Court of Appeals Overturns FDA Ban on Electrical Stimulation Devices Used at JRC

July 12, 2021

In a 2-1 decision, the D.C. Circuit Court of Appeals vacated a 2020 FDA rule banning the use devices that deliver electric shocks to individuals with self-injurious and aggressive behaviors.  The devices at issue, also known as Graduated Electronic Decelerators (GEDs), are manufactured and used in only one program – the Judge Rotenberg Center based in Canton, Massachusetts. 

The FDA’s rule was issued following years of public testimony and comments, the convening of an expert panel, and an exhaustive review of the professional literature.  Taken together, this body of evidence led the FDA to conclude that these devices presented an unreasonable and substantial risk of injury, particularly given the existence of state-of-the-art alternatives proven to be safe and effective.  The FDA also concluded that there was no credible evidence of the efficacy or long-term benefit of these devices. 

The FDA’s rule was challenged by JRC and its parent association.  National organizations of physicians, researchers, and administrators of state disability and special education systems filed a Friend of the Court brief in support of the FDA, stating that the rule is “consistent with the overwhelming weight of scientific literature … and actual treatment practice across the country,” and that “[u]sing electric shock for aversive conditioning is painful, psychologically damaging, and often physically harmful.”

However, the Court did not evaluate the body of evidence supporting the FDA’s decision.  Nor did it entertain arguments by JRC that the FDA’s decision was arbitrary and capricious.  Rather, the three Judge panel concluded that the FDA did not have the statutory authority to ban a device for some uses but not others, and that the rule violated a legal prohibition against interference in the practice of medicine.   In a dissenting opinion, Chief Justice Srinivasan concluded that the FDA’s interpretation of the statute was entitled to deference based on Supreme Court precedent, and that it was permissible for the agency to exercise its authority in a more tailored fashion, rather than be forced to ban a device for all uses.  Judge Srinivasan also adopted the FDA’s view that a device banned for a specific purpose, cannot be “legally marketed” for that purpose, and therefore would not interfere with the practice of medicine.

The decision to seek further appeal of the Circuit Court’s decision, including a request for rehearing, rests with the United States Solicitor General.

For more than 30 years, the Center has worked with local and national advocates to end to the use of highly restrictive or aversive interventions on individuals with disabilities.  The Center will continue to advocate for effective, evidence-based services, including positive behavioral supports, that increase individuals’ skills, independence, and autonomy, and remains committed to ensuring people with disabilities are treated with the respect and dignity they deserve.