[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Pages 7106-7108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02128]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22-22]
Ester Mark, M.D.; Decision and Order
On March 12, 2022, the Drug Enforcement Administration
(hereinafter, DEA or Government) issued an Order to Show Cause
(hereinafter, OSC) to Ester Mark, M.D. (hereinafter, Respondent) of
California, alleging that Respondent materially falsified both her
April 2019 initial application for a DEA Certificate of Registration
and her February 2022 renewal application for that same
[[Page 7107]]
registration. OSC, at 3-4 (citing 21 U.S.C. 824(a)(1)).\1\
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\1\ The Government sought to revoke the registration in
question, No. FM8267052 at the registered address of 9950 Research
Drive #A, Irvine, California 92618. Id. at 1.
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A hearing was held before DEA Administrative Law Judge Paul E.
Soeffing (hereinafter, the ALJ), who on October 3, 2022, issued his
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
(hereinafter, RD). The RD recommended revocation of Respondent's
registration and denial of Respondent's application for renewal of her
registration. RD, at 18. Respondent did not file exceptions to the
RD.\2\ Having reviewed the entire record, the Agency adopts and hereby
incorporates by reference the entirety of the ALJ's rulings,
credibility findings,\3\ findings of fact, conclusions of law,
sanctions analysis, and recommended sanction found in the RD. I.
Findings of Fact
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\2\ On October 26, 2022, Respondent filed a Motion to Extend
Deadline to File Exceptions. On October 27, 2022, the ALJ issued an
Order Denying Respondent's Untimely Motion to Extend Deadline to
File Exceptions.
\3\ The Agency adopts the ALJ's summary of each of the
witnesses' testimonies as well as the ALJ's assessment of each of
the witnesses' credibility. See RD, at 3-7. The Agency agrees with
the ALJ that the Diversion Investigator's testimony, which was
focused on the non-controversial introduction of documentary
evidence and the Diversion Investigator's contact with the case, was
credible in that it was consistent, genuine, and without indication
of any animosity towards Respondent. Id. at 5. Further, the Agency
agrees with the ALJ that Respondent's testimony was at times
irrelevant, non-responsive, defensive, and dismissive and was not
fully credible. Id. at 7.
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The following facts are undisputed. On or about June 12, 2015, the
Medical Board of California filed an accusation against Respondent
seeking a decision to revoke or suspend Respondent's California medical
license. RD, at 3. Further, on or about December 9, 2015, a felony
complaint was filed against Respondent in the Superior Court of
California, County of Orange, alleging five counts of unlawfully
possessing for sale a controlled substance and five counts of
unlawfully prescribing a controlled substance without a legitimate
medical purpose. Id. Both the accusation filed against Respondent's
state medical license and the criminal case against Respondent remained
pending at all relevant times. Id. at 3, 5 (citing Tr. 35-36;
Government Exhibit (hereinafter, GX) 4-8, 11). On or about July 7,
2017, DEA issued an OSC, proposing to revoke Respondent's DEA
Certificate of Registration No. BM5370123 because Respondent's
continued registration was inconsistent with the public interest. RD,
at 2-3. On March 31, 2021, DEA issued a Final Order revoking that
registration. Id. at 3.
On April 2, 2019, Respondent applied for a new DEA Certificate of
Registration.\4\ Tr. 16, 40-42, 47; GX 2, at 1. The first question on
the application asked whether Respondent had ``ever been convicted of a
crime in connection with controlled substance(s) under state or federal
law . . . or [is] any such action pending?'' and Respondent answered
``no,'' even though she had a pending criminal action against her. RD,
at 10-11; Tr. 40-41; GX 2, at 1; GX 6-8. The second question on the
application asked whether Respondent had ``ever surrendered (for cause)
or had a federal controlled substance registration revoked, suspended,
restricted or denied, or is any such action pending?'' and Respondent
answered ``no,'' even though she had a pending OSC against her for her
previous DEA registration. RD, at 10-11; Tr. 41-42, 44-45; GX 2, at 1;
GX 9-10. Finally, the third question on the application asked whether
Respondent had ``ever surrendered (for cause) or had a state
professional license or controlled substance registration revoked,
suspended, denied, restricted, or placed on probation, or is any such
action pending?'' and Respondent answered, ``no,'' even though she had
a pending disciplinary action with the Medical Board of California. RD,
at 9-12; Tr. 47; GX 2, at 1; GX 4-5, 11.
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\4\ Both initial and renewal applications for a DEA registration
include four liability questions, and if a registrant answers
``yes'' to any of the four questions, then the application is
flagged for review before it can be approved. RD, at 4-5; Tr. 17. In
contrast, if a registrant answers ``no'' to all four liability
questions, then the application is automatically approved. RD, at 4;
Tr. 50. Because Respondent answered ``no'' to all four liability
questions, her application was automatically approved and she
received a new DEA registration. RD, at 4; Tr. 48, 50.
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Here, the Agency finds that Respondent's answers to the liability
questions on her initial application for DEA registration were clearly
false; nonetheless, on January 31, 2022, Respondent applied for renewal
of her registration and once again falsely answered ``no'' to the first
and third liability questions on the application.\5\ RD, at 12; Tr. 16-
17, 20-21, 28-29; GX 3, at 1; GX 4-8, 11. The Agency also finds from
clear, unequivocal, convincing, and unrebutted evidence that in each of
the instances in which Respondent provided an incorrect answer to a
liability question, she either knew or should have known that her
answers were incorrect due to her awareness of the status of the
various actions against her.\6\
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\5\ Regarding the first liability question, the Diversion
Investigator (hereinafter, the DI) testified that Respondent's
answer of ``no'' was untruthful because at the time of her renewal
application, Respondent was still ``pending state charges.'' Tr. at
21-20, 35-36; GX 3, at 1; GX 6-8. Regarding the third liability
question, the DI testified that Respondent's answer of ``no'' was
untruthful because at the time of her renewal application,
Respondent still had a pending disciplinary action with the Medical
Board of California. Tr. 28-29, 35-36; GX 4-5, 11; RD, at 5-6, 12.
\6\ Regarding the first liability question on both her initial
and renewal applications, Respondent testified that she had been
aware of the pending criminal action against her at the time of both
her initial and renewal applications. Tr. 67-68, 74-75, 88; see also
GX 6-8. As such, Respondent knew or should have known at the time of
her initial and renewal applications that she had a pending criminal
action against her and thus knew or should have known that her
answers of ``no'' to the first liability question on both
applications were false. See GX 2, at 1; GX 3, at 1. Regarding the
second liability question on Respondent's initial application,
Respondent testified that she went through the administrative
hearing process and filed exceptions and so had been aware of the
pending OSC against her for her previous DEA registration at the
time of her initial application. Tr. 74; see also GX 9-10. As such,
Respondent knew or should have known at the time of her initial
application that she had a pending OSC against her for her previous
DEA registration and thus knew or should have known that her answer
of ``no'' to the second liability question was false. See GX 2, at
1. Finally, regarding the third liability question on both her
initial and renewal applications, Respondent testified that she had
been aware of the Medical Board of California's pending accusation
against her at the time of both her initial and renewal
applications. Tr. 70-71, 74-75, 89; see also GX 4-5; GX 11. As such,
Respondent knew or should have known at the time of her initial and
renewal applications that she had a pending disciplinary action with
the Medical Board of California and thus knew or should have known
that her answers of ``no'' to the third liability question on both
applications were false. See GX 2, at 1; GX 3, at 1.
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Regarding her incorrect answers to the liability questions on both
her initial and renewal applications, Respondent testified that she had
thought that she was responding truthfully but had been confused. Tr.
80; RD, at 6-7.\7\ Conversely, the DI testified that she contacted
Respondent in November 2021 regarding the incorrect answers on her
initial application, but Respondent did not ask for clarification
regarding any confusion that she had had with the liability questions
and went on to again answer ``no'' to the first and third liability
questions on her renewal application even after the DI had spoken with
her regarding ``liability questions as a whole'' and the pending
criminal and disciplinary charges. Tr. at 99-100; see also GX 3, at 1.
In regards to her conversation with the DI, Respondent testified that
the DI ``wasn't really fair,'' ``was never specific,'' and ``just told
[her] that [she] [had] lied on the application.'' Tr. at 90, 105-106.
Here, the Agency finds, as the ALJ found, that
[[Page 7108]]
``the Respondent's arguments that her false statements were made
because she was `confused' are not credible.'' RD, at 14.\8\
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\7\ See also Tr. 66-75, 79, 84-85, 87; GX 2, at 1; GX 3, at 1.
\8\ Further, even if it was true that Respondent had been
confused, as the ALJ noted, ``the Respondent had the opportunity to
resolve any confusion she had when she spoke with the DI regarding
her [renewal] application, but she did not do so.'' Id.; see also
Tr. 92, 99-100.
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II. Discussion
The Administrator is authorized to revoke a registration if the
registrant has materially falsified an application for registration. 21
U.S.C. 824(a)(1); see also RD, at 8. Further, Agency decisions have
repeatedly held that false responses to the liability questions on an
application for registration are material. Kevin J. Dobi, APRN, 87 FR
38184, 38184 (2022) (collecting cases); see also RD, at 9, 12-15.
Regarding Respondent's claims that she had thought that she was
responding truthfully to the liability questions on both her initial
and renewal applications, see supra I, Agency precedent has found that
the Government must only show that a respondent knew or should have
known that her response to a liability question was false. Narciso A.
Reyes, M.D., 83 FR 61678, 61680 (2018) (citing Samuel S. Jackson,
D.D.S., 72 FR 23848, 23852 (2007)); see also RD, at 12-15. As such, a
respondent's claim that she misunderstood a liability question, or
otherwise inadvertently provided a false answer to a liability
question, is not a defense when the Government has made such a showing.
Reyes, 83 FR 61680 (citing Alvin Darby, M.D., 75 FR 26993, 26999
(2010)). Indeed, the respondent bears the responsibility to carefully
read the liability questions and to answer them honestly; ``[a]llegedly
misunderstanding or misinterpreting liability questions does not
relieve the [respondent] of this responsibility.'' Zelideh I. Cordova-
Velazco, M.D., 83 FR 62902, 62906 (2018) (internal citations omitted).
Having read and analyzed the record, the Agency finds from clear,
unequivocal, convincing, and unrebutted evidence that Respondent's
initial application for a new registration, submitted in April 2019,
contains three material falsifications and that Respondent's renewal
application for her registration, submitted in January 2022, contains
two material falsifications. See supra I. Moreover, even if it is true
that Respondent's incorrect answers to the liability questions were
caused by confusion or were otherwise inadvertent, it is
inconsequential. As such, the Agency finds that the Government has
established a prima facie case for revocation of Respondent's
registration pursuant to 21 U.S.C. 824(a)(1).
III. Sanction
Here, the Government has established grounds to revoke Respondent's
registration; thus, the burden shifts to Respondent to show why she can
be entrusted with the responsibility of registration. Garret Howard
Smith, M.D., 83 FR 18882, 18910 (2018). When a registrant has committed
acts inconsistent with the public interest, she must both accept
responsibility and demonstrate that she has undertaken corrective
measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195, 77 FR
62316, 62339 (2012) (internal quotations omitted). Here, as the ALJ
found, Respondent ``failed to unequivocally accept responsibility at
any point during her testimony.'' RD, at 15-16. Respondent instead
offered various excuses and reasoning as to why she incorrectly
answered the liability questions and continually emphasized that she
had been confused, blaming the wording of the questions, the DI, and
the Agency for her false answers that she knew or should have known
were false. See supra I; RD, at 16-17.
When a registrant fails to make the threshold showing of acceptance
of responsibility, the Agency need not address the registrant's
remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019)
(citing Jones Total Health Care Pharmacy, L.L.C. & SND Health Care,
L.L.C., 81 FR 79188, 79202-03 (2016)); Daniel A. Glick, D.D.S., 80 FR
74800, 74801, 74810 (2015). Even so, in the current matter, Respondent
has made no showing of any remedial measures other than changing her
response to the second liability question from ``no'' to ``yes'' on her
renewal application once she became aware of the revocation of her
previous DEA registration. See supra I. Because Respondent still
continued to incorrectly answer ``no'' to the first and third liability
questions on her renewal application and because Respondent has not
offered evidence of any additional measures that she has taken to
ensure that she will correctly answer any liability questions in the
future, Respondent has not sufficiently demonstrated that she is ready
to be entrusted with the responsibility of registration.
In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74810. In this case, the
Agency believes that revocation of Respondent's registration would
deter Respondent and the general registrant community from failing to
meet their obligation to provide accurate and truthful responses on an
application for DEA registration. Kareem Hubbard, M.D., 87 FR 21156,
21164 (2022); RD, at 17. Moreover, Respondent's misconduct was also
egregious. See Garrett Howard Smith, M.D., 83 FR 18910 (collecting
cases). As the ALJ noted, ``[t]he Respondent's actions of submitting
not one, but two applications that include multiple material
falsifications goes `to the heart of the CSA.' '' RD, at 17 (quoting
Crosby Pharmacy and Wellness, 87 FR 21212, 21215 (2022)).
Having reviewed the record in its entirety, the Agency finds that
Respondent cannot be entrusted with the responsibility of DEA
registration. Accordingly, the Agency will order that Respondent's
registration be revoked and that Respondent's application for renewal
of her registration be denied.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
FM8267052 issued to Ester Mark, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny any pending applications of Ester Mark, M.D., to renew or modify
this registration, as well as any other pending application of Ester
Mark, M.D., for additional registration in California. This Order is
effective March 6, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 25, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-02128 Filed 2-1-23; 8:45 am]
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