Federal appeals court vacates FDA rule banning electric shock devices to treat self-harming behavior

By Ganesh Setty, CNN

A Massachusetts school for individuals with severe behavioral issues and intellectual disabilities can continue to use electric shock devices to stop students from harming themselves and others, a federal court ruled earlier this month, after the US Food and Drug Administration sought to ban such usage in 2020.

The case surrounds the rarely administered and highly controversial use of electric stimulation devices (ESDs) to treat individuals who put themselves, and sometimes others, at severe risk of injury. The FDA and critics have said the risks outweigh the benefits, while proponents, including students’ parents, say the practice is a court-approved, medically sound last resort with no viable alternative.

In March 2020, the FDA banned the use of ESDs in particular contexts, saying the devices provide an “unreasonable and substantial risk of illness or injury.” The FDA’s ban only extended to the use ESDs for treating self-injurious or aggressive behavior, still allowing their use for the treatment of smoking addiction, among other purposes.

In a 2-1 decision on July 6, the Washington D.C. Circuit Court of Appeals ruled that the FDA’s ban violated federal law by interfering with the authority of healthcare practitioners to practice medicine, paving the way for the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, to continue its electric shock therapy. The legal issue in question was whether the FDA’s authority 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 lacks the statutory authority to ban a medical device for a particular use, we do not address petitioners’ other arguments, including whether the ban was arbitrary and capricious or whether substantial evidence supported the FDA’s factual determinations,” the ruling states.

Additionally, Massachusetts has already “taken a very active role” in regulating the privately owned center’s use of ESDs, the court wrote.

In a 2018 report by the state’s Department of Developmental Services, regulators said the center met most state requirements, while recommending extra steps to be taken in the area of human rights.

In 2010, the Department of Justice said it was investigating JRC for “use of aversive restraints and electro-shocks.”

CNN has reached out to the DOJ on the status of the investigation.

“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,” JRC’s Parents Association said in a statement.

Beyond the medical debate on of the use of ESDs to treat self-injurious behavior, Mike Flammia, the attorney representing JRC and students’ parents in the case, told CNN that the court’s decision supports the relationship between a patient and their doctor.

It is important “because it protects what all of us cherish, and that is the ability to go to our doctor and have our doctor 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 Educational Center is the only facility in the country that still uses electric shock therapy in such a way, according to the decision, going so far as to manufacture its own devices which are subject to federal and state regulation. The school says it treats about 20% of its approximately 300 students with its device, termed a “graduated electronic decelerator” (GED), as a last resort treatment.

“These clients will bang their head until they suffer a stroke, or blindness from dislodging a retina. They will break their own bones, they will violently attack others. They had no life until they came to JRC,” Flammia said. “All the other many hospitals and programs that tried to treat them before coming to JRC with the traditional treatments were unsuccessful, and they were living a life of constant mechanical and chemical restraint and isolation.”

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

That process allows for a patient to have their own court-appointed lawyer and requires multiple health practitioners to confirm no other treatments were effective, among other safeguards, according to Flammia and the ruling.

“It’s just a rubber stamp,” 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 an outspoken critic of JRC, equating the shock therapy to “torture.”

“Every state has people that they support who have severe behavioral issues. And every state has non-profit, or some for-profit, agencies that serve those people humanely and effectively,” she said, adding that she believes there isn’t enough oversight for when 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 that the people that oppose this treatment, they’ll tell you over and over again [that] there are other treatments that work as well if not better. And they’ll talk about positive behavior supports, which JRC does all of that,” the attorney continued. “They’ll talk about drugs –psychotropic medications. These clients at JRC, they’ve tried all that. Numerous drugs, numerous diagnoses, numerous combinations of drugs.”

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

Alternatives to electric shock therapy are a better approach, FDA says

When the FDA announced the ban in 2020, the agency cited several concerns with using electric shock devices as a treatment for aggressive behavior or self-injury.

“Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns and tissue damage,” the FDA said. “In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain.”

“The FDA believes that state-of-the-art behavioral treatments, such as positive behavioral support, and medications can enable health care providers to find alternative approaches for curbing self-injurious or aggressive behaviors in their patients.”

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

“Part of the reason that people with disabilities have behavioral problems, behaviors that we find challenging, is that they’re protesting the crappy lives that we offer them,” she said. “It’s that person’s only form of protest and it’s a critique of the life that they’re being offered.”

“It’s like there’s no greater human impulse than to be in charge of your own life. And what JRC does, to an extent beyond what any other provider in the country does, is strip people of choice and control.”

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