End to Electroshock Device Use on Disabled People Lies With FDA

As Massachusetts’ highest court wrestles with the question of whether to end a decades-long clash over the use of a painful electric shock device on people with disabilities, advocates say the US Food and Drug Administration currently has the authority to ban the device and end the fight.

A 35-year-old legal agreement allows the Canton, Mass.-based Judge Rotenberg Center to use a Graduated Electronic Decelerator device on patients with self-injurious behaviors and says the treatment is an important last resort for patients who saw little benefit from medication and other types of treatment.

Parents that send their children to the facility “wanted something better” than for their children to be “stuck in locked psychiatric wards” or sedated, said Michael Flammia, a member of Eckert Seamans Cherin & Mellott LLC, who represents the center. It accepts patients as young as five experiencing severe emotional and behavioral issues, as well as patients with intellectual disabilities or who are on the autism spectrum.

The FDA—along with the Centers for Medicare & Medicaid Services, many states, and medical and disability groups—opposes the treatment, which the United Nations deemed torture in a 2013 report. However, the FDA is yet to use the authority given to it by Congress in this year’s omnibus appropriations bill to ban the device nationwide to treat self-injurious behavior.

Disability advocacy groups have met with the FDA to try to persuade them to swiftly issue a rule banning that use of the device. “What counts as swiftly within a government agency is not what we would count as moving swiftly as advocates,” said Zoe Gross, director of advocacy for the Autistic Self Advocacy Network. “But I’m hopeful that there will be a rule soon,” Gross said.

The Massachusetts’ Supreme Judicial Court could resolve the fight in the next few months, but the justices appeared to favor prolonging the battle by punting the issue back to a lower court at a May 3 oral argument.

Every day the treatment remains in use is another day vulnerable groups experience “physical harm like burns and long lasting mental harm like PTSD, anxiety, and depression,” Gross said.

“Imagine being subjected to sustained torture. How would you feel if that were happening to you?” Gross said.

Controversial Treatment

The Judge Rotenberg Center is the only residential facility in the world that treats people with disabilities using electric shock treatment.

The center takes all patients, no matter how severe their behavior, who have often tried a handful of other methods before turning to the treatment, Flammia said.

The Massachusetts Supreme Judicial Court justices acknowledged that protecting the treatment could be important for the small group of patients who have run out of options to treat self-injurious behavior like head-banging or eye-gouging.

Massachusetts’ Department of Developmental Services has been trying to regulate the facility for decades, sparking a 1986 class action that led the consent decree protecting the center’s use of “aversive procedures.”

The state wants the court to vacate the consent decree to ensure that vulnerable patients are treated in a “more effective and more humane way” that aligns with the current standard of care, Timothy Casey, assistant attorney general, said at oral arguments.

Years of Litigation

Massachusetts’ top judges were troubled at oral argument by the fact that the testimony in the case was several years old, leaving them without up-to-date information on the current standard of care.

“It’s possible that this concern could lead the court to order a remand and instruct the trial court to consider more contemporaneous evidence,” said Kathryn Rucker, an attorney for the Center for Public Representation, who represented disability advocacy groups in an amicus brief.

It took five years for a lower court to make its initial ruling on the consent decree and three more years for the court to assemble the record for appeal, so a remand could drag out the litigation for several more years, the Massachusetts Attorney General’s office said.

The state presented “an overwhelming amount of evidence—professional research, peer reviewed literature, state and federal agency positions,” and testimony from provider associations “that really confirms and underscores that the change in the standard of care is significant nationwide, and unequivocally disavows the use of painful aversive interventions,” Rucker said.

New Authority

The FDA’s last most recent attempt to ban the use of the electric shock device on disabled people failed after a federal appeals court found in 2021 that the agency lacks authority to ban a medical device for just one of its uses.

The US Court of Appeals for the District of Columbia Circuit struck down a rule that took more than four years to promulgate, spanning the Obama and Trump administrations.

Congress gave the FDA the authority to ban a device for “one or more intended uses” in this year’s omnibus.

“Now we are at the point where the FDA needs to go through the entire rulemaking process again,” said Robyn Linscott, director of education and family policy for The Arc, a disability rights advocacy organization.

“We hope that it moves much more quickly than the four-plus year process it took the first time,” Linscott said.

Almost 150 disability rights and medical groups are calling on the FDA to swiftly issue a new rule banning the use of the device on people with disabilities.

A spokesperson for the agency said it’s “continuing to evaluate the provisions in the omnibus legislation and their impact with regards to the oversight of these devices.”

The Judge Rotenberg Center is prepared to challenge the FDA “if they fail to do a fair and thorough analysis” to support banning the device’s use, Flammia said.

“There is a federal statute that says the FDA shall not interfere with the practice of medicine. It was our argument before and it was successful, and it will be our argument again,” Flammia said.