Judge Rotenberg Educ. Ctr., Inc. v. U.S. Food & Drug Admin.
This text of 376 F. Supp. 3d 47 (Judge Rotenberg Educ. Ctr., Inc. v. U.S. Food & Drug Admin.) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
BERYL A. HOWELL, Chief Judge *53Judge 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"),
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 *54and treatment-resistant" self-injurious behavior, are treated with the GED, which is an "electrical stimulation device."
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.
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.
For the year between March 2013 and April 2014, the FDA and JRC representatives did not communicate.
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BERYL A. HOWELL, Chief Judge *53Judge 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"),
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 *54and treatment-resistant" self-injurious behavior, are treated with the GED, which is an "electrical stimulation device."
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.
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.
For the year between March 2013 and April 2014, the FDA and JRC representatives did not communicate.
Two years after the panel convened, the FDA, on April 25, 2016, published the Proposed *55Ban, which, if finalized, would prohibit JRC's use of the GED.
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]."
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.
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."
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.
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.
DFOI made five separate productions to the plaintiffs: on September 7 and 28, 2016,
The OCC, for its part, made three productions of its own records to the plaintiffs on the following dates: December 4 and 22, 2017,
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,
The ORA made two productions to the plaintiffs: on June 4, 2018, of 10 redacted pages,
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.
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,
D. THE LITIGATION HISTORY
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 *57of 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 ,
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.
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 *58had 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.
The parties' cross motions for summary judgment are now ripe for resolution.2
II. LEGAL STANDARD
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. ,
FOIA was enacted "to promote the 'broad disclosure of Government records' by generally requiring federal agencies to make their records available to the public on request." DiBacco v. U.S. Army ,
FOIA authorizes federal courts to "enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld from the complainant."
III. DISCUSSION
The parties' cross-motions for summary judgment raise four categories of disagreements: (1) whether the defendants have impermissibly withheld non-responsive information contained in otherwise responsive records; (2) whether the defendants have properly invoked the deliberative-process privilege under FOIA Exemption 5, see
The D.C. Circuit recently clarified that an agency in receipt of a FOIA request need not produce non-responsive records, but must nonetheless release non-responsive information within a responsive record. Am. Immigration Lawyers Ass'n v. Exec. Office for Immigration Review ("AILA "),
"Although FOIA includes a definition section, [ 5 U.S.C.] § 551, that section provides no definition of the term 'record.' " AILA ,
Here, if the defendants had committed to a consistent understanding of when information should be treated as a single agency record, or separated into multiple agency records, that understanding could have prompted focused judicial review. Yet, the defendants' withholding of non-responsive information in this case suffers a more fundamental problem: midway through litigation the defendants reclassified collections of information that had been treated as one agency record as multiple agency records.
As the D.C. Circuit has said about an agency's determination of whether a document meets FOIA's definition of "agency record," courts must "be careful to ensure that '[t]he term 'agency records' ... not be manipulated to avoid the basic structure of the FOIA: records are presumptively *61disclosable unless the government can show that one of the enumerated exemptions applies.' " Consumer Fed'n of Am. ,
That the defendants have altered their conception of what constitutes a single record is evident from comparison of the defendants' second Vaughn Index and third Vaughn Index. Recall that FOIA requires agencies to account for records only if they are responsive to a request. See AILA ,
For example, the third Vaughn Index entry for an email attachment, Bates-stamped JRC OES Supplemental 1 001770-71, describes the email attachment as is its own record. See 3rd Index at 356-57. By contrast, in the earlier, second Vaughn Index, the agency described the same document as non-responsive, but "included in this production only because it is an attachment to an email that contains another attachment that includes responsive material." 2nd Index at 352-53. The second Vaughn Index reveals that the defendants viewed the email attachment as a piece of a single record that included the parent email and additional attachment. Otherwise, the record would not have been included in the index at all. Examples of a similar shift litter the indices. Compare 2nd Index at 335-36 with 3rd Index at 339-40; compare 2nd Index at 350-51 with 3rd Index at 354-55; compare 2nd Index at 352-53 with 3rd Index at 356-57; compare 2nd Index at 735-36 with 3rd Index at 752-53; compare 2nd Index at 781-82 with 3rd Index at 799-800.
The defendants' reclassifications are even more troubling because many were done to split emails and their attachments into multiple records. While emails and their attachments are not per se a single record, at a minimum "attachments should reasonably be considered part and parcel of the email by which they were sent" when the email "make[s] explicit reference to, or include[s] discussion of, the missing attachments."
*62Coffey v. Bureau of Land Mgmt. ,
Here, however, the defendants need not be given the chance to explain why some emails and attachments should be considered as distinct records because reclassifying records midway through litigation is improper. Accordingly, the defendants must release all records currently listed on the third Vaughn Index as being withheld for non-responsiveness that are not also subject to a FOIA statutory exemption.
B. THE FDA'S EXEMPTION 5 WITHHOLDINGS
FOIA Exemption 5 permits agencies to withhold "inter-agency or intra agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency."
"To qualify for the deliberative process privilege, an intra-agency memorandum must be both pre-decisional and deliberative." Abtew ,
To gauge whether the deliberative-process privilege has been asserted appropriately, the government must explain, for each withheld record, at least, (1) "what deliberative process is involved, ... (2) the role played by the documents in issue in the course of that process, ... and (3) the nature of the decisionmaking authority vested in the office or person issuing the disputed document[s], and the positions in the chain of command of the parties to the documents." Ctr. for Biological Diversity v. U.S. Envtl. Prot. Agency ,
Broadly, the defendants withheld under the deliberative-process privilege two groups of records: (1) those reflecting deliberations about regulatory and enforcement decisions and (2) drafts of documents.
*64Defs.' Mem. P. & A. Supp. Defs.' Mot. Partial Summ. J. ("Defs.' Mem.") at 26-27, ECF No. 25. The first group of documents generally relate to the "appropriateness of different regulatory approaches as well as opinions and recommendations about how to best effectuate the regulatory approaches being considered." Id. at 27. The defendants enumerate the specific decisions to which the records relate as including "whether to propose a ban of electrical stimulation devices," First DFOI Decl. ¶ 44; "the regulatory strategy the agency should take with respect to JRC and [electrical stimulation devices]," First NE-DO Decl. ¶ 24; "discussion about how to respond to JRC's request for a part 16 hearing," OCC Decl. ¶ 43; "discussions about appropriate follow-up activity following the 2014 advisory panel meeting," ORA Decl. ¶ 19; "the status of inspections of the [JRC]," id. ; the "FDA's draft proposed rule-making regarding [electrical stimulation devices]," HHS Decl. ¶ 21; and the decision to send a draft letter to the United States Special Rapporteur on Torture, Decl. of Nelson D. Hermilla, Department of Justice ("DOJ Decl.") ¶ 11, ECF No. 24-1. As for second group of records, drafts, although not deliberative per se, have been withheld to keep from public view editorial judgments that could be inferred from comparing a final record to a prior version. Defs.' Mem. at 27-28; see also First NE-DO Decl. ¶ 24.
The plaintiffs attack the defendants' withholdings under the deliberative-process privilege from several directions. First, the plaintiffs argue the defendants' descriptions of the basis for Exemption 5 withholdings is deficient because the defendants have excluded dates of records. Pls.' Mem. Supp. Cross-Mot. Summ. J. & Opp'n Defs.' Mot. Summ. J. ("Pls.' Opp'n") at 11-12, ECF No. 30. Second, the descriptions are inadequate for describing too generally the deliberative processes to which withheld records contributed. Id. at 20-21. Third, the defendants have omitted the decisionmaking authority of the individuals related to a record. Id. at 21-22. Fourth, the plaintiffs maintain that, insofar as can be discerned, the defendants have impermissibly applied Exemption 5 to draft documents, id. at 23-26, and to records that are not predecisional or are purely factual, id. at 26-29.
The Court considers each of the ways in which the defendants' Exemption 5 withholdings are insufficiently explained, and then defendants' application of Exemption 5 to draft documents. Review of whether withheld documents are actually predecisional, however, is not possible at this point because for many records the defendants have not explained the basis of the exemption well enough to assess whether it has been properly claimed.
1. The FDA's Omission of Dates
The plaintiffs contend that the absence of dates associated with records is a problem that renders the defendants' Vaughn indices "structurally deficient." Pls.' Opp'n at 10. Although the plaintiffs press the view that every Vaughn index must contain certain information, including, among other things, record dates, see id. at 10-12, a Vaughn index serves a function: to "justify [an agency's] actions without compromising its original withholdings by disclosing too much information." Judicial Watch, Inc. v. Food & Drug Admin. ,
Of course, when an agency uses a Vaughn index to justify withholdings, the index cannot be organized in a way that fails to "fulfill the purposes of ... providing sufficient information to the requester and the Court for a fair evaluation of the propriety of any withholding." Ctr. for Biological Diversity ,
At the same time, the defendants have applied Exemption 5 to some undated records. 2nd Index at 474-75, 732-33; 3rd Index at 481-82, 749-50.5 Without a date, the plaintiffs claim that "there is no way of knowing when ... this email was generated, and thus whether this email is actually predecisional." Pls.' Opp'n at 11. Yet, the D.C. Circuit has never imposed a categorical rule against undated entries. Judicial Watch I ,
In the end, as discussed in the next section, the defendants' Exemption 5 justifications may be inadequate, but the absence of a date is not the problem.
2. The FDA's Descriptions of the Deliberative Process
Moving to the decision processes to which withheld records relate, an agency's "Exemption 5 claims must be supported with specificity and [in] detail." Senate of Puerto Rico v. U.S. Dep't of Justice ,
The plaintiffs assert that some of the defendants' descriptions of the deliberative processes to which records contributed are too vague to permit the necessary analysis of whether withheld records are predecisional. Pls.' Opp'n at 20. The plaintiffs are right. Emblematic of the problem, the Vaughn indices' descriptions of the deliberative processes to which records contributed include an "action being taken on electrical stimulation devices," 2nd Index at 2-3; 3rd Index at 2-3; "possible actions," 2nd Index at 4-5; 3rd Index at 4-5; "agency action," 2nd Index at 8-9; 3rd Index at 8-9; "action regarding [electrical stimulation devices] (such as proposing a rule)," 2nd Index at 732-33; 3rd Index at 749-50; "numerous matters being worked on," 2nd Index at 1749-50; 3rd Index at 1797-98; "regulatory action FDA is considering," 2nd Index at 1065-66; 3rd Index at 1090-91. Despite the defendants' numerous declarations generally describing the deliberative process undertaken by various FDA, in many cases the defendants fail to link those descriptions with entries on the Vaughn Indices, thus impeding review of whether the record is in fact predecisional.
Nevertheless, the defendants stand by their nebulous descriptions, commenting that "a government agency invoking the [deliberative-process privilege] may rely on a relatively broad deliberative process that covers many documents if that is, in fact, the relevant process." Defs.' Reply at 17. Permissive rules are needed, in the defendants' view, to " 'encourage the candid and frank exchange of ideas' within agencies" and "to ensure that agencies do not have to 'operate in a fishbowl.' "
Each of the defendants' arguments is unavailing. First, referencing entries in which the deliberative process might have *67been described with the requisite level of detail is not a response to the inadequacy of the remaining descriptions. Second, the defendants' claim that whatever records have not been connected to an identifiable decisionmaking process should be treated as related to deliberation about the content of the Proposed Ban is unacceptable. See 100Reporters LLC , 248 F.Supp.3d at 153 ("Accepting DOJ and Defendant Intervenors' view of the deliberative process at issue would create a four-year umbrella effectively shielding all agency action from review without accounting for any subsidiary agency decisions."). If agencies could shield from review thousands of agency records because a years-long rule-making was underway, the deliberative-process privilege would be the exemption that ate the entire FOIA disclosure scheme. That simply will not do.
The defendants' effort to define the deliberative process so broadly is rejected because the withheld records may in fact pertain to a litany of subsidiary decisions that defendants fail to acknowledge. Indeed, although the agency, and not the requester, has the burden of justifying the exemptions, Pub. Citizen Health Research Grp. ,
The defendants must update their Vaughn Indices to identify with adequate specificity the agency decision to which a record relates.6
As for decisionmaking authority, the plaintiffs observe that the defendants have wholly "omitted information about the positions and responsibilities of the authors and recipients (other than some attorneys) of the records." Pls.' Opp'n at 22. The defendants do not dispute their omission, Defs.' Reply at 10-12, but bemoan the "extraordinary burden" if required "to provide a job description for each and every person who authored, sent, and/or received a document listed on the nearly 2,000-page index," id. at 11. In the alternative, the defendants propose that descriptions of decisionmaking authority are unnecessary to resolve the propriety of defendants' withholding under the deliberative-process privilege because the defendants otherwise connect the records to "ongoing work" on a final rulemaking or to "contemporaneous thoughts and opinions about plans for work that should be done to support FDA's efforts." Id. at 12. Moreover, the defendants dismiss the necessity of identifying the relationship between the individuals connected to a record if the author is plainly in an advice-giving role. Id. (citing Judicial Watch, Inc. v. U.S. Dep't of Justice ("Judicial Watch II "),
Contrary to the defendants' position, explaining decisionmaking authority is an essential ingredient to justifying withholdings under the deliberative process exemption. See Access Reports v. Dep't of Justice ,
Lastly, the effort that the defendants must undertake to identify the authority of individuals attached to a given record is not as daunting as defendants fear. While the defendants express trepidation about needing to "provide a job description for each and every person who authored, sent, *69and/or received a document listed on the nearly 2,000-page index," which surely would be a "Herculean" task, Defs.' Reply at 11, no such undertaking is necessary. The "key feature ... is the relation between the author and recipients of the document." Access Reports ,
Thus, the defendants next Vaughn Index must explain the dynamic between the author or individual sending, and the individuals receiving, the withheld record at issue to meet the requirement that record was part of the deliberative process.
4. Withholding of Draft Documents
Finally, the plaintiffs also contend that the defendants have improperly withheld draft documents under Exemption 5. See Pls.' Opp'n at 23-26. Documents designated as "drafts" are not per se covered under the deliberative-process privilege, but rather must meet the same two criteria as any other record. Arthur Andersen ,
The plaintiffs first argue that the "Defendants withheld drafts or parts of drafts that FDA ultimately adopted," or, at a minimum, the defendants have failed to establish otherwise. Pls.' Opp'n at 25; see also Pls.' Reply at 10 ("Defendants admit that information in several records 'may ... have been adopted in the government's final document.' " As examples, the plaintiffs cite: (1) three partially withheld drafts of letters subsequently sent to the United Nations Special Rapporteur on Torture, see 2nd Index at 139-40, 940-41, 963; 3rd Index at 140-41, 962-63, 985-86; (2) a partially withheld draft of "Key Messages and Responsive Q & A" which contained "talking points about the proposed rule," see 2nd Index at 288-89; 3rd Index at 290-91; (3) a fully withheld draft of the Proposed Ban, see 2nd Index at 474-75; 3rd Index at 481-82; and (4) a partially withheld draft of a Form 483, which captured observations made during an inspection of JRC's premises, see 2nd Index at 1607; 3rd Index at 1636-37. The defendants answer that "[a]t most, the plaintiffs show that some of the drafts contain views, opinions, or other material that was eventually reflected in the final agency document." Defs.' Reply at 23.
The defendants pick up on a nuance in the law governing FOIA's application to drafts that the plaintiffs skip past. A draft, as mentioned, even if once evincing deliberation, may "lose that status if it is adopted, formally or informally, as the agency position on an issue or is used by the agency in its dealings with the public." Arthur Andersen ,
Applying these principles first to the early drafts of the Proposed Ban, so long as a draft contributed to the deliberative back-and-forth, and was not formally or informally the agency's working law, that draft does not lose its character because the Proposed Ban paralleled a draft in some measure. Indeed, for the withheld draft that the plaintiffs cite, the defendants state explicitly that the draft was "not in its final form." 2nd Index at 474; 3rd Index at 481-82. Similarly, regarding the draft talking points cited by plaintiffs, the defendants explicitly state this document "contains redline edits and comment bubbles" and was later turned into a version of the agency's final position. 2nd Index at 288-89; 3rd Index at 290-91. As for the draft letters to the United Nations, the Index is explicit that the withheld drafts "contain[ ] comments from government employees suggesting certain changes to the draft letter before it is finalized" and explain that the letter was "subsequently finalized." See 2nd Index at 139-40, 940-41, 963; 3rd Index at 140-41, 962-63, 985-86. Finally, the entry for the Form 483 references the existence of a separate, final agency position and explains that changes between this draft and the final version would disclose "editorial judgments of government staff." 2nd Index at 1607; 3rd Index at 1636-37.
Separately, the plaintiffs accuse the defendants have applying the deliberative-process privilege to "draft records simply because they are drafts" or to records that are not actually drafts. Pls.' Opp'n at 23-24. The plaintiffs provide a single example of each. Yet, the FDA's Executive Summary prepared for the April 24, 2014 panel, the record allegedly withheld simply because it is a draft, was withheld because "[t]his redline draft contains editorial comments of agency staff" to be considered before the document was finalized. 2nd Index at 992-93; 3rd Index at 1015. That application of Exemption 5 is proper. The record that plaintiffs allege is not actually a draft is a version of Power Point, prepared to "brief[ ] the FDA Commissioner about a possible Proposed Rule." 2nd Index at 531-33; 3rd Index at 538-40. Here, the defendants not only claim that the record is a draft, but that comparison of this version to the final version could reveal "editorial decisions of agency staff." 2nd Index at 531-33; 3rd Index at 538-40. Indeed, other entries in the Vaughn Index reference a final version of this Power Point. See, e.g. , 2nd Index at 142-44; 3rd Index at 143-45.7
*71The defendants are entitled to partial summary judgment for the draft records withheld under Exemption 5.8
C. THE FDA'S EXEMPTION 6 WITHHOLDINGS
The plaintiffs also contest the sufficiency of the defendants' withholdings under Exemption 6, which permits agencies to withhold "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy."
Review of personal privacy withholdings under Exemption 6 proceeds in stages. Stage one requires the Court to "determine whether the [records] are personnel, medical or 'similar' files covered by Exemption 6." AILA ,
*72The defendants have applied Exemption 6 to personal or medical files that identify JRC patients. Defs.' Mem. at 30; Defs.' Reply at 31.10 As to step one, the defendants correctly state that Exemption 6 applies to those records because the statute explicitly covers medical files. Defs.' Mem. at 30; see also Defs.' Reply at 31. For step two, the defendants contend that releasing identifying information "would constitute a clearly unwarranted invasion of privacy," and the public has "no apparent interest in gaining access to the medical records of individual JRC patients." Defs.' Mem. at 30-31. Alternatively, the defendants assert that the public's interest in disclosure yields to the privacy interest. Id. at 31.
Relying on the D.C. Circuit's opinion in AILA , the plaintiffs answer that, at a minimum, the defendants have applied an impermissibly categorical approach to assessing the privacy interests implicated by records containing personally identifying information. Pls.' Opp'n at 33-35. In AILA , the requester had sought from the government records related to conduct of immigration judges.
Sure enough, the plaintiffs have identified ways in which the government's assessment of the competing public and private interests papers over important context for records related to at least five people whose names have been redacted from the produced records. First, several withheld records identify former JRC patients. See, e.g. , 2nd Index at 93-94, 130-31, 132-33; see also, e.g. , 3rd Index at 94-95, 131-32, 133-34. Importantly for the privacy interests at stake, some former JRC patients have been very vocal about their experiences at JRC, including speaking with media outlets, testifying at the April 2014 panel meeting, and posting videos about JRC to YouTube. Pls.' Opp'n at 36; Pls.' SMF ¶¶ 17, 21, 23, 24. Yet, none of the index entries describing documents that identify former patients appreciates that the patients' public comments might diminish their interest in guarding their identity. That context must be considered.
Similarly, a fourth individual for whom the defendants have redacted identifying information submitted a consumer complaint to the FDA about JRC's use of the GED and declared an intent to share "this issue with social media such as Facebook to make the public aware of this issue." Pls.' Decl., Ex. 27. Yet, the Vaughn Index entry for this record says no more than that releasing the complainant's name "would constitute a clearly unwarranted invasion of personal privacy." 2nd Index at 1502-04; 3rd Index at 1531-32. Missing from that analysis is any acknowledgment that the complainant expressed an intent to publicize his or her views. While defendants need not scour the internet to determine what public comments an individual identified in a responsive record has made, the government cannot meet its burden under Exemption 6 by ignoring information sitting on the face of the record.
Finally, the defendants redacted the name of a former JRC employee who agreed to be interviewed for a piece that ran on CBS. Pls.' Decl., Ex. 30. The JRC employee's name is redacted from an email that references the employee's participation in the CBS story, yet the corresponding index entry does not discuss the individual's privacy interest, let alone account for how the invited publicity might affect that privacy interest. 2nd Index at 827-28; 3rd Index at 845-55. Although the defendants now concede this particular redaction was improper, Defs.' Reply at 34 n.15, the third Vaughn Index does not reflect that the error has been corrected, 3rd Index at 845-55. This information must be disclosed, and the plaintiffs are, consequently, granted partial summary judgment as to this record.
Despite failing to take a nuanced approach to the Exemption 6 balancing analysis, the defendants repeat that they have properly applied Exemption 6 because "an individual does not forfeit all privacy interest merely by making some public statements." Defs.' Reply at 34. That response misses the point. The defendants have not met their burden because they have forgone a necessary step in Exemption 6's balancing standard-properly defining the interests on either side of the equation. Redacting the identities of individuals who have publicly associated themselves with the very views that redaction intends to shield, without considering how that welcomed publicity changes the privacy interest, improperly ascribes a uniform privacy interest to one's identity and ignores a fact that minimizes any asserted privacy interest. That tack does not survive AILA . See
The defendants must also take a more nuanced approach to assessing the public's interest in the disclosure of identities. AILA ,
To say that the defendants have not conducted the necessary balancing is not to say that the agency will not, eventually, be able to "support redacting identifying information in all cases if its justifications for doing so were framed in a more targeted manner." AILA ,
*75D. SEGREGABILITY
As for the last issue, segregability, FOIA requires that "[a]ny reasonably segregable portion of a record shall be provided to any person requesting such record after deletion of the portions which are exempt under this subsection."
The defendants here have provided a sufficiently detailed justification. The defendants have submitted eight affidavits, each certifying to the represented FDA or HHS component's performance of "a careful page-by-page, line-by-line review of all records." Defs.' Mem. at 33 (citing First DFOI Decl. ¶ 40; First NE-DO Decl. ¶ 20; OCC Decl. ¶ 39; DOJ Decl. ¶ 7; Decl. of Eric F. Stein, Department of State ¶ 11, ECF No. 24-8 ; ORA Decl. ¶ 15; HHS Decl. ¶ 15; First Community Living Decl. ¶ 15). The same affidavits confirm that all reasonably segregable information has been disclosed.
Thus, the Court finds that as to draft records withheld under Exemption 5's deliberative-process privilege, records withheld under Exemption 5's attorney-client privilege, records withheld under Exemption 6 to conceal personal information about low-level JRC employees and the contact information of government employees, and records withheld under Exemption 7(c), the defendants have released all segregable information.
Through no fault of either party, this case is onerous. Indeed, the plaintiffs' massive FOIA requests returned over 24,000 *76responsive records, to say nothing of the 60,000 records that CDRH is in the process of producing. Such broad requests are understandable given that the records relate to the agency's regulation, and possible ban, of a treatment practice that the plaintiffs adamantly believe in. Of course, the volume of records is so substantial only because the defendants have been diligently considering the need for regulation for quite some time.
Nevertheless, issues relevant to this litigation have not been presented with clarity and neither party is blameless. On the defendants' side, too much has been painted with too broad a brush. While the end, at least for now, of the defendants' regulatory work is the Proposed Ban, the defendants have made an awful lot of intermediary decisions to get from the point at which JRC did not have to obtain 510(k) clearance for the GED to proposing a rule that would ban the GED altogether. In making those decisions, the FDA consulted with many individuals, including former JRC patients. Certainly, as a baseline, all JRC patients have a privacy interest in their medical history, but some individuals can exhibit behaviors reflecting a lesser interest in maintaining that privacy. The plaintiffs have done no better, identifying general problems with the defendants' production but offering only a smattering of examples of those purported problems, which fall short of their obligation under Federal Rule of Civil Procedure 56. See, supra n.5. Consequently, the plaintiffs have provided insufficient precision as to how many records, or which records, the plaintiffs are actually challenging, other than the relatively small number from the voluminous Vaughn indices that are specifically cited in the briefing.
Shortcuts, especially with such a large body of records, are tempting, and in this case both parties have taken some. FOIA litigation works best, however, when the defendants are clear about how and why exemptions have been applied and the plaintiffs are clear about where they believe the defendants have gone wrong. Of course, going forward, the remaining issues in this case may be narrowed by the parties conferring about the production, with this Memorandum Opinion providing some guidance. If the parties require another round of summary judgment briefing, they must do better focusing on which withholdings are still contested. To that end, any subsequent Vaughn Index must plainly identify the records in dispute.
IV. CONCLUSION
For the foregoing reasons, the defendants' Motion for Partial Summary Judgment, ECF No. 25, is GRANTED in part and DENIED in part. The defendants are granted partial summary judgment for withholdings under Exemption 5's attorney-client privilege, for withholdings of draft records under Exemption 5's deliberative-process privilege, for withholdings under Exemption 6 that conceal the personal information of low-level JRC employees or the contact information of government employees, and for withholdings under Exemption 7(c). As for the remaining withholdings under Exemption 5's deliberative-process privilege and under Exemption 6, the defendants must supplement their Vaughn Index and/or declarations consistent with this Memorandum Opinion.
The plaintiffs' Cross-Motion for Partial Summary Judgment, ECF No. 30, is GRANTED in part and DENIED in part. The plaintiffs are granted summary judgment with respect to the defendants' withholding of non-responsive information. The defendants must produce all such records not otherwise being withheld under one of FOIA's statutory exemptions. The plaintiffs *77also are granted summary judgment as the record identifying the JRC employee who was interviewed by CBS, Bates-stamped JRC OES Supplemental 1 005549-53. The plaintiffs' cross-motion is otherwise denied.
The parties are directed to submit, by April 19, 2019, a joint status report as to the progress, if any, the parties have made to narrow the issues in dispute and to propose a schedule to govern further proceedings in this matter. If additional briefing will be required, the parties should provide their views on whether such briefing can be combined with any briefing that may be necessary regarding CDRH's response to the plaintiffs' FOIA requests.
An Order consistent with this Memorandum Opinion will be contemporaneously entered.
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 relate only to the records released by components in the first group.
The plaintiffs have requested a hearing, see Pls.' Cross-Mot. at 1, but that request is denied as unnecessary given the voluminous record in this case. LCvR 7(f) (authorizing oral hearings at "the discretion of the Court").
The plaintiffs have also challenged the defendants' failure to produce roughly 150 email attachments to records from the New England District Office, Pls.' Reply Supp. Cross-Mot. Summ. J. ("Pls.' Reply") at 20, ECF No. 35, which attachments originated with FDA's CDRH, First NE-DO Decl. ¶ 19. Those attachments have been referred to CDRH to be included in a future production. See Suppl. Decl. of Barbara A. Recupero, New England District Office ¶ 5, ECF No. 33-4. The plaintiffs contend that referral to CDRH is no substitute for releasing the attachments because the New England District Office "remains responsible for producing these attachments." Pls.' Reply at 20. Yet, "agencies that receive FOIA requests and discover responsive documents that were created by another agency may forward, or 'refer,' those requests to the agency that 'originated' the document." Elec. Privacy Info. Ctr. v. Nat'l Sec. Agency ,
Although the plaintiffs' motion for summary judgment challenged the defendants' withholdings under Exemption 5's attorney-client privilege, see Pls.' Opp'n at 29-31, the plaintiffs did not respond to any of the defendants' counter-arguments, see generally Pls.' Reply. Consequently, the plaintiffs have conceded the defendants' arguments. See Philipp v. Fed. Republic of Germany ,
The plaintiffs claim that "many entries in the Updated Index lack dates," but cite only a single example, see Pls.' Opp'n at 11 (citing 2nd Index at 732-33), leaving to the Court the task of sifting through the extensive Vaughn indices to find evidence of the plaintiffs' point. The plaintiffs are cautioned that, in any future round of summary judgment briefing, they must point to specific entries in the Vaughn indices to sustain any particular challenge to the sufficiency of the defendants' response to their FOIA requests. See Fed. R. Civ. P. 56(c)(3) ("The court need consider only the cited materials, but it may consider other materials in the record."); Fed. R. Civ. P. 56(c)(1)(A) (directing that the "party asserting that a fact ... is genuinely disputed must support the assertion by ... citing to particular parts of materials in the record"). Failure "to properly address another party's assertion of fact as required by Rule 56(c)," may result in any records not specifically challenged to be "undisputed for purposes of the motion." Fed. R. Civ. P. 56(e)(2).
Given the volume of withheld records and the length of the defendants' Vaughn Index, for clarity of the analysis in any future summary judgment briefing, records may be sequentially numbered with a unique document number that would make reference simpler and location on the Vaughn Index more readily accessible, than use of only a Bates-stamp number, and will permit the parties and the Court to appreciate the total number of disputed records at issue. For those records withheld under the deliberative-process privilege, the defendants may employ efficient methods of describing the decisions triggering application of Exemption 5. For example, the defendants could submit an affidavit listing all decisions to which the responsive records relate and include in the Vaughn Index a cross-reference to that affidavit or group the records on the Vaughn Index by the specific decisions to which they relate.
The plaintiffs also argue that this Power Point is unlikely to be predecisional because the presentation was organized more than a year after the FDA started drafting the Proposed Ban. Pls.' Opp'n at 24. By that logic, in which the relevant decision is the decision to initiate some process, the deliberative process would evaporate. Rather, the decision to which the Power Point contributed is the promulgation of the Proposed Ban, see 2nd Index at 531-33; 3rd Index at 538-40, a process which, at the time of the presentation to the FDA Commissioner, had not been completed.
To facilitate review of contested records in any subsequent round of summary judgment briefing, the defendants are directed to indicate in some manner on a subsequent version of the third Vaughn Index, or in a separate index, the specific record entries withheld under Exemption 5's deliberative-process privilege for which the defendants have been granted partial summary judgment.
The defendants stress that in Carter v. Department of Commerce ,
The defendants also withheld "the identities of lower-level employees of JRC and contact information of government employees in sensitive occupations," under Exemption 6. Defs.' Mem. at 31. The plaintiffs do not contest these withholdings. Pls.' Opp'n at 32-33 n.18. Thus, the defendants are granted partial summary judgment as to this category of Exemption 6 withholdings. To facilitate review of contested records in any subsequent round of summary judgment briefing, the defendants are directed to indicate in some manner on a subsequent version of the third Vaughn Index, or in a separate index, the specific record entries withheld under Exemption 6 to protect personal information about lower-level employees or contact information of government employees for which the defendants have been granted partial summary judgment.
The defendants also withheld some records pursuant to Exemption 7(c). Rather than present any argument as to these withholdings, the plaintiffs simply "reserve their right to advance this argument in the future." Pls.' Opp'n at 16 n.9. Such reservation of argument does not suffice to preserve the objection. Now was the time to challenge the defendants' withholdings and to move this case to resolution. See DeSilva v. U.S. Dep't of Hous. & Urban Dev. ,
Largely, the plaintiffs' segregability arguments are repackaged from their arguments against the application of the deliberative-process privilege. For example, the plaintiffs argue that factual and background information contained within records withheld under the deliberative-process privilege should be released. Pls.' Opp'n at 41-42. Given that the Court is not issuing a ruling on the deliberative-process privilege expect as to draft records, segregability issues as to these withholdings cannot be resolved at this juncture.
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