## Facts

- The Judge Rotenberg Educational Center, Inc. (JRC) operated a Massachusetts residential facility treating individuals with severe intellectual and developmental disabilities, including patients with extreme self-injurious or aggressive behavior.
- JRC used an electrical stimulation device (ESD), the Graduated Electronic Decelerator (GED), which delivers brief electric shocks through skin electrodes to deter such behaviors.
- Massachusetts law imposed extensive procedural safeguards for this treatment, including medical certifications, committee review, and state-court approval.
- The FDA regulates ESDs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA) and had treated certain ESDs as legally marketed devices.
- In March 2020, after rulemaking, the FDA issued a final rule banning ESDs only for the indication of treating self-injurious or aggressive behavior, while leaving the devices lawful for other uses.
- The FDA found that, for that indication, ESDs presented an unreasonable and substantial risk of illness or injury and that labeling changes would not adequately mitigate the risks.
- JRC and certain parents/guardians petitioned for review in the D.C. Circuit.

## Issues

1. Whether FDCA § 396 (the “practice of medicine” provision) bars the FDA from using FDCA § 360f to ban only a particular use of a device that remains “legally marketed” for other uses.
2. Whether the FDA’s risk-benefit findings supporting the ban were arbitrary and capricious (not reached if the agency lacked statutory authority).

## Decision

- The court granted the petitions for review and vacated the FDA’s final rule.
- The court held the FDA exceeded its statutory authority by imposing a use-specific ban that limited or interfered with physicians’ authority to prescribe or administer a legally marketed device.
- Because the rule was invalid on statutory-authority grounds, the court did not address the arbitrary-and-capricious challenges.
- Chief Judge Srinivasan dissented, concluding the FDA could impose a use-specific ban under § 360f and that § 396 did not prevent it.

## Legal Principles

- FDCA § 396 restricts the FDA from limiting or interfering with a health care practitioner’s authority to prescribe or administer any legally marketed device to a patient for any condition or disease.
- When a device remains legally marketed for at least some uses, a use-specific prohibition on prescribing/administering that device for a particular condition constitutes impermissible interference with medical practice under § 396.
- FDCA § 360f authorizes banning devices that pose an unreasonable and substantial risk, but (under the majority’s reading) that authority does not extend to banning only a subset of uses while the device remains legally marketed for other uses.
- Courts may vacate an agency rule without reaching record-based challenges when the rule fails for lack of statutory authority.

## Conclusion

The D.C. Circuit vacated the FDA’s rule banning electrical stimulation devices only for treating self-injurious or aggressive behavior, holding that a use-specific ban on an otherwise legally marketed device unlawfully interfered with physician authority protected by FDCA § 396.


Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 2021)