90 FR 87 pgs. 19310-19313 - Margaret Dennis, D.M.D.; Default Decision and Order
Type: NOTICEVolume: 90Number: 87Pages: 19310 - 19313
Pages: 19310, 19311, 19312, 19313FR document: [FR Doc. 2025-07934 Filed 5-6-25; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Margaret Dennis, D.M.D.; Default Decision and Order
I. Introduction
On October 31, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Margaret Dennis, D.M.D., of Jacksonville, FL (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Registrant of the immediate suspension of her DEA Certificate of Registration, No. BD1443732, pursuant to 21 U.S.C. 824(d), alleging that Registrant's continued registration constitutes "?`an imminent danger to the public health or safety.'?" Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposed the revocation of Registrant's registration, alleging that Registrant's continued registration is inconsistent with the public interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
The OSC/ISO alleged that between at least January of 2013 until at least July of 2024, Registrant issued numerous prescriptions for controlled substances to at least four patients despite, among other things: (1) failing to establish a proper medical justification for prescribing; (2) prescribing outside the scope of her practice; and (3) failing to appropriately address red flags of abuse or diversion. Id. The OSC/ISO alleged that Registrant's noted prescribing practices were in violation of the Controlled Substances Act's (CSA's) implementing regulations and Florida state law. Id. at 2-3. 1
Footnotes:
1 ?The Agency need not adjudicate the criminal violations alleged in the instant OSC/ISO. Ruan v. United States, 597 U.S. 450 (2022) (decided in the context of criminal proceedings).
The OSC/ISO notified Registrant of her right to file with DEA a written request for a hearing and an answer, and that if she failed to file such a request, she would be deemed to have waived her right to a hearing and be in default. RFAAX 1, at 7-8 (citing 21 CFR 1301.43). Here, Registrant did not request a hearing. RFAA, at 1. 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); see also RFAAX 1, at 8 (providing notice to Registrant).
Footnotes:
2 ?Based on the Government's submissions in its RFAA dated December 12, 2024, the Agency finds that service of the OSC/ISO on Registrant was adequate. According to the included Declaration from a DEA Diversion Investigator (DI), on November 1, 2024, after attempting to serve Registrant at Registrant's registered location, the DI "reached out [to Registrant's] counsel and confirmed representation of [Registrant] for purposes of any administrative proceedings." RFAAX 2, at 1. On the same date, following the confirmation of representation, the DI emailed Registrant's counsel a copy of the OSC/ISO and copied Registrant on the email. Id. Here, the Agency finds that Registrant was successfully served the OSC/ISO by email and that the DI's efforts to serve Registrant by other means were "?`reasonably calculated, under all the circumstances, to apprise [Registrant] of the pendency of the action.'?" Jones v. Flowers, 547 U.S. 220, 226 (2006) (quoting Mullane v. Central Hanover Bank & Trust Co., 339 U.S. 306, 314 (1950)); see also Mohammed S. Aljanaby, M.D., 82 FR 34552, 34552 (2017) (finding that service by email satisfies due process where the email is not returned as undeliverable and other methods have been unsuccessful).
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]?1316.67." Id. §?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.
II. Applicable Law
[top] As the Supreme Court stated in Gonzales v. Raich, "the main objectives
Here, the OSC/ISO's allegations concern the CSA's "strict requirements regarding registration . . . and recordkeeping" and, therefore, go to the heart of the CSA's "closed regulatory system" specifically designed "to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances." Id.
A. Improper Prescribing (21 CFR 1306.04(a); Fla. Stat. Secs. 456.44, 466.028; Fla. Admin. Code Ann. r. 64B8-9.003)
The OSC/ISO alleges that for over ten years, Registrant "issued multiple controlled substance prescriptions to patients without undertaking actions typical of medical professionals, such as conducting and documenting a complete medical history, properly assessing the needs of individuals for controlled substances, and monitoring patient medication compliance." RFAAX 1, at 4. According to CSA regulations, a prescription for a controlled substance is proper only if "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 CFR 1306.04(a).
Moreover, Florida law requires a practitioner to, among other things: (1) prescribe controlled substances only after conducting a complete medical history and physical examination; (2) document the presence of one or more recognized medical indications for the use of a controlled substance; (3) create a written treatment plan with goals and objectives; (4) discuss the risks and benefits of the use of controlled substances with the patient; (5) see the patient at regular intervals and conduct periodic reviews of the effectiveness of the treatment; (6) assess patient risk for aberrant drug-related behavior, continue to monitor that risk on an ongoing basis, and provided special attention to patients at risk for abusing their medication; and (7) maintain accurate, current, and complete records that are accessible and readily available for review. Fla. Stat. sec. 456.44.
Florida law also provides a list of acts that constitute grounds for disciplinary action against dentists and other dental practitioners, including, among others: "(p) [p]rescribing . . . any controlled substance, other than in the course of the professional practice of the dentist . . . without regard to his or her intent"; "(r) [p]rescribing, procuring, ordering, dispensing, administering, supplying, selling, or giving any drug which is a Schedule II amphetamine . . . "; "(x) [b]eing guilty of incompetence or negligence by . . . the undertaking of diagnosis and treatment for which the dentist is not qualified by training or experience . . . "; and "(y) [p]racticing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities which the licensee knows or has reason to know that she or he is not competent to perform." Id. sec. 466.028.
Finally, Florida law requires that medical records, among other things, must have "sufficient detail to clearly demonstrate why the course of treatment was undertaken" and must "contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately." Fla. Admin. Code Ann. R. 64B8-9.003.
III. Findings of Fact
The Agency finds that, in light of Registrant's default, the factual allegations in the OSC/ISO are deemed admitted.
A. Prescribing to D.B.
Registrant admits that between June 1, 2021, and July 1, 2024, Registrant issued to D.B. prescriptions for controlled substances including dextroamphetamine-amphetamine (a Schedule II stimulant), hydromorphone (a Schedule II opioid), and alprazolam (a Schedule IV benzodiazepine). RFAAX 1, at 4. Registrant admits that she failed to establish a proper medical justification for prescribing dextroamphetamine-amphetamine to D.B., specifically, because Registrant issued the prescriptions without any diagnostic workup, rationale, or treatment plan. Id. Additionally, Registrant admits that under Florida prescribing regulations, Registrant's prescribing of dextroamphetamine-amphetamine was outside the scope of dental practice and facial pain management. Id.
Registrant admits that she prescribed D.B. increasingly high daily dosages of hydromorphone, as high as 237 MME, without proper medical indication, rationale, or evidence of improvement in pain and function. Id. Registrant further admits that she failed to document justification for prescribing opioids and benzodiazepines concurrently. Id. Finally, Registrant admits that Registrant failed to properly monitor D.B.'s medication compliance and failed to appropriately address red flags of abuse or diversion that D.B. presented. 3 Id.
Footnotes:
3 ?For example, D.B. has a history of prior management with Suboxone, but Registrant issued the controlled substance prescriptions to D.B. without any diagnostic workup pertaining to chemical dependency or substance abuse and without performing any toxicology screening. Id.
Registrant admits and the Agency finds substantial record evidence that the above-referenced controlled substance prescriptions issued to D.B. were issued outside the usual course of professional practice and not for a legitimate medical purpose. Id. at 4-5. The Agency further finds substantial record evidence that the prescribing of amphetamine-dextroamphetamine to D.B. was outside the scope of Registrant's practice.
B. Prescribing to D.G.
Registrant admits that between December 9, 2019, and January 13, 2022, Registrant issued to D.G. prescriptions for controlled substances including oxycodone (a Schedule II opioid), morphine (a Schedule II opioid), and alprazolam. Id. at 5. Registrant admits that she failed to establish a proper medical justification for prescribing benzodiazepines to D.G., specifically, because Registrant issued the prescriptions with no pertinent medical workup. Id.
Registrant admits that she failed to maintain adequate medical records for her treatment of D.G.; specifically, seven years of medical charts were missing from D.G.'s records. Id. Registrant also admits that Registrant failed to document justification for prescribing opioids and benzodiazepines concurrently. Id. Finally, Registrant admits that Registrant failed to properly monitor D.G.'s medication compliance and failed to appropriately address red flags of abuse or diversion that D.G. presented. 4 Id.
Footnotes:
4 ?For example, Registrant admits that she failed to address D.G.'s history of substance abuse and chemical dependency diagnosis, such as by performing toxicology screening. Id. Registrant also admits that Registrant did not attempt to obtain medical records pertaining to D.G.'s chemical dependency diagnosis or inpatient treatment. Id.
[top] Registrant admits and the Agency finds substantial record evidence that the above-referenced controlled substance prescriptions issued to D.G. were issued outside the usual course of
C. Prescribing to M.G.
Registrant is deemed to have admitted that between October 11, 2018, and February 22, 2019, Registrant issued to M.G. prescriptions for controlled substances including oxycodone, tramadol (a Schedule IV opioid), morphine sulfate (a Schedule II opioid), methadone (a Schedule II opioid), and carisoprodol (a Schedule IV muscle relaxant). Id.
Registrant also admits that she prescribed M.G. increasingly high daily dosages of multiple controlled substances without rationale supporting the medical necessity or evidence of improvement in pain and function. Id. Specifically, Registrant admits that Registrant prescribed Patient M.G. oxycodone, tramadol, morphine sulfate, methadone, and carisoprodol on multiple occasions, increasing Patient M.G.'s daily dosage from 45 MME to 270 MME without supporting medical necessity. Id. Finally, Registrant admits that she failed to properly monitor Patient M.G.'s medication compliance. 5 Id. at 5.
Footnotes:
5 ?For example, Registrant admits that she did not pursue a chemical dependency diagnosis inquiry, did not discuss potential substance abuse issues with M.G., and did not perform any toxicology screening. Id. at 6.
Registrant admits and the Agency finds substantial record evidence that the above-referenced controlled substance prescriptions issued to M.G. were issued outside the usual course of professional practice and not for a legitimate medical purpose. Id. at 6.
D. Prescribing to I.R.
Registrant is deemed to have admitted that between December 19, 2019, and June 13, 2024, Registrant issued to I.R. prescriptions for controlled substances including oxycodone, methadone, diazepam (a Schedule IV benzodiazepine), and alprazolam. Id. Further, Registrant admits that over a four-day period between August and September 2021, Registrant prescribed multiple high dosage controlled substances to I.R. with a MME as high as 1,935. Id. These prescriptions were issued without proper medical justification and with no evidence of improvement in pain and function. Id.
Registrant also admits that she failed to maintain adequate medical records for the treatment of I.R., specifically, by lacking the documentation that appropriately accounted for the initiation of controlled substance prescriptions and their subsequent dosage increases over the years. Id. Moreover, Registrant admits that she failed to request pertinent and recent medical records regarding treatment I.R. disclosed that he/she received elsewhere. Id.
Registrant admits that she failed to document justification for prescribing opioids and benzodiazepines concurrently. Id. Finally, Registrant admits that she failed to properly monitor I.R.'s medication compliance and failed to appropriately address red flags of abuse or diversion that I.R. presented. 6 Id.
Footnotes:
6 ?Specifically, Registrant admits that she prescribed controlled substances, and increased the dosages at I.R.'s request, without performing or entertaining toxicology screening. Id. Registrant admits that this occurred despite numerous and repeated red flags, including, but not limited to: I.R. obtaining narcotics from "?`other sources'?"; "?`an increased use of Valium'?"; an admission from I.R. that I.R. "?`used to search out moms' meds'?"; I.R.'s "?`doub[ling] up [controlled substances] to have a good day'?"; a report of suicidal gesturing; admitted cocaine use; and other "inconsistent and alarming patient statements." Id.
Registrant admits and the Agency finds substantial record evidence that the above-referenced controlled substance prescriptions issued to I.R. were issued outside the usual course of professional practice and not for a legitimate medical purpose. Id. at 6.
E. Expert Review
DEA retained an independent medical expert to review, among other materials, information regarding all of the above-noted controlled substance prescriptions as well as Registrant's patient files for D.B., D.G., M.G., and I.R. Id. at 7. DEA's medical expert concluded that all of the above-noted controlled substance prescriptions violated minimal medical standards applicable to Registrant's practice of medicine in Florida. Id. Further, DEA's medical expert concluded that Registrant's misconduct put D.B., D.G., M.G., and I.R. at risk for abuse, addiction, overdose, and death. Id.
IV. Discussion
A. The Controlled Substances Act's Public Interest Factors
Pursuant to 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 . . . has committed such acts as would render his registration under . . . [21 U.S.C. 823] inconsistent with the public interest as determined by such section." 21 U.S.C. 824(a)(4). In the case of a "practitioner," Congress directed the Attorney General to consider five factors in making the public interest determination. 21 U.S.C. 823(g)(1)(A-E). 7
Footnotes:
7 ?The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(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.
The five factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J., dissenting) ("It is well established that these factors are to be considered in the disjunctive," citing In re Arora, 60 FR 4447, 4448 (1995)); 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. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H. Gillis, M.D., 58 FR 37507, 37508 (1993).
According to Agency decisions, the Agency "may rely on any one or a combination of factors and may give each factor the weight [it] deems 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).
[top] Moreover, while the Agency is required to consider each of the factors, it "need not make explicit findings as to each one." MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also 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 the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have been considered, the Agency finds that the Government's evidence in support of its prima facie public interest revocation case regarding Registrant's violations of the CSA's implementing regulations is confined to Factors B and D. RFAAX 1, at 4. Moreover, the Government has the burden of proof in this proceeding. 5 U.S.C.A. 556(d); 21 CFR 1301.44.
B. Factors B and/or D-Registrant's Registration Is Inconsistent With the Public Interest
Evidence is considered under Public Interest Factors B and D when it reflects compliance or non-compliance with federal and local laws related to controlled substances and experience dispensing controlled substances. 21 U.S.C. 823(g)(1)(B) and (D); see also Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022). Here, as the Agency finds above, Registrant is deemed to admit and the Agency finds that for over ten years, Registrant issued numerous prescriptions for controlled substances to at least four patients without, among other things, having proper medical justification, resolving red flags of abuse or diversion, or maintaining proper medical records. Supra Section III. The Agency further finds that each of the above-reference prescriptions were outside the usual course of professional practice and not for a legitimate medical purpose. Supra Section III; see also RFAAX 1, at 4-7. The Agency further finds substantial record evidence that the prescribing of amphetamine-dextroamphetamine to D.B. was outside the scope of Registrant's practice. Supra Section III.A.
As such, the Agency finds substantial record evidence that the Registrant violated 21 CFR 1306.04(a), Fla. Stat. secs. 456.44, 466.028, and Fla. Admin. Code Ann. r. 64B8-9.003. After weighing Factors B and D, the Agency further finds that Registrant's continued registration is outside the public interest. 21 U.S.C. 823(g)(1). Accordingly, the Agency finds that the Government established a prima facie case, that Registrant did not rebut that prima facie case, and that there is substantial record evidence supporting the revocation of Registrant's registration. 21 U.S.C. 823(g)(1).
V. Sanction
Here, the Government has met its prima facie burden of showing that Registrant's continued registration is inconsistent with the public interest due to her numerous violations pertaining to her controlled substance prescribing. Accordingly, the burden shifts to Registrant to show why she can be entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882, 18904 (2018); supra sections III and IV.
The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual registrant. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is the best predictor of future performance, DEA Administrators have required that a registrant who has committed acts inconsistent with the public interest must accept responsibility for those acts and demonstrate that he will not engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). A registrant's acceptance of responsibility must be unequivocal. Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's candor during the investigation and hearing has been an important factor in determining acceptance of responsibility and the appropriate sanction. Id. Further, the Agency has found that the egregiousness and extent of the misconduct are significant factors in determining the appropriate sanction. Id. at 834 & n.4. The Agency has also considered the need to deter similar acts by the registrant and by the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, Registrant did not request a hearing and did not otherwise avail herself of the opportunity to refute the Government's case. As such, there is no record evidence that Registrant takes responsibility, let alone unequivocal responsibility, for the founded violations, meaning, among other things, that it is not reasonable to believe that Registrant's future controlled substance-related actions will comply with legal requirements. Accordingly, Registrant did not convince the Agency that she can be entrusted with a registration.
Further, the interests of specific and general deterrence weigh in favor of revocation. Given the foundational nature of Registrant's violations, a sanction less than revocation would send a message to the existing and prospective registrant community that compliance with the law is not a condition precedent to maintaining a registration.
In sum, Registrant has not offered any evidence on the record that rebuts the Government's case for revocation of her registration, and Registrant has not demonstrated that she can be entrusted with the responsibility of registration. Accordingly, the Agency will order the revocation of Respondent's registration.
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(g)(1), I hereby revoke DEA Certificate of Registration No. BD1443732 issued to Margaret Dennis, D.M.D. Further, 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(g)(1), I hereby deny any pending applications of Margaret Dennis, D.M.D., to renew or modify this registration, as well as any other pending application of Margaret Dennis, D.M.D., for additional registration in Florida. This Order is effective June 6, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on May 1, 2025, by Acting Administrator Derek Maltz. 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. 2025-07934 Filed 5-6-25; 8:45 am]
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