Court overturns FDA ban on shock device for ASD Students

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ASPartOfMe
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06 Jul 2021, 7:21 pm

Reuters

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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.


ASAN Denounces Court Ruling on Electric Skin Shock
Quote:
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. We continue to allow the treatment of Autistic people that we do not allow on terrorists at Guantanamo Bay. This is truly a real-life horror story where you think the monster is dead and it keeps coming back to life. The disability advocacy groups have been trying unsuccessfully to stop this real-life nightmare since the 1980s!!


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Last edited by ASPartOfMe on 06 Jul 2021, 7:39 pm, edited 1 time in total.

Jiheisho
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06 Jul 2021, 7:36 pm

ASPartOfMe wrote:
I am totally stunned.


(Maybe not the best choice of words, but) I totally agree. The FDA inaction on this was appalling to begin with. I hope the FDA appeals the decision.



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06 Jul 2021, 7:50 pm

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.

My advice to the families and disability rights advocates is to find the correct organization who do have the authority to regulate the shock devices and then bring this case again but this time with the correct organization backing them.

Remember judges are only supposed to only go by the facts of the law. That is what this judge did. The FDA overstepped their bounds and unfortunately, like it or not, the judge put them in their place.

Don't get me wrong. I don't like the outcome of this decision and I'm sure the judge didn't like it either.



Jiheisho
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06 Jul 2021, 8:09 pm

cubedemon6073 wrote:
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.



ASPartOfMe
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06 Jul 2021, 8:19 pm

I am not a lawyer what is the way forward?.
While ABA is, unfortunately, the gold standard autism behavioral treatment shock device is a widely disapproved medical procedure. If you can't shut the facility can something be done to the doctors that practice this "treatment"?


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06 Jul 2021, 8:23 pm

Jiheisho wrote:
cubedemon6073 wrote:
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.


Are you sure that they have this authority? I thought the authority was just food and drugs.

If they do have the authority then I would appeal to a higher court. And, if I was the FDA I would get the best lawyers to make sure the i's are dotted and the t's are crossed.

If they don't have the authority then the disability rights advocates need to go to those who do have the authority.

But, I do think that it needs to be established in the higher court what the FDA's authority is exactly based upon law.

I'm not a lawyer but I do think these are the most logical steps forward.



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06 Jul 2021, 9:26 pm

cubedemon6073 wrote:
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.


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06 Jul 2021, 9:52 pm

Mona Pereth wrote:
cubedemon6073 wrote:
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.


The issue is that one has to be able to provide legal proof as defined by the courts that the FDA has the authority it claims.

This is how you would have to do this.

You would have to explain How a shock device is a medical device? You would have to define what a medical device as legally understood by the courts in their presentation style and then explain how a shock device is a medical device in the legal way the courts would accept it in their presentation style.

If this can't be done then it has not been established that the FDA has the authority to regulate and control this device. The FDA would have to be able to establish and prove their authority and I truthfully hope they can and do. And, I hope they can shut this f*****g horrible place down. They need to get the best lawyers they can afford to do this.



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06 Jul 2021, 10:52 pm

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


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06 Jul 2021, 11:01 pm

I feel like shock collars probably shouldn't be condoned by a civilized society.


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07 Jul 2021, 12:22 am

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


The Senior Circuit Judge who wrote the opinion is David Santelle who was appointed by Reagan. He was joined in the majority by Circut Judge Gregory Katsas a Trump appointee.

Dissenting was Chief Judge Sri Srinivasan who was appointed by Obama.

United States Court of Appeals for the District of Columbia Circuit - Wikipedia


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07 Jul 2021, 12:44 am

I can't imagine they'd allow dogs to receive shock treatment. And rightfully so.



Mona Pereth
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07 Jul 2021, 8:04 am

Here is a corrected link to the ASAN article: ASAN Denounces Court Ruling on Electric Skin Shock.

The specific technicality on which the court overturned the FDA's decision is this:

Quote:
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.

Therefore:

Quote:
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.

Doesn't look to me like the device has any other purpose -- here's the Wikipedia article about it. So hopefully the FDA shouldn't have a problem with banning it completely.


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07 Jul 2021, 10:16 am

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

The 200 pound kid who’s throwing pc monitors across the room and putting their fist through a door or someone’s teeth

Not punishment for getting the wrong answer in some ABA task.

Not saying their isn’t a better way but there is a difference.

In psychiatric hospitals they use injected tranq in the backside that is not much less undignified.

The problem is the same in prisons and psychiatric hospitals everywhere how to control the big guy or girl from hurting someone when they loose it.



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07 Jul 2021, 10:55 am

carlos55 wrote:
Having read the article it seems this is about controlling those who are a danger to themselves and maybe others.

... 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:

Quote:
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.”

The article also says:

Quote:
Originally, the Rotenberg Center was set up to treat the most troubled children: severely autistic and mentally retarded 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.”


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07 Jul 2021, 11:51 am

Mona Pereth wrote:
carlos55 wrote:
Having read the article it seems this is about controlling those who are a danger to themselves and maybe others.

... 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:

Quote:
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.”

The article also says:

Quote:
Originally, the Rotenberg Center was set up to treat the most troubled children: severely autistic and mentally retarded 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.”


Like all physical restraining its all about judgement & discretion good & bad staff.

In prison they use battons that cause physical injury inc cuts & bruises, in pysic hospitals they use tranq injections, on the street the police as we all know use restraining techniques & guns that can kill.

Unfortunatly the spiders web trap spiderman uses in the movies doesnt exist.

Its not pretty but if you or your family member had to confront someone waving a knife around who was out of control you would want them properly restrained too.

From my understanding there are multiple tools for this from simple talking & calming to getting physical