Appeals court opposes FDA ban on electric shock to people with disabilities


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

The judges’ 2-1 decision this week will allow the Judge Rotenberg Education Center in Canton, Mass., To continue using shock devices on its residents. The center, which accommodates a mix of children and adults with severe developmental and emotional disabilities, has been one of the most controversial institutions for people with disabilities in the country for half a century. NBC News has covered years of efforts by the FDA to stop school use of the devices.

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

The center denounced the ban and asked a federal court to review it. The majority opinion of the judges in the case on Tuesday overturned the ban, saying the FDA cannot ban the use of electric shocks on people with intellectual disabilities because federal law prohibits the agency from interfering with the practice. of medicine, which is regulated by the states.

“We conclude that the FDA does not have the statutory authority to ban a medical device for a particular use,” the majority wrote.

Michael Flammia, the center’s lawyer, said Rotenberg executives are happy with the move, which will allow its employees to continue to give electric shocks to some of their residents to correct potentially aggressive or self-destructive behavior when d other measures have failed.

For decades, disability rights activists, former residents and the state of Massachusetts have been pushing to stop use of the device, called a Graduated Electronic Decelerator (GED), or to shut down the school altogether. The FDA assembled a panel of experts to study GED, held hearings, and received thousands of pages of testimony and documents from the school. After two years, the FDA announced it would ban GED, but it took another four years to finalize the rule.

Opponents cite a history of scandals as examples of how GED can be abused and why the school should be closed. In one case in 2002, a student was tied to a restraining board for seven hours and was shocked 31 times after he did not remove his jacket when asked to do so. Five years later, another student was shocked 77 times in a single night, after a caller asked staff to do so.

Managers at the center said such incidents are now a thing of the past and they have made “countless changes to our policies and procedures,” including limitations on the use of the device and special training for it. ‘use. The center said it only used the shocks with the approval of the patient’s family and a local judge. Flammia said shock therapy is needed to prevent patients from violently self-harming.

Supporters, many of whom are parents of the residents of the center, say the methods the center uses are the best and sometimes the last hope for dealing with some of the most difficult cases of developmental and emotional disability in the country. Many residents at the center have severe autism spectrum disorders and are non-verbal and dangerously self-harm – some have been kicked out or rejected by half a dozen other schools and treatment programs.

The parents ‘association at the Judge Rotenberg Education Center said in a statement it supported the judges’ decision.

“We have and will continue to fight to keep our loved ones safe and alive and to maintain access to this lifesaving treatment of last resort,” the association said.


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