Salman Akbar, M.D.; Decision and Order

CourtDrug Enforcement Administration
Citation86 FR 52181
Published date20 September 2021
SectionNotices
Record Number2021-20247
52181
Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices
*A
I have made minor, nonsubstantive,
grammatical changes to the RD. Where I have made
substantive changes, omitted language for brevity or
relevance, or where I have added to or modified the
Chief ALJ’s opinion, I have noted the edits in
brackets, and I have included specific descriptions
of the modifications in brackets or in footnotes
marked with an asterisk and a letter.
Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
Overview of This Information
Collection
Type of Information Collection:
Revision of a currently approved
collection.
The Title of the Form/Collection:
Report of Multiple Sale or Other
Disposition of Pistols and Revolvers.
The agency form number, if any, and
the applicable component of the
Department sponsoring the collection:
Form number: ATF Form 3310.4.
Component: Bureau of Alcohol,
Tobacco, Firearms and Explosives, U.S.
Department of Justice.
Affected public who will be asked or
required to respond, as well as a brief
abstract:
Primary: Business or other for-profit.
Other: Federal Government and State,
Local, or Tribal Government.
Abstract: The Report of Multiple Sale
or Other Disposition of Pistols and
Revolvers—ATF Form 3310.4 is used to
report multiple sale or other disposition
of two or more pistols, revolvers, or any
combination of pistols or revolvers to an
unlicensed person, whether it occurs
one time or within five consecutive
business days.
An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: An estimated 82,011
respondents will complete this form
approximately 6.33365 times annually,
and it will take each respondent
approximately 15 minutes to complete
their responses.
An estimate of the total public burden
(in hours) associated with the
collection: The estimated annual public
burden associated with this collection is
129,857 hours, which is equal to 82,011
(# of respondents) * 6.33365 (# of
responses per respondent) * .25 (15
mins).
An Explanation of the Change in
Estimates: The increase in total
respondents, responses, and burden
hours, by 4,106, 63,495, and 15,873
hours respectively, is due to the revision
of agency estimates, and a general
increase in the number of respondents
since the last renewal in 2018.
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, Mail Stop
3E.405A, Washington, DC 20530.
Dated: September 14, 2021.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2021–20187 Filed 9–17–21; 8:45 am]
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20–15]
Salman Akbar, M.D.; Decision and
Order
On March 2, 2020, a former Acting
Administrator of the Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause and Immediate Suspension of
Registration (hereinafter, OSC) to
Salman Akbar, M.D. (hereinafter,
Respondent). Administrative Law Judge
Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at
1. The OSC informed Respondent of the
immediate suspension of his DEA
Certificate of Registration Number
BA5092856 (hereinafter, registration)
and proposed its revocation, the denial
of any pending applications for renewal
or modification of such registration, and
the denial of any pending applications
for additional DEA registrations
pursuant to 21 U.S.C. 824(a)(4) and
823(f), because Respondent’s
‘‘continued registration is inconsistent
with the public interest.’’ Id. (citing 21
U.S.C. 824(a)(4) and 823(f)).
In response to the OSC, Respondent
timely requested a hearing before an
Administrative Law Judge. ALJ Ex. 2.
The hearing in this matter was
conducted from July 21–22, 2020 at the
DEA Hearing Facility in Arlington,
Virginia, with the parties and their
witnesses participating through video-
teleconference. On August 20, 2020,
Chief Administrative Law Judge John J.
Mulrooney (hereinafter, Chief ALJ)
issued his Recommended Rulings,
Findings of Fact, Conclusions of Law
and Decision (hereinafter,
Recommended Decision or RD). On
September 9, 2020, the Government and
Respondent filed exceptions to the
Recommended Decision (hereinafter,
Gov Exceptions and Resp Exceptions,
respectively). Having reviewed the
entire record, I find the Respondent’s
Exceptions without merit and I adopt
the Chief ALJ’s rulings, findings of fact,
conclusions of law, and recommended
sanction with minor modifications,
where noted herein.
*A
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(f), I hereby
revoke DEA Certificate of Registration
No. BA5092856 issued to Salman Akbar,
M.D. Pursuant to 28 CFR 0.100(b) and
the authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(f), I further
hereby deny any pending application of
Salman Akbar, M.D. to renew or modify
this registration, as well as any other
pending application of Salman Akbar,
M.D. for registration in Virginia. This
Order is effective October 20, 2021.
Anne Milgram,
Administrator.
The Respondent’s Exceptions
In his Posthearing Brief, Respondent
acknowledged that the Government had
‘‘offered sufficient evidence to establish
a prima facie case,’’ but he argued that
his registration should not be revoked,
because he had ‘‘countered the
Government’s showing with substantial
mitigating evidence that demonstrates
his continued registration will not be
harmful to the public interest.’’ ALJ Ex.
20 (Resp Posthearing), at 1. The Chief
ALJ disagreed with Respondent, finding
that revocation was the appropriate
remedy, based on Respondent’s failure
to accept responsibility for his
misconduct and his failure to offer
sufficient remedial evidence. RD, at 33–
38. In determining that Respondent had
not adequately accepted responsibility,
the Chief ALJ relied in part on
Respondent’s statements that he always
issues prescriptions within the usual
course of professional practice and for a
legitimate medical purpose. See, e.g., id.
at 35 (citing Tr. 427–29).
Respondent takes Exception to the
Chief ALJ’s reliance on these statements.
Respondent argues that these statements
do not negate his acceptance of
responsibility, because he made them
‘‘as a layman physician and not as a
person versed in law.’’ Resp Exceptions,
at 1. Respondent asserts that he
‘‘recognized that he failed to meet the
standards of care established by Virginia
law,’’ but he ‘‘did not . . . recognize
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*B
See George Pursley, M.D., 85 FR 80,162, 80,188
(2020) (finding that Respondent’s attempts to
minimize his misconduct indicated that he
‘‘lack[ed] familiarity with applicable controlled
substance legal requirements’’ and ‘‘put into
question the value he assigned to practicing
medicine in compliance with the applicable
standard of care’’).
that under DEA regulations this meant
as a matter of law that the drugs were
not issued for a legitimate medical
purpose within the usual course of
professional practice.’’ Id. Respondent
states that he ‘‘recognizes now that as a
legal matter he did not establish a bona
fide doctor-patient relationship, but
when testifying he believed as a matter
of fact that he was acting as a doctor
attempting to provide treatment to a
patient in need of care.’’ Id. at 3.
I reject Respondent’s Exception for
several reasons. First, Respondent’s
statement that he ‘‘recognized that he
failed to meet the standards of care
established by Virginia law’’ is not
supported by the record. During the
following exchange, Respondent
repeatedly and emphatically affirmed
that the prescriptions that he issued
were within the usual course of
professional practice in Virginia:
Q: And you issued [all of] these
prescriptions, you believe, acting in the
ordinary course of professional practice?
A: Absolutely, it was in the course of my
medical practice.
Q: And that’s again, true for all of the—for
the prescription for tramadol that you issued
on July 23, 2019?
A: It’s absolutely true.
Q: And that’s true for the prescription for
tramadol and the prescription for Ativan that
you issued on August 28, 2019?
A: That is correct, and I have no doubts
about it.
Q: And do you also believe that you issued
the prescriptions for Ativan and tramadol on
September 27, 2019, when in doing so you
were acting in the ordinary course of
professional practice for a physician in
Virginia?
A: Absolutely acting in the course of my
medical practice.
Q: And you were acting in the usual course
of professional practice on November 5,
2019, when you issued prescriptions to
Patient SD for tramadol and for Ativan?
A: I was acting in the course of my medical
practice.
Tr. 428–29. I am also not persuaded
by Respondent’s implication that he did
not understand that by testifying that he
issued prescriptions ‘‘in the usual
course of professional practice in
Virginia,’’ he was testifying that the
prescriptions were issued in accordance
with Virginia law and the applicable
Virginia standard of care. Respondent
did not convey any confusion when he
testified that he ‘‘ha[d] no doubts’’ that
he ‘‘absolutely’’ issued the prescriptions
in the usual course of professional
practice. Id. If he had misunderstood
what the phrase ‘‘in the usual course of
professional practice’’ meant, he could
have asked for clarification. This phrase
should not have been foreign to
Respondent, because he had just
observed the testimony of the
Government’s medical expert, who
repeatedly testified that Respondent’s
prescriptions were not issued in the
usual course of professional practice in
Virginia. See, e.g., id. at 205, 214, 218,
220, 231, 255, 258–59, 261, 282–87, 337,
439.
Second, I disagree with Respondent’s
argument that he was merely testifying
as a layperson who was not well versed
in the law, and therefore, that his
statements should not be found as
undermining his acceptance of
responsibility. Respondent was not
testifying merely as a layperson, but as
a Virginia physician and a DEA
registrant who is expected to be
knowledgeable about the basic tenets of
medical practice and the appropriate
prescribing of controlled substances.
Respondent’s failure to appreciate his
obligations under federal and state law
further demonstrates that his continued
registration is inconsistent with the
public interest. See, e.g., The Medicine
Shoppe, 79 FR 59,504, 59,508–11
(2014). In Medicine Shoppe, the
respondent initially accepted
responsibility for his misconduct, but
later testified that he ‘‘never do[es]
diversion’’ and that he disagreed with
the Government’s expert’s testimony
that he filled unlawful prescriptions. Id.
at 59,509–10. The respondent testified:
‘‘There’s no prescription that [the
Government’s medical expert] said that
I should have [sic] filled that I looked
at it from her point of view.’’ Id. at
59,510. Based on this testimony, the
former Deputy Administrator found that
the respondent’s ‘‘understanding of his
obligations as a dispenser of controlled
substances [was] so lacking as to
preclude a finding that Respondent’s
registration is consistent with the public
interest.’’ Id. at 59,510 (citing 21 U.S.C.
823(f) and 824(a)(4)). Respondent’s
testimony in this case similarly
evidences a failure to appreciate his
basic obligations under federal and state
law, which demonstrates that his
registration is inconsistent with the
public interest.
Finally, I give little weight to
Respondent’s assertion that he now
recognizes that he did not establish a
bona fide doctor-patient relationship,
but when he testified ‘‘he believed as a
matter of fact that he was acting as a
doctor attempting to provide treatment
to a patient in need of care.’’ Id. at 3.
I give little weight to these statements
that were made off of the record. At the
hearing, Respondent’s remorse for his
misconduct quickly dissipated when he
was cross examined. See, e.g., Tr. 428–
29. Moreover, Respondent minimizes
his misconduct in his Exceptions,
which undercuts his acceptance of
responsibility and elucidates his lack of
familiarity with federal and state law.
*B
For example, Respondent states that
when he testified, he believed as a
factual matter that he prescribed
medication ‘‘for a legitimate purpose
. . . of providing medical care to a
patient. . . who presented with back
pain and anxiety.’’ Resp Exceptions, at
3 (citing Tr. 380–81). And although
Respondent acknowledges that he did
not comply with the Virginia standard
of care, he asserts that ‘‘from a layman’s
perspective,’’ he believed that he was
‘‘acting as a physician’’ who ‘‘was
prescribing [] medication for a licit
purpose,’’ not ‘‘as a common drug dealer
giving drugs to anyone willing to pay a
certain price.’’ Id.
Respondent’s attempts to distinguish
himself from a ‘‘common drug dealer’’
indicate that he fails to appreciate the
egregiousness of his misconduct.
Respondent ignored Patient SD’s
admissions that he had taken controlled
substances from a friend, and he failed
to comply with even the most basic
requirements of the applicable Virginia
standard of care, such as performing a
physical examination and establishing a
diagnosis for Patient SD’s back pain.
See, e.g., Tr. 78–79, 207–211, 228–30.
After issuing three tramadol
prescriptions to Patient SD, Respondent
asked SD during the fourth visit,
‘‘[W]hat diagnosis are we using for you?
For the back pain. We got to have a
diagnosis, and granted, you aren’t
getting a whole lot of it from me, but,
ah, what can I use. Do you know any
reason why you have back pain?’’ Gov’t
Ex. 13, at 2. Respondent issued a fourth
tramadol prescription at that visit, even
though Patient SD said that he had ‘‘no
idea’’ what was causing the back pain,
and told Respondent that he had been
‘‘pretty good for a while’’ when
Respondent asked him where his pain
was located. Id.
Given Respondent’s approach to
prescribing opioids, I am concerned that
Respondent continues to imply that he
was ‘‘attempting to provide treatment to
a patient in need of care’’ and not
‘‘dispensing medications for anyone
seeking a fix.’’ Resp Exceptions, at 3.
Therefore, I reject Respondent’s
Exceptions and concur with the Chief
ALJ’s conclusions that Respondent did
not unequivocally accept responsibility
for his misconduct, and that his
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*C
I have omitted the RD’s discussion of the
procedural history to avoid repetition with my
introduction.
1
[Footnote omitted, see supra n.*C]
2
[Omitted footnote discussing the administrative
tribunal’s jurisdiction over the immediate
suspension order.]
*D
According to Agency Records, Respondent’s
registered address has changed to 909 Hioaks RD,
Suite F, Richmond, Virginia 23225–4038.
3
Counsel for both parties have represented that
the Respondent timely filed an application to renew
his DEA registration in advance of these
proceedings. [Citation omitted.]
E
This stipulation cites to the version of the
regulation that was effective from February 7, 2019,
to August 15, 2019. The lettering of the regulation’s
various subsections has changed in subsequent
versions, but there were no substantive changes that
impact my Decision.
*F
This stipulation cites to the version of the
regulation that was effective from December 14,
2015, to June 16, 2019. The lettering of the
regulation’s various subsections has changed in
subsequent versions, but there were no substantive
changes to the regulation that impact my Decision.
*G
This stipulation cites to the version of the
regulation that was effective from December 14,
2015, to June 16, 2019. The lettering of the
regulation’s various subsections has changed in
subsequent versions, but there were no substantive
changes to the regulation that impact my Decision.
registration is inconsistent with the
public interest.
The issue before the Administrator is
whether the record as a whole
establishes that it would be inconsistent
with the public interest under 21 U.S.C.
824(a)(4) and 823(f) to allow
Respondent to retain his DEA
registration.
The decision below is based on my
consideration of the entire
Administrative Record, including all of
the testimony, admitted exhibits, and
the oral and written arguments of
counsel. I adopt the ALJ’s
Recommended Decision with noted
modifications.
David M. Locher, Esq. and John E.
Beerbower, Esq., for the Government
Joseph R. Pope, Esq. for the Respondent
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
The Allegations *
C12
The Government alleges that the
Respondent’s DEA registration should
be revoked because, over the course of
four visits, the Respondent issued seven
illegitimate controlled substance
prescriptions to a DEA undercover Task
Force Officer. ALJ Ex. 1, at 2.
The Evidence
Stipulations
The parties entered into factual
stipulations which were accepted by the
tribunal. The following factual matters
are deemed conclusively established in
this case:
1. The Respondent is registered with DEA
as a practitioner to handle substances in
Schedules II through V under DEA COR No.
BA5092856. The Respondent’s registered
address is 10708 Old Prescott Road,
Richmond, Virginia 23233.
*D
2. The Respondent’s COR expires by its
own terms on June 30, 2020.
3
3. Oxycodone is a Schedule II controlled
substance pursuant to 21 C.F.R
§ 1308.12(b)(1)(xiii).*
E
Percocet is a brand
name drug containing oxycodone.
4. Alprazolam is a Schedule IV controlled
substance pursuant to 21 CFR 1308.14(c)(2).
Xanax is a brand name drug containing
alprazolam.
5. Diazepam is a Schedule IV controlled
substance pursuant to 21 CFR
1308.14(c)(16).
*F
Valium is brand name drug
containing diazepam.
6. Lorazepam is a Schedule IV controlled
substance pursuant to 21 C.F.R
§ 1308.14(c)(30).
*G
Ativan is a brand name
drug containing lorazepam.
7. Tramadol is a Schedule IV controlled
substance pursuant to 21 CFR 1308.14(b)(3).
8. Government Exhibit 1 is a true and
correct copy of the Respondent’s patient file
for Patient SD.
9. On July 23, 2019, the Respondent issued
a prescription to Patient SD for 20 dosage
units of tramadol 50 mg.
10. Government Exhibit 2 is a true and
correct copy of the prescription for 20 dosage
units of tramadol 50 mg that the Respondent
issued to Patient SD on July 23, 2019.
11. Government Exhibit 3 contains a true
and correct recording of the Respondent’s
interaction with Patient SD on July 23, 2019.
12. Government Exhibit 4 is a true and
correct transcript of the Respondent’s
interaction with Patient SD on July 23, 2019.
13. On August 28, 2019, the Respondent
issued prescriptions to Patient SD for 20
dosage units of tramadol 50 mg and 30
dosage units of Ativan 0.5 mg.
14. Government Exhibit 5 is a true and
correct copy of the prescriptions the
Respondent issued to Patient SD on August
28, 2019.
15. Government Exhibit 6 contains a true
and correct video recording of the
Respondent’s interaction with Patient SD on
August 28, 2019.
16. Government Exhibit 7 is a true and
correct transcript of the Respondent’s
interaction with Patient SD on August 28,
2019.
17. On September 27, 2019, the
Respondent issued prescriptions to Patient
SD for 30 dosage units of tramadol 50 mg and
30 dosage units of Ativan 0.5 mg.
18. Government Exhibit 8 is a true and
correct copy of the prescriptions the
Respondent issued to Patient SD on
September 27, 2019.
19. Government Exhibit 9 contains a true
and correct video recording of the
Respondent’s interaction with Patient SD on
September 27, 2019.
20. Government Exhibit 10 is a true and
correct transcript of the Respondent’s
interaction with Patient SD on September 27,
2019.
21. On November 5, 2019, the Respondent
issued prescriptions to Patient SD for 30
dosage units of tramadol 50 mg and 30
dosage units of Ativan 0.5 mg.
22. Government Exhibit 11 is a true and
correct copy of the prescriptions issued to
Patient SD on November 5, 2019.
23. Government Exhibit 12 contains a true
and correct video recording of the
Respondent’s interaction with Patient SD on
November 5, 2019.
24. Government Exhibit 13 is a true and
correct transcript of the Respondent’s
interaction with Patient SD on November 5,
2019.
25. Patient SD was provided with a
document entitled ‘‘Pain Treatment with
Opioid Medications: Patient Agreement’’
during his visit to the Respondent’s clinic on
November 5, 2019.
26. Government Exhibit 14 is a true and
correct copy of the Virginia Prescription Drug
Monitoring Program Audit Report showing
searches by the Respondent for Patient SD.
27. Government Exhibit 16 contains a true
and correct copy of ‘‘New Safety Measures
Announced for Opioid Analgesics,
Prescription Opioid Cough Products, and
Benzodiazepines,’’ published by the Food
and Drug Administration (FDA).
28. Government Exhibit 16 contains a true
and correct copy of the FDA label for Ativan.
The Government’s Case
The Government’s case consisted of
the testimony from the lead Diversion
Investigator on the case, the DEA Task
Force Officer who made undercover
visits to the Respondent’s office, and an
expert witness.
Diversion Investigator
As its first witness, the Government
called a Diversion Investigator
(hereinafter, DI), who testified that he
has been a DI for seven years, the last
two of which have been in the
Richmond Field Office. Tr. 27. DI was
the lead investigator in the case against
the Respondent. Id. at 30. He testified
that the investigation into the
Respondent’s prescribing practices
began when DEA received a tip from an
individual who stated that they were a
patient of the Respondent. Id. This
individual informed DEA that ‘‘a lot of
drug addicts’’ seemed to be frequenting
the Respondent’s office. Id. This tip was
received and documented by the office’s
assigned Task Force Officer (hereinafter,
TFO). Id. at 32.
Acting on the tip information, DI
consulted numerous databases, both
inside and outside DEA. Id. at 33. One
of the databases he checked was the
Virginia Prescription Monitoring
Program (hereinafter, the Virginia PMP
or the PMP) database to analyze data for
any possible patterns regarding the
Respondent’s controlled substance
prescribing. Id. at 33, 63; Gov’t Ex. 14.
The witness explained that the Virginia
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4
The Government did not base its case on
multiple patients living at the same address. This
information was offered and considered strictly to
explain information which informed the DI’s
investigative progress.
5
DI Pumphrey confirmed that Scott Davis is a
fictitious name. Tr. 34.
6
[Content of footnote addressed in text.]6
*H
This sentence was modified to clarify that DEA
requested Respondent’s Virginia PMP queries from
the Virginia Department of Health Professions.
7
Government Exhibit 1 contains the medical
records that the Respondent’s office maintained
under the name Scott Davis (Patient SD), which
were retrieved during the search of the
Respondent’s clinic. Tr. 38–39. Government Exhibit
2 is a copy of a prescription for tramadol written
by the Respondent for Patient SD at UC Visit #1.
Id. at 40–41, 42–46. Government Exhibit 3 is a
video recording of UC Visit #1. Id. at 46–48.
Government Exhibit 4 is a transcript of the UC Visit
#1 videotape. Id. at 49–50. Government Exhibit 5
contains the prescriptions written for Patient SD at
UC Visit #2. Id. at 51–52. Government Exhibit 6 is
the video recording of UC Visit #2. Id. at 53–54.
Government Exhibit 7 is a transcript of the UC Visit
#2 videotape. Id. at 54–55. Government Exhibit 8
contains the prescriptions for tramadol and Ativan
that were written by the Respondent for Patient SD
at UC Visit #2. Id. at 55–56. Government Exhibit 9
is the video recording of UC Visit #3. Id. at 56–57.
Government Exhibit 10 is a transcript of the UC
Visit #3 videotape. Id. at 57. Government Exhibit 11
is the two prescriptions for tramadol and Ativan
written by the Respondent for Patient SD at UC
Visit #3. Id. at 57–58. Government Exhibit 12 is a
video recording of UC Visit #4. Id. at 58–59.
Government Exhibit 13 is the transcript of the UC
Visit #4 videotape. Id. at 59. Government Exhibit 14
documents the queries to the Virginia PMP made
regarding the Respondent as part of the
investigation. Id. at 59. DI confirmed that he ran the
query and received the information on April 3,
2020. Id. at 59–60. He further testified that this data
was a ‘‘special request’’ in that he directly contacted
the Virginia Department of Health Professionals to
request this data. Id. at 60. Government Exhibit 14
is the document he received as a result of this
inquiry. Id. at 60–61.
8
Tr. 75.
9
The form demonstrates a miniscule dot outside
each of the respective boxes pertaining to the use
of recreational drugs and back problems. Gov’t Ex.
1, at 7; Tr. 120–21, 154–56. The dots are tiny and
do not provide any level of ambiguity as to the
responses (or lack thereof). Indeed, during his
testimony, the Respondent, beyond a general
acknowledgement of their existence, Tr. 378, did
not allude to any significance that should be
attached to these two little dots, and no significance
is placed on their presence for the purposes of this
recommended decision.
PMP database allows investigators to
determine the prescriptions a
practitioner has issued and where the
prescriptions were dispensed. Tr. 33. DI
explained that he was searching for
potential ‘‘red flags,’’ such as
prescriptions for high strengths and
dosages of medications that are
commonly abused or diverted and
prescriptions for high strengths/dosages
of these drugs that are dispensed to
multiple people residing at the same
address. Id. at 62. DI testified that the
PMP data regarding the Respondent
presented some unusual commonalities
among individuals within the same
household who were patients of the
Respondent.
4
Id. at 63. He testified that,
at least in his view at the time, these
data points constituted red flags which
warranted further investigation. Id.
DI testified that the investigation of
the Respondent progressed to the
deployment of a DEA TFO who
conducted multiple undercover visits to
the Respondent’s practice. Id. at 34.
According to DI, TFO made four
undercover visits (hereinafter, UC
Visits) to the Respondent’s office using
an alias (Scott Davis).
5
Id. at 34–35. The
UC Visits were conducted on July 23,
2019 (hereinafter, UC Visit #1), August
28, 2019 (hereinafter, UC Visit #2),
September 27, 2019 (hereinafter, UC
Visit #3), and November 5, 2019
(hereinafter, UC Visit #4), respectively.
Id. at 35. It is DI’s understanding that
the UC Visits were recorded by the TFO
using a concealed device, and that
controlled substance prescriptions were
issued to the TFO by the Respondent at
the culmination of each visit. Id. at 36;
see Gov’t Exs. 2, 3, 5, 6, 8, 9, 11, 12.
Each of the scrips procured by the TFO
from the Respondent’s office were
turned over to the Richmond DEA office
and maintained in the DEA evidence
system. Tr. 36. The recordings likewise
were maintained in the DEA evidence
system, and were subsequently
transcribed by a Federal Bureau of
Investigation (hereinafter, FBI)
transcriber. Tr. 36–37, 50; see Gov’t Exs.
4, 7, 10, 13.
Using the information acquired
during the course of the investigation, a
search warrant was secured by DEA and
executed at the Respondent’s clinic on
March 3, 2020. Tr. 37. In the course of
this search, the medical records for the
TFO under his fictitious name (Scott
Davis or Patient SD) were among the
documents identified and seized. Id.;
Gov’t Ex. 1. Additionally, DEA
requested data from the Virginia
Department of Health Professions,
which reflected that the Respondent had
queried the Virginia PMP regarding
Patient SD.
6*H
Tr. 38; Gov’t Ex. 14. DI’s
testimony was used to authenticate
multiple Government exhibits, which
included documents uncovered during
the search as well as those produced in
the course of the investigation.
7
Following the execution of the search
warrant, DEA personnel hired an expert,
Dr. John F. Dombrowski, to evaluate
what they had acquired and learned
during the course of their investigation.
Tr. 62.
DI presented as an objective regulator
and investigator with no discernable
motive to fabricate or exaggerate. The
testimony of this witness was
sufficiently detailed, plausible, and
internally consistent to be afforded full
credibility in this case.
TFO
The Government presented the
testimony of the agent who conducted
the undercover visits to the
Respondent’s practice, TFO. TFO
testified that he has been a detective
with the City of Greenfield (Wisconsin)
Police Department (GPD) for eighteen
years and has been cross-designated by
DEA as a TFO for the past seven years.
Tr. 66–69. He was assigned to assist in
the investigation that spawned the
current charges against the Respondent.
Id. at 66–68. TFO testified that he is
experienced in undercover work, having
personally conducted and provided
testimony regarding somewhere
between 100 and 200 undercover
operations. Id. at 69.
TFO testified that he assumed the
name Scott Davis (for which he had a
fabricated driver’s license) to conduct
his operation at the Respondent’s office
and that he recorded his UC Visits on
audio visual recording equipment. Id. at
70, 87. TFO testified that following a
preliminary visit with the Respondent’s
office staff, he appeared for a July 23,
2019 office visit (UC Visit #1). Id. at 71.
Upon his arrival, the Respondent’s
office staff had the TFO pay an office
visit fee
8
and fill out a medical
questionnaire. Id. at 73; Gov’t Ex. 1, at
7. According to TFO, based on his
experience, he completed the
questionnaire in such a way as to
monitor whether the prescriber was
fulfilling his responsibility to ensure
that pain medications were not being
diverted. Id. at 75–77. Under the
heading ‘‘Reason for Visit,’’ the TFO put
the words ‘‘need new doctor
prescription.’’ Gov’t Ex. 1, at 7; Tr. 119.
Although he knew he planned to
(falsely) describe back discomfort to the
Respondent, the TFO intentionally
declined to check the box adjacent to
‘‘Back Problems’’ in the ‘‘Past Medical
History’’ section of the form. Gov’t Ex.
1, at 7; Tr. 74. Similarly, the TFO left
a blank response to the query, ‘‘Do you
use recreational drugs?’’ Gov’t Ex. 1, at
7. TFO recounted that neither of these
potential diversion red flags were raised
with him by the Respondent or his staff
during any of his UC Visits.
9
Tr. 74–75.
After completing the medical
questionnaire during UC Visit #1, the
TFO was escorted to an exam room by
a staff member and had his vitals taken.
Id. at 75, 77, 88. The Respondent met
with the TFO after the staff finished
taking his vitals. Id. at 77. The cover
story the TFO presented to the
Respondent was that he is an active
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10
Tr. 125.
11
The TFO testified that he chose Percocet based
on his understanding that it is a medication that is
‘‘more highly sought after by addicts.’’ Tr. 164.
12
The questionnaire contained no reference to
tramadol. Gov’t Ex. 1, at 4.
13
Tr. 79; Gov’t Ex. 1, at 4.
14
The TFO testified that he volunteered this in
‘‘trying to minimize the symptoms.’’ Tr. 83.
15
Tramadol is a Schedule IV controlled
substance. 21 CFR 1308.4(b)(3); Stip. 7.
16
Tr. 89–90. The TFO was unable to recall
whether he told the Respondent that he had an x-
ray or an MRI. Id. at 79.
17
The questionnaire contained no reference to
oxycodone. Gov’t Ex. 1, at 4.
18
The TFO testified that he told the Respondent
he could not just stop ‘‘because I wanted to show
that I was dependent—potentially addicted but
dependent upon that pain medication.’’ Tr. 84.
19
Trazadone is not a controlled substance.
20
Tr. 85.
21
Tr. 81–82, 90–91, 133. The TFO testified that
he was wearing a T-shirt. Tr. 82.
construction worker
10
who recently
moved to the Richmond area from
Milwaukee and needed to establish with
a new doctor to refill his medications.
Id. at 78; Gov’t Ex. 4, at 2. On his
questionnaire, the TFO indicated a
specific strength and dosage of
Percocet
11
under the ‘‘Current
Medications’’ section. Gov’t Ex. 1, at 7.
Upon meeting TFO, the Respondent
initiated his contact with ‘‘What’s going
on? What can I help you with?’’ Gov’t
Ex. 4, at 2. When the TFO started to
explain his move to the area and need
for a new physician (all of which was
contrived), the Respondent interrupted
with ‘‘For this kinda stuff? Percocet?’’
and described Percocet as ‘‘[a]lmost
outlawed.’’ Id.; see also Tr. 123. The
TFO told the Respondent that the
Percocet he referred to on the
questionnaire was for his back, and that
he moved to perform construction work
in the Richmond area. Gov’t Ex. 4, at 2.
The Respondent asked the TFO, ‘‘[s]o
where in the back, and how much
Percocet are you needing?’’ Id. The TFO
volunteered the following rather
startling admission: ‘‘Unfortunately, I
had to, uh, like from a friend or a
girlfriend, that sort of thing, get some
pills here and there. Uh, the tramadol’s
actually been working pretty
decent.’’
12
Id. at 3; Tr. 78–79. Without
any follow-up or even apparent reaction
to the revelation that his patient had just
admitted to acquiring diverted drugs,
13
the Respondent asked him about the
source of his back pain, to which the
TFO replied that he did not know, but
that at some point he had fallen from a
ladder and recovered by ‘‘just doing
[his] job.’’ Gov’t Ex. 1, at 4; Tr. 79. Later
in their conversation, the Respondent
admonished the TFO that ‘‘[j]ust
because you fell off of a ladder doesn’t
mean anything.’’ Gov’t Ex. 1, at 7. The
witness told the Respondent that there
were no radiation symptoms down the
legs.
14
Id. at 4. There was some
additional discussion about other
options and creams and the Respondent
reiterated that ‘‘[t]he rules are so strict
about Percocet. Especially 10 [milligram
dosage].’’ Id. at 5. After confirming on
multiple occasions that the TFO brought
no imaging, and explaining that he
would, at some point, have to procure
an x-ray, the Respondent explained that
while he would not be prescribing
Percocet, ‘‘I can give you a few
tramadols
15
until you can get an x-ray,
and you’re going to have to show me
that there is something going on with
your back.’’ Id. The TFO testified that he
never provided any imaging to the
Respondent at that visit. Tr. 89–90.
The TFO told the Respondent that he
thought he could procure an ‘‘older’’ x-
ray or MRI
16
from his former address in
Milwaukee, that he kept working while
prescribed oxycodone for a couple of
years,
17
and that since he was on
oxycodone for that long, ‘‘it’s like, I
mean, I can’t just stop.’’
18
Gov’t Ex. 4,
at 6, 8. There was no follow-up from the
Respondent regarding the TFO’s
estimation that he was unable to ‘‘just
stop’’ taking oxycodone. Id. The
Respondent gave no indication that he
was concerned about potential
dependence or addiction.
When the TFO raised the issue that he
has ‘‘a tough time, like falling asleep,
and relaxing at the end of the day,’’ the
Respondent’s reaction was ‘‘Ok, and
here’s some Trazadone
19
for that,’’
describing the medication as the ‘‘[m]ost
commonly prescribed sleeping medicine
in the country.’’ Id. at 6–7. Although at
one point during their brief, eight-
minute
20
time together, the Respondent
touched the TFO’s back through his
shirt for one-to-two seconds,
21
no
physical exam was conducted on the
undercover officer by anyone at any
time during UC Visit #1. Tr. 77, 83. The
Respondent prescribed twenty 50
milligram (mg) tramadol tablets, which
the TFO did not fill. Gov’t Ex. 2; Tr. 85–
86.
The TFO returned to the Respondent’s
office for another undercover visit on
August 28, 2019 (UC Visit #2). Tr. 87.
Similar to his first UC Visit, the TFO
paid an office visit fee, and was escorted
to an exam room for two-to-three
minutes, where his vital signs were
taken and he was asked the reason for
his visit. Id. at 89. He was joined in the
exam room by the Respondent shortly
thereafter, where the TFO informed the
doctor that he had come for a tramadol
refill. Id. at 89. In response to the
Respondent’s inquiry about the imaging
results the TFO had agreed to bring, the
latter told him that he had located them
in Milwaukee, but neglected to bring
them with him. Id. at 89–90, 136; Gov’t
Ex. 7, at 2. The Respondent replied,
‘‘Uhhh, I need that. Alright, I’ll just give
you twenty for now, and ah, I need you
to bring that .... Then I’ll give you
more.’’ Gov’t Ex. 7, at 2; see also Tr. 136.
The Respondent went on to explain that
once he has the opportunity ‘‘to look at’’
the imaging ‘‘we could do regular sixty
[tablets], if there is . . . [s]ignificant
pathology . . . [o]f your back.’’ Gov’t Ex.
7, at 3.
The Respondent asked the TFO if he
experienced spasms, but got no answer.
Id. He again touched a spot on the
TFO’s back through his shirt for one-to-
two seconds, and was told by his patient
that he had identified the locus of pain,
‘‘if it’s bothering me, uh, that’s where it
is.’’ Gov’t Ex. 7, at 3; Tr. 90–91, 137.
Remarkably, the Respondent explained
his understanding of the prescribing
standard to the TFO in this way:
Alright, right now, I can only list back pain
as a diagnosis, but ya know, in our file we
need more than that. Like a herniated disc,
or a compressed disc, or something, ya
know? Something more concrete.
Gov’t Ex. 7, at 3. After another
assurance that he would bring his
imaging on his next visit, the TFO made
the following request: ‘‘Oh, oh, I was
gonna say, c-can I get a scrip for Xanax
too?’’ explaining that the tramadol
‘‘helps me during the day, but the Xanax
makes me feel a lot better and relaxed
in the evening.’’ Id. at 4. A few follow
up questions by the Respondent made it
clear that the TFO did not know (or was
not willing to say) what his prior dose
of Xanax was. Id. The Respondent
confided in his patient that since the
emergence of the current opioid crisis,
‘‘I don’t like to prescribe Xanax
anymore,’’ and noted the addictive
qualities of Xanax. Id. The Respondent
said he would be willing to prescribe
Ativan as a less addictive alternative. Id.
at 4–5; Tr. 92. No mental status exam
was conducted. Tr. 92. In fact, no
questions about any mental health
conditions were directed to the TFO. Id.
The TFO’s response to all of this was to
let the Respondent know that he had
also tried Valium in the past, to which
the Respondent replied, ‘‘No, no, no, no,
no.’’ Gov’t Ex. 7, at 4–5. Just as was true
at UC Visit #1, no physical exam was
conducted by the Respondent or any
staff member during UC Visit #2. Tr. 89.
The TFO was asked no questions about
how he was doing on the previously-
prescribed tramadol, but at the
conclusion of his four-minute visit with
the Respondent, he received
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22
Tr. 97.
23
Tr. 98.
24
Gov’t Ex. 1, at 2–3.
25
Tr. 112.
26
The Respondent asked the TFO to ‘‘let [him]
know when [he has] insurance so [the Respondent]
can set [him] up for that x-ray.’’ Gov’t Ex. 13, at 5.
27
Dr. Dombrowski’s curriculum vitae
(hereinafter, CV) was received into evidence
without objection. Gov’t Ex. 15; Tr. 170.
prescriptions for tramadol and Ativan.
Gov’t Ex. 5, at 1–2.
The TFO paid another undercover
visit to the Respondent’s practice on
September 27, 2019 (UC Visit #3). Tr.
94. Like his other visits, he paid his
office fee, was escorted to an exam
room, had his vitals taken, and waited
for the doctor. Id. at 96. Before the staff
member departed, the TFO did take the
opportunity to assure her that he was
presently experiencing neither pain nor
anxiety. Id. at 97.
Upon the Respondent’s arrival in the
exam room, the TFO told him he was
there for tramadol and Ativan refills. Id.
Consistent with the TFO’s assurances to
the staff member, he told the
Respondent, regarding his back pain,
‘‘I’m feeling pretty good.’’ Gov’t Ex. 10,
at 2; see also Tr. 98–99, 142, 162. When
he re-told the Respondent that he did
not know the cause of his back pain,
22
the Respondent presented the following
suggestion: ‘‘Why don’t we just give you
twenty of tramadol? It’s no big deal.’’
Gov’t Ex. 10, at 2. When the Respondent
inquired about any factors that might
exacerbate the back issues, the TFO
responded with, ‘‘Yeah, I mean, like
right now I feel ok, but [you n]ever
know.’’ Id. The Respondent’s reaction to
this non-sequitur answer was to propose
various activities that possibly could
make this worse, but this patient was
not taking the bait. Id. at 2–3. He merely
offered that ‘‘the Ativan was pretty
good.’’ Id. at 3. The Respondent’s
astonishing response to this colloquy
was:
Alright, no problem. Ativan is a low, uh,
low benzodiazepine, um, equivalent. Ok. So
it’s probably a better one to use anyway. Ok?
Yeah. I’ll increase the number of tramadols
to thirty. Ok?
Id. Not surprisingly, the TFO readily
concurred in this unsolicited
medication increase, which was
unsupported by any discussion about
the relative merits or efficacy of the
prior dose of twenty tablets, to which
the Respondent amicably replied, ‘‘You
happy? Good.’’ Id. Following some level
of banter, doctor and patient ended their
time together. Id. As was true in the
other adventures at the Respondent’s
office, the TFO provided no imaging or
other medical records,
23
and no
physical exam was performed on the
TFO by the Respondent or any staff
member. Tr. 96, 98. One variation in
this visit is that the Respondent did not
touch the TFO’s back at all. Id. at 98.
There was no inquiry about the efficacy
of (or anything else about) the
previously-prescribed tramadol, but at
the conclusion of the two minutes the
two men spent together during UC Visit
#3, the Respondent issued prescriptions
for Ativan and an increased dosage of
tramadol. Id. at 99–102, 162; Gov’t Ex.
8, at 1–2.
The TFO’s final undercover visit to
the Respondent’s office (UC Visit #4)
occurred on November 5, 2019. Tr. 102.
As had generally been the routine, the
TFO paid his office visit fee and was
taken back into an exam room by a staff
member where vital signs were taken.
Id. at 104. In a slight variation from
prior experience, the TFO was
presented with a pain management
contract
24
and two questionnaires. Id. at
104–107, 111. The first questionnaire is
entitled, ‘‘Generalized Anxiety Disorder
7–Item (GAD–7) Scale’’ (Anxiety
Questionnaire), and the second bore the
title, ‘‘Pain Diagram and Pain Rating’’
(Pain Questionnaire). Id.; Gov’t Ex. 1, at
12–13. The TFO put extremely low
marks and low frequency of occurrence
on both questionnaires, demonstrating a
low level of symptoms. Gov’t Ex. 1, at
12–13; Tr. 107, 109–11, 146–52.
After the staff member departed, the
Respondent entered. Tr. 112. The TFO
told the Respondent that he was feeling
‘‘[n]ot too bad,’’ and that he came in for
the ‘‘[s]ame thing as the last few times.
Just the refills.’’ Gov’t Ex. 13, at 2; Tr.
112. The Respondent told the TFO he
was refreshing his recollection by
examining his chart, and narrated his
recall process as follows:
Ok. So what diagnosis are we using for
you? For the back pain. We got to have a
diagnosis, and granted, you aren’t getting a
whole lot of it from me, but, ah, what can I
use[?] Do you know any reason why you have
back pain?
Gov’t Ex. 13, at 2. Once again, the
TFO assured the Respondent that he
‘‘ha[d] no idea’’ why he had back pain.
Id.; see also Tr. 112. He elaborated that
he liked what the Respondent was
prescribing, ‘‘[b]ecause it’s been pretty
good for a while . . . .’’ Gov’t Ex. 13,
at 2. The TFO pointed to a spot on his
back and identified the spot as the locus
of the pain, ‘‘[i]f it would be bothering
me.’’ Id.
As had become their custom during
their visits, the TFO provided neither
imaging nor prior medical records,
25
but
Respondent asked, ‘‘[D]o you mind
getting a chest film for me?’’ Gov’t Ex.
13, at 3. Beyond a two-to-three second
finger push on the back through the
TFO’s shirt, no physical examination
took place, and no dialogue occurred
regarding the efficacy of the medications
prescribed in the past, physical
function, mental health, or pain level.
Tr. 113–15. This time, the TFO pushed
back a bit on acquiring an x-ray, citing
a current lack of insurance as an
impediment.
26
Tr. 145. However, the
lack of insurance and concomitant lack
of imaging did not serve as an
impediment to the Respondent
continuing to write controlled substance
prescriptions, and at the end of the visit,
the TFO walked away with
prescriptions for tramadol and Ativan.
Gov’t Ex. 11; Tr. 115–17.
The TFO presented as an objective
law enforcement officer with no
apparent agenda beyond telling the
truth. When asked, he was freely willing
to agree with the Respondent’s counsel
on numerous points, but presented the
impression of being confident in what
he remembered about the case. Overall,
this witness’s testimony was sufficiently
detailed, internally consistent, and
plausible to be afforded full credibility
in this case.
Dr. John F. Dombrowski, M.D., F.A.S.A.
The Government called Dr. John F.
Dombrowski as its final witness. Tr.
168. Dr. Dombrowski testified that he is
currently employed as a physician at the
Washington Pain Center in Washington,
DC
27
Id. He holds licenses to practice
medicine in Maryland, Virginia, Florida,
and the District of Columbia. Id.; Gov’t
Ex. 15. Dr. Dombrowski received his
medical training at Georgetown
University and Yale University before
entering private practice in Richmond,
Virginia, and eventually coming to
practice in Washington, DC Tr. 170;
Gov’t Ex. 15. In addition to working as
a physician, he is presently the CEO of
the Washington Pain Center. Tr. 171;
Gov’t Ex. 15. In his capacity as a
physician, Dr. Dombrowski performs
injection therapy as an anesthesiologist
as well as medication management for
chronic pain patients. Tr. 171. He is
additionally the director of several
methadone clinics in the Washington,
DC, area, as well as a detox facility in
Maryland. Id. at 171–72; Gov’t Ex. 15.
His primary areas of expertise are
anesthesiology, addiction medicine, and
pain medicine. Tr. 172. Dr. Dombrowski
is a member of the American Society of
Anesthesiology, the Interventional Pain
Societies, and some other professional
organizations relating to his areas of
specialty. Id.; Gov’t Ex. 15. Dr.
Dombrowski has board certifications
from the American Board of Pain
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28
Dr. Dombrowski estimates that his work as an
expert witness is roughly comprised of sixty
percent defense work and forty percent plaintiff
work. Tr. 173–74.
29
Dr. Dombrowski described the taking of a
thorough history and conducting a thorough
physical as the ‘‘mainstay’’ of the prescribing
standard. Tr. 211.
30
The witness acknowledged that there could be
a difference between the comprehensive level of
examination conducted during a first visit to a
physician and subsequent visits where the
examination may become more focused. Tr. 192–93,
227.
31
In a confusing and peculiar twist, at another
point in his testimony, Dr. Dombrowski also
testified that in his opinion, today’s doctors ‘‘get
way too many tests [and] don’t spend enough time
talking to patients.’’ Tr. 329.
32
Dr. Dombrowski also observed that the TFO’s
pain symptoms as self-reported in the Pain
Questionnaire (Gov’t Ex. 1, at 12) appear to be so
minimal that they call into question the
Respondent’s decision to prescribe controlled
substances to address them. Tr. 261–65. The
Government’s expert made the same observations
and conclusions regarding the TFO’s purported
mental health issues as self-reported in the Anxiety
Questionnaire (Gov’t Ex. 1, at 13), which were
likewise so mild as to call into question the
decision to prescribe controlled medications to treat
them. Tr. 270–73.
Medicine, the American Board of
Addiction Medicine, the American
Board of Anesthesiology, the National
Board of Medical Examiners, and the
American Board of Preventive
Medicine. Tr. 348; Gov’t Ex. 15.
Additionally, he maintains a clinical
practice and is a DEA registrant. Tr.
172–73. His practice includes the
regular prescribing of controlled
substances, including but not limited to
opioids and benzodiazepines. Id. at 173.
In the past, he has provided expert
testimony regarding the medical
practice of other physicians.
28
Id. He has
previously opined professionally on the
use of opioid medications to treat
chronic pain. Id. at 174. In forming his
expert opinion, Dr. Dombrowski
reviewed the relevant Virginia laws
relating to the standard of care for
prescribing opioids for chronic pain. Id.
at 175. In the absence of an objection,
Dr. Dombrowski was tendered and
accepted as an expert in the applicable
standards of care for prescribing
controlled substances within the usual
course of professional practice in
Virginia. Id. at 176–77.
Dr. Dombrowski testified that in order
to be compliant with the standard of
care in Virginia, a physician must
establish a medical relationship with a
patient by taking a thorough history,
performing a physical exam, and
acquiring any necessary lab work before
prescribing a controlled substance.
29
Id.
at 179, 211–12. Dr. Dombrowski
described finding a diagnosis as the
‘‘hallmark’’ for proper controlled
substance prescribing in Virginia. Id. at
185. According to the witness,
discerning a correct diagnosis, or in
other words, divining the etiology for
the pain symptom, ‘‘is everything
because once I determine what the
problem is, then I can come up with a
host of modalities to treat that one
problem.’’ Id. at 199. ‘‘Pain,’’ Dr.
Dombrowski explained, ‘‘is just a
symptom, it’s not the reason.’’ Id. at 200.
In regard to establishing a valid
diagnosis, he testified that a medical
history and physical constitute about
eighty percent of a proper diagnosis. Id.
at 179. It is Dr. Dombrowski’s view that
the objective aspects of the physical
examination ‘‘bolster’’ the subjective
observations of the patient. Id. at 182.
The physical examination, as described
by Dr. Dombrowski, generally includes
some level of bodily manipulation to
attempt to explore and replicate the
pain symptoms, followed by testing to
investigate potential issues, such as
neurologic compromise.
30
Id. at 182–83.
The witness described some of the fairly
extensive standard steps required in a
proper physical examination, to include
spine palpation, having the patient
stand up and touch their toes, twisting
movements of various parts of the body,
conducting a heel-toe walk, a sensory
evaluation, and conducting a straight-
leg raise exercise. Id. at 195–97. The
witness also discussed the vital role of
testing, such as obtaining an MRI, CT
scan, or other imaging ‘‘to back up your
diagnosis.’’
31
Id. at 211–12. In response
to a query by the Respondent’s counsel
at the hearing about a patient presenting
with a generalized complaint of back
pain, Dr. Dombrowski supplied the
following explanation of some of the
precursor steps required in Virginia to
meet the minimum controlled substance
prescribing standard:
So basically what you first want to do is
take a thorough history, before you even get
to the exam. Talking about where’s the pain;
how has the pain affected you; how has it
affected your quality of life, your activities of
daily living; the quality of the pain in terms
of burning, stabbing, aching, et cetera? Where
is the pain located, where does the pain go?
Does it run down a leg, does it remain in
your back? Et cetera. And then along with
that—before you even get into the physical,
which I’ll get to, you also want to understand
. . . how long have you had it for? Is this
acute? Is this chronic? [ ] [W]hat have you
tried in the past? Were there x-rays in the
past? Things like that to give me, as a new
physician, some understanding of then how
to move forward. Once I understand the
patient’s thorough history and getting all that
information, before we even do the exam,
then we go do the exam. The exam for back
pain just would be obviously having the
patient stand. Ask them . . . [to] point to
where it hurts. And they would then direct
me where it hurts. I would place my hand
or hands there, palpate, feel, in terms . . . of
if the muscles are tight or are they soft? If I
push hard, does it reproduce the pain? And
then along with that, we start then having the
patient move, to see if movement would
cause pain, such as forward flexion, back
extension, or rotation to the sides. To see if
it, again, exacerbates the pain that they have
or mitigates—makes it better. And that gives
me an understanding on what particular
diagnosis it is. And then moving forward
outside of the back exam . . . you . . . do
a neurologic exam. Again, assessing for any
pain to the extremities. And with that pain,
is there associated weakness? Having them
stand on their feet, heels, feeling their thighs
.... That’s just a cursory exam. There’s
other things that we can talk about, but that’s
a basic exam. I hope that explained it.
Id. at 325–27.
Dr. Dombrowski highlighted the
importance of acquiring prior medical
records and probing issues such as past
substance abuse in compiling an
adequate medical history. Id. at 183–84.
He explained that prior substance abuse
does not necessarily stand as a barrier
to pain treatment, but it could oblige the
physician to employ more caution,
potentially requiring such measures as
urine drug screens (hereinafter, UDS)
and/or pill counts. Id. at 184, 202.
A mental status evaluation, according
to the witness, may also be required to
gauge the patient’s true need for pain
medication, as well as a discussion
regarding the risks, benefits, and
dangers associated with prescribed
drugs. Id. at 184–87. Dr. Dombrowski
also testified that informed consent and
the utilization of an opioid contract is
a required controlled substance
prescribing standard in Virginia. Id. at
187–88. Documentation of the steps
taken, according to Dr. Dombrowski, is
also an element in meeting the
controlled substance prescribing
standard in Virginia. Id. at 189–91.
Dr. Dombrowski testified that after
reviewing the transcripts of visits and
medical records prepared in connection
with the Respondent’s care of the TFO,
in his expert opinion, the Respondent’s
controlled substance prescribing fell
below the applicable standard in
Virginia. Id. at 205, 214, 218, 220, 231,
255, 258–59, 261, 282–87, 337, 439. The
witness determined that a proper
physical exam was never conducted,
and that to the extent the progress notes
indicated such an exam was conducted,
those notes, when compared to the UC
videotapes and transcripts, are patently
false. Id. at 207–211, 228–30. No proper
physical
32
or mental health diagnoses
were ever made or supported by the
charts. Id. at 230, 232–36, 254, 283.
Lacking also across board in the visits
is a substance abuse history, a
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33
Gov’t Ex. 16.
34
The Respondent’s CV was received into the
record without objection. Resp’t Ex. 1; Tr. 352.
35
The Respondent testified that he has worked at
Encompass hospitals for about three years. Tr. 371.
36
The Respondent offered that a post-surgery hip
fracture patient is a common example of where he
would regularly provide pain management and
prescribe pain medications, such as tramadol,
oxycodone, or hydrocodone. Tr. 369.
37
Resp’t Exs. 2–5.
psychosocial history, a mental status
evaluation, UDS testing, a documented
risk/benefits discussion, an exit strategy
discussion, a medication disposal
discussion, or anything approaching a
proper, documented diagnosis. Id. at
212–218, 221–24, 227–28, 237–38, 244–
48, 252–60, 277–82, 337, 443. Regarding
UC Visit #2, Dr. Dombrowski
specifically observed that the TFO
returned to the office well beyond a
time where the prescribed medication
would, if taken as directed, have run
out, and despite this lapse, no follow-up
was pursued by the Respondent. Id. at
223–25. The standard of care, according
to Dr. Dombrowski, would require the
prescriber to seek clarification from the
patient as to what effect the lapse had
on symptom control, or as the witness
put it, ‘‘I mean, do you even need my
medication?’’ Id. at 224. UC Visit #3 had
the same gapped medication issue, with
the same lack of follow-up on the
Respondent’s part. Id. at 248–50. The
witness testified that in some cases the
Respondent’s prescribing fell below the
standard of care by his absence of
preliminary ground work, other times
by the relative paucity of (even
subjective) symptoms, and other times
by his lack of follow-up questions in the
face of indicia that should have called
the bona fides of the patient’s intentions
and genuine need for medication into
issue. Id. at 268–69, 272–73, 277, 337–
38. The Respondent also fell short of the
Virginia prescribing standard of care
when he increased the TFO’s tramadol
dosage with no documented explanation
and no conceivable basis being provided
by the chart entries or interactions as
video-recorded at the time of UC Visit
#3. Id. at 255–56.
Dr. Dombrowski also discussed his
observations regarding a PMP report
generated to reflect the Respondent’s
queries concerning the TFO. Id. at 225.
Specifically, the fact that the
Respondent (or his staff) actually
queried the PMP and were, thus, aware
that the TFO was not filling any of the
prescriptions he issued needed, at a
minimum, to be explored and resolved
with the patient, and his failure to do so
fell below the applicable prescribing
standard in Virginia. Id. at 226, 250–51,
273–74, 276–77. Failure by the
Respondent to follow up on the
patient’s request for specific
medications by name also fell below the
applicable standard. Id. at 235–36, 251.
Also below the applicable standard,
according to Dr. Dombrowski, was a
failure to comply with follow-up
requirements attendant upon the black
box warning issued by the FDA
regarding the simultaneous prescribing
of opiates and benzodiazepines.
33
Id. at
239–44. The Respondent prescribed this
dangerous combination of medicines
without engaging in any precautionary
and follow-up steps, such as
establishing and documenting
extenuating circumstances. Id. at 239–
44, 283.
Dr. Dombrowski testified that, in his
expert opinion, none of the controlled
substance prescriptions detailed in the
Government’s case were issued for a
legitimate medical purpose in the
normal course of a professional practice.
Id. at 286.
The Government’s expert witness
presented as a qualified, measured,
knowledgeable expert, with no
indications of any agenda beyond a
dispassionate evaluation of the facts
applied to the applicable standard. His
testimony was persuasive, and in this
case, his opinions are entitled to
controlling weight.
The Respondent’s Case
The Respondent’s case consisted
exclusively of his own testimony.
34
He
testified that he currently maintains a
private internal medicine practice that
treats physical and mental health issues
in what he characterizes as ‘‘an
underprivileged and lower
socioeconomic population of the
Richmond area, and particularly the
inner city [of] Richmond.’’ Tr. 353–54.
The Respondent reckons that he is
treating twenty to thirty percent of his
private practice patients with opioids.
Id. at 353–56.
In addition to the Respondent’s
private practice, he testified that he also
works at two rehabilitation hospitals
run by Encompass,
35
which he describes
as ‘‘a national corporation that is
running inpatient rehabilitation
hospitals as well as outpatient home
health agencies.’’ Id. at 365. The
Respondent explained that in his
hospital practice he manages the post-
acute care of patients discharged from
acute care facilities. Id. The Respondent
related that the hospital aspect of his
practice involves pain management to
the extent he fills in for staff physiatrists
when they are unavailable.
36
Id. at 369.
According to the Respondent, between
his private practice and hospital
responsibilities, he is currently at work
seven days a week. Id. at 368.
The Respondent remembered the TFO
and remembered his interactions with
him as patient Scott Davis. Id. at 376,
378–79. In that regard, the Respondent
testified that he was unable to
specifically recall whether he conducted
a straight-leg raise on the patient, but
was of the opinion that he would have,
because it is his custom to do so. Id. at
381. The Respondent related that he
observed the patient walk
approximately thirty to forty feet inside
the office on his way out, and
specifically recalled directing him to
office staff to guide him on procuring an
x-ray. Id. at 381–82. He testified that he
assessed the amount of Percocet the
TFO disclosed as previously prescribed
as a ‘‘large dosage.’’ Id. at 378. The
Respondent described himself as being
‘‘cognizant of [his patients’] financial
struggles’’ and attributed his decision to
prescribe pain medication without
reviewing imaging as justified by his
desire ‘‘to help a construction worker
get through the day without having to
lose his job.’’ Id. at 383; see also id. at
426–27. He also noted, that in his
opinion, the risks associated with the
tramadol he prescribed to the TFO are
curtailed by the drug’s ‘‘very low
addictive potential.’’ Id. at 383. It was
this same low-addictive-risk estimation
that also persuaded the Respondent to
discount the TFO’s admission that he
had procured drugs illegally through his
friend and girlfriend. Id. at 384. When
prompted by his counsel, the
Respondent expressed recognition that
this was an errant course of action,
because ‘‘I have to be very strict with
the DEA rules,’’ and if asked to do so
again, the Respondent represented that
he ‘‘will wholeheartedly counsel them
for a long time.’’ Id.
The Respondent acknowledged that,
after listening to the testimony of the
Government’s expert, his medical
examination of the TFO was not as
thorough as it should have been, and
that under the circumstances, his
prescribing of Ativan, and combining
medications as he did, was a mistake.
Id. at 384–85, 387. The Respondent
represented that he ‘‘take[s]
responsibility.’’ Id. at 385. During his
testimony, he provided assurances that
he has (after practicing medicine for
approximately seventeen years) recently
taken continuing medical education
courses
37
so that he now understands
the basic elements for a rudimentary
physical examination. Id. at 384–85.
The Respondent’s limited confessions
of error notwithstanding, the issue of
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38
Tr. 81–82, 90–91, 133.
39
Gov’t Ex. 1, at 7.
40
The Respondent also sought support in reports
he obtained from the PMP administrators regarding
the relative percentage of his controlled substance
prescribing compared to his peers. Resp’t Ex. 7; Tr.
362–64. However, the value of this evidence was
mortally undermined by the designation on the
printout that the Respondent was being compared
to geriatric medicine practitioners. Resp’t Ex. 7; Tr.
434–35. The Respondent theorized that his PMP
designation may have been a residual effect from a
time when he did a lot of work in nursing homes.
Tr. 436. Dr. Dombrowski persuasively testified that
because physicians treating geriatric patients tend
to prescribe higher amounts of pain medication due
to the chronic problems associated with age, the
comparison of geriatric practice with the
Respondent’s practice is not a relevant one. Tr.
440–41. Accordingly, this evidence is of negligible
value in these proceedings.
41
There was no indication in the record that the
TFO would have been utilizing an ‘‘outlying
pharmacy,’’ or what geographic location constituted
a pharmacy to be ‘‘outlying.’’
whether he comprehends and accepts
that he was wrong presents as entirely
unclear on this record. He took issue
with the TFO’s recollection that he
palpated his back for one-to-two
seconds,
38
and maintained that it was
really a six-to-seven second evolution.
Id. at 386. The Respondent also
quibbled with the time spent with the
patient during UC Visit #3, pushing
back on the testimony that it was only
two minutes, suggesting that it may
have been three. Id. at 388–89. The
Respondent explained that he
prescribed Ativan because he recalled a
reference to anxiety on the TFO’s intake
form.
39
Id. at 387. More fundamentally,
when asked if he issued the
prescriptions to the TFO for a legitimate
medical purpose, all ambiguity fled
him, and he responded with an
unequivocal ‘‘I surely did. There was
nothing illegitimate about it.’’ Id. at 427.
Additionally, even though the evidence
reflected that the exams memorialized
in his progress notes never occurred
during any of the UC Visits, the
Respondent would only offer, ‘‘I’m not
sure, I may not have [conducted those
exams],’’ and, ‘‘I may have, I may not
have. I was on autopilot and . . . there
may be errors in the documentation.’’
Id. at 430, 432, 433. The Respondent
would not concede that notes reflecting
examinations clearly shown as fictional
by the UC Visit recordings were in fact
false, offering ‘‘I am not sure if it is or
not’’ and ‘‘I cannot be conclusive about
it.’’ Id. at 432–34. The strongest
admission on this issue that he could
muster during his testimony was the
possibility of an ‘‘error in
documentation.’’ Id. at 433. Indeed, the
Respondent insisted that each charged
prescription was issued for a legitimate
medical purpose because ‘‘I do not issue
prescriptions for illegitimate medical
purposes,’’ and clarified that he has ‘‘no
doubts about it.’’ Id. at 427–28.
Likewise, the Respondent was equally
committed to the proposition that every
one of the charged prescriptions was
issued in the usual course of
professional practice, asserting that he
was ‘‘[a]bsolutely acting in the course of
[his] medical practice.’’ Id. at 429.
In addressing the boost in tramadol
that occurred unsolicited at the
conclusion of UC Visit #3, the
Respondent explained the increase by
saying that he ‘‘became a bit more
comfortable with the patient,’’ because
he was not seeking early refills and he
‘‘felt that [the TFO] was not diverting
any—there was no signs of diversion—
no signs of doctor shopping.’’ Id. at 391–
92; see also id. at 393–94. The
Respondent’s basis for concluding that
the patient was not doctor shopping was
based on his review of PMP data. Id. at
392. Interestingly, a review of PMP data
would have also informed the
Respondent that the prescriptions he
issued to the TFO were never actually
dispensed, but the Respondent testified
that doctor shopping was essentially his
exclusive focus in reviewing PMP
data.
40
The Respondent ascribed his
discounting of the information about the
no-fills based on his view that
pharmacies, particularly ‘‘outlying
pharmacies,’’
41
frequently do not enter
dispensing data into the PMP. Id. at 393.
He testified that he declined to follow
up on this potential anomaly because
‘‘[i]t’s very time-consuming.’’ Id. at 395.
Thus, the Respondent by his own
admission ascribed confidence in the
PMP insofar as it reflected no other
prescribers, but none to the extent that
the prescribed medications were not
being filled. Id. at 393–95.
On the issue of remedial steps, the
Respondent testified that he has
completed numerous continuing
medical education courses (hereinafter,
CME) aimed at improving his controlled
substance prescribing practices, and that
some of the courses provided him with
valuable information. Resp’t Exs. 2–5;
Tr. 384–85, 398–415. The Respondent
testified that the CME he completed was
done online with a quiz administered at
the conclusion. Tr. 414–21. The
Respondent also offered the corrective
action plan (hereinafter, CAP) that he
had apparently filed with the Agency in
accordance with 21 U.S.C. 824(c)(3).
Resp’t Ex. 8; Tr. 421–22. The CAP
modestly proposes that the Respondent
will take two specified CMEs (and such
other additional CMEs which may be
designated by DEA). Resp’t Ex. 8. The
CAP further proposes that the
Respondent is willing to undergo a
period of ‘‘partial suspension’’ of his
COR pending completion of these CMEs
that will restrict him to prescribing
under Schedules IV and V. Id.
The Respondent testified that these
proceedings have emotionally affected
him in a way that is more grave than the
COVID–19 epidemic. Tr. 424. His
sleeping has been affected and he
describes himself as being ‘‘anxious all
the time.’’ Id. The Respondent offered
assurances that he ‘‘will not prescribe
until [he] ha[s] the data,’’ and that
although ‘‘[i]n the past, in [his] practice,
[he] used to cut people breaks. [He] will
not do that anymore, [he]’ll be 100
percent by the book and by the rules.’’
Id. at 424–25. The Respondent then
proposed the novel argument that he
had no intention of ever even using his
COR to prescribe controlled substances
(i.e., to conduct the regulated activity
that is authorized by a DEA
registration), but that he merely wanted
to maintain his registered status to assist
him in securing employment. Id. at 425–
26.
It is beyond argument that the
Respondent is the witness with the most
at stake in these proceedings, and thus,
is the witness with the greatest
pressures to influence his perspective
and testimony. However, even apart
from these considerations, there was
much in the Respondent’s presentation
that devalued his credibility and the
force that can be attached to his
testimony. When faced with
examinations that he noted in his
progress notes, which he plainly saw
did not take place in the UC Visit
videos, the Respondent was unwilling
to admit what his eyes could scarcely
deny: He did not perform the
examinations he documented. Id. at
432–33. Even after agreeing with much
of Dr. Dombrowski’s testimony, the
Respondent relentlessly adhered to his
position that his prescriptions were
issued for a legitimate medical purpose
and in the usual course of a professional
medical practice. Id. at 427–29. His
unambiguous commitments to prescribe
within the applicable standard of care in
the future were matched with his
equally unambiguous commitment to
never prescribe again so long as the
Agency maintains him in status so that
he can secure medical employment. Id.
at 424–26. The only thing that appeared
sure about the Respondent’s testimony
was an apparent commitment to saying
anything under oath that might induce
the Agency to continue him in status.
That is not to say that the Respondent’s
testimony was completely bereft of any
reliability. Indeed, there were
biographical and other elements of his
testimony that can be credited, but
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where (as happened not infrequently
here) his testimony stands in conflict
with other reliable evidence of record, it
must be viewed with great caution and
skepticism.
Other facts required for a disposition
of the present case are set forth in the
balance of this decision.
The Analysis
Public Interest Determination: The
Standard
Under 21 U.S.C. 824(a)(4), the Agency
may revoke the DEA registration of a
registrant if the registrant ‘‘has
committed such acts as would render
his registration . . . inconsistent with
the public interest.’’ 21 U.S.C. 824(a)(4).
Congress has circumscribed the
definition of public interest in this
context by directing consideration of the
following factors:
(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The [registrant’s] experience in
dispensing, or conducting research with
respect to controlled substances.
(3) The [registrant’s] conviction record
under Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
21 U.S.C. 823(f).
‘‘These factors are to be considered in
the disjunctive.’’ Robert A. Leslie, M.D.,
68 FR 15,227, 15,230 (2003). Any one or
a combination of factors may be relied
upon, and when exercising authority as
an impartial adjudicator, the Agency
may properly give each factor whatever
weight it deems appropriate in
determining whether a registrant’s DEA
registration should be revoked. Id.; see
Morall v. DEA, 412 F.3d 165, 173–74
(D.C. Cir. 2005). Moreover, the Agency
is ‘‘not required to make findings as to
all of the factors,’’ Hoxie v. DEA, 419
F.3d 477, 482 (6th Cir. 2005); Morall,
412 F.3d at 173, and is not required to
discuss consideration of each factor in
equal detail, or even every factor in any
given level of detail. Trawick v. DEA,
861 F.2d 72, 76 (4th Cir. 1988) (holding
that the Administrator’s obligation to
explain the decision rationale may be
satisfied even if only minimal
consideration is given to the relevant
factors, and that remand is required
only when it is unclear whether the
relevant factors were considered at all).
The balancing of the public interest
factors ‘‘is not a contest in which score
is kept; the Agency is not required to
mechanically count up the factors and
determine how many favor the
Government and how many favor the
registrant. Rather, it is an inquiry which
focuses on protecting the public interest
. . . .’’ Jayam Krishna-Iyer, M.D., 74 FR
459, 462 (2009).
In adjudicating a revocation of a DEA
registration, the DEA has the burden of
proving that the requirements for the
revocation it seeks are satisfied. 21 CFR
1301.44(e). Where the Government has
met this burden by making a prima facie
case for revocation of a registrant’s COR,
the burden of production then shifts to
the registrant to show that, given the
totality of the facts and circumstances in
the record, revoking the registrant’s COR
would not be appropriate. Med. Shoppe-
Jonesborough, 73 FR 364, 387 (2008).
Further, ‘‘to rebut the Government’s
prima facie case, [the Respondent] is
required not only to accept
responsibility for [the established]
misconduct, but also to demonstrate
what corrective measures [have been]
undertaken to prevent the re-occurrence
of similar acts.’’ Jeri Hassman, M.D., 75
FR 8194, 8236 (2010); accord Krishna-
Iyer, 74 FR at 464 n.8. In determining
whether and to what extent a sanction
is appropriate, consideration must be
given to both the egregiousness of the
offense established by the Government’s
evidence and the Agency’s interest in
both specific and general deterrence.
David A. Ruben, M.D., 78 FR 38,363,
38,364, 38,385 (2013).
Normal hardships to the registrant,
and even to the surrounding
community, which are attendant upon
lack of registration, are not a relevant
consideration. See Linda Sue Cheek,
M.D., 76 FR 66,972, 66,972–73 (2011);
Gregory D. Owens, D.D.S., 74 FR 36,751,
36,757 (2009). Further, the Agency’s
conclusion that ‘‘past performance is the
best predictor of future performance’’
has been sustained on review in the
courts, Alra Labs., Inc. v. DEA, 54 F.3d
450, 452 (7th Cir. 1995), as has the
Agency’s consistent policy of strongly
weighing whether a registrant who has
committed acts inconsistent with the
public interest has accepted
responsibility and demonstrated that he
or she will not engage in future
misconduct. Hoxie, 419 F.3d at 483; see
also Ronald Lynch, M.D., 75 FR 78,745,
78,754 (2010) (holding that the
respondent’s attempts to minimize
misconduct undermined acceptance of
responsibility); George Mathew, M.D.,
75 FR 66,138, 66,140, 66,145, 66,148
(2010); George C. Aycock, M.D., 74 FR
17,529, 17,543 (2009); Krishna-Iyer, 74
FR at 463; Steven M. Abbadessa, D.O.,
74 FR 10,077, 10,078 (2009); Med.
Shoppe-Jonesborough, 73 FR at 387.
Although the burden of proof at this
administrative hearing is a
preponderance-of-the-evidence
standard, see Steadman v. SEC, 450 U.S.
91, 100–03 (1981), the Agency’s
ultimate factual findings will be
sustained on review to the extent they
are supported by ‘‘substantial
evidence.’’ Hoxie, 419 F.3d at 481–82.
While ‘‘the possibility of drawing two
inconsistent conclusions from the
evidence’’ does not limit the
Administrator’s ability to find facts on
either side of the contested issues in the
case, Shatz v. U.S. Dep’t of Justice, 873
F.2d 1089, 1092 (8th Cir. 1989), all
‘‘important aspect[s] of the problem,’’
such as a respondent’s defense or
explanation that runs counter to the
Government’s evidence, must be
considered. Wedgewood Vill. Pharmacy
v. DEA, 509 F.3d 541, 549 (D.C. Cir.
2007); see Humphreys v. DEA, 96 F.3d
658, 663 (3d Cir. 1996). The ultimate
disposition of the case ‘‘must be ‘in
accordance with’ the weight of the
evidence, not simply supported by
enough evidence ‘to justify, if the trial
were to a jury, a refusal to direct a
verdict when the conclusion sought to
be drawn from it is one of fact for the
jury.’ ’’ Steadman, 450 U.S. at 99
(quoting Consolo v. FMC, 303 U.S. 607,
620 (1966)).
Regarding the exercise of
discretionary authority, the courts have
recognized that gross deviations from
past Agency precedent must be
adequately supported, Morall, 412 F.3d
at 183, but mere unevenness in
application does not, standing alone,
render a particular discretionary action
unwarranted. Chein v. DEA, 533 F.3d
828, 835 (D.C. Cir. 2008), cert. denied,
555 U.S. 1139 (2009); cf. Dep’t of
Homeland Security v. Regents of Univ.
of Cal., No. 18–587, 592 U.S. __, slip op.
at 22–23 (June 18, 2020) (holding that an
agency must carefully justify significant
departures from prior policy where
reliance interests are implicated). It is
well settled that, because the
Administrative Law Judge has had the
opportunity to observe the demeanor
and conduct of hearing witnesses, the
factual findings set forth in this
recommended decision are entitled to
significant deference, see Universal
Camera Corp. v. NLRB, 340 U.S. 474,
496 (1951), and that this recommended
decision constitutes an important part of
the record that must be considered in
the Agency’s final decision. Morall, 412
F.3d at 179. However, any
recommendations set forth herein
regarding the exercise of discretion are
by no means binding on the
Administrator and do not limit the
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42
ALJ Ex. 19, at 29.
43
The record contains no recommendation from
any state licensing board or professional
disciplinary authority (Factor One), but, aside from
cases establishing a complete lack of state authority,
the presence or absence of such a recommendation
has not historically been a case-dispositive issue
under the Agency’s precedent. Patrick W. Stodola,
M.D., 74 FR 20,727, 20,730 (2009); Krishna-Iyer, 74
FR at 461. Similarly, there is no record evidence of
a conviction record relating to regulated activity
(Factor Three). Even apart from the fact that the
plain language of this factor does not appear to
emphasize the absence of such a conviction record,
myriad considerations are factored into a decision
to initiate, pursue, and dispose of criminal
proceedings by federal, state, and local prosecution
authorities which lessen the logical impact of the
absence of such a record. See Robert L. Dougherty,
M.D., 76 FR 16,823, 16,833 n.13 (2011); Dewey C.
MacKay, M.D., 75 FR 49,956, 49,973 (2010)
(‘‘[W]hile a history of criminal convictions for
offenses involving the distribution or dispensing of
controlled substances is a highly relevant
consideration, there are any number of reasons why
a registrant may not have been convicted of such
an offense, and thus, the absence of such a
conviction is of considerably less consequence in
the public interest inquiry.’’), aff’d, MacKay v. DEA,
664 F.3d 808 (10th Cir. 2011); Ladapo O. Shyngle,
M.D., 74 FR 6056, 6057 n.2 (2009). Therefore, the
absence of criminal convictions militates neither for
nor against the revocation sought by the
Government. Because the Government’s allegations
and evidence fit squarely within the parameters of
Factors Two and Four and do not raise ‘‘other
conduct which may threaten the public health and
safety,’’ see 21 U.S.C. 823(f)(5), Factor Five militates
neither for nor against the sanction sought by the
Government in this case.
exercise of that discretion. 5 U.S.C.
557(b); River Forest Pharmacy, Inc. v.
DEA, 501 F.2d 1202, 1206 (7th Cir.
1974); Attorney General’s Manual on the
Administrative Procedure Act § 8(a)
(1947).
Factors Two and Four: The
Respondent’s Experience Dispensing
Controlled Substances and Compliance
With Federal, State, and Local Law
The Government has founded its
theory for sanction exclusively on
Public Interest Factors Two and Four,
42
and it is under those two factors that the
lion’s share of the evidence of record
relates.
43
In this case, the gravamen of
the allegations in the OSC, as well as the
factual concentration of much of the
evidence presented, share as a principal
focus the manner in which the
Respondent has managed that part of his
practice relative to prescribing
controlled substances and acts allegedly
committed in connection with that
practice. Thus, it is analytically logical
to consider Public Interest Factors Two
and Four together. That being said,
Factors Two and Four involve analysis
of both common and distinct
considerations.
The DEA regulations provide that to
be effective, a prescription must be
issued for a legitimate medical purpose
by a practitioner acting in the usual
course of professional practice. 21 CFR
1306.04(a). The Supreme Court has
opined that, ‘‘the prescription
requirement . . . ensures patients use
controlled substances under the
supervision of a doctor so as to prevent
addiction and recreational abuse.’’
Gonzales v. Oregon, 546 U.S. 243, 274
(2006). Further, the Agency’s authority
to revoke a registration is not limited to
instances where a practitioner has
intentionally diverted controlled
substances. Bienvenido Tan, 76 FR
17,673, 17,689 (2011); see MacKay, 75
FR at 49,974 n.35 (holding that
revocation is not precluded merely
because the conduct was
‘‘unintentional, innocent, or devoid of
improper motive’’).
To effectuate the dual goals of
conquering drug abuse and controlling
both legitimate and illegitimate traffic in
controlled substances, ‘‘Congress
devised a closed regulatory system
making it unlawful to manufacture,
distribute, dispense, or possess any
controlled substance except in a manner
authorized by the [Controlled
Substances Act (CSA)].’’ Gonzales v.
Raich, 545 U.S. 1, 13 (2005). Consistent
with the maintenance of that closed
regulatory system, subject to limited
exceptions not relevant here, a
controlled substance may only be
dispensed upon a prescription issued by
a practitioner, and such a prescription is
unlawful unless it is ‘‘issued for a
legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 U.S.C. 829; 21 CFR
1306.04(a). Furthermore, ‘‘[a]n order
purporting to be a prescription issued
not in the usual course of professional
treatment . . . is not a prescription
within the meaning and intent of [21
U.S.C. 829] and the person knowingly
. . . issuing it, shall be subject to the
penalties provided for violations of the
provisions of law relating to controlled
substances.’’ 21 CFR 1306.04(a).
The prescription requirement is
designed to ensure that controlled
substances are used under the
supervision of a doctor, as a bulwark
against the risk of addiction and
recreational abuse. Aycock, 74 FR at
17,541 (citing Gonzales, 546 U.S. at
274); United States v. Moore, 423 U.S.
122, 135, 142–43 (1975) (noting that
evidence established that a physician
exceeded the bounds of professional
practice when he gave inadequate
examinations or none at all, ignored the
results of the tests he did make, and
took no precautions against misuse and
diversion). The prescription
requirement likewise stands as a
proscription against doctors ‘‘peddling
to patients who crave the drugs for those
prohibited uses.’’ Aycock, 74 FR at
17,541 (citing Gonzales, 546 U.S. at
274). A registered practitioner is
authorized to dispense, which the CSA
defines as ‘‘to deliver a controlled
substance to an ultimate user . . . by, or
pursuant to the lawful order of, a
practitioner.’’ 21 U.S.C. 802(10); see also
Rose Mary Jacinta Lewis, 72 FR 4035,
4040 (2007). The courts have sustained
criminal convictions based on the
issuing of illegitimate prescriptions
where physicians conducted no
physical examinations or sham physical
examinations. United States v. Alerre,
430 F.3d 681, 690–91 (4th Cir. 2005),
cert. denied, 574 U.S. 1113 (2006);
United States v. Norris, 780 F.2d 1207,
1209 (5th Cir. 1986).
While true that the CSA authorizes
the ‘‘regulat[ion of] medical practice
insofar as it bars doctors from using
their prescription-writing powers as a
means to engage in illicit drug dealing
and trafficking as conventionally
understood,’’ Gonzales, 546 U.S. at 909–
10, an evaluation of cognizant state
standards is essential. Joseph Gaudio,
M.D., 74 FR 10,083, 10,090 (2009);
Kamir Garces-Mejias, M.D., 72 FR
54,931, 54,935 (2007); United
Prescription Servs., Inc., 72 FR 50,397,
50,407 (2007). In this adjudication, the
evaluation of the Respondent’s
prescribing practices must be consistent
with the CSA’s recognition of state
regulation of the medical profession and
its bar on physicians from engaging in
unlawful prescribing. Aycock, 74 FR at
17,541. The analysis must be ‘‘tethered
securely’’ to state law and federal
regulations in application of the public
interest factors, and may not be based
on a mere disagreement between experts
as to the most efficacious way to
prescribe controlled substances to treat
chronic pain. Volkman v. DEA, 567 F.3d
215, 223 (6th Cir. 2009) (citing
Gonzales, 546 U.S. at 272, 274).
Under the CSA, it is fundamental that
a practitioner establish and maintain a
bona fide doctor-patient relationship in
order to act ‘‘in the usual course of . . .
professional practice and to issue a
prescription for a legitimate medical
purpose.’’ Mackay, 75 FR at 49,973
(internal quotations omitted); Stodola,
74 FR at 20731; Shyngle, 74 FR at 6057–
58 (citing Moore, 423 U.S. at 141–43).
The CSA generally looks to state law to
determine whether a bona fide doctor-
patient relationship was established and
maintained. Stodola, 74 FR at 20,731;
Shyngle, 74 FR at 6058; Garces-Mejias,
72 FR at 54,935; United Prescription
Servs., 72 FR at 50407.
Here, the relevant provisions of state
law largely mirror the CSA and its
regulations where they do not go
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44
21 U.S.C. 802(21), 823(f).
45
Regarding the prescribing of controlled
substances, the Virginia Code specifically requires
compliance with federal telemedicine provisions
which do not impact the current proceedings. Va.
Code Ann. §54.1–3303(B).
46
Tr. 427–29.
47
[Footnote omitted.]
*I
Although Dr. Dombrowski testified that
Respondent did not comply with ethical standards,
see Tr. 287, the Government did not notify
Respondent of this testimony in the OSC or in its
prehearing statements. Therefore, I do not consider
the Government’s allegations with respect to
subsection twelve in my public interest analysis.
*J
I find that the OSC provided adequate notice of
the Virginia Code subsections that the Government
charged Respondent with having violated. Although
the Chief ALJ did not sustain these allegations
based in part, because there were ‘‘multiple
potential factual scenarios [] available under a
single statutory scheme,’’ and the Government did
not sufficiently specify the application of the facts
to the alleged violations, see RD, at 30, upon further
review, I find that the Government quoted from four
subsections of Va. Code Ann. §54.1–2915(A) in
paragraph five, and then identified the
prescriptions in paragraph six that violated the state
laws enumerated in paragraph five. See OSC, at ¶¶
5.c, 6. The Government afforded Respondent the
opportunity to prepare a defense by identifying
each subsection of the Virginia Code at issue, and
by providing a factual basis for its allegations that
Respondent could have harmed or injured a patient.
See, e.g., OSC, at 5–7 (noting that Respondent
prescribed opioids and benzodiazepines
concurrently, and that the concurrent prescribing of
these drugs ‘‘poses a significant risk of addiction or
other adverse consequences’’); Gov’t Prehearing, at
19, 22, 25 (same); id. at 14 (stating that Dr.
Dombrowski was expected to testify that
‘‘Respondent’s actions put Patient S.D. at risk for
harm, including addiction or other adverse medical
outcomes;’’) see also Darrell Risner, D.M.D., 61 FR
728, 730 (1996) (‘‘[T]he parameters of the hearing
are determined by the prehearing statements.’’).
Although I agree that the charging documents
would have benefited from further explanation, I
find that the prehearing statement and the OSC
together provided adequate notice in order for the
Respondent to ‘‘be timely informed of . . . the
matters of fact and law asserted.’’ 5 U.S.C. 554(b)(3);
see also 21 CFR 1301.37(c) (requiring that the OSC
‘‘contain a statement of the legal basis for [a]
hearing and for the denial, revocation, or
suspension of registration and a summary of the
matters of fact and law asserted’’). Previous Agency
Decisions have stated that ‘‘[t]he primary function
of notice is to afford [a] respondent an opportunity
to prepare a defense by investigating the basis of the
complaint and fashioning an explanation that
refutes the charge of unlawful behavior.’’ Wesley
Pope, M.D., 82 FR 14,944, 14,947 (2017) (internal
citation omitted). Because I have found that these
allegations were adequately noticed, I have added
this section addressing these allegations.
beyond it. Compare Va. Code Ann.
§ 54.1–3303(C) with 21 CFR 1304.06(a).
Section 54.1–3303(A), like its CSA
counterpart,
44
limits controlled
substance prescribing to licensed
practitioners. The Virginia Code also
requires that a bona fide patient-
practitioner relationship precede the
issuing of all prescriptions (controlled
and non-controlled)
45
in the state. Va.
Code Ann. § 54.1–3303(B). The elements
of a bona fide patient-practitioner
relationship are spelled out in the code,
and require that prior to prescribing, the
practitioner must have:
(i) Obtained or caused to be obtained a
medical or drug history of the patient; (ii)
provided information to the patient about the
benefits and risks of the drug being
prescribed; (iii) performed or caused to be
performed an appropriate examination of the
patient, either physically or by the use of
instrumentation and diagnostic equipment
through which images and medical records
may be transmitted electronically; and (iv)
initiated additional interventions and follow-
up care, if necessary, especially if a
prescribed drug may have serious side
effects. Except in cases involving a medical
emergency, the examination required
pursuant to clause (iii) shall be performed by
the practitioner prescribing the controlled
substance, a practitioner who practices in the
same group as the practitioner prescribing
the controlled substance, or a consulting
practitioner.
Id.
The Virginia Administrative Code
provides further direction for
practitioners prescribing opioids for
chronic pain. 18 Va. Admin. Code § 85–
21–60. Under this provision:
Prior to initiating management of chronic
pain with a controlled substance containing
an opioid, a medical history and physical
examination, to include a mental status
examination, shall be performed and
documented in the medical record,
including: (1) The nature and intensity of the
pain; (2) current and past treatments for pain;
(3) underlying or coexisting diseases or
conditions; (4) the effect of the pain on
physical and psychological function, quality
of life, and activities of daily living; (5)
psychiatric, addiction, and substance misuse
history of the patient and any family history
of addiction or substance misuse; (6) a urine
drug screen or serum medication level; (7) a
query of the [PMP]; (8) an assessment of the
patient’s history and risk of substance
misuse; and (9) a request for prior applicable
records.
Va. Admin. Code § 85–21–60(A).
Furthermore, prior to opioid drug
treatment initiation, the prescribing
doctor is required to counsel the patient
on known risks and benefits of opioid
therapy, patient responsibilities
regarding storing and disposal, and a
treatment exit strategy. Id.
The applicable Virginia Code
provisions are completely consistent
with the standards as outlined by the
Government’s expert, Dr. Dombrowski.
Tr. 179, 183–88, 199, 211–12. Beyond
the specified elements of the requisite
relationship, history, examination,
counseling, and follow-up care, Dr.
Dombrowski explained that informed
consent, exit strategy counseling, and
adequate documentation also comprise
vital parts of the prescribing standards
in Virginia. Tr. 184–91. Beyond the
Respondent’s unsupported protestations
that all of his controlled substance
prescribing has been legal,
46
the
testimony of the Government’s expert
stands uncontroverted on the present
record. When an administrative tribunal
elects to disregard the uncontradicted
opinion of an expert, it runs the risk of
improperly declaring itself as an
interpreter of medical knowledge. Ross
v. Gardner, 365 F.2d 554 (6th Cir. 1966).
There is no shortage of reliable expert
knowledge in the present record, it is
uncontroverted, and it is not favorable
to the Respondent.
In reviewing the evidence of record
(including the stipulations of the
parties), and applying the consistent
and unchallenged controlled substance
prescribing standards applicable in
Virginia, the evidence preponderantly
establishes the Respondent’s registration
and practitioner status, as well as the
Government’s allegations that he
prescribed controlled substances to the
TFO during the course of four
undercover visits. Accordingly, OSC
allegations 3, 6, 7, 8, 9, 11, 12, 15, 16,
19, and 20 are SUSTAINED.
The OSC in this case also alleges that
the Respondent engaged in
unprofessional conduct as that term is
defined in the Virginia Code.
47
ALJ Ex.
1, at ¶¶ 10, 14, 18, 22. [Specifically, the
OSC alleges violations of four
subsections of Va. Code Ann. § 54.1–
2915. ALJ Ex. 1 at ¶ 5.c (stating that
‘‘Va. Code Ann. § 54.1–2915(A) defin[es]
unprofessional conduct as including,
among other things: [3] ‘[i]ntentional or
negligent conduct in the practice of any
branch of the healing arts that causes or
is likely to cause injury to a patient or
patients;’ [12] ‘[c]onducting his practice
in a manner contrary to the standards of
ethics of his branch of the healing
arts;’
*I
[13] ‘[c]onducting his practice in
such a manner as to be a danger to the
health and welfare of his patients or to
the public;’ and [17] ‘[v]iolating any
provision of statute or regulation, state
or federal, relating to the manufacture,
distribution, dispensing, or
administration of drugs’’); id. at ¶¶ 6
(stating that Respondent issued four
prescriptions in violation of ‘‘federal
and Virginia law noted in paragraphs 4–
5, above’’).
*J
I find that Respondent
violated subsections three and thirteen,
based on Dr. Dombrowski’s testimony
confirming that Respondent engaged in
conduct that was likely to injure Patient
SD, as well as Dr. Dombrowski’s
testimony that Respondent committed
numerous treatment failures that led to
the prescribing of controlled substances
outside of the applicable standard of
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*K
The RD states that ‘‘DEA is without authority
to hold that a registrant has committed
unprofessional conduct regarding the practice of
medicine, a clear function of the state’s police
powers.’’ RD, at 30 (citing Gonzales, 546 U.S. at
274). While I agree with the Chief ALJ that findings
on these matters often require expertise in assessing
unprofessional conduct that the Agency lacks, the
state law violations in this case were supported by
the unrebutted testimony of a Virginia medical
expert, Dr. Dombrowski. Dr. Dombrowski testified
that Respondent prescribed a dangerous
combination of controlled substances without
‘‘engaging in any precautionary and follow-up
steps,’’ Tr. 239–44, 283, and he confirmed that
Respondent’s conduct was likely to cause injury to
Patient SD. Id. at 286. Therefore, I find that Dr.
Dombrowski’s testimony provides a basis for
sustaining these state law violations.
Although I am considering these additional
allegations of violations of state law, they ultimately
do not add substantially to my analysis under
Factors Two and Four. I agree with the Chief ALJ
that these violations further support my conclusion
that Respondent’s prescribing fell below the
applicable standard of care in Virginia. See RD, at
31 n.49 (‘‘[C]onduct which falls within a state’s
definition of unprofessional conduct (or is
otherwise improper under state law), which
supports the proposition that a practitioner’s
prescribing fell below the applicable standard of
care (as is the case here), will generally be
supportive of a finding that a registrant’s controlled
substance prescribing was in violation of the
CSA.’’).
48
[Footnote omitted.]
49
[Content of footnote discussed above, see supra
n.*K.]
50
[The RD took official notice, pursuant to 5
U.S.C. 556(e) and 21 CFR 1316.59(e), that naloxone
was an opioid antagonist that is commonly used to
counter the effects of an opioid overdose and/or
adverse reaction. RD, at 31 n.50 (citing 81 FR 44,714
(2016)). The RD notified the parties that they may
file objections to this official notice within fifteen
calendar days from receipt of the RD. Id. Neither
party filed objections, so I adopt the Chief ALJ’s
finding.]
51
The Government’s expert witness, Dr.
Dombrowski, did not include the prescribing of
naloxone within the elements required to satisfy the
Virginia controlled substance prescribing standard
of care.
*L
Text deleted for consistency with my finding
below that the violation of the Virginia Naloxone
Regulation is sufficiently related to the CSA’s core
purposes to be considered under Factor Four.
*M
Modified for clarification.
*N
Citations omitted. I have also deleted text for
consistency with my finding below that the
violation of the Virginia Naloxone Regulation is
sufficiently related to the CSA’s core purposes to be
considered under Factor Four.
*O
We have previously identified the CSA’s core
purposes of preventing drug abuse and diversion by
analyzing the statute’s legislative history. See, e.g.,
John O. Dimowo, M.D., 85 FR 15,800, 15,810 n.K,
M (2020); Fred Samimi, M.D., 79 FR 18,698,
18,709–10 (2014). As further discussed herein, it is
axiomatic that another core purpose of the CSA is
to protect patients from the drug-related deaths and
injuries that may result from drug abuse and
diversion. This core purpose is evident in the CSA’s
legislative history and underlies the entire statute.
In 1984, Congress expanded DEA’s authority to
deny practitioners’ applications for DEA
registrations by adding the public interest factors to
Section 823. Controlled Substances Penalties
Amendments Act of 1984, Public Law 98–473, 511,
98 Stat. 1837, 2073 (1984) (codified at 21 U.S.C.
823(f)(1)–(5)). Prior to the addition of these public
interest factors, DEA’s grounds to deny a
practitioner’s application were limited. DEA was
required to grant an application unless the
applicant was not ‘‘authorized to dispense . . .
[controlled substances] under the law of the State
in which they practice[d].’’ Controlled Substances
Act, Public Law 91–513, 303, 84 Stat. 1236, 1255
(1970) (codified at 21 U.S.C. 823(f)). The Senate
Report explained that because of DEA’s ‘‘very
limited’’ grounds for denial, the Controlled
Substances Act had not been very effective at
addressing diversion at the practitioner level, where
eighty to ninety percent of diversion occurs. Senate
Report, at 261–62, 1984 U.S.C.C.A.N., at 3443–44.
Thus, the public interest factors were added to
‘‘strengthen the Government’s authority to regulate
controlled substances.’’ Senate Report, at 262, 1984
U.S.C.C.A.N., at 3444.
The Senate Report observed that ‘‘[i]t is estimated
that between 60 and 70 percent of all drug-related
deaths and injuries involve drugs that were
originally part of the legitimate drug production
and distribution chain.’’ Senate Report, at 260, 1984
U.S.C.C.A.N., at 3442. The CSA seeks to prevent
these drug-related deaths and injuries by
‘‘maintaining . . . [a] ’closed’ system at the
practitioner level. Senate Report, at 262, 1984
U.S.C.C.A.N., at 3444. The CSA’s focus on patient
safety is evident in the Senate Report’s discussion
of the procedures for scheduling drugs. The Senate
Report observes that it is important to have swift
procedures for scheduling new drugs, because of
the ‘‘significant health problem[s]’’ that may result
when an ‘‘as yet uncontrolled drug rapidly enters
the illicit market.’’ Id. Indeed, drugs are designated
as controlled substances precisely because of their
potential to harm patients. See, e.g., Senate Report,
at 261, 1984 U.S.C.C.A.N., at 3443 (noting that
drugs are placed into one of five schedules ‘‘based
on the severity of the abuse potential of a particular
drug, the extent to which it leads to physical or
psychological dependence, and has an accepted
medical use . . .’’). Thus, at its core, the CSA seeks
to protect patients from the adverse health
consequences that may result from dangerous and
addictive drugs. Therefore, as found below, my
consideration under Factor Four of a state law
violation that significantly increases the risk of
these adverse consequences is related to a core
purpose of the CSA.
52
18 Va. Admin. Code §85–21–70(B)(3).
*
P
Respondent issued concurrent prescriptions to
Patient SD for opioids and benzodiazepines on
August 28, 2019; September 27, 2019; and
November 5, 2019, but he failed to prescribe
naloxone, as required by state law. Tr. 93–94, 101,
116; Gov’t Ex. 5, 8, 11; 18 Va. Admin. Code §85–
21–70(B)(3) (requiring naloxone to be prescribed
when opioids and benzodiazepines are prescribed
concurrently).
care in Virginia and not for a legitimate
medical purpose. Tr. 286; see also, e.g.,
id. at 207–11.
*K
Additionally, I find that
Respondent violated subsection
seventeen based on my finding above
that Respondent violated state and
federal law. Therefore, OSC allegations
10, 14, 18, and 22 are SUSTAINED.]
48 49
In the OSC, the Government also
charged the Respondent with an
additional violation of state law in
asserting that the Respondent was in
violation of the Virginia Code for failing
to prescribe naloxone
50
(the Virginia
Naloxone Regulation). ALJ Ex. 1 at ¶¶
13, 17, 21. This is a novel charge for this
tribunal.
51
The Virginia Naloxone
Regulation, in pertinent part, states that
when initiating opioid treatment, a
practitioner shall ‘‘[p]rescribe naloxone
for any patient when risk factors of
overdose, substance abuse, doses in
excess of 120 [morphine milligram
equivalent] per day, or concomitant
benzodiazepine[s] are present.’’ 18 Va.
Admin. Code § 85–21–70(B)(3).
*L
An analysis of the relative merits of
this novel allegation are best considered
within the framework of Public Interest
Factor Four (compliance with
applicable state laws relating to
controlled substances). 21 U.S.C.
823(f)(4). The actions of a regulatory
agency must bear a rational relationship
to the purposes of the statute it is
charged with enforcing. See Judulang v.
Holder, 556 U.S. 42, 63 (2011)
(invalidating Board of Immigration
Appeals decision making practice where
the ‘‘rule [was] unmoored from the
purposes and concerns of the
immigration laws’’). [Consequently,
when the Agency has analyzed whether
state law violations are relevant to its
Factor Four analysis, it has considered
whether those state laws have a rational
relationship to the core purposes of the
CSA in preventing drug abuse and
diversion.]
*M
Pharmacy Doctors
Enterprises d/b/a Zion Clinic Pharmacy,
83 FR 10,876, 10,900 (2018) [(stating
that the state law provisions at issue ‘‘go
to the heart of the controlled substance
anti-diversion mission—drug abuse
prevention and control’’)].*
N
*
O
[As explained above, my
consideration of a violation of a state
law under Factor Four must bear a
rational relationship to a core purpose
of the CSA, as does my consideration of
all the public interest factors. See
Judulang v. Holder, 556 U.S. at 63.
Additionally, the language of Factor
Four requires that the state law be
‘‘relat[ed] to controlled substances.’’
These two concepts are easily conflated,
but they are importantly distinct. In this
case, I find that Respondent’s violation
of the Virginia Naloxone Regulation
52
bears a rational relationship to a core
purpose of the CSA such that it is
appropriate for me to consider it under
Factor Four, and also that the state
regulation is ‘‘relat[ed] to controlled
substances’’ as the statute requires. 21
U.S.C. 823(a)(4). Respondent’s failure to
prescribe naloxone put Patient SD at
risk for overdose or death resulting from
concurrent opioid and benzodiazepine
prescriptions.*
P
Thus, Respondent’s
violation of this regulation bears a
rational relationship to the core
purposes of the CSA of preventing the
abuse of controlled substances and the
adverse health consequences that might
result from such abuse.
I have omitted the RD’s discussion of
the purpose of the Virginia Naloxone
Regulation and its legislative history,
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*Q
See Hippenmeyer, 86 FR at 33,768 n.62 (citing,
e.g., In the Matter of Brian R. Briggs, M.D., No. MD–
15–0164A, 2017 WL 554258 (Feb. 2, 2017) (issuing
a Letter of Reprimand and placing respondent on
probation for prescribing controlled substances to a
live-in girlfriend—who was also receiving opioids
from other providers—without maintaining medical
records and without ‘‘perform[ing] and
document[ing] an appropriate physical and mental
examination’’); In the Matter of Warren Moody,
M.D., No. MD–07–0874A, 2007 WL 3375035 (Oct.
16, 2007) (summarily suspending physician’s
license for various forms of misconduct, including
prescribing controlled substances to friends without
maintaining medical records); In the Matter of
David Landau, M.D., No. MD–17–0777A, 2018 WL
2192279 (Apr. 16, 2018) (issuing a Letter of
Reprimand against a physician for various forms of
misconduct, including prescribing controlled
substances to a friend without maintaining
adequate medical records).
*R
The Smith decision involved an offer to trade
an automatic weapon for cocaine. 508 U.S. at 225.
The decision addressed the question of whether the
exchange of a firearm for cocaine constitutes using
a firearm ‘‘during and in relation to . . . [a] drug
trafficking crime’’ within the meaning of 18 U.S.C.
924(c)(1). Id. The Supreme Court’s analysis cited
prior Supreme Court and appellate court decisions
interpreting the phrase ‘‘in relation to’’ and
concluding that the phrase should be interpreted
expansively. Id. at 237; see, e.g., District of
Columbia v. Greater Washington Board of Trade,
506 U.S. 125, 129 (1992) (‘‘We have repeatedly
stated that a law ‘relate[s] to’ a covered employee
benefit plan . . . ‘if it has a connection with or
reference to such a plan.’ . . . This reading is true
to the ordinary meaning of ‘relate to’ . . . and thus
gives effect to the ‘deliberately expansive’ language
chosen by Congress.’’); United States v. Harris, 959
F.2d 246, 261 (D.C. Cir. 1992) (per curiam) (‘‘The
only limitation is that the guns be used ‘‘in
relation’’ to the drug trafficking crime involved,
which we think requires no more than the guns
facilitate the predicate offense in some way.’’);
United States v. Phelps, 877 F.2d 28 (9th Cir. 1989)
(concluding that the situation was ‘‘unusual’’ and
not covered, the court stated that ‘‘the phrase ’in
relation to’ is broad’’).
The Supreme Court also cited a dictionary
definition in its analysis. 508 U.S. at 237–38. It
stated that ‘‘[a]ccording to Webster’s, ’in relation to’
means ‘with reference to’ or ‘as regards.’’’ Id. at 237.
It concluded, thus, that the phrase ‘‘in relation to,’’
at a minimum, ‘‘clarifies that the firearm must have
some purpose or effect with respect to the drug
trafficking crime; its presence or involvement
cannot be the result of accident or coincidence.’’ Id.
at 238. The Court also stated that ‘‘the gun at least
must ‘facilitate[e], or ha[ve] the potential of
facilitating,’ the drug trafficking offense.’’ Id.
53
[Footnote omitted.]
54
[Footnote omitted.]
55
[Footnote omitted.]
*
S
As found above, there is substantial record
evidence that Respondent issued controlled
substance prescriptions outside the usual course of
the professional practice and beneath the applicable
standard of care in Virginia and in violation of state
law. I, therefore, have concluded that Respondent
engaged in misconduct which supports the
revocation of his registration. See Wesley Pope, 82
FR 14,944, 14,985 (2017).
For purposes of the imminent danger inquiry, my
findings also lead to the conclusion that
Respondent has ‘‘fail[ed] . . . to maintain effective
controls against diversion or otherwise comply with
the obligations of a registrant’’ under the CSA. 21
U.S.C. 824(d)(2). At the time the Government issued
the OSC, the Government had clear evidence that
Respondent repeatedly issued prescriptions without
having a sound rationale or legitimate medical
purpose for doing so, which establishes ‘‘a
substantial likelihood of an immediate threat that
death, serious bodily harm, or abuse of a controlled
substance . . . [would] occur in the absence of the
immediate suspension’’ of Respondent’s
registration. Id.
because I have concluded that the
regulation, as applied to the facts of this
case, supplies a sufficient nexus to
controlled substances to be
appropriately considered under Factor
Four. In analyzing the legislative intent
of the state law, the RD was likely
addressing a particular Agency decision,
which stated that in determining
whether a state law is ‘‘related to
controlled substances’’ under Factor
Four, ‘‘the mere fact that a violation of
a state rule occurs in the context of the
dispensing of controlled substances
does not necessarily mean that the
violation has a sufficient nexus to the
CSA’s core purpose of preventing the
diversion and abuse of controlled
substances.’’ Fred Samimi, M.D., 79 FR
18,698, 18,710 (2014) (citing 21 U.S.C.
823(f)(4). As explained above, I concur
that a violation of state law must have
a rational relationship to the core
purposes of the CSA in order for me to
consider it under Factor Four; however,
that important concept should not be
conflated with whether the state law is
‘‘relat[ed] to controlled substances’’ as
required by the statute, which is what
seemed to happen when the former
Administrator in Samimi cited to the
intent of the state law itself as the basis
for finding that the law in that case was
not sufficiently related to controlled
substances. Id. (finding that the
particular state law’s ‘‘provisions [were]
not directed at preventing diversion’’).
Nothing in the CSA itself nor its
legislative history requires such a
limited view of ‘‘laws relating to
controlled substances,’’ and although
these sentences in Samimi could be read
to imply that the Agency would be
required to assess the state law’s
purpose, I can find no reason to analyze
the legislative intent of every state law
alleged for consideration under Factor
Four. See 21 U.S.C. 823(f)(4).
In fact, the Agency has—both prior to
and subsequent to the Samimi
decision—frequently considered
violations of state statutes that are
applicable to all medications, not just
controlled substances, under Factor
Four without analyzing the legislative
intent of these statutes. See, e.g., Joseph
Gaudio, M.D., 74 FR 10,083, 10,091
(2009) (considering under Factor Four
the respondent’s violation of a state law
that stated that it is ‘‘unprofessional
conduct’’ for a physician to ‘‘provid[e]
treatment . . . via electronic or other
means unless the licensee has
performed a history and physical
examination of the patient . . .’’); Carol
Hippenmeyer, M.D., 86 FR 33,748,
33,768 (considering under Factor Four
the respondent’s violation of state laws
stating that it is ‘‘unprofessional
conduct’’ for a physician to fail to
‘‘maintain adequate medical records’’
and to ‘‘prescrib[e] . . . a prescription
medication . . . to a person unless the
[physician] first conducts a physical or
mental health status examination of that
person or has previously established a
doctor-patient relationship’’). The core
purpose of these statutes may not be
directed at preventing the abuse and
diversion of controlled substances;
however, when the state addresses
prescribing that presents a risk of
diversion or substance abuse, these are
the statutes that are charged. For
example, the Arizona Medical Board
frequently cites violations of the state
laws requiring physicians to maintain
adequate medical records and perform
physical examinations in disciplinary
actions against physicians who are
prescribing controlled substances
without taking appropriate steps to
prevent diversion.
*Q
Therefore, a broad interpretation of
‘‘laws relating to controlled substances’’
in Section 823(f)(4) is consistent with
previous Agency Decisions. It is also
consistent with the Supreme Court’s
interpretation of the phrase ‘‘relating to’’
in other contexts. According to the
Supreme Court, the phrase ‘‘in relation
to’’ is to be interpreted expansively, and
means ‘‘with reference to’’ or ‘‘as
regards.’’ Smith v. United States, 508
U.S. 223, 237 (1993).
*R
Thus, prior Agency Decisions and
Supreme Court precedent support my
conclusion that the Virginia Naloxone
Regulation is related to controlled
substances under Factor Four and that
Respondent’s violation of the regulation
is relevant to my Factor Four analysis
under the CSA.]
53 54 55
*
S
Recommendation
The evidence of record
preponderantly establishes that the
Respondent has committed acts which
render his continued registration
inconsistent with the public interest.
See 21 CFR 1301.44(e) (establishing the
burden of proof in DEA administrative
proceedings). Because the Government
has met its burden in demonstrating that
the revocation it seeks is authorized, to
avoid sanction the Respondent must
show that given the totality of the facts
and circumstances revocation is not
warranted. See Med. Shoppe-
Jonesborough, 73 FR at 387. In order to
rebut the Government’s prima facie
case, the Respondent must demonstrate
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56
Resp’t Ex. 8.
57
Tr. 388–89.
58
Tr. 430–33.
59
ALJ Ex. 20, at 15.
60
Id.
61
Hassman, 75 FR at 8236.
62
ALJ Ex. 19, at 34.
not only an unequivocal acceptance of
responsibility but also a demonstrable
plan of action to avoid similar conduct
in the future. See Hassman, 75 FR at
8236. He has accomplished neither
objective.
Agency precedent is clear that a
respondent must unequivocally admit
fault as opposed to a ‘‘generalized
acceptance of responsibility.’’ The
Medicine Shoppe, 79 FR 59,504, 59,510
(2014); see also Lon F. Alexander, M.D.,
82 FR 49704, 49,728 (2017). To satisfy
this burden, a respondent must ‘‘show
true remorse’’ or an ‘‘acknowledgment
of wrongdoing.’’ Alexander, 82 FR at
49,728 (citing Michael S. Moore, 76 FR
45,867, 45,877 (2011); Wesley G.
Harline, 65 FR 5665, 5671 (2000)). The
Agency has made it clear that
unequivocal acceptance of
responsibility is paramount for avoiding
a sanction. Dougherty, 76 FR at 16,834
(citing Krishna-Iyer, 74 FR at 464). This
feature of the Agency’s interpretation of
its statutory mandate on the exercise of
its discretionary function under the CSA
has been sustained on review. Jones
Total Health Care Pharmacy, LLC v.
DEA, 881 F.3d 823, 830–31 (11th Cir.
2018); MacKay, 664 F.3d at 822; Hoxie,
419 F.3d at 483.
As discussed, supra, on the issue of
remedial steps aimed at the avoidance
of reoccurrence, the Respondent, in
addition to promises that he will be
compliant in the future, has submitted
into evidence the CAP
56
he previously
filed with the Agency, as well as several
certificates showing completion from
some CME courses that the Respondent
completed online. Resp’t Exs. 2–8; Tr.
414–21. The Respondent’s CAP contains
a somewhat minimalist proposal that he
will take two specified CMEs (and other
additional CMEs designated by DEA).
Resp’t Ex. 8. The CAP further proposes
that the Respondent is willing to
undergo a period of ‘‘partial
suspension’’ of his COR pending
completion of these CMEs that will
restrict him to prescribing under
Schedules IV and V. Id. In addition to
these rather modest plans for remedial
action, the Respondent (to the apparent
surprise of everyone at the hearing)
tendered a remarkable, novel, and
illogical proposal. He offered that if the
Agency would only grant him a
registration to handle controlled
substances, he would covenant never to
actually use it. Tr. 425–26. The
Respondent explained that he seeks the
reinstatement and continuation of his
COR, not to conduct the regulated
activity it authorizes, but rather, because
he considers it a necessary prerequisite
to securing or continuing employment
as a physician. Id.
Suffice it to say that the Respondent’s
remedial action plans are unimpressive
at best, and in the case of his attempt
to secure a non-functional COR, illogical
and cynical, but inasmuch as the
evidence of record fails to demonstrate
an unequivocal acceptance of
responsibility, the issue of remedial
steps could hardly be considered as case
dispositive. The Agency has
consistently held that for either prong
(acceptance of responsibility and
remedial steps) to be considered in
sanction amelioration, both prongs must
have been established. Ajay S. Ahuja,
M.D., 84 FR 5479, 5498 n.33 (2019);
Jones Total Health Care Pharmacy,
L.L.C., & SND Health Care, 81 FR
79,188, 79,202–03 (2016); Hassman, 75
FR at 8236. If one prong is absent, the
other becomes irrelevant. Both or
neither has been the rule for many
years. The Respondent quibbled on the
precise amount of seconds devoted to
palpations,
57
and refused to accept that
examinations, which were documented
in the paperwork but clearly absent
from the UC Visit videotapes, did not
take place.
58
As discussed in
considerable detail, supra, even after
sitting through the Government’s
evidence, the Respondent maintains
that all of the controlled substance
prescriptions he ever issued (including
those issued during the four UC Visits
established in these proceedings) were
legitimate and within the usual course
of a professional practice. Tr. 427–29.
The Respondent presented as a
practitioner who genuinely believes he
did nothing really that wrong. As he
described it, he ‘‘used to cut people
‘breaks,’’’ but ‘‘will not do that anymore
. . . .’’ Tr. 424–25. The Respondent’s
closing brief representation that ‘‘he has
fully accepted responsibility . . .’’
59
is
simply not supported by the record.
Without plumbing the depths of what
constitutes an unequivocal acceptance
of responsibility, it is clear that a terse
‘‘[yes], I do’’ response to an inquiry from
his counsel about whether he made ‘‘a
mistake’’ by what he characterized as
prescribing a ‘‘low[-]addictive
potential’’ and low-overdose potential
drug to the undercover patient so the
hapless patient could ‘‘get through the
day and get through [his] work,’’
60
misses the mark.
While the transgressions alleged and
proved here are serious and numerous,
it is arguable that a true, unequivocal
acceptance of responsibility, coupled
with a thoughtful plan of remedial
action could have gone a long way to
supporting a creditable case for sanction
lenity. Indeed, while true that the
Agency’s precedents hold the lack of an
unambiguous acceptance of
responsibility and a remedial action
plan as a cold bar to the avoidance of
a sanction,
61
the wisdom of the
Agency’s policy is vindicated in this
case by the reality that the Respondent
still believes that he has never issued a
controlled substance prescription that
was not legitimate and not within the
usual course of a professional practice.
The only potential he sees for error
appears to be his innate kindness,
which caused him to ‘‘cut breaks’’ to his
fellow man. He was confronted with
progress notes written in his own hand
detailing the results of examinations
that he never administered, yet he
would not concede his mendacity. As
highlighted by the Government in its
closing brief,
62
the Respondent’s
generation of false chart information
supports the fair inference that he was
attempting to create a justification for
controlled substance prescriptions he
understood to be unsupportable under
the law. See Syed Jawed Akhter-Zaidi,
M.D., 80 FR 42,963, 49,964 (2015)
(holding that where a practitioner
creates a false record when prescribing
a controlled substance, there is a
presumption that the practitioner
[‘‘falsified the records in order to justify
the prescribing of controlled substances,
and that in prescribing the controlled
substances, Respondent acted outside
the usual course of professional practice
and lacked a legitimate medical
purpose’’]). He spent tiny minutes of
time with the TFO before issuing
controlled substances and dickered
about the amount of seconds actually
devoted to the interaction and the
palpations. This is a man who believes
he made no true mistakes. The Agency
is thus faced with a choice of imposing
a registration sanction or imposing none
and therein creating a strong likelihood
that it will be instituting new
proceedings, charging the same conduct
against the same doctor soon thereafter.
To the extent the Respondent, after
being present at this hearing, does not
see that he was not acting as a reliable
registrant, it is highly unlikely that he
will see the light in a month, a week, or
a day from an Agency action that affords
him another chance. To be sure, the
Respondent credibly testified that
getting caught and being put into
proceedings caused a certain degree of
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63
Tr. 424.
64
Tr. 391–94.
1
The Request for Hearing is stamped received on
July 30, 2019.
emotional consternation,
63
but that is
not the same as accepting responsibility,
which is something he clearly is
unwilling to do. On this point there is
little room for logical, dispassionate
dissent. Thus, in the face of a prima
facie case, without the Respondent
meeting the evidence with a convincing,
unequivocal acceptance of
responsibility and proposing thoughtful,
concrete remedial measures geared
toward avoiding future transgressions,
the record supports the imposition of a
sanction. That a sanction is supported
does not end the inquiry, however.
In determining whether and to what
extent imposing a sanction is
appropriate, consideration must also be
given to the Agency’s interest in both
specific and general deterrence and the
egregiousness of the offenses established
by the Government’s evidence. Ruben,
78 FR at 38,364, 38,385. Considerations
of specific and general deterrence in this
case militate in favor of revocation. As
discussed, supra, the Respondent has
made it clear that he feels that he was
not so much wrong as misunderstood
and, in a way, nitpicked. As discussed,
supra, he feels his prescriptions were
legitimate, if lenient. Tr. 424–425.
Although he uttered words in support of
regret, where a person does not accept
as true the errors shown to him by hard
evidence, the hopes of true future
deterrence are diminished, and mortally
so. The interests of specific deterrence,
therefore, compel the imposition of a
sanction.
Likewise, as the regulator in this field,
the Agency bears the responsibility to
deter similar misconduct on the part of
others for the protection of the public at
large. Ruben, 78 FR at 38,385. To
continue the Respondent’s registration
privileges on the present record would
send a message to the regulated
community that it is acceptable to spend
less than ten minutes, and sometimes
less than two minutes with a patient,
conduct no exams, document exams not
conducted, procure neither prior
records nor objective testing, prescribe
dangerous controlled substances,
increase the dosages without basis or
regret, and continue to do so even in the
face of information that the purported
patient is not even filling the
prescriptions. The interests of general
deterrence militate powerfully in favor
of a sanction on this record.
Regarding the egregiousness of the
Respondent’s conduct, as discussed,
supra, the Respondent did virtually
nothing to satisfy (or even further) his
responsibilities as a DEA registrant on
four occasions. He had no basis for a
valid diagnosis, he had no prior medical
records, called no prior treating
physician, had no imaging, conducted
no examination to speak of, doctored up
phony examination results, ignored
evidence that the prescriptions were not
being filled by his purported patient,
disregarded the gaps where the patient
would have been without the medicine
he was prescribing (even if it had been
dispensed and taken as directed), and
actually increased the dosage for no
articulated reason beyond the fuzzy
concept that he had an increased level
of ‘‘comfort[ ]’’
64
(based apparently on
little more than the TFO’s decision to
keep coming back for more drugs). Even
disregarding the very real likelihood
that these four UC Visits presented a
vivid snapshot of the Respondent’s
practice in general, the blithe manner in
which he doled out controlled medicine
to this undercover officer was nothing
short of astonishing. The egregiousness
of the established transgressions in this
case, and the reckless abandon with
which the Respondent ignored his
obligations provides a unique window
into the systemic gravity of the current
opioid crisis.
A balancing of the statutory public
interest factors, coupled with
consideration of the Respondent’s
failure to meaningfully accept
responsibility, the absence of record
evidence of thoughtful and continuing
remedial measures to guard against
recurrence, and the Agency’s interest in
deterrence, supports the conclusion that
this Respondent should not continue to
be entrusted with a registration.
Accordingly, it is respectfully
recommended that the Respondent’s
DEA COR should be REVOKED, and any
pending applications for renewal should
be DENIED.
Dated: August 20, 2020.
John J. Mulrooney, II,
U.S. Chief Administrative Law Judge.
[FR Doc. 2021–20247 Filed 9–17–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19–31]
Lisa M. Jones, N.P.; Dismissal of
Proceedings
I. Introduction
On June 28, 2019, a former Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Lisa Mae Jones, N.P.
(hereinafter, Applicant), of Mount Airy,
North Carolina. Administrative Law
Judge Exhibit (hereinafter, ALJX) 1
(Order to Show Cause (hereinafter,
OSC)), at 1. The OSC proposed the
denial of Applicant’s application
(Application No. W19018692M) for a
DEA certificate of registration
(hereinafter, North Carolina-based
registration application) and ‘‘any other
applications for any other DEA
registrations’’ on the ground that she
‘‘materially falsified’’ her application
‘‘in violation of 21 U.S.C. 824(a)(1) and
823(f).’’ Id.
The substantive ground for the
proceeding, as more specifically alleged
in the OSC, is that Applicant’s ‘‘failure
to disclose the disciplinary actions
taken against . . . [her] nursing licenses
(viz., the denial of . . . [her] application
in Illinois and the fact that . . . [her]
Tennessee and Iowa nursing licenses
were placed on probation) constitutes
material falsification of . . . [her]
application for a DEA Certificate of
Registration.’’ Id. at 4.
The OSC notified Applicant 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 4 (citing 21
CFR 1301.43). The OSC also notified
Applicant of the opportunity to file a
corrective action plan. OSC, at 5 (citing
21 U.S.C. 824(c)(2)(C)). Applicant
requested a hearing. ALJX 2 (Request for
Hearing dated July 22, 2019), ALJX 4
(Order for Prehearing Statements dated
July 23, 2019), at 1 (stating that counsel
for Applicant filed a hearing request on
July 22, 2019).
1
The matter was placed on the docket
of the Office of Administrative Law
Judges and assigned to the Chief
Administrative Law Judge (hereinafter,
ALJ), John J. Mulrooney, II. The Chief
ALJ noted thirteen stipulations agreed
upon by the parties and ‘‘conclusively
accepted as fact in these proceedings.’’
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge dated
November 21, 2019 (hereinafter, RD), at
4–5. The second and third stipulations
state that Applicant ‘‘is currently
licensed in the State of North Carolina
as a Nurse Practitioner under Approval
No. 5011528’’ and that her ‘‘North
Carolina Approval (license) expires by
its own terms on May 31, 2020.’’ Id. at
4.
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