[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84613-84615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 84615]]

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]
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