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# FDA ‘Fails to Follow Science’ in Electroshock Case: Attorneys
- URL: https://www.fdaweb.com/fda-fails-to-follow-science-in-electroshock-case-attorneys/
- Published: 2024-03-27T12:00:00.000Z
- Updated: 2026-09-14T14:26:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156641

Attorneys **Jeffrey Gibbs** (Hyman, Phelps & McNamara) and **Christian Stephens** (Eckert, Seamans, Cherin & Mellott) say FDA has failed to follow the science in its lengthy battle to prevent the Judge Rotenberg Educational Center (JRC) in Canton, MA, from using an electrical stimulation device (ESD or electroshock) to treat patients with self-injurious behavior or aggressive behavior (SIB/AB). Writing in a Washington Legal Foundation *Legal Backgrounder*, the two attorneys, who represented the Rotenberg Center in litigation against FDA, [say](https://www.wlf.org/2024/03/21/publishing/legal-backgrounders/fdas-misguided-quest-to-regulate-the-practice-of-medicine-implicates-federalism-concerns/?ref=fdaweb.com) the agency’s efforts to ban one specific use of an ESD “are not supported by science, impermissibly intrude on the ability of physicians to practice medicine, and run afoul of the 10th Amendment,” which enumerates federal powers.

The backgrounder describes the extensive review and planning that precedes any treatment plan for SIB/AB patients with ESD at the Rotenberg Center, including approval by a state court for each patient. It also notes that Massachusetts courts have upheld the use of aversives as a treatment methodology. (The ESD is placed on a patient’s body and can deliver a two-second shock to the surface of the patient’s skin to condition the patient not to engage in the unacceptable SIB/AB, the paper says.)

In 3/2020, FDA issued a final rule declaring that ESDs create an unreasonable and substantial risk of illness or injury when used for aversive therapy in SIB/AB cases, but not for any other use. The attorneys say the JRC challenged the rule in the DC Court of Appeals, which issued a 7/2021 decision invalidating the regulation.

After deciding not to appeal to the Supreme Court, the attorneys write, FDA “used informal backchannels to lobby Congress.” Congress refused to ban ESD use in SIB/AB cases as FDA requested, they say, but did agree to give FDA authority to ban specific intended uses of medical devices.

Phelps and Stephens say FDA has again proposed to ban ESDs used for aversive therapy in SIB/AB cases. “FDA’s decision to focus so much effort on the banning of one specific use of a device used at one facility to successfully treat the SIB/AB of approximately 50 total patients is baffling,” they write. “During FY 2022, FDA received nearly 3,000,000 reports of adverse events with devices. During that same period, and for years prior to that, there was not a single reported adverse event with an ESD at JRC. And the ESDs used at JRC, unlike most other medical devices, are subject to intense, ongoing judicial and regulatory scrutiny on the state level. This extensive scrutiny has not revealed any evidence of harm to patients when the devices are used as intended, while providing strong evidence of treatment effectiveness.”:

The paper also complains that FDA is regulating the practice of medicine by prohibiting practitioners from using an otherwise permissible and legal medical device only when treating a specific medical condition.