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Case Name Judge Rotenburg Center v. Food and Drug Administration ID-DC-0002
Docket / Court 20-1087 ( No Court )
State/Territory District of Columbia
Case Type(s) Intellectual Disability (Facility)
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 ... read more >
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. __ F.4th __, 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.

As of July 11, 2021 the case remains open, pending the disposition of any petitions for rehearing by the D.C. Circuit or certiorari by the U.S. Supreme Court.

Jonah Hudson-Erdman - 07/11/2021


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Issues and Causes of Action
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Issues
Defendant-type
Hospital/Health Department
Disability
Mental impairment
General
Aggressive behavior
Informed consent/involuntary medication
Medical/Mental Health
Self-injurious behaviors
Mental Disability
Autism
Plaintiff Type
Private Plaintiff
Special Case Type
Appellate Court is initial court
Type of Facility
Non-government non-profit
Causes of Action Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.
Defendant(s) Food and Drug Administration
Plaintiff Description A non profit facility providing education and therapy for people with mental disabilities and several parents of patients at that facility.
Class action status sought No
Class action status outcome Not sought
Filed Pro Se No
Prevailing Party Plaintiff
Public Int. Lawyer No
Nature of Relief Injunction / Injunctive-like Settlement
Source of Relief Litigation
Filed 03/26/2020
Case Ongoing Yes
Case Listing ID-MA-0002 : Judge Rotenberg Educational Center, Inc. v. Commissioner of the Department of Mental Retardation (State Court)
Court Docket(s)
U.S. Court of Appeals
07/06/2021
20-1087
ID-DC-0002-9000.pdf | Detail
Source: PACER [Public Access to Court Electronic Records]
General Documents
D.D.C.
03/21/2019
Memorandum Opinion [ECF# 39] (376 F.Supp.3d 47)
ID-DC-0002-0002.pdf | WESTLAW| LEXIS | Detail
Source: Google Scholar
U.S. Court of Appeals
07/06/2021
Opinion of the Court (3 F.4th 390)
ID-DC-0002-0001.pdf | WESTLAW| LEXIS | Detail
Source: Westlaw
show all people docs
Judges Howell, Beryl Alaine (D.D.C.) show/hide docs
ID-DC-0002-0002
Sentelle, David Bryan (W.D.N.C., D.C. Circuit) show/hide docs
ID-DC-0002-0001
Srinivasan, Srikanth (D.C. Circuit) show/hide docs
ID-DC-0002-0001
Plaintiff's Lawyers Cacace, Joseph M (Massachusetts) show/hide docs
ID-DC-0002-9000
Deal, Alexandra H (Massachusetts) show/hide docs
ID-DC-0002-9000
Flammia, Michael P (Massachusetts) show/hide docs
ID-DC-0002-0001 | ID-DC-0002-9000
Longosz, Edward John (District of Columbia) show/hide docs
ID-DC-0002-9000
Rodgers, Matthew D (Massachusetts) show/hide docs
ID-DC-0002-9000
Stephens, Christian (Massachusetts) show/hide docs
ID-DC-0002-9000
Stern, Max D. (Massachusetts) show/hide docs
ID-DC-0002-0001
Defendant's Lawyers Aguilar, Daniel (District of Columbia) show/hide docs
ID-DC-0002-0001 | ID-DC-0002-9000
Ellsworth, Felicia H. (Massachusetts) show/hide docs
ID-DC-0002-0001 | ID-DC-0002-9000
McIntosh, Scott R. (District of Columbia) show/hide docs
ID-DC-0002-9000
Samp, Richard A. (District of Columbia) show/hide docs
ID-DC-0002-0001 | ID-DC-0002-9000

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