Mid-Atlantic Health Law TOPICS

A divided federal appeals court recently overturned the ban by U.S. Food and Drug Administration (FDA) on the use of electric shock devices for the purpose of treating aggressive or self-injurious behaviors.

The Facts

The case arose from a 2020 FDA rule that banned electric shock devices when used to treat self-injurious or aggressive behaviors. The devices are used by health care practitioners in other contexts to treat addictions and other conditions; however, the FDA rule prohibited the devices from being used to treat aggressive or self-injurious behaviors, such as head banging and self-biting. 

The FDA justified the ban based on weak evidence of effectiveness when used to treat aggressive or self-injurious behaviors, as well as concerns over serious psychological and physical risks, including depression, fear, worsening of underlying symptoms, pain, burns and tissue damage. 

The Judge Rotenberg Educational Center, Inc. (Center), a nonprofit residential treatment center that treats people with severe mental disabilities, together with the parents and guardians of some of the patients, challenged the FDA rule. 

At the time, the Center was the only facility in the country that still used electric shock devices to treat individuals who injure themselves or who are aggressive. The Center argued that the electric shock devices were a “treatment of last resort, and its recipients are at risk of grievous bodily harm, or even death, without it.”

The Decision

In a 2-1 decision striking down the ban, the federal appeals court ruled that once the FDA approved the electric shock devices, it did not have the authority to limit health care practitioners’ use of the devices. 

The court recognized that the FDA has the authority to ban a medical device altogether, but it ruled that the FDA’s ban on the devices for a specific use was an impermissible attempt to regulate the practice of medicine. By limiting the use of the devices, the FDA interfered with physicians’ ability to administer or prescribe the devices as a physician sees fit. Accordingly, the court overturned the FDA rule.

The court’s Chief Judge dissented from the majority’s decision. The Chief Judge would have deferred to the FDA’s determination of which devices can be marketed for which purposes, and upheld the FDA’s ban on electric shock devices to treat self-injurious or aggressive behaviors.

The Chief Judge noted that the FDA had conducted a years-long study of whether to ban the use of electric shock devices intended to treat self-injurious or aggressive behaviors. The Chief Judge did not believe the FDA should be forced “to make an all-or-nothing choice” in banning the devices altogether or only for a specific purpose.

Barry F. Rosen
410-576-4224 • brosen@gfrlaw.com