Court Won’t Reconsider FDA Ban On Shock Devices For Those With Disabilities
The Food and Drug Administration has once again been rebuffed by a federal appeals court in its yearslong push to ban devices used to administer electric shocks on people with developmental disabilities.
The U.S. Court of Appeals for the D.C. Circuit issued an order late last month rejecting the FDA’s bid to rehear a case centering on a regulation finalized in 2020 barring what are known as electrical stimulation devices. The devices send electrical shocks through electrodes attached to the skin in order to condition people not to engage in self-injurious or aggressive behaviors.
Earlier this year, the D.C. Circuit Court of Appeals overturned the FDA rule after three of the panel’s judges heard the case. The agency fought back, asking that the case come before all 11 of the court’s judges, but now that effort has been denied.
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At issue are devices believed to be used at only one facility in the U.S. — the Judge Rotenberg Educational Center in Canton, Mass., which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems.
For years disability advocates have worked to halt use of the skin shock devices arguing that they are torturous. Backers of the Rotenberg Center, however, say that the electrical stimulation devices are a last resort for individuals with severe behaviors who have not responded to other treatments.
In finalizing the ban last year, the FDA said that the devices presented an “unreasonable and substantial risk of illness or injury,” citing evidence of psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder.
Advocates with the Autistic Self Advocacy Network, who have long fought to end use of the skin shock devices, said in a statement that they were “outraged” by the court’s decision not to reconsider the case, allowing the Rotenberg Center to continue using the devices.
The Rotenberg Center sued to stop the ban, leading the judges from the D.C. Circuit Court of Appeals to find in July that the FDA overstepped its authority. The court opinion indicated that the agency could ban a device, but the FDA erred because it only barred electrical stimulation devices for the purpose of treating aggressive or self-injurious behavior while continuing to permit the devices for other uses.
“ASAN calls on the FDA to do whatever it takes to reinstate a ban by immediately reintroducing a new rule that would address the court’s concerns while effectively banning these devices,” the statement said. “The devices used at the Judge Rotenberg Center are very different from devices used for other purposes, so this should be easy for the FDA to do.”
The FDA declined to comment on the matter.
For its part, however, the Judge Rotenberg Center said in a statement that it is “pleased” that the court decided not to rehear the case.
“The court’s ruling allows clients to receive court-approved and court-monitored Graduated Electronic Decelerator (GED) treatment as part of its holistic treatment plan for profound aggressive or self-injurious behavior,” the statement said. “The GED is utilized when all other treatments have failed, and its recipients are at risk of grievous bodily harm, or even death, without it. The treatment allows these individuals to learn, to live in the community, to enjoy visits with their families and, most importantly, to be safe and free of chemical or physical restraints.”