A federal appeals court in Washington, D.C., overturned the U.S. Food and Drug Administration’s ban on the use of electric shock devices on people with mental disabilities by a Massachusetts residential school.
The judges’ 2-1 decision this week will allow the Judge Rotenberg Educational Center in Canton, Mass., to continue using shock devices on its residents. The center, which serves 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 covered the FDA's years-long effort to stop the school's use of 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 could bring. It is only the third such ban in the agency's history. While it applied 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 decried the ban and petitioned a federal court to review it. The judges’ majority opinion in the case Tuesday overturned that ban, stating that the FDA cannot ban the use of electric shock on intellectually disabled people because federal law restricts the agency from interfering with the practice of medicine, which is regulated by states.
"We conclude that the FDA lacks the statutory authority to ban a medical device for a particular use," the majority judges wrote.
Michael Flammia, the center’s attorney, said that Rotenberg leaders are content with the ruling, which will allow its workers to continue giving electric shocks to a portion of their residents to correct potentially aggressive or self-harming behavior when other measures have failed.
Disability rights activists, former residents and the state of Massachusetts have for decades pushed to stop the use of the device, called a graduated electronic decelerator (GED), or shut down the school altogether. The FDA assembled a panel of experts to study the GED, held hearings, and received thousands of pages of testimony and documentation from the school. After two years, the FDA announced it would ban the GED, but 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 shuttered. In one case in 2002, a student was tied to a restraint board for seven hours and shocked 31 times after he didn't take off his jacket when told to. Five years later, another student was shocked 77 times in just one night, after a prank caller instructed staff to do so.
The center's leaders said such incidents are now in the past and they have made "countless changes to our policies and procedures," including limits on using the device and special training to operate it. The center said it only uses shocks with approval from a patient’s family and a local judge. Flammia said that the shock treatment is necessary to prevent the patients from violent self-injury.
Supporters, many of them parents of the center's residents, say that 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 residents at the center have severe autism spectrum disorders and are non-verbal and dangerously self-harming — some have been kicked out of or rejected by half a dozen other schools and treatment programs.
The Judge Rotenberg Educational Center Parents Association said in a statement that they supported the judges’ decision.
“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,” the association said.
www.nbcnews.com
The judges’ 2-1 decision this week will allow the Judge Rotenberg Educational Center in Canton, Mass., to continue using shock devices on its residents. The center, which serves 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 covered the FDA's years-long effort to stop the school's use of 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 could bring. It is only the third such ban in the agency's history. While it applied 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 decried the ban and petitioned a federal court to review it. The judges’ majority opinion in the case Tuesday overturned that ban, stating that the FDA cannot ban the use of electric shock on intellectually disabled people because federal law restricts the agency from interfering with the practice of medicine, which is regulated by states.
"We conclude that the FDA lacks the statutory authority to ban a medical device for a particular use," the majority judges wrote.
Michael Flammia, the center’s attorney, said that Rotenberg leaders are content with the ruling, which will allow its workers to continue giving electric shocks to a portion of their residents to correct potentially aggressive or self-harming behavior when other measures have failed.
Disability rights activists, former residents and the state of Massachusetts have for decades pushed to stop the use of the device, called a graduated electronic decelerator (GED), or shut down the school altogether. The FDA assembled a panel of experts to study the GED, held hearings, and received thousands of pages of testimony and documentation from the school. After two years, the FDA announced it would ban the GED, but 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 shuttered. In one case in 2002, a student was tied to a restraint board for seven hours and shocked 31 times after he didn't take off his jacket when told to. Five years later, another student was shocked 77 times in just one night, after a prank caller instructed staff to do so.
The center's leaders said such incidents are now in the past and they have made "countless changes to our policies and procedures," including limits on using the device and special training to operate it. The center said it only uses shocks with approval from a patient’s family and a local judge. Flammia said that the shock treatment is necessary to prevent the patients from violent self-injury.
Supporters, many of them parents of the center's residents, say that 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 residents at the center have severe autism spectrum disorders and are non-verbal and dangerously self-harming — some have been kicked out of or rejected by half a dozen other schools and treatment programs.
The Judge Rotenberg Educational Center Parents Association said in a statement that they supported the judges’ decision.
“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,” the association said.
Appeals court axes FDA ban of electric shock on the disabled
The judges’ 2-1 decision this week will allow the Judge Rotenberg Educational Center in Canton, Mass., to continue using shock devices on its residents.
www.nbcnews.com
