Notice2021-16003
Erica N. Grant, M.D.; Decision and Order
Primary source
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Published
July 28, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40641-40650]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16003]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Erica N. Grant, M.D.; Decision and Order
I. Introduction
On August 24, 2018, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to Erica
N. Grant, M.D. (hereinafter, Respondent) of Irving, Texas. OSC, at 1.
The OSC proposed the revocation of Respondent's Certificate of
Registration No. FG2374053 for three reasons. Id. First, it alleged
that Respondent was ``convicted of a felony under State law relating to
a controlled substance.'' Id. (citing 21 U.S.C. 824(a)(2)). Second, it
alleged that it was ``inconsistent with the public interest'' for
Respondent to maintain her registration. OSC, at 1 (citing 21 U.S.C.
824(a)(4) in conjunction with 21 U.S.C. 823(f)). Third, the OSC alleged
that Respondent ``materially falsified the application'' for renewal of
her registration. OSC, at 1 (citing 21 U.S.C. 824(a)(1)).
Specifically, the OSC alleged that Respondent's ``no contest'' plea
to a second-degree felony in Texas, ``Attempting to Possess a
Controlled Substance by Fraud in violation of Texas Health and Safety
Code Sec. 481.129,'' ``is a conviction providing a sufficient basis
for the revocation'' of her registration. OSC, at 2, 3. Further, the
OSC alleged that, ``[t]o determine what is in the `public interest,'
DEA considers, among other things, the registrant's `conviction record
under Federal or State laws relating to the manufacture, distribution,
or dispensing of controlled substances.' '' Id. at 2. Finally,
according to the OSC, ``DEA may revoke a registrant's DEA . . .
[registration] upon a finding that the registrant materially falsified
any application filed pursuant to, or required by, the Controlled
Substances Act'' (hereinafter, CSA), such as by a ``failure to report .
. . [an] arrest for a controlled substance felony.'' Id. at 2, 3.
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 3 (citing 21
CFR 1301.43). The OSC also notified Respondent of the opportunity to
submit a corrective action plan. OSC, at 3-4 (citing 21 U.S.C.
824(c)(2)(C)).
By transmittal dated September 21, 2018, Respondent waived her
right to a hearing and filed a written statement and a proposed
Corrective Action Plan. Request for Final Agency Action (hereinafter,
RFAA) Exhibit (hereinafter, collectively, RFAAX) 10 (Respondent's
Hearing Waiver and Written Statement in Response to the OSC
(hereinafter, Written Statement)) and RFAAX 11 (Respondent's Request
for Corrective Action Plan (hereinafter, CAP)).\1\ Respondent's written
statement explicitly references her receipt of the OSC.\2\ RFAAX 10, at
1.
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\1\ RFAAX 12 is the DEA Assistant Administrator's letter to
Respondent, dated January 29, 2019, rejecting her proposed CAP.
\2\ In addition, the RFAA represents that ``Respondent
acknowledged service of a copy of the . . . [OSC] in a telephone
conversation with [a] DEA Diversion Investigator.'' RFAA, at 3
(citing RFAAX 9 (Declaration of Diversion Investigator (hereinafter,
DI), dated October 1, 2018), at 2).
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Based on all of the evidence in the record, I find that the
Government's service of the OSC was legally sufficient. In addition,
also based on all of the evidence in the record, I find that Respondent
timely filed her Written Statement and proposed CAP.\3\
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\3\ Respondent's Written Statement is dated September 21, 2018.
It appears that Respondent transmitted her proposed CAP along with
her Written Statement. The OSC is dated August 24, 2018; therefore,
Respondent's submissions are clearly timely regardless of when
Respondent received service of the OSC. 21 CFR 1301.43.
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[[Page 40642]]
The Government forwarded its RFAA, along with the evidentiary
record, to this office on August 27, 2019.
I issue this Decision and Order based on the Government's
submission, which includes Respondent's Written Statement and proposed
CAP, and is the entire record before me. 21 CFR 1301.43(e).
II. Findings of Fact
A. Respondent's DEA Controlled Substance Registration
Respondent is the holder of DEA Certificate of Registration No.
FG2374053 at the registered address of 665 W LBJ Freeway, Suite 217,
Irving, TX 75063 and a separate ``mail-to'' address. RFAAX 2
(Certification of Registration History, dated November 23, 2018), at 1.
Pursuant to this registration, Respondent is authorized to dispense
controlled substances in schedules II through V as a practitioner. Id.
Respondent's registration expired on September 30, 2019, and is in an
``active pending status.'' Id.
B. The Investigation of Respondent
According to the DI assigned to this matter, the Texas Medical
Board (hereinafter, TMB) notified him that Respondent was the subject
of an Agreed Order Upon Formal Filing, In the Matter of the License of
Erica Nicole Grant, M.D., License No. N-4438 (Before the TMB) dated
March 2, 2018 (hereinafter, Agreed Order). RFAAX 9, at 1 (referencing
RFAAX 3).\4\ His investigation ensued and included obtaining copies of
the Agreed Order and documents from the 195th Judicial District Court
of Dallas County, Texas related to Respondent's nolo contendere plea.
RFAAX 9, at 2.
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\4\ Respondent also submitted the Agreed Order for the record.
RFAAX 11.
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C. The Government's Case
The Government's case includes nine exhibits. The content of some
of those exhibits is also attached to Respondent's Written Statement.
RFAA, at 6-7; infra Section II.D.
The DI Declaration certifies the authenticity of RFAA Exhibits 2
through 8. RFAAX 9, at 2. The DI Declaration, signed and attested to be
``true and correct'' under penalty of perjury, further states that DI
interviewed Respondent ``at her offices in Irving, Texas'' on June 1,
2018. Id. at 2. According to the DI Declaration, ``In that interview, .
. . [Respondent] admitted that she had diverted multiple controlled
substances from numerous patients at Parkland Hospital in Dallas,
Texas.'' Id. The DI Declaration also states that Respondent ``admitted
she diverted Dilaudid, Morphine, Versed, and Fentanyl.'' Id.
The Government submitted a two-page document entitled, ``Affidavit
for Arrest Warrant or Capias,'' of the Dallas County Hospital District
Police Department, dated April 5, 2016 (hereinafter, Arrest Warrant
Affidavit).\5\ RFAAX 6. According to the Arrest Warrant Affidavit, the
Parkland Health and Hospital System Director of Pharmacy contacted the
Drug Diversion Control Officer about ``an issue developed in Anesthesia
at Parkland Hospital . . . in which . . . [Respondent] . . . was drug
screened . . . and sent to a rehabilitation facility at an unidentified
location.'' Id. at 1. Subsequently, according to the Arrest Warrant
Affidavit, relevant records about ``all controlled substances removed
from any Pyxis within the hospital'' by Respondent between November 23,
2015, and February 18, 2016, were reviewed and compared with
Respondent's documented entries. Id. This review led to the discovery
of one ``discrepancy/diversion.'' Id.
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\5\ The RFAA cites Factor Three in support of the OSC allegation
that Respondent's continued registration is inconsistent with the
public interest. RFAA, at 5; 21 U.S.C. 824(a)(4) in conjunction with
21 U.S.C. 823(f)(3).
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According to the Arrest Warrant Affidavit, Respondent removed one
hydromorphone 1 mg/1 mL syringe from a Pyxis located in the Labor &
Delivery Alcove for a patient. Id. According to the patient's
anesthesia records, however, the hydromorphone was not administered to
the patient, ``nor was a procedure opened requiring the Hydromorphone''
for that patient. Id. Further, ``[a]n additional review of the Pyxis in
Anesthesia and Labor & Delivery, between . . . [February 6, 2016, and
February 17, 2016,] disclosed that no employee in Anesthesia, to
include . . . [Respondent,] returned or wasted through Pyxis
Hydromorphone removed from the Pyxis in Anesthesia and Labor and
Delivery'' for that patient. Id. at 1-2. The Arrest Warrant Affidavit
states that ``there was no Anesthesia event for this patient'' on
February 6, 2016. Id. at 2. The Arrest Warrant Affidavit concludes
that, ``[b]ased upon the documentation,'' Respondent ``did not
administer the Hydromorphone to . . . [the patient], but fraudulently
obtained the controlled substance, by stating that the controlled
substance would be administered to . . . [the patient].'' Id. The
Arrest Warrant Affidavit shows that a Dallas County, Texas Magistrate
determined, based on her examination of the Arrest Warrant Affidavit,
that probable cause existed for the issuance of an arrest warrant for
Respondent. Id.
The Government submitted Respondent's Arraignment Sheet dated April
7, 2016. RFAAX 7, at 1. According to this document, Respondent was
arraigned on two charges of ``Fraud Del CS/Prescription Sch II.'' Id.
It also shows that bond was set at $2,500 for each charge. Id.
The Government also submitted Respondent's Judicial Confession, The
State of Texas v. Erica Nicole Grant, No. F1644784 (195th Judicial
District Court, Dallas County, Texas May 26, 2017) (hereinafter,
Judicial Confession). RFAAX 4. The Judicial Confession memorializes
Respondent's admission that, ``on or about the 6th day of February,
2016, in Dallas County, Texas,'' she ``did intentionally and knowingly
possess and attempt to possess a controlled substance, namely:
Hydromorphone, by misrepresentation, fraud, forgery, deception and
subterfuge.'' Id. at 1. Respondent's signed statement concludes with
these words: ``I further judicially confess that I committed the
offense with which I stand charged exactly as alleged in the indictment
in this cause.'' Id. In addition to Respondent, her attorney, the
Assistant District attorney, the Deputy District Clerk, and the
Presiding Judge signed this document. Id.
The Government submitted the Order of Deferred Adjudication, The
State of Texas v. Erica Nicole Grant, No. F-1644784-N (195th Judicial
District Court, Dallas County, Texas May 26, 2017) (hereinafter,
Deferred Adjudication Order), RFAAX 5, at 1. According to this seven-
page exhibit, the Deferred Adjudication Order was entered for a second-
degree felony, ``Obstruction Controlled Substance Fraud Drug 1/2,'' on
May 26, 2017.\6\ Id. It shows that Respondent pled nolo contendere to
an Information, that adjudication of guilt was deferred, and that
Respondent was placed on community supervision for two years. Id.
According to the document, Respondent ``appeared in person with
Counsel.'' Id. The other pages of this exhibit are the ``Conditions of
Community Supervision'' (three pages), the ``Court's Admonishment on
Right to Order of Nondisclosure'' (one page), and
[[Page 40643]]
the ``Judgment/Certificate of Thumbprint'' (one page). Id. at 3-7.
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\6\ The Deferred Adjudication Order lists the offense as
``Obstruction Controlled Substance Fraud Drug 1/2.'' RFAAX 5, at 1.
Under ``Statute for Offense,'' the document shows ``481.29 Penal
Code.'' Id. The latter entry appears to be a scrivener's error for
section 481.129 of the Texas Health and Safety Code. See RFAA, at 3.
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The Government put into the record the registration renewal
application that Respondent submitted on August 11, 2016.\7\ RFAAX 8,
at 1. According to RFAAX 8, Respondent answered ``N'' (meaning ``no'')
to whether she had ``ever been convicted of a crime in connection with
controlled substance(s) under state or federal law . . ., or any such
action pending.'' RFAAX 8, at 1. According to the Government, the fact
that DEA did not rely on Respondent's ``N'' response does not make that
response ``immaterial'' under past Agency decisions' interpretations of
21 U.S.C. 824(a)(1) and the Supreme Court's definition of ``material''
in Kungys v. United States, 485 U.S. 759, 770 (1988). RFAA, at 5-6.
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\7\ RFAAX 8 is a more legible version of the first page of the
attachment to RFAAX 2. According to RFAAX 2 and RFAAX 8, the
registration renewal application ``Submission Date'' is August 11,
2016. RFAAX 2, at 2; RFAAX 8, at 1. According to the Certification
of Registration History, the ``last approved renewal of this DEA
registration was on August 15, 2016.'' RFAAX 2, at 1.
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The Government also submitted a copy of the Agreed Order. RFAAX 3;
see also infra Section II.D. According to the RFAA's ``Statement of
Undisputed Material Facts,'' the Government argues that, ``[b]etween
November 2015 and February 2016, Respondent withdrew medications,
including controlled substances[,] from at least 80 patients from the
Parkland Hospital Pyxis System'' and ``[d]uring that time, Respondent
diverted controlled substances, including Dilaudid, Morphine, Versed,
and Fentanyl for her own use.'' RFAA, at 2 (citing RFAAX 3 and RFAAX
9). The Government does not provide a page cite to RFAAX 3 for this
citation in its RFAA and I do not see all of the asserted statements in
RFAAX 3. The RFAA contains no other reference to RFAAX 3 and includes
no other document from the TMB. The DI Declaration, RFAAX 9, states
that Respondent ``admitted that she had diverted multiple controlled
substances from numerous patents at Parkland Hospital in Dallas,
Texas'' and that Respondent ``admitted she diverted Dilaudid, Morphine,
Versed, and Fentanyl.'' RFAAX 9, at 2. Accordingly, I find that two
portions of the Government-proposed statements of undisputed material
facts, that Respondent withdrew controlled substances ``from at least
80 patients'' and ``for her own use,'' are not supported by the
evidence the RFAA cites, or by substantial record evidence.\8\
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\8\ See also, regarding ``from at least 80 patients,'' RFAAX 6,
at 1 (``Based on . . . [the Parkland Health & Hospital System
Director of Pharmacy's] information, the Pyxis (CareFusion) Records
in reference to all controlled substances removed from any Pyxis
within the hospital by . . . [Respondent], between 11/23/2015 and
02/18/2016, were reviewed, and all removals were compared to the
entries . . . [Respondent] documented in each patient's Anesthesia
Record. The following discrepancies/diversions were discovered:
Drug--Hydromorphone 1 mg/1 mL: (Schedule II).'') and, regarding
``for her own use,'' RFAAX 3, at 3-4 and RFAAX 11, at 11-12
(specifying TMB's Conclusions of Law that the Board is authorized to
take disciplinary action against Respondent ``based on Respondent's
inability to practice medicine with reasonable skill and safety to
patients because of . . . (C) excessive use of drugs, narcotics,
chemicals, or another substance, or (D) a mental or physical
condition'' and ``Respondent's use of alcohol or drugs in an
intemperate manner that, in the opinion of the Board, could endanger
the lives of patients,'' while not including a finding specifying
that Respondent ingested any of the controlled substances she
admitted diverting). RFAAX 3, at 2-3 and RFAAX 11, at 10-11.
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D. Respondent's Case
As already discussed, Respondent submitted a timely Written
Statement and proposed CAP. Supra section I. In her Written Statement,
Respondent stated that she is an anesthesiologist whose ``entire
practice and . . . ability to make a living . . . as a single parent
with a son in college and caregiver for . . . [her] 79 year-old mother
and disabled sister is dependent on . . . [her] ability to provide a
balanced anesthetic to patients which is not limited to, but includes
controlled substances.'' RFAAX 10, at 1. She admitted that ``diversion
of controlled substances occurred as stated from November 2015 through
February 11, 2016'' and characterized it as a ``complete lack of
judgment.'' Id. Her Written Statement places the diversion in the
context of her contemporaneous personal life experiences ``never . . .
as an excuse'' but ``rather [as] an explanation for which I have always
taken 100% responsibility.'' Id. Respondent, ``[i]n accepting
responsibility,'' has ``done everything in . . . [her] power to correct
. . . [her] actions and 31 months later, . . . continue[s] to work hard
at maintaining sobriety and gain the trust of those . . . lost,
including the public.'' Id. She wrote, ``I accept sole responsibility
and I have taken actions to become sober and healthy and continue to do
such.'' Id. at 2. Stating that this is her ``first offense,'' she added
that she is ``working diligently for it to never occur again'' and
asked for the opportunity ``to continue to demonstrate'' that she
``ha[s] been rehabilitated and will always put the trust of the public
first and foremost.'' Id. at 2-3.
Respondent's Written Statement includes a list, consisting of about
half of a single-spaced page, describing the ``course of action'' she
has taken ``since February 11, 2016,'' to ``maintain[ ] sobriety and a
healthy lifestyle.'' Id. at 3. She stated that her ``course of action''
includes inpatient and outpatient rehabilitation, participation in
Alcoholics Anonymous or Caduceus meetings three times a week, bimonthly
sessions with a therapist, weekly random drug testing beginning in
October 2016, as-needed sessions with an Addiction Specialist, and a
personal spirituality program. Id. I find a matter of concern about
Respondent's candor based on my review of this section of Respondent's
Written Statement and the Agreed Order. In her Written Statement,
Respondent wrote ``[NO incidents]'' after stating that her course of
action includes ``[w]eekly random drug testing beginning October 2016
under voluntary agreement with . . . [TMB] with continuation under
final order March, 2018.'' Id. The Agreed Order states, in the section
entitled ``Specific Panel Findings,'' that ``Respondent voluntarily
submitted to interim drug testing with the . . . [TMB]; however, she
has had four missed calls and one late drug screen. She has not tested
positive for any substances.'' RFAAX 3, at 3 and RFAAX 11, at 11. It
appears that Respondent's ``[NO incidents]'' representation is
addressing the situation after the Agreed Order went into effect and
that the ``Specific Panel Findings'' of the Agreed Order is describing
the situation leading up to creation of the ``Agreed Order.'' The
matter of concern to me, thus, is Respondent's candor in this
proceeding because she presented facts showing herself in a positive
light and did not present related facts showing herself in an
unfavorable light. Had Respondent requested and participated in a
hearing, she would have been able to address my concern about her
candor. She chose, as she is entitled under the regulations, to waive
her opportunity for a hearing and to submit the Written Statement
instead. RFAAX 10, at 1, 2; 21 CFR 1301.43. As the regulation notes,
``Such statement, if admissible, shall be made a part of the record and
shall be considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact
asserted therein.'' 21 CFR 1301.43(c).
About another half page, single spaced, of the Written Statement
lists conditions to which the Agreed Order subjects Respondent.\9\
RFAAX 10, at 3. I interpret Respondent's intent for including those
conditions after the ``course of action'' list was to highlight
[[Page 40644]]
additional steps she agreed to follow for up to ten years. Id.
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\9\ Respondent attached the Agreed Order to her proposed CAP.
RFAAX 11, at 9-23; infra.
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In her CAP, Respondent proposed that ``the requirements outlined in
the Texas Medical Board Public Order #18-270 [the Agreed Order] . . .
be accepted as an action plan and proceedings to revoke her DEA . . .
[registration] be discontinued effective immediately.'' RFAAX 11, at 1,
citing id. at 9-23.\10\ Respondent represented that she has been
``compliant with the actions'' required by the Agreed Order and that
she will report ``immediately'' to DEA the suspension of her medical
license resulting from a violation of the Agreed Order.
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\10\ RFAAX 11, at 9-23 is the same document that the Government
submitted at RFAAX 3.
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Attached to Respondent's proposed CAP are (1) one page from the
2006 Edition of the DEA ``Practitioner's Manual'' entitled ``Form-224a
Renewal Application for Registration,'' id. at 3; (2) the Deferred
Adjudication Order, id. at 4-5; (3) Conditions of Community
Supervision, The State of Texas v. Erica Nicole Grant, No. F-1644784-N
(195th Judicial District Court, Dallas County, Texas May 26, 2017), id.
at 6-7; (4) Order Dismissing Proceedings and Granting Early Discharge
From Community Supervision Following Deferred Adjudication, The State
of Texas v. Erica Nicole Grant, No. F1644784N (195th JDC, Dallas
County, Texas May 29, 2018) (hereinafter, Order Dismissing Proceedings
and Granting Early Discharge), id. at 8; and (5) the Agreed Order, id.
at 9-23. The Deferred Adjudication Order, the Conditions of Community
Supervision, and the Agreed Order are also part of the Government's
case.\11\ Supra section II.C.
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\11\ The page from the 2006 Edition of the DEA ``Practitioner's
Manual'' includes the text of the first Liability question. RFAAX
11, at 3. According to the 2006 Edition, that question asks ``Has
the applicant ever been convicted of a crime in connection with
controlled substances under state or federal law''? Id. Based on
this version of the first Liability question, Respondent
``disputes'' the OSC allegations that she was ``convicted'' of a
crime in connection with controlled substances. Id. at 1-2 (citing
id. at 3). Instead, she stated, she pled nolo contendere, ``received
deferred adjudication probation,'' ``was released a year early from
probation'' on May 29, 2018, and, therefore, ``the case is dismissed
as a non-conviction.'' RFAAX 10, at 2.
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The Order Dismissing Proceedings and Granting Early Discharge
states that Respondent ``satisfactorily fulfilled'' all conditions of
community supervision and that ``the best interests of society and . .
. [Respondent] will be served by granting the early discharge from
community supervision and dismissing the proceedings.'' RFAAX 11, at 8.
The Order Dismissing Proceedings and Granting Early Discharge
terminates the ``period of supervision'' about a year early, discharges
Respondent from community supervision, and dismisses ``all proceedings
in this cause'' against Respondent. Id.
The Agreed Order between Respondent and the TMB was signed and
entered by the TMB presiding officer on March 2, 2018. RFAAX 3, at 15
and RFAAX 11, at 23. According to the Agreed Order's ``Mitigating
Factor'' section, ``Respondent neither admits nor denies the
information given above.'' RFAAX 3, at 3 and RFAAX 11, at 11. The
``Specific Panel Findings'' section is ``above'' the ``Mitigating
Factor'' section and, thus, I find that Respondent neither admitted nor
denied the TMB's General and Specific Panel Findings. RFAAX 3, at 3 and
RFAAX 11, at 11. I also find, though, that Respondent ``agree[d] to the
entry of th[e] Agreed Order,'' and agreed ``to comply with its terms
and conditions'' to ``avoid further investigation, hearings, and the
expense and inconvenience of litigation.'' RFAAX 3, at 3 and RFAAX 11,
at 11.
The terms of the Agreed Order subject Respondent to multiple
conditions for ten years. RFAAX 3, at 5 and RFAAX 11, at 13.
Respondent's noncompliance with, or violation of, specified Agreed
Order conditions could lead to the immediate suspension of her medical
license. RFAAX 3, at 5-6, 8 and RFAAX 11, at 13-14, 16. The Agreed
Order affords Respondent the opportunity to seek amendment or
termination of the conditions after two years following the date of the
Agreed Order's entry and once a year thereafter. RFAAX 3, at 13 and
RFAAX 11, at 21. There is no evidence in the record that Respondent
availed herself of the opportunity to seek amendment or termination of
the Agreed Order's conditions.\12\
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\12\ This is not surprising given that the Government submitted
its RFAA less than two years after the date the Agreed Order was
entered. RFAA, at 6.
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The TMB's ``Specific Panel Findings,'' which are matters that
Respondent ``neither admits nor denies,'' contain five paragraphs.
RFAAX 3, at 2-3 and RFAAX 11, at 10-11; see also supra. The TMB's first
specific panel finding is that ``Respondent admitted that she diverted
drugs through the Pyxis system that should have gone to patients'' and
that ``[t]hese violations impacted patient care and involved lying to
patients and her employer.'' RFAAX 3, at 2 and RFAAX 11, at 10. The
second TMB specific panel finding is that ``Respondent admitted that
she has struggled with addiction and substance abuse.'' RFAAX 3, at 2
and RFAAX 11, at 10. The third TMB specific panel finding is that
``Respondent was suspended from her position at Parkland Hospital after
a peer review action'' and that ``[t[his suspension was related to her
diversion of controlled substances and her substance abuse issues.''
RFAAX 3, at 2 and RFAAX 11, at 10. The fourth TMB specific panel
finding is that ``Respondent admitted that she treated herself with
controlled substances.'' \13\ RFAAX 3, at 2 and RFAAX 11, at 10. The
last TMB specific panel finding is that ``Respondent voluntarily
submitted to interim drug testing with the Board,'' that ``she has had
four missed calls and one late drug screen,'' and that ``[s]he has not
tested positive for any substances.'' RFAAX 3, at 3 and RFAAX 11, at
11.
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\13\ I find that Respondent's admission that she treated herself
with controlled substances does not necessarily mean that she
admitted to ingesting the controlled substances she diverted. RFAAX
3, at 2 and RFAAX 11, at 10.
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The Agreed Order's ``Conclusions of Law'' suggest that the TMB
concluded that it had nine bases for disciplining Respondent ``[b]ased
on the above [General and Specific Panel] Findings.'' RFAAX 3, at 3 and
RFAAX 11, at 11. First, the TMB concluded that Respondent committed an
act prohibited under Texas statute, Texas Occupations Code Annotated
Sec. 164.052 (2018). RFAAX 3, at 3 and RFAAX 11, at 11. Second, the
TMB concluded that Respondent violated TMB rules requiring the
maintenance of adequate medical records. RFAAX 3, at 3 and RFAAX 11, at
11. Third, the TMB concluded that Respondent was unable to practice
medicine with reasonable skill and safety to patients because of
excessive use of drugs, narcotics, chemicals, or other substance, or a
mental or physical condition. RFAAX 3, at 3 and RFAAX 11, at 11.
Fourth, the TMB concluded that Respondent failed to practice medicine
in an acceptable professional manner consistent with public health and
welfare due to negligence in performing medical services, failing to
use proper diligence in her professional practice, failing to safeguard
against potential complications, and inappropriate prescription of
dangerous drugs or controlled substances to herself, family members, or
others in which there is a close personal relationship. RFAAX 3, at 3-4
and RFAAX 11, at 11-12.
Fifth, the TMB concluded that Respondent's use of alcohol or drugs
in an intemperate manner could endanger the lives of patients. RFAAX 3,
at 4 and RFAAX 11, at 12. Sixth, the TMB concluded that Respondent's
unprofessional or dishonorable conduct likely to deceive or defraud the
public
[[Page 40645]]
or injure the public included providing medically unnecessary services,
submitting a billing statement to a patient or a third-party payor that
she should have known was improper, and violating state law concerning
insurance fraud and concerning prescribing or administering without a
valid medical purpose. RFAAX 3, at 4 and RFAAX 11, at 12. Seventh, the
TMB concluded that Respondent prescribed or administered a drug or
treatment that was nontherapeutic in nature, or that was nontherapeutic
in the manner administered or prescribed. RFAAX 3, at 4 and RFAAX 11,
at 12. Eighth, the TMB concluded that Respondent prescribed,
administered, or dispensed dangerous drugs or controlled substances in
a manner inconsistent with public health and welfare. RFAAX 3, at 4 and
RFAAX 11, at 12. Ninth, the TMB concluded that Respondent's improper
billing practices violated Texas law. RFAAX 3, at 4 and RFAAX 11, at
12.
There is substantial congruity between the evidence submitted by
the Government and Respondent's evidence. I now address the OSC's
allegations in the order in which they appear in the OSC.
E. Allegation That Respondent Has Been Convicted of a Felony Related to
a Controlled Substance (21 U.S.C. 824(a)(2))
Based on substantial record evidence, including the evidence that
both the Government and Respondent submitted, I find that Respondent
pled nolo contendere to a second-degree Texas felony relating to a
controlled substance, hydromorphone, and that adjudication of her guilt
was deferred. See, e.g., RFAAX 4, at 1 (hydromorphone); RFAAX 5, at 1
(controlled substance); RFAAX 11, at 4 (controlled substance); id. at 8
(``CS'' and ``Sch II'').
F. Allegation That Respondent's Registration Is Inconsistent With the
Public Interest (21 U.S.C. 824(a)(4) and 823(f))
The section of the Government's RFAA addressing the 21 U.S.C.
824(a)(4) public interest basis for revocation of Respondent's
registration focuses exclusively on Factor Three, 21 U.S.C. 823(f)(3):
Respondent's ``conviction record under Federal or State laws relating
to the . . . dispensing of controlled substances.'' \14\ RFAA, at 5.
The Government argues that Respondent's nolo contendere plea to a
second-degree controlled substance felony under Texas law justifies
revocation of Respondent's registration. Id.
---------------------------------------------------------------------------
\14\ The CSA defines ``dispense'' to mean ``to deliver a
controlled substance to an ultimate user . . . by, or pursuant to
the lawful order of, a practitioner, including the prescribing and
administering of a controlled substance.'' 21 U.S.C. 802(10).
---------------------------------------------------------------------------
As already discussed, I find that Respondent pled nolo contendere
to a second-degree Texas felony relating to a controlled substance,
hydromorphone, and that adjudication of her guilt was deferred. Supra
section II.E. More specifically, I find substantial record evidence
that Respondent pled as follows: ``on or about the 6th day of February,
2016, in Dallas County, Texas, I did intentionally and knowingly
possess and attempt to possess a controlled substance, namely,
HYDROMORPHONE, by misrepresentation, fraud, forgery, deception and
subterfuge.'' RFAAX 4, at 1. Further, I find substantial record
evidence based on the above findings and the unrefuted Affidavit for
Arrest Warrant or Capias that Respondent did not return or waste the
hydromorphone. RFAAX 6, at 1-2. I do not find substantial record
evidence about what Respondent did with the hydromorphone that she pled
to fraudulently possessing or attempting to possess.
While the Government focused exclusively on Factor Three, the OSC's
allegations based on 21 U.S.C. 824(a)(4) and 823(f) are broader.
Accordingly, I am analyzing, making findings of fact about, and drawing
conclusions of law based on the entire text of 21 U.S.C. 823(f).
I find substantial record evidence that Respondent admitted that
she engaged in the ``diversion of controlled substances'' ``from
November 2015 through February 11, 2016.'' \15\ RFAAX 11, at 1; RFAAX
10, at 1. I find substantial record evidence that Respondent, ``[w]hile
making such an admission of diversion, . . . denie[d] all the above
[OSC] charges against her as described in the Waiver of Hearing letter
dated September 21, 2018.'' RFAAX 11, at 1. I find substantial record
evidence that Respondent characterized as ``unfortunate'' the legal
action taken by ``Parkland Hospital, the affiliate hospital where the
diversion occurred,'' and stated that the legal action was taken
``unbeknownst and at the disapproval of the committee that led to a
series of events as outlined in the facts.'' \16\ RFAAX 10, at 1.
---------------------------------------------------------------------------
\15\ According to Respondent's Written Statement, ``The
diversion of controlled substances occurred as stated from November
2015 through February 11, 2016.'' RFAAX 10, at 1. The meaning of
``as stated'' might refer to the allegations of the OSC, but since
it is not clear, I am not making a finding about the meaning of the
phrase.
\16\ Respondent's reference to ``the facts'' appears to refer to
the OSC's ``summary of the matters of fact and law at issue.'' OSC,
at 1.
---------------------------------------------------------------------------
I find substantial record evidence that Respondent's Written
Statement disputes the OSC's material falsification and felony
conviction charges on the basis of the Texas ``deferred adjudication
probation,'' and states that, ``[i]n summary, I do not deny nor have I
ever in the past the unfortunate course of actions I decided to take by
diverting controlled substances.'' Id. at 2. I find substantial record
evidence that her Written Statement further states that, ``I accept
sole responsibility and I have taken actions to become sober and
healthy and continue to do such.'' Id. I find substantial record
evidence that Respondent's Written Statement asks that she be
``allow[ed] . . . to continue to demonstrate that . . . [she has] been
rehabilitated and will always put the trust of the public first and
foremost.'' Id. at 2-3. I find substantial record evidence that the
Written Statement represents that ``this is . . . [Respondent's] first
offense and . . . [she] is working diligently for it to never occur
again.'' Id. at 3.
I find there is substantial record evidence that Respondent
admitted that she ``had diverted multiple controlled substances from
numerous patients at Parkland Hospital in Dallas, Texas.'' RFAAX 9, at
2. I find there is substantial record evidence that Respondent admitted
that she ``diverted Dilaudid, Morphine, Versed, and Fentanyl.'' Id.
I find there is substantial record evidence that Respondent and the
TMB entered into an Agreed Order that was signed and entered by the TMB
presiding officer on March 2, 2018. RFAAX 3, at 15 and RFAAX 11, at 23.
I find substantial record evidence that Respondent neither admitted nor
denied the TMB's General and Specific Panel Findings. RFAAX 3, at 3 and
RFAAX 11, at 11. I find substantial record evidence that Respondent
``agree[d] to the entry of th[e] Agreed Order,'' and agreed ``to comply
with its terms and conditions'' to ``avoid further investigation,
hearings, and the expense and inconvenience of litigation.'' RFAAX 3,
at 3 and RFAAX 11, at 11. I find substantial record evidence that the
terms of the Agreed Order subject Respondent to multiple conditions for
up to ten years, that Respondent's noncompliance with, or violation of,
specified Agreed Order conditions could lead to the immediate
suspension of her medical license, and that the Agreed Order affords
Respondent the
[[Page 40646]]
opportunity to seek amendment or termination of the conditions after
two years following the date of the Agreed Order's entry and once a
year thereafter. RFAAX 3, at 5-13 and RFAAX 11, at 13-21.
I find substantial record evidence that the TMB found that
``Respondent admitted that she diverted drugs through the Pyxis system
that should have gone to patients'' and that ``[t]hese violations
impacted patient care and involved lying to patients and her
employer.'' RFAAX 3, at 2 and RFAAX 11, at 10. I find substantial
record evidence that the TMB found that ``Respondent admitted that she
has struggled with addiction and substance abuse.'' RFAAX 3, at 2 and
RFAAX 11, at 10. I find substantial record evidence that the TMB found
that ``Respondent was suspended from her position at Parkland Hospital
after a peer review action'' and that ``[t[his suspension was related
to her diversion of controlled substances and her substance abuse
issues.'' RFAAX 3, at 2 and RFAAX 11, at 10. I find substantial record
evidence that the TMB found that ``Respondent admitted that she treated
herself with controlled substances.'' RFAAX 3, at 2 and RFAAX 11, at
10. I find substantial record evidence that the TMB found that
``Respondent voluntarily submitted to interim drug testing with the
Board,'' that ``she has had four missed calls and one late drug
screen,'' and that ``[s]he has not tested positive for any
substances.'' RFAAX 3, at 3 and RFAAX 11, at 11.
I find substantial record evidence that the TMB concluded that it
had multiple bases under Texas law for disciplining Respondent,
including her failure to maintain adequate medical records; her
inability to practice medicine with reasonable skill and safety to
patients because of excessive substance use or a mental or physical
condition; her failure to practice medicine in an acceptable
professional manner consistent with public health and welfare due to,
among other things, her negligence, improper diligence, not
safeguarding against potential complications, and inappropriate
prescription of dangerous drugs or controlled substances; her use of
alcohol or drugs in an intemperate manner that could endanger the lives
of patients; and her unprofessional or dishonorable conduct likely to
deceive or defraud the public or injure the public including
prescribing or administering a controlled substance without a valid
medical purpose (Tex. Health & Safety Code Sec. 481.071(a). RFAAX 3,
at 3-4 and RFAAX 11, at 11-12.
G. Allegation That Respondent Materially Falsified a Renewal
Application (21 U.S.C. 824(a)(1))
I find clear, unequivocal, and convincing record evidence that, on
April 7, 2016, Respondent was arraigned on charges that she violated a
second-degree Texas felony involving a controlled substance. RFAAX 7,
at 1; see also RFAAX 6, at 1-2. I find clear, unequivocal, and
convincing record evidence that Respondent answered ``N'' to the first
Liability question on the registration renewal application that she
submitted on or about August 11, 2016. RFAAX 2, at 2 and RFAAX 8, at 1.
I find clear, unequivocal, and convincing record evidence that the text
of the first Liability question on the registration renewal application
that Respondent submitted on or about August 11, 2016, asked whether
Respondent had ``ever been convicted of a crime in connection with
controlled substance(s) under state or federal law . . . or any such
action pending.'' \17\ RFAAX 2, at 2 and RFAAX 8, at 1. I find clear,
unequivocal, and convincing record evidence that the date of
Respondent's Judicial Confession is May 26, 2017. RFAAX 4, at 1.
Accordingly, I find clear, unequivocal, and convincing record evidence
that Respondent's ``N'' response to the first Liability question on the
registration renewal application that she submitted on or about August
11, 2016, was false because, on April 7, 2016, Respondent was arraigned
on charges that she violated a second-degree Texas felony involving a
controlled substance.
---------------------------------------------------------------------------
\17\ Respondent submitted evidence about the exact wording of
the first Liability question. RFAAX 11, at 3. I find clear,
unequivocal, and convincing record evidence that Respondent's
proffered evidence, from 2006, is out-of-date and obsolete and,
therefore, irrelevant to this adjudication. Id., compare with RFAAX
2, at 2; RFAAX 8, at 1.
---------------------------------------------------------------------------
III. Discussion
A. The Controlled Substances Act
Under the CSA, ``[a] registration . . . to . . . distribute[ ] or
dispense a controlled substance . . . may be suspended or revoked by
the Attorney General upon a finding that the registrant--(1) has
materially falsified any application filed pursuant to or required by
this subchapter or subchapter II; (2) has been convicted of a felony
under . . . any . . . law of the United States, or of any State,
relating to any substance defined in this subchapter as a controlled
substance; . . . [or] (4) has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined by such section.'' 21 U.S.C. 824(a). The
OSC alleges these three bases for revocation of Respondent's
registration: violations of 21 U.S.C. 824(a)(1), (2), and (4).
B. Allegation That Respondent Materially Falsified an Application (21
U.S.C. 824(a)(1))
As already discussed, I find clear, unequivocal, and convincing
evidence that Respondent submitted a registration renewal application
containing a false answer to the first Liability question. Supra
section II.G. My finding about Respondent's submission of a false
answer involves Respondent's arraignment on charges that she violated a
second-degree, controlled-substance related Texas felony about four
months before her submission of the registration renewal application.
Id. Respondent's false submission, therefore, implicates Factor Four,
Respondent's ``[c]ompliance with applicable State, Federal, or local
laws relating to controlled substances.'' 21 U.S.C. 823(f)(4).
Respondent's false response to the first Liability question directly
implicated my statutorily-mandated analysis and my decision by
depriving me of legally relevant facts when I evaluated Respondent's
registration renewal application. RFAAX 2, at 1; see also Frank Joseph
Stirlacci, M.D., 85 FR 45,229, 45,235 (2020). Accordingly, I find,
based on the CSA and the analysis underlying multiple Supreme Court
decisions explaining ``materiality,'' that the falsity Respondent
submitted was material. Frank Joseph Stirlacci, M.D., 85 FR at 45,235.
Respondent's Written Statement argues that her nolo contendere plea
to a second-degree Texas felony is ``not a conviction,'' because ``it
is a deferred adjudication probation that was completed May 29, 2018
and is therefore discharged as a non-conviction.'' RFAAX 10, at 2. She
posited that, ``It is not considered a conviction under Texas law.''
Id. There are two reasons why I disagree with Respondent's arguments.
First, the Agency established over thirty years ago, and reiterated
as recently as about ten years ago, that a deferred adjudication is
``still a `conviction' within the meaning of the . . . [CSA] even if
the proceedings are later dismissed.'' Kimberly Maloney, N.P., 76 FR
60,922, 60,922 (2011). In reaching this conclusion, the Agency
explained that, ``[a]ny other interpretation would mean that the
conviction could only be considered between its date and the date of
its subsequent dismissal.'' Id., citing Edson
[[Page 40647]]
W. Redard, M.D., 65 FR 30,616, 30,618 (2000).
Second, Respondent's Written Statement arguments do not account for
the fact, as I already found, that the first Liability question on the
registration renewal application that she submitted asked whether she
had ``ever been convicted of a crime in connection with controlled
substance(s) under state or federal law . . . or any such action
pending'' [emphasis added]. RFAAX 2, at 2; RFAAX 8, at 1; see also
supra section II.G. I already found that Respondent submitted her
registration renewal application on or about August 11, 2016, that she
was arraigned on charges that she violated a second-degree Texas felony
involving a controlled substance on April 7, 2016, and that she pled
guilty on May 26, 2017. Supra section II.G. As such, Respondent had
already been arraigned, meaning there was an ``action pending,'' when
she submitted her registration renewal application on or about August
11, 2016. Her ``N'' response to the first Liability question on that
renewal application, therefore, was false, because there was already a
second-degree Texas controlled-substance related felony action pending.
After considering, analyzing, and evaluating Respondent's
arguments, I find clear, convincing, and unequivocal record evidence
and conclude that Respondent materially falsified the registration
renewal application she submitted on or about August 11, 2016.
Accordingly, I find that there is clear, convincing, and unequivocal
evidence in the record supporting revocation of Respondent's
registration based on her having ``materially falsified any application
filed pursuant to or required by this subchapter or subchapter II.'' 21
U.S.C. 824(a)(1).
C. Allegation That Respondent Has Been Convicted of a Felony Relating
to Any Controlled Substance (21 U.S.C. 824(a)(2))
As already discussed, I find, based on substantial record evidence,
including evidence that both the Government and Respondent submitted,
that Respondent pled nolo contendere to a second-degree Texas felony
relating to a controlled substance, hydromorphone, and that
adjudication of her guilt was deferred. Supra section II.E.; see also
section II.F.
I find substantial record evidence that the second-degree Texas
felony to which Respondent pled is section 481.129 of the Texas Health
and Safety Code. RFAAX 4, at 1; see also RFAA, at 2. Chapter 481 is the
Texas Controlled Substances Act. Every offense in the version of
subchapter 129 of the Texas Controlled Substances Act in effect when
Respondent pled nolo contendere in which the word ``fraud'' appears
concerns controlled substances. See, e.g., Tex. Health and Safety Code
Sec. Sec. 481.129(a)(5)(A), (B), and (C). 481.129(a)(6), and
481.129(a-1) (2017). Respondent's ``Judicial Confession'' states that
she ``did intentionally and knowingly possess and attempt to possess a
controlled substance, namely: HYDROMORPHONE, by misrepresentation,
fraud, forgery, deception and subterfuge.'' RFAAX 4, at 1. Texas Health
and Safety Code Sec. 481.129(a)(5)(A) states that a ``person commits
an offense if the person knowingly . . . possesses, obtains, or
attempts to possess or obtain a controlled substance or an increased
quantity of a controlled substance . . . by misrepresentation, fraud,
forgery, deception, or subterfuge.'' Tex. Health and Safety Code
Sec. Sec. 481.129(a)(5)(A) (2017). Accordingly, I find substantial
record evidence that Respondent pled nolo contendere to a Texas felony
relating to a controlled substance, Tex. Health and Safety Code
Sec. Sec. 481.129(a)(5)(A) (2017). 21 U.S.C. 824(a)(2).
I note the record evidence showing that, pursuant to deferred
adjudication, the proceedings against Respondent were dismissed and
Respondent was discharged early from community supervision. RFAAX 11,
at 8. As already discussed, though, under prior Agency decisions, an
Order dismissing proceedings following deferred adjudication does not
change the fact that Respondent pled nolo contendere to a second-degree
Texas felony. Supra section III.B. Accordingly, I find that there is
substantial evidence in the record supporting revocation of
Respondent's registration based on her Texas second-degree controlled
substance-related felony conviction. 21 U.S.C. 824(a)(2).
D. Allegation That Respondent's Registration Is Inconsistent With the
Public Interest (21 U.S.C. 824(a)(4) and 823(f))
As already discussed, the CSA provides for the revocation or
suspension of a registration to distribute or dispense a controlled
substance ``upon a finding that the registrant . . . has committed such
acts as would render his registration under section 823 of this title
inconsistent with the public interest as determined by such section.''
21 U.S.C. 824(a)(4). In the case of a ``practitioner,'' which is
defined in 21 U.S.C. 802(21) to include a ``physician,'' Congress
directed consideration of the following factors in making the public
interest determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the . . . distribution[ ] or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f). These factors are considered in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).
According to Agency decisions, I ``may rely on any one or a
combination of factors and may give each factor the weight [I] deem[ ]
appropriate in determining whether'' to revoke a registration. Id.; see
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't
Admin., 841 F.3d 707, 711 (6th Cir. 2016)); MacKay v. Drug Enf't
Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U.S. Drug Enf't
Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin.,
419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to
consider each of the factors, I ``need not make explicit findings as to
each one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222);
see also Akhtar-Zaidi, 841 F.3d at 711; Hoxie, 419 F.3d at 482. ``In
short, . . . the Agency is not required to mechanically count up the
factors and determine how many favor the Government and how many favor
the registrant. Rather, it is an inquiry which focuses on protecting
the public interest; what matters is the seriousness of the
registrant's misconduct.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 462
(2009). Accordingly, as appellate courts have recognized, findings
under a single factor are sufficient to support the revocation of a
registration. MacKay, 664 F.3d at 821.
In this matter, the Government's RFAA addresses Factor Three. RFAA,
at 5; see also supra section II.F.; infra. In addition to Factor Three,
I consider all of the public interest factors that are relevant to the
record evidence. 21 U.S.C. 823(f).
1. Factor One--Recommendation of the Appropriate State Licensing Board
Factor One calls for consideration of the ``recommendation of the
appropriate state licensing board or professional
[[Page 40648]]
disciplinary authority'' in the public interest determination. 21
U.S.C. 823(f)(1). The record evidence does not include a direct
recommendation to the Agency from the TMB about Respondent's continued
registration.
As already discussed, both the Government and Respondent submitted
the Agreed Order for the record. Supra sections II.C. and II.D. There
is some congruence between the matters addressed in the Agreed Order
and the OSC allegations, such as Respondent's diversion of controlled
substances. See, e.g., OSC, at 2; RFAAX 3, at 2-4; RFAAX 11, at 10-12.
The Agreed Order states that the TMB found multiple bases under Texas
law for disciplining Respondent. RFAAX 3, at 3-5 and RFAAX 11, at 11-
13; see also supra section II.D. It subjects Respondent to multiple
conditions for up to ten years. RFAAX 3, at 5-13 and RFAAX 11, at 13-
21; see also supra section II.D.
While the Agreed Order is not a direct recommendation for purposes
of Factor One, it does indicate a possible response to some of the
allegations and evidence before me. John O. Dimowo, M.D., 85 FR 15,800,
15,810 (2020).\18\ I apply the same analysis and reach the same
conclusion here given the differences between the allegations and
evidence set out in the Agreed Order and the allegations and evidence
before me. In sum, while the fact that the Agreed Order conditioned
Respondent's medical license, as opposed to revoking or suspending it,
is not dispositive of the public interest inquiry in this case and is
minimized due to the differences in the charges underlying the Agreed
Order and the OSC charges I am adjudicating, I consider the fact that
the TMB conditioned Respondent's medical license, as opposed to
revoking or suspending it, and I give that aspect of the Agreed Order
minimal weight in Respondent's favor.
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\18\ The John O. Dimowo, M.D. Agency decision stands for the
proposition that ``[a]lthough statutory analysis [of the CSA] may
not definitively settle . . . [the breadth of the cognizable state
`recommendation' referenced in Factor One], the most impartial and
reasonable course of action is to continue to take into
consideration all actions indicating a recommendation from an
appropriate state.'' 85 FR at 15,810.
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2. Factors Two and/or Four--The Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
As already discussed, there is substantial record evidence of
Respondent's negative controlled substance dispensing and non-
compliance with applicable laws related to controlled substances. See,
e.g., supra section II.F. For example, I already found that Respondent,
herself, admitted that she engaged in the ``diversion of controlled
substances'' ``from November 2015 through February 11, 2016.'' Id.; cf.
id. (referencing the Agreed Order and Respondent's decision not to
admit or deny the TMB's General and Specific Panel Findings). I further
found that Respondent, herself, admitted ``the unfortunate course of
action . . . [she] decided to take by diverting controlled
substances.'' Id.
I also found that the Government submitted substantial evidence
that Respondent admitted, to the DI, diverting multiple controlled
substances from numerous patients at Parkland Hospital. Id. I further
found substantial record evidence that Respondent also admitted to the
DI that she ``diverted Dilaudid, Morphine, Versed, and Fentanyl.'' Id.
In addition, I already found substantial record evidence that the
TMB's findings included that ``Respondent admitted that she diverted
drugs through the Pyxis system that should have gone to patients,''
``Respondent admitted that she has struggled with addiction and
substance abuse,'' ``Respondent was suspended from her position at
Parkland Hospital after a peer review action'' and ``[t[his suspension
was related to her diversion of controlled substances and her substance
abuse issues,'' ``Respondent admitted that she treated herself with
controlled substances,'' and ``Respondent voluntarily submitted to
interim drug testing with the Board,'' that ``she has had four missed
calls and one late drug screen,'' and that ``[s]he has not tested
positive for any substances.'' Id.
I also found substantial record evidence that the TMB concluded
that it had multiple bases under Texas law for disciplining Respondent.
Id. The multiple bases for disciplining Respondent under Texas law
included her prescribing or administering a controlled substance
without a valid medical purpose. Id.
I find that these matters directly implicate Factors Two and/or
Four and strongly weigh against Respondent.
3. Factor Three--The Respondent's Conviction Record Under State Laws
Relating to the Manufacture, Distribution, or Dispensing of Controlled
Substances
I already found that Respondent was convicted under Texas law of a
second-degree felony relating to a controlled substance. Supra section
II.E. and section III.C. (concerning 21 U.S.C. 824(a)(2)). Concerning
Factor Three and the OSC charge under 21 U.S.C. 824(a)(4), in
conjunction with 21 U.S.C. 823(f)(3), the Government's RFAA argues that
``revocation is justified by . . . [Respondent's] State conviction
record relating to [the] manufacture, distribution, or dispensing of
controlled substances as evidenced by her nolo contendere plea to a
second-degree controlled substance felony in Texas.'' RFAA, at 5. The
RFAA cites RFAAX 4 and RFAAX 5 to support this statement. Id. In its
next sentence, the RFAA states that ``Respondent pled nolo contendere
to intentionally and knowingly possessing and attempting to possess a
controlled substance, hydromorphone, by misrepresentation, fraud,
forgery, deception, and subterfuge.'' Id. Again, the RFAA cites RFAAX 4
and RFAAX 5 as support for this statement. Id. It also cites 21 U.S.C.
823(f)(3) and 21 U.S.C. 824(a)(4), reconfirming that this portion of
the RFAA is addressing the public interest basis for revocation. After
a ``see also'' signal, the Government cited generally to three Agency
decisions. Id.
The first decision involves a nolo contendere plea, a deferred
entry of judgment, and the subsequent dismissal of proceedings. Edson
W. Redard, M.D., 65 FR 30,616 (2000), cited supra section III.B. As
already discussed, that decision states that the Agency ``has
consistently held that a plea of nolo contendere constitutes a
`conviction' within the meaning of 21 U.S.C. 824(a)(2).'' Id. at
30,618. Concerning Factor Three, the decision has one sentence in a
one-sentence paragraph: ``As previously discussed, factor three is
relevant since the Deputy Administrator finds that Respondent was
convicted of a felony offense relating to controlled substances.'' Id.
at 30,619. The decision's ``previous discussion'' was that the doctor
had pled nolo contendere to one count of obtaining and attempting to
obtain hydrocodone by fraud. Id. at 30,617. The decision does not
elaborate on its one-sentence Factor Three conclusion.
The second and third Agency decisions that the Government cited to
support its argument that Factor Three is relevant are Jana Marjenhoff,
D.O., 80 FR 29,067 (2015) and David D. Miller, M.D., 60 FR 54,511
(1995). RFAA, at 5. According to Jana Marjenhoff, D.O., ``[r]egarding
Factor Three, the record in this case does not contain evidence that
the Respondent has been convicted of (or even charged with) a crime
related to any of the controlled substance activities designated under
this provision in the CSA.'' 80 FR at 29,089 [footnote omitted]. This
sentence does
[[Page 40649]]
not appear to support the Government's Factor Three argument.
Regarding David D. Miller, M.D., the decision explains that the
doctor pled nolo contendere in state court to the unlawful distribution
of marijuana and concluded that this plea ``established a prima facie
case under factor three.'' 60 FR at 54,512 [emphasis added]. I agree
with this conclusion. 21 U.S.C. 823(f)(3). I note that, according to
the record evidence before me in this matter, Respondent pled to a
second-degree State felony ``possession'' charge, not to a charge about
``the manufacture, distribution, or dispensing of controlled
substances.'' Id.; see also RFAAX 4, at 1 (memorializing Respondent's
Judicial Confession that she ``did intentionally and knowingly possess
and attempt to possess a controlled substance, namely: HYDROMORPHONE,
by misrepresentation, fraud, forgery, deception and subterfuge'').
For all of these reasons, I conclude that the record before me
contains no evidence, or contains insufficiently developed evidence, to
support my crediting the Government's Factor Three-related argument.
Accordingly, I do not find record evidence that fits the ``manufacture,
distribution, or dispensing of controlled substances'' criteria of
Factor Three.
4. Factor Five--Such Other Conduct Which May Threaten the Public Health
and Safety
As already discussed, the record contains substantial evidence,
submitted both by the Government and by Respondent, about Respondent's
conduct which may threaten the public health and safety. See, e.g.,
supra section II.F. First, according to the ``Specific Panel Findings''
of the Agreed Order, the TMB found that Respondent's diversion of drugs
through the Pyxis system ``impacted patient care and involved lying to
patients and her employer.'' RFAAX 3, at 2 and RFAAX 11, at 10.
Second, based on all of its Findings and the correlation of its
Findings with legal requirements, the TMB concluded that there were
multiple ways that Respondent's conduct may threaten the public health
and safety. RFAAX 3, at 3-4 and RFAAX 11, at 11-12. It concluded that
Respondent was unable to ``practice medicine with reasonable skill and
safety to patients,'' because of excessive substance use or a mental or
physical condition. RFAAX 3, at 3 and RFAAX 11, at 11. The TMB
concluded that Respondent had failed to ``practice medicine in an
acceptable professional manner consistent with public health and
welfare'' due to, among other things, her negligence in performing
medical services, improper diligence in her professional practice, her
failure to safeguard against potential complications, and her
inappropriate prescription of dangerous drugs or controlled substances.
RFAAX 3, at 3-4 and RFAAX 11, at 11-12. The TMB also concluded that
``Respondent's use of alcohol or drugs in an intemperate manner . . .
could endanger the lives of patients.'' RFAAX 3, at 4 and RFAAX 11, at
12. Further, the TMB concluded that Respondent engaged in
``unprofessional or dishonorable conduct that is likely to deceive or
defraud the public or injure the public.'' RFAAX 3, at 4 and RFAAX 11,
at 12.
I find that these matters directly implicate Factor Five and
strongly weigh against Respondent.
5. Summary of Factors One, Two, Three, Four, and Five
As I found above, the Agreed Order is not a direct recommendation
for purposes of Factor One, but it does indicate a possible response to
some of the allegations and evidence before me. Supra section III.D.1.
While the fact that the Agreed Order conditioned Respondent's medical
license, as opposed to revoking or suspending it, is not dispositive of
the public interest inquiry in this case and is minimized due to the
differences in the charges underlying the Agreed Order and the OSC
charges, I consider the fact that the TMB conditioned Respondent's
medical license, as opposed to revoking or suspending it, and I give
that aspect of the Agreed Order minimal weight in Respondent's favor.
Id.
Regarding Factors Two and Four, I find substantial record evidence,
including from Respondent's admissions, of her negative controlled
substance dispensing experience, her diversion of controlled
substances, and her noncompliance with applicable laws relating to
controlled substances. See, e.g., supra section II.F. and section
III.D.2. I give this record evidence significant weight against
Respondent.
Regarding Factor Three, I find no relevant record evidence.
Regarding Factor Five, I find substantial record evidence that
Respondent engaged in conduct which may threaten the public health and
safety. Supra, e.g., section II.F. and section III.D.4. I give this
record evidence significant weight against Respondent.
Accordingly, I conclude that it would be ``inconsistent with the
public interest'' for Respondent to retain her registration due to the
significant record evidence implicating Factor Two, Factor Four, and
Factor Five, despite the record evidence implicating Factor One, and
regardless of the lack of record evidence implicating Factor Three. 21
U.S.C. 824(a)(4) and 21 U.S.C. 823(f); see Wesley Pope, 82 FR 14,944,
14,985 (2017).
IV. Sanction
Where, as here, the Government presented three, independent bases
for the revocation of Respondent's registration, and Respondent did not
present evidence rebutting any of the three bases, it is then up to
Respondent ``to assure the Administrator'' that she ``can be entrusted
with the responsibilit[ies] that accompany registration.'' White v.
Drug Enf't Admin., 626 F. App'x 493, 496 (5th Cir. 2015); see also
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018) (quoting Akhtar-Zaidi v. Drug Enf't Admin.,
841 F.3d 707, 711 (6th Cir. 2016)); MacKay v. Drug Enf't Admin., 664
F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. Drug Enf't Admin.,
567 F.3d 215, 222 (6th Cir. 2009) quoting Hoxie v. Drug Enf't Admin.,
419 F.3d 477, 482 (6th Cir. 2005)). As the Fifth Circuit also stated,
``[s]uch evidence includes acceptance of responsibility and a
demonstration that the . . . [Respondent] `will not engage in future
misconduct.' '' White v. Drug Enf't Admin., 626 F. App'x at 496; see
also Pharmacy Doctors Enterprises, Inc. v. Drug Enf't Admin., 789 F.
App'x, 724, 733 (2019) (citing Jones Total Health Care Pharmacy, LLC v.
Drug Enf't Admin., 881 F.3d at 831 (citing MacKay v. Drug Enf't Admin.,
664 F.3d at 820 (noting that past performance is the best predictor of
future performance and, when a registrant has ``failed to comply with .
. . [her] responsibilities in the past, it makes sense for the agency
to consider whether . . . [she] will change . . . [her] behavior in the
future'') and Alra Labs., Inc. v. Drug Enf't Admin., 54 F.3d 450, 452
(7th Cir. 1995) (``An agency rationally may conclude that past
performance is the best predictor of future performance.''))).
The Agency has decided that the egregiousness and extent of
misconduct are significant factors in determining the appropriate
sanction. Garrett Howard Smith, M.D., 83 FR 18,882, 18,910 (2018)
(collecting cases); Samuel Mintlow, M.D., 80 FR at 3652 (``Obviously,
the egregiousness and extent of a registrant's misconduct are
significant factors in determining the appropriate sanction.''). The
Agency has also considered the need to deter similar acts in the future
by Respondent and by the community of registrants. Garrett
[[Page 40650]]
Howard Smith, M.D., 83 FR at 18,910; Samuel Mintlow, M.D., 80 FR at
3652.
In terms of egregiousness, the violations that the substantial
record evidence shows Respondent committed go to the heart of the CSA:
Not complying with the closed regulatory system devised to ``prevent
the diversion of drugs from legitimate to illicit channels'' and not
prescribing controlled substances in compliance with the applicable
standard of care and in the usual course of professional practice.
Gonzales v. Raich, 545 U.S. at 13-14, 27.
Respondent's submissions address her acceptance of responsibility.
RFAAX 10 and RFAAX 11. According to her Written Statement, she has
``always taken 100% responsibility'' for her diversion of controlled
substances.'' RFAAX 10, at 1. It also states that she does ``not deny
nor . . . [has she] ever in the past the unfortunate course of actions
. . . [she] decided to take by diverting controlled substances.'' Id.
at 2. Her Written Statement continues with her ``accept[ing] sole
responsibility and . . . [stating that she has] taken actions to become
sober and healthy and continue[s] to do such.'' Id.
Respondent's choice to submit a Written Statement, instead of
taking advantage of her right to a hearing, means that she cannot
answer questions about her acceptance of responsibility. The several
areas of concern I have about her acceptance of responsibility,
therefore, remain unresolved. First, Respondent's statements accepting
responsibility are expressed only in the general terms of diverting
controlled substances. Id. at 1, 2. Second, she does not accept
responsibility for all of the OSC's founded allegations. Instead, she
is explicit in her ``deni[al of] all the above charges against her,''
meaning, at least, the OSC charges that she was convicted of a felony
relating to a controlled substance and that she materially falsified
her registration renewal application. RFAAX 11, at 1. Third, she does
not address, let alone accept responsibility for, the conduct the TMB
found as a basis for disciplining Respondent. RFAAX 3, at 3-5 and RFAAX
11, at 11-13.
Consequently, Respondent's acceptance of responsibility is not
broad enough to encompass all of the Agency's charges against her.
RFAAX 3, at 3-5 and RFAAX 11, at 1, 11-13. As such, it is not
unequivocal, as the Agency requires. Jeffrey Stein, M.D., 84 FR 46,968,
46,972-73 (2019) (unequivocal acceptance of responsibility); Jayam
Krishna-Iyer, M.D., 74 FR 459, 463 (2009) (collecting cases). These
deficiencies are concerning as they may mean that Respondent is not
ready and/or willing to appreciate (1) the full extent of her
misconduct and the (2) breadth of the harm her misconduct caused. I am
also left wondering what Respondent learned from her misconduct, and
whether Respondent has the resources to avoid committing the misconduct
again.
For example, Respondent's statements accepting responsibility
connect this acceptance with a violation of ``the oath . . . [she] took
as a physician and trusted public figure.'' RFAAX 10, at 1. This, of
course, is good and appropriate, and it ties into her statements that
she has ``done everything in . . . [her] power to correct . . . [her]
actions,'' and that ``she continue[s] to work hard at maintaining
sobriety and gain[ing] the trust of those that . . . [she has] lost,
including the public.'' Id. Her acceptance of responsibility does not
appear to extend beyond the impact of her misconduct on herself, her
sobriety, and the public's perception of her trustworthiness. For
example, she focuses on herself as she characterizes as ``unfortunate''
Parkland Hospital's taking legal action concerning her diversion of
controlled substances. RFAAX 10, at 1; supra section II.F. She does not
mention, let alone unequivocally accept responsibility for, potentially
endangering the lives of the Hospital's patients. RFAAX 3, at 3-4 and
RFAAX 11, at 11-12. By way of further example, she does not acknowledge
that her misconduct, not complying with the closed regulatory system
devised to ``prevent the diversion of drugs from legitimate to illicit
channels,'' goes to the heart of the CSA. Gonzales v. Raich, 545 U.S.
at 13-14, 27. Her stated ``hard work'' goes to ``maintaining sobriety
and gain[ing] the trust of those that . . . [she has] lost, including
the public,'' but not, apparently, also to regaining the trust of the
Agency whose statutory responsibilities include determining who may be
entrusted with the responsibilities of a controlled substance
registration.
For all of the above reasons, it is not reasonable for me, at this
time, to trust that Respondent will comply with all controlled-
substance related legal requirements in the future.\19\ Alra Labs.,
Inc. v. Drug Enf't Admin., 54 F.3d at 452 (``An agency rationally may
conclude that past performance is the best predictor of future
performance.''). Accordingly, I shall order that Respondent's
registration be revoked and that all pending applications to renew or
modify Respondent's registration, and any pending application for a new
registration in Texas, be denied.
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\19\ I do not consider remedial measures when a Respondent does
not unequivocally accept responsibility. As discussed, the scope of
Respondent's presentation of remedial efforts was limited and,
therefore, unpersuasive and not reassuring.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of
Registration No. FG2374053 issued to Erica N. Grant, M.D. Pursuant to
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and
21 U.S.C. 823(f), I further hereby deny any pending application of
Erica N. Grant, M.D., to renew or modify this registration, as well as
any other pending application of Erica N. Grant, M.D. for registration
in Texas. This Order is effective August 27, 2021.
Anne Milgram,
Administrator.
[FR Doc. 2021-16003 Filed 7-27-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on July 28, 2021.
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