United States District Court, District of Columbia
JUDGE ROTENBERNG EDUCATIONAL CENTER, INC. et al., Plaintiffs,
U.S. FOOD AND DRUG ADMINISTRATION and U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendants.
A. HOWELL CHIEF 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.
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. 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
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.
FDA'S RULEMAKING FOR ELECTRICAL STIMULATION
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).
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),
fication510k/default.htm (last visited Mar. 20, 2019). JRC
received that clearance in 1994. Pls.' SMF ¶ 3
(citing Food & Drug Admin., Premarket Notification
(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 &
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.
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).
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).
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.
THE PLAINTIFFS' FOIA REQUESTS
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).
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).
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).
THE FDA'S PROCESSING OF THE PLAINTIFFS' FOIA
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).
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.
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.
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).
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).
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).
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).
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.
THE LITIGATION HISTORY
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.
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.
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).
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.
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.
parties' cross motions for summary judgment are now ripe
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 . .