuring that a registrant complies
with the laws and regulations governing
controlled substances in the future. Id.
General deterrence concerns the DEA’s
responsibility to deter conduct similar
to the proven allegations against the
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respondent for the protection of the
public at large. Id. In this case, I agree
with the Chief ALJ that ‘‘the absence of
a sanction where a DEA registrant has
been convicted of actually intentionally
distributing crack cocaine would send a
powerful message to the regulated
community that even the most blatant
intentional diversion will carry no
consequences.’’ RD, at 40.
In Respondent’s favor, Respondent
has been held accountable for his
criminal behavior—having been
sentenced to prison and temporarily
losing his medical license. He has met
the requirements for rehabilitation and
for obtaining a conditional medical
license. However, based on the facts of
this case, I find it difficult to find that
this accountability will have a deterrent
effect on the potential for Respondent’s
relapse, because he has faced serious
consequences many times in his life—
losing his wife and family, getting
expelled from medical school, losing his
job, getting arrested, going to jail, etc.—
and none of those things seemed to
deter him from repeating his behavior
until now.
Although Respondent testified
extensively about the accountability to
which he is held pursuant to his
agreement with the Tennessee Medical
Foundation, and many of his character
witnesses testified about how much that
accountability comforted them, I cannot
find that accountability necessarily to be
a sufficient deterrent from abuse of his
controlled substances registration due to
his history of repeatedly ignoring
accountability measures,20 even at the
risk of incarceration. Therefore, in spite
of his commendable sobriety thus far, I
have reason to doubt his claim that he
would always be a compliant registrant.
See George R. Smith, M.D., 78 FR 44972,
44980 (2013). Particularly, I remain
concerned that if he relapsed, which the
record has demonstrated previously
occurred on several occasions, while
entrusted with a controlled substances
registration, he could harm himself and
others too quickly for detection by this
Agency or his monitoring. Ensuring that
a registrant is trustworthy to comply
with all relevant aspects of the CSA
without constant oversight is crucial to
the Agency’s ability to complete its
mission of preventing diversion within
20 There is also evidence on the record that at the
time of the hearing that Respondent might not have
been in compliance with his monitoring
requirements due to his monitor’s illness and that
he did not inform the state board or the Tennessee
Medical Foundation of the lapse in monitoring. See
supra n.14. I find that this lapse is mitigated by its
circumstances, but that it is further evidence that
Respondent has repeatedly demonstrated disregard
for accountability measures.
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such a large regulated population.
Jeffrey Stein, M.D., 84 FR at 46974.
As discussed above, to receive a
registration when grounds for denial
exist, a respondent must convince the
Administrator that his acceptance of
responsibility and remorse are
sufficiently credible to demonstrate that
the misconduct will not reoccur and
that he can be entrusted with a
registration. Having reviewed the record
in its entirety, I find that Respondent
has not met this burden. Accordingly, I
will order the denial of Respondent’s
application for a certificate of
registration.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny the pending
application for a Certificate of
Registration, Control Number
W18124612C, submitted by Robert
Wayne Locklear, M.D., as well as any
other pending application of Robert
Wayne Locklear, M.D. for additional
registration in Tennessee. This Order is
effective July 26, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–13525 Filed 6–24–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 18–50]
Carol Hippenmeyer, M.D.; Decision and
Order
On August 20, 2018, a former Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Carol
Hippenmeyer, M.D. (hereinafter,
Respondent). Administrative Law Judge
Exhibit (hereinafter, ALJX) 1 (OSC), at 1.
The OSC proposed the revocation of
Respondent’s DEA Certificates of
Registration BH3877733, FH2922119,
FH2922121, FH2922133, FH2922157,
and FH2922169, on the ground that her
‘‘continued registrations are
inconsistent with the public interest.’’
Id. (citing 21 U.S.C. 823(f) and
824(a)(4)).
I. Procedural History
The OSC alleged that Respondent
‘‘violated Federal and Arizona state law
by issuing controlled substance
prescriptions outside the usual course of
professional practice and for other than
PO 00000
Frm 00116
Fmt 4703
Sfmt 4703
a legitimate medical purpose’’ to three
patients between February 3, 2017, and
December 6, 2017. Id. at 3–5 (citing
violations of 21 U.S.C. 841(a)(1), 21 CFR
1306.04(a), and Ariz. Rev. Stat. Ann.
§ 32–1401(27)). The OSC alleged that
Respondent issued these prescriptions
‘‘without performing an adequate
physical exam, without taking a
sufficient patient history, without
determining the frequency and intensity
of the patient’s pain, without arriving at
a legitimate diagnosis, and without
maintaining adequate medical records.’’
Id. at 5. The OSC also alleged that
Respondent issued these prescriptions
‘‘despite the fact that all three of these
individuals had manifested one or more
‘red flags’ for abuse and/or diversion.’’
Id. at 5. The OSC stated that by issuing
these prescriptions, Respondent
committed ‘‘numerous acts of unlawful
prescribing, any one of which could
independently establish the sort of
intentional diversion . . . that would
justify the revocation of [her] DEA
registrations.’’ Id. at 6.
The OSC notified Respondent of her
right to request a hearing on the
allegations or to submit a written
statement while waiving her right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 6 (citing 21
CFR 1301.43). Applicant timely
requested a hearing by letter dated
September 19, 2018. ALJX 3 (Order for
Prehearing Statements), at 1
(interpreting ALJX 2 (Request for
Hearing)).
The matter was placed on the docket
of the Office of Administrative Law
Judges and assigned to Administrative
Law Judge Charles Wm. Dorman
(hereinafter, the ALJ). On September 25,
2018, the ALJ established a schedule for
the filing of prehearing statements.
Order for Prehearing Statements, at 1.
The Government filed its Prehearing
Statement on October 5, 2018, and its
Supplemental Prehearing Statement on
October 30, 2018. ALJX 4 (Government’s
Prehearing Statement) and 7
(Government’s Supplemental Prehearing
Statement), respectively. Respondent
filed her Prehearing Statement on
October 19, 2018, and her Supplemental
Prehearing Statement on October 30,
2018. ALJX 5 (Respondent’s Prehearing
Statement) and 8 (Respondent’s
Supplemental Prehearing Statement),
respectively.
On October 23, 2018, the ALJ issued
a Prehearing Ruling that, among other
things, set out the thirteen stipulations
already agreed upon and established
schedules for the filing of additional
joint stipulations and supplemental
E:\FR\FM\25JNN1.SGM
25JNN1
Agencies
[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33738-33748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13525]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-18]
Robert Wayne Locklear, M.D.; Decision and Order
I. Procedural History
On March 26, 2019, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to Robert
Wayne Locklear, M.D., (hereinafter, Respondent) of Johnson City,
Tennessee. Administrative Law Judge (hereinafter, ALJ) Exhibit
(hereinafter, ALJX) 1 (OSC), at 1. The OSC proposed the denial of
Respondent's application for a DEA Certificate of Registration,
Application Control No. W18124612C, ``pursuant to 21 U.S.C. 824(a)(2) &
(a)(5), because [Respondent has] been convicted of a felony related to
controlled substances and because [he has] been excluded from
participation in a program pursuant to section 1320a-7(a) of Title
42.'' Id.
Specifically, the OSC alleged that, on October 8, 2014, Judgment
was entered against Respondent in the United States District Court for
the Eastern District of Tennessee (hereinafter, E.D. Tenn.) ``after
[Respondent] pled guilty to: one count of `Conspiracy to Distribute a
Quantity of Cocaine Base,' in violation of 21 U.S.C. 846 &
841(b)(1)(C); and one count of `Conspiracy to Defraud a Health Care
Benefit Program,' in violation of 18 U.S.C. 1347 & 1349.'' Id. at 2
(citing U.S. v. Robert Wayne Locklear, No. 2:14-CR-38 (E.D. Tenn. Oct.
8, 2014)). The OSC alleged that Respondent's conviction of a felony
related to controlled substances warrants the denial of Respondent's
application pursuant to 21 U.S.C. 824(a)(2).
The OSC further alleged that ``based on [such] conviction, the U.S.
Department of Health and Human Services, Office of Inspector General
(`HHS/OIG') mandatorily excluded [Respondent] from participation in
Medicare, Medicaid, and all Federal health care programs pursuant to 42
U.S.C. 1320a-7(a).'' Id. The OSC stated that this exclusion took effect
on June 18, 2015, and ``runs for a period of ten years,'' and that such
exclusion ``warrants denial of [Respondent's] application for DEA
registration pursuant to 21 U.S.C. 824(a)(5).'' Id.
The Order to Show Cause notified Respondent of the right to request
a hearing on the allegations or to submit
[[Page 33739]]
a written statement, while waiving the right to a hearing, the
procedures for electing each option, and the consequences for failing
to elect either option. Id. at 2-3 (citing 21 CFR 1301.43). The OSC
also notified Respondent of the opportunity to submit a corrective
action plan. Id. at 3-4 (citing 21 U.S.C. 824(c)(2)(C)).
On April 8, 2019, Respondent timely filed a request for a hearing,
in which he affirmed his conviction and stated that he ``developed a
severe addiction to cocaine and alcohol'' and that he had been ``clean
and sober and active in Recovery since June 27th, 2013.'' ALJX 2
(Request for a Hearing, at 2).
The matter was placed on the docket of the Office of Administrative
Law Judges and assigned to Chief Administrative Law Judge John J.
Mulrooney II (hereinafter, the Chief ALJ). On April 10, 2019, the ALJ
established a schedule for the filing of prehearing statements. ALJX 3
(Amended Order for Prehearing Statements), at 1-2. The Government filed
a Motion for Summary Disposition on April 16, 2019, alleging that there
was no genuine issue of material fact and separately filed a Prehearing
Statement on the same date. ALJX 4 (hereinafter, Govt MSD) and ALJX 5
(hereinafter, Govt Prehearing). Respondent pro se filed a Motion for
Continuance requesting a delay in the prehearing while he awaited a
response on his Corrective Action Plan.\1\ ALJX 7 (Motion for
Continuance). The Chief ALJ denied the Motion for Continuance, because
``the filing and pendency of a corrective action plan, standing alone,
presents no impediment to proceeding as scheduled or any cognizable
justification for a continuance . . . .'' ALJX 8 (Order Denying
Respondent's Motion for Continuance). On May 3, 2019, Respondent pro se
filed his Prehearing Statement. ALJX 9 (hereinafter, Resp Prehearing).
The Chief ALJ issued a Prehearing Ruling on May 10, 2019, which, among
other things, set out six stipulations \2\ already agreed upon and
established schedules for the filing of additional joint stipulations
and supplemental prehearing statements. ALJX 10 (Prehearing Ruling). On
May 17, 2019, Respondent filed a Notice of Appearance of counsel and
filed requests for continuance and extension of time as a result of
obtaining counsel, which the Chief ALJ considered in amending his
prehearing deadlines. ALJX 11-15.
---------------------------------------------------------------------------
\1\ Respondent did not introduce the Corrective Action Plan into
the record.
\2\ The Stipulations included the fact that Respondent
voluntarily surrendered for cause his previous DEA registration on
July 8, 2013; the fact that Respondent was excluded from
participation in Medicare, Medicaid, and all Federal health care
programs pursuant to 42 U.S.C. 1320a-7(a) effective June 18, 2015;
the fact that on October 8, 2014, Respondent was convicted in E.D.
Tenn. Of one count of ``Conspiracy to Distribute a Quantity Cocaine
Base'' and one count of ``Conspiracy to Defraud a Health Care
Benefit Program;'' and the fact that Respondent received a
conditional medical license in the State of Tennessee on November
16, 2018. ALJX 10, at 2.
---------------------------------------------------------------------------
On June 13, 2019, Respondent filed a Response to Government's
Statement of Undisputed Material Facts and Statement of Additional
Undisputed Material Fact of Respondent Robert Wayne Locklear, M.D., in
which he confirmed the previous stipulations, but clarified that ``on
the day he was arrested by the Drug Task Force that, although he never
sold any, he shared some illegal substances with others that same
day.'' ALJX 16, at 2. On that same date, Respondent also filed a
Response to Motion for Summary Disposition of Respondent Robert Wayne
Locklear, M.D., in which he argued that material facts exist related to
why Respondent can be entrusted with his DEA registration, and that
Respondent ``is no longer a threat to the public . . . .'' ALJX 17
(Respondent's Response to MSD), at 6-7. Further on that same date,
Respondent filed a Second Prehearing Statement of Respondent Robert
Wayne Locklear, M.D. (hereinafter, Resp Supp Prehearing). ALJX 18. On
June 18, 2019, the Chief ALJ denied the Government's Motion for Summary
Disposition, finding that ``the Agency has established that where the
Government has met its burden by making a prima facie case for
sanction, the burden of production then shifts to a respondent to show
that, given the totality of the facts and circumstances in the record,
denial or revocation [of] the registrant's registration would not be
appropriate.'' ALJX 20, at 8 (citations omitted). I have reviewed and
agree with the procedural rulings of the Chief ALJ during the
administration of the hearing.
The hearing in this matter spanned one day.\3\ On August 29, 2019,
the Government filed its Proposed Findings of Fact and Conclusions of
Law and Respondent filed his Proposed Findings of Fact and Conclusions
of Law of Respondent Robert Wayne Locklear, M.D. ALJX 26 (hereinafter,
Govt Posthearing); ALJX 25 (hereinafter, Resp Posthearing). The
Recommended Rulings, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge (hereinafter, RD) is dated September
11, 2019. On October 8, 2019, the Chief ALJ transmitted his RD, along
with the certified record, to me, and certified that no exceptions were
filed by either party. ALJ Transmittal Letter, at 1.\4\
---------------------------------------------------------------------------
\3\ Hearings were held in Knoxville, Tennessee on July 30, 2019.
\4\ Respondent filed a Motion to Reopen the Record on January
21, 2021 (hereinafter, Resp Mot to Reopen), which the Chief ALJ
denied on January 25, 2021. The Respondent noted in this filing that
Respondent should be allowed to reopen the record for the submission
of new ``material evidence,'' because the Respondent believed that
the Chief ALJ ``took issue with Dr. Locklear's intention to
imminently petition the Board for removal of the practice monitoring
requirement'' and asserts that despite such removal, Respondent
maintains the advocacy of the Tennessee Medical Foundation. Resp Mot
to Reopen, at 2. I found evidence in the record transmitted to me on
October 8, 2019, that supported the finding that Respondent would be
required to maintain the Tennessee Medical Foundation's advocacy in
order to maintain his medical license. See infra n.12. Specifically,
in addition to Respondent's testimony that he would continue to have
the Tennessee Medical Foundation's advocacy for life, Tr. 129, the
conditions on Respondent's medical license required the maintenance
of the ``advocacy of the Tennessee Medical Foundation for the
duration of time that [he is] licensed in Tennessee.'' RX 17, at 1.
Therefore, although Respondent's proposed evidence may be more
current, that finding has already been included in the record.
Further, I do not find the continuance of this advocacy or the
removal of the practice monitor to ultimately affect my final
decision in the matter. As explained in infra IV, Respondent has
repeatedly evaded accountability measures in the past, and I cannot
entrust him with the responsibility of a controlled substances
registration.
---------------------------------------------------------------------------
Having considered this matter in the entirety, I find that
Respondent has been convicted of a felony related to controlled
substances and has been excluded from participation in a program
pursuant to section 1320a-7(a) of Title 42, and that therefore, there
is a basis to deny Respondent's application. See infra III. I further
find that, given the facts on the record, Respondent has not
established sufficient mitigating evidence to assure me that he can be
entrusted with a controlled substances registration.
I issue this Decision and Order based on the entire record before
me. 21 CFR 1301.43(e). I make the following findings of fact.
II. Findings of Fact
A. Stipulations
1. Respondent's DEA Registration
On November 21, 2018, Respondent filed an application (Application
Control No. W18124612C) for a DEA Certificate of Registration as a
practitioner in schedules II-V, with a proposed registered location at
Recovery Associates Inc., 401 E Main St., Ste 3, Johnson City,
Tennessee 37601-4891. Government Exhibit (hereinafter, GX) (Certificate
of Non-Registration) 1, at 1; see also RD, at 3 (Stipulation
(hereinafter, Stip) 1).
[[Page 33740]]
On July 8, 2013, Respondent submitted a Form DEA-104, Voluntary
Surrender of Controlled Substances Privileges, surrendering his
previous DEA Registration Control No. BL7274107. GX 2 (DEA-104); see
also RD, at 3 (Stip 2).
2. Respondent's Conviction
On October 8, 2014, judgment was entered against Respondent in the
United States District Court for the Eastern District of Tennessee
(hereinafter, E.D. Tenn.) after the Respondent pled guilty to one count
of ``Conspiracy to Distribute a Quantity of Cocaine Base,'' in
violation of 21 U.S.C. 841(b)(1)(C) & 846, and one count of
``Conspiracy to Defraud a Health Care Benefit Program,'' in violation
of 18 U.S.C. 1347 & 1349.'' U.S. v. Robert Wayne Locklear, No. 2:14-CR-
38 (E.D. Tenn. Oct. 8, 2014)). RD, at 3 (Stip 3); see also GX 3 (Plea
Agreement) and GX 4 (Judgment in a Criminal Case).
3. Respondent's Exclusion
Based on the Respondent's conviction, HHS/OIG mandatorily excluded
the Respondent from participation in Medicare, Medicaid, and all
federal health care programs under 42 U.S.C. 1320a-7(a). RD, at 4 (Stip
4). The exclusion was effective on June 18, 2015, and runs for a
minimum period of ten years. Id.; see also GX 5 (Exclusion Letter), at
1.
4. Respondent's State License
The Respondent received a conditional medical license in the State
of Tennessee on November 16, 2018. RD, at 4 (Stip. 6); see also RX 17
(Letter from the Board of Medical Examiners); RX 18 (Conditional
Medical License).
B. The Government's Case
The Government's documentary evidence consists primarily of records
supporting the stipulated facts. GX 1-6. The Government called one
witness, a Diversion Investigator (hereinafter, the DI). RD, at 4; Tr.
17-33. The DI testified that she has been employed by DEA for
approximately eleven years and as a DI for over three and a half years.
Tr. 18. The DI testified that she became familiar with Respondent due
to his answers to the liability questions on the DEA application and
she testified as to the basis of the Government Exhibits 2-6. Id. at
18-30. The Chief ALJ found, and I agree that the DI's testimony ``was
primarily focused on the non-controversial introduction of documentary
evidence and her contact with this case'' and ``merits full credibility
in these proceedings.'' RD, at 6.
The Government's evidence includes the Plea Agreement in
Respondent's criminal case, the stipulated facts of which describe
Respondent's conspiracy to defraud a health care benefit program and
his interactions with law enforcement regarding his crack/cocaine use,
including his conspiracy to distribute. Regarding Respondent's drug
charges, the plea agreement stated:
Between the approximate month of January 2013 and continuing
through the month of July 2013, in the Eastern District of Tennessee
and elsewhere, conservatively, the defendant did knowingly,
intentionally, and without authority, conspire with at least one
other person to distribute approximately at least 5.6 but less than
11.2 grams of a mixture and substance containing a detectable amount
of cocaine base (``crack''), a Schedule II controlled substance.
GX 3, at 3.
The plea agreement further detailed that Respondent had smoked
crack cocaine prior to seeing patients on May 13, 2013. Id. at 5. On
June 5, 2013, police seized crack cocaine from Respondent, and he
admitted that ``he had a drug problem'' and that ``he had been smoking
crack a few times a day (before, during and after work).'' Id. On June
11, 2013, Respondent was arrested and crack cocaine was seized from his
person. Id. He admitted that ``a total of $2,000 worth of crack cocaine
was purchased that morning and that he and several others smoked some
of it'' and that ``he gave the dealer from Knoxville and her friends
approximately $200 to $300 worth of crack cocaine to help them out.''
Id. at 6-7.
In addition to his drug use, the plea agreement provided details as
to Respondent's unlawful actions regarding his conspiracy to defraud a
health care benefit program. Id. ``The [Respondent] operated two
businesses in the Eastern District of Tennessee: Trinity Internal
Medicine and Sleep (`TIMS') and Trinity Recover Clinic (`TRC'). TIMS
was a primary care medical practice . . . TRC was operated as an office
based substance abuse treatment program . . . .'' Id. at 3. The Plea
Agreement stated that, ``[d]ue primarily to his usage of crack cocaine
and alcohol, the defendant was frequently physically absent from the
medical practices TIMS and TRC during periods when the medical
practices were open for business and providing medical services to
patients who were enrolled in health care benefit programs.'' Id. at 8.
According to the plea agreement, while Respondent was absent, he ``told
office staff to see patients and prescribe medications, including
Suboxone in his absence,'' even though he ``knew that no employee/
medical assistant at his practice was properly licensed or trained to
provide these requisite medical services.'' Id. Further, the plea
agreement states that Respondent ``often did not examine, interview or
treat the patients on return visits, was often absent from the practice
when the patients returned and thus did not attend to or assess the
patients' medical conditions.'' Id. at 9.
The plea agreement concluded that Respondent's absence from the
office ``caused the pharmacies to submit claims to health benefits
programs and receive reimbursement for prescriptions that had been
issued outside of the usual course of professional practice and without
a finding of medical necessity.'' Id. Additionally, ``laboratory
service providers [ ] submitted claims to health care benefits programs
. . . when in fact, the testing had not been reviewed or directed by
[Respondent] for the purpose of diagnosing or treating a medical
condition.'' Id. Furthermore, ``[o]n numerous occasions, drug screens
came back positive for the presence of other scheduled drugs such as
marijuana or heroin, but the patients continued to have their Suboxone
prescriptions called in anyway.'' Id. at 9. The plea agreement provided
numerous examples of the claims filed to health care benefits programs
and found: ``an approximate total of 150 dates of service where a
prescription was issued and [Respondent] was not present to examine the
patient;'' ``the total amount of loss to be applied in this case,
conservatively, is more than $120,000 but less than $200,000;'' and
that ``this offense involved 10 or more victims (health care benefit
companies).'' Id. at 13.
C. The Respondent's Case
Respondent submitted documentary evidence including records related
to his conviction, sentencing, probation, treatment for substance
abuse, and medical license. See Respondent's Exhibits (hereinafter,
RX). Respondent also testified on his own behalf and submitted an
affidavit signed by himself \5\ and testimony of character witnesses,
coworkers, and family members. Tr. 33-167; RX 7.
---------------------------------------------------------------------------
\5\ The Chief ALJ noted, and I agree that this affidavit was
allowed into the record with the caveat that it would be subject to
cross-examination at the hearing. RD, at 15-16 n.43.
---------------------------------------------------------------------------
Respondent testified that he attended Duke Medical School. Tr. 50-
51. He admitted that ``second year of medical school, [he] began
experimenting with
[[Page 33741]]
crack, and it took [him] down very fast, very quickly.'' Id. at 149.
After medical school, Respondent testified that he practiced at
Takoma Medical Center from 2002 to 2012 in ``internal medicine.'' Id.
at 51. Respondent stated, ``I had moved out of my home [in]
approximately 2005 because I wanted to--I wanted to drink, drug \6\ and
womanize. And in 2008, my [wife]--she had had enough . . . and we
divorced in 2008. And then my drinking continued to get worse. At this
point, I hadn't started back drugging. I had done some drugs back when
I was in college, in medical school, but I hadn't started back.'' Id.
at 52. In 2012, he testified that his employer at Takoma Medical Center
``asked [him] to leave because of [his] erratic behavior with [his]
drinking. So [he] went and opened up [his] own practice in 2012, and it
wasn't a month after [he] was in private practice that [he] started
using drugs again.'' Id. Respondent stated that ``a big part of it was
at that point [he] had no accountability.'' \7\ Id.
---------------------------------------------------------------------------
\6\ It is noted that this is inconsistent with what Respondent
said a few sentences later, that he ``hadn't started back
drugging.'' Tr. 52.
\7\ It is unclear what Respondent meant by this statement. The
record demonstrates that as a result of this behavior, he lost his
practice, medical license and was arrested and went to jail.
Additionally, he had previously almost been removed from medical
school, been divorced and been required to leave his job at Takoma
Medical Center due to his addiction. I disagree with the statement
that he had no accountability--it instead appears that he did not
regard these consequences as important at the time.
---------------------------------------------------------------------------
Respondent further testified that he and his wife reconciled in
2012, when he was ``at the height of [his] drug addiction,'' before he
was arrested and that he ``tormented her and put her through H-E double
L.'' Id. at 55. Since the arrest, he stated that he turned his life
around. He said, ``I was completely broken and I wanted to do whatever
was recommended so that I could get better. I had a baby on the way,
and grown kids, and a--and a woman at this time who was not my wife
again, but who loved me, and so I did--I followed the suggestions, went
to church, went to meetings, did whatever was recommended I do.'' Id.
at 56.
Respondent introduced a letter from Talbott Recovery Campus in
Atlanta, Georgia (hereinafter, Talbott), which stated that he had
``successfully completed all phases of his treatment program.'' RX 8.
He testified that he competed a 90-day inpatient program there, because
``the judge allowed me--offered me to go to rehab if--to get out of
jail.'' Tr. 65-66. When asked if there was bail, Respondent stated, ``I
was initially given bail and initially released, but I ran the first
time.'' Id. at 67. He explained that after his arrest, he went to rehab
in Alabama at Bradford Health Services (hereinafter, Bradford), where
he was for about ``six days,'' but he ``wanted to use drugs,'' and so
he escaped and was later ``picked up by a bounty hunter'' after he had
been living with other drug addicts for a few days. Id. at 69-70. Then
Respondent testified that he then went to jail \8\ for eleven days and
``unbelievably, the judge allowed me to go--to leave again and go to
rehab within 11 days.'' Id. at 71. When asked why he went to Talbott
instead of Bradford, Respondent stated, ``[w]e didn't want to go back
to Bradford, and we told the judge that Bradford wasn't good for me,
when it really wasn't Bradford, it was me. But we--it was an angle to
go somewhere else.'' Id. at 73. Respondent further explained that it
was ``an excuse to maybe try something different'' and he did not
``know that Bradford would have even taken [him] back.'' Id. at 74.
---------------------------------------------------------------------------
\8\ Respondent testified that he lost his bail, and he could not
remember how much it was, but his wife could probably remember. Tr.
70-71. Later, when asked about whether there was bail after his time
at Talbott, he stated, ``It's fuzzy. I think there might have been,
Judge. Honestly, I don't know.'' Id. at 78.
---------------------------------------------------------------------------
Respondent submitted his first agreement with the Tennessee Medical
Foundation, which memorialized his sobriety date as June 27, 2013, and
was signed prior to his admission to Talbott's rehabilitation program
on January 26, 2013. Id. at 85; RX 12, at 7. After he was released from
Talbott on October 6, 2013, Respondent testified that he ``went home,
and it was about a year and a half before [he] got sentenced to
prison.'' Id. at 78; RX 7, at 2; RX 8, at 1. After his year in prison,
Respondent was released early and signed up for a halfway house through
which he completed another rehabilitation program. Id. at 82-84; RX 13.
Respondent testified that he pled guilty in federal court,
``because he was guilty'' and that he was ``[v]ery. Very sorry.'' Id.
at 34. He testified that he was sentenced to two years in a
penitentiary, ``but served only one because [he] completed a drug
program in prison.'' Id. He stated that after prison, he held various
jobs making pizza dough, working as a secretary and a personal trainer,
and then in 2016, he ``got a job as a peer counselor in a drug
treatment program,'' because he ``felt like it was [his] purpose.'' Id.
at 35. Respondent stated that he worked at East Tennessee Recovery and
for the past two years, he has been working at Recovery Associates. Id.
at 36.
Respondent stated that he wanted to get his medical license back
because he ``was in recovery and wanted to help people.'' Id. at 58. To
regain his medical license, he had to ``do a competency evaluation,''
which he passed. Id. Respondent testified that he is ``closely
monitored'' through the Tennessee Medical Foundation and that
monitoring includes: Random drug screens that began an average of
``once a week to once every two weeks'' and are now ``about once a
month;'' checking in every morning seven days a week to see if
Respondent requires a screen that day, and ``on occasion, they ask
[him] to do a nail sample;'' going to ``a Caduceus \9\ meeting once a
week;'' and, ``[he has] \10\ to go to three--at least three other 12-
step recovery meetings a week outside of that, so at least four
meetings a week.'' Id. at 38. Further, Respondent testified that he
``meet[s] with a supervisor every three months who reports to the
Tennessee Medical Foundation. We have to participate in a retreat once
a year.'' Respondent added that he has to meet with a counselor and
``licensed addictionologist once a quarter to be evaluated,'' and the
addictionologist is a psychiatrist and also monitors his depression.
Id. at 60. He stated that if he did not meet the requirements of the
Tennessee Medical Foundation, ``they would report me--report me
immediately to the board and my license would be revoked.'' Id. at 60-
61. Respondent introduced into evidence his second agreement \11\ with
the Tennessee Medical Foundation, which was executed on January 11,
2016, and expires 5 years after its date of execution. RX 16, at 2.
Respondent further submitted a letter, dated October 12, 2018, from the
Tennessee Board of Medical Examiners, which granted him a conditional
medical license, and among other things, required a practice monitor
for six months and the maintenance of the ``advocacy of the Tennessee
Medical Foundation for the duration of time that [he is] licensed in
Tennessee.'' \12\ RX 17, at 1.
---------------------------------------------------------------------------
\9\ A Caduceus meeting is ``a meeting for physicians and other
health care professionals in recovery, a peer support group.'' Tr.
38.
\10\ The Chief ALJ asked Respondent if it was ``mandated to go
to Caduceus plus the three other 12-step recovery'' every week, and
Respondent answered affirmatively. Tr. 40
\11\ This agreement, as well as the first agreement, included a
provision to which Respondent agreed stating, ``I will not seek
employment or work in pain medicine, addiction medicine, or any
medication assisted treatment (MAT) center for a minimum of the
first 2 (two) years under the [ ] contract.'' RX 16, at 6; RX 12, at
6.
\12\ Respondent testified that when his five years expired with
the Tennessee Medical Foundation, he would enter a new contract and
that he and the foundation ``both agreed that [he] need[s] to be on
a lifetime contract.'' Tr. 129. Although the Chief ALJ had noted
that Respondent's agreement was expiring shortly, RD, at 36, I find
that the record supports that even if certain restrictions, such as
the practice monitoring were lifted, Respondent would likely
continue to have some sort of accountability monitored through the
Tennessee Medical Foundation for the duration of his medical
license. The language in his conditional license was clear that this
would be a requirement for ``the duration of time that [he is]
licensed in Tennessee.'' RX 17, at 1. Therefore, I find that the
record support that Respondent will maintain the Tennessee Medical
Foundation's advocacy for the duration of his practice of medicine.
I also have found below that even with the full accountability
measures in place, Respondent has not demonstrated that he can be
entrusted with a controlled substances registration. See supra IV.
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[[Page 33742]]
Respondent also submitted a letter from the Tennessee Medical
Foundation, which was written at the request of his malpractice
insurance that states that Respondent is ``in compliance with all of
the requirements of his monitoring contract.'' RX 15, at 1; Tr. 97-101.
The purpose of Respondent's controlled substances registration,
Respondent testified, would be to work in addiction medicine at
Recovery Associates, and also to open up a practice with his wife,
based on direct primary care ``where patients pay a certain fee a month
to get unlimited access to the physician,'' because Respondent is
excluded from federal health care programs. Tr. 103-05.
Respondent testified that his supervisor at Recovery Associates Dr.
H.\13\ ``has a terminal illness and that's why he's not able to be here
today. And he's been very supportive and encouraging for me.'' Id. at
47. Respondent stated that Dr. H. was scheduled to testify, but he has
``end stage myeloma, and he is bedridden at the moment.'' Id. at 138.
When asked on cross examination how Dr. H. is ``effectively
monitoring'' his practice if he is ill, Respondent stated that ``he has
been monitoring me up to this point, but there's other doctors there
that are also involved'' and that Dr. H. was onsite ``about a week and
a half ago.'' Id. at 140. Respondent responded affirmatively to the
follow up of whether the Tennessee Medical Board knows that Dr. H. is
too ill to be on site monitoring his practice. Id. Then he said,
``Well, let me--let me rephrase that. I don't--I haven't said anything
to the Tennessee Medical Board, and at this point I don't practice.''
Id. at 141. Respondent admitted that he is required to have a practice
monitor by the medical board and Dr. H. is that practice monitor.\14\
Id. He then shifted his position and stated that when Dr. H. is not
there, ``then what I do--I occasionally see patients individually, and
then I give the patient charts to the doctor, but then they see the
patient themselves individually.'' Id. at 142. The Chief ALJ asked
whether Dr. H. was ``not there 50 percent of the time now, and he's not
going to be there 50 percent of the time if he has end stage multiple
myeloma, right?'' Id. at 145. Respondent answered, ``He has been--he's
been around for a while. He's had--he's had it for 10 years, 11 years.
He's just not there to--right now.'' Id.
---------------------------------------------------------------------------
\13\ Respondent also testified that his conditional medical
license ``means that I can only practice for a certain physician
[Dr. H].'' Tr. 121.
\14\ Respondent's conditional medical license required reporting
from his practice monitor every month for six months, which started
on the effective date of November 14, 2018; therefore, six months
had likely passed before Dr. H. became bedridden before this hearing
on July 30, 2019; however, the letter from the Board states that
Respondent must ``petition for an Order of Compliance to have the
monitoring requirements lifted.'' RX 17, at 1. Respondent testified
that he was going to ask for the conditions on his license to be
removed, ``as soon as [he] can get the paperwork in'' and
``imminently.'' Tr. 133. Therefore, although the period of six
months had elapsed, the conditions on his medical license leave open
the question of whether Respondent might have been required to have
a practice monitor at the time that Dr. H. became ill. This raises a
concern, because Respondent testified that he had not notified the
Board or the Tennessee Medical Foundation about Dr. H.'s inability
to monitor him. Id. at 141. Ultimately, as explained below,
Respondent's other egregious behavior is more compelling in deciding
a sanction in this case, but both Respondent's change in answers
regarding this topic and his lack of communication with the Board or
the Tennessee Medical Foundation certainly raise concerns about my
ability to trust him.
---------------------------------------------------------------------------
Regarding Respondent's plans for his controlled substances
registration, Respondent stated that his ``training is internal
medicine, so what [he'd] be doing . . . [he'd] be treating adults for
medical issues, anything from diabetes, to COPD, to congestive heart
failure to hypertension.'' Id. at 48. When asked how he plans to work
with drug addicts, he stated that he ``feel[s] confident that [he has]
a strong support system in place.'' Tr. 128-29.
Respondent testified that he accepts responsibility and is
remorseful for both the felony and the exclusion. Tr. 134-35. When
asked why he believes he can be a responsible DEA registrant,
Respondent answered, ``I think that the same--it's the same reasons I
can be--I'm responsible with the--with the things that I've been given
so far. The last thing I want to do--I--I'm not the same person I was.
I've been rehabilitated. The last thing I want to do is hurt someone.''
Id. at 136. When asked whether ``working with patients who are being
treated for substance abuse puts [him] at increased risk for relapse
[him]self,'' he admitted that ``[t]here are times it can be a trigger,
yes.'' Id. at 137. He testified, ``I work in an environment--I make
sure I work in an environment that's recovery-oriented, that most \15\
of the people there are in active recovery, so they not only--I'm not
only accountable to my support system outside of work, I'm accountable
at work.'' Id.
---------------------------------------------------------------------------
\15\ Respondent noted that 100 percent of the patients are being
treated with buprenorphine and that the typical course of treatment
time is ``at least two years'' and that when someone gets off
buprenorphine, ``[t]hey usually just don't show back up.'' Tr. 125-
26. Later, he stated, ``They don't come back, so they're discharged,
but we don't know why they're not coming back, oftentimes.'' Id.
---------------------------------------------------------------------------
The Chief ALJ asked Respondent about his previous rehabilitation
efforts and Respondent admitted that ``second year of medical school,
[he] began experimenting with crack, and it took [him] down very fast,
very quickly.'' Id. at 149. When asked by the Chief ALJ, he admitted
that at the time, he had started the clinical portion and was ``in and
out of a support role in patient care,'' while he was experimenting
with crack. Id. at 149-50. Respondent admitted that he was ``directed
to rehab by the faculty at Duke'' after he ``went to the emergency
room'' and he had to go to inpatient rehab for 30 days and then was
sober for five years. Id. at 151. Respondent testified
I was being monitored by the medical school and the residency
program, so as soon as that monitoring was lifted--but all along, I
had it in the back of my head that I could drink. I still thought I
could drink. I knew I couldn't do drugs, but I thought I could drink
successfully. But I couldn't drink while I was being monitored, so
as soon as the five years was up and I no longer had any
supervision, I had it in my head I was going to drink, and I did.''
Id. at 152.
He then stated that he had to leave Takoma Hospital because of a
``culmination of events related to [his] drinking,'' including ``not
showing up for work, being erratic, outbursts'' and he was sent to the
Tennessee Medical Foundation for an evaluation, during which he ``lied,
and Tennessee Medical Foundation recommended some inpatient programs or
some retreats for [his] depression and trauma issues, but [he] never
followed through.'' Id. at 154. He stated that he was asked to leave
Takoma because of the refusal to complete rehabilitation and
``inappropriate behavior'' and he sometimes showed up to work in an
``incapacitated status.'' Id. at 155. But then he retracted and
clarified that he was not under the influence at Takoma and that it was
really the inappropriate behavior in texting a colleague that
[[Page 33743]]
precipitated his departure from Takoma. Id. at 156.
Respondent admitted that during the time leading up to his arrest,
he was not showing up to work, and that as a result, ``there were other
people making decisions about controlled substances who weren't
qualified to do that'' and doing so was ``extremely'' dangerous and
``[he] put them at risk, as well as the patient.'' Id. at 160. He said
that he believed that he was successful at Talbott's rehabilitation
program because he ``was in jail long enough'' and ``because [he] had
the right mindset by that point.'' Id. at 164.
Regarding Respondent's credibility, the Chief ALJ found that:
As the witness with the most at stake at the hearing, the
Respondent is certainly imbued with the largest motive to embellish
and fabricate. Additionally, it cannot escape notice that the
Respondent has a lengthy history of convincing responsible,
experienced professionals of his sincerity. He has convinced medical
school administrators, rehabilitation professionals, physicians, a
judge and family members that he has periodically been
rehabilitated.
RD, at 18. The Chief ALJ further noted ``internal inconsistencies in
the Respondent's testimony. . . .'' For example, he found that
Respondent testified at first that his TMF monitor was unavailable to
testify because he was bedridden, and when asked whether he had
notified the TMF that his monitor was unable to monitor him, Respondent
stated that he had not, ``then said (contrary to prior testimony) that
monitoring was unnecessary because he was not practicing.'' Id. The
Chief ALJ also noted that Respondent admitted to lying to Takoma
Hospital and TMF, id. (citing Tr. 154), and lying so that a District
Court Judge would send him to a different rehabilitation facility, id.
The Chief ALJ concluded that ``there were biographical elements and
other areas where the Respondent's testimony could be credited.
However, where the Respondent's testimony conflicts with objective,
established facts of record, other evidence and testimony in the
record, and common sense, that testimony must be viewed with robust
skepticism.'' Id. at 18-19. I agree with the Chief ALJ, and although I
appreciate Respondent's honesty about his previous incidents of lying
to a Judge to get what he wanted, it makes it very difficult for me to
be able to trust that he is not being honest now as an angle to
manipulate my decision. See RD, at 18. I also find that there were
additional moments of inconsistency, such as when he discussed the
reasons for his dismissal from Takoma--at first he stated that he had
erratic behavior, such as outbursts and not showing up to work, Tr.
154, but then he insisted that he was never impaired at Takoma and that
he was really dismissed because of his inappropriate texting, id. at
156. I find it unlikely given the ``erratic'' behavior and tardiness
that he was never impaired at work.
Respondent's wife, S.L., testified on his behalf. Tr. 170-190. She
testified that she has known Respondent since middle school. Tr. 170-
71. S.L. testified that she is an addiction counselor and that she and
Respondent were divorced in 2008 and remarried in 2018. Id. S.L.
believes Respondent that he has not used drugs or alcohol in the last
six years, because she has ``been there, and also because there's a lot
of things in place to ensure that he doesn't.'' Id. at 172-73. When
asked why she trusts Respondent, she said, ``I didn't start out, you
know, trusting him, you know, when he first came out of recovery. But
you know, over the years, I've definitely come to trust him. I wouldn't
have remarried him if I--if I didn't.'' Id. at 173. She testified about
his previous rehabilitation efforts in medical school and stated, that
``I think it was a situation where he came out and he did really well
when he had some--you know, he was going to meetings. He was doing
everything that he needed to do. From that standpoint--stayed sober. I
can't remember how many years.'' Id. at 184. But then she stated,
``When he stopped going to meetings, when he stopped doing the things
that were the basis of recovery, I was a little wary, you know.'' Id.
However, she followed, ``[a]nd that's why I'm hoping like this time,
for me--you know, there's a lot of things that are put in place that--
to hold him accountable, and that's been good for me in knowing--you
know, it's not on me to keep an eye and try to predict, you know, our
behavior, because we can't. We can't.'' Id. When the Chief ALJ asked
her if the difference is that there are safeguards in place now, she
agreed, but also added that ``his general well-being is better. His
mental health is better.'' Id. at 186.
The Chief ALJ found, and I agree, that ``[n]otwithstanding the
obvious reality that [S.L.] has a vested interest in the issuance of a
COR to her husband so that they can bring their joint practice plans to
fruition, she presented as a generally candid witness whose testimony
bore sufficient detail, internal consistency, and plausibility to be
afforded credibility in these proceedings.'' RD, at 20.
Respondent next presented the testimony of Dr. G., who is an
``addiction medicine specialist'' \16\ and who has known Respondent
``nine years, probably since 2010.'' Tr. 191-211. Dr. G. testified that
he knew Respondent before and after his recovery, and that before, they
were ``colleagues in the sense that [Respondent] saw some patients that
had some substance use disorders, and it's a small-knit group of people
in recovery. . . .'' Id. at 192. Dr. G. testified that he took over the
care of some of Respondent's patients during his addiction. Id. at 193.
Now, Dr. G. sees Respondent ``once a week, every week, for the past six
years'' as part of a recovery meeting for medical professionals, where
they are peers. Id. at 194. Dr. G. testified that Respondent has never
been impaired at one of those meetings. Id. at 201, 206. Dr. G. also
described that impression of the difference between Respondent now and
his previous acquaintance with Respondent in 2012 as ``day and night.''
Id. at 206. He further testified that Respondent has been doing all of
the things that are important for recovery. Id. at 206-07. He further
stated that ``[t]he wonderful thing about [the Tennessee Medical
foundation contract] is I know [Respondent] every day has to pick up a
phone, and he's got to punch in a number and he's got to see if he's
being drug screened, seven days a week.'' Id. at 208. He further
stated, ``It made me think about that when you said would I be able to
tell if [Respondent] was doing something. Well, there's not only me,
there is the Tennessee Medical Foundation that has advocated for
[Respondent], that--he is under their monitoring.'' Id. Dr. G. also
testified that he feels Respondent has been rehabilitated and when
asked if he would trust his judgment in taking care of patients, he
said, ``Absolutely.'' Id. at 210.
---------------------------------------------------------------------------
\16\ Respondent's attorney moved to qualify Dr. G. as an expert
witness, but the Chief ALJ found, and I agree, that there had not
been adequate notice that Respondent would call upon Dr. G. as an
expert. Tr. 202-04.
---------------------------------------------------------------------------
The Chief ALJ found, and I agree, that some of Dr. G.'s testimony
was ``likely more broad and optimistic than his objective bases for
those positions would justify. . . . [it] was sufficiently detailed,
plausible, and internally consistent to be deemed credible in these
proceedings.'' RD, at 24.
The next witness to testify on behalf of Respondent was M.C., who
is a licensed clinical social worker and a peer \17\ colleague of
Respondent for
[[Page 33744]]
about six years and sees him ``anywhere from two to four times a week
in person'' at work. Tr. 212-13. M.C. testified that he would be able
to tell if Respondent ever had come into work impaired, because he is
``a recovering drug addict [himself], so [he] know[s] what it looks
like, what it smells like, what it tastes like, what it acts like,''
and he has never seen Respondent impaired. Id. at 214-15. M.C.
described Respondent as ``transparent,'' because as he stated, ``in
recovery, if a person's going to get clean, stay clean, they have to
get honest.'' Id. at 215. He further stated that he would trust his
clinical judgment, although he has never observed him with patients,
because he is ``behind closed doors.'' Id. at 225-26. The Chief ALJ
found, and I agree, that ``[w]hile the depth of his knowledge of the
Respondent's suitability to discharge the duties of a DEA registrant is
extremely limited, M.C. presented testimony that was sufficiently
cogent, detailed, plausible, and internally consistent to be considered
generally credible.'' RD, at 25.
---------------------------------------------------------------------------
\17\ Respondent testified initially that M.C. is charged with
monitoring him as he is ``the head counselor at the program, which
is part of [Respondent's] job role.'' Tr. 145. However, later he
clarified that the ``person who does the direct monitoring is Dr.
H.'' Id. at 146. It was clear from M.C.'s testimony that he does not
monitor Respondent's patient care or ``supervise [him] in any way.''
Id. at 226.
---------------------------------------------------------------------------
Another of Respondent's co-workers, W.J., who is a certified peer
specialist and has known Respondent for three and a half years
testified on his behalf. Tr. 228-30. He testified that Respondent
became his first sponsor, but they became such close friends that he is
no longer his sponsor. Id. at 233. He said he has never seen Respondent
impaired and that he trusts Respondent ``with [his] life.'' Id. at 230,
233. The Chief ALJ found, and I agree, that although Respondent's
assistance to W.J. is ``undoubtedly commendable,'' ``there was very
little presented through [W.J.] that can be objectively considered as
helpful in determining whether the Agency can have confidence that
Respondent can/will discharge his duties as a DEA registrant.'' RD, at
26.
Respondent's son, C.L., also testified on his father's behalf. He
stated that he is studying experimental biological psychology to
conduct ``addiction and pharmacological research.'' Tr. 237. He
testified that he was interested in the subject because of his parents'
work and ``the things that we've experienced as a family . . .'' Id. at
238. When asked about his relationship with his father, he stated,
``Today, it's fantastic.'' He further stated that he believes his
father is sober, because ``he was just an entirely different person,
but you know, it's--hasn't been anything like that in a very long time.
. . .'' Id. at 239. He also testified that he and his father had built
trust and that he trusted his father now, but there was a time when he
did not, ``because there was no--there was no sort of stability.'' Id.
at 243.
Respondent's oldest son, R.L., also testified on his father's
behalf. Id. at 244-55. He testified that he is a youth minister in
North Carolina and working on a master's degree in cultural studies.
Id. at 247. When asked if he trusts his father, he stated, ``I trust
that he is--he is moving in--you know, moving in the right direction,
and so it's just been, you know exciting and just encouraging for me to
see, so yeah. Yes, I do, I trust him.'' Id. at 248-49. He testified
that he has seen his father mature, and control his anger. Id. at 249-
50. When asked if he believes his father has been sober for six years,
he said, ``I've never seen any evidence of it, never heard any--of
anything from my parents, or sisters, or anybody, and continuing to see
him grow, so yeah, I believe him.'' Id. at 250.
With respect to both of Respondent's sons, the Chief ALJ found, and
I agree, that C.L. and R.L. presented as ``loving'' sons, ``seeking to
support [their] father and family.'' RD, at 21. He found that their
testimony was ``internally consistent, plausible, and based on the
questions [they were] asked, adequately detailed.'' However, he
ultimately found, and I agree, that ``there was very little practical
value added'' by these witnesses as ``to a determination of whether the
issuance of a [registration] would be in the public interest.'' Id. at
21-22.
Respondent also presented the testimony of the Reverend at his
church, where Respondent teaches Sunday school and has ``a significant
role.'' Tr. 258. He testified that he has known Respondent for about
three years and that he trusts Respondent and described him as
reliable--``if he says something, he's going to do that.'' Id. at 260.
The Chief ALJ concluded, and I agree, that in part due to the
limitations on the time and context that the Reverend has known the
Respondent, the Reverend ``presented as a responsible dedicated pastor
whose testimony however believable, added only minimally to an
objective determination of whether the Respondent should be entrusted
with a DEA COR.'' RD, at 27.
III. Discussion
In this matter, as already discussed, the OSC calls for my
adjudication of the application for registration based on the charge
that Respondent has been convicted of a felony related to controlled
substances and that he was excluded from participation in a program
pursuant to section 1320a-7(a) of Title 42. OSC, at 1-4; supra sections
II.A and II.D. Both of these are bases for revocation or suspension or
a controlled substances registration under 21 U.S.C. 824(a)(2) &
(a)(5). The OSC does not allege that granting Respondent's application
would be inconsistent with the public interest based on consideration
of the factors in 21 U.S.C. 823(f)(1) through (5) (hereinafter, the
public interest factors). The Government raised the public interest
factors in its Posthearing Brief; however, the Chief ALJ found that
they were ``unavailable as a basis for sanction in these proceedings,''
due to the late stage in which they were raised. See RD, at 28 n.65.
Accordingly, the OSC's specific substantive bases for proposing the
denial of Registrant's registration application are his felony
conviction and his mandatory exclusion under 21 U.S.C. 824(a)(2) &
(a)(5). OSC, at 1-4.
Prior Agency decisions have addressed whether it is appropriate to
consider a provision of 21 U.S.C. 824(a) when determining whether or
not to grant a practitioner registration application. For over forty-
five years, Agency decisions have concluded that it is.
In John R. Amato, M.D., 40 FR 22852 (1975), the Agency issued an
Order to Show Cause regarding Dr. Amato's application on November 6,
1974. Id. The Order to Show Cause referenced a medical license
revocation issued by the New Jersey Board of Medical Examiners. Id. The
Agency's analysis began by citing, and agreeing with, Administrative
Law Judge Parker's conclusion, ``as a matter of law,'' that the state
dispensing authority requirement of section 823(f) ``must logically
give the Administrator the authority to deny a registration if the
practitioner is not authorized by the State to dispense controlled
substances.'' \18\ Id. The Administrator agreed, stating ``[t]o hold
otherwise would mean that all applications would have to be granted
only to be revoked the next day under 21 U.S.C. 824(a)(3).'' Id. The
Administrator also stated that ``[t]his agency has consistently held
that where a registration can be revoked under section 824, it can, a
fortiori, be denied under section 823.'' Id. The Administrator stated
that he accepted Judge Parker's recommendation that the application be
denied because Dr. Amato lacked authority in New Jersey
[[Page 33745]]
``to administer, dispense or prescribe controlled substances.'' Id.
---------------------------------------------------------------------------
\18\ Section 303(f) states that the Attorney General shall
register practitioners if they have authority to ``dispense . . .
controlled substances under the laws of the State in which . . .
[they] practice[ ].'' 21 U.S.C. 823(f).
---------------------------------------------------------------------------
Other Agency decisions from the 1970s and 1980s similarly concluded
that a provision of section 824 may be the basis for the denial of a
practitioner registration application. See, e.g., Arthur R. Black,
D.O., 49 FR 33183, 33183 (1984) (denying practitioner registration
application for ``two lawful grounds'': A federal felony conviction and
material falsification of the application); Brady Kortland Fleming,
D.O., 46 FR 45841, 45842 (1981) (denying practitioner registration
application due to past controlled substance-related federal felony
conviction); Thomas W. Moore, Jr., M.D., 45 FR 40743, 40743-44 (1980)
(denying practitioner registration application due to past controlled
substance-related federal felony convictions); Raphael C. Ciliento,
M.D., 44 FR 30466, 30466 (1979) (denying practitioner registration
application due to past controlled substance-related state felony
conviction and applicant's decision not to attend the hearing he
requested and show why denial is not appropriate).
I agree with the results of all of these Agency decisions.
An Agency decision from the 1990s, when the practitioner portions
of sections 823 and 824 looked more like they do today than when the
Agency decided the above-cited decision, likewise concluded that a
practitioner registration application may be denied based on a
provision of section 824. Dinorah Drug Store, Inc., 61 FR 15972 (1996).
Dinorah is the adjudication of a practitioner registration application
by a retail pharmacy. Id. at 15972. The Order to Show Cause referenced
21 U.S.C. 823(f) as well as 21 U.S.C. 824(a)(5) (mandatory exclusion
from federal health care programs). Id.
The parties disagreed on whether a provision of section 824 could
be the basis for the denial of a pharmacy's registration application.
Id. at 15973. The Government's position was that section 824(a)(5) ``is
to be construed as not only grounds for the suspension or revocation of
a DEA registration, but also as a basis for the denial of an
application for a DEA registration.'' Id. The pharmacy's position was
that section 824(a)(5) is ``limited to the revocation or suspension of
already existing registrations.'' Id.
According to the Agency's decision in Dinorah:
To reject 21 U.S.C. 824(a)(5) as a basis for the denial of DEA
registration makes little sense. The result would be to grant the
application for registration, only to possibly turn around and
propose to revoke or suspend that registration based on registrant's
exclusion from a Medicare program. A statutory construction which
would impute a useless act to Congress will be viewed as unsound and
rejected. South Corp. v. United States, 690 F.2d [1369], 1374 (Fed.
Cir. 1982).
Id. In other words, the basis for the decision's conclusion is
statutory construction as articulated by the Federal Circuit. Id. The
decision thus concluded that ``21 U.S.C. 824(a)(5) may serve as a basis
for the denial of a DEA registration.'' Id.
Dinorah is also instructive for its analysis of the application and
its conclusion to grant the application despite the mandatory
exclusion. Id. at 15973-74. The decision, citing the ALJ, agreed that
``[s]ince denial of registration under Section 824(a)(5) is
discretionary, the factors listed in Section 823(f) may be considered
in determining whether the granting of [the] Respondent's application
is inconsistent with the public interest.'' Id. at 15973. The decision
analyzed each of the public interest factors, finding each of them
relevant. Id. at 15973-74; 21 U.S.C. 823(f). The Deputy Administrator's
analysis of the public interest factors was favorable to the pharmacy,
while he explicitly stated that he did not ``condone'' the fraudulent
activity in which the pharmacy and its owner had engaged. 61 FR at
15974. Accordingly, the Deputy Administrator approved the pharmacy's
registration application. Id. I agree with my predecessor's conclusion
that a provision of section 824 may be the basis for the denial of a
practitioner registration application and that allegations related to
section 823 remain relevant to the adjudication of a practitioner
registration application when a provision of section 824 is involved.
Accordingly, when considering an application for a registration, I
will consider any allegations related to the grounds for denial of an
application under 823 and will also consider any allegations that the
applicant meets one of the five grounds for revocation or suspension of
a registration under section 824. See id. at 15973-74.
i. 21 U.S.C. 823(f): The Five Public Interest Factors
Pursuant to section 303(f) of the CSA, ``[t]he Attorney General
shall register practitioners . . . to dispense . . . controlled
substances . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Section 303(f) further provides that an
application for a practitioner's registration may be denied upon a
determination that ``the issuance of such registration . . . would be
inconsistent with the public interest.'' Id. In making the public
interest determination, the CSA requires consideration of the following
factors:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety. 21 U.S.C. 823(f).
In this case, it is undisputed that Respondent holds a valid state
medical license and is authorized to dispense controlled substances in
the State of Tennessee where he practices. RX 17, 18. The Government
did not allege that Respondent's registration would be inconsistent
with the public interest pursuant to section 823 in the OSC and did not
advance any arguments or present any evidence under the public interest
factors in its case at hearing. See OSC; Govt Prehearing. Instead, the
Government based its initial case in section 824 alleging that
Respondent's conviction of a felony related to controlled substances
and his mandatory exclusion from federal health programs merit the
denial of his registration under 21 U.S.C. 824(a)(2) & (a)(5). See OSC;
Govt Prehearing. Because the Government has not alleged that
Respondent's registration is inconsistent with the public interest
under section 823, I will not deny Respondent's application based on
section 823, and although I have considered 823, I will not analyze
Respondent's application under the public interest factors. Therefore,
in accordance with prior agency decisions, I will move to assess
whether the Government has proven by substantial evidence that one or
more grounds for revocation exist under 21 U.S.C. 824(a).
ii. 21 U.S.C. 824(a)(2) & (a)(5)
Each subsection of section 824(a) provides an independent ground to
impose a sanction on a registrant. Arnold E. Feldman, M.D., 82 FR
39614, 39617 (2017); see also Gilbert L. Franklin, D.D.S., 57 FR 3441
(1992) (``[M]andatory exclusion from participation in the Medicare
program constitutes an independent ground for revocation pursuant to 21
U.S.C. [Sec. ]
[[Page 33746]]
824(a)(5).''). Pursuant to 824(a)(2), the Attorney General is
authorized to suspend or revoke a registration ``upon a finding that
the registrant . . . has been convicted of a felony under this
subchapter or subchapter II of this chapter or any other law of the
United States . . . relating to any substance defined in this
subchapter as a controlled substance or a list I chemical.'' 21 U.S.C.
824(a)(2). The ground in 21 U.S.C. 824(a)(5) requires that the
registrant ``has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of Title
42.'' 42 U.S.C. 1320a-7(a) provides a list of four predicate offenses
for which exclusion from Medicare, Medicaid, and other federal health
care programs is mandatory and sets out mandatory timeframes for such
exclusion. Id.
Here, there is no dispute in the record that Respondent is
mandatorily excluded pursuant to Section 1320a-7(a) of Title 42 and,
therefore, that a ground for the revocation or suspension of
Registrant's registration exists. 21 U.S.C. 824(a)(5). There is also no
dispute in the record that Respondent has been convicted one count of
``Conspiracy to Distribute a Quantity of Cocaine Base,'' in violation
of 21 U.S.C. 841(b)(1)(C) & 846, which constitutes a felony conviction
``relating to'' controlled substances as those terms are defined in 21
U.S.C. 824(a)(2). William J. O'Brien, III, D.O., 82 FR 46527, 46529
(2017).
Where, as here, the Government has met its prima facie burden of
showing that two grounds for revocation exists, the burden shifts to
the Registrant to show why he can be entrusted with a registration. See
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019).
IV. Sanction
Where, as in the instant case, the Government has established
grounds to deny a registration, I will review any evidence and argument
the respondent submitted to determine whether or not the respondent has
presented ``sufficient mitigating evidence to assure the Administrator
that [he] can be trusted with the responsibility carried by such a
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)). `` `Moreover,
because ``past performance is the best predictor of future
performance,'' ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452
(7th Cir. 1995), [the Agency] has repeatedly held that where a
registrant has committed acts inconsistent with the public interest,
the registrant must accept responsibility for [the registrant's]
actions and demonstrate that [registrant] will not engage in future
misconduct.' '' Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting
Medicine Shoppe, 73 FR 364, 387 (2008)); see also Samuel S. Jackson,
D.D.S., 72 FR at 23853; John H. Kennnedy, M.D., 71 FR 35705, 35709
(2006); Prince George Daniels, D.D.S., 60 FR 62884, 62887 (1995). The
issue of trust is necessarily a fact-dependent determination based on
the circumstances presented by the individual respondent; therefore,
the Agency looks at factors, such as the acceptance of responsibility
and the credibility of that acceptance as it relates to the probability
of repeat violations or behavior and the nature of the misconduct that
forms the basis for sanction, while also considering the Agency's
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 (2016).
In evaluating the degree required of a respondent's acceptance of
responsibility to entrust him with a registration, in Mohammed Asgar,
M.D., the Agency looked for ``unequivocal acceptance of responsibility
when a respondent has committed knowing or intentional misconduct.'' 83
FR 29569, 29572 (2018) (citing Lon F. Alexander, M.D., 82 FR 49704,
49728). Here, Respondent pled guilty to one count of ``Conspiracy to
Distribute a Quantity of Cocaine Base,'' in violation of 21 U.S.C.
841(b)(1)(C) & 846, and one count of ``Conspiracy to Defraud a Health
Care Benefit Program,'' in violation of 18 U.S.C. 1347 & 1349. U.S. v.
Robert Wayne Locklear, No. 2:14-CR-38 (E.D. Tenn. Oct. 8, 2014)). I
will, therefore, look for a clear acceptance of responsibility from
Respondent.
Respondent took concrete actions to accept responsibility for his
misconduct while his criminal case was ongoing. He did so by pleading
guilty to the charges in Federal Court. Respondent testified that he
pled guilty in federal court ``because he was guilty'' and that he was
``[v]ery. Very sorry.'' Tr. at 34. However, after his arrest, he was
given the option of entering an inpatient rehabilitation program in
lieu of incarceration, and after only six days, he escaped, because he
``wanted to use drugs.'' Id. at 67-68. By his own admission, it was not
until he had been ``in jail long enough,'' that he was fully ready to
accept rehabilitation. Id. at 167. It is difficult to credit
Respondent's guilty pleas as full acceptance of responsibility given
his behavior after his arrest.
Regarding Respondent's acceptance of responsibility for the health
care benefit fraud, the Chief ALJ found, and I agree that:
During his testimony, the Respondent complacently agreed that
allowing unqualified administrative staff personnel to hand out
controlled substance prescriptions while he was absent from his
office due to his drug and alcohol abuse was ``[e]xtremely
dangerous.'' Tr. 160. He even allowed that he ``put [his staff] at
risk, as well as the patient,'' but his demeanor conveyed no
indication that he regretted his actions or even recognized the
monetary and safety ramifications of those actions. The message his
nonchalant testimonial demeanor conveyed was that it happened, he
got caught, and his actions merited no further reflection.
RD, at 32. I defer to the Chief ALJ's assessment of Respondent's
demeanor. Because the Administrative Law Judge has had the opportunity
to observe the demeanor and conduct of hearing witnesses, the factual
findings regarding demeanor set forth in his recommended decision are
entitled to significant deference. Universal Camera Corp. v. NLRB, 340
U.S. 474, 496 (1951); Jeffery J. Becker, D.D.S., and Jeffery J. Becker,
D.D.S., Affordable Care, 77 FR 72387, 72403 (2012). I find the Chief
ALJ's characterization of Respondent's reaction in making these
statements to be important in this case, particularly because the
illegal conduct involved the prescribing of controlled substances--the
very responsibility with which Respondent now seeks to be entrusted.
Furthermore, the magnitude of the offense is staggering--the plea
agreement included 150 dates of service where a prescription was issued
and Respondent was not present to examine the patient. GX 3, at 13. The
offense therefore, warranted much more attention and focus from
Respondent in accepting responsibility. This crime did not just affect
federal health care programs, but also the patients, who were not
receiving adequate medical care, and Respondent's staff, who as
Respondent noted, he put at risk for malpractice and even potential
criminal liability. The plea agreement also noted that ``[o]n numerous
occasions, drug screens came back positive for the presence of other
scheduled drugs such as marijuana or heroin, but the patients continued
to have their Suboxone prescriptions called in anyway.'' GX 3, at 9.
Additionally, Respondent admitted that he saw patients after smoking
crack cocaine. Id. at 5. This behavior is directly related to his
controlled substance registration--and I find that the magnitude of the
harm that he caused and could have caused merited more than a
``nonchalant'' admission.\19\
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\19\ There is no mention at all of the conduct related to
prescribing in the affidavit Respondent submitted, see RX 7, and he
submitted no testimony on his own about this specific matter. The
Chief ALJ had to ask him about the controlled substances
prescriptions in the plea agreement. Tr. 160.
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[[Page 33747]]
Regarding Respondent's acceptance of responsibility for his felony
conviction for Conspiracy to Distribute a Quantity of Cocaine Base, he
testified that he accepts responsibility and is remorseful. Tr. 134-35.
Although he made these overall statements, in the affidavit he
submitted, he stated that he ``admitted on the day [he] was arrested by
the Drug Task Force that, although [he] never sold any illegal
substances, [he] shared some crack cocaine with others that same day.''
RX 7. Respondent seems to assume that the act of sharing somehow would
improve my view of his actions, when in truth the fact that he
distributed an illegal substance to others is serious misconduct in
considering whether he can be entrusted with a controlled substance
registration, irrespective of whether he did so as a gift or for
payment. In sharing crack cocaine, he endangered the lives of these
individuals and brought them further into the same spiral of addiction
in which he was swirling. This statement, which qualifies what he did
not do, appears to be aimed at minimizing the egregiousness of his
conduct, which the Agency has previously weighed against a finding of
acceptance of full responsibility. See Ronald Lynch, M.D., 75 FR 78745,
78754 (2010) (Respondent did not accept responsibility noting that he
``repeatedly attempted to minimize his [egregious] misconduct''; see
also Michael White, M.D., 79 FR 62957, 62967 (2014) (finding that
Respondent's ``acceptance of responsibility was tenuous at best'' and
that he ``minimized the severity of his misconduct by suggesting that
he thinks the requirements for prescribing Phentermine are too
strict.'').
As to his demeanor in his acceptance of responsibility for the
felony charge, the Chief ALJ remarked that Respondent ``cooly related''
the events leading up to his arrest. RD, at 33. He further stated that:
If the Respondent understands that doling out crack cocaine in a
hotel room, particularly when committed by one who had been
entrusted with a DEA registration, was reprehensible, that
understanding was reflected in neither his language nor his tone
during the hearing. In his testimony, he described his actions with
no more emotion than if he were recounting an uneventful shopping
trip to a local mall.
RD, at 34.
I also find it of significance in evaluating Respondent's
acceptance of responsibility that he did not seem to be aware of the
full extent of the harm that he caused. For example, when the Chief ALJ
asked him what happened to his bail when he escaped from Bradford,
Respondent testified that it was ``lost,'' and he could not remember
how much it was, but his ``wife could probably tell you for sure.'' Tr.
70-71; supra n.8. And, again, when asked about whether he posted bail
after Talbott, he answered that it was ``fuzzy,'' and ``I think there
might have been.'' Id. at 78. The fact that he did not fully understand
the financial impact on his family and left the responsibility of that
knowledge to his wife, does not demonstrate full acceptance of
responsibility for his misconduct.
Further, the Chief ALJ noted, and I agree, that Respondent ``was
repeatedly successful in convincing persons in authority to afford him
the benefit of rehabilitation.'' Id. at 35; see Tr. 152-53 (Duke
Medical School); Tr. 153-59 (Takoma Medical Center); Tr. 162 (District
Court Judge who sent him to Bradford); Tr. 168-69 (District Court Judge
sent him to Talbott after he escaped from Bradford); Tr. 78-79
(released after Talbott). Like the Chief ALJ, I find Respondent's
admission that he described his statements to a District Court Judge
that he could not go back to Bradford Rehabilitation as ``an angle to
go somewhere else,'' id. at 73, to be of particular concern, see RD, at
36. Although I credit his retrospective honesty, in deciding whether I
can trust him, I cannot ignore the fact that he has successfully angled
to obtain trust repeatedly, and repeatedly abused that trust.
The Agency has decided that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Garrett Howard Smith, M.D., 83 FR at 18910 (collecting
cases). The Agency has also considered the need to deter similar acts
by a respondent and by the community of registrants. Id. In this case,
there is no doubt that the Respondent's felonies and past behavior are
egregious. His acts related to his controlled substances registration--
instructing unqualified staff to issue controlled substances
prescriptions on his behalf and without properly considering contrary
urine drug screens, I find to be particularly egregious. Further, as
the Chief ALJ stated, ``intentionally and volitionally distributing
crack cocaine is a grave departure from even the most minimal standard
of responsibility to guard against diversion that is expected of a DEA
registrant. It is not that he just came up short in preventing drug
diversion, he intentionally diverted crack cocaine.'' RD, at 39.
As the Chief ALJ noted, although the Agency has permitted
registrants to maintain or obtain registrations based on demonstrated
unequivocal acceptance of responsibility and ``concrete, sincere
efforts at rehabilitation,'' many of these cases involved no harm to
anyone beyond the respondent and no grounds for revocation under
Section 824; whereas, in this case, the ``record reflects the
distribution of crack to others, the placement of his patients in
extreme danger, professional (even criminal) exposure inflicted on his
office staff, and monetary damages to various health care providers who
submitted reimbursement claims.'' RD, at 38 (citing Ronald F. Lambert,
D.D.S., 78 FR 62662, 62664 (2013); Kimberly Maloney, N.P., 76 FR 60922,
60927-28 (2011); John J. Cienki, M.D. 63 FR 52293, 52296 (1998)
(parentheticals omitted)).
Generally, I find Respondent's recovery to be commendable given his
lengthy and difficult battle with addiction. Respondent cited the
support of his friends and family numerous times as being essential to
his recovery. Tr. 128-29, 136, 137. Although the testimony of his
network of family and friends who support him is important to
understanding their opinions about the status of his recovery, I find
that overall, their opinions are not the best evidence for me to use to
determine my ability to be entrust Respondent with a controlled
substances registration. See Raymond A. Carlson, 53 FR 7425 (1988)
(finding that none of the character ``witnesses was in a position to
make an adequate assessment of [r]espondent's ability to properly
handle controlled substances.''). Further, I find that the record
evidence of Respondent's egregious controlled substance dispensing-
related violations is relevant to my evaluation and outweighs all of
the record evidence from his family, friend, colleague, and minister
that he has been generally trustworthy and reliable since his recovery.
See George Pursley, M.D. 85 FR 80162, 80180 (2020).
In addition to acceptance of responsibility, the Agency also gives
consideration to both specific and general deterrence when determining
an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810
(2015). Specific deterrence is the DEA's interest in ensuring that a
registrant complies with the laws and regulations governing controlled
substances in the future. Id. General deterrence concerns the DEA's
responsibility to deter conduct similar to the proven allegations
against the
[[Page 33748]]
respondent for the protection of the public at large. Id. In this case,
I agree with the Chief ALJ that ``the absence of a sanction where a DEA
registrant has been convicted of actually intentionally distributing
crack cocaine would send a powerful message to the regulated community
that even the most blatant intentional diversion will carry no
consequences.'' RD, at 40.
In Respondent's favor, Respondent has been held accountable for his
criminal behavior--having been sentenced to prison and temporarily
losing his medical license. He has met the requirements for
rehabilitation and for obtaining a conditional medical license.
However, based on the facts of this case, I find it difficult to find
that this accountability will have a deterrent effect on the potential
for Respondent's relapse, because he has faced serious consequences
many times in his life--losing his wife and family, getting expelled
from medical school, losing his job, getting arrested, going to jail,
etc.--and none of those things seemed to deter him from repeating his
behavior until now.
Although Respondent testified extensively about the accountability
to which he is held pursuant to his agreement with the Tennessee
Medical Foundation, and many of his character witnesses testified about
how much that accountability comforted them, I cannot find that
accountability necessarily to be a sufficient deterrent from abuse of
his controlled substances registration due to his history of repeatedly
ignoring accountability measures,\20\ even at the risk of
incarceration. Therefore, in spite of his commendable sobriety thus
far, I have reason to doubt his claim that he would always be a
compliant registrant. See George R. Smith, M.D., 78 FR 44972, 44980
(2013). Particularly, I remain concerned that if he relapsed, which the
record has demonstrated previously occurred on several occasions, while
entrusted with a controlled substances registration, he could harm
himself and others too quickly for detection by this Agency or his
monitoring. Ensuring that a registrant is trustworthy to comply with
all relevant aspects of the CSA without constant oversight is crucial
to the Agency's ability to complete its mission of preventing diversion
within such a large regulated population. Jeffrey Stein, M.D., 84 FR at
46974.
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\20\ There is also evidence on the record that at the time of
the hearing that Respondent might not have been in compliance with
his monitoring requirements due to his monitor's illness and that he
did not inform the state board or the Tennessee Medical Foundation
of the lapse in monitoring. See supra n.14. I find that this lapse
is mitigated by its circumstances, but that it is further evidence
that Respondent has repeatedly demonstrated disregard for
accountability measures.
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As discussed above, to receive a registration when grounds for
denial exist, a respondent must convince the Administrator that his
acceptance of responsibility and remorse are sufficiently credible to
demonstrate that the misconduct will not reoccur and that he can be
entrusted with a registration. Having reviewed the record in its
entirety, I find that Respondent has not met this burden. Accordingly,
I will order the denial of Respondent's application for a certificate
of registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f), I hereby deny the pending application for a Certificate
of Registration, Control Number W18124612C, submitted by Robert Wayne
Locklear, M.D., as well as any other pending application of Robert
Wayne Locklear, M.D. for additional registration in Tennessee. This
Order is effective July 26, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-13525 Filed 6-24-21; 8:45 am]
BILLING CODE 4410-09-P