D.C. Circuit Court of Appeals Overturns Ban Imposed on Electrical Stimulation Device
On July 06, 2021, the U.S. Court of Appeals for the D.C. Circuit, a three judge panel, overturned the ban imposed by the Food and Drug Administration (FDA) on the use of electric shock medical devices in order to correct aggressive or self-harming behavior in patients at a school for the disabled. The Judge Rotenberg Educational Center, Inc. v. FDA, No. 20-1087.
The plaintiff, the Judge Rotenberg Educations Center, is a facility located in Massachusetts, which treats patients with severe behavioral issues and intellectual disabilities. Before the said ban was imposed by the FDA, the plaintiff used to treat some of its patients having severe self-injurious or aggressive behavior with an electrical stimulation device (ESD). The treatment briefly shocks patients, resulting into reduction or ending the self-injurious behaviors. The devices are manufactured by the plaintiff and it is the only facility in the States that uses ESD in such a treatment. Needless to say, the treatment aforesaid has been a highly controversial practice. FDA regulates the usage of aversive conditioning devices including the ones that use electrical shocks, and had classified them as Class II medical devices subjection to special controls.
In the year 2016, FDA proposed to impose a ban on usage of ESDs for self-injurious or aggressive behavior. The FDA concluded that the treatment caused psychological and physical harm to patients and the evidence for its effectiveness was weak. FDA promulgated a final rule banning the device for the treatment in 2020. The ban was challenged by the plaintiff. The issue which arose before the Court was whether FDA had a legal authority to ban an otherwise legal device for a particular intended use. The three-judge panel considered the statutory language and concluded that “a device either is banned or it is not. It speaks of no authority to place a device in an intermediate state of ‘banned in some uses.’” Further, the majority analyzed the language of the Practice of Medicine provision of the FD&C Act, which states restriction upon FDA to construe any part of the FD&C to “limit and interfere” with a practitioners’ authority to prescribe or administer “any legally marketed device” to a patient. The Court agreed with the plaintiff that to ban a medical device for a particular use limits or interferes with medical practice, which is in violation of FD&C Act. The Court, therefore, vacated FDA’s rule banning ESD for self-injurious or aggressive behavior.
However, Chief Judge Sri Srinivasan filed a dissenting opinion stating that FDA has the authority to impose a ban on a device for a particular device. Judge Srinivasan highlighted that cranial electrotherapy stimulators are regulated by FDA as Class II devices when they are used to treat insomnia or anxiety, and as Class III when intended to treat depression.
The judgment delivered by majority of the three judge bench is contrary to the FDA’s longstanding view that the agency holds the legal authority to differentiate among devices based upon the intended use. The Court seems to have taken a narrow interpretation of the Banned Device and Practice of Medicine provisions of the FD&C Act. It’s reluctance to allow FDA to regulate devices based upon their intended use might also have implication on FDA’s restriction on the off-label promotion of drugs, thereby limiting FDA’s authority.