Amicus Briefs
The Judge Rotenberg Educational Center v. FDA; Aponte v. FDA
CASE SUMMARY
NCLA filed this amicus brief in the U.S. Court of Appeals for the District of Columbia Circuit supporting a challenge to a Final Rule issued by the Food and Drug Administration (FDA). The Rule banned “electrical stimulation devices” (ESDs) for aversive therapy, in use in only one treatment facility in the United States—the Judge Rotenberg Educational Center in Canton, Massachusetts.
NCLA argued that the statute on which FDA relied did not provide FDA the rulemaking authority it sought to exercise. Congress adopted the statute to permit FDA to move swiftly to prevent manufacturers from continuing to distribute fraudulent or hazardous medical devices commercially during the time it would take for FDA to prevail in a court proceeding. That rationale was inapplicable when, as here, no manufacturer was seeking to distribute the devices targeted by FDA commercially.
In a victory for NCLA, the appeals court struck down FDA’s Final Rule as an improper attempt by FDA to regulate the practice of medicine. The court’s July 2021 ruling agreed with NCLA that federal law barred FDA from regulating the practice of medicine and reserved such regulation to state governments. In December 2021, the court denied FDA’s petition for rehearing en banc.
OUR TEAM
RELEVANT MATERIALS
NCLA FILINGS
Petition for Rehearing En Banc for the Federal Respondents
September 10, 2021 | Read More
Opinion of the U.S. Court of Appeals for the District of Columbia Circuit
July 6, 2021 | Read More
Brief for the Federal Respondents
January 15, 2021 | Read More
Brief of the New Civil Liberties Alliance as Amicus Curiae in Support of Petitioners, Urging Vacatur
November 23, 2020 | Read More
PRESS RELEASES
IN THE MEDIA
Parents Defend Electric Shock as Extreme Tool for Extreme Cases
Courthouse News Service
February 8, 2023