Judge Rotenberg Educational Center, Inc. v. FDA

The Judge Rotenberg Educational Center (the center) (plaintiff) was a Massachusetts treatment facility for patients with severe mental disabilities, including conditions that manifested through aggressive and potentially severe self-harming behaviors. The center was the only facility in the United States that used electric-shock therapy to treat patients who exhibited the self-injurious or aggressive behaviors. The center manufactured its own electrical-stimulation devices for use in electric-shock treatments. Before the center could administer electric-shock treatment, Massachusetts required peer review of the treatment decision, certification from multiple healthcare practitioners that the treatment was not contraindicated and that no other treatments would be effective, ratification by a human-rights committee, and approval by a state court. The Food and Drug Administration (FDA) (defendant) regulated aversive conditioning devices, including electrical-stimulation devices, as Class II devices under the federal Food, Drug, and Cosmetic Act (FDCA). Class II devices included medical devices that the FDA considered reasonably safe and effective when subject to certain conditions. In 2020, the FDA promulgated a rule banning electrical-stimulation devices for the treatment of self-injurious or aggressive behavior. The FDA justified the rule by pointing to evidence that treatment with the devices harmed patients and a lack of conclusive evidence that the devices effectively reduced self-injurious or aggressive behavior in the long term. The center challenged the FDA’s rule in the United States Court of Appeals for the D.C. Circuit.