FDA Ban On Shock Device Used On Disabled Students Overturned By Washington, DC, Court

A ban by the US Food and Drug Administration on shock devices used to "correct" aggressive behavior in disabled adults and children has been overturned by a Washington, DC, circuit court, Reuters reports.

The school at the center of this ruling is Judge Rotenberg Educational Center in Massachusetts. The school has been criticized for the use of these devices. While the school argues that the electric shock treatment helps disabled students and adults interact with their environment without engaging in self-destructive or aggressive behaviors, disability-rights activists liken the use of the devices to torture.

Surprisingly, even parents of students at the school have lobbied on behalf of the use of these treatments, insisting the benefits outweigh the risks. The court ruled in their favor, saying the FDA ban was a regulation of the practice of medicine beyond the agency's authority.

Parents and disability rights activists find themselves on different sides of a legal argument regarding the use of shock devices on disabled students. The Judge Rotenberg Educational Center in Massachusetts is the only facility in the country using graduated electronic decelerators. These devices are used to treat self-injurious or aggressive behavior in disabled students and adults at the facility.

The facility lost its ability to use the treatment in May 2020, when the US Food and Drug Administration banned the devices, making them the third device ever to be banned by the agency. This came after disability rights activists spoke out against the use of the shock devices, likening them to torture.

"Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage," the FDA said in a statement last spring.

"In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain."

Attorneys for the facility cited parents who supported the use of the treatment. "Patients who receive it are those who have proved resistant to all other therapies," Max Stern argued in the DC circuit court on July 2.

"They have seen their health restored, their lives changed or saved from this treatment. The GED is not hazardous; it's simply unpopular with advocates who don't like the thought of it. But there's no legal basis to ban a device to get the advocates and their sympathizers peace of mind."

The facility explains that students are only recommended for the shock devices if several other forms of treatment have failed. A psychologist, peer review committee, and human rights committee are involved in that approval process.

"Over 200 JRC patients have received GED treatment during the last 25 years; many responded so well they were able to return home, and some even live independently and support themselves, marry, and raise families," the brief states.

They also noted that while the FDA banned these devices for this specific use, it's still being used to stop practices like nail biting and smoking. A judge agreed that this was one of several grounds to overturn the FDA ban.

"The FDA has no authority to choose what medical devices a practitioner should prescribe or administer or for which conditions," the judge said.