Court Throws Out FDA Ban On Shock Devices For Those With Developmental Disabilities
A federal appeals court has overturned a Food and Drug Administration ban on devices used to administer electric shocks on people with developmental disabilities, allowing the devices to continue to be used to address behavior issues.
In a 2-1 opinion this month, the U.S. Court of Appeals for the D.C. Circuit found that the FDA overstepped its authority when it issued a regulation last year to bar 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.
The devices are only known to be used at one place — 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. The facility has faced criticism for years from disability advocates who argue that the skin shocks amount to torture. But backers of the center insist that the electric shocks offer a necessary option for people with severe behaviors who have exhausted other treatments.
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When the FDA finalized the regulation, it cited an “unreasonable and substantial risk of illness or injury” from the devices pointing to evidence of psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder.
The federal appeals court determined that while the FDA has the authority to ban a device, the agency acted inappropriately because the regulation only sought to disallow electrical stimulation devices for the purpose of treating aggressive or self-injurious behavior while continuing to the allow the devices for other uses. The court found that such a limited ban amounted to regulating the practice of medicine, which is outside the purview of the FDA.
“The FDA has no authority to choose what medical devices a practitioner should prescribe or administer or for which conditions,” reads the court opinion.
Currently, the Rotenberg Center said it uses the device called the graduated electronic decelerator, or GED, with 51 residents all of whom are adults. The court decision means that the practice can continue.
“The GED is a treatment of last resort, and its recipients are at risk of grievous bodily harm, or even death, without it,” the Rotenberg Center said in a statement. “With the treatment, these residents can continue to participate in enriching experiences, enjoy visits with their families and, most importantly, live in safety and freedom from self-injurious and aggressive behaviors.”
Likewise, parents of those at the center praised the decision.
“We are grateful for the careful deliberation and the decision reached by the court and these judges. We have and will continue to fight to keep our loved ones safe and alive and to retain access to this life saving treatment of last resort,” the Judge Rotenberg Educational Center Parents Association said.
Advocates with the Autistic Self Advocacy Network, which has long pushed to end use of the skin shock devices, said that the FDA needs to take a firmer stand.
“The next step is clear,” the group said in a statement. “The FDA must completely ban the GED and similar devices. ASAN calls on the FDA to immediately pursue a new, complete ban. We will continue to advocate fiercely until this torture is finally ended.”
The FDA said it does not comment on “possible, pending or ongoing litigation.”