Filed Date: March 27, 2020
Case Ongoing
Clearinghouse coding complete
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 (“the 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. Behavioral Research Institute v. Secretary of Administration, Petition of Kaufman, and Judge Rotenberg Educational Center, Inc. v. Commissioner of the Department of Mental Retardation (see related cases), are some of the cases brought surrounding various issues related to JRC's use of aversive therapies and funding. 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 a 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 17-2092, 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 defendants moved for summary judgment on May 4, 2020. However, on August 24, 2020, Judge Howell issued an order staying the motion for summary judgment to allow the parties to narrow the issues remaining in the case.
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, 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 ruling of the D.C. Circuit vacating the FDA’s rule did not become final until February 2, 2022 (after the D.C. Circuit declined to rehear the case en banc and the FDA did not petition the Supreme Court for certiorari).
After the D.C. Circuit’s decision, the issues remaining related to outstanding FOIA requests of records that the defendants continued to withhold or were produced with redactions. On August 19, 2022, the plaintiffs moved to amend their complaint to add a new FOIA request submitted that year. However, Chief Judge Howell denied the plaintiffs’ motion to amend their complaint on November 1, 2022. The court began by noting that the case should be nearing a resolution, with only the defendants’ motion for summary judgment pending (which had been stayed in 2020). In a Rule 15(d) analysis, the court noted that the FOIA request at issue came nearly six years after the initial FOIA requests giving rise to this litigation, and that they were directed to purported lobbying efforts to have the vacated rule reestablished by legislative action. The court found that allowing the plaintiffs’ proposed supplement would (1) prevent the economic and speedy disposition of the existing controversy between the parties, (2) cause undue delay by further “putting off” the pending motion for summary judgment, and (3) prejudice the rights of the defendants. The court concluded by advising that if the plaintiffs were dissatisfied with the FDA’s response to their new FOIA request, the proper course of action would be to file a new lawsuit. 2022 WL 16845801.
On March 29, 2023, the plaintiffs filed a cross-motion for summary judgment. Both plaintiffs' and defendants’ motions for summary judgment remain and the case is ongoing as of June 2024.
Summary Authors
Jonah Hudson-Erdman (7/11/2021)
Jonah Hudson-Erdman (4/7/2022)
Stephanie Chin (3/17/2023)
Behavioral Research Institute v. Secretary of Administration, Massachusetts state trial court (1989)
Petition of Kaufman, Massachusetts state trial court (1991)
For PACER's information on parties and their attorneys, see: https://www.courtlistener.com/docket/59849295/parties/the-judge-rotenberg-education-v-fda/
Aguilar, Daniel (District of Columbia)
Attorney, Edward John (District of Columbia)
Attorney, Felicia H. (District of Columbia)
Attorney, Daniel J. (District of Columbia)
Attorney, Scott R. (District of Columbia)
Aguilar, Daniel (District of Columbia)
Baer, Michael Hendry (District of Columbia)
Bennett, Michelle (District of Columbia)
Berwick, Benjamin Leon (District of Columbia)
Braswell, Marina Utgoff (District of Columbia)
Burch, Alan R. (District of Columbia)
Burnham, James Mahoney (District of Columbia)
Caplen, Robert Aaron (District of Columbia)
Cirino, Paul (District of Columbia)
Clark, Andrew E. (District of Columbia)
Cohen, Jason Todd (District of Columbia)
Coles-Huff, Doris Denise (District of Columbia)
Cutini, Drake S. (District of Columbia)
Ellison, James Philip (District of Columbia)
Ellsworth, Felicia H. (Massachusetts)
Fowler, Adrienne Elise (District of Columbia)
Goulka, Jeremiah (District of Columbia)
Grogg, Adam (District of Columbia)
Gural, Roger Joseph (District of Columbia)
Hammond, Derek S. (District of Columbia)
Harvey, Gordon Michael (District of Columbia)
Haynes, Fred Elmore (District of Columbia)
Humphreys, Bradley P. (District of Columbia)
Kade, Elizabeth L. (District of Columbia)
Kell, Gerald Cooper (District of Columbia)
Kirschner, Adam D. (District of Columbia)
Kolsky, Joshua M. (District of Columbia)
Kopplin, Rebecca Michelle (District of Columbia)
Layton, Elisabeth (District of Columbia)
Littman, M. Jared (District of Columbia)
Lyons, Jane M. (District of Columbia)
Maier, Peter Rolf (District of Columbia)
McBarnette, Andrea (District of Columbia)
McIntosh, Scott R. (District of Columbia)
Momeni, Mercedeh (District of Columbia)
Myers, Steven A. (District of Columbia)
Nebeker, William Mark (District of Columbia)
Peterson, Benton Gregory (District of Columbia)
Pruski, Jacek (District of Columbia)
Russell, Beverly Maria (District of Columbia)
Samp, Richard A. (District of Columbia)
Scannapieco, Gabriel H. (District of Columbia)
Schaefer, Daniel Patrick (District of Columbia)
Seabrook, April Denise (District of Columbia)
Simon, Jeremy S. (District of Columbia)
See docket on RECAP: https://www.courtlistener.com/docket/59849295/the-judge-rotenberg-education-v-fda/
Last updated Dec. 16, 2024, 5:42 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 27, 2020
Case Ongoing: Yes
Plaintiffs
Plaintiff Description:
A nonprofit facility providing education and therapy for people with mental disabilities and several parents of patients at that facility.
Plaintiff Type(s):
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):
Facility Type(s):
Case Details
Causes of Action:
Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.
Special Case Type(s):
Appellate Court is initial court
Available Documents:
Outcome
Prevailing Party: Plaintiff
Nature of Relief:
Injunction / Injunctive-like Settlement
Source of Relief:
Issues
General/Misc.:
Informed consent/involuntary medication
Disability and Disability Rights:
Medical/Mental Health Care: