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Judge Rotenberg Educational Center, Inc. v. U.S. Food and Drug Administration

United States District Court, District of Columbia

March 21, 2019




         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.

         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.


         “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), (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), 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), (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.


         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).


         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 (citing First DFOI Decl. ¶¶ 22-25). In addition, two HHS divisions outside the FDA agreed to produce records responsive to the First, Second, and Fourth Requests. Id. ¶ 20 (citing First DFOI Decl. ¶ 26). The Third Request was directed only to the CDRH's Division of Information Disclosure. Id. ¶ 18 (citing First DFOI Decl. ¶ 24). From September 2016 through July 2018, HHS and multiple FDA components produced records to the plaintiffs, as summarized below.

         DFOI made five separate productions to the plaintiffs: on September 7 and 28, 2016, id. ¶¶ 21, 23, 24 (citing First DFOI Decl. ¶¶ 31-34); on February 13, 2018, id. ¶ 30 (citing First DFOI Decl. ¶ 27); and on July 2 and 11, 2018, id. ¶ 28 (citing First DFOI Decl. ¶ 38). In total, DFOI produced roughly 10, 000 pages of redacted records.

         The OCC, for its part, made three productions of its own records to the plaintiffs on the following dates: December 4 and 22, 2017, id. ¶¶ 40, 45, 51 (citing Decl. of David Mednick, Office of the Chief Counsel (“OCC Decl.”) ¶¶ 17, 24, 31, ECF No. 24-4); and March 5, 2018, id. ¶ 53 (citing OCC Decl. ¶ 33). All told, the plaintiffs received, with redactions, “a total of over 2, 800 pages of OCC records.” Id. ¶ 58 (citing OCC Decl. ¶ 38). Separately, the OCC produced, on March 19, June 13, and June 18, 2018, after consultation with the Department of Justice (“DO J”), redacted records that had originated within DOJ. Id. ¶¶ 39, 41, 44, 46, 52, 55 (citing OCC Decl. ¶¶ 16, 18, 25, 32, 35). Likewise, the OCC released, on April 3, and May 14, 2018, after consultation with separate HHS divisions, 26 pages and 58 pages, respectively, of redacted records that originated within those divisions. Id. ¶¶ 41, 56, 73, 75 (citing OCC Decl. ¶¶ 19, 36; Decl. of Michael S. Marquis, Department of Health and Human Services (“HHS Decl.”) ¶¶ 7, 8, ECF No. 24-3). Finally, the OCC provided, on February 13, 2018, after consultation with the Department of State (“State”), redacted records that originated with State. Id. ¶¶ 47, 54 (citing OCC Decl. ¶¶ 26, 34).

         The New England District Office, too, had responsive records. That office made four productions to the plaintiffs on the following dates: on September 26, 2016, of 16 redacted pages, id. ¶¶ 60, 61 (citing First Decl. of Barbara A. Recupero, New England District Office (“First NE-DO Decl.”) ¶ 11, 12, ECF No. 24-7); on May 2, 2018, of 562 redacted pages, id. ¶ 65 (citing First NE-DO Decl. ¶ 18); and on June 15 and June 20, 2018, totaling 10, 205 redacted pages, id. (citing First NE-DO Decl. ¶ 18).

         The ORA made two productions to the plaintiffs: on June 4, 2018, of 10 redacted pages, id. ¶ 71 (citing Decl. of Melissa Pickworth, Office of Regulatory Affairs (“ORA Decl.”) ¶ 14, ECF No. 24-6); and on June 29, 2018, of 372 pages of redacted records, id. (citing ORA Decl. ¶ 14).

         Two HHS divisions outside the FDA produced records to the plaintiffs beyond the records released in consultation with the OCC. The first division-the Office of the Secretary-released 756 pages of redacted records, identified through an internal search, on June 15, 2018. Id. ¶ 78 (citing HHS Decl. ¶ 14). The second division-the Administration for Community Living-provided the plaintiffs, on July 6, 2018, with 485 pages of redacted records. Id. ¶ 82 (citing First Decl. of Richard Nicholls, Administration for Community Living (“First Community Living Decl.”) ¶ 11, ECF No. 24-5).

         In total, HHS divisions, both inside and outside the FDA, but excluding the CDRH, have produced 24, 241 pages of records to date. Pls.' SMF ¶ 39. Of those pages, approximately 12, 642 pages were redacted in full, id. ¶ 42, and another 1, 340 pages were redacted in part, id. ¶ 44.


         The FDA now has produced over 24, 000 pages, largely spurred on by the plaintiffs' instant lawsuit. Indeed, from the plaintiffs' submission of four FOIA requests between July and December 2016, to their initiation of this lawsuit in October 2017, see Compl., the defendants had released only 92 pages of records, Pls.' SMF ¶ 35.

         Shortly after the plaintiffs' filed their complaint, and after the Court instructed the parties to propose a briefing schedule to govern proceedings in this case, Min. Order (Dec. 7, 2017), the defendants started releasing records to the plaintiffs, as described supra in Section I.C. By January 2018, the defendants claimed that all FDA divisions other than the CDRH, which had not yet started releasing responsive documents, had responded in full to the plaintiffs' FOIA requests, see Suppl. Joint Meet & Confer Report at 8, ECF No. 16, a plainly erroneous claim given the productions subsequently made throughout 2018. At that time, the CDRH estimated that its search had uncovered roughly 60, 000 pages of records responsive to the plaintiffs' requests. Id. at 9.

         The apparent semi-complete nature of the production was too great an obstacle for the parties to agree on a schedule to govern proceedings in this case, see generally id., prompting the need for a status conference to accomplish that case management task, Min. Order (Jan. 19, 2018) (scheduling status conference); Min. Order (Jan. 25, 2018) (re-scheduling status conference). Following the February 2, 2018 status conference, the case was bifurcated. “CDRH and any other HHS component to which a referral has been made” were ordered to “make a rolling production of no fewer than 5, 000 pages per month to the plaintiffs, beginning on March 1, 2018, and continuing every sixty days thereafter until production is complete.” Min. Order (Feb. 2, 2018). Separately, the Court entered a scheduling order setting a deadline for the other defendants to file an index of documents withheld in full or in part-known as a Vaughn Index, see Vaughn v. Rosen, 484 F.2d 820 (D.C. Cir. 1973)-and deadlines for the parties to file dispositive motions “as to issues arising from the responses by each FDA component other than the [CDRH].” Min. Order (Feb. 2, 2018).

         The defendants filed their first Vaughn index by the initial deadline. See Original Vaughn Index, ECF No. 19-1. By agreement of the parties, however, see Joint Mot. Revise & Extend Scheduling Order, ECF No. 20, the scheduling order was modified to set a new deadline for an updated Vaughn index and the filing of dispositive motions, see Min. Order (Mar. 29, 2018). After additional extensions, the defendants moved for partial summary judgment, see Defs.' Mot., and provided an updated Vaughn Index, see Updated Vaughn Index (“2nd Index”), ECF No. 24-9. That index, totaling 1, 929 pages, gives a Bates-stamp number, description, date, author, recipients, the basis for withholdings, and the number of pages fully withheld, for all records withheld in full or in part. Id. The index confirms that the defendants have withheld records under three FOIA Exemptions: (1) FOIA Exemption 5's deliberative-process privilege and attorney-client privilege, 5 U.S.C. § 552(b)(5); (2) Exemption 6's shield for personnel, medical and similar files, “the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, ” id. § 552(b)(6); and (3) Exemption 7(c)'s protection for law enforcement records that “could reasonably be expected to constitute an unwarranted invasion of privacy, ” id. § 552(b)(7)(C), a narrower category of records implicating personal privacy interests than Exemption 6.

         After the plaintiffs filed their cross-motion for summary judgment, see Pls.' Cross-Mot., the defendants filed a third version of the Vaughn Index, 50 pages longer than the prior version, which corrected some problems that the plaintiffs had identified. See Suppl. Vaughn Index (“3rd Index”), ECF No. 33-2. That index is 1, 979 pages and, like the prior versions, gives for most withheld documents a Bates-stamp number, a description, the document's date, author and recipients, whether the document was withheld in part or in full, the basis for any withholding, and the number of pages fully withheld. Id.

         The parties' cross motions for summary judgment are now ripe for resolution.[2]


         Under Federal Rule of Civil Procedure 56, summary judgment shall be granted “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). “In FOIA cases, ‘summary judgment may be granted on the basis of agency affidavits if they contain reasonable specificity of detail rather than merely conclusory statements, and if they are not called into question by contradictory evidence in the record or by evidence of agency bad faith.'” Judicial Watch, Inc. v. U.S. Secret Serv., 726 F.3d 208, 215 (D.C. Cir. 2013) (quoting Consumer Fed'n of Am. v. U.S. Dep't of Agric., 455 F.3d 283, 287 (D.C. Cir. 2006)); see also Students Against Genocide v. Dep't of State, 257 F.3d 828, 833 (D.C. Cir. 2001) (“[A]n agency is entitled to summary judgment if no material facts are in dispute and if it demonstrates ‘that each document that falls within the class requested either has been produced . . ...

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