The Judge Rotenberg Educational Center, Inc. v. FDA, 3f4th390

Judge Rotenberg Educational Center (JRC) used a graduated electronic decelerator (electrical shock device) to treat severe self-injurious and aggressive behavior in patients with developmental disabilities; JRC is the only U.S. facility still using the therapy.
The FDA, after reviewing safety and efficacy evidence, promulgated a 2020 rule banning electrical stimulation devices when used to treat self-injurious or aggressive behavior, but permitting other uses (e.g., addiction treatment).
The FDA classified such aversive-conditioning devices as Class II and relied on evidence of physical and psychological risks plus weak long-term efficacy for the targeted use to justify a use-specific ban.
Petitioners (JRC and parents/guardians) challenged the Rule, arguing the FDA lacked statutory authority to ban a device for a particular intended use because that would impermissibly regulate the practice of medicine.
The court framed the controlling question around two statutes: 21 U.S.C. § 360f (FDA banning authority) and 21 U.S.C. § 396 (prohibiting construction of the chapter so as to limit or interfere with a practitioner’s authority to prescribe or administer any legally marketed device).
The D.C. Circuit majority held that § 396 prohibits the FDA from banning a device for a particular use and vacated the FDA’s use-specific ban; the dissent would have sustained the FDA under Chevron deference.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether FDA may ban an otherwise legal device for a particular intended use	§ 396 forbids the FDA from limiting or interfering with a practitioner’s authority to prescribe or administer any "legally marketed device"; a use-specific ban interferes with off-label practice and state regulation of medicine	§ 396 only protects devices that remain legally marketed for the particular use; banning a device for a particular use simply removes lawful marketing for that use and does not conflict with § 396; FDA can regulate based on intended use	Majority: § 396 unambiguously bars the FDA from issuing a use-specific ban because it limits/interferes with practitioners’ ability to use legally marketed devices; vacated the Rule; Dissent: FDA’s reading is permissible under Chevron and a tailored ban is lawful

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (discusses FDA regulation and recognizes off-label use as within physician discretion)
Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984) (framework for judicial deference to agency statutory interpretations)
Gonzales v. Oregon, 546 U.S. 243 (2006) (federal executive cannot intrude on state-regulated medical practice absent clear congressional authorization)
Will v. Michigan Dep’t of State Police, 491 U.S. 58 (1989) (clear-statement principle when federal law affects state-federal balance)
N.C. State Bd. of Dental Exam’rs v. FTC, 574 U.S. 494 (2015) (limits on state action and regulatory authority in certain contexts)
Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519 (2012) (constraints on federal power and federalism considerations)
Am. Bar Ass’n v. FTC, 430 F.3d 457 (D.C. Cir. 2005) (agency may not regulate the practice of law absent clear congressional authorization)
Catawba Cnty. v. EPA, 571 F.3d 20 (D.C. Cir. 2009) (discusses Chevron step-one inquiry and statutory ambiguity)
Marbury v. Madison, 5 U.S. (1 Cranch) 137 (1803) (foundational principle limits of government power)