A federal appeals court has overturned the Food and Drug Administration’s ban on the use of electric shock devices to correct aggressive or self-harming behavior in adults and children at a Massachusetts school for the developmentally disabled.
In a 2-1 opinion, the U.S. Court of Appeals for the D.C. Circuit found that the ban was a regulation of the practice of medicine, which is beyond the FDA’s authority. The ruling was a victory for the Judge Rotenberg Educational Center and a group of parents and guardians of its students, which had challenged the regulation.
The school, which is represented by Michael Flammia of Eckert Seamans Cherin & Mellott, said in a statement that it was pleased with the ruling, which would allow it to continue using the shock treatment.
“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,” it said.
It gets better:
The agency announced the ban on the use of electric shock devices to treat aggressive or self-harming behavior last March. Rotenberg, the only facility in the U.S. that manufactures and uses such devices for that purpose, had drawn harsh criticism from disability rights advocates, who said the practice could cause severe psychological and physical injuries.
The ban relied on a statute that gives the FDA the authority to pull unreasonably dangerous devices off the market.
That authority has been used only twice: once for a type of hair implant and once for the use of powdered gloves in surgery. While the powdered glove ban similarly targeted a particular use of a device, rather than banning it outright, it was never tested in court.
In petitioning the D.C. Circuit to overturn the ban, Rotenberg and the parents and guardians argued that the shock treatment was beneficial for patients who did not respond to any other treatment. The case was argued in April.
Senior Circuit Judge David Sentelle, writing for the majority, said that Congress has explicitly prohibited the FDA from regulating the practice of medicine, leaving that to the states. He said that a “use-specific” ban like the one at issue “interferes with a practitioner’s authority by restricting the available range of devices through regulatory action.”
“The FDA has no authority to choose what medical devices a practitioner should prescribe or administer or for which conditions,” the judge wrote.
Who is this David Sentelle, who is basically undermining the entire principle of the FDA? A Reagan appointee who was a mentor to a young Neil Gorsuch.