[Federal Register Volume 86, Number 108 (Tuesday, June 8, 2021)]
[Notices]
[Pages 30494-30496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11982]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-31]


Jennifer L. St. Croix, M.D.; Order Denying Motion To Stay

I. Introduction

    On April 12, 2021, I issued a Decision and Order revoking, 
effective May 12, 2021, Certificate of Registration No. FS2669868 
issued to Jennifer L. St. Croix, M.D. (hereinafter, Petitioner) at a 
registered address in Tennessee. Jennifer L. St. Croix, M.D., 86 FR 
19010 (April 12, 2021) (hereinafter, April 12, 2021 Decision/Order). On 
May 6, 2021, Petitioner's Counsel filed by email with the Drug 
Enforcement Administration Office of the Administrative Law Judges 
(hereinafter, OALJ) a Motion to Stay Enforcement Pending Appeal 
(hereinafter, Motion to Stay) and served by email the Drug Enforcement 
Administration Office of Chief Counsel (hereinafter, DEA or 
Government). The OALJ forwarded the Motion to Stay to my office. On May 
7, 2021, I ordered the Government to respond to Petitioner's Motion to 
Stay no later than 5:00 p.m. on Monday, May 10, 2021. The Government 
filed a timely response (hereinafter, Govt Opposition), arguing that 
the Motion to Stay should be denied.
    Later in the day of May 7, 2021, the United States Department of 
Justice alerted my office that Petitioner had filed a pro se petition 
with the District of Columbia Circuit Court of Appeals for review of my 
April 12, 2021 Decision/Order. Petition for Review of Agency Decision, 
St. Croix v. United States Drug Enforcement Administration, 21-1116 
(dated May 5, 2021) (hereinafter, Review Petition). Petitioner 
identified her address on her Review Petition to be in Las Vegas, 
Nevada. Review Petition, at 1.
    Having considered the merits of Petitioner's Motion to Stay and of 
the Government's Response in conjunction with the record evidence, I 
deny Petitioner's Motion to Stay.

II. The April 12, 2021 Decision/Order

    Petitioner requested a hearing on the allegations that the Order to 
Show Cause (hereinafter, OSC) made against her. 86 FR at 19011. She 
attended the hearing with her attorney. Id. at 19018. After the 
Government rested, Petitioner's counsel made a motion for summary 
disposition. Id. at 19017-18. After the Chief Administrative Law Judge 
(hereinafter, ALJ) heard from both the Petitioner's and the 
Government's counsels on the motion, he ruled on the motion from the 
bench, denying it in part and reserving it in part. Id. Petitioner then 
advised the Chief ALJ that she chose not to present a case. Id. at 
19018. Following discussion about that decision, Petitioner sought and 
obtained from the Chief ALJ time to consult with her attorney. Id. 
After the opportunity to consult, Petitioner re-stated her decision not 
to put on a case. Id. Accordingly, Petitioner knowingly declined the 
opportunity to offer documentary evidence and oral testimony for the 
record.
    In my April 12, 2021 Decision/Order, I found that Petitioner ``had 
committed such acts as would render . . . [her] registration 
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). The acts 
alleged in the OSC for which I found the Government had submitted 
substantial evidentiary support for the record and had proven were 
legal violations were (1) that Petitioner issued controlled substance 
prescriptions for no legitimate purpose and outside the usual course of 
professional practice, (2) that Petitioner failed to maintain medical 
records pertaining to her prescribing of controlled substances, (3) 
that Petitioner provided misleading information to investigating DEA 
agents, (4) that Petitioner failed to provide fully-compliant 
controlled substance prescription drug logs to DEA for periods during 
which she issued controlled substance prescriptions, (5) that 
Petitioner stored controlled substances at an unregistered location, 
and (6) that Petitioner failed to provide effective controls or 
procedures to guard against the theft or diversion of controlled 
substances. 86 FR at 19019-21, 19023-25. I did not find substantial 
evidence and/or a legal basis to support the OSC's allegations (1) that 
Petitioner had continued to issue controlled substance prescriptions to 
individuals who are intimate or close acquaintances, and to an 
individual with whom she had a ``romantic interaction,'' (2) that 
Petitioner violated 21 U.S.C. 843(a)(4)(A) by failing to comply with 
the terms of her June 2011 Memorandum of Agreement (hereinafter, MOA) 
with DEA, (3) that Petitioner did not maintain records of the 
controlled substances she dispensed, and (4) that Petitioner did not 
conduct an initial inventory of the controlled substances she received. 
Id. at 19019-20, 19022-25.
    In adjudicating the OSC issued to Petitioner, I found that 
Petitioner made legal arguments that conflict with a core principle of 
the Controlled Substances Act (hereinafter, CSA)--the establishment of 
a closed regulatory system devised to ``prevent the diversion of drugs 
from legitimate to illicit channels.'' Gonzales v. Raich, 545 U.S. 1, 
13-14, 27 (2005). I found that Petitioner proposed a course of action 
regarding the storage of controlled substances that would be a danger 
to public health and safety as it would allow the storage of controlled 
substances anywhere, as long as no dispensing took place at the 
location. 86 FR at 19024. I declined to accept Petitioner's arguments, 
concluding that to do so would conflict with my authority under the CSA 
and would establish a dangerous policy. Id.
    In my adjudication of the OSC issued to Petitioner, I also 
determined that Petitioner urged me to accept positions that minimize 
statutory and regulatory inventory requirements. Id. I rejected those 
positions as well.

III. Petitioner's Motion To Stay

    Petitioner argues that there are multiple reasons why her Motion to 
Stay satisfies the applicable legal standard and why I should grant her 
requested relief. First, she argues that there is a substantial 
likelihood that her review petition will prevail because she has had 
``no further issues regarding her prescribing and management of 
controlled substances . . . over the past seven years.'' Motion to 
Stay, at 3. Petitioner also argues that the reviewing Circuit Court 
will find in her favor because the penalty I assessed in my April 12, 
2021 Decision/Order ``is excessive, unjust, and disproportionate to her 
actions'' based on her ``review of other administrative actions against 
physicians.'' Id. at 4.
    Second, Petitioner posits that she will suffer irreparable injury 
if enforcement of my April 12, 2021 Decision/Order is not stayed. ``It 
would be difficult,'' the Motion to Stay argues, ``to overstate the 
impact that the loss of her [DEA registration] would have on . . . 
[her] ability to earn a living.'' Id. She states that enforcement of my 
April 12, 2021 Decision/Order ``will result in the immediate loss of 
her current position and essentially make her unemployable as a 
physician.'' Id. She also states that she ``will not be able to recover 
her lost income that will result from her sudden unemployment'' and 
that a stay of enforcement ``would allow . . . [her] to continue to 
support herself while she explores other employment opportunities.'' 
Id. at 5.

[[Page 30495]]

    Third, Petitioner argues that no party ``will be harmed if the 
enforcement of the . . . [April 12, 2021 Decision/Order] is stayed.'' 
Id. In support of this argument, Petitioner states that the enforcement 
proceeding never ``alleged that any action or omission by . . . [her] 
resulted in harm to any person,'' and that DEA ``did not apparently see 
. . . [her] as posing any kind of imminent threat or danger to her . . 
. patients, as it never sought any sort of injunction or immediate 
suspension of her certificate.'' Id. She also argues that ``no parties 
have been harmed in the past and there is no likelihood that any 
parties would be harmed if a stay of enforcement is granted.'' Id. at 
6.
    Fourth, Petitioner states in her Motion to Stay that the ``public 
interest is in allowing an experienced practitioner to keep practicing 
in a medical specialty that is urgently needed during a global 
pandemic.'' \1\ Id. at 6. Petitioner indicates that she would like ``to 
at least give proper notice to her employer and allow sufficient time 
to try and find a suitable employment.'' Id. Petitioner's definition of 
``proper notice'' appears to be connected to ``at least until this 
action has been finally concluded.'' Id. at 7. Petitioner also claims 
that, ``as she is a woman of Asian descent, . . . [she] is particularly 
suited to provide compassionate and understanding treatment to patients 
who have been the victim of ongoing racial/ethnic prejudices, as she 
herself has experienced these prejudices herself.'' Id. at 6.
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    \1\ According to the Motion to Stay, Petitioner is ``actively 
engaged in the care and treatment of individuals in desperate need 
of medical care, and . . . does not pose any immediate danger to the 
community.'' Motion to Stay, at 6.
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IV. The Government's Opposition to the Motion to Stay

    As already discussed, the Government opposes Petitioner's Motion to 
Stay. Supra section I. Regarding whether Petitioner is likely to 
prevail on appeal, the Government states that the Motion to Stay 
``assigns no legal or factual errors to the Acting Administrator's 
decision.'' Govt Opposition, at 3. It argues that Petitioner's Motion 
to Stay ``points (without analysis or comparison) to a single court of 
appeals decision finding that the Agency's decision to revoke a 
practitioner's registration was `arbitrary.' '' Id. (citing Morall v. 
Drug Enf't Admin., 412 F.3d 165, 181 (D.C. Cir. 2005)). According to 
the Government, ``Morall offers . . . [Petitioner] here no relief'' 
because, ``as the D.C. Circuit has since reiterated, `under the 
Administrative Procedure Act, the [Agency's] choice of sanction is 
entitled to substantial deference.' '' Govt Opposition, at 3 (citing 
Chien v. Drug Enf't Admin., 533 F.3d 828, 835 (D.C. Cir. 2008) (quoting 
Morall, 412 F.3d at 177)). The Government's Opposition states that an 
``Agency's sanction decision is `arbitrary' only if it is a `flagrant 
departure from DEA policy and practice . . . and if the departure is 
not only unexplained, but entirely unrecognized in the [Agency's] 
decision.' '' Govt Opposition, at 3-4 (citing Chien, 533 F.3d at 836 
(quoting Morall, 412 F.3d at 183) (emphasis added by the Government)). 
The Government concludes that Petitioner has not shown that the April 
12, 2021 Decision/Order was ``arbitrary'' and that she ` ``has not 
established a serious question going to the merits of [her] appeal, 
much less a substantial likelihood of success on the merits of [her] 
petition for review to warrant the issuance of a stay.' '' Govt 
Opposition, at 3, 5 (quoting Medicine Shoppe-Jonesborough, Motion to 
Stay Denial, 73 FR 3997, 3998 (2008)).
    Regarding whether Petitioner's Motion to Stay demonstrates 
irreparable harm, the Government argues that it does not, because it 
``offers no evidence in support'' of its claims that revocation ``would 
`result in the immediate loss of her current position and essentially 
make her unemployable as a physician.' '' Govt Opposition, at 5 (citing 
Medicine Shoppe-Jonesborough, 73 FR at 3998). The Government concludes 
that Petitioner's allegations of harm are ``entirely speculative and, 
as importantly, unsubstantiated.'' Govt Opposition, at 6.

V. The Applicable Legal Standard

    The Supreme Court has addressed the purpose of stays and the legal 
standard for the evaluation of motions to stay. In Scripps-Howard 
Radio, Inc. v. Fed. Communications Comm'n, the Supreme Court ruled that 
``it is reasonable that an appellate court should be able to prevent 
irreparable injury to the parties or to the public resulting from the 
premature enforcement of a determination which may later be found to 
have been wrong . . . [and it] has always been held, therefore, that, 
as part of its traditional equipment for the administration of justice, 
a federal court can stay the enforcement of a judgment pending the 
outcome of an appeal.'' 316 U.S. 4, 9-10 (1942).
    In 2009, the Supreme Court provided the legal standard applicable 
to Petitioner's Motion to Stay. Nken v. Holder, 556 U.S. 418 (2009). 
According to Nken, four factors guide a court's exercise of discretion 
to stay enforcement of an order pending review, and the party 
requesting the stay ``bears the burden of showing that the 
circumstances justify an exercise of that discretion.'' 556 U.S. at 
433-34. The four factors are ``(1) whether the stay applicant has made 
a strong showing that he is likely to succeed on the merits; (2) 
whether the applicant will be irreparably injured absent a stay; (3) 
whether issuance of the stay will substantially injure the other 
parties interested in the proceeding; and (4) where the public interest 
lies.'' Id. at 434. According to the Court, the ``first two factors of 
the traditional standard are the most critical.'' Id. If the applicant 
satisfies the first two factors, ``the traditional stay inquiry calls 
for assessing the harm to the opposing party and weighing the public 
interest.'' Id. at 435. When the Government is the opposing party, 
these two factors merge. Id.

VI. Application of the Legal Standard to Petitioner's Motion to Stay

    Having analyzed the Motion to Stay, the Government's Opposition, 
and the entire record in this matter, I find that Petitioner has not 
met her burden of showing that the circumstances justify an exercise of 
my discretion to stay, pending appellate review, enforcement of the 
sanction I ordered on April 12, 2021. Id. at 433-34.
    Regarding whether there is a substantial likelihood that Petitioner 
will prevail on the merits, even if Petitioner had substantiated her 
argument, which she did not, that she has had ``no further issues 
regarding her prescribing and management of controlled substances'' for 
the last seven years, her argument is irrelevant to my adjudication of 
the OSC and to the Circuit Court's review of my Decision/Order.\2\ The 
OSC at issue, dated April 12, 2017, and the adjudication of that OSC 
concern Petitioner's unlawful and allegedly unlawful acts during a 
specified period before April 12, 2017. As such, Petitioner's argument 
that she has had ``no further issues regarding her prescribing and 
management of controlled substances'' since the date of the OSC is of 
no relevance.
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    \2\ Petitioner likely referenced ``seven'' years because the 
record evidence includes a three-year MOA between Petitioner and DEA 
dated June 2011. DEA issued her the Tennessee-based registration, 
whose revocation is effective tomorrow, because she agreed to the 
MOA's terms.
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    For the portion of the alleged seven-year period that is before the 
date of the OSC, I note that neither this Agency nor any other federal 
law enforcement agency is required to bring all possible charges 
against any subject at one time. See, e.g., Heckler v. Chaney, 470 U.S.

[[Page 30496]]

821, 831 (1985) (``This Court has recognized on several occasions over 
many years that an agency's decision not to prosecute or enforce, 
whether through civil or criminal process, is a decision generally 
committed to an agency's absolute discretion.''). Instead, agencies 
exercise their investigative and prosecutorial discretion based on 
matters such as enforcement priorities and the availability of 
resources. See, e.g., id. at 831-32.
    Further, Petitioner has had, and continues to have, the option of 
submitting an application for a new DEA registration. The Agency's 
decisions make clear that an applicant's past actions that violate the 
law need not result in her being denied a DEA registration 
indefinitely. See, e.g., Michele L. Martinho, M.D., 86 FR 24012 (2021).
    Regarding her allegation that the sanction I assessed in my April 
12, 2021 Decision/Order is ``excessive, unjust, and disproportionate to 
her actions,'' Petitioner neither submitted evidence for the record 
during the hearing on the OSC nor now submits evidence that 
substantiates it. My April 21, 2021 Decision/Order, however, explains 
how violations that I found Petitioner had committed go to the heart of 
the CSA and its implementing regulations, and rejects her arguments 
that minimize applicable legal requirements. See, e.g., 86 FR at 19024. 
Accordingly, I do not find persuasive Petitioner's arguments that there 
is a substantial likelihood that she will prevail on the merits upon 
appellate review, and I reject them.
    Petitioner's irreparable injury arguments are predictions that she 
does not tether to existing or new record evidence. For example, as 
already discussed, Petitioner provides an address for herself in Las 
Vegas, Nevada in the pro se review petition she recently filed in the 
District of Columbia Circuit. Supra n.1. There is no record evidence, 
and she submitted no new evidence along with this or her Review 
Petition filing, that Petitioner is registered in Nevada or even that 
she is licensed to practice medicine in Nevada. Petitioner's 
irreparable injury arguments related to any future loss by her of 
earned income, therefore, are without a sufficient basis in record 
evidence. Accordingly, I reject them.
    Further, Petitioner's loss of earned income claims are of a generic 
nature that any practitioner whose registration had been revoked or 
suspended could make. Even if Petitioner had submitted record evidence 
substantiating these predictions, the CSA does not direct me to 
consider her loss of earned income or potential loss of earned income. 
Accordingly, I do not accept Petitioner's irreparable injury arguments.
    Nken makes clear that the ``first two factors of the traditional 
standard are the most critical.'' 556 U.S. at 434. It also explains 
that, if the applicant satisfies the first two factors, ``the 
traditional stay inquiry calls for assessing the harm to the opposing 
party and weighing the public interest.'' Id. at 435. Here, Petitioner 
has not satisfied either of the first two factors. Supreme Court case 
law makes clear that I need not address Petitioner's arguments 
regarding the third and fourth stay factors. Id. For the sake of having 
a complete record, however, I shall do so.
    Assuming, arguendo, the accuracy of Petitioner's arguments that she 
has never been accused of harming a person, and of her suggestion that 
the third factor addresses such harm, I find that the legal violations 
I sustained in my April 12, 2021 Decision/Order do not include harm to 
a person among their elements. Accordingly, I find Petitioner's third 
factor arguments to be irrelevant, and I reject them.
    Fourth, even if the record evidence substantiates Petitioner's 
public interest claims, which it does not, the Agency has rejected 
community impact arguments. See, e.g., Perry County Food & Drug, 80 FR 
70084 (2015). Accordingly, I reject Petitioner's public interest 
arguments.
    Having determined that Petitioner has not met her burden of showing 
that the circumstances justify an exercise of my discretion to stay 
enforcement of the sanction I ordered on April 12, 2021, pending 
appellate review, I deny her Motion to Stay.

    It is so ordered.

    Dated: May 11, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-11982 Filed 6-7-21; 8:45 am]
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