FDA Medical Device Ban Overturned For the First Time

July 7, 2021By Anne K. Walsh & Jeffrey N. Gibbs

In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban.  In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation.

The only place in the country that uses GEDs for SIB/AB is the Judge Rotenberg Educational Center in Massachusetts (JRC), and the patients it treats suffer from severe behaviors, such as head-banging or self-biting, that have not been resolved using conventional treatments.  FDA cleared 510(k)s for GEDs in the 1990s.  The use of GEDs by JRC is subject to extensive regulation by Massachusetts, including the need for a judge to authorize the treatment for any patient.  In 2018, a Massachusetts court upheld the use of GEDs in treating patients with SIB/AB, finding the device to be effective in treating refractory patients.

In April 2020, JRC and the parents and guardians of its patients petitioned the D.C. Circuit Court of Appeals to overturn the ban.  (Hyman, Phelps & McNamara helped represent JRC in this matter.)  Petitioners argued that the banning statute did not provide FDA authority to issue a use-specific ban, and that FDA’s ban on GEDs used for certain conditions, but not others, interfered with Congress’ explicit mandate in the Federal Food, Drug, and Cosmetic Act that “nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease . . . .”  21 U.S.C. § 396.  Petitioners also argued that the ban violated the Administrative Procedure Act in multiple respects, including the failure to consider all relevant information and the agency’s unexplained reversals in position.

In a 2-1 decision issued on July 6, 2021, the court granted the petitions for review and vacated FDA’s rule on the ground that FDA did not have legal authority to ban an otherwise legal device for a particular use.  Senior Circuit Judge Sentelle, who drafted the opinion, found determinative the statutory restriction prohibiting FDA from interfering in the practice of medicine:

When Congress has spoken in a statute, we assume that it says what it means and that the statute means what it says.  In this case, the statute says that the FDA is not to construe its statute so as to interfere with the practice of medicine.  That means that the FDA may not enact the regulation at issue before us.

The court clearly distinguished FDA’s authority to ban a device from being marketed at all, as compared to a ban on particular uses of a device that could continue to be marketed.

The court asked during oral argument, and mentioned again in its opinion, why FDA did not argue that Chevron deference applied to its action, as is typical in cases involving an agency’s interpretation of its statute.  The court noted, however, that even if the banning statute and the practice of medicine statute are unambiguous, “this does not mandate the FDA’s conclusion that the statute authorizes it to take this action,” i.e., banning GEDs only when used for the treatment of SIB/AB.

Noting that states have traditionally regulated the practice of medicine, the court also applied principles of federalism to support its conclusion: “Choosing what treatments are or are not appropriate for a particular condition is at the heart of 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.”  Thus, the court concluded that FDA has no authority to choose what medical devices a practitioner prescribes or administers to its patients, which is what the ban did.

In his dissent, Chief Judge Srinivasan wrote that FDA could exercise its banning authority in a more tailored fashion and that it was counterintuitive to read the statute as an “all-or-nothing banning power.”  Applying Chevron, Judge Srinivasan concluded that the practice of medicine statute does not unambiguously foreclose FDA’s position, and therefore the court must defer to FDA’s interpretation as long as it is reasonable and consistent with the statute’s purpose.

Given that FDA has only sought to ban devices two other times (prosthetic hair fibers and powdered gloves), the court’s construction of the relationship between the ban provision and section 396 may have limited effect.  Nevertheless, between its interpretation of the practice of medicine provision in section 396 and its strong invocation of federalism to protect the practice of medicine, the decision may curb FDA’s authority to regulate how clinicians treat their patients.

Categories: Medical Devices