Notice2024-24575
David Carlos Rodriguez, M.D.; Decision and Order
Primary source
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Published
October 23, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 89 Issue 205 (Wednesday, October 23, 2024)</title>
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[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84613-84615]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24575]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
David Carlos Rodriguez, M.D.; Decision and Order
On September 11, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to David Carlos
Rodriguez, M.D. (Registrant), of Lake City, South Carolina. Request for
Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 7. The OSC
proposed the revocation of Registrant's DEA Certificate of Registration
(registration) No. BR6910803, alleging that Registrant has committed
such acts as would render his registration inconsistent with the public
interest. Id. at 3 (citing 21 U.S.C. 823(g)(1), 824(a)(4)).\1\
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\1\ According to Agency records, Registrant's registration
expired on April 30, 2024. The fact that a registrant allows his
registration to expire during the pendency of an OSC does not impact
the Agency's jurisdiction or prerogative under the Controlled
Substances Act (CSA) to adjudicate the OSC to finality. Jeffrey D.
Olsen, M.D., 84 FR 68,474, 68,476-68,479 (2019).
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The OSC notified Registrant of his right to file with DEA a written
request for hearing, and that if he failed to file such a request, he
would be deemed to have waived his right to a hearing and be in
default. Id. at 5-6 (citing 21 CFR 1301.43). Here, Registrant did not
request a hearing. RFAA, at 2.\2\ ``A default, unless excused, shall be
deemed to constitute a waiver of the registrant's/applicant's right to
a hearing and an admission of the factual allegations of the [OSC].''
21 CFR 1301.43(e).
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\2\ Based on the Government's submissions in its RFAA dated
December 5, 2023, the Agency finds that service of the OSC on
Registrant was adequate. Specifically, the RFAA indicates that on
October 16, 2023, Registrant was personally served with the OSC by a
DEA Diversion Investigator. RFAA, at 1; RFAAX 2.
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Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' Id. Sec. 1301.43(f)(1). Here,
the Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 1; see
also 21 CFR 1316.67.
I. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are admitted.\3\ Registrant is deemed to
have admitted and the Agency finds that from at least January 2018
through at least January 2019, Registrant issued multiple controlled
substance prescriptions to five patients that lacked a legitimate
medical purpose and were issued outside the usual course of
professional practice. RFAAX 1, at 3, 5.
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\3\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC. Ruan v. United States, 142 S. Ct. 2,370
(2022) (decided in the context of criminal proceedings).
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A. Prescribing to C.R.
Registrant is deemed to have admitted that between May 2018 and
December 2018, on approximately a monthly basis, Registrant issued
prescriptions for various quantities of oxycodone 30 mg (a Schedule II
opioid) to C.R. RFAAX 1, at 3. Registrant issued these controlled
substance prescriptions without conducting an appropriate evaluation,
without making a proper diagnosis, without providing a therapeutic
plan, and without discussing the risks, benefits, and treatment options
with the patient. Id. Further, during several of C.R.'s visits to
Registrant's office, Registrant engaged in sexual conduct with C.R.
prior to issuing C.R. the prescriptions. Id.
B. Prescribing to K.D.
Registrant is deemed to have admitted that between January 2018 and
December 2018, on an approximately monthly basis, Registrant issued
prescriptions for various quantities of alprazolam 2 mg (a Schedule IV
benzodiazepine), zolpidem tartrate 10 mg (a Schedule IV sedative), and
dextroamphetamine-amphetamine 20 mg (a Schedule II stimulant) to K.D.
Id. at 4. Registrant issued these controlled substance prescriptions
without conducting an appropriate evaluation, without making a proper
diagnosis, without providing a therapeutic plan, and without discussing
the risks, benefits, and treatment options with the patient. Id.
C. Prescribing to R.R.
Registrant is deemed to have admitted that between October 2018 and
December 2018, on an approximately monthly basis, Registrant issued
prescriptions for various quantities of alprazolam 0.5 mg and
acetaminophen-hydrocodone 325/10 mg (a Schedule II opioid) to R.R. Id.
Again, Registrant issued these controlled substance prescriptions
without conducting an appropriate evaluation, without making a proper
diagnosis, without providing a therapeutic plan, and without discussing
the risks, benefits, and treatment options with the patient. Id. On
several of these occasions, Registrant prescribed opioids with a
benzodiazepine, which Registrant is deemed to have admitted is a drug
cocktail that is associated with diversion, without adequately
documenting his reasoning for issuing
[[Page 84614]]
prescriptions for an opioid and benzodiazepine.\4\ Id. at 4.
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\4\ The OSC also alleges that Registrant's combined prescribing
of an opioid and a benzodiazepine ``disregarded the Centers for
Disease Control and Prevention (CDC) guidance to `use particular
caution when prescribing opioid pain medication and benzodiazepines
concurrently.' '' Id. (citing CDC Guidelines for Prescribing Opioids
for Chronic Pain, 71 Morbidity and Mortality Weekly Report, 3, 16
(2022)). The Summary for the CDC Guidance carefully states that its
``[r]ecommendations should not be applied as inflexible standards of
care across patient populations.'' CDC Guidelines for Prescribing
Opioids for Chronic Pain, at 1. Accordingly, the Agency's decision
relies not on the CDC Guidelines, but on the Government's Expert,
who opined that Registrant had ``numerous deviations from the
standard of care.'' RFAAX 1, at 5.
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D. Prescribing to T.F.
Registrant is deemed to have admitted that between April 2018 and
November 2018, on an approximately monthly basis, Registrant issued
prescriptions for various quantities of oxycodone 10 mg, oxycodone 15
mg, and alprazolam 1 mg to T.F. Id. Registrant also issued a
prescription for testosterone 200 mg (a Schedule III steroid) to T.F.
Id. Registrant issued these controlled substance prescriptions without
conducting an appropriate evaluation, without making a proper
diagnosis, without providing a therapeutic plan, and without discussing
the risks, benefits, and treatment options with the patient. Id.
Registrant admits that he increased the oxycodone dosage from 10 mg to
15 mg without medical justification. Id. As with R.R., on several of
these occasions, Registrant prescribed opioids with a benzodiazepine to
T.F. without adequately documenting his reasoning. Id. at 4-5.
E. Prescribing to B.P.
Between March 2018 and December 2018, on an approximately monthly
basis, Registrant issued prescriptions for various quantities of
acetaminophen-oxycodone 325/10 mg (a Schedule II opioid),
lisdexamfetamine 30 mg (a Schedule II stimulant), and lisdexamfetamine
40 mg to Patient B.P. Id. at 5. Registrant issued these controlled
substance prescriptions without conducting an appropriate evaluation,
without making a proper diagnosis, without providing a therapeutic
plan, and without discussing the risks, benefits, and treatment options
with the patient. Id. Furthermore, Registrant admits that he increased
the lisdexamfetamine dosage from 30 mg to 40 mg without medical
justification. Id.
F. Inadequate and Fraudulent Patient Records
In addition to his improper prescribing detailed above, Registrant
is deemed to have admitted that on December 11, 2018, in response to a
subpoena, his office represented to the South Carolina Department of
Labor, Licensing and Regulation Office of Investigations and
Enforcement that his office had no documentation for patients C.R,
K.D., R.R., T.F., and B.P. Id. Registrant is also deemed to have
admitted that on August 15, 2019, pursuant to a search and seizure
warrant from the South Carolina Department of Health and Environmental
Control, his office provided fraudulent and doctored patient records.
Id.
G. The Government's Expert
According to the OSC, DEA retained an independent medical expert to
review information regarding all of the controlled substance
prescriptions detailed above, as well as Registrant's patient files for
Patients C.R., K.D., R.R., T.F., and B.P. Id. Based on Registrant's
numerous deviations from the standard of care, the medical expert
concluded, and Registrant is deemed to have admitted, that the
prescriptions were not issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice. Id. Accordingly, Registrant is deemed to have admitted and
the Agency finds that the above-listed controlled substance
prescriptions were issued beneath the standard of care. Id.
II. Discussion
A. The Five Public Interest Factors
Under the CSA, ``[a] registration . . . to . . . dispense a
controlled substance . . . may be suspended or revoked by the Attorney
General 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 under such
section.'' 21 U.S.C. 824(a). In making the public interest
determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(B) The [registrant]'s experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant]'s conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The Agency considers these public interest factors in the
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin.,
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993).
While the Agency has considered all of the public interest factors
in 21 U.S.C. 823(g)(1),\5\ the Government's evidence in support of its
prima facie case for revocation of Registrant's registration is
confined to Factors B and D. See RFAAX 1, at 3. Moreover, the
Government has the burden of proof in this proceeding. 21 CFR 1301.44.
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\5\ As to Factor A, the record contains no evidence of a
recommendation from any state licensing board or professional
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an
absence of such evidence ``does not weigh for or against a
determination as to whether continuation of the [registrant's] DEA
certification is consistent with the public interest.'' Roni
Dreszer, M.D., 76 FR 19434, 19444 (2011). As to Factor C, there is
no evidence in the record that Registrant has been convicted of an
offense under either federal or state law ``relating to the
manufacture, distribution, or dispensing of controlled substances.''
21 U.S.C. 823(g)(1)(C). Agency cases have found that ``the absence
of such a conviction is of considerably less consequence in the
public interest inquiry'' and is therefore not dispositive. Dewey C.
MacKay, M.D., 75 FR 49956, 49973 (2010). Finally, as to Factor E,
the Government's evidence fits squarely within the parameters of
Factors B and D and does not raise ``other conduct which may
threaten the public health and safety.'' 21 U.S.C. 823(g)(1)(E).
Accordingly, Factor E does not weigh for or against Registrant.
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Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that Registrant's continued registration
would be ``inconsistent with the public interest.'' 21 U.S.C.
824(a)(4).
B. Factors B and D
Evidence is considered under Public Interest Factors B and D when
it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21156, 21162 (2022). In the current matter, the Government has
alleged that Registrant violated both federal and state law regulating
controlled substances. RFAAX 1, at 1-3. Specifically, under federal
regulations, a prescription for a controlled substance is valid only if
``issued for a legitimate medical purpose
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by an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a).
As for South Carolina state law, grounds for disciplinary action
against a physician include when the physician has: ``engaged in
dishonorable, unethical, or unprofessional conduct that is likely
either to deceive, defraud, or harm the public''; ``violated the code
of medical ethics adopted by the [State Board of Medical Examiners] or
has been found by the [State Board of Medical Examiners] to lack the
ethical or professional competence to practice''; ``failed to prepare
or maintain an adequate patient record of care provided''; ``engaged in
behavior that exploits the physician-patient relationship in a sexual
way''; and ``improperly managed medical records, including failure to
maintain timely, legible, accurate, and complete medical records.''
S.C. Code Ann. Sec. 40-47-110.
Further, South Carolina regulations require that prior to
prescribing to a patient, a physician must establish a proper
physician-patient relationship, which entails that the physician ``make
an informed medical judgment based on the circumstances of the
situation and on the [physician's] training and experience'';
``personally perform and document an appropriate history and physical
examination, make a diagnosis, and formulate a therapeutic plan'';
``discuss with the patient the diagnosis and the evidence for it, and
the risks and benefits of various treatment options''; and ``ensure the
availability of the [physician] or coverage for the patient for
appropriate follow-up care.'' Id. Sec. 40-47-113(A).\6\
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\6\ South Carolina Code of Regulations Sec. 81-60, entitled
Principles of Medical Ethics, states in subsection A that ``a
physician shall be dedicated to providing competent medical service
with compassion and respect for human dignity.''
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Here, consistent with Registrant's admissions, the Agency finds
that Registrant repeatedly issued prescriptions for controlled
substances without conducting an appropriate evaluation, without making
a proper diagnosis, without providing a therapeutic plan, and without
discussing the risks, benefits and treatment options with his patients.
RFAAX 1, at 3-5. Registrant has also admitted and the Agency finds that
Registrant: engaged in sexual conduct with a patient prior to issuing
the patient prescriptions for controlled substances; issued a cocktail
prescription of opioids and a benzodiazepine to multiple patients on
multiple occasions while failing to document his reasoning for so
doing; and increased the dosages of controlled substance prescriptions
for multiple patients without medical justification for so doing. Id.
Based on Registrant's numerous deviations from the standard of care,
DEA's medical expert concluded, and the Agency finds, that these
prescriptions were not issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice. Id. at 5. Registrant has further admitted that he failed to
provide adequate patient records to one group of state officials, then
provided fraudulent patient records to another group of state
officials. Id. As such, the Agency finds that Registrant violated 21
CFR 1306.04(a) and South Carolina Code Sec. Sec. 40-47-110 and 40-47-
113.
Accordingly, the Agency finds that Factors B and D weigh in favor
of revocation of Registrant's registration and thus finds Registrant's
continued registration to be inconsistent with the public interest in
balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds
that Registrant failed to provide any evidence to rebut the
Government's prima facie case.
III. Sanction
Where, as here, the Government has established grounds for
revocation, the burden shifts to the registrant to show why he can be
entrusted with the responsibility carried by a registration. Garret
Howard Smith, M.D., 83 FR 18882, 18910 (2018). To establish that he can
be entrusted with registration, a registrant must both accept
responsibility and demonstrate that he has undertaken corrective
measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195, 77 FR
62316, 62339 (2012); see also Michele L. Martinho, M.D., 86 FR 24012,
24019 (2021); George D. Gowder, III, M.D., 89 FR 76152, 76154 (2024).
Trust is necessarily a fact-dependent determination based on individual
circumstances; therefore, the Agency looks at factors such as the
acceptance of responsibility, the credibility of that acceptance as it
relates to the probability of repeat violations or behavior, the nature
of the misconduct that forms the basis for sanction, and the Agency's
interest in deterring similar acts. See, e.g., Robert Wayne Locklear,
M.D., 86 FR 33738, 33746 (2021).
Here, Registrant failed to answer the allegations contained in the
OSC and did not otherwise avail himself of the opportunity to refute
the Government's case. As such, Registrant has made no representations
as to his future compliance with the CSA nor made any demonstration
that he can be entrusted with registration. Moreover, the evidence
presented by the Government shows that Registrant violated the CSA,
further indicating that Registrant cannot be entrusted.
Accordingly, the Agency will order the revocation of Registrant's
registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BR6910803 issued to David Carlos Rodriguez, M.D. Further, pursuant to
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1),
I hereby deny any pending applications of David Carlos Rodriguez, M.D.,
to renew or modify this registration, as well as any other pending
application of David Carlos Rodriguez, M.D., for additional
registration in South Carolina. This Order is effective November 22,
2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 15, 2024, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-24575 Filed 10-22-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on October 23, 2024.
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