Judge Rotenberg Educ. Ctr., Inc. v. U.S. Food & Drug Admin.

• Citation: 376 F.Supp.3d 47
• Decision Date: 21 March 2019
• Docket Number: Civil Action No. 17-2092 (BAH)
• Parties: JUDGE ROTENBERG EDUCATIONAL CENTER, INC. et al., Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION and U.S. Department of Health and Human Services, Defendants.
• Court: U.S. District Court — District of Columbia

376 F.Supp.3d 47

JUDGE ROTENBERG EDUCATIONAL CENTER, INC. et al., Plaintiffs,

v.U.S. FOOD AND DRUG ADMINISTRATION and U.S. Department of Health and Human Services, Defendants.

Civil Action No. 17-2092 (BAH)

United States District Court, District of Columbia.

Signed March 21, 2019

Max D. Stern, Pro Hac Vice, Todd & Weld LLP, Michael P. Flammia, Pro Hac Vice, Eckert Seamans Cherin & Mellott, LLC, Boston, MA, Edward J. Longosz, II, Eckert Seamans Cherin & Mellott, LLC, Washington, DC, for Plaintiffs.

William Mark Nebeker, U.S. Attorney's Office for the District of Columbia, Washington, DC, for Defendants.

MEMORANDUM OPINION

BERYL A. HOWELL, Chief JudgeJudge 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.

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 device." Id. (citing JRC E.D. Decl. ¶ 3). For each patient, a probate judge has determined that electrical stimulation "is the most effective, least-restrictive treatment for [the patient's] severe behaviors." Id. (citing JRC E.D. Decl. ¶ 3).

JRC's treatment methods have been on the FDA's radar for nearly three decades. In 1991, JRC applied to the FDA for pre-market clearance, also known as 510(k) clearance, for the first version of the GED. Id. ¶ 3 (citing FOOD & DRUG ADMIN. , Premarket Notification 510(k) , https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K911820 (last visited Mar. 21, 2019) ). "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device," and is required when a manufacturer intends to introduce a medical device into distribution for the first time, or to introduce a device that has undergone changes since the previous clearance that might affect the device's safety or effectiveness. FOOD & DRUG ADMIN. , 510(k) Premarket Notification 510(k) , https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNoti fication510k/default.htm (last visited Mar. 20, 2019). JRC received that clearance in 1994. Pls.' SMF ¶ 3 (citing FOOD & DRUG ADMIN. , Premarket Notification 510(k) , https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K911820 (last visited Mar. 21, 2019) ). In 2000, after JRC had substantially modified the GED, the FDA, following an inspection of JRC's premises, advised that JRC need not obtain a new 510(k) clearance. Id. ¶ 5 (citing Decl. of Matthew D. Rodgers, plaintiffs' counsel ("Pls.' Decl."), Ex. 34, ECF Nos. 28-2 & 28-3).

A decade later, the FDA notified JRC that, although the FDA told JRC in 2000 that "GED devices were exempt from the 510(k) requirement ... [w]e have learned that this is not accurate." Pls.' Decl., Ex. 37; see also Pls.' SMF ¶ 8. The FDA explained that GEDs are "devices" under the Food, Drug and Cosmetic Act and must receive 510(k) clearance before marketing. Pls.' Decl., Ex. 37. Thus, the JRC was told to submit new 510(k) paperwork for the GED because of modifications made since 1994. Pls.' Decl., Ex. 37; see also Pls.' SMF ¶ 8.

At the FDA's request, JRC provided a "pre-submission" in February 2013 in anticipation of JRC's eventual 510(k) application. Pls.' SMF ¶ 13 (citing Pls.' Decl., Ex. 1). The parties set a meeting for March 25, 2013 to discuss the pre-submission, but the FDA cancelled the meeting shortly before the scheduled date. Id. ¶¶ 13–14 (citing Pls.' Decl., Ex. 2). Around the same time, the FDA met with "anti-aversive advocacy groups" and several former JRC patients. Id. ¶¶ 15–16 (citing Pls.' Decl., Ex. 12).

For the year between March 2013 and April 2014, the FDA and JRC representatives did not communicate. Id. ¶ 20 (citing JRC E.D. Decl. ¶ 7). In April 2014, JRC received notice that a committee of the FDA's Center for Devices and Radiological Health ("CDRH") had organized a panel on neurological devices, which panel convened on April 24, 2014, id. (citing JRC E.D. Decl. ¶ 7), and heard testimony, inter alia , from two former JRC patients and one former JRC employee, id. ¶ 21 (citing Pls.' Decl., Ex. 21). The panel was divided on the health benefits of the GED. Id. ¶ 22 (citing Proposed Ban, 81 Fed. Reg. at 24401 ).

Two years after the panel convened, the FDA, on April 25, 2016, published the Proposed Ban, which, if finalized, would prohibit JRC's use of the GED. Id. ¶ 25 (citing Proposed Ban, 81 Fed. Reg. at 24,393 ). The FDA has not published a final rule. Id. ¶ 27.

B. THE PLAINTIFFS' FOIA REQUESTS

Nearly three months after the FDA published the Proposed Ban, Peterson submitted, on July 19, 2016, six identical FOIA requests to the FDA and five FDA components ("First Request"). Defs.' Statement Of Material Facts As To Which There Is No Genuine Issue ("Defs.' SMF") ¶ 2 (citing Compl., Exs. A-1 – A-6, ECF Nos. 1-1 – 1-6). The First Request asked for records about, among other things, "FDA inspections of JRC; the Neurological Devices Panel of the Medical Devices Advisory Committee; and FDA's proposed ban of [electrical stimulation devices]." Id. (citing Compl., Exs. A-1 – A-6, ECF Nos. 1-1 – 1-6). The FDA, consistent with internal regulations, consolidated these requests for processing. Id. ¶ 3 (citing First Decl. of Sarah Kotler, Division of Freedom of Information ("First DFOI Decl.") ¶ 15, ECF No. 24-2 ).

Peterson sent two additional FOIA requests to the FDA on August 23, 2016. One of these requests sought, among other things, records dating back to 2012 of meetings between FDA employees and stakeholders in electrical stimulation devices; of communications between the FDA and other divisions of HHS about electrical stimulation devices; of literature analyzing electrical stimulation devices that the FDA received or created; and of communications or records between FDA employees and former patients of JRC. Id. ¶ 4 (citing Compl., Ex. F ("Second Request"), ECF No. 1-11 ). The other request sought "materials related to expert opinions from three individuals about electrical stimulation devices." Id. ¶ 5 (citing Compl., Ex. H ("Third Request"), ECF No. 1-13 ).

Finally, on December 27, 2016, JRC submitted a letter that the FDA treated as a FOIA request ("Fourth Request"), in which JRC sought "information related to statements made in FDA's Federal Register notice announcing a proposed ban on electrical stimulation devices." Id. ¶ 6 (citing Compl., Ex. J, ECF No. 1-15 ). The Parents Association sent a letter on February 27, 2017, joining the Fourth Request. Pls.' SMF ¶ 33 (citing Compl., Ex. M, ECF No. 1-8 ).

C. THE FDA'S PROCESSING OF THE PLAINTIFFS' FOIA REQUESTS

When the FDA receives a FOIA request, the FDA's Division of Freedom of Information ("DFOI"), the unit responsible for the FOIA compliance, directs the request to the FDA components most likely to possess responsive records. Defs.' SMF ¶¶ 7, 11 (citing First DFOI Decl. ¶¶ 7, 11). DFOI also is tasked with locating any responsive records that have been previously produced in response to separate FOIA requests. Id. ¶ 12 (citing First DFOI Decl. ¶ 11).

After receiving the plaintiffs' four FOIA requests, DFOI distributed the First, Second and Fourth Requests to four FDA components: the Office of the Chief Counsel ("OCC"), the New England District Office, the CDRH's Division of Information Disclosure, and the Office of Regulatory Affairs ("ORA"), so that each could search for responsive documents. Id. ¶¶ 16–19 (ci...