D. C. Circuit Court of Appeals Overturns FDA Ban on Shock Medical Devices

In a 2-1 opinion, decided on July 6, a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit has overturned the Food and Drug Administration’s ban on the use of electric shock medical devices to correct aggressive or self-harming behavior in patients at a school for the disabled.¹  We analyze this case because it has significant implications for FDA’s ability to regulate medical devices based on their specific intended uses.

Background

The Judge Rotenberg Educational Center (The Center) is a facility in Massachusetts that treats patients with severe behavioral issues and intellectual disabilities. Before the ban was at issue in this case, The Center treated some of its patients exhibiting severe self-injurious or aggressive behavior with an electrical stimulation device (ESD) that briefly shocks patients, causing them to reduce or cease their self-injurious behaviors. The Center manufactures its own devices and is the only facility in the country that uses ESDs in this way, a highly controversial practice. Other health care facilities use ESDs to treat other conditions, including smoking, alcohol, and drug addictions.

FDA regulates aversive conditioning devices, including ones that use electrical shocks, as Class II medical devices subject to special controls.²

In 2016, FDA proposed banning ESDs for self-injurious or aggressive behavior. In the proposed rule, FDA concluded that the therapy caused psychological and physical harm to patients and that the evidence of the devices’ effectiveness was weak. The agency determined that the devices presented a substantial and unreasonable risk to self-injurious and aggressive patients, justifying banning the devices for that specific use under the Banned Devices provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act).³  FDA promulgated a final rule banning the device for this particular use in 2020 (the rule allowed ESDs to be legally marketed for other purposes), and The Center challenged that regulation.

The Court of Appeals Decision

The case presents the issue of whether FDA has the legal authority to ban an otherwise legal device for a particular intended use. The majority of the three-judge panel considered the statutory language (FDA may make “such device a banned device”) and concluded that “the natural reading of that language suggests 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.’”

In addition, the majority analyzed the language of the Practice of Medicine provision of the FD&C Act, which restricts FDA to construe any part of the FD&C Act to “limit or interfere” with a practitioner’s authority to prescribe or administer “any legally marketed device” to a patient.⁴  The majority agreed with The Center that banning a medical device for a particular use limits or interferes with the practice of medicine in violation of the FD&C Act, and vacated the FDA’s rule banning ESDs for self-injurious or aggressive behavior.

Chief Judge Sri Srinivasan filed a dissenting opinion, arguing that FDA has the authority to ban the device for a particular use, agreeing with the agency that it has the authority to regulate devices based on their specific intended uses. Judge Srinivasan pointed out that cranial electrotherapy stimulators are regulated by FDA as Class II devices when used to treat insomnia or anxiety, but are Class III devices when intended to treat depression.

AGG’s Analysis & Observations

• While the two statutes at issue in the case are medical device-specific, because the decision addresses a product’s intended use and regulation of the practice of medicine, it could potentially affect FDA’s authority over prescription drugs, including enforcement of off-label promotion.

• Intended use is a fundamental concept in the FD&C Act, FDA regulations, and food and drug case law. Intended use determines whether a product is regulated as a drug or medical device, and has significant implications for FDA’s regulatory scheme and about how manufacturers promote their products. The majority opinion is at odds with FDA’s longstanding view that the agency has the legal authority to distinguish between devices based on their intended use.

• The majority opinion is a narrow (textualist) interpretation of the Banned Device and Practice of Medicine provisions of the FD&C Act. In addition, it partly relies on federalism concerns, i.e., preserving the balance of power between the federal government and the states (the states have traditionally regulated the practice of medicine). The majority opinion views FDA’s rule as an attempt to regulate the practice of medicine: “Therefore, before we would permit the FDA to dictate whether practitioners may administer electrical stimulation therapy to self-injuring and aggressive patients, we would require an explicit statement from Congress to that effect.”

• The court’s reluctance to allow FDA to distinguish between different approved uses might have implications for FDA’s restrictions on the off-label promotion of drugs. Although the case and the statutes involved have no direct connection to drugs, litigants and courts will likely cite this decision to argue in favor of limiting FDA’s authority.

• For all the preceding reasons, we believe that the Department of Justice, on behalf of FDA, is likely to request a rehearing en banc (a hearing before the entire D.C. Circuit Court of Appeals). If a rehearing is denied, DOJ could consider an appeal to the U.S. Supreme Court.

[1] The Judge Rotenberg Educational Center, Inc. v. FDA, U.S. Court of Appeals for the D.C. Circuit, No. 20-1087.

[2] 21 C.F.R. § 882.5235.

[3] Section 516 of the FD&C Act (21 U.S.C. § 360f). FDA has used this authority only twice before for a type of hair implant and for the use of powdered gloves in surgery. The powdered glove ban similarly targeted a particular use of a device, but was never challenged in court.

[4] Section 1006 of the FD&C Act (21 U.S.C. § 396).