[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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