Appeals courtroom axes FDA ban of electrical shock on the disabled

A federal appeals court in Washington, DC, overturned the U.S. Food and Drug Administration’s ban on the use of electric batons for people with intellectual disabilities through a residential school in Massachusetts.

The judges’ 2-1 ruling this week will allow Judge Rotenberg Educational Center in Canton, Massachusetts to continue using shock devices on its residents. The center, which caters to a mix of children and adults with severe developmental and emotional disabilities, has been one of the most controversial facilities for people with disabilities in the country for half a century. NBC News reported on the FDA’s years of efforts to stop the school from using the devices.

In early March last year, the FDA took the rare step of banning the device, finding that the significant risk of harm outweighed any medical benefit. It is only the third such ban in the agency’s history. While it is a category of “electrical stimulation devices used for self-harming or aggressive behavior,” the agency found that only one facility in the country uses such devices – the Judge Rotenberg Center.

The center rejected the ban and petitioned a federal court for a review. The majority opinion of the judges in the case on Tuesday lifted that ban, stating that the FDA cannot ban the use of electric shocks on intellectually disabled people because federal law prevents the agency from interfering with state-regulated practice of medicine.

“We come to the conclusion that the FDA lacks the legal authority to ban a medical device for a specific use,” wrote the majority judges.

Michael Flammia, the center’s attorney, said Rotenberg’s leaders were pleased with the ruling, which will allow its staff to continue to give electric shocks to some of their residents to correct potentially aggressive or self-harming behavior when other measures have failed are.

Disability rights activists, former residents, and the state of Massachusetts have been pushing for decades to end or close school altogether, the device known as a Graduated Electronic Decelerator (GED). The FDA assembled a panel of experts to study the GED, held hearings, and received thousands of pages of testimony and records from the school. After two years, the FDA announced it would ban the GED, but it took another four years to finalize the rule.

Opponents point to a history of scandals as examples of how the GED can be abused and why the school should be closed. In one case in 2002, a student was handcuffed to a holding board for seven hours and shocked 31 times after failing to take off his jacket when prompted. Five years later, another student was shocked 77 times in just one night after a joke caller instructed staff to do so.

The center’s leaders said that such incidents are a thing of the past and they have made “countless changes to our policies and procedures,” including restrictions on using the device and special training on how to operate it. The center said it used shock only with the consent of a patient’s family and a local judge. Flammia said the shock treatment was necessary to prevent patients from violent self-harm.

Supporters, many of them parents of the center’s residents, say the methods used by the center are the best, and sometimes last, hope to address some of the most difficult developmental and emotional disability cases in the country. Many of the center’s residents have severe autism spectrum disorders and are non-verbal and dangerously self-harming – some have been kicked or rejected from half a dozen other schools and treatment programs.

The parents ‘association of the judge Rotenberg Educational Center said in a statement that it supports the judges’ decision.

“We have and will continue to fight to keep our loved ones safe and alive and to keep access to this life-saving treatment as a last resort,” the association said.

Comments are closed.