In The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration, the U.S. Court of Appeals for the D.C. Circuit overturned a 2020 Food and Drug Administration (“FDA”) rule banning the use of electrical stimulation devices to treat patients suffering from severe self-injurious and aggressive behaviors. The court concluded the FDA did not have the legal authority to ban the particular use of an approved device.

The appeal was sought by The Judge Rotenberg Educational Center (“Center”) and the parents and guardians of its patients, arguing that the FDA lacked the authority to ban the use of approved medical devices for a particular purpose. Prior to the FDA’s ban, the Center used FDA-approved electrical stimulation devices to treat patients suffering from severe mental disabilities who did not respond to conventional behavioral and pharmacological practices. These patients exhibited self-injurious behaviors such as self-biting and head-banging extreme enough to cause self-inflicted brain trauma, broken and protruding bones and blindness. The Center was subject to extensive regulation, including federal regulations for Class II devices and state regulations requiring certification by multiple providers and ratification by peer review and human rights committees. While the Center was the only facility in the U.S. to use electric shock therapy to treat individuals suffering from severe self-injurious and aggressive behaviors, other health care practitioners used the devices to treat a variety of other conditions, such as tobacco, alcohol, drug addictions and inappropriate sexual behaviors following traumatic brain injuries. Based on evidence from medical literature and program data, the FDA concluded that electrical stimulation devices present a substantial and unreasonable risk to self-injurious patients.

The court considered two statutes from the Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 360f and 21 U.S.C. § 396. While § 360f authorizes the FDA to ban medical devices, § 396 denies the agency the authority to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” Finding that the statutes are unambiguous, the court concluded that, subject to state regulation, “Section 396 protects the liberty of doctors and patients to use approved devices in any manner they wish,” reasoning that a use-specific ban both limits and interferes with a practitioner’s authority by restricting the use of approved devices. The court also noted that the Tenth Amendment of the U.S. Constitution reserves powers not delegated to the federal government for the states, and that the states have traditionally regulated the practice of medicine. The FDA would need a clear grant of authority to enact use-specific bans, and, far from granting such authority, the Act explicitly withheld it. The court accordingly vacated the rule.

Practical Takeaways

While the FDA may place an outright ban on a medical device pursuant to 21 U.S.C. § 360f of the Act, the D.C. Circuit has determined that the agency lacks authority to ban a particular use of an approved medical device.

This case is likely to serve as important precedent in resolving future disagreements about the practice of medicine between health care entities and regulating agencies—especially federal agencies.