FDA Cannot Ban Use of Electric Shock Devices for Harmful Behaviors

Last year, in a rare move, the FDA issued a final rule banning products known as electrical stimulation devices when used for the purpose of reducing or stopping self-injurious and aggressive behavior. This week, a federal appeals court in Washington, D.C., ruled against the FDA’s ban, in favor of the only facility in the U.S. still using the devices in such a way.

The Judge Rotenberg Educational Center in Canton, Massachusetts said that it provides education and treatment to individuals with behavioral, emotional, and/or psychiatric problems, as well as those with intellectual disabilities and those on the autism spectrum. After the FDA issued its rule in March 2020, the center, along with parents and guardians of patients who had received or sought to receive the treatment, petitioned the court to review the ban.

The center explained that some of its patients suffer from severe self-injurious and aggressive behaviors “that are difficult or impossible to treat using conventional behavioral and pharmacological techniques,” according to court documents. Additionally, some patients’ behaviors “are extreme enough that they have suffered self-inflicted brain trauma, broken and protruding bones, and blindness.”

The devices in question — which are typically used to treat about 20% of the center’s patients at any given time — administer brief electrical shocks through electrodes attached to the skin of patients in order to reduce or stop their behavior, court documents noted. Though the center is currently unique in its use of the devices, they have also been used to treat other conditions, such as tobacco addiction.

In 2016, the FDA proposed banning the devices for self-injurious and aggressive behaviors due to a bevy of concerns. The agency cited psychological and physical risks, including depression, fear, panic, worsening of underlying symptoms, pain, burns, errant shocks, and even post-traumatic stress disorder. The FDA also concluded that there was weak evidence regarding the devices’ effectiveness for these harmful behaviors.

When the FDA issued its final rule last year, they said that it estimated between 45 and 50 patients at the Judge Rotenberg Educational Center were being exposed to the devices. The agency added that it believed 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.”

Ultimately, the U.S. Court of Appeals for the District of Columbia Circuit cited Congressional statute in its ruling this week.

“In this case, the statute says that the FDA is not to construe its statute so as to interfere with the practice of medicine,” the court’s opinion stated. “That means that the FDA may not enact the regulation at issue before us. 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 Judge Rotenberg Educational Center said in an emailed statement that it, along with the parents and guardians of its patients, are pleased that the court vacated the FDA’s rule because the agency interfered with the practice of medicine when not authorized to do so.

The device used “is a treatment of last resort, and its recipients are at risk of grievous bodily harm, or even death, without it. 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,” the statement continued.

In a separate statement, the Judge Rotenberg Educational Center Parents Association said: “There is no other treatment for our loved ones, and we will not stand by as they are mechanically or chemically restrained. In 2018, the Judge Rotenberg Center prevailed in a Massachusetts court case where, after 44 days of evidence and arguments, the court found that the treatment is humane, safe, and highly effective for a population of clients who have exhausted all other options available to them.”

The association added that it is “looking forward to allowing their loved ones to receive this life saving treatment without further governmental interference.”

The FDA declined to comment on the ruling or any potential next steps. However, advocates for individuals with disabilities have supported the agency’s ban, with several — including the American Association on Intellectual and Developmental Disabilities (AAIDD) — even filing an amicus brief in the case.

“We are disappointed in the ruling,” Margaret Nygren, EdD, executive director and CEO of AAIDD, told MedPage Today. “This is simply not an effective way to achieve behavior change, giving people electric shock.”

Though “there are a lot of medical treatments that are painful,” such as incision site pain after surgery, “the pain is really a byproduct,” she noted. When it comes to electric shock, “the pain is not a byproduct,” but the treatment itself.

It is alarming that electric shock is still being used on people, Nygren added.

“As long as something remains legal, there’s always a danger that it can be implemented without any kind of recourse, ” she said.