[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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