D.C. Circuit overturns FDA ban on shock device for disabled students

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
  • Ban regulates the practice of medicine, divided panel finds
  • Petitioner is only U.S. school to use controversial treatment

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.

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"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.

"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," an association of parents said in a statement. The parents in the case were represented by Max Stern of Todd & Weld.

The FDA did not immediately respond to a request for comment.

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.

Sentelle was joined by Circuit Judge Gregory Katsas.

Chief Judge Sri Srinivasan dissented, writing that, since the FDA could ban the device entirely, it was "hard to perceive why Congress could want to deny the agency that middle-ground option."

The case is The Judge Rotenberg Educational Center Inc v. FDA, D.C. Circuit U.S. Court of Appeals, No. 20-1087.

For the parents: Max Stern of Todd & Weld

For the school: Michael Flammia of Eckert Seamans Cherin & Mellott

For the FDA: Daniel Aguilar of the U.S. Department of Justice

Read more:

Circuit weighs ban on electric shock device for developmentally disabled patients

(NOTE: This story has been updated to add comments from the Rotenberg Center and from a parents' association.)

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.