Stephen E. Owusu, D.P.M.; Decision and Order, 3343-3352 [2022-01108]
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Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices
find that there is clear, convincing, and
unequivocal evidence in the record
supporting denial of Applicant’s
application based on his material
falsification of his application. 21 U.S.C.
824(a)(1).
Date Thirty Days From the Date of
Publication in the Federal Register].
Anne Milgram,
Administrator.
[FR Doc. 2022–01112 Filed 1–20–22; 8:45 am]
BILLING CODE 4410–09–P
C. Sanction
Here, there is no dispute in the record
that Applicant is mandatorily excluded
pursuant to Section 1320a–7(a) of Title
42, and, further that Applicant
materially falsified his application for a
controlled substance registration, and
therefore, that grounds for the denial of
Applicant’s application exist. Where, as
here, the Government has met its prima
facie burden of showing that grounds
for denial exist, the burden shifts to the
Applicant to show why he can be
entrusted with a registration. Garrett
Howard Smith, M.D., 83 FR 18,882,
18,910 (2018) (collecting cases).
In this case, Applicant failed to
respond to the Government’s Order to
Show Cause and did not avail himself
of the opportunity to refute the
Government’s case. See RFAA, at 2.
Therefore, Applicant has not provided
any remorse or assurances that he
would implement remedial measures to
ensure such conduct is not repeated.
Such silence weighs against the
Applicant’s registration. Zvi H. Perper,
M.D., 77 FR at 64,142, citing Medicine
Shoppe, 73 FR at 387; see also Samuel
S. Jackson, 72 FR at 23,853. Further, due
to the lack of a statement or testimony
from Applicant, it is unclear whether
Applicant can be entrusted with a DEA
registration; and therefore, I find that
sanction is appropriate to protect the
public from a recurrence of Applicant’s
unlawful actions in the context of his
CSA registration. See Leo R. Miller,
M.D., 53 FR 21,931, 21,932 (1988).
Consequently, I find that the factors
weigh in favor of sanction and I shall
order the sanctions the Government
requested, as contained in the Order
below.
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Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f) and 21 U.S.C. 824(a), I hereby
deny the pending application for a
Certificate of Registration, Control
Number H21079595C, submitted by
Daniel R. Nevarre, M.D., as well as any
other pending application of Daniel R.
Nevarre, M.D. for additional registration
in Utah. This Order is effective [insert
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21–5]
Stephen E. Owusu, D.P.M.; Decision
and Order
On October 22, 2020, a former
Assistant Administrator, Diversion
Control Division, of the Drug
Enforcement Administration
(hereinafter, DEA or Government),
issued an Order to Show Cause
(hereinafter, OSC) to Stephen E. Owusu,
D.P.M. (hereinafter, Respondent) of
Brooklyn, New York. Administrative
Law Judge Exhibit (hereinafter, ALJX) 1
(OSC), at 1. The OSC proposed the
denial of Respondent’s application for
DEA Certificate of Registration No.
W19061136C (hereinafter, COR or
registration) and the denial of any
applications for any other DEA
registrations pursuant to 21 U.S.C.
824(a)(2) and 824(a)(5) because
Respondent was convicted of a felony
related to controlled substances and
because Respondent has been excluded
from participation in Medicare,
Medicaid, and all federal health care
programs pursuant to 42 U.S.C. 1320a–
7(a). Id.
On November 23, 2020, the
Respondent timely requested a hearing,
which commenced (and ended) on
February 17, 2021, at the DEA Hearing
Facility in Arlington, Virginia with the
parties, counsel, and witnesses
participating via video teleconference
(VTC). On April 9, 2021, Administrative
Law Judge Teresa A. Wallbaum
(hereinafter, the ALJ) issued her
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
(hereinafter, Recommended Decision or
RD). By letter dated May 4, 2021, the
ALJ certified and transmitted the record
to me for final Agency action. In the
letter, the ALJ advised that neither party
filed exceptions. Having reviewed the
entire record, I adopt the ALJ’s rulings,
findings of fact, as modified,
conclusions of law and recommended
sanction with minor modifications,
where noted herein.*A
*A I have made minor modifications to the RD. I
have substituted initials or titles for the names of
witnesses and patients to protect their privacy and
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Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Teresa A. Wallbaum; Administrative
Law Judge
April 9, 2021
*B Respondent proceeded pro se
throughout the entire case.1 Respondent
timely filed a Request for Hearing. A
Prehearing Conference was conducted
on January 12, 2021, via VTC. 2A
hearing on the merits of the OSC
allegations was conducted on February
17, 2021, via VTC at the DEA Hearing
Facility in Arlington, Virginia. The
Government filed a Post-Hearing Brief
on March 26, 2021.
The issue to be ultimately decided by
the Acting Administrator, with the
assistance of this Recommended
Decision, is whether Respondent’s
application should be denied based
I have made minor, nonsubstantive, grammatical
changes and nonsubstantive, conforming edits.
Where I have made substantive changes, omitted
language for brevity or relevance, or where I have
added to or modified the ALJ’s opinion, I have
noted the edits with an asterisk, and I have
included specific descriptions of the modifications
in brackets following the asterisk or in footnotes
marked with a letter and an asterisk. Within those
brackets and footnotes, the use of the personal
pronoun ‘‘I’’ refers to myself—the Administrator.
*B I have omitted a section of the RD’s discussion
of the procedural history to avoid repetition with
my introduction.
1 Respondent was advised during the Prehearing
Conference that, under 21 CFR 1316.50, he had the
right to seek representation by a qualified attorney
at his own expense. Respondent was also advised
that, if he continued to represent himself, he would
be held to the same standards and procedural
requirements of an attorney, including adherence to
the procedural orders and rulings of this tribunal
and to the procedural rules set forth in 21 CFR
1316.41–1316.68. ALJ Ex. 13 at 2, n.3. During the
merits hearing, Respondent acknowledged that he
had been so advised and confirmed that he wanted
to proceed pro se. Tr. 7–8.
2 Respondent failed to submit a Prehearing
Statement by the December 29, 2020, deadline set
out in this tribunal’s Order for Prehearing
Statements. ALJ Ex. 3. The tribunal then issued an
Order Directing Compliance, which gave
Respondent until January 4, 2021, to show good
cause as to why he did not comply with the Order
for Prehearing Statements. ALJ Ex. 7. Respondent
then filed a Prehearing Statement on January 4,
2021, but did not offer any attempt to show good
cause for his late filing. ALJ Ex. 8. The tribunal
issued a Second Order Directing Compliance on
January 4, 2021, requiring Respondent to show good
cause. ALJ Ex. 9. Respondent then filed a document
styled ‘‘Requisite Good Cause for Late Filing,’’ in
which he purported to show good cause. ALJ Ex.
10. Thereafter, the tribunal issued an Order
Regarding Respondent’s Late Filed Prehearing
Statement, which set out several of Respondent’s
failures to comply with the Order for Prehearing
Statements, including late filings and at least two
failures to serve pleadings on opposing counsel.
ALJ Ex. 11. The Order also directed Respondent to
file a Prehearing Statement in compliance with the
Order for Prehearing Statements by January 11,
2021. Id. Respondent finally did file a compliant
Prehearing Statement on January 10, 2021. ALJ Ex.
12.
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upon his felony conviction related to
controlled substances and/or his
exclusion from participation in a federal
health care program pursuant to 42
U.S.C. 1320a–7(a).
After carefully considering the
testimony elicited at the hearing, the
admitted exhibits, the arguments of
counsel, and the record as a whole, I
have set forth my recommended
findings of fact and conclusions of law
below.3
I. Findings of Fact
A. Allegations
The Government alleges that the
denial of Respondent’s application is
supported by incontrovertible record
evidence that he has been both
convicted of a felony related to
controlled substances and excluded
from participation in a federal health
care program. ALJ Ex. 1. The
Government further alleges that
judgment was entered against
Respondent in the United States District
Court for the Eastern District of New
York after pleading guilty to one count
of Conspiracy to Distribute Oxycodone,
a Class C Felony, in violation of 21
U.S.C. 841(a), (b)(1)(C), and 846.4 The
Government also alleges that the U.S.
Department of Health and Human
Services, Office of Inspector General
(HHS/OIG) mandatorily excluded
Respondent from participation in
Medicare, Medicaid, and all federal
health care programs pursuant to 42
U.S.C. 1320a–7(a).5 According to the
Government, this exclusion was
effective as of October 19, 2017, and
runs for a period of five years.6 ALJ Ex.
1.
B. Stipulations
The following stipulations were
mutually agreed upon by the parties and
are conclusively accepted as fact in
these proceedings:
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1. On or about June 12, 2019, Respondent
filed with the DEA an application for
registration as a practitioner in Schedules II
through V pursuant to DEA control number
W19061136C, with a proposed registered
3 After conducting the merits hearing in this case,
the tribunal mailed a hard copy of the transcript of
the hearing to both parties. Despite two separate
delivery attempts, the hard copy could not be
delivered to Respondent’s address. Chambers
reached out to Respondent to confirm his address,
but delivery was never effectuated. Respondent
was, however, provided with an electronic version
of the transcript and had an opportunity to submit
corrections to the transcript.
4 United States v. Stephen Owusu, No. 2:11–CR–
0709–001 (LDW) (E.D.N.Y. June 13, 2017).
5 Respondent has stipulated to the factual basis
underlying this allegation. See Stip. 5.
6 Respondent has stipulated to the factual basis
underlying this allegation. See Stip. 5.
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address of 106 Pennsylvania Ave., Suite 1,
Brooklyn, NY 11207–2427.
2. On or about July 19, 2011, Respondent
surrendered for cause his previous DEA
registration, No. BO3613331.
3. On June 13, 2017, Judgment was entered
against Respondent in the United States
District Court for the Eastern District of New
York after Respondent pleaded guilty to one
count of ‘‘Conspiracy to Distribute
Oxycodone, a Class C Felony,’’ in violation
of 21 U.S.C. 841(a), (b)(1)(C), and 846. United
States v. Stephen Owusu, No. 2:11–CR–
0709–001 (LDW) (E.D.N.Y. June 13, 2017).
4. Based on Respondent’s conviction, the
New York State Office of the Medicaid
Inspector General excluded Respondent from
participation in the New York Medicaid
program. The exclusion was effective August
30, 2017.
5. Based on Respondent’s conviction, the
U.S. Department of Health and Human
Services, Office of Inspector General (HHS/
OIG), mandatorily excluded Respondent from
participation in Medicare, Medicaid, and all
federal health care programs pursuant to 42
U.S.C. 1320a–7(a). The exclusion was
effective on October 19, 2017, and runs for
a period of five years.
6. Reinstatement of eligibility to participate
in Medicare, Medicaid, and all federal health
care programs after exclusion by HHS/OIG is
not automatic.
7. Respondent is currently excluded from
participation in Medicare, Medicaid, and all
federal health care programs.
C. Government’s Case-in-Chief
The Government’s case-in-chief
consisted of the testimony of a single
witness, a DEA Diversion Group
Supervisor (hereinafter, the GS). The GS
testified that her duty station is the New
York Field Division, located in New
York City, where she has served in her
capacity as a group supervisor for
approximately one year. Tr. 21–22.
Before the GS was promoted to group
supervisor, she worked as a Diversion
Investigator for approximately 24 Years.
Tr. 22. In her position as a group
supervisor, the GS is required to
undergo periodic training as a part of
her duties. Tr. 23. Further, she has been
involved in over 200 DEA investigations
throughout her career. Id.
Respondent came to the attention of
the GS when she was assigned his
application for DEA registration. Tr. 24.
The GS also testified that she
interviewed Respondent on two
occasions. Id. Through the testimony of
the GS, the Government laid the
foundation for the introduction of
multiple exhibits in support of its
allegations.7
The parties agree, and the evidence
demonstrates, that, on June 13, 2017,
7 Specifically,
the testimony from the GS laid the
foundation for Government Exhibits 1, 4, 5, 6, 7, 8,
and 9. Tr. 24–26, 28–29, 31–33, 34–35, 36–39, 40–
41, 42–43.
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Respondent pleaded guilty to one count
of Conspiracy to Distribute Oxycodone,
a Class C Felony, in violation of 21
U.S.C. 841(a), (b)(1)(C), and 846. Gov.
Ex. 5, 6.8 The Department of Health and
Human Services, Office of Inspector
General sent Respondent a letter,
informing him that he had been
excluded from Medicare, Medicaid, and
all federal health care programs for a
period beginning on October 19, 2017,
and lasting a minimum of five years.
Gov. Ex. 8; Tr. 40. The GS also testified
that the New York State Office of the
Medicaid Inspector General had sent
Respondent a letter informing him that
he had been excluded from the state’s
Medicaid program. Gov. Ex. 7; Tr. 36–
37.
Respondent’s exclusion from
Medicare, Medicaid, and all federal
health care programs, along with
Respondent’s conviction of Conspiracy
to Distribute Oxycodone, are the bases
of the Government’s present case
opposing Respondent’s application for a
new COR. The GS testified that, on
February 16, 2021, she ran a new search
on a web page of the U.S. Department
of Health and Human Services, Office of
Inspector General, and confirmed
through that search that Respondent
was still excluded from all federal
health care programs. Tr. 43.
The GS came across as an objective
investigator, with no discernable motive
to mislead, fabricate, or exaggerate. The
testimony of this witness was primarily
focused on the uncontroversial 9
introduction of documentary evidence
and her contact with this case, and was
sufficiently detailed, plausible, and
internally consistent to be afforded full
credibility.
D. Respondent’s Case
Respondent, proceeding pro se,
presented his own testimony and
offered four exhibits in support of his
case. According to Respondent, he
received a Bachelor’s degree from the
University of New York and thereafter
studied genetic engineering in a Ph.D.
program. Tr. 51. He departed that
program with a Master’s Degree and
entered Temple University Medical
School, where he studied Podiatric
Medicine. Id. Respondent graduated
from Temple University in 1992 and
completed his residence at a Veterans’
Affairs hospital in Brooklyn, New York.
Tr. 52. He obtained medical licenses in
both New York and Pennsylvania and
8 Respondent also stipulated to this conviction.
See Stip. 3, infra.
9 Respondent did not object to the admission of
any exhibit offered by the Government. Tr. 26, 30,
33, 35, 39, 42, 43–44.
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began practicing medicine in New York
in 1994. Tr. 53; 57.
Respondent has worked both as a solo
practitioner and a clinic physician,
specializing in wound care at two
different clinics. Tr. 54; 57–59. In one of
those clinics, Respondent served as the
director, specializing in baric
neuropathy, supervising three to four
nurses and nurse practitioners, and
seeing 50 patients a day. Tr. 54–56. For
nearly ten years, starting in 1998, he
also worked in a dialysis clinic
specializing in treating patients in ‘‘endstage renal dialysis’’ who suffered lower
extremity problems. Tr. 61–63.
Respondent testified that, prior to
2011, he never had any disciplinary
problems in either New York or
Pennsylvania and had no arrests or
convictions. Tr. 60; 64; 87.
Respondent admitted that he pleaded
guilty to one count of Conspiracy to
Distribute Oxycodone on June 13, 2017,
in violation of 21 U.S.C. 841(a),
(b)(1)(C), and 846. Stip. 3; United States
v. Stephen Owusu, No. 2:11–CR–0709–
001 (LDW) (E.D.N.Y. June 13, 2017). But
Respondent’s description of the events
behind that conviction evolved over the
course of these proceedings. In his
second Prehearing Statement,10
Respondent referenced ‘‘2 falsified
prescriptions in [his] name to which
[he] was called to cooperate with the
police for prosecution [and] lost
prescription pads that a pharmacist
attested to but which [his] lawyers
would not allow court trial.’’ ALJ Ex. 12
at 3; see also Tr. 131–32 (affirming
statement as accurate). In his
Supplemental Prehearing Statement,
Respondent stated that he ‘‘never
conspired to sell or distribute
oxycodone and [he] will never conspire
to sell or distribute oxycodone or any
controlled substance(s).’’ ALJ Ex. 14 at
5.
During the hearing, Respondent
testified that he had prescribed
oxycodone for one patient (who had
been referred to him by another, trusted
patient) on the patient’s third visit. Tr.
67–70. Specifically, he prescribed the
oxycodone because the patient had
brought oxycodone in with him, told the
Respondent he had taken it from his
brother, and it was the only medication
that reduced his pain. Tr. 69–70.
Respondent refilled the oxycodone
prescription approximately once a
month or once every two months for
two years. Tr. 74. The same patient
brought in a couple of friends on the
10 Given Respondent’s failure to summarize his
testimony in his initial Prehearing Statement, this
tribunal directed that he file a revised Prehearing
Statement, which he did on January 10, 2021. ALJ
Ex. 12.
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same construction site where he worked
and Respondent likewise prescribed
those patients oxycodone. Tr. 75.
Respondent explained that he
prescribed oxycodone because he was
‘‘very naı¨ve’’ and sometimes ‘‘too
helpful’’ or ‘‘too kind.’’ Tr. 64 and 76.
He also testified that two prescription
pads were lost from his office and ‘‘a lot
of guys’’ had come to the pharmacy and
written prescriptions from his pad. Tr.
76. According to Respondent, someone
from the pharmacy would have testified
for him. Tr. 76; Tr. 108. Respondent’s
lawyers, however, declined to
investigate his defense and DEA
produced only 20 of the 200 it alleged
were illegal. Tr. 108–109; see also Tr.
126 (he stated that DEA never showed
him the other 180 prescriptions).
On cross-examination, Respondent
admitted that, on one occasion, he
delivered multiple oxycodone
prescriptions to a patient in a parking
lot at 8:30 p.m. or 9:00 p.m. Tr. 113–
115. He did so ‘‘from the kindness of
[his] heart’’ because the patient was
taking his son to a football practice or
game and could not make it to the
medical office in time. Tr. 109–110. At
the time, Respondent did not realize it
was a ‘‘setup,’’ and that it was ‘‘staged.’’
Id.; see also Tr. 113 (‘‘I would call it
staged. Why? Because I had no idea
what was going on.’’). The patient was,
in fact, an informant or, as Respondent
testified: ‘‘the very person who they
accused [Respondent] [of] conspiring to
distribute oxycodone with was
somebody . . . [Respondent] didn’t
know was already a criminal [and] who
had already been incriminated. And
then the Court used him . . . as an
informant, sent him to [Respondent],
[he] asked [Respondent] for the
medication, and this is how it began.’’
Tr. 65 (cleaned up).
Respondent insisted that he charged
the patient $70, even though the patient
paid him $300 for the prescriptions, and
testified that ‘‘why [the patient] gave
[him] $300, [he doesn’t] know.’’ Tr. 115.
When interviewed by DEA agents, he
admitted that he made approximately
$30,000 over the course of two years for
these patients. Tr. 111–112. He viewed
the cash payment in the parking lot as
‘‘almost like a technicality’’ because the
patient would have paid him the same
amount had he come into the office. Tr.
126.
When asked whether he had
examined his patients before
prescribing, Respondent provided an
evasive answer:
Q: Dr. Owusu, isn’t it true that you issued
multiple prescriptions for oxycodone without
examining the patients?
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A: I examined them, Your Honor.
Counsellor, I examined them.
Q: All of them?
A: Well, the—the initial—the initial
patients, all of them were examined.
Tr. 117.
Respondent emphasized that he was
hesitant to explain his prior convictions
because he did not ‘‘want it to be
misconstrued as a lack of penitence and
a lack of repentance.’’ Tr. 50; see also
Tr. 133. Ultimately, however,
Respondent testified repeatedly that—
despite his guilty plea—he did not, in
fact, conspire to distribute oxycodone.
See, e.g., Tr. 64 (‘‘I was not a coconspirator, and I did not conspire at
all.’’); id. (‘‘this so-called conspiracy
case’’); Tr. 65. (‘‘the record will show I
never had—never was involved in any—
any infraction of the law. Never,
never.’’); Tr. 66 (‘‘I was never, myself,
never, and I would say—I would say
until my dying day, never conspired to
distribute drugs. Never. And I never
will, Your Honor.’’); Tr. 78 (attorney
believed he was innocent); Tr. 80 (‘‘But
all those conspiratorial charges that they
added on, no.’’); Tr. 116 (‘‘I was
innocent, okay?’’); Tr. 125 (affirming
statement made in his Prehearing
Statement that he had accepted
responsibility ‘‘despite the fact I never
conspired to sell or distribute
oxycodone’’); Tr. 134 (at plea hearing,
under oath, he admitted that he had
pleaded guilty even though many of his
statements were ‘‘not only just not true
. . . I just didn’t feel like a lot of them
were right.’’).
Rather, Respondent claimed that he
was forced, and indeed tricked, into
pleading guilty by his lawyers. See, e.g.,
Tr. 78 (‘‘I thought I was going for [the
lawyer] to take me to a DEA office. I
went to him that day with the
understanding that we were going to the
DEA office to help me get my DEA
license back. And I went to the
courtroom, and that was the day he
made me plead guilty.’’); Tr. 79–80 (‘‘I
had to say yes because my lawyer told
me to just say yes—yes, yes, and I . . .
went all along like that’’); Tr. 76
(attorney forced him to plead guilty
because he feared a racially unjust trial);
Tr. 116 (attorney forced him to plead
guilty because of ‘‘the circumstances,
the location of the Court, the selection
of the jury’’). At one point, however,
Respondent also acknowledged that his
attorney told him to plead guilty
because of the incriminating video
recording. Tr. 112.
Respondent admitted that he was
guilty, but just for the ‘‘two
prescriptions I wrote . . . . [T]hat’s
what . . . my guilt is about.’’ Tr. 80. He
acknowledged that he had appeared
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before a federal district court judge for
his plea hearing, signed his plea
agreement, pleaded guilty under oath,
was sentenced based on the facts he
admitted, and told the district court
judge that his guilty plea was voluntary.
Tr. 130–134. Respondent was sentenced
to three years’ probation (Tr. 81), which
he completed early without any
infractions (Tr. 97–98; Resp’t Ex. 3).
Indeed, Respondent often cast himself
as the victim—repeatedly stating that he
‘‘suffered’’ because of the conviction.
For example, after recounting the facts
behind his conviction, Respondent
stated: ‘‘They were the things I have
suffered in the past, okay? Some of the
things I look back on, and I—I’ve
suffered for the last ten years because.’’
Tr. 132; see also Tr. 161 (‘‘I have
suffered a lot, and I have learned a
lot.’’). In other instances, Respondent
described himself as a victim (Tr. 64)
who had been ‘‘punished enough’’ (Tr.
105). Indeed, Respondent’s primary
argument for obtaining his registration
was ‘‘it’s been enough time for
punishment. It’s been enough time that
I have . . . paid the penalty.’’ Tr. 163.
[Respondent also stated, ‘‘So, I am
trustworthy. I’ve never been in a
situation where my credibility ever, ever
was in question until this situation
. . . . I can promise you, I can, you
know, that definitely I have learnt my
lesson and very, very, well. And this
will never again be repeated, never. Tr.
106]
According to Respondent, he has not
earned his living from the practice of
medicine since his arrest, since it is
impossible to practice without a DEA
registration. Tr. 61; Tr. 82–83. He
admitted, however, that it was possible
to practice without a DEA registration,
although such practice would be
limited. Tr. 119–121.
As for remedial measures, Respondent
testified that he had taken four classes
regarding opioid addiction—one in
September 2011, one in 2019, one in
July 2020, and one in February 2021. Tr.
83–86.11 Three of those classes were
mandated by the New York licensing
board; the 2019 training was a day of
specialized training at a general medical
conference. Tr. 84–85. Respondent still
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11 In
his revised Prehearing Statement,
Respondent described his training as: ‘‘One whole
day OPIOID CRISIS class I attended around Fall
2011; several other continuing medical educational
SEMINARS attended in the years; A requisite precertifying OPIOID crisis, addiction and treatment
course for all NY State Practitioners taken in 2018.’’
ALJ Ex. 12 at 4. Although there is some discrepancy
between this description and Respondent’s
testimony at trial, I do not question that Respondent
has taken multiple courses over the years,
especially as many of those courses were mandatory
for his continued licensure.
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has a current medical license in New
York, valid until September 30, 2023.
Tr. 86–91; Resp’t Ex. 1.
Finally, Respondent submitted a letter
from Dr. B.-A. (doctor of Public
Administration) regarding Respondent’s
current work at his clinic supporting his
character. Resp’t Ex. 2; Tr. 96; 123.12
As noted in more detail in the
Analysis section, infra, Respondent’s
testimony did not present as credible on
the key issue of his culpability because
he contradicted his representations
under oath in the federal prosecution,
his description of events was not
plausible, and he minimized his own
responsibility.
E. Government’s Rebuttal Case
The Government offered one rebuttal
witness—a Special Agent of the Drug
Enforcement Administration
(hereinafter, the SA). The SA testified
that he is assigned to the Long Island
District Office in Central Islip, New
York. Tr. 138. The Special Agent also
testified that he has been a Special
Agent with DEA since 1996, and that his
job duties include conducting
investigations, some of which are
undercover. Tr. 139. In approximately
2011, The Special Agent became
familiar with Respondent during an
investigation involving oxycodone
distribution. Tr. 139–140. During that
investigation, Respondent was
identified and arrested. Tr. 140.
An individual named B. C.—a patient
of Dr. Owusu’s—cooperated with the
Government in this 2011 investigation.
Id. B.C. specifically provided the SA
and other agents at DEA with
information regarding his illegal
purchase of prescription narcotics from
Respondent. Id. At the direction of DEA,
B.C. met with Respondent while
wearing a concealed video recording
device. Tr. 140–141. The SA, along with
several other DEA agents, observed the
meeting between Respondent and B.C.
Tr. 142. The SA also later retrieved the
video recording device from B.C. and
observed the video recording of the
meeting. Tr. 143. Respondent and B.C.
met in the Mercy Hospital parking lot in
Rockville Center, New York. Tr. 141.
12 This tribunal sustained the Government’s
objection regarding Respondent’s Exhibit 4, which
was a ‘‘Certificate of Relief from Disabilities’’ from
the New York Department of Corrections and
Supervision. Tr. 104. That document was excluded
for two reasons. First, this tribunal could not
ascertain its authenticity given numerous
inconsistencies, including a docket number that did
not match the docket number on Respondent’s
federal conviction. Tr. 99–104. Second, it was not
relevant because it did not specifically relate to
Respondent’s medical license. Tr.100. [I agree with
the ALJ and find that this document is not legally
relevant to the current matter.]
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During the meeting, B.C. purchased
prescriptions for narcotics from
Respondent. Id. Initially, when asked
how many prescriptions B.C. had
purchased during the meeting, the SA
testified that he did not remember. Id.
The SA, relying upon a post-arrest
report, testified that Respondent had
issued numerous prescriptions during
the recorded transaction with B.C., but
that the report did not specify how
many.13 Tr. 147–48. The SA also
testified that Respondent had admitted
that he had met several times with B.C.
over a several-year period, and that he
had sold B.C. oxycodone pills for $300
cash per prescription. Tr. 144–45. The
SA testified that, after being read his
Miranda warning in the SA’s presence,
Respondent stated that he had made
approximately $40,000 from selling
illegal prescriptions to B.C. Tr. 145, 153.
The SA testified that, after his arrest,
Respondent stated that he did conduct
a physical examination of B.C. before
selling the prescription narcotics, but
that, once confronted with the video of
the transaction, Respondent admitted
that was a lie—that, in fact, no
examination was conducted—and
apologized for lying. Id. The SA, when
asked to summarize the content of the
video, stated that he had not reviewed
the video recently, but that he thought
it showed B.C. getting into Respondent’s
vehicle for a short period of time,
paying for the prescriptions for
narcotics, and then exiting the vehicle.
Tr. 146. Later, when asked about the
video recording, The SA testified that he
was mistaken, and then corrected
himself and stated that, in fact, B.C. and
Respondent stayed in their respective
cars throughout the transaction, and that
B.C. did not enter Respondent’s vehicle.
Tr. 154.
On cross-examination, the SA
testified that he recalled seeing the
meeting between Respondent and B.C.
Tr. 149. He also testified that he was not
sure if he ever had to move his vehicle
to get a better view of the transaction,
and he could not remember if his view
was obstructed at any time. Id. The SA
did, however, recall that there were
multiple DEA agents conducting
surveillance in the area in order to
observe the transaction, and he stated
that he was in constant radio
communication with those agents. Id.
He also testified that at least one of
13 This post-arrest report is also known as a
DEA–6, which is a report of investigation. Tr. 143.
The SA testified that this specific DEA–6 was titled,
‘‘Post Arrest Statements of Dr. Stephen Owusu on
July 19, 2011, at 175 Pine Lawn Road, Melville,
New York.’’ Id. At the time the report was made,
this was the address of the Long Island DEA office.
Id.
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those agents would have had a good
view of the transaction at any given
time. Id. The SA also could not recall
how much money B.C. had given
Respondent during the transaction, but
testified that any money B.C. had given
Respondent would have been provided
by DEA. Tr. 149–150. The SA further
testified that the interrogation of
Respondent took place in Melville, New
York, where the Long Island DEA field
office was located at the time. Tr. 151.
The SA came across as an objective
investigator, with no discernible motive
to mislead, fabricate, or exaggerate.
Though at times, the SA did struggle to
remember certain details, he readily
admitted what he did not remember,
and when his recollection was
refreshed, his testimony was sufficiently
detailed, plausible, and internally
consistent to be afforded full credibility.
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II. Discussion
The Government opposes
Respondent’s COR application under
the dual bases that he has been
convicted of a controlled-substancerelated felony and that he has been
excluded from participating in a
specified federal health care program.
ALJ Ex. 1.*C[In its OSC, the Government
relies upon grounds Congress provided
to support revocation/suspension, not
denial of an application. Prior Agency
decisions have addressed whether it is
appropriate to consider a provision of
21 U.S.C. 824(a) when determining
whether or not to grant a practitioner
registration application. For over fortyfive years, Agency decisions have
concluded that it is. Robert Wayne
Locklear, M.D., 86 FR at 33744–45
(collecting cases); see also, William
Ralph Kincaid. In Robert Wayne
Locklear, M.D., the former Acting
Administrator stated his agreement with
the results of these past decisions and
reaffirmed that a provision of section
824 may be the basis for the denial of
a practitioner registration application.
86 FR at 33745. He also clarified that
allegations related to section 823 remain
relevant to the adjudication of a
practitioner registration application
when a provision of section 824 is
involved. Id.
Accordingly, when considering an
application for a registration, I will
consider any actionable allegations
related to the grounds for denial of an
application under 823 and will also
consider any allegations that the
applicant meets one of the five grounds
*C I have substituted the RD’s language assessing
the application of the revocation grounds to my
assessment of an application under 21 U.S.C. 823(f)
in accordance with recent decisions.
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for revocation or suspension of a
registration under section 824. Id. See
also Dinorah Drug Store, Inc., 61 FR
15972, 15973–74 (1996).
relating to any substance defined in this
subchapter as a controlled substance . . . [or]
(5) has been excluded (or directed to be
excluded) from participation in a program
pursuant to section 1320a–7(a) of Title 42.
A. 21 U.S.C. 823(f): The Five Public
Interest Factors
21 U.S.C. 824(a)(2) and (5). Each ground
is herein addressed in seriatim.
Pursuant to section 303(f) of the CSA,
‘‘[t]he Attorney General shall register
practitioners . . . to dispense . . .
controlled substances . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Section 303(f) further
provides that an application for a
practitioner’s registration may be denied
upon a determination that ‘‘the issuance
of such registration . . . would be
inconsistent with the public interest.’’
Id. In making the public interest
determination, the CSA requires
consideration of the following factors:
B. Exclusion From Participation in a
Federal Health Care Program
The Government seeks denial of
Respondent’s COR application under 21
U.S.C. 824(a)(5) because he has been
excluded from participation in a federal
health care program (Mandatory
Medicare Exclusion or MME). [The
Agency has] discretion to deny a
respondent’s application for a COR if
Respondent ‘‘has been excluded (or
directed to be excluded) from
participation in a program pursuant to
[42 U.S.C. 1320a–7(a)].’’ 21 U.S.C.
824(a)(5) (2012). See supra II. Section
1320a–7 comprises the exclusion of
individuals or entities by the Secretary
of the U.S. Department of Health and
Human Services (HHS) from
participating in federal health care
programs. 42 U.S.C. 1320a–7 (2012). A
federal health care program is (1) a plan
or program providing health benefits
and which is funded in some way by the
U.S. government; 14 or (2) a state health
care program or plan receiving certain
approval or funding from the U.S.
government.15 DEA decisions clearly
establish that Medicare and Medicaid
programs are among those federal health
care programs in which exclusion from
one of them can constitute a basis for
denial of a COR application. See, e.g.,
Daniel Ortiz-Vargas, M.D., 69 FR 62095,
62095–96 (2004); Joseph M. Piacentile,
M.D., 62 FR 35527, 35527–28 (1997);
Anibal P. Herrera, M.D., 61 FR 65075,
65077 (1996); Suresh Gandotra, M.D., 58
FR 64781, 64782 (1993); George D.
Osafo, M.D., 58 FR 37508, 37509 (1993).
Specifically, subsection (a) of
§ 1320a–7, the part of the statute
referenced by 21 U.S.C. 824(a)(5),
dictates when HHS is required to
exclude individuals or entities.16 Id.
§ 1320a–7(a) (‘‘The Secretary shall
exclude the following individuals and
entities from participation in any
[f]ederal health care program . . . .’’)
(emphasis added). There are four
instances requiring mandatory
exclusion: (1) conviction of a criminal
offense ‘‘related to the delivery of an
item or services under [42 U.S.C. 1395
et seq.] or under any [s]tate health care
(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing, or conducting research with
respect to controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
21 U.S.C. 823(f).
In this case, it is undisputed that
Respondent holds a valid state medical
license and is authorized to dispense
controlled substances in the State of
New York where he practices.
Because the Government has not
alleged that Respondent’s registration is
inconsistent with the public interest
under section 823, and although I have
considered 823, I will not analyze
Respondent’s application under the
public interest factors. Therefore, in
accordance with prior agency decisions,
I will move to assess whether the
Government has proven by substantial
evidence that a ground for revocation
exists under 21 U.S.C. 824(a).]
Regarding the two revocation/
suspension grounds the Government
specifically relied on in this case, the
CSA, in pertinent part, states the
following:
A registration pursuant to section 824 of
this title to . . . dispense a controlled
substance . . . may be suspended or revoked
by the Attorney General upon a finding that
the registrant:
(2) has been convicted of a felony under
this subchapter or subchapter II or any other
law of the United States, or of any State,
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14 42
U.S.C. 1320a–7b(f).
U.S.C. 1320a–7(h).
16 In contrast to subsection (a), subsection (b) of
42 U.S.C. 1320a–7 provides sixteen discretionary
grounds of exclusion from health care programs. 42
U.S.C. 1320a–7(b) (2012).
15 42
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program’’; (2) conviction, ‘‘under
[f]ederal or [s]tate law,’’ related to
patient ‘‘neglect or abuse’’ connected
‘‘with the delivery of a health care item
or service[;] (3) [f]elony conviction
related to health care fraud’’; and ‘‘(4)
[f]elony conviction related to . . . the
unlawful manufacture, distribution,
prescription, or dispensing of a
controlled substance.’’ Id. The
unambiguous words of the CSA in 21
U.S.C. 824(a)(5) provide that a
practitioner’s registration ‘‘may be
suspended or revoked’’ if the
practitioner ‘‘has been excluded’’ from
participating in a program pursuant to
42 U.S.C. 1320a–7(a). 21 U.S.C.
824(a)(5). DEA has strictly interpreted
this provision and acknowledged that
the Administrator has discretionary
power to suspend or revoke a
registration only when the practitioner
has been mandatorily excluded from a
federal health care program under
subsection (a) of 42 U.S.C. 1320a–7. See,
e.g., Terese, Inc., d/b/a Peach Orchard
Drugs, 76 FR 46843, 46847 (2011);
Herrera, 61 FR at 65077; Gandotra, 58
FR at 64782; Nelson Ramirez-Gonzalez,
M.D., 58 FR 52787, 52788 (1993). As
specified by the CSA, the misconduct
mandating exclusion does not need to
relate to controlled substances in order
to provide the Administrator with the
power to suspend or revoke (or in this
case deny an application for) a COR.
Jeffrey Stein, M.D., 84 FR 46968, 46973
(2019); Ortiz-Vargas, 69 FR at 62095–96;
Melvin N. Seglin, M.D., 63 FR 70431,
70433 (1998); Osafo, 58 FR at 37509.
[Omitted for brevity.]
When DEA alleges that a practitioner
has been mandatorily excluded from a
federal health care program under 42
U.S.C. 1320a–7a, and thus seeks to
impose a COR sanction, the Government
bears the burden to prove that such an
exclusion occurred. Jin, 77 FR at 35023;
see also, 21 CFR 1301.44(d) (2018) (‘‘At
[a] hearing for the denial of a [COR], the
[Government] shall have the burden of
proving that the requirements for such
registration . . . are not satisfied.’’).
However, even a mandatory exclusion
does not curtail the authority of DEA to
independently weigh the evidence
presented and exercise discretion. Stein,
84 FR at 46970 [omitted parenthetical.]
Accordingly, DEA is not required to
deny Respondent’s COR application
merely because he is subject to a
mandatory exclusion. Id.
*D In the instant case, it is undisputed
that Respondent was excluded from
*D Per the usual format of Agency decisions, I
have removed the discussion of the legal standard
for a respondent’s acceptance of responsibility from
the prima facie analysis to the Sanction section
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participation in federal health care
programs under the mandatory
authority of 42 U.S.C. 1320a–7a. Stip. 4;
Gov’t Ex. 5. Consequently, under
§ 824(a)(5), it is within the discretion of
the Agency to determine, based on the
entire record, whether Respondent’s
exclusion from federal health care
programs renders granting his
application for a COR inappropriate. See
Narcisco A. Reyes, M.D., 83 FR 61678,
61681 (2018) (holding that where the
Government has demonstrated the
requisite mandatory federal health care
program exclusion(s) it has satisfied its
prima facie case, shifting the burden to
the respondent[]). Inasmuch as the
parties have stipulated to Respondent’s
exclusion and the record contains
evidence establishing as much, the
Government has met its burden in this
regard. Stip. 4, 5, 7; See 21 CFR
1301.44(d) (2018).
*E Accordingly, in review of the
evidence of record, including the
stipulations of the parties, OSC
Allegation 3 is sustained.
C. Controlled-Substance-Related Felony
Conviction
The Government also alleges that
Respondent’s application should be
denied because he has been convicted of
a felony related to controlled
substances, pursuant to 21 U.S.C.
824(a)(2). Under that provision, the
Attorney General may suspend or
revoke a registration issued under 21
U.S.C. 823 ‘‘upon a finding that the
registrant . . . has been convicted of a
felony under this subchapter or
subchapter II or any other law of the
United States, or of any State, relating
to any substance defined in this
subchapter as a controlled substance or
a list I chemical.’’ 21 U.S.C.
824(a)(2)(emphasis added).
*F The fact of Respondent’s
conviction in this case has been
conclusively established. Stip 3. There
is no question that Respondent pleaded
guilty to one count of ‘‘Conspiracy to
Distribute Oxycodone, a Class C
below. Further, in the Sanction section below, I
have combined the ALJ’s analysis of Respondent’s
acceptance of responsibility pertaining to the
mandatory exclusion allegation with the ALJ’s
analysis of Respondent’s acceptance of
responsibility pertaining to the controlled substance
felony conviction allegation. I have also combined
the former two analysis sections with the brief
summary regarding the Respondent’s acceptance of
responsibility that the ALJ had originally included
in the Sanction section. I have not made substantive
changes except where noted in brackets. See infra.
*E Analysis of Respondent’s acceptance of
responsibility moved to Sanction section. See supra
n.*D.
*F Discussion of the legal standard for a
respondent’s acceptance of responsibility moved to
Sanction section. See supra n.*D.
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Fmt 4703
Sfmt 4703
Felony,’’ in violation of 21 U.S.C.
841(a), (b)(1)(C) and 846,17 which is a
felony related to a controlled substance.
It is thus beyond argument that the
Government met is prima facie burden
of proving that Respondent has been
convicted of a felony related to
controlled substances.
*G Accordingly, in review of the
evidence of record, including the
stipulations of the parties, OSC
Allegation 2 is sustained.
III. Sanction
Inasmuch as Congress has determined
that a mandatory health care program
exclusion constitutes an adequate basis
for sanction, once the Government has
demonstrated that a respondent has
been so excluded, the burden shifts to
the respondent to show that registration
should be granted as a matter of
discretion. See Jin, 77 FR at 35023. This
burden may be carried by establishing
an unequivocal acceptance of
responsibility for the misconduct that
formed the basis of the exclusion and by
adequately demonstrating remedial
measures to ensure against repetition.
Id.; Stein, 84 FR at 46972–73
(respondent’s assertion that his
misdeeds had no effect on his patients
held to indicate a minimization of his
acceptance of responsibility rendering it
less than unequivocal). This acceptance
of responsibility must be unequivocal; a
registrant’s dishonesty under oath
undermines the registrant’s acceptance
of responsibility and shows that the
registrant ‘‘cannot be entrusted with a
registration.’’ Rose Mary Jacinta Lewis,
M.D., 72 FR 4035, 4042 (2007). Mere
stipulation to facts without admitting to
misconduct does not amount to an
acceptance of responsibility. Ajay S.
Ahuja, M.D., 84 FR 5479, 5498 n.32
(2019). Moreover, a respondent’s own
statements minimizing his or her
misconduct weigh against any
acceptance of responsibility. Arvinder
Singh, M.D., 81 FR 8247, 8249–51
(2016).
In Jin, the Agency relied, in part upon
Melvin N. Seglin, M.D., 63 FR 70431
(1998), a case in which the Agency
found that the respondent ‘‘accepted
responsibility for his misconduct which
was not likely to recur.’’ Id. at 35026. In
evaluating the reasonableness of
sanctions generally, the Agency has also
required an evaluation of the
egregiousness of the proven misconduct
as well as an analysis of considerations
17 United States v. Stephen Owusu, No. 2:11–CR–
0709–001 (LDW) (E.D.N.Y. June 13, 2017).
*G Analysis of Respondent’s acceptance of
responsibility moved to Sanction section. See supra
n.*D.
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of specific and general deterrence,18 and
these factors have been specifically
applied by the Agency in the MME
context. Arvinder Singh, M.D., 81 FR
8247, 8248 (2016). The egregiousness of
the conduct is also considered in the
MME context, even when a controlledsubstance-related crime does not form
the basis of the exclusion. Stein, 84 FR
at 46973.
Further, the Agency has stated that
‘‘ordinarily[,] a respondent who has
been convicted of a felony subject to
§ 824(a)(2) is entitled to present a case
as to why his registration should not be
revoked (or his application denied)’’
because conviction of a felony under the
CSA is not a per se bar to registration.
William J. O’Brien, III, D.O., 82 FR
46527, 46529 (2017). As is the case with
other DEA administrative enforcement
cases seeking a sanction, once the
Government has met its prima facie
case, under § 824(a)(2) by merely
establishing the existence of the
requisite conviction,19 a respondent can
avoid sanction only to the extent he/
she/it is able to demonstrate an
unequivocal acceptance of
responsibility and remedial steps that
are tailored to preventing recurrence.
Singh, 81 FR at 8250 (‘‘[The respondent]
was required to acknowledge the full
scope of his criminal behavior and the
risk of diversion it created . . . .’’);
Hassman, 75 FR at 8236; Ronald Lynch,
M.D., 75 FR 78745, 78753 (2010)
(holding that the respondent’s attempts
to minimize misconduct undermined
purported acceptance of responsibility);
see also Michael A. White, M.D., 79 FR
62957, 62967 (2014); Steven M.
Abbadessa, M.D., 74 FR 10077, 10081
(2009).
There can be no debate that the
Government has met its prima facie
burden of proving that the requirements
for a sanction pursuant to 21 U.S.C.
824(a)(2) and (5) are satisfied. It is well
established that, in cases involving
Medicare exclusion and prior
convictions, a respondent must show
that he unequivocally accepts
responsibility for his past misconduct if
he wishes this tribunal to exercise its
discretionary authority to grant a COR.
See, e.g., Stein, 84 FR at 46972.
Accordingly, unequivocal acceptance of
responsibility for both bases of
18 David A. Ruben, 78 FR 38363, 38364, 38385
(2013).
19 Dan Hale, D.O., 69 FR 69402, 69406 (2004)
(‘‘. . . facts established by criminal convictions are
res judicata and cannot be re-litigated in a DEA
administrative forum.’’); Raymond A. Carlson, M.D.,
53 FR 7425, 7426 (1988) (‘‘the conviction alone
provides sufficient statutory authority to support
the revocation of Respondent’s DEA Certificate of
Registration.’’).
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established misconduct stands as a
condition precedent for Respondent to
prevail.
The purpose of this process is to
determine whether the applicant can
and should be entrusted with
responsibly discharging the life and
death duties of a DEA registrant. For
this purpose, acceptance of
responsibility is critical. 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, L.L.C. v. DEA, 881 F.3d 823, 830–
31 (11th Cir. 2018); MacKay v. DEA, 664
F.3d 808, 822 (10th Cir. 2011); see also,
Hoxie v. DEA, 419 F.3d 477, 483 (6th
Cir. 2005) (holding that admitting fault
and candor with investigators are both
important factors in determining
whether a physician is fit to hold a
COR). Agency prior decisions are clear
that a Respondent must ‘‘unequivocally
admit fault’’ as opposed to demonstrate
a ‘‘generalized acceptance of
responsibility.’’ The Medicine Shoppe,
79 FR 59504, 59510 (2014); see also, Lon
F. Alexander, M.D., 82 FR 49704, 49728
(2017). To satisfy this burden,
Respondent must ‘‘show true remorse’’
or an ‘‘acknowledgement of
wrongdoing.’’ Robert A. Leslie, 68 FR
15227, 15228 (2003). The Agency has
made it clear that unequivocal
acceptance of responsibility is
paramount for avoiding sanction. Robert
L. Dougherty, M.D., 76 FR 16823, 16834
(2011) (citing Jayam Krishna-Iyer, 74 FR
459, 464 (2009)). However, no legal
authority holds that such acceptance,
standing alone, guarantees a favorable
result for every applicant or registrant.
A. Acceptance of Responsibility
To avoid sanction, it is incumbent
upon Respondent to demonstrate
acceptance of responsibility for his
actions and remedial measures taken,
and Respondent fails to persuade the
tribunal that granting his application for
a COR would be consistent with the
public interest. To begin, Respondent’s
testimony was not candid. Candor to the
court is of paramount importance. The
issue of trust is necessarily a factdependent determination based on the
circumstances presented by the
individual respondent; therefore, the
Agency looks at factors, such as the
acceptance of responsibility and the
credibility of that acceptance as it
relates to the probability of repeat
violations. A registrant’s candor during
the investigation and hearing is an
important factor in determining
acceptance of responsibility and the
appropriate sanction; as is whether the
registrant’s acceptance of responsibility
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3349
is unequivocal. Heavenly Care
Pharmacy, 85 FR 53402, 53420 (2020);
see also Fred Samimi, M.D., 79 FR
18698, 18713 (2014); Robert F. Hunt,
D.O., 75 FR 49995, 50004 (2010).
Moreover, throughout his testimony,
Respondent had ample opportunity to
take full and unequivocal responsibility
for his misconduct. Yet repeatedly,
when pressed on the details of his
conviction, Respondent failed to do so,
often deflecting blame to his lawyers,
who, he says, forced him to accept a
plea deal. Tr. 76–80; 116; ALJ Ex. 14 at
2 (referring to ‘‘unscrupulous lawyers
whose solutions were worse than the
problem’’). This refusal to accept blame
is compounded by the inescapable
conclusion that Respondent’s testimony
was not credible on the key facts
surrounding his federal conviction for
conspiracy to distribute oxycodone. For
example, when asked about the
surrender of his previous DEA
registration, Respondent made a point to
‘‘clarify’’ by stating, ‘‘I pleaded guilty
. . . that I wrote those medications. I
wrote them without . . . an attending.
But all those conspiratorial charges that
they added on, no. . . . [I]n the . . .
two pads I wrote—the two prescriptions
I wrote, I pleaded guilty for that. . . .
[T]hat’s what . . . my guilt is about.’’
Tr. 80. This is far from true. As outlined
by the stipulations in these proceedings,
Respondent pleaded guilty in federal
court to Conspiracy to Distribute
Oxycodone. Stip. 3. Although part of the
indictment against him included
allegations that Respondent had left
prescription pads unattended, and those
pads ended up the source of falsified
prescriptions, Respondent’s guilt is
about much more than that. Respondent
was arrested after an undercover
operation, detailed by the testimony of
the SA. Tr. 138–155. This transaction
amounted to an illegal sale of narcotics
and had nothing to do with
Respondent’s lost prescription pads.
Respondent’s attempt, therefore, to
direct focus in these proceedings to the
lost pads, rather than the sale of
oxycodone prescriptions in a parking
lot, amounts to a failure to accept
responsibility for the entirety of his
criminal conduct. As if that were not a
poor enough reflection of his credibility,
Respondent repeatedly and explicitly
insisted that he never conspired to
distribute oxycodone—the very conduct
to which he pleaded guilty before a
federal judge. Tr. 64–66; 78; 116; 125;
ALJ 14 at 5.
Respondent’s failure to acknowledge
the full scope of his criminal liability
presents a more significant problem—
although Respondent admitted that he
had appeared before a federal district
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court judge for his plea hearing, signed
his plea agreement, pleaded guilty
under oath, was sentenced based on the
facts he admitted, and told the district
court judge that his guilty plea was
voluntary (Tr. 130–134), Respondent
also disavowed those proceedings. For
example, Respondent took the
implausible position that, on the day he
pleaded guilty, he showed up to his
lawyer’s office thinking the two of them
were going to speak to the prosecutor in
his case about getting his DEA license
back. Tr. 78–79.
Indeed, Respondent testified in this
hearing that his attorney told him to just
‘‘follow his orders’’ and ‘‘made [him]
plead guilty.’’ Tr. 79. Even more
disturbing, Respondent testified that he
had to say yes because ‘‘my lawyer told
me to just say yes—yes, yes, and I—and
I went all along like that.’’ Tr. 80. Later,
in these proceedings, Respondent
admitted that his statements under oath
at his plea hearing, before a federal
district court judge, were ‘‘not only just
not true . . . I just didn’t feel like a lot
of them were right.’’ Tr. 134.
Respondent’s claims that he was
forced or tricked into pleading guilty are
simply not believable. Respondent’s
late-night delivery of multiple
oxycodone prescriptions in a parking lot
in exchange for $300 in cash was
captured on video-tape. Tr. 113–115. As
even Respondent admitted, his attorney
told him he would have to plead guilty
because of that incriminating recording.
Tr. 112. Even when faced with this fact,
Respondent again diverted blame to his
lawyers, stating that they discouraged
him from going to trial because the
federal court in which he would be tried
was a ‘‘white Court’’ and that
Respondent’s race would be a
disadvantage at trial. Id. See also Tr.
131–32; ALJ Ex. 12 at 3.
Ultimately, this tribunal cannot ignore
that Respondent has changed his
version of events—under oath—in two
different judicial proceedings. By
pleading guilty, Respondent obtained a
benefit of acceptance of responsibility
and, ultimately, a sentence of probation
despite facing a Guideline Sentence of
57 to 71 months. Tr. 130; Govt Ex. 5.
Before this tribunal, when faced with
the consequences of that plea,
Respondent repeatedly proclaimed his
innocence of the conspiracy to
distribute oxycodone, minimizing his
involvement to two prescriptions. Tr.
64–66, 80, 125; ALJ Ex. 14. It is hard to
see how Respondent’s testimony in this
tribunal, when held up against his plea
agreement, amounts to anything more
than Respondent’s attempt to have his
proverbial cake and eat it too. His guilty
plea in federal court saved him from
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significant prison time. But now, when
faced with the consequences of that
plea, he has changed the story in an
effort to obtain a DEA registration.
Either he was dishonest in federal court,
or he was dishonest in these
proceedings. Either way, Respondent
was dishonest and has failed to accept
full responsibility for his actions.
Other implausible aspects of
Respondent’s testimony certainly do not
assist his request for a COR as they
demonstrate a lack of candor. For
example, Respondent’s first instinct
when speaking with DEA was to lie
about whether he had performed an
evaluation of the patient in the car—
retracting that statement only when
confronted with the existence of a
video-recording and apologizing to DEA
for his lie. Tr. 145. Significantly,
Respondent’s lie demonstrated clear
consciousness of guilt—he stated he had
examined his patient because he knew
delivering prescriptions at night in a
parking lot was wrong. Similarly
unbelievable is Respondent’s statement
that he only charged his patient $70 for
the parking lot prescriptions and had no
idea why he was given $300 in cash. Tr.
115. This statement is inconsistent with
the post-arrest statement, in which he
admitted that he charged his patients
$300 for the prescriptions. Tr. 142. Nor
is it plausible that a pharmacy
representative would have testified that
multiple people filled out Respondent’s
prescription pads in front of pharmacy
staff (Tr. 76, 108)—activity that would
certainly have imperiled the pharmacy’s
DEA registration.20
All these inconsistencies are
accompanied by a final troubling truth
about Respondent’s testimony: In the
end, he saw himself as a victim.
Respondent consistently referred to the
undercover operation resulting in his
arrest as ‘‘staged’’ or a ‘‘set-up.’’ Tr. 109–
110, 113–115. Additionally, Respondent
repeatedly contended that he had
‘‘suffered a lot’’ (Tr. 161) and had been
‘‘punished enough.’’ Tr. 105, 163; ALJ
Ex. 12 at 3 (‘‘I will acknowledge that the
length of my punishment has been
excessive and therefore demands a
judicial reprieve.’’); ALJ Ex. 14 at 4–5
(describing the ‘‘windfall repercussions
from this catastrophe. . . .’’). In his
20 These examples of inconsistencies are merely
the most egregious. There were others. For example,
Respondent insisted he earned only $30,000 from
the patients to whom he prescribed Oxycodone (Tr.
111), whereas the SA testified that Respondent told
DEA he had made $40,000 from these patients (Tr.
142). [I agree with the ALJ that this statement was
not as egregious as the other inconsistencies,
because after SA’s testimony, Respondent appeared
to admit that he had memory problems; however,
I do note that the inconsistency further served to
downplay the egregiousness of his crime. Tr. 155.]
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Supplemental Prehearing Statement, he
even asked, ‘‘How much more damage/
harm do you suppose is enough to
satisfy/pacify the arm of the law?’’ ALJ
Ex 14 at 3. And when Respondent
claimed that he had accepted
responsibility for his misconduct, he
did so only with a caveat that his
lawyers forced him to plead guilty. Tr.
161–62 (claiming that he accepts
responsibility even though that some
things in the Government’s criminal
case against him ‘‘were not true’’). This
conditional acceptance of responsibility
is a far cry from unequivocal acceptance
required to be entrusted with a DEA
registration. See Rose Mary Jacinta
Lewis, 72 FR at 4042 (affirming an
immediate suspension when the
respondent lied under oath to downplay
her misconduct); see also Singh, 81 FR
at 8249–51 (denying an application for
a COR when the respondent repeatedly
disputed the extent of his misconduct).
Nor did Respondent’s testimony at any
point express true remorse for his
wrongful conduct. See Michael S.
Moore, M.D., 76 FR 45867, 45868 (2011)
(requiring a registrant to show ‘‘true
remorse’’ for wrongful conduct in order
to find an acceptance of responsibility).
Having concluded that Respondent
has failed to prove an unequivocal
acceptance of responsibility, I need not
address remedial measures. Ajay S.
Ahuja, M.D., 84 FR 5479, 5498 n.33
(2019); Daniel A. Glick, D.D.S., 80 FR
74800, 74801, 74810 (2015).
Nevertheless, even if remedial measures
were considered, they would not change
the result.
The burden is on the respondent to
present sufficient evidence of his
remedial measures. See Scott D.
Fedosky, M.D., 76 FR 71375, 71378
(2011) (declining to give weight to
remedial measures where the
respondent testified about them but did
not present any corroborating evidence
to support his claim). And even if a
respondent does introduce specific
evidence of remedial measures,
registration will not be granted unless
such measures demonstrate that he or
she can be entrusted with a COR. Jeri
Hassman. M.D., 75 FR 8194, 8237 (2010)
(denying a COR where the Agency
found that the respondent had learned
nothing from the remedial steps she had
taken).
Respondent claims that, prior to his
arrest, he had ‘‘no idea’’ of the severity
of the opioid epidemic. Tr. 83. He
testified that he attended a mandatory
class on opioids, which every prescriber
must take. Tr. 84. Respondent also
testified that he would take another
class on February 28, 2021, but he did
not provide any level of detail as to the
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curriculum of the class. Id. According to
Respondent, these classes are required
of prescribers every year, and the
upcoming February 28 class will be his
fourth class. Id. Respondent also
testified that he had attended a
conference in July 2019 on the topic of
General Medicine, and that the last class
in the conference focused on the opioid
pandemic. Tr. 85–86.
To begin, it is of course troubling that
a medical professional with a COR
would not appreciate the severity of the
opioid drug crisis in this country. See
Hassman, 75 FR at 8237. And while
Respondent testified as to several
classes he has taken on the subject, most
of those were mandatory. Furthermore,
Respondent’s testimony does not
provide a level of detail sufficient for
this tribunal to evaluate the classes and
whether they constitute remedial
measures. On its face, a mandatory class
that all prescribers are required to take
does not present as remedial in nature.
Nor does mere compliance with
mandatory requirements inspire
confidence that Respondent has learned
from his past misconduct and can now
be entrusted with a COR. See id. Simply
put, Respondent has not made an
adequate showing of remedial measures
[such that I could entrust him with a
registration.]
Overall, as Respondent faces the
hurdle of demonstrating an adequate
acceptance of responsibility, his
testimony was just not credible.
Certainly, it would strain all bounds of
reasonable jurisprudence to find that
Respondent has accepted responsibility
for his actions, despite his trivialization
of his misconduct, his disavowal of his
statements under oath in his plea
hearing in federal district court, his
implausible testimony, and his own
view of himself as a victim.21 Here, it
21 Respondent did, at times, testify as to his love
of the medical profession and desire to help people.
Tr. 62–63, 65. In addition, Respondent’s Exhibit 2
is a letter from Dr. B.-A., the CEO of the American
Medical Center, which is a clinic that Respondent
has volunteered at. Resp’t Ex. 2. The letter espouses
the virtues of Respondent, and details the
difficulties of finding medical professionals to work
for clinics in impoverished areas, such as the one
where Respondent volunteers. [Omitted. The letter
can be of limited weight in this proceeding,
however, because I have limited ability to assess the
actual credibility of the reference given its written
form. See Michael S. Moore, M.D., 76 FR 45867,
45873 (2011) (evaluating the weight to be attached
to letters provided by the respondent’s hospital
administrators and peers in light of the fact that the
authors were not subjected to the rigors of cross
examination). Further, it offers little value in
assessing the Respondent’s suitability to discharge
the duties of a DEA registrant. Finally, absent
Respondent’s unequivocal acceptance of
responsibility, what little value the letter might
have offered me in evaluating my ability to trust
Respondent is nullified by the fact that he himself
has not shown me that he can be so entrusted. See
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bears repeating that Respondent did not
accept responsibility unequivocally. In
fact, it is hard to imagine a purported
acceptance more equivocal than the one
he offered. Respondent’s own testimony
is riddled with inconsistencies,
statements that are inconsistent with
admissions he made under oath in a
federal criminal proceeding,
implausible statements, and numerous
examples of Respondent portraying
himself as the victim. Indeed, there was
no real expression of remorse, but a
view that he had been unfairly targeted
and ‘‘set up’’ by DEA and accusations of
impropriety in the criminal
proceedings. See, e.g., Tr. 109–10
(describing parking lot transaction as a
‘‘setup’’); Tr. 126 (suggesting DEA
improperly withheld 180 of the 200
prescriptions written on his allegedly
stolen prescription pads). Respondent’s
lack of any meaningful acceptance of
responsibility presents an
insurmountable barrier to his
application for a COR.
In any event, given the limited scope
of Respondent’s remedial measures,
those measures do not change the
outcome. His limited efforts do not
establish a plan of remedial measures
that assure the tribunal that he will not
repeat the established transgressions.
See Hassman, 75 FR at 8236. This case
must be decided not merely upon what
he says, but what he says and does. C.f.
Alra Laboratories v. DEA, 54 F.3d 450,
452 (7th Cir. 1995) (sustaining the
Agency’s conclusion that past
performance is the best predictor of
future performance).
Although he testified that he has
taken several classes on the opioid
epidemic, Respondent provided no
information about these classes. Nor
does completion of one mandatory class
per year tend to show that Respondent
has taken sufficient remedial measures
to address his past misconduct—or to
even appreciate the egregiousness of
this conduct. While Respondent
claimed that he was naı¨ve (Tr. 55, 76),
and did not appreciate the full extent of
the pandemic, he failed to articulate
what specific steps he would take to
ensure that his misconduct resulting in
diversion would not be repeated.
William Ralph Kincaid, 86 FR 40636, 40641 (2021).]
Respondent’s past service—even his volunteer
service—is simply not enough to outweigh his lack
of acceptance of responsibility in these proceedings.
The letter has no other relevance, as the Agency has
consistently held that community impact is not a
relevant consideration under the public interest
factors. Linda Sue Cheek, M.D., 76 FR at 66972; see
also Gregory D. Owens, D.D.S., 74 FR 36751, 36757
(2009). Here, the evidence of community impact
offered by Respondent does nothing to explain the
issues of credibility his testimony presents.
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Accordingly, I find that, in the face of
the Government’s prima facie case,
Respondent has failed to unequivocally
accept responsibility for his past
misconduct; therefore, he cannot be
trusted with a DEA COR. See Singh, 81
FR at 8250.
B. Specific and General Deterrence
In determining whether and to what
extent imposing a sanction is
appropriate, consideration must be
given to the Agency’s interest in both
specific and general deterrence as well
as the egregiousness of the offenses
established by the Government’s
evidence. David A. Ruben, 78 FR 38363,
38384, 38385 (2013). The Agency has
previously found [based on specific
circumstances] that criminal
convictions and sanctions by state
licensing authorities can sufficiently
deter physicians from engaging in
misconduct, making the denial of an
application for, or revocation of, a COR
unnecessary to achieve the goal of
general deterrence. Kansky J. Delisma,
M.D., 85 FR 23845, 23854 (2020).
Likewise, such punitive measures can
suffice to deter the registrant or
applicant from future misconduct,
making revocation or denial of an
application unnecessary to achieve
specific deterrence. Id.
With respect to specific deterrence,
Respondent failed in these proceedings
to portray a registrant who is
remorseful, and who has worked hard to
change for the better. Rather,
Respondent came across as a person
who says the right thing in order to get
what he wants, and, when pressed, does
not own up to his mistakes. Without a
better indication of remorse, the tribunal
can only conclude that granting
Respondent a COR would put the public
at risk of Respondent’s previous
diversionary behavior. Moreover, with
respect to general deterrence, the
Agency bears the responsibility to deter
conduct similar to Respondent’s past
misconduct. Ruben, 78 FR at 38385.
Granting a COR to an applicant who has
neither unequivocally taken
responsibility for his misconduct, nor
demonstrated sufficient remedial
measures to ensure such conduct will
not happen again, would send a
message to all that, so long as one
completes a mandatory class or two per
year, there will be few consequences to
diverting controlled substances.
C. Egregiousness
Finally, this tribunal finds that Dr.
Owusu’s behavior was egregious. Dr.
Owusu conducted a transaction that
differs in no material respect from a
drug deal. He sold multiple
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prescriptions for powerful controlled
substances at night, in a parking lot, in
a manner designed to avoid detection.
Both then and now, Respondent has
responded with calculated, inconsistent
statements designed to escape
culpability. In Gonzales v. Oregon, 546
U.S. 243, 270 (2006), the Supreme Court
made clear that DEA has authority
under the Controlled Substances Act to
bar illicit drug dealing and trafficking as
traditionally understood. Respondent,
in this case, engaged in conduct that
constitutes drug trafficking as
traditionally understood, and,
accordingly, the appropriate sanction is
denial of his application for a DEA
registration.
Accordingly, it is herein respectfully
recommended that Respondent’s
application for a DEA registration be
denied.
Dated: April 9, 2021.
Teresa A. Wallbaum,
Administrative Law Judge.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny the pending
application for a Certificate of
Registration, Control Number
W19061136C, submitted by Stephen E.
Owusu, D.P.M., as well as any other
pending application of Stephen E.
Owusu, D.P.M., for additional
registration in New York. This Order is
effective February 22, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022–01108 Filed 1–20–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22–1]
jspears on DSK121TN23PROD with NOTICES1
Alex E. Torres, M.D.; Decision and
Order
On August 11, 2021, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Alex E.
Torres, M.D. (hereinafter, Respondent)
of San Diego, California. OSC, at 1 and
3. The OSC proposed the revocation of
Respondent’s Certificate of Registration
No. BT1734943. Id. at 1. It alleged that
Respondent is ‘‘without authority to
handle controlled substances in
California, the state in which
[Respondent is] registered with DEA.’’
Id. at 2 (citing 21 U.S.C. 824(a)(3)).
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Specifically, the OSC alleged that on
March 18, 2021, Respondent entered
into a Stipulated Surrender of License
and Order (hereinafter, Stipulated
Surrender) with the Medical Board of
California (hereinafter, the Board)
‘‘whereby [Respondent] agreed to
surrender [his] California state medical
license.’’ Id. According to the OSC,
Respondent agreed to the Stipulated
Surrender after the Board alleged, inter
alia, that ‘‘[Respondent] negligently
treated three patients, failed to maintain
adequate and accurate records, and
[was] impaired due to mental illness.’’
Id. The OSC stated that the Board issued
its Decision adopting the Stipulated
Surrender on March 22, 2021, with the
Decision becoming effective on March
29, 2021. Id.
The OSC notified Respondent of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2–3 (citing
21 CFR 1301.43). The OSC also notified
Respondent of the opportunity to
submit a corrective action plan. Id. at 3
(citing 21 U.S.C. 824(c)(2)(C)).
By letter dated October 12, 2021,
Respondent timely requested a hearing.1
Administrative Law Judge Exhibit
(hereinafter, ALJX) 4 (Request for
Hearing), at 1. According to the Request
for Hearing, ‘‘[Respondent] never agreed
to surrender his California DEA license
. . . [and] the [Board] didn’t make any
claim against [Respondent’s] DEA
license.’’ Id. at 2. Further, the Request
for Hearing states that ‘‘[d]uring [the
Board] process [Respondent] denied the
allegations against him.’’ Id. According
to the Request for Hearing, ‘‘[n]one of
the allegations against [Respondent]
were related to drug prescription [sic]’’
and ‘‘the patient’s [sic] allegations
against [Respondent] were made
because he refused to prescribe them
controlled pain medications.’’ Id.
Finally, the Request for Hearing states
that, ‘‘[t]he mental illness claimed by
[the Board] was refuted and proved
wrong with a psychiatric evaluation
performed to [Respondent] after the
Board alleged [that] he was mentally
ill.’’ Id.
The Office of Administrative Law
Judges put the matter on the docket and
assigned it to Administrative Law Judge
Paul E. Soeffing (hereinafter, the ALJ).
The ALJ issued the Briefing Schedule on
October 13, 2021. On October 21, 2021,
the Government timely filed its Notice
of Filing of Evidence and Motion for
Summary Disposition (hereinafter,
Government’s Motion). Order Granting
the Government’s Motion for Summary
Disposition, and Recommended
Rulings, Findings of Fact, Conclusions
of Law, and Decision of the
Administrative Law Judge (hereinafter,
Recommended Decision or RD), at 2. In
its Motion, the Government ‘‘request[ed]
summary disposition and a
recommendation that Respondent’s DEA
Certificate of Registration as a
practitioner be revoked based on his
lack of authority to handle controlled
substances in the State of California, the
state in which he is registered with the
DEA.’’ Government’s Motion, at 5.
Respondent did not answer the
Government’s Motion.2 He did,
however, address the OSC and the
Government’s allegations in his Request
for Hearing. Request for Hearing, at 1–
2. I have reviewed and considered the
Request for Hearing as part of, and along
with, the entire record before me.
The ALJ issued his Recommended
Decision on November 2, 2021, granting
the Government’s Motion and finding
that ‘‘[a]s the Respondent does not have
authority as a practitioner in California,
there is no other fact of consequence for
[the] tribunal to decide in order to
determine whether or not he is entitled
to hold a [DEA registration].’’ RD, at 6.
Further, the ALJ recommended that
Respondent’s DEA registration be
revoked and that any application to
renew or modify his registration and
any applications for any other DEA
registrations in California be denied
‘‘based on [Respondent’s] lack of state
authority to practice medicine or handle
controlled substances in California.’’ Id.
at 6–7. By letter dated November 29,
2021, the ALJ certified and transmitted
the record to me for final Agency action.
In the letter, the ALJ advised that no
exceptions were filed by either party.
Transmittal Letter, at 1.
I issue this Decision and Order based
on the entire record before me. 21 CFR
1301.43(e). I make the following
findings of fact.
1 The Request for Hearing was filed on October
13, 2021. Order for Evidence of Lack of State
Authority and Directing the Government to File
Evidence Regarding the Service of the Order to
Show Cause (hereinafter, Briefing Schedule), at 1.
I find that the Government’s service of the OSC was
adequate and that the Request for Hearing was
timely filed on October 13, 2021. See RD, at n.1.
2 I find that the Office of Administrative Law
Judges properly served Respondent on all
occasions. The Certificate of Service for the
Government’s Motion certifies that the Government
served Respondent’s counsel at the email address
provided in Respondent’s Request for Hearing.
Request for Hearing, at 1–2.
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Agencies
[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3343-3352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01108]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21-5]
Stephen E. Owusu, D.P.M.; Decision and Order
On October 22, 2020, a former Assistant Administrator, Diversion
Control Division, of the Drug Enforcement Administration (hereinafter,
DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to
Stephen E. Owusu, D.P.M. (hereinafter, Respondent) of Brooklyn, New
York. Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (OSC), at
1. The OSC proposed the denial of Respondent's application for DEA
Certificate of Registration No. W19061136C (hereinafter, COR or
registration) and the denial of any applications for any other DEA
registrations pursuant to 21 U.S.C. 824(a)(2) and 824(a)(5) because
Respondent was convicted of a felony related to controlled substances
and because Respondent has been excluded from participation in
Medicare, Medicaid, and all federal health care programs pursuant to 42
U.S.C. 1320a-7(a). Id.
On November 23, 2020, the Respondent timely requested a hearing,
which commenced (and ended) on February 17, 2021, at the DEA Hearing
Facility in Arlington, Virginia with the parties, counsel, and
witnesses participating via video teleconference (VTC). On April 9,
2021, Administrative Law Judge Teresa A. Wallbaum (hereinafter, the
ALJ) issued her Recommended Rulings, Findings of Fact, Conclusions of
Law, and Decision of the Administrative Law Judge (hereinafter,
Recommended Decision or RD). By letter dated May 4, 2021, the ALJ
certified and transmitted the record to me for final Agency action. In
the letter, the ALJ advised that neither party filed exceptions. Having
reviewed the entire record, I adopt the ALJ's rulings, findings of
fact, as modified, conclusions of law and recommended sanction with
minor modifications, where noted herein.*\A\
---------------------------------------------------------------------------
*\A\ I have made minor modifications to the RD. I have
substituted initials or titles for the names of witnesses and
patients to protect their privacy and I have made minor,
nonsubstantive, grammatical changes and nonsubstantive, conforming
edits. Where I have made substantive changes, omitted language for
brevity or relevance, or where I have added to or modified the ALJ's
opinion, I have noted the edits with an asterisk, and I have
included specific descriptions of the modifications in brackets
following the asterisk or in footnotes marked with a letter and an
asterisk. Within those brackets and footnotes, the use of the
personal pronoun ``I'' refers to myself--the Administrator.
---------------------------------------------------------------------------
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Teresa A. Wallbaum; Administrative Law Judge
April 9, 2021
*\B\ Respondent proceeded pro se throughout the entire case.\1\
Respondent timely filed a Request for Hearing. A Prehearing Conference
was conducted on January 12, 2021, via VTC. \2\A hearing on the merits
of the OSC allegations was conducted on February 17, 2021, via VTC at
the DEA Hearing Facility in Arlington, Virginia. The Government filed a
Post-Hearing Brief on March 26, 2021.
---------------------------------------------------------------------------
*\B\ I have omitted a section of the RD's discussion of the
procedural history to avoid repetition with my introduction.
\1\ Respondent was advised during the Prehearing Conference
that, under 21 CFR 1316.50, he had the right to seek representation
by a qualified attorney at his own expense. Respondent was also
advised that, if he continued to represent himself, he would be held
to the same standards and procedural requirements of an attorney,
including adherence to the procedural orders and rulings of this
tribunal and to the procedural rules set forth in 21 CFR 1316.41-
1316.68. ALJ Ex. 13 at 2, n.3. During the merits hearing, Respondent
acknowledged that he had been so advised and confirmed that he
wanted to proceed pro se. Tr. 7-8.
\2\ Respondent failed to submit a Prehearing Statement by the
December 29, 2020, deadline set out in this tribunal's Order for
Prehearing Statements. ALJ Ex. 3. The tribunal then issued an Order
Directing Compliance, which gave Respondent until January 4, 2021,
to show good cause as to why he did not comply with the Order for
Prehearing Statements. ALJ Ex. 7. Respondent then filed a Prehearing
Statement on January 4, 2021, but did not offer any attempt to show
good cause for his late filing. ALJ Ex. 8. The tribunal issued a
Second Order Directing Compliance on January 4, 2021, requiring
Respondent to show good cause. ALJ Ex. 9. Respondent then filed a
document styled ``Requisite Good Cause for Late Filing,'' in which
he purported to show good cause. ALJ Ex. 10. Thereafter, the
tribunal issued an Order Regarding Respondent's Late Filed
Prehearing Statement, which set out several of Respondent's failures
to comply with the Order for Prehearing Statements, including late
filings and at least two failures to serve pleadings on opposing
counsel. ALJ Ex. 11. The Order also directed Respondent to file a
Prehearing Statement in compliance with the Order for Prehearing
Statements by January 11, 2021. Id. Respondent finally did file a
compliant Prehearing Statement on January 10, 2021. ALJ Ex. 12.
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The issue to be ultimately decided by the Acting Administrator,
with the assistance of this Recommended Decision, is whether
Respondent's application should be denied based
[[Page 3344]]
upon his felony conviction related to controlled substances and/or his
exclusion from participation in a federal health care program pursuant
to 42 U.S.C. 1320a-7(a).
After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
of law below.\3\
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\3\ After conducting the merits hearing in this case, the
tribunal mailed a hard copy of the transcript of the hearing to both
parties. Despite two separate delivery attempts, the hard copy could
not be delivered to Respondent's address. Chambers reached out to
Respondent to confirm his address, but delivery was never
effectuated. Respondent was, however, provided with an electronic
version of the transcript and had an opportunity to submit
corrections to the transcript.
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I. Findings of Fact
A. Allegations
The Government alleges that the denial of Respondent's application
is supported by incontrovertible record evidence that he has been both
convicted of a felony related to controlled substances and excluded
from participation in a federal health care program. ALJ Ex. 1. The
Government further alleges that judgment was entered against Respondent
in the United States District Court for the Eastern District of New
York after pleading guilty to one count of Conspiracy to Distribute
Oxycodone, a Class C Felony, in violation of 21 U.S.C. 841(a),
(b)(1)(C), and 846.\4\ The Government also alleges that the U.S.
Department of Health and Human Services, Office of Inspector General
(HHS/OIG) mandatorily excluded Respondent from participation in
Medicare, Medicaid, and all federal health care programs pursuant to 42
U.S.C. 1320a-7(a).\5\ According to the Government, this exclusion was
effective as of October 19, 2017, and runs for a period of five
years.\6\ ALJ Ex. 1.
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\4\ United States v. Stephen Owusu, No. 2:11-CR-0709-001 (LDW)
(E.D.N.Y. June 13, 2017).
\5\ Respondent has stipulated to the factual basis underlying
this allegation. See Stip. 5.
\6\ Respondent has stipulated to the factual basis underlying
this allegation. See Stip. 5.
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B. Stipulations
The following stipulations were mutually agreed upon by the parties
and are conclusively accepted as fact in these proceedings:
1. On or about June 12, 2019, Respondent filed with the DEA an
application for registration as a practitioner in Schedules II
through V pursuant to DEA control number W19061136C, with a proposed
registered address of 106 Pennsylvania Ave., Suite 1, Brooklyn, NY
11207-2427.
2. On or about July 19, 2011, Respondent surrendered for cause
his previous DEA registration, No. BO3613331.
3. On June 13, 2017, Judgment was entered against Respondent in
the United States District Court for the Eastern District of New
York after Respondent pleaded guilty to one count of ``Conspiracy to
Distribute Oxycodone, a Class C Felony,'' in violation of 21 U.S.C.
841(a), (b)(1)(C), and 846. United States v. Stephen Owusu, No.
2:11-CR-0709-001 (LDW) (E.D.N.Y. June 13, 2017).
4. Based on Respondent's conviction, the New York State Office
of the Medicaid Inspector General excluded Respondent from
participation in the New York Medicaid program. The exclusion was
effective August 30, 2017.
5. Based on Respondent's conviction, the U.S. Department of
Health and Human Services, Office of Inspector General (HHS/OIG),
mandatorily excluded Respondent from participation in Medicare,
Medicaid, and all federal health care programs pursuant to 42 U.S.C.
1320a-7(a). The exclusion was effective on October 19, 2017, and
runs for a period of five years.
6. Reinstatement of eligibility to participate in Medicare,
Medicaid, and all federal health care programs after exclusion by
HHS/OIG is not automatic.
7. Respondent is currently excluded from participation in
Medicare, Medicaid, and all federal health care programs.
C. Government's Case-in-Chief
The Government's case-in-chief consisted of the testimony of a
single witness, a DEA Diversion Group Supervisor (hereinafter, the GS).
The GS testified that her duty station is the New York Field Division,
located in New York City, where she has served in her capacity as a
group supervisor for approximately one year. Tr. 21-22. Before the GS
was promoted to group supervisor, she worked as a Diversion
Investigator for approximately 24 Years. Tr. 22. In her position as a
group supervisor, the GS is required to undergo periodic training as a
part of her duties. Tr. 23. Further, she has been involved in over 200
DEA investigations throughout her career. Id.
Respondent came to the attention of the GS when she was assigned
his application for DEA registration. Tr. 24. The GS also testified
that she interviewed Respondent on two occasions. Id. Through the
testimony of the GS, the Government laid the foundation for the
introduction of multiple exhibits in support of its allegations.\7\
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\7\ Specifically, the testimony from the GS laid the foundation
for Government Exhibits 1, 4, 5, 6, 7, 8, and 9. Tr. 24-26, 28-29,
31-33, 34-35, 36-39, 40-41, 42-43.
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The parties agree, and the evidence demonstrates, that, on June 13,
2017, Respondent pleaded guilty to one count of Conspiracy to
Distribute Oxycodone, a Class C Felony, in violation of 21 U.S.C.
841(a), (b)(1)(C), and 846. Gov. Ex. 5, 6.\8\ The Department of Health
and Human Services, Office of Inspector General sent Respondent a
letter, informing him that he had been excluded from Medicare,
Medicaid, and all federal health care programs for a period beginning
on October 19, 2017, and lasting a minimum of five years. Gov. Ex. 8;
Tr. 40. The GS also testified that the New York State Office of the
Medicaid Inspector General had sent Respondent a letter informing him
that he had been excluded from the state's Medicaid program. Gov. Ex.
7; Tr. 36-37.
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\8\ Respondent also stipulated to this conviction. See Stip. 3,
infra.
---------------------------------------------------------------------------
Respondent's exclusion from Medicare, Medicaid, and all federal
health care programs, along with Respondent's conviction of Conspiracy
to Distribute Oxycodone, are the bases of the Government's present case
opposing Respondent's application for a new COR. The GS testified that,
on February 16, 2021, she ran a new search on a web page of the U.S.
Department of Health and Human Services, Office of Inspector General,
and confirmed through that search that Respondent was still excluded
from all federal health care programs. Tr. 43.
The GS came across as an objective investigator, with no
discernable motive to mislead, fabricate, or exaggerate. The testimony
of this witness was primarily focused on the uncontroversial \9\
introduction of documentary evidence and her contact with this case,
and was sufficiently detailed, plausible, and internally consistent to
be afforded full credibility.
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\9\ Respondent did not object to the admission of any exhibit
offered by the Government. Tr. 26, 30, 33, 35, 39, 42, 43-44.
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D. Respondent's Case
Respondent, proceeding pro se, presented his own testimony and
offered four exhibits in support of his case. According to Respondent,
he received a Bachelor's degree from the University of New York and
thereafter studied genetic engineering in a Ph.D. program. Tr. 51. He
departed that program with a Master's Degree and entered Temple
University Medical School, where he studied Podiatric Medicine. Id.
Respondent graduated from Temple University in 1992 and completed his
residence at a Veterans' Affairs hospital in Brooklyn, New York. Tr.
52. He obtained medical licenses in both New York and Pennsylvania and
[[Page 3345]]
began practicing medicine in New York in 1994. Tr. 53; 57.
Respondent has worked both as a solo practitioner and a clinic
physician, specializing in wound care at two different clinics. Tr. 54;
57-59. In one of those clinics, Respondent served as the director,
specializing in baric neuropathy, supervising three to four nurses and
nurse practitioners, and seeing 50 patients a day. Tr. 54-56. For
nearly ten years, starting in 1998, he also worked in a dialysis clinic
specializing in treating patients in ``end-stage renal dialysis'' who
suffered lower extremity problems. Tr. 61-63.
Respondent testified that, prior to 2011, he never had any
disciplinary problems in either New York or Pennsylvania and had no
arrests or convictions. Tr. 60; 64; 87.
Respondent admitted that he pleaded guilty to one count of
Conspiracy to Distribute Oxycodone on June 13, 2017, in violation of 21
U.S.C. 841(a), (b)(1)(C), and 846. Stip. 3; United States v. Stephen
Owusu, No. 2:11-CR-0709-001 (LDW) (E.D.N.Y. June 13, 2017). But
Respondent's description of the events behind that conviction evolved
over the course of these proceedings. In his second Prehearing
Statement,\10\ Respondent referenced ``2 falsified prescriptions in
[his] name to which [he] was called to cooperate with the police for
prosecution [and] lost prescription pads that a pharmacist attested to
but which [his] lawyers would not allow court trial.'' ALJ Ex. 12 at 3;
see also Tr. 131-32 (affirming statement as accurate). In his
Supplemental Prehearing Statement, Respondent stated that he ``never
conspired to sell or distribute oxycodone and [he] will never conspire
to sell or distribute oxycodone or any controlled substance(s).'' ALJ
Ex. 14 at 5.
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\10\ Given Respondent's failure to summarize his testimony in
his initial Prehearing Statement, this tribunal directed that he
file a revised Prehearing Statement, which he did on January 10,
2021. ALJ Ex. 12.
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During the hearing, Respondent testified that he had prescribed
oxycodone for one patient (who had been referred to him by another,
trusted patient) on the patient's third visit. Tr. 67-70. Specifically,
he prescribed the oxycodone because the patient had brought oxycodone
in with him, told the Respondent he had taken it from his brother, and
it was the only medication that reduced his pain. Tr. 69-70. Respondent
refilled the oxycodone prescription approximately once a month or once
every two months for two years. Tr. 74. The same patient brought in a
couple of friends on the same construction site where he worked and
Respondent likewise prescribed those patients oxycodone. Tr. 75.
Respondent explained that he prescribed oxycodone because he was ``very
na[iuml]ve'' and sometimes ``too helpful'' or ``too kind.'' Tr. 64 and
76.
He also testified that two prescription pads were lost from his
office and ``a lot of guys'' had come to the pharmacy and written
prescriptions from his pad. Tr. 76. According to Respondent, someone
from the pharmacy would have testified for him. Tr. 76; Tr. 108.
Respondent's lawyers, however, declined to investigate his defense and
DEA produced only 20 of the 200 it alleged were illegal. Tr. 108-109;
see also Tr. 126 (he stated that DEA never showed him the other 180
prescriptions).
On cross-examination, Respondent admitted that, on one occasion, he
delivered multiple oxycodone prescriptions to a patient in a parking
lot at 8:30 p.m. or 9:00 p.m. Tr. 113-115. He did so ``from the
kindness of [his] heart'' because the patient was taking his son to a
football practice or game and could not make it to the medical office
in time. Tr. 109-110. At the time, Respondent did not realize it was a
``setup,'' and that it was ``staged.'' Id.; see also Tr. 113 (``I would
call it staged. Why? Because I had no idea what was going on.''). The
patient was, in fact, an informant or, as Respondent testified: ``the
very person who they accused [Respondent] [of] conspiring to distribute
oxycodone with was somebody . . . [Respondent] didn't know was already
a criminal [and] who had already been incriminated. And then the Court
used him . . . as an informant, sent him to [Respondent], [he] asked
[Respondent] for the medication, and this is how it began.'' Tr. 65
(cleaned up).
Respondent insisted that he charged the patient $70, even though
the patient paid him $300 for the prescriptions, and testified that
``why [the patient] gave [him] $300, [he doesn't] know.'' Tr. 115. When
interviewed by DEA agents, he admitted that he made approximately
$30,000 over the course of two years for these patients. Tr. 111-112.
He viewed the cash payment in the parking lot as ``almost like a
technicality'' because the patient would have paid him the same amount
had he come into the office. Tr. 126.
When asked whether he had examined his patients before prescribing,
Respondent provided an evasive answer:
Q: Dr. Owusu, isn't it true that you issued multiple
prescriptions for oxycodone without examining the patients?
A: I examined them, Your Honor. Counsellor, I examined them.
Q: All of them?
A: Well, the--the initial--the initial patients, all of them
were examined.
Tr. 117.
Respondent emphasized that he was hesitant to explain his prior
convictions because he did not ``want it to be misconstrued as a lack
of penitence and a lack of repentance.'' Tr. 50; see also Tr. 133.
Ultimately, however, Respondent testified repeatedly that--despite his
guilty plea--he did not, in fact, conspire to distribute oxycodone.
See, e.g., Tr. 64 (``I was not a co-conspirator, and I did not conspire
at all.''); id. (``this so-called conspiracy case''); Tr. 65. (``the
record will show I never had--never was involved in any--any infraction
of the law. Never, never.''); Tr. 66 (``I was never, myself, never, and
I would say--I would say until my dying day, never conspired to
distribute drugs. Never. And I never will, Your Honor.''); Tr. 78
(attorney believed he was innocent); Tr. 80 (``But all those
conspiratorial charges that they added on, no.''); Tr. 116 (``I was
innocent, okay?''); Tr. 125 (affirming statement made in his Prehearing
Statement that he had accepted responsibility ``despite the fact I
never conspired to sell or distribute oxycodone''); Tr. 134 (at plea
hearing, under oath, he admitted that he had pleaded guilty even though
many of his statements were ``not only just not true . . . I just
didn't feel like a lot of them were right.'').
Rather, Respondent claimed that he was forced, and indeed tricked,
into pleading guilty by his lawyers. See, e.g., Tr. 78 (``I thought I
was going for [the lawyer] to take me to a DEA office. I went to him
that day with the understanding that we were going to the DEA office to
help me get my DEA license back. And I went to the courtroom, and that
was the day he made me plead guilty.''); Tr. 79-80 (``I had to say yes
because my lawyer told me to just say yes--yes, yes, and I . . . went
all along like that''); Tr. 76 (attorney forced him to plead guilty
because he feared a racially unjust trial); Tr. 116 (attorney forced
him to plead guilty because of ``the circumstances, the location of the
Court, the selection of the jury''). At one point, however, Respondent
also acknowledged that his attorney told him to plead guilty because of
the incriminating video recording. Tr. 112.
Respondent admitted that he was guilty, but just for the ``two
prescriptions I wrote . . . . [T]hat's what . . . my guilt is about.''
Tr. 80. He acknowledged that he had appeared
[[Page 3346]]
before a federal district court judge for his plea hearing, signed his
plea agreement, pleaded guilty under oath, was sentenced based on the
facts he admitted, and told the district court judge that his guilty
plea was voluntary. Tr. 130-134. Respondent was sentenced to three
years' probation (Tr. 81), which he completed early without any
infractions (Tr. 97-98; Resp't Ex. 3).
Indeed, Respondent often cast himself as the victim--repeatedly
stating that he ``suffered'' because of the conviction. For example,
after recounting the facts behind his conviction, Respondent stated:
``They were the things I have suffered in the past, okay? Some of the
things I look back on, and I--I've suffered for the last ten years
because.'' Tr. 132; see also Tr. 161 (``I have suffered a lot, and I
have learned a lot.''). In other instances, Respondent described
himself as a victim (Tr. 64) who had been ``punished enough'' (Tr.
105). Indeed, Respondent's primary argument for obtaining his
registration was ``it's been enough time for punishment. It's been
enough time that I have . . . paid the penalty.'' Tr. 163. [Respondent
also stated, ``So, I am trustworthy. I've never been in a situation
where my credibility ever, ever was in question until this situation .
. . . I can promise you, I can, you know, that definitely I have learnt
my lesson and very, very, well. And this will never again be repeated,
never. Tr. 106]
According to Respondent, he has not earned his living from the
practice of medicine since his arrest, since it is impossible to
practice without a DEA registration. Tr. 61; Tr. 82-83. He admitted,
however, that it was possible to practice without a DEA registration,
although such practice would be limited. Tr. 119-121.
As for remedial measures, Respondent testified that he had taken
four classes regarding opioid addiction--one in September 2011, one in
2019, one in July 2020, and one in February 2021. Tr. 83-86.\11\ Three
of those classes were mandated by the New York licensing board; the
2019 training was a day of specialized training at a general medical
conference. Tr. 84-85. Respondent still has a current medical license
in New York, valid until September 30, 2023. Tr. 86-91; Resp't Ex. 1.
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\11\ In his revised Prehearing Statement, Respondent described
his training as: ``One whole day OPIOID CRISIS class I attended
around Fall 2011; several other continuing medical educational
SEMINARS attended in the years; A requisite pre-certifying OPIOID
crisis, addiction and treatment course for all NY State
Practitioners taken in 2018.'' ALJ Ex. 12 at 4. Although there is
some discrepancy between this description and Respondent's testimony
at trial, I do not question that Respondent has taken multiple
courses over the years, especially as many of those courses were
mandatory for his continued licensure.
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Finally, Respondent submitted a letter from Dr. B.-A. (doctor of
Public Administration) regarding Respondent's current work at his
clinic supporting his character. Resp't Ex. 2; Tr. 96; 123.\12\
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\12\ This tribunal sustained the Government's objection
regarding Respondent's Exhibit 4, which was a ``Certificate of
Relief from Disabilities'' from the New York Department of
Corrections and Supervision. Tr. 104. That document was excluded for
two reasons. First, this tribunal could not ascertain its
authenticity given numerous inconsistencies, including a docket
number that did not match the docket number on Respondent's federal
conviction. Tr. 99-104. Second, it was not relevant because it did
not specifically relate to Respondent's medical license. Tr.100. [I
agree with the ALJ and find that this document is not legally
relevant to the current matter.]
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As noted in more detail in the Analysis section, infra,
Respondent's testimony did not present as credible on the key issue of
his culpability because he contradicted his representations under oath
in the federal prosecution, his description of events was not
plausible, and he minimized his own responsibility.
E. Government's Rebuttal Case
The Government offered one rebuttal witness--a Special Agent of the
Drug Enforcement Administration (hereinafter, the SA). The SA testified
that he is assigned to the Long Island District Office in Central
Islip, New York. Tr. 138. The Special Agent also testified that he has
been a Special Agent with DEA since 1996, and that his job duties
include conducting investigations, some of which are undercover. Tr.
139. In approximately 2011, The Special Agent became familiar with
Respondent during an investigation involving oxycodone distribution.
Tr. 139-140. During that investigation, Respondent was identified and
arrested. Tr. 140.
An individual named B. C.--a patient of Dr. Owusu's--cooperated
with the Government in this 2011 investigation. Id. B.C. specifically
provided the SA and other agents at DEA with information regarding his
illegal purchase of prescription narcotics from Respondent. Id. At the
direction of DEA, B.C. met with Respondent while wearing a concealed
video recording device. Tr. 140-141. The SA, along with several other
DEA agents, observed the meeting between Respondent and B.C. Tr. 142.
The SA also later retrieved the video recording device from B.C. and
observed the video recording of the meeting. Tr. 143. Respondent and
B.C. met in the Mercy Hospital parking lot in Rockville Center, New
York. Tr. 141. During the meeting, B.C. purchased prescriptions for
narcotics from Respondent. Id. Initially, when asked how many
prescriptions B.C. had purchased during the meeting, the SA testified
that he did not remember. Id.
The SA, relying upon a post-arrest report, testified that
Respondent had issued numerous prescriptions during the recorded
transaction with B.C., but that the report did not specify how
many.\13\ Tr. 147-48. The SA also testified that Respondent had
admitted that he had met several times with B.C. over a several-year
period, and that he had sold B.C. oxycodone pills for $300 cash per
prescription. Tr. 144-45. The SA testified that, after being read his
Miranda warning in the SA's presence, Respondent stated that he had
made approximately $40,000 from selling illegal prescriptions to B.C.
Tr. 145, 153.
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\13\ This post-arrest report is also known as a DEA-6, which is
a report of investigation. Tr. 143. The SA testified that this
specific DEA-6 was titled, ``Post Arrest Statements of Dr. Stephen
Owusu on July 19, 2011, at 175 Pine Lawn Road, Melville, New York.''
Id. At the time the report was made, this was the address of the
Long Island DEA office. Id.
---------------------------------------------------------------------------
The SA testified that, after his arrest, Respondent stated that he
did conduct a physical examination of B.C. before selling the
prescription narcotics, but that, once confronted with the video of the
transaction, Respondent admitted that was a lie--that, in fact, no
examination was conducted--and apologized for lying. Id. The SA, when
asked to summarize the content of the video, stated that he had not
reviewed the video recently, but that he thought it showed B.C. getting
into Respondent's vehicle for a short period of time, paying for the
prescriptions for narcotics, and then exiting the vehicle. Tr. 146.
Later, when asked about the video recording, The SA testified that he
was mistaken, and then corrected himself and stated that, in fact, B.C.
and Respondent stayed in their respective cars throughout the
transaction, and that B.C. did not enter Respondent's vehicle. Tr. 154.
On cross-examination, the SA testified that he recalled seeing the
meeting between Respondent and B.C. Tr. 149. He also testified that he
was not sure if he ever had to move his vehicle to get a better view of
the transaction, and he could not remember if his view was obstructed
at any time. Id. The SA did, however, recall that there were multiple
DEA agents conducting surveillance in the area in order to observe the
transaction, and he stated that he was in constant radio communication
with those agents. Id. He also testified that at least one of
[[Page 3347]]
those agents would have had a good view of the transaction at any given
time. Id. The SA also could not recall how much money B.C. had given
Respondent during the transaction, but testified that any money B.C.
had given Respondent would have been provided by DEA. Tr. 149-150. The
SA further testified that the interrogation of Respondent took place in
Melville, New York, where the Long Island DEA field office was located
at the time. Tr. 151.
The SA came across as an objective investigator, with no
discernible motive to mislead, fabricate, or exaggerate. Though at
times, the SA did struggle to remember certain details, he readily
admitted what he did not remember, and when his recollection was
refreshed, his testimony was sufficiently detailed, plausible, and
internally consistent to be afforded full credibility.
II. Discussion
The Government opposes Respondent's COR application under the dual
bases that he has been convicted of a controlled-substance-related
felony and that he has been excluded from participating in a specified
federal health care program. ALJ Ex. 1.*\C\[In its OSC, the Government
relies upon grounds Congress provided to support revocation/suspension,
not denial of an application. Prior Agency decisions have addressed
whether it is appropriate to consider a provision of 21 U.S.C. 824(a)
when determining whether or not to grant a practitioner registration
application. For over forty-five years, Agency decisions have concluded
that it is. Robert Wayne Locklear, M.D., 86 FR at 33744-45 (collecting
cases); see also, William Ralph Kincaid. In Robert Wayne Locklear,
M.D., the former Acting Administrator stated his agreement with the
results of these past decisions and reaffirmed that a provision of
section 824 may be the basis for the denial of a practitioner
registration application. 86 FR at 33745. He also clarified that
allegations related to section 823 remain relevant to the adjudication
of a practitioner registration application when a provision of section
824 is involved. Id.
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*\C\ I have substituted the RD's language assessing the
application of the revocation grounds to my assessment of an
application under 21 U.S.C. 823(f) in accordance with recent
decisions.
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Accordingly, when considering an application for a registration, I
will consider any actionable allegations related to the grounds for
denial of an application under 823 and will also consider any
allegations that the applicant meets one of the five grounds for
revocation or suspension of a registration under section 824. Id. See
also Dinorah Drug Store, Inc., 61 FR 15972, 15973-74 (1996).
A. 21 U.S.C. 823(f): The Five Public Interest Factors
Pursuant to section 303(f) of the CSA, ``[t]he Attorney General
shall register practitioners . . . to dispense . . . controlled
substances . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Section 303(f) further provides that an
application for a practitioner's registration may be denied upon a
determination that ``the issuance of such registration . . . would be
inconsistent with the public interest.'' Id. In making the public
interest determination, the CSA requires consideration of the following
factors:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
In this case, it is undisputed that Respondent holds a valid state
medical license and is authorized to dispense controlled substances in
the State of New York where he practices.
Because the Government has not alleged that Respondent's
registration is inconsistent with the public interest under section
823, and although I have considered 823, I will not analyze
Respondent's application under the public interest factors. Therefore,
in accordance with prior agency decisions, I will move to assess
whether the Government has proven by substantial evidence that a ground
for revocation exists under 21 U.S.C. 824(a).]
Regarding the two revocation/suspension grounds the Government
specifically relied on in this case, the CSA, in pertinent part, states
the following:
A registration pursuant to section 824 of this title to . . .
dispense a controlled substance . . . may be suspended or revoked by
the Attorney General upon a finding that the registrant:
(2) has been convicted of a felony under this subchapter or
subchapter II or any other law of the United States, or of any
State, relating to any substance defined in this subchapter as a
controlled substance . . . [or]
(5) has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of Title
42.
21 U.S.C. 824(a)(2) and (5). Each ground is herein addressed in
seriatim.
B. Exclusion From Participation in a Federal Health Care Program
The Government seeks denial of Respondent's COR application under
21 U.S.C. 824(a)(5) because he has been excluded from participation in
a federal health care program (Mandatory Medicare Exclusion or MME).
[The Agency has] discretion to deny a respondent's application for a
COR if Respondent ``has been excluded (or directed to be excluded) from
participation in a program pursuant to [42 U.S.C. 1320a-7(a)].'' 21
U.S.C. 824(a)(5) (2012). See supra II. Section 1320a-7 comprises the
exclusion of individuals or entities by the Secretary of the U.S.
Department of Health and Human Services (HHS) from participating in
federal health care programs. 42 U.S.C. 1320a-7 (2012). A federal
health care program is (1) a plan or program providing health benefits
and which is funded in some way by the U.S. government; \14\ or (2) a
state health care program or plan receiving certain approval or funding
from the U.S. government.\15\ DEA decisions clearly establish that
Medicare and Medicaid programs are among those federal health care
programs in which exclusion from one of them can constitute a basis for
denial of a COR application. See, e.g., Daniel Ortiz-Vargas, M.D., 69
FR 62095, 62095-96 (2004); Joseph M. Piacentile, M.D., 62 FR 35527,
35527-28 (1997); Anibal P. Herrera, M.D., 61 FR 65075, 65077 (1996);
Suresh Gandotra, M.D., 58 FR 64781, 64782 (1993); George D. Osafo,
M.D., 58 FR 37508, 37509 (1993).
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\14\ 42 U.S.C. 1320a-7b(f).
\15\ 42 U.S.C. 1320a-7(h).
---------------------------------------------------------------------------
Specifically, subsection (a) of Sec. 1320a-7, the part of the
statute referenced by 21 U.S.C. 824(a)(5), dictates when HHS is
required to exclude individuals or entities.\16\ Id. Sec. 1320a-7(a)
(``The Secretary shall exclude the following individuals and entities
from participation in any [f]ederal health care program . . . .'')
(emphasis added). There are four instances requiring mandatory
exclusion: (1) conviction of a criminal offense ``related to the
delivery of an item or services under [42 U.S.C. 1395 et seq.] or under
any [s]tate health care
[[Page 3348]]
program''; (2) conviction, ``under [f]ederal or [s]tate law,'' related
to patient ``neglect or abuse'' connected ``with the delivery of a
health care item or service[;] (3) [f]elony conviction related to
health care fraud''; and ``(4) [f]elony conviction related to . . . the
unlawful manufacture, distribution, prescription, or dispensing of a
controlled substance.'' Id. The unambiguous words of the CSA in 21
U.S.C. 824(a)(5) provide that a practitioner's registration ``may be
suspended or revoked'' if the practitioner ``has been excluded'' from
participating in a program pursuant to 42 U.S.C. 1320a-7(a). 21 U.S.C.
824(a)(5). DEA has strictly interpreted this provision and acknowledged
that the Administrator has discretionary power to suspend or revoke a
registration only when the practitioner has been mandatorily excluded
from a federal health care program under subsection (a) of 42 U.S.C.
1320a-7. See, e.g., Terese, Inc., d/b/a Peach Orchard Drugs, 76 FR
46843, 46847 (2011); Herrera, 61 FR at 65077; Gandotra, 58 FR at 64782;
Nelson Ramirez-Gonzalez, M.D., 58 FR 52787, 52788 (1993). As specified
by the CSA, the misconduct mandating exclusion does not need to relate
to controlled substances in order to provide the Administrator with the
power to suspend or revoke (or in this case deny an application for) a
COR. Jeffrey Stein, M.D., 84 FR 46968, 46973 (2019); Ortiz-Vargas, 69
FR at 62095-96; Melvin N. Seglin, M.D., 63 FR 70431, 70433 (1998);
Osafo, 58 FR at 37509. [Omitted for brevity.]
---------------------------------------------------------------------------
\16\ In contrast to subsection (a), subsection (b) of 42 U.S.C.
1320a-7 provides sixteen discretionary grounds of exclusion from
health care programs. 42 U.S.C. 1320a-7(b) (2012).
---------------------------------------------------------------------------
When DEA alleges that a practitioner has been mandatorily excluded
from a federal health care program under 42 U.S.C. 1320a-7a, and thus
seeks to impose a COR sanction, the Government bears the burden to
prove that such an exclusion occurred. Jin, 77 FR at 35023; see also,
21 CFR 1301.44(d) (2018) (``At [a] hearing for the denial of a [COR],
the [Government] shall have the burden of proving that the requirements
for such registration . . . are not satisfied.''). However, even a
mandatory exclusion does not curtail the authority of DEA to
independently weigh the evidence presented and exercise discretion.
Stein, 84 FR at 46970 [omitted parenthetical.] Accordingly, DEA is not
required to deny Respondent's COR application merely because he is
subject to a mandatory exclusion. Id.
*\D\ In the instant case, it is undisputed that Respondent was
excluded from participation in federal health care programs under the
mandatory authority of 42 U.S.C. 1320a-7a. Stip. 4; Gov't Ex. 5.
Consequently, under Sec. 824(a)(5), it is within the discretion of the
Agency to determine, based on the entire record, whether Respondent's
exclusion from federal health care programs renders granting his
application for a COR inappropriate. See Narcisco A. Reyes, M.D., 83 FR
61678, 61681 (2018) (holding that where the Government has demonstrated
the requisite mandatory federal health care program exclusion(s) it has
satisfied its prima facie case, shifting the burden to the
respondent[]). Inasmuch as the parties have stipulated to Respondent's
exclusion and the record contains evidence establishing as much, the
Government has met its burden in this regard. Stip. 4, 5, 7; See 21 CFR
1301.44(d) (2018).
---------------------------------------------------------------------------
*\D\ Per the usual format of Agency decisions, I have removed
the discussion of the legal standard for a respondent's acceptance
of responsibility from the prima facie analysis to the Sanction
section below. Further, in the Sanction section below, I have
combined the ALJ's analysis of Respondent's acceptance of
responsibility pertaining to the mandatory exclusion allegation with
the ALJ's analysis of Respondent's acceptance of responsibility
pertaining to the controlled substance felony conviction allegation.
I have also combined the former two analysis sections with the brief
summary regarding the Respondent's acceptance of responsibility that
the ALJ had originally included in the Sanction section. I have not
made substantive changes except where noted in brackets. See infra.
---------------------------------------------------------------------------
*\E\ Accordingly, in review of the evidence of record, including
the stipulations of the parties, OSC Allegation 3 is sustained.
---------------------------------------------------------------------------
*\E\ Analysis of Respondent's acceptance of responsibility moved
to Sanction section. See supra n.*D.
---------------------------------------------------------------------------
C. Controlled-Substance-Related Felony Conviction
The Government also alleges that Respondent's application should be
denied because he has been convicted of a felony related to controlled
substances, pursuant to 21 U.S.C. 824(a)(2). Under that provision, the
Attorney General may suspend or revoke a registration issued under 21
U.S.C. 823 ``upon a finding that the registrant . . . has been
convicted of a felony under this subchapter or subchapter II or any
other law of the United States, or of any State, relating to any
substance defined in this subchapter as a controlled substance or a
list I chemical.'' 21 U.S.C. 824(a)(2)(emphasis added).
*\F\ The fact of Respondent's conviction in this case has been
conclusively established. Stip 3. There is no question that Respondent
pleaded guilty to one count of ``Conspiracy to Distribute Oxycodone, a
Class C Felony,'' in violation of 21 U.S.C. 841(a), (b)(1)(C) and
846,\17\ which is a felony related to a controlled substance. It is
thus beyond argument that the Government met is prima facie burden of
proving that Respondent has been convicted of a felony related to
controlled substances.
---------------------------------------------------------------------------
*\F\ Discussion of the legal standard for a respondent's
acceptance of responsibility moved to Sanction section. See supra
n.*D.
\17\ United States v. Stephen Owusu, No. 2:11-CR-0709-001 (LDW)
(E.D.N.Y. June 13, 2017).
---------------------------------------------------------------------------
*\G\ Accordingly, in review of the evidence of record, including
the stipulations of the parties, OSC Allegation 2 is sustained.
---------------------------------------------------------------------------
*\G\ Analysis of Respondent's acceptance of responsibility moved
to Sanction section. See supra n.*D.
---------------------------------------------------------------------------
III. Sanction
Inasmuch as Congress has determined that a mandatory health care
program exclusion constitutes an adequate basis for sanction, once the
Government has demonstrated that a respondent has been so excluded, the
burden shifts to the respondent to show that registration should be
granted as a matter of discretion. See Jin, 77 FR at 35023. This burden
may be carried by establishing an unequivocal acceptance of
responsibility for the misconduct that formed the basis of the
exclusion and by adequately demonstrating remedial measures to ensure
against repetition. Id.; Stein, 84 FR at 46972-73 (respondent's
assertion that his misdeeds had no effect on his patients held to
indicate a minimization of his acceptance of responsibility rendering
it less than unequivocal). This acceptance of responsibility must be
unequivocal; a registrant's dishonesty under oath undermines the
registrant's acceptance of responsibility and shows that the registrant
``cannot be entrusted with a registration.'' Rose Mary Jacinta Lewis,
M.D., 72 FR 4035, 4042 (2007). Mere stipulation to facts without
admitting to misconduct does not amount to an acceptance of
responsibility. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.32 (2019).
Moreover, a respondent's own statements minimizing his or her
misconduct weigh against any acceptance of responsibility. Arvinder
Singh, M.D., 81 FR 8247, 8249-51 (2016).
In Jin, the Agency relied, in part upon Melvin N. Seglin, M.D., 63
FR 70431 (1998), a case in which the Agency found that the respondent
``accepted responsibility for his misconduct which was not likely to
recur.'' Id. at 35026. In evaluating the reasonableness of sanctions
generally, the Agency has also required an evaluation of the
egregiousness of the proven misconduct as well as an analysis of
considerations
[[Page 3349]]
of specific and general deterrence,\18\ and these factors have been
specifically applied by the Agency in the MME context. Arvinder Singh,
M.D., 81 FR 8247, 8248 (2016). The egregiousness of the conduct is also
considered in the MME context, even when a controlled-substance-related
crime does not form the basis of the exclusion. Stein, 84 FR at 46973.
---------------------------------------------------------------------------
\18\ David A. Ruben, 78 FR 38363, 38364, 38385 (2013).
---------------------------------------------------------------------------
Further, the Agency has stated that ``ordinarily[,] a respondent
who has been convicted of a felony subject to Sec. 824(a)(2) is
entitled to present a case as to why his registration should not be
revoked (or his application denied)'' because conviction of a felony
under the CSA is not a per se bar to registration. William J. O'Brien,
III, D.O., 82 FR 46527, 46529 (2017). As is the case with other DEA
administrative enforcement cases seeking a sanction, once the
Government has met its prima facie case, under Sec. 824(a)(2) by
merely establishing the existence of the requisite conviction,\19\ a
respondent can avoid sanction only to the extent he/she/it is able to
demonstrate an unequivocal acceptance of responsibility and remedial
steps that are tailored to preventing recurrence. Singh, 81 FR at 8250
(``[The respondent] was required to acknowledge the full scope of his
criminal behavior and the risk of diversion it created . . . .'');
Hassman, 75 FR at 8236; Ronald Lynch, M.D., 75 FR 78745, 78753 (2010)
(holding that the respondent's attempts to minimize misconduct
undermined purported acceptance of responsibility); see also Michael A.
White, M.D., 79 FR 62957, 62967 (2014); Steven M. Abbadessa, M.D., 74
FR 10077, 10081 (2009).
---------------------------------------------------------------------------
\19\ Dan Hale, D.O., 69 FR 69402, 69406 (2004) (``. . . facts
established by criminal convictions are res judicata and cannot be
re-litigated in a DEA administrative forum.''); Raymond A. Carlson,
M.D., 53 FR 7425, 7426 (1988) (``the conviction alone provides
sufficient statutory authority to support the revocation of
Respondent's DEA Certificate of Registration.'').
---------------------------------------------------------------------------
There can be no debate that the Government has met its prima facie
burden of proving that the requirements for a sanction pursuant to 21
U.S.C. 824(a)(2) and (5) are satisfied. It is well established that, in
cases involving Medicare exclusion and prior convictions, a respondent
must show that he unequivocally accepts responsibility for his past
misconduct if he wishes this tribunal to exercise its discretionary
authority to grant a COR. See, e.g., Stein, 84 FR at 46972.
Accordingly, unequivocal acceptance of responsibility for both bases of
established misconduct stands as a condition precedent for Respondent
to prevail.
The purpose of this process is to determine whether the applicant
can and should be entrusted with responsibly discharging the life and
death duties of a DEA registrant. For this purpose, acceptance of
responsibility is critical. 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, L.L.C.
v. DEA, 881 F.3d 823, 830-31 (11th Cir. 2018); MacKay v. DEA, 664 F.3d
808, 822 (10th Cir. 2011); see also, Hoxie v. DEA, 419 F.3d 477, 483
(6th Cir. 2005) (holding that admitting fault and candor with
investigators are both important factors in determining whether a
physician is fit to hold a COR). Agency prior decisions are clear that
a Respondent must ``unequivocally admit fault'' as opposed to
demonstrate a ``generalized acceptance of responsibility.'' The
Medicine Shoppe, 79 FR 59504, 59510 (2014); see also, Lon F. Alexander,
M.D., 82 FR 49704, 49728 (2017). To satisfy this burden, Respondent
must ``show true remorse'' or an ``acknowledgement of wrongdoing.''
Robert A. Leslie, 68 FR 15227, 15228 (2003). The Agency has made it
clear that unequivocal acceptance of responsibility is paramount for
avoiding sanction. Robert L. Dougherty, M.D., 76 FR 16823, 16834 (2011)
(citing Jayam Krishna-Iyer, 74 FR 459, 464 (2009)). However, no legal
authority holds that such acceptance, standing alone, guarantees a
favorable result for every applicant or registrant.
A. Acceptance of Responsibility
To avoid sanction, it is incumbent upon Respondent to demonstrate
acceptance of responsibility for his actions and remedial measures
taken, and Respondent fails to persuade the tribunal that granting his
application for a COR would be consistent with the public interest. To
begin, Respondent's testimony was not candid. Candor to the court is of
paramount importance. The issue of trust is necessarily a fact-
dependent determination based on the circumstances presented by the
individual respondent; therefore, the Agency looks at factors, such as
the acceptance of responsibility and the credibility of that acceptance
as it relates to the probability of repeat violations. A registrant's
candor during the investigation and hearing is an important factor in
determining acceptance of responsibility and the appropriate sanction;
as is whether the registrant's acceptance of responsibility is
unequivocal. Heavenly Care Pharmacy, 85 FR 53402, 53420 (2020); see
also Fred Samimi, M.D., 79 FR 18698, 18713 (2014); Robert F. Hunt,
D.O., 75 FR 49995, 50004 (2010).
Moreover, throughout his testimony, Respondent had ample
opportunity to take full and unequivocal responsibility for his
misconduct. Yet repeatedly, when pressed on the details of his
conviction, Respondent failed to do so, often deflecting blame to his
lawyers, who, he says, forced him to accept a plea deal. Tr. 76-80;
116; ALJ Ex. 14 at 2 (referring to ``unscrupulous lawyers whose
solutions were worse than the problem''). This refusal to accept blame
is compounded by the inescapable conclusion that Respondent's testimony
was not credible on the key facts surrounding his federal conviction
for conspiracy to distribute oxycodone. For example, when asked about
the surrender of his previous DEA registration, Respondent made a point
to ``clarify'' by stating, ``I pleaded guilty . . . that I wrote those
medications. I wrote them without . . . an attending. But all those
conspiratorial charges that they added on, no. . . . [I]n the . . . two
pads I wrote--the two prescriptions I wrote, I pleaded guilty for that.
. . . [T]hat's what . . . my guilt is about.'' Tr. 80. This is far from
true. As outlined by the stipulations in these proceedings, Respondent
pleaded guilty in federal court to Conspiracy to Distribute Oxycodone.
Stip. 3. Although part of the indictment against him included
allegations that Respondent had left prescription pads unattended, and
those pads ended up the source of falsified prescriptions, Respondent's
guilt is about much more than that. Respondent was arrested after an
undercover operation, detailed by the testimony of the SA. Tr. 138-155.
This transaction amounted to an illegal sale of narcotics and had
nothing to do with Respondent's lost prescription pads. Respondent's
attempt, therefore, to direct focus in these proceedings to the lost
pads, rather than the sale of oxycodone prescriptions in a parking lot,
amounts to a failure to accept responsibility for the entirety of his
criminal conduct. As if that were not a poor enough reflection of his
credibility, Respondent repeatedly and explicitly insisted that he
never conspired to distribute oxycodone--the very conduct to which he
pleaded guilty before a federal judge. Tr. 64-66; 78; 116; 125; ALJ 14
at 5.
Respondent's failure to acknowledge the full scope of his criminal
liability presents a more significant problem--although Respondent
admitted that he had appeared before a federal district
[[Page 3350]]
court judge for his plea hearing, signed his plea agreement, pleaded
guilty under oath, was sentenced based on the facts he admitted, and
told the district court judge that his guilty plea was voluntary (Tr.
130-134), Respondent also disavowed those proceedings. For example,
Respondent took the implausible position that, on the day he pleaded
guilty, he showed up to his lawyer's office thinking the two of them
were going to speak to the prosecutor in his case about getting his DEA
license back. Tr. 78-79.
Indeed, Respondent testified in this hearing that his attorney told
him to just ``follow his orders'' and ``made [him] plead guilty.'' Tr.
79. Even more disturbing, Respondent testified that he had to say yes
because ``my lawyer told me to just say yes--yes, yes, and I--and I
went all along like that.'' Tr. 80. Later, in these proceedings,
Respondent admitted that his statements under oath at his plea hearing,
before a federal district court judge, were ``not only just not true .
. . I just didn't feel like a lot of them were right.'' Tr. 134.
Respondent's claims that he was forced or tricked into pleading
guilty are simply not believable. Respondent's late-night delivery of
multiple oxycodone prescriptions in a parking lot in exchange for $300
in cash was captured on video-tape. Tr. 113-115. As even Respondent
admitted, his attorney told him he would have to plead guilty because
of that incriminating recording. Tr. 112. Even when faced with this
fact, Respondent again diverted blame to his lawyers, stating that they
discouraged him from going to trial because the federal court in which
he would be tried was a ``white Court'' and that Respondent's race
would be a disadvantage at trial. Id. See also Tr. 131-32; ALJ Ex. 12
at 3.
Ultimately, this tribunal cannot ignore that Respondent has changed
his version of events--under oath--in two different judicial
proceedings. By pleading guilty, Respondent obtained a benefit of
acceptance of responsibility and, ultimately, a sentence of probation
despite facing a Guideline Sentence of 57 to 71 months. Tr. 130; Govt
Ex. 5. Before this tribunal, when faced with the consequences of that
plea, Respondent repeatedly proclaimed his innocence of the conspiracy
to distribute oxycodone, minimizing his involvement to two
prescriptions. Tr. 64-66, 80, 125; ALJ Ex. 14. It is hard to see how
Respondent's testimony in this tribunal, when held up against his plea
agreement, amounts to anything more than Respondent's attempt to have
his proverbial cake and eat it too. His guilty plea in federal court
saved him from significant prison time. But now, when faced with the
consequences of that plea, he has changed the story in an effort to
obtain a DEA registration. Either he was dishonest in federal court, or
he was dishonest in these proceedings. Either way, Respondent was
dishonest and has failed to accept full responsibility for his actions.
Other implausible aspects of Respondent's testimony certainly do
not assist his request for a COR as they demonstrate a lack of candor.
For example, Respondent's first instinct when speaking with DEA was to
lie about whether he had performed an evaluation of the patient in the
car--retracting that statement only when confronted with the existence
of a video-recording and apologizing to DEA for his lie. Tr. 145.
Significantly, Respondent's lie demonstrated clear consciousness of
guilt--he stated he had examined his patient because he knew delivering
prescriptions at night in a parking lot was wrong. Similarly
unbelievable is Respondent's statement that he only charged his patient
$70 for the parking lot prescriptions and had no idea why he was given
$300 in cash. Tr. 115. This statement is inconsistent with the post-
arrest statement, in which he admitted that he charged his patients
$300 for the prescriptions. Tr. 142. Nor is it plausible that a
pharmacy representative would have testified that multiple people
filled out Respondent's prescription pads in front of pharmacy staff
(Tr. 76, 108)--activity that would certainly have imperiled the
pharmacy's DEA registration.\20\
---------------------------------------------------------------------------
\20\ These examples of inconsistencies are merely the most
egregious. There were others. For example, Respondent insisted he
earned only $30,000 from the patients to whom he prescribed
Oxycodone (Tr. 111), whereas the SA testified that Respondent told
DEA he had made $40,000 from these patients (Tr. 142). [I agree with
the ALJ that this statement was not as egregious as the other
inconsistencies, because after SA's testimony, Respondent appeared
to admit that he had memory problems; however, I do note that the
inconsistency further served to downplay the egregiousness of his
crime. Tr. 155.]
---------------------------------------------------------------------------
All these inconsistencies are accompanied by a final troubling
truth about Respondent's testimony: In the end, he saw himself as a
victim. Respondent consistently referred to the undercover operation
resulting in his arrest as ``staged'' or a ``set-up.'' Tr. 109-110,
113-115. Additionally, Respondent repeatedly contended that he had
``suffered a lot'' (Tr. 161) and had been ``punished enough.'' Tr. 105,
163; ALJ Ex. 12 at 3 (``I will acknowledge that the length of my
punishment has been excessive and therefore demands a judicial
reprieve.''); ALJ Ex. 14 at 4-5 (describing the ``windfall
repercussions from this catastrophe. . . .''). In his Supplemental
Prehearing Statement, he even asked, ``How much more damage/harm do you
suppose is enough to satisfy/pacify the arm of the law?'' ALJ Ex 14 at
3. And when Respondent claimed that he had accepted responsibility for
his misconduct, he did so only with a caveat that his lawyers forced
him to plead guilty. Tr. 161-62 (claiming that he accepts
responsibility even though that some things in the Government's
criminal case against him ``were not true''). This conditional
acceptance of responsibility is a far cry from unequivocal acceptance
required to be entrusted with a DEA registration. See Rose Mary Jacinta
Lewis, 72 FR at 4042 (affirming an immediate suspension when the
respondent lied under oath to downplay her misconduct); see also Singh,
81 FR at 8249-51 (denying an application for a COR when the respondent
repeatedly disputed the extent of his misconduct). Nor did Respondent's
testimony at any point express true remorse for his wrongful conduct.
See Michael S. Moore, M.D., 76 FR 45867, 45868 (2011) (requiring a
registrant to show ``true remorse'' for wrongful conduct in order to
find an acceptance of responsibility).
Having concluded that Respondent has failed to prove an unequivocal
acceptance of responsibility, I need not address remedial measures.
Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019); Daniel A. Glick,
D.D.S., 80 FR 74800, 74801, 74810 (2015). Nevertheless, even if
remedial measures were considered, they would not change the result.
The burden is on the respondent to present sufficient evidence of
his remedial measures. See Scott D. Fedosky, M.D., 76 FR 71375, 71378
(2011) (declining to give weight to remedial measures where the
respondent testified about them but did not present any corroborating
evidence to support his claim). And even if a respondent does introduce
specific evidence of remedial measures, registration will not be
granted unless such measures demonstrate that he or she can be
entrusted with a COR. Jeri Hassman. M.D., 75 FR 8194, 8237 (2010)
(denying a COR where the Agency found that the respondent had learned
nothing from the remedial steps she had taken).
Respondent claims that, prior to his arrest, he had ``no idea'' of
the severity of the opioid epidemic. Tr. 83. He testified that he
attended a mandatory class on opioids, which every prescriber must
take. Tr. 84. Respondent also testified that he would take another
class on February 28, 2021, but he did not provide any level of detail
as to the
[[Page 3351]]
curriculum of the class. Id. According to Respondent, these classes are
required of prescribers every year, and the upcoming February 28 class
will be his fourth class. Id. Respondent also testified that he had
attended a conference in July 2019 on the topic of General Medicine,
and that the last class in the conference focused on the opioid
pandemic. Tr. 85-86.
To begin, it is of course troubling that a medical professional
with a COR would not appreciate the severity of the opioid drug crisis
in this country. See Hassman, 75 FR at 8237. And while Respondent
testified as to several classes he has taken on the subject, most of
those were mandatory. Furthermore, Respondent's testimony does not
provide a level of detail sufficient for this tribunal to evaluate the
classes and whether they constitute remedial measures. On its face, a
mandatory class that all prescribers are required to take does not
present as remedial in nature. Nor does mere compliance with mandatory
requirements inspire confidence that Respondent has learned from his
past misconduct and can now be entrusted with a COR. See id. Simply
put, Respondent has not made an adequate showing of remedial measures
[such that I could entrust him with a registration.]
Overall, as Respondent faces the hurdle of demonstrating an
adequate acceptance of responsibility, his testimony was just not
credible. Certainly, it would strain all bounds of reasonable
jurisprudence to find that Respondent has accepted responsibility for
his actions, despite his trivialization of his misconduct, his
disavowal of his statements under oath in his plea hearing in federal
district court, his implausible testimony, and his own view of himself
as a victim.\21\ Here, it bears repeating that Respondent did not
accept responsibility unequivocally. In fact, it is hard to imagine a
purported acceptance more equivocal than the one he offered.
Respondent's own testimony is riddled with inconsistencies, statements
that are inconsistent with admissions he made under oath in a federal
criminal proceeding, implausible statements, and numerous examples of
Respondent portraying himself as the victim. Indeed, there was no real
expression of remorse, but a view that he had been unfairly targeted
and ``set up'' by DEA and accusations of impropriety in the criminal
proceedings. See, e.g., Tr. 109-10 (describing parking lot transaction
as a ``setup''); Tr. 126 (suggesting DEA improperly withheld 180 of the
200 prescriptions written on his allegedly stolen prescription pads).
Respondent's lack of any meaningful acceptance of responsibility
presents an insurmountable barrier to his application for a COR.
---------------------------------------------------------------------------
\21\ Respondent did, at times, testify as to his love of the
medical profession and desire to help people. Tr. 62-63, 65. In
addition, Respondent's Exhibit 2 is a letter from Dr. B.-A., the CEO
of the American Medical Center, which is a clinic that Respondent
has volunteered at. Resp't Ex. 2. The letter espouses the virtues of
Respondent, and details the difficulties of finding medical
professionals to work for clinics in impoverished areas, such as the
one where Respondent volunteers. [Omitted. The letter can be of
limited weight in this proceeding, however, because I have limited
ability to assess the actual credibility of the reference given its
written form. See Michael S. Moore, M.D., 76 FR 45867, 45873 (2011)
(evaluating the weight to be attached to letters provided by the
respondent's hospital administrators and peers in light of the fact
that the authors were not subjected to the rigors of cross
examination). Further, it offers little value in assessing the
Respondent's suitability to discharge the duties of a DEA
registrant. Finally, absent Respondent's unequivocal acceptance of
responsibility, what little value the letter might have offered me
in evaluating my ability to trust Respondent is nullified by the
fact that he himself has not shown me that he can be so entrusted.
See William Ralph Kincaid, 86 FR 40636, 40641 (2021).] Respondent's
past service--even his volunteer service--is simply not enough to
outweigh his lack of acceptance of responsibility in these
proceedings. The letter has no other relevance, as the Agency has
consistently held that community impact is not a relevant
consideration under the public interest factors. Linda Sue Cheek,
M.D., 76 FR at 66972; see also Gregory D. Owens, D.D.S., 74 FR
36751, 36757 (2009). Here, the evidence of community impact offered
by Respondent does nothing to explain the issues of credibility his
testimony presents.
---------------------------------------------------------------------------
In any event, given the limited scope of Respondent's remedial
measures, those measures do not change the outcome. His limited efforts
do not establish a plan of remedial measures that assure the tribunal
that he will not repeat the established transgressions. See Hassman, 75
FR at 8236. This case must be decided not merely upon what he says, but
what he says and does. C.f. Alra Laboratories v. DEA, 54 F.3d 450, 452
(7th Cir. 1995) (sustaining the Agency's conclusion that past
performance is the best predictor of future performance).
Although he testified that he has taken several classes on the
opioid epidemic, Respondent provided no information about these
classes. Nor does completion of one mandatory class per year tend to
show that Respondent has taken sufficient remedial measures to address
his past misconduct--or to even appreciate the egregiousness of this
conduct. While Respondent claimed that he was na[iuml]ve (Tr. 55, 76),
and did not appreciate the full extent of the pandemic, he failed to
articulate what specific steps he would take to ensure that his
misconduct resulting in diversion would not be repeated.
Accordingly, I find that, in the face of the Government's prima
facie case, Respondent has failed to unequivocally accept
responsibility for his past misconduct; therefore, he cannot be trusted
with a DEA COR. See Singh, 81 FR at 8250.
B. Specific and General Deterrence
In determining whether and to what extent imposing a sanction is
appropriate, consideration must be given to the Agency's interest in
both specific and general deterrence as well as the egregiousness of
the offenses established by the Government's evidence. David A. Ruben,
78 FR 38363, 38384, 38385 (2013). The Agency has previously found
[based on specific circumstances] that criminal convictions and
sanctions by state licensing authorities can sufficiently deter
physicians from engaging in misconduct, making the denial of an
application for, or revocation of, a COR unnecessary to achieve the
goal of general deterrence. Kansky J. Delisma, M.D., 85 FR 23845, 23854
(2020). Likewise, such punitive measures can suffice to deter the
registrant or applicant from future misconduct, making revocation or
denial of an application unnecessary to achieve specific deterrence.
Id.
With respect to specific deterrence, Respondent failed in these
proceedings to portray a registrant who is remorseful, and who has
worked hard to change for the better. Rather, Respondent came across as
a person who says the right thing in order to get what he wants, and,
when pressed, does not own up to his mistakes. Without a better
indication of remorse, the tribunal can only conclude that granting
Respondent a COR would put the public at risk of Respondent's previous
diversionary behavior. Moreover, with respect to general deterrence,
the Agency bears the responsibility to deter conduct similar to
Respondent's past misconduct. Ruben, 78 FR at 38385. Granting a COR to
an applicant who has neither unequivocally taken responsibility for his
misconduct, nor demonstrated sufficient remedial measures to ensure
such conduct will not happen again, would send a message to all that,
so long as one completes a mandatory class or two per year, there will
be few consequences to diverting controlled substances.
C. Egregiousness
Finally, this tribunal finds that Dr. Owusu's behavior was
egregious. Dr. Owusu conducted a transaction that differs in no
material respect from a drug deal. He sold multiple
[[Page 3352]]
prescriptions for powerful controlled substances at night, in a parking
lot, in a manner designed to avoid detection. Both then and now,
Respondent has responded with calculated, inconsistent statements
designed to escape culpability. In Gonzales v. Oregon, 546 U.S. 243,
270 (2006), the Supreme Court made clear that DEA has authority under
the Controlled Substances Act to bar illicit drug dealing and
trafficking as traditionally understood. Respondent, in this case,
engaged in conduct that constitutes drug trafficking as traditionally
understood, and, accordingly, the appropriate sanction is denial of his
application for a DEA registration.
Accordingly, it is herein respectfully recommended that
Respondent's application for a DEA registration be denied.
Dated: April 9, 2021.
Teresa A. Wallbaum,
Administrative Law Judge.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f), I hereby deny the pending application for a Certificate
of Registration, Control Number W19061136C, submitted by Stephen E.
Owusu, D.P.M., as well as any other pending application of Stephen E.
Owusu, D.P.M., for additional registration in New York. This Order is
effective February 22, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022-01108 Filed 1-20-22; 8:45 am]
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