Case: Judge Rotenburg Center v. Food and Drug Administration

20-cv-01087 | U. S. Court of Appeals for the District of Columbia Circuit

Filed Date: March 26, 2020

Closed Date: Nov. 22, 2021

Clearinghouse coding complete

Case Summary

This case concerns the Food and Drug Administration’s (FDA) ability to ban the use of electrical stimulation devices to treat self-injurious or aggressive behavior. The petitioners are the Judge Rotenburg Center, a facility in Massachusetts that provides treatment and education to people with serious mental disabilities, like autism, and a group of parents of patients at the Center. The Center is the only place in the country where electrical stimulation is used to prevent self-harm or aggressi…

This case concerns the Food and Drug Administration’s (FDA) ability to ban the use of electrical stimulation devices to treat self-injurious or aggressive behavior. The petitioners are the Judge Rotenburg Center, a facility in Massachusetts that provides treatment and education to people with serious mental disabilities, like autism, and a group of parents of patients at the Center. The Center is the only place in the country where electrical stimulation is used to prevent self-harm or aggression in people with mental disabilities. This treatment functions by administering an electric shock to a patient when they behave in a certain way, thus discouraging or stopping the behavior. Using electrical shocks on people with disabilities is extremely controversial and the Center has been engaged in litigation since the 1980s with Massachusetts authorities about its use of “aversive therapies” like electrical stimulation. See ID-MA-0002. In fact, the Center’s present name comes from the state trial judge who enjoined the Commonwealth’s attempt to revoke its license to provide services in 1986.

On March 6, 2020, the FDA issued a ban on the device used by the Center to administer electrical stimulation treatment. The FDA had previously issued proposed ban of the device in 2016. The Center responded by filing a Freedom of Information Act request for records from the FDA related to the ban, which itself was the subject of litigation. See 376 F. Supp .3d 47. Shortly after the final ban was enacted, the facility and parents, represented by private counsel, filed a petition for review of the agency’s rule in the U.S. Court of Appeals for the D.C. Circuit. They argued that the FDA's ban was arbitrary and capricious, in violation of the Administrative Procedures Act and that the process which led to the ban was characterized by bad faith and undue political pressure.

The case was assigned to a panel consisting of Chief Judge Sri Srinivasan, and Judges Gregory G. Katsas and David B. Sentelle. The panel heard argument on April 23, 2021 and issued an opinion on July 6, 2021. 3 F.4th 390, 2021 WL 2799891. Judge Sentelle wrote the majority opinion, joined by Judge Katsas, vacating the FDA's rule. The majority found that the rule violated two statutes: 21 U.S.C. § 360f, which allows the FDA to ban medical devices and 21 U.S.C. § 396, which prevents the FDA from regulating the practice of medicine. In the majority’s view, the FDA’s choice to, in effect, ban the use of electrical stimulation to treat people with mental disabilities, but not other patients, overstepped its statutory authorities. Instead of banning a medical device, the FDA was impermissibly regulating the practice of medicine. It also noted that allowing FDA regulation of medical practice, an area traditionally left to state regulation, the rule raised federalism concerns. Chief Judge Srinivasan dissented, arguing that the FDA was permitted by statute to impose a more tailored ban on medical devices for particular purposes, given that was permitted to impose a blanket ban.

The same day the court issued its opinion, it also issued an order staying the mandate until the end of any rehearing procedures. However, on November 22, 2021, the full D.C. Circuit declined to hear the case en banc. The deadline for filing a petition for certiorari has now passed and the case is now closed.

Summary Authors

Jonah Hudson-Erdman (7/11/2021)

Jonah Hudson-Erdman (4/7/2022)

Related Cases

Judge Rotenberg Educational Center, Inc. v. Commissioner of the Department of Mental Retardation, Massachusetts state trial court (1986)

People


Judge(s)

Howell, Beryl Alaine (District of Columbia)

Sentelle, David Bryan (District of Columbia)

Srinivasan, Srikanth (District of Columbia)

Attorneys(s) for Plaintiff

Cacace, Joseph M (Massachusetts)

Deal, Alexandra H (Massachusetts)

Flammia, Michael P (Massachusetts)

Longosz, Edward John (District of Columbia)

Rodgers, Matthew D (Massachusetts)

Stephens, Christian (Massachusetts)

Stern, Max D. (Massachusetts)

Judge(s)

Howell, Beryl Alaine (District of Columbia)

Sentelle, David Bryan (District of Columbia)

Srinivasan, Srikanth (District of Columbia)

Attorneys(s) for Plaintiff

Cacace, Joseph M (Massachusetts)

Deal, Alexandra H (Massachusetts)

Flammia, Michael P (Massachusetts)

Longosz, Edward John (District of Columbia)

Rodgers, Matthew D (Massachusetts)

Stephens, Christian (Massachusetts)

Stern, Max D. (Massachusetts)

Attorneys(s) for Defendant

Aguilar, Daniel (District of Columbia)

Ellsworth, Felicia H. (Massachusetts)

McIntosh, Scott R. (District of Columbia)

Samp, Richard A. (District of Columbia)

Documents in the Clearinghouse

Document

Docket [PACER]

The Judge Rotenberg Education v. FDA

July 6, 2021 Docket
39

Memorandum Opinion

The Judge Rotenberg Educational Center v. United States Food and Drug Administration

U.S. District Court for the District of Columbia

376 F.Supp.3d 47

March 21, 2019 Order/Opinion

Opinion of the Court

The Judge Rotenberg Educational Center v. United States Food and Drug Administration

3 F.4th 390, 2021 WL 2799891

July 6, 2021 Order/Opinion

Docket

Last updated May 11, 2022, 8 p.m.

Docket sheet not available via the Clearinghouse.

State / Territory: District of Columbia

Case Type(s):

Intellectual Disability (Facility)

Key Dates

Filing Date: March 26, 2020

Closing Date: Nov. 22, 2021

Case Ongoing: No

Plaintiffs

Plaintiff Description:

A non profit facility providing education and therapy for people with mental disabilities and several parents of patients at that facility.

Plaintiff Type(s):

Private Plaintiff

Public Interest Lawyer: No

Filed Pro Se: No

Class Action Sought: No

Class Action Outcome: Not sought

Defendants

Food and Drug Administration (Washington, District of Columbia), Federal

Defendant Type(s):

Hospital/Health Department

Case Details

Causes of Action:

Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.

Special Case Type(s):

Appellate Court is initial court

Availably Documents:

Trial Court Docket

Any published opinion

Outcome

Prevailing Party: Plaintiff

Nature of Relief:

Injunction / Injunctive-like Settlement

Source of Relief:

Litigation

Issues

General:

Aggressive behavior

Informed consent/involuntary medication

Disability:

Mental impairment

Mental Disability:

Autism

Medical/Mental Health:

Self-injurious behaviors

Type of Facility:

Non-government non-profit