Appeals court overturns FDA’s ban of electric shock device

Regulatory NewsRegulatory News | 08 July 2021 |  By 

In a 2-1 decision, a federal court of appeals in Washington, DC struck down the US Food and Drug Administration’s (FDA) ban on electrical stimulation devices (ESDs) used at a single facility in Massachusetts to treat self-injurious behavior (SIB) or aggressive behavior (AB).
The US Court of Appeals for the DC Circuit, in siding with the plaintiffs, found that FDA’s ban on the devices for their particular use is not supported under statute and infringes on the practice of medicine.
FDA first proposed banning the Class II devices, also referred to as graduated electronic decelerators (GEDs), for SIB or AB in 2016 based on the recommendation of an advisory panel in 2014. In the Federal Register notice proposing the ban, FDA wrote the use of the devices to treat aggressive and self-injurious behavior poses “a substantial and unreasonable” risk to patients. FDA also said there was inconclusive evidence that the benefits of such treatment outweigh the risks.
Four years later, FDA banned the devices, which at the time were used solely by the Judge Rotenberg Educational Center (JRC) in Canton, MA to treat approximately 50 patients at the facility. The move marked only the third time the agency had banned a medical device after banning powdered gloves in 2016 and prosthetic hair fibers in 1983. (RELATED: FDA seeks ban on electric stimulation devices used in aversive therapy, Regulatory Focus 22 April 2016; FDA bans electrical stimulation devices for aggressive, self-injurious behavior, Regulatory Focus 4 March 2020)
In response, the Judge Rotenberg Center and the JRC Parents and Friends Association, Inc. challenged the ban in court and separately petitioned FDA to stay the ban’s provisions calling for patient-directed transition plans for devices in use on specific patients by September 2020. FDA granted the petitions in August 2020, citing the COVID-19 public health emergency. “The stay is in the public interest and interest of justice because of the ongoing national emergency,” the agency wrote, adding that it would substantively respond to the petitions after the public health emergency ends.
In its opinion, the court looks at two statutes underpinning the arguments in the case. The first, 21 USC  § 360f, grants FDA the authority to ban medical devices; the second, 21 USC § 396, prohibits FDA from regulating the practice of medicine.
In this instance, the court finds that FDA’s authority to ban devices does not extend to banning specific uses of legally marketed devices. “The statute states that the FDA may make ‘such device a banned device,’ and 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,’” the court writes.
The court also notes that section 396 “expressly denies the FDA authority to construe any part of the Food, Drug, and Cosmetic Act, including its authority to ban devices under section 360f, to permit FDA to,” limit or interfere with medical practitioners’ authority to prescribe or administer legally marketed devices.
Here, the court points out that the devices are still “legally marketed” because it is “legally marketed if it is lawful for a manufacturer to sell the device or a practitioner to prescribe or administer it,” citing other uses for ESDs, such as quitting smoking. “The statute does not suggest … a limitation that the device must be marketed for the particular use for which the practitioner wants to utilize the device,” the court said, arguing that such an interpretation would “eviscerate” protection of off-label use.
The court adds that had Congress intended for FDA’s banning authority to escape constraint by section 396, it could have done so via legislation.
“No one disputes that section 360f permits the FDA to ban a device completely. The FDA could even decline to approve a device in the first instance. The problem is that once the FDA approves a device and then tries to ban it for specific uses, it defies the limitation that section 396 imposes,” the court concludes.
The court also raises Federalism issues, noting that states have traditionally regulated the practice of medicine and citing Massachusetts’ “very active role in regulating the [Judge Rotenberg] Center’s use of electrical stimulation devices.”
In his dissenting opinion, Chief Judge Srinivasan argues that, “It is eminently reasonable—and entirely consistent with the statute’s purposes—to conclude that the FDA may impose a more targeted ban focused solely on a device’s unreasonably dangerous intended uses.”
US Court of Appeals for the DC Circuit


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