JUDGE ROTENBERG EDUC. v. U.S. FOOD AND DRUG ADMIN.

No. 20-1087 Consolidated with 20-1088.

3 F.4th 390 (2021)

The JUDGE ROTENBERG EDUCATIONAL CENTER, INC., Petitioner v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Respondents.

United States Court of Appeals, District of Columbia Circuit.

Decided July 6, 2021.


Attorney(s) appearing for the Case

Max D. Stern argued the cause for petitioners Luis Aponte, et al. With him on the briefs were Joseph M. Cacace , and Alexandra H. Deal .

Michael P. Flammia argued the cause for petitioner The Judge Rotenberg Educational Center, Inc. With him on the briefs were Christian B. W. Stephens , Matthew D. Rodgers , Edward J. Longosz, II , and Jeffrey N. Gibbs .

Richard A. Samp was on the brief for amicus curiae The New Civil Liberties Alliance in support of petitioners.

Daniel Aguilar , Attorney, U.S. Department of Justice, argued the cause for respondents. With him on the brief were Sarah E. Harrington , Deputy Assistant Attorney General, and Scott R. Mcintosh , Attorney.

Felicia H. Ellsworth was on the brief for amici curiae American Academy of Pediatrics, et al. in support of respondents.

Dissenting opinion filed by Chief Judge Srinivasan.


The Judge Rotenberg Educational Center and the parents and guardians of its patients both petition for review of a Food and Drug Administration (FDA) rule banning electrical stimulation devices used to treat aggressive or self-injurious behavior. In its rule, the FDA determined that the devices present an unreasonable...

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