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Source and Scope of Public Health Legal Powers

The Judge Rotenberg Educational Center, Inc. v. U.S. Food & Drug Administration

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Overview

The Judge Rotenberg Educational Center, Inc. v. U.S. Food & Drug Administration (U.S. Court of Appeals, D.C. Circuit, July 6, 2021): The U.S. Court of Appeals, D.C. Circuit, vacated FDA’s rule prohibiting the use of electric shock harnesses as a behavioral deterrent for patients exhibiting aggressive or self-injuring behavior. FDA approved the harnesses as medical devices, but in a regulation finalized in 2020, banned the use of these devices for aggressive or self-injuring behavior. The petitioner is the only facility in the country that uses these devices for treating aggressive or self-injuring behavior; they are more widely used to treat tobacco, alcohol, and drug addiction.  While FDA had the legal authority to ban medical devices, it could not ban them for select uses. The court reasoned that 21 U.S.C. § 396 prohibits FDA from regulating the practice of medicine, and that banning for select uses contravenes this prohibition. Federalism concerns also arose because the regulation of medicine traditionally falls within the states’ purview. Consequently, the court vacated the regulations. Read the decision here.

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