Court overturns FDA ban on shock device for ASD Students

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A federal appeals court has overturned the Food and Drug Administration's ban on the use of electric shock devices to correct aggressive or self-harming behavior in adults and children at a Massachusetts school for the developmentally disabled.

In a 2-1 opinion, the D.C. Circuit U.S. Court of Appeals found that the ban was a regulation of the practice of medicine, which is beyond the FDA's authority. The ruling was a victory for the Judge Rotenberg Educational Center and a group of parents and guardians of its students, which had challenged the regulation.

The school, which is represented by Michael Flammia of Eckert Seamans Cherin & Mellott, said in a statement that it was pleased with the ruling, which would allow it to continue using the shock treatment.

The agency announced the ban on the use of electric shock devices to treat aggressive or self-harming behavior last March. Rotenberg, the only facility in the U.S. that manufactures and uses such devices for that purpose, had drawn harsh criticism from disability rights advocates, who said the practice could cause severe psychological and physical injuries.

The Autistic Self Advocacy Network is heartbroken and outraged by today’s court decision striking down a regulation that would have banned the use of the graduated electronic decelerator (GED), a skin shock device used on people with disabilities. These devices, which the United Nations has recognized as torture, involve causing severe pain in an attempt to control behavior and are only used at the Judge Rotenberg Center (JRC), an institution in Massachusetts.

The disability community has fought for decades against the use of skin shocks on our people. Last year, after receiving extensive input from experts and community members, the FDA finalized regulations that banned the manufacture, distribution, and use of skin shock devices. The regulation was finalized four years after it had been introduced and six years after an expert panel had recommended the ban, with strong bipartisan support. Over 300,000 people had signed a petition urging the FDA to act.

Instead of following the new regulations, the JRC immediately filed a lawsuit against the FDA so that they could continue torturing people with disabilities. This lawsuit was only the most recent of a long string of aggressive lawsuits fighting attempts to curb their abuses of human rights. Although the trial court had initially upheld the FDA’s regulations, today the DC Circuit overturned that decision because the FDA’s regulation specifically bans the use of the GED for one purpose (behavior modification). The DC Circuit Court ruled that the FDA has the authority to ban a device completely, but does not have the authority to ban only one possible use of a device. The next step is clear: 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.

Our community is currently grieving and outraged on behalf of the many disabled people who will continue to experience daily abuse as a result of this decision. But our fight is not over, and we are not giving up. ASAN will continue to use every tool at our disposal and work with state and federal policymakers to end the torture at the JRC and all other uses of aversive treatment. We will not rest until no disabled person is subjected to torture in the name of “treatment”.

I am totally stunned.

The problem is that the FDA's regulation only extends to food and drugs not shock devices.

Except the FDA has the authority to ban medical devices including this shock device. The ruling was because the FDA banned a particular use rather than ban the device outright, but the third judge said the ruling did not consider the congressional intent.

This is extremely unfortunate but the judge made the correct decision. The problem is that the FDA's regulation only extends to food and drugs not shock devices.

Actually, no, the FDA does regulate medical devices.

I bet the two judges who voted to overturn the ban are Trump/Bush appointees

Although the trial court had initially upheld the FDA’s regulations, today the DC Circuit overturned that decision because the FDA’s regulation specifically bans the use of the GED for one purpose (behavior modification). The DC Circuit Court ruled that the FDA has the authority to ban a device completely, but does not have the authority to ban only one possible use of a device.

The next step is clear: 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.

Having read the article it seems this is about controlling those who are a danger to themselves and maybe others.

Four years earlier, in 2002, Andre McCollins walked into a Rotenberg Center classroom at 9:33 a.m. and refused to take off his coat. “It was a new classroom,” said his lawyer Ben Novotny of Lubin & Meyer in Boston. “He doesn’t like change.” For this transgression, Andre received one shock.

He then tried to crawl under a table. “Staffers pulled him out and put him in a four-point restraint face down,” Novotny says. While restrained, he kept screaming and tensing up his body, prompting 30 more shocks. Finally, at 4:30 p.m., the staffers untied his restraints. “The entire weekend, he spent in a psychotic, catatonic state,” Novotny says. “He has permanent brain damage from the stress response from that day.”

Originally, the Rotenberg Center was set up to treat the most troubled children: severely autistic and mentally ret*d boys and girls whose behavior was so aggressive and self-destructive (pulling out clumps of hair, banging their head against the wall for hours) that nothing else seemed to work — except aversion therapy in the form of electric shocks.

Over time, however, the Rotenberg Center expanded its mission and began taking in all sorts of troubled kids: kids who’d been diagnosed with ADD or ADHD, kids who’d been to jail, kids who had bipolar illness or schizophrenia, kids who’d been booted out of other treatment programs. It even runs radio ads to bring in new students, including a spot on Hot 97 last year that prompted threats of a boycott by a children’s rights advocate.

In 2006, I visited the Rotenberg Center and later wrote about the place for Mother Jones. At the time, it was teeming with kids from New York City, many from the city’s poorest neighborhoods. One of the youngest was a 9-year-old named Rodrigo. There was no rule about how old you had to be to receive shocks; he was wearing electrodes on his legs so that staffers could zap him if he misbehaved. “I want to move to another school,” he told me. As I walked through a classroom, a 15-year-old girl from the Bronx held up a sheet of paper where she’d scribbled a message with pink marker: “HELP US.”

... such as a kid refusing to take off his coat? See Trial Shows Autistic Brooklyn Kid Shocked Repeatedly As ‘Treatment’, New York Magazine, Apr. 12, 2012. According to this article:


The article also says: