UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA JUDGE ROTENBERNG EDUCATIONAL CENTER, INC. et al., Civil Action No. 17-2092 (BAH) Plaintiffs, Chief Judge Beryl A. Howell v. U.S. FOOD AND DRUG ADMINISTRATION and U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendants. MEMORANDUM OPINION Judge Rotenberg Educational Center, Inc. (“JRC”) is described as a non-profit treatment center for “patients who engage in self-injurious and aggressive behaviors.” Compl. ¶ 4, ECF No. 1. For some patients, JRC’s treatment regimen includes use of the Graduated Electronic Decelerator (“GED”), which is an “electrical stimulation device.” Id. ¶ 1. In 2016, the Food and Drug Administration (“FDA”), a division of the Department of Health and Human Services (“HHS”), published a proposed rule that would ban use of the GED. See Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior (“Proposed Ban”), 81 Fed. Reg. 24,386 (Apr. 25, 2016). Following publication of the Proposed Ban, JRC, as well as JRC Parents and Friends Association, Inc. (“Parents Association”), and Paul E. Peterson, who is the father of an adult patient at JRC and himself a member of the Parents Association (collectively, the plaintiffs), submitted requests under the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, to the FDA for records related to, among other things, the Proposed Ban, see Compl. ¶¶ 23, 35, 48. 1 Now, the defendants—the FDA and HHS—claim to have partially completed their response to the plaintiffs’ FOIA requests by producing, with appropriate withholdings, all responsive records.1 The plaintiffs, however, argue that the defendants have failed to justify, or misapplied, FOIA’s production exemptions in withholding certain responsive records and have otherwise withheld documents without any statutory authority. Accordingly, the parties have cross-moved for partial summary judgment. Defs.’ Mot. Partial Summ. J. (“Defs.’ Mot.”), ECF No. 25; Pls.’ Cross-Mot. Partial Summ. J. (“Pls.’ Cross-Mot.”), ECF No. 30. For the reasons set forth below, both the defendants’ motion and the plaintiffs’ cross-motion are granted in part and denied in part. I. BACKGROUND This section summarizes the regulatory history of the JRC’s GED, the plaintiffs’ FOIA requests, the defendants’ response to those requests, and the current litigation posture in this case. A. THE FDA’S RULEMAKING FOR ELECTRICAL STIMULATION DEVICES “JRC is a residential program” that treats patients “who engage in severe problem behaviors, including self-injurious behavior . . . and aggressive behavior.” Pls.’ Statement of Material Facts As To Which There Is No Genuine Dispute (“Pls.’ SMF”), ¶ 1, ECF No. 30 (citing Decl. of Glenda P. Crookes, Executive Director of JRC (“JRC E.D. Decl.”) ¶ 3, ECF No. 28-1). Forty-eight of JRC’s patients, “all of whom engage in life threatening and treatment- resistant” self-injurious behavior, are treated with the GED, which is an “electrical stimulation 1 On February 2, 2018, the case was bifurcated. See Min. Order (Feb. 2, 2018). “[E]ach FDA component other than the Center for Devices and Radiological Health (‘CDRH’)” was put on one production and briefing schedule; CDRH was put on another. Id. The pending motions ...
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