The case concerns the rarely administered and highly controversial use of electrical stimulation (ESD) devices to treat people who put themselves, and sometimes others, at a serious risk of injury. The FDA and critics have said the risks outweigh the benefits, while supporters, including parents of students, say the practice is a court-approved, medically healthy last resort with no viable alternative.

In March 2020, the FDA banned the use of electrostatic discharge in specific settings, saying the devices pose an “unreasonable and substantial risk of illness or injury.” The FDA ban only extended to the use of ESDs to treat self-injurious or aggressive behavior, still allowing their use for the treatment of tobacco addiction, among others.
In a July 6 2-1 decision, the Washington DC Circuit Court of Appeals ruled that the FDA ban violated federal law by interfering with the authority of medical professionals to practice medicine, opening the way to the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, to continue his electroconvulsive therapy. The legal question in question was whether the power of the FDA to completely ban a device included the power to partially ban an already authorized device, depending on how it is used. The FDA approves and regulates medical devices as well as drugs.

“Because we conclude that the FDA does not have the legal authority to ban a medical device for a particular use, we do not address the petitioners’ other arguments, including whether the ban was arbitrary and capricious or whether there is evidence substantive supported the factual determinations of the “FDA,” states in power.

Additionally, Massachusetts has already “played a very active role” in regulating the use of ESDs by the private center, the court wrote.

In a 2018 report from the State Development Services Department, regulators said the center meets most of the state’s requirements, while recommending further action in the area of ​​human rights. man.
In 2010, the Justice Department said it was investigating the JRC for “using aversive restraints and electric shock”.

CNN has contacted the DOJ on the status of the investigation.

“We are grateful for the careful deliberation and decision made by the tribunal and these judges. We have and will continue to fight to keep our loved ones safe and alive and to maintain access to this life-saving last resort treatment. lives, ”JRC parents said. The association said in a statement.

Beyond the medical debate over using ESDs to treat self-injurious behavior, Mike Flammia, the lawyer representing the JRC and parents of students in the case, told CNN that the court ruling supported the relationship between a patient and his doctor.

It’s important “because it protects what we all treasure, and it’s the ability to go to our doctor and ask him to decide what is the best treatment,” he said.

The FDA did not return CNN’s requests for comment.

Only one school uses the treatment

The Judge Rotenberg Education Center is the only facility in the country that still uses electroconvulsive therapy in such a way, according to the ruling, going so far as to manufacture its own devices that are subject to federal and state regulation. The school says it treats about 20% of its roughly 300 students with its device, called a “graduated electronic decelerator” (GED), as a last resort.

“These clients are going to bang their heads until they have a stroke or blindness due to dislodged retina. They will break their bones, they will violently attack others. They had no life until they came to JRC, ”said Flammia. “All of the many other hospitals and programs that tried to treat them before coming to JRC with traditional treatments failed, and they lived a life of constant mechanical and chemical restraint and isolation.”

Flammia, who said he himself underwent the shock therapy, explained that the JRC had an agreement with the state to seek court approval before a GED was used.

This process allows a patient to have their own duty counsel and requires multiple health care practitioners to confirm that no other treatment has been effective, among other safeguards, according to Flammia and the ruling.

“It’s just a tampon,” Nancy Weiss, director of the National Leadership Consortium on Developmental Disabilities at the University of Delaware, told CNN. Since the early 1990s, Weiss has been a vocal critic of the JRC, equating shock therapy with “torture.”

“Every state has people it supports who have serious behavioral problems. And every state has nonprofit or for-profit agencies that serve these people in a humane and efficient manner,” she said, adding that she thought there was not enough. monitoring for each time a shock is used.

According to Flammia, only a licensed psychologist or licensed behavior analyst overseeing a student’s education plan can administer a shock.

“I know the people who oppose this treatment, they will tell you again and again [that] there are other treatments that work just as well if not better. And they will talk about supporting positive behavior, that the CCR does all of this, ”the lawyer continued. “They will talk about drugs – mind-altering drugs. These JRC clients, they tried all that. Many drugs, many diagnoses, many combinations of drugs. ”

“It doesn’t work for these clients,” he said.

Alternatives to Electric Shock Therapy Better Approach, FDA Says

When the FDA announced the ban in 2020, the agency cited several concerns about the use of electric shock devices as a treatment for aggressive behavior or self-harm.

“The evidence indicates that 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 addition, many people exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain.”

“The FDA believes that advanced behavioral treatments, such as positive behavioral support, and medications may enable healthcare providers to find alternative approaches to addressing self-injurious or aggressive behaviors in their patients. ”

Because the JRC uses such positive behavioral support in tandem with shock therapy, the use of GED renders the alternatives ineffective, Weiss says.

“Part of the reason people with disabilities have behavior problems, behaviors that we find difficult, is that they protest the shitty life we ​​give them,” she said. “It is the only form of protest from this person and it is a critique of the life offered to him.”

“It is as if there is no greater human impulse than to be in charge of your own life. And what the JRC does, far beyond what any other supplier in the country does is depriving people of choice and control. “

CNN’s Maggie Fox and Christina Carrega contributed to this story.

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