Ester Mark, M.D.; Decision and Order, 7106-7108 [2023-02128]
Download as PDF
7106
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Notices
Avenue, Harlingen, Texas 78550. Id. at
1. The OSC alleged that Registrant’s
registration should be revoked because
Registrant is ‘‘currently without
authority to handle controlled
substances in the State of Texas, the
state in which [he is] registered with
DEA.’’ Id. at 2 (citing 21 U.S.C.
824(a)(3)).
The Agency makes the following
findings of fact based on the
uncontroverted evidence submitted by
the Government in its RFAA dated
January 3, 2023.1
Findings of Fact
On July 20, 2021, the Texas Physician
Assistant Board issued an Order of
Temporary Suspension that suspended
Registrant’s Texas physician assistant
license. RFAAX 3, Attachment B, at 1,
5–6. According to Texas online records,
of which the Agency takes official
notice, Registrant’s license is still
suspended.2 Texas Medical Board
License Verification, https://
profile.tmb.state.tx.us (last visited date
of signature of this Order). Accordingly,
the Agency finds that Registrant is not
currently licensed to engage in the
practice of medicine in Texas, the state
in which he is registered with the DEA.
khammond on DSKJM1Z7X2PROD with NOTICES
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (hereinafter, CSA)
‘‘upon a finding that the registrant . . .
has had his State license or registration
suspended . . . [or] revoked . . . by
1 Based on the Declarations from a DEA Diversion
Investigator and a DEA Special Agent, the Agency
finds that the Government’s service of the OSC on
Registrant was adequate. RFAAX 2, at 1–2; RFAAX
3, at 2–3. Further, based on the Government’s
assertions in its RFAA, the Agency finds that more
than thirty days have passed since Registrant was
served with the OSC and Registrant has neither
requested a hearing nor submitted a written
statement or corrective action plan and therefore
has waived any such rights. RFAA, at 3; RFAAX 3,
at 3; see also 21 CFR 1301.43 and 21 U.S.C.
824(c)(2).
2 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Registrant may dispute the Agency’s finding by
filing a properly supported motion for
reconsideration of findings of fact within fifteen
calendar days of the date of this Order. Any such
motion and response shall be filed and served by
email to the other party and to the DEA Office of
the Administrator, Drug Enforcement
Administration at dea.addo.attorneys@dea.gov.
VerDate Sep<11>2014
18:57 Feb 01, 2023
Jkt 259001
competent State authority and is no
longer authorized by State law to engage
in the . . . dispensing of controlled
substances.’’ With respect to a
practitioner, the DEA has also long held
that the possession of authority to
dispense controlled substances under
the laws of the state in which a
practitioner engages in professional
practice is a fundamental condition for
obtaining and maintaining a
practitioner’s registration. See, e.g.,
James L. Hooper, M.D., 76 FR 71371
(2011), pet. for rev. denied, 481 F. App’x
826 (4th Cir. 2012); Frederick Marsh
Blanton, M.D., 43 FR 27616, 27617
(1978).3
According to Texas statute,
‘‘[d]ispense’’ means ‘‘the delivery of a
controlled substance in the course of
professional practice or research, by a
practitioner or person acting under the
lawful order of a practitioner, to an
ultimate user or research subject. The
term includes the prescribing,
administering, packaging, labeling, or
compounding necessary to prepare the
substance for delivery.’’ Tex. Health &
Safety Code Ann. section 481.002(12)
(2022). Further, a ‘‘practitioner’’ means
a ‘‘a physician . . . or other person
licensed, registered, or otherwise
permitted to distribute, dispense,
analyze, conduct research with respect
to, or administer a controlled substance
in the course of professional practice or
research in this state.’’ Id. at section
481.002(39)(A).
Here, the undisputed evidence in the
record is that Registrant currently lacks
authority to practice medicine in Texas.
As discussed above, a person must be a
licensed practitioner to dispense a
controlled substance in Texas. Thus,
because Registrant lacks authority to
practice medicine in Texas and,
therefore, is not authorized to handle
controlled substances in Texas,
Registrant is not eligible to maintain a
DEA registration. Accordingly, the
Agency will order that Registrant’s DEA
registration be revoked.
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. MM3333109 issued
to Fernando Mendez, P.A. 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 Fernando Mendez, P.A.,
to renew or modify this registration, as
well as any other pending application of
Fernando Mendez, P.A., for additional
registration in Texas. 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. 2023–02122 Filed 2–1–23; 8:45 am]
BILLING CODE 4410–09–P
3 This
rule derives from the text of two provisions
of the CSA. First, Congress defined the term
‘‘practitioner’’ to mean ‘‘a physician . . . or other
person licensed, registered, or otherwise permitted,
by . . . the jurisdiction in which he practices . . . ,
to distribute, dispense, . . . [or] administer . . . a
controlled substance in the course of professional
practice.’’ 21 U.S.C. 802(21). Second, in setting the
requirements for obtaining a practitioner’s
registration, Congress directed that ‘‘[t]he Attorney
General shall register practitioners . . . 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). Because Congress has
clearly mandated that a practitioner possess state
authority in order to be deemed a practitioner under
the CSA, the DEA has held repeatedly that
revocation of a practitioner’s registration is the
appropriate sanction whenever he is no longer
authorized to dispense controlled substances under
the laws of the state in which he practices. See, e.g.,
James L. Hooper, 76 FR 71371–72; Sheran Arden
Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick
A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby
Watts, M.D., 53 FR 11919, 11920 (1988); Frederick
Marsh Blanton, 43 FR at 27617.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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
E:\FR\FM\02FEN1.SGM
02FEN1
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Notices
registration. OSC, at 3–4 (citing 21
U.S.C. 824(a)(1)).1
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
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
khammond on DSKJM1Z7X2PROD with NOTICES
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.
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.
VerDate Sep<11>2014
18:57 Feb 01, 2023
Jkt 259001
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.
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
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.
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.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
7107
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
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
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.
7 See also Tr. 66–75, 79, 84–85, 87; GX 2, at 1;
GX 3, at 1.
E:\FR\FM\02FEN1.SGM
02FEN1
7108
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
‘‘the Respondent’s arguments that her
false statements were made because she
was ‘confused’ are not credible.’’ RD, at
14.8
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
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.
VerDate Sep<11>2014
18:57 Feb 01, 2023
Jkt 259001
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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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]
BILLING CODE 4410–09–P
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[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]
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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]
BILLING CODE 4410-09-P