Court filing

FDA brief supporting Rule 59(e) motion to alter judgment — PHMPT v. FDA

Record facts

Court	U.S. District Court for the Northern District of Texas
Filed	2025-01-03

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 104 · 2025-01-03 · Docket on CourtListener

Summary

The FDA's brief in support of its motion to alter or amend judgment under Federal Rule of Civil Procedure 59(e) in Public Health and Medical Professionals for Transparency v. United States Food and Drug Administration, Civil Action No. 4:21-cv-01058-P, in the U.S. District Court for the Northern District of Texas, filed January 3, 2025 as Document 104. It asks the court to stay the June 30, 2025 deadline in the December 6, 2024 Order for processing the emergency use authorization file until production concludes in PHMPT II, No. 4:22-cv-915-P, and then to set a rate of 55,000 pages per month. It argues exceptional circumstances and due diligence under 5 U.S.C. § 552(a)(6)(C)(i) and invokes the court's inherent authority under Landis v. N. Am. Co. It states that the December 6, 2024 Order adds at least 589,600 pages to the agency's processing obligations. The brief is 30 pages.

Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used

Full text

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
___________________________________

)
PUBLIC HEALTH AND MEDICAL
)
PROFESSIONALS FOR

)
TRANSPARENCY

)

Plaintiff,
)

)
v.

) Civil Action No. 4:21-cv-01058-P

)
UNITED STATES FOOD AND DRUG
)
ADMINISTRATION,

)

Defendant.
)
___________________________________ )

DEFENDANT’S BRIEF IN SUPPORT OF MOTION TO ALTER OR AMEND
JUDGMENT PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 59(e)

Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 1 of 30 PageID 2763

TABLE OF CONTENTS
I.
INTRODUCTION .............................................................................................................. 1
II.
BACKGROUND ................................................................................................................ 2
III.
LEGAL STANDARDS ...................................................................................................... 7
A. Legal Standard Under 5 U.S.C. § 552(a)(6)(C)(i) ................................................... 7
B. Inherent Authority to Stay Proceedings under Landis ........................................... 10
IV.
ARGUMENT .................................................................................................................... 11
A. The Court Should Alter or Amend the December 6, 2024 Order by
Granting the Requested Stay Under 5 U.S.C. § 552(a)(6)(C)(i) Because
FDA Can Demonstrate “Exceptional Circumstances” and “Due
Diligence.” ............................................................................................................ 11
1.
This Court’s PHMPT II Order Requiring Production of at Least
180,000 Pages Per Month until June 30, 2025, and Other Increased
Obligations, Constitute “Exceptional Circumstances.” ............................ 12

2.
FDA is Exercising “Due Diligence.” ........................................................ 16

B.
Landis Also Supports the Court Altering or Amending the December 6,
2024 Order by Granting the Request to Stay. ....................................................... 20

C. FDA Must Exercise Due Care in its Processing of Potentially Responsive
Records. ................................................................................................................ 22
D.
Alteration or Amendment of the December 6, 2024 Order is Appropriate
to Correct Clear Error and/or Prevent Manifest Injustice. .................................... 22
V.
CONCLUSION ................................................................................................................. 24

Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 2 of 30 PageID 2764

TABLE OF AUTHORITIES
Cases

Page(s)
Appleton v. FDA,
254 F. Supp. 2d 6 (D.D.C. 2003) .............................................................................................. 10
Belize Soc. Dev. Ltd. v. Gov’t of Belize,
668 F.3d 724 (D.C. Cir. 2012) .................................................................................................. 20
Brown v. Lumpkin,
Civ. A. No. 19-2301, 2021 WL 3847491 (N.D. Tex. Aug. 27, 2021) ...................................... 20
Campaign for Accountability v. Dep’t of Just.,
280 F. Supp. 3d 112 (D.D.C. 2017) .......................................................................................... 10
Child.’s Health Def. v. FDA,
Civ. A. No. 23-0220 (RDM), 2024 WL 147851 (D.D.C. Jan. 12, 2024) ............................. 5, 16
Child.’s Health Def. v. CDC,
Civ. A. No. 23-0431 (TNM), 2024 WL 3521593 (D.D.C. July 24, 2024) ..................... 5, 11, 21

Democracy Forward Found. v. Dep’t of Just.,
354 F. Supp. 3d 55 (D.D.C. 2018) ........................................................................................ 9, 10
Eakin v. U.S. Dep’t of Defense,
Civ. A. No. 16-972-RCL, 2017 WL 3301733 (W.D. Tex. Aug. 2, 2017) .................................. 8
Edward H. Bohlin Co. v. Banning Co.,
6 F.3d 350 (5th Cir. 1993) .......................................................................................................... 7
Elec. Frontier Found. v. Dep’t of Just.,
517 F. Supp. 2d 111 (D.D.C. 2007) ...................................................................................... 8, 15
Elec. Frontier Found. v. Off. of Dir. of Nat’l Intel.,
Civ. A. No. 08-1023, 2009 WL 773340 (N.D. Cal. Mar. 23, 2009) ......................................... 11
Energy Future Coal. v. Off. of Mgmt. & Budget,
200 F. Supp. 3d 154 (D.D.C. 2016) ................................................................................ 9, 10, 17
Food Mktg. Inst. v. Argus Leader Media,
588 U.S. 427 (2019) .................................................................................................................. 22
Huddleston v. FBI,
Civ. A. No. 20-0447, 2021 WL 1837548 (E.D. Tex. May 7, 2021) ......................................... 11
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 3 of 30 PageID 2765

iii

In re Benjamin Moore & Co.,
318 F.3d 626 (5th Cir. 2002) ...................................................................................................... 7
Jones v. Stephens,
998 F. Supp. 2d 529 (N.D. Tex. 2014) ....................................................................................... 7
Landis v. N. Am. Co.,
299 U.S. 248 (1936) ........................................................................................................ 2, 10, 20
Nat’l Sec. Archive v. SEC,
770 F. Supp. 2d 6 (D.D.C. 2011) ................................................................................................ 9
Open Am. v. Watergate Special Prosecution Force,
547 F.2d 605 (D.C. Cir. 1976) .................................................................................................... 8
Shapiro v. Dep’t of Just.,
Civ. A. No. 12-313 (BAH), 2014 WL 12912625 (D.D.C. Dec. 8, 2014) ................................... 8
Statutes
5 U.S.C. § 552(a)(6) ............................................................................................................... passim

Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 4 of 30 PageID 2766

I.
INTRODUCTION

The U.S. Food and Drug Administration (“FDA”) is undertaking unprecedented efforts to
process federal records related to the development of COVID-19 vaccines under the Freedom of
Information Act (“FOIA”). See Hr’g Tr. Jan. 28, 2022 at 9:19–23, ECF No. 58. Despite this
extraordinary effort, however, FDA cannot meet the Court’s most recent production deadline in
this case while complying with the current production deadline in PHMPT v. FDA, No. 4:22-cv-
915-P (N.D. Tex.) (“PHMPT II”). This Court has not considered the agency’s ability to comply
with such a deadline while working at full capacity to satisfy the production mandate already
imposed in PHMPT II. Accordingly, for the reasons discussed below, Defendant FDA
respectfully moves, under Federal Rule of Civil Procedure 59(e), to alter or amend the June 30,
2025 production deadline set forth in the Court’s December 6, 2024 Order regarding the
emergency use authorization (“EUA”) file, see ECF No. 101 at 9, for the original Pfizer COVID-
19 vaccine for individuals 16 years old and older. Defendant requests that the Court stay the June
deadline until the conclusion of production in PHMPT II. Defendant further proposes that, within
14 days of completion of production in PHMPT II, the parties file a joint status report advising
the Court and setting forth a proposed processing schedule for the responsive EUA file at a rate of
55,000 pages per month. See ECF No. 35; ECF No. 56 (modifying Jan. 2022 Order in part).
Alteration or amendment of the December 6, 2024 Order is warranted to correct clear error
and/or prevent manifest injustice, given that the Court never considered the timing necessary to
search for and process further records, the availability of agency resources, or the agency’s other
processing obligations and responsibilities under FOIA. A stay of the deadline is also appropriate
because (1) “exceptional circumstance exist” given this Court’s production Order in PHMPT II,
the agency’s other essential FOIA obligations, and the fact that the Court’s December 6, 2024
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 5 of 30 PageID 2767

Order in this case—PHMPT v. FDA, No. 4:22-cv-1058-P (N.D. Tex.) (“PHMPT I”)—adds at least
589,600 pages to the agency’s processing obligations through June 30, 2025, and (2) FDA “is
exercising due diligence in responding to the [FOIA] request,” given its extraordinary efforts to
hire, train, and otherwise maximize efficiencies to comply with this Court’s Orders in PHMPT I
and PHMPT II and its other FOIA obligations, and the fact that it has a multi-track process for
handling FOIA requests in which requests in each queue are generally assigned to reviewers for
processing on a first-in, first-out basis. 5 U.S.C. § 552(a)(6)(C). Alternatively, the Court may
grant the requested stay using “the power inherent in every court to control the disposition of the
causes on its docket with economy of time and effort for itself, for counsel, and for litigants.”
Landis v. N. Am. Co., 299 U.S. 248, 254 (1936).
The requested stay will help Defendant triage its limited resources while complying with
this Court’s substantial production Order in PHMPT II. The requested alteration of the June 30,
2025 deadline will also better ensure that, when the agency is able to turn to the responsive EUA
file records, it can conduct a careful review to determine releasability. Nine courts have
considered similar motions requesting litigation stays in light of this Court’s prior production
Orders in this case and in PHMPT II and have entered stays ranging from six months to eighteen
months. No court has denied a stay. As in those cases, these circumstances justify a stay of the
June 30, 2025 production deadline set forth in the Court’s December 6, 2024 Order. In support of
this motion, Defendant also includes a declaration from Suzann Burk (“Burk Decl.”), Director of
the Division of Disclosure and Oversight Management in FDA’s Center for Biologics Evaluation
and Research (“CBER”).
II.
BACKGROUND
This case concerns Plaintiff’s FOIA Request for “[a]ll data and information for the Pfizer
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 6 of 30 PageID 2768

Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on
the Vaccine Adverse Events Reporting System.” See Pl.’s FOIA Request, ECF No. 1-1 at 1.
Plaintiff’s FOIA Request further clarified that (a) “Pfizer Vaccine” meant “the Pfizer-BioNTech
COVID-19 Vaccine, marketed as Comirnaty . . . for individuals 16 years of age and older” and
(b) its Request “includ[ed] but [was] not limited to all data and information in the biological
product file, as defined in 21 C.F.R. § 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R.
§ 601.51(e).” In January 2022, the Court ordered FDA to process approximately 55,000 pages of
records responsive to this Request every 30 days, an order which the Court acknowledged to be
“unprecedented” at the time. ECF No. 35 at 3; see also ECF No. 56. In compliance with the
Court’s Orders, the “FDA . . . produced some 1,200,874 pages of responsive records.” ECF No.
101 at 2. After this processing was complete, the parties reached an impasse over whether FDA
had reasonably understood the scope of Plaintiff’s FOIA Request to seek only data and
information in the biological product file, as defined in 21 C.F.R. § 601.51(a), for the Pfizer-
BioNTech Comirnaty vaccine approved for individuals 16 years of age and older. Plaintiff argued
that the EUA file for Pfizer’s COVID-19 vaccine authorized for individuals 16 years of age and
older was also responsive to its Request. Summary judgment briefing to resolve the issue
followed. See ECF Nos. 90–100. In its summary judgment briefing, Plaintiff requested a February
20, 2025 production deadline, to which FDA responded that such a deadline was not possible. See
ECF No. 94 at 22; ECF No. 99, Ex A. ¶ 27. The parties did not otherwise address the time and
resources that would be necessary to process further records in this case, nor was the Court updated
on the substantial efforts the agency has taken to comply with the production mandate in PHMPT
II as well as other essential FOIA obligations. On December 6, 2024, the Court granted Plaintiff’s
motion for summary judgment and ordered FDA to process the “responsive EUA file,” by no later
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 7 of 30 PageID 2769

than June 30, 2025. ECF No. 101 at 9.
Since January 2022, CBER’s Access Litigation and Freedom of Information Branch
(“ALFOI”) has been working at full capacity to satisfy the productions ordered by this Court in
PHMPT I and PHMPT II, as well as other essential FOIA obligations. Burk. Decl. ¶ 6 (App’x
002). Collectively, this Court’s prior Orders in PHMPT I and PHMPT II have required ALFOI to
process at least an average of 55,000 pages per month from March 2022 to June 2023; 90,000 to
110,000 pages per month from July 2023 to November 2023; and, starting in December 2023, at
least 180,000 pages per month until June 2025. See Order at 1, PHMPT I, ECF No. 56, Feb. 2,
2022; Order at 1–2, PHMPT II, ECF No. 38, June 12, 2023. Due to the number of estimated pages
left to produce in PHMPT II, however, ALFOI will need to produce an average of more than
230,000 pages per month to meet the Court’s June 30, 2025 production deadline in that case. Burk
Decl. ¶ 6 (App’x 003). As of January 2, 2025, between this case and PHMPT II, the Plaintiffs
have received approximately 4.5 million pages of records related to COVID-19 vaccines, with at
least 1.2 million pages of records still to be processed in PHMPT II. Id. ¶ 19 (App’x 010). These
substantial productions have come alongside a backdrop of other increased workload obligations,
including an increase in FOIA requests and FOIA litigation stemming, in large part, from requests
related to FDA’s work pertaining to the COVID-19 pandemic. Id. ¶ 6 (App’x 003); see also id.
¶¶ 15–18 (App’x 008–010). The Court’s December 6, 2024 Order adds, at a minimum, 589,600
pages to ALFOI’s processing obligations through June 30, 2025 in this case. Id. ¶ 6 (App’x 003).
As a result of the exceptional circumstances posed by this Court’s production Orders in
PHMPT I and PHMPT II, FDA and/or the U.S. Department of Health and Human Services
(“HHS”) have moved for eighteen-month stays in thirteen FOIA cases seeking CBER-maintained
records. Id. ¶ 26 (App’x 014). Every court that has considered the stay motion has granted it in
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 8 of 30 PageID 2770

whole or in part. See Wright v. Dep’t of Health & Hum. Servs., Civ. A. No. 22-1378 (RC), ECF
No. 28 (D.D.C. Oct. 13, 2023) (granting unopposed motion for eighteen-month stay); Informed
Consent Action Network (“ICAN”) v. FDA, Civ. A. No. 23-0219 (RBW), ECF No. 27 (D.D.C.
Nov. 21, 2023) (vacating all pending deadlines and setting status conference in six months), ECF
No. 29 (D.D.C. May 24, 2024) (extending stay, with status conference in six months), (Nov. 25,
2024) (minute order extending stay, with status conference in approximately seven months);
Children’s Health Def. v. FDA, Civ. A. No. 23-2316 (LLA) (D.D.C. Dec. 13, 2023) (minute order
granting eighteen-month stay until further order of court, with status report in six months
addressing need for further stay of proceedings), (Dec. 23, 2024) (minute order keeping stay in
place until further order of the court); Children’s Health Def. v. FDA, Civ. A. No. 23-0220 (RDM),
2024 WL 147851 (D.D.C. Jan. 12, 2024) (granting stay of six months, with joint status report in
six months), (Oct. 24, 2024) (minute order recognizing “the unusual and extraordinary demands
placed on the FDA” and FDA’s hiring and training efforts and concluding “all that the Court can
do is require the most expeditious processing of the request at issue, consistent with reality,” so
that FDA should “begin processing the responsive documents no later than August 9, 2026”);
Children’s Health Def. v. CDC, Civ. A. No. 23-0431 (TNM), 2024 WL 3521593, at *5–6 (D.D.C.
July 24, 2024) (granting stay of six months, with status conference in six months to determine
whether stay should be extended); ICAN v. FDA, Civ. A. 23-3675 (JMC) (D.D.C. Sept. 4, 2024)
(minute order granting stay of six months, with joint status report in six months); ICAN v. FDA,
Civ. A. No. 23-3282 (ABJ), ECF No. 23 (D.D.C. October 11, 2024) (granting stay of six months
until March 14, 2025, with status report due on March 14, 2025 addressing need for further stay
of proceedings); John Solomon v. Dep’t of Health & Hum. Servs., Civ. A. No. 24-0572 (RBW),
ECF No. 25 (D.D.C. Oct. 25, 2024) (order granting stay until June 26, 2026, with a status
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 9 of 30 PageID 2771

conference scheduled for July 8, 2025, to “apprise the Court of the status of this case”); ICAN v.
FDA, Civ. A. No. 24-1761 (CJN), ECF No. 18 (D.D.C. Nov. 20, 2024) (granting stay for
approximately 8 months, until July 21, 2025 with a status report on or before July 23, 2025). In a
tenth case, the plaintiff voluntarily dismissed its suit without prejudice after the stay motion was
filed. See Stip. of Dismissal Without Prejudice, ICAN v. FDA, Civ. A. No. 23-1508 (CKK), ECF
No. 15 (D.D.C. Oct. 2, 2023). A motion for stay is pending in the other three cases. See ICAN v.
FDA, Civ. A. No. 24-1555 (RCL), ECF No. 13 (D.D.C. Sept. 25, 2024) (stay motion filed); ICAN
v. FDA, Civ. A. No. 24-1905 (JDB), ECF No. 14 (D.D.C. Oct. 25, 2024), (same); ICAN v. FDA,
Civ. A. No. 24-1906 (CRC), ECF No. 16 (D.D.C. Nov. 4, 2024) (same); see also Burk. Decl. ¶ 26
(App’x 014–017).
FDA is exercising due diligence and has made, and continues to make, extraordinary
efforts to hire, train, and otherwise maximize efficiencies to comply with this Court’s Orders in
PHMPT I and PHMPT II and FDA’s other FOIA obligations. Among other things, ALFOI hired
and trained contractors (approximately nine full-time and one part-time) to focus on processing
records in this case, at an estimated cost of approximately $3.5 million through October 2023.
Burk Decl. ¶ 19–20 (App’x 010–011). Because of PHMPT II and an increase in FOIA litigation,
ALFOI also brought on board six new employees between June 2023 and December 2023, five
new employees between January 2024 and May 2024, and three new employees between October
2024 and December 2024—all of whom are currently being trained. Id. ¶ 22 (App’x 011); see
also id. ¶ 27 (App’x 017). However, it takes approximately two years for new staff to be fully
trained. Id. ¶ 24 (App’x 012). The training process initially slows the pace of processing
outstanding requests because more senior employees must review the new employees’ work, often
line-by-line and word-by-word, to ensure that records are being correctly reviewed for necessary
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 10 of 30 PageID 2772

redactions. Id. (App’x 012–013). Thus, despite ALFOI’s good-faith investment in increasing its
future processing capacity by training new employees, its resources remain limited during this
lengthy onboarding period. Id. (App’x 013).
Therefore, in spite of the agency’s extraordinary efforts, it cannot concurrently process and
produce the responsive EUA file as contemplated by the Court in its December 6, 2024 Order and
also comply with the current production deadline in PHMPT II, absent a stay of the production
deadline. Id. ¶ 34 (App’x 019–020).
III.
LEGAL STANDARDS

District courts have considerable discretion to alter or amend a judgment under Rule 59(e).
See Edward H. Bohlin Co. v. Banning Co., 6 F.3d 350, 355 (5th Cir. 1993). Generally, the reasons
for altering or amending a judgment pursuant to Rule 59(e) are an intervening change in
controlling law, the availability of new evidence not previously available, or the need to correct a
clear error or prevent manifest injustice. See, e.g., In re Benjamin Moore & Co., 318 F.3d 626,
629 (5th Cir. 2002). Courts are required to strike the proper balance between the need for finality
and the need to render a just decision on the basis of “all the facts.” Jones v. Stephens, 998 F.
Supp. 2d 529, 536 (N.D. Tex. 2014) (quoting Bohlin, 6 F.3d at 355). Stays in FOIA cases may be
granted under either 5 U.S.C. § 552(a)(6)(C) or Landis. Each is discussed in turn.
A.
Legal Standard Under 5 U.S.C. § 552(a)(6)(C)(i)

Generally, an agency that has received a FOIA request is expected to “determine within
20 days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of any such
request whether to comply with such request.” 5 U.S.C. § 552(a)(6)(A)(i). However, under
Section 552(a)(6)(C)(i), “[i]f the Government can show exceptional circumstances exist and that
the agency is exercising due diligence in responding to the request, the court may retain
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 11 of 30 PageID 2773

jurisdiction and allow the agency additional time to complete its review of the records.” Id.
§ 552(a)(6)(C)(i).

In Open America v. Watergate Special Prosecution Force, 547 F.2d 605 (D.C. Cir. 1976),
the D.C. Circuit explained that “exceptional circumstances” existed to justify a stay within the
meaning of Section 552(a)(6)(C)(i) when “an agency . . . is deluged with a volume of [FOIA]
requests for information vastly in excess of that anticipated by Congress” and “when the existing
resources are inadequate to deal with the volume of such requests within the time limits” provided
by FOIA. Id. at 616. The D.C. Circuit also found that the agency was exercising “due diligence”
because it had a large staff, separated between complex and simple cases, and handled cases on a
first-in, first-out system. Id. at 613. Congress subsequently amended FOIA to endorse the logic
of Open America. See Elec. Frontier Found. v. Dep’t of Just., 517 F. Supp. 2d 111, 116–17
(D.D.C. 2007) (explaining the 1996 amendments to FOIA).

Exceptional circumstances exist where there is, for example, a substantial, unpredictable
increase in the number of FOIA requests that an agency receives. See id. at 119 (finding
“exceptional circumstances” when there was a one-third increase in FOIA requests and inadequate
numbers of staff available to handle the increased volume); Shapiro v. Dep’t of Just., Civ. A. No.
12-313 (BAH), 2014 WL 12912625, at *2 (D.D.C. Dec. 8, 2014) (finding “exceptional
circumstances” where a repeat plaintiff filed eighty-one FOIA requests with the agency totaling
375,000 pages and comprising six to seven percent of the agency’s monthly intake, and the agency
“could not reasonably have planned for a single citizen to consume such a vast quantity of the
agency’s FOIA resources”); Eakin v. U.S. Dep’t of Defense, Civ. A. No. 16-972-RCL, 2017 WL
3301733, at *7–8 (W.D. Tex. Aug. 2, 2017) (granting Open America stay, where “[g]iven the
sheer volume of plaintiff’s request, and a large number of other requests the office must process,”
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 12 of 30 PageID 2774

the agency’s “resources are inadequate to process the request within the time limits set forth in
[the] statute”).

Exceptional circumstances also can be shown by an increase in FOIA litigation. For
example, exceptional circumstances exist where “resources—and most notably, FOIA staff
members—ha[d] been diverted to assist with multiple FOIA lawsuits, at least five of which are
particularly resource-intensive and involve tens of thousands of documents.” Nat’l Sec. Archive
v. SEC, 770 F. Supp. 2d 6, 9 (D.D.C. 2011). A combination of increased FOIA requests and
litigation can also demonstrate “exceptional circumstances.” Energy Future Coal. v. Off. of Mgmt.
& Budget, 200 F. Supp. 3d 154, 161–62 (D.D.C. 2016) (finding “exceptional circumstances” and
granting six-month stay of FOIA proceedings where an agency had sixty-eight pending FOIA
requests, twenty-seven of which predated plaintiffs’ request, and was in litigation in two other
FOIA cases).

When an agency demonstrates exceptional circumstances that rise above a predictable
workload of requests, it needs to show due diligence to receive a stay but does not need to show
that it is reducing the backlog of pending requests. See 5 U.S.C. § 552(a)(6)(C)(ii) (adding limits
to “exceptional circumstances” that apply only when a delay results from a “predictable agency
workload of requests,” in which case an agency must show “reasonable progress in reducing its
backlog of pending requests”); Democracy Forward Found. v. Dep’t of Just., 354 F. Supp. 3d 55,
60 (D.D.C. 2018) (“Because the court finds that exceptional circumstances exist based on the
dramatic increase in FOIA requests and the agency’s exercise of due diligence in responding to
those requests, the court need not reach the question whether Defendant is making reasonable
progress in reducing its backlog.”).

An agency acts with due diligence when it processes requests on a first-in, first-out basis,
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 13 of 30 PageID 2775

see, e.g., Appleton v. FDA, 254 F. Supp. 2d 6, 10 (D.D.C. 2003) (concluding that “the defendants
have demonstrated good-faith efforts and due diligence in processing the plaintiff’s request on a
first-in, first-out basis”), or processes them in a “multi-track” system of “simple” requests, which
are expedited, and “complex” requests, which take longer to process, see Energy Future Coal.,
200 F. Supp. 3d at 162 (finding that “[the agency] has exercised due diligence by processing
Plaintiffs’ FOIA request within [the agency’s] ‘multi-track’ processing system,” under which “[the
agency] resolves ‘simple’ and ‘expedited’ requests in an expedited fashion, while [the agency]
concurrently responds to ‘complex requests’ by making rolling productions”). An agency may
also show due diligence by reorganizing its resources to better respond to increased FOIA
requests, or by pursuing additional funding or employees, although the latter steps are not required.
Democracy Forward Found., 354 F. Supp. 3d at 62 (finding “due diligence” based on agency’s
efforts to reorganize staff and create complex and expedited queues in response to increased FOIA
requests, even where agency did not seek additional funding for FOIA processing or increase the
number of employees).
B.
Inherent Authority to Stay Proceedings under Landis

An alternative ground for issuance of a FOIA litigation stay is a court’s exercise of its
inherent authority to control its docket. Landis, 299 U.S. at 254. “The power to stay proceedings
is incidental to the power inherent in every court to control the disposition of the causes on its
docket with economy of time and effort for itself, for counsel, and for litigants.” Id. To issue a
Landis stay, a court balances competing interests, weighing the specific hardships to the parties
and the interest in judicial economy. See id. at 255.

Courts have specifically applied Landis to grant stays in FOIA cases. See, e.g., Campaign
for Accountability v. Dep’t of Just., 280 F. Supp. 3d 112, 114–17 (D.D.C. 2017) (citing Landis
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 14 of 30 PageID 2776

and granting stay in FOIA action to allow Office of Legal Counsel to evaluate the agency’s
position regarding refined claims in an amended complaint); Children’s Health Def. v. CDC, Civ.
A. No. 23-0431 (TNM), 2024 WL 3521593, at *5–6 (D.D.C. July 24, 2024) (granting stay
pursuant to Landis to, among other things, (i) avoid adding to agency burden from extraordinary
production order imposed by another court, (ii) prevent risk of interference with stayed cases
involving the same documents, and (iii) maintain fairness to other requesters waiting in the queue
longer than plaintiff); Huddleston v. FBI, Civ. A. No. 20-0447, 2021 WL 1837548, at *2 (E.D.
Tex. May 7, 2021) (citing Landis to grant stay followed by production at “a standardized rate of
500 pages per month” due to “strained resources of their departments and significant volumes of
other FOIA requests”); see also Elec. Frontier Found. v. Off. of Dir. of Nat’l Intel., Civ. A. No.
08-1023, 2009 WL 773340, at *2–4 (N.D. Cal. Mar. 23, 2009) (granting Landis stay to plaintiff
who requested time to review newly issued FOIA guidelines; defendant would not be prejudiced,
and stay would further orderly course of justice).
IV.
ARGUMENT
A.
The Court Should Alter or Amend the December 6, 2024 Order by Granting the
Requested Stay Under 5 U.S.C. § 552(a)(6)(C)(i) Because FDA Can Demonstrate
“Exceptional Circumstances” and “Due Diligence.”

This Court should stay the production deadline in its December 6, 2024 Order because
FDA can show, under Section 552(a)(6)(C)(i): (i) “exceptional circumstances” based on this
Court’s unprecedented Orders requiring voluminous production in this case and PHMPT II and
substantial increases in FOIA requests and litigation involving ALFOI; and (ii) “due diligence”
based on the extraordinary efforts ALFOI took to comply with the PHMPT I 2022 Orders and has
been taking to comply with the PHMPT II Order, including hiring and training new staff and
contractors, reorganizing and triaging staff resources, and continuing to seek additional funding.
As noted above, every court that has ruled on a motion for stay in a FOIA suit seeking CBER
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 15 of 30 PageID 2777

records on similar grounds has granted the motion in whole or in part.
1.
This Court’s PHMPT II Order Requiring Production of at Least 180,000
Pages Per Month until June 30, 2025, and Other Increased Obligations,
Constitute “Exceptional Circumstances.”

FDA has been facing “exceptional circumstances.” The concurrent court-ordered
productions in this case and PHMPT II have involved approximately 5.7 million pages of COVID-
19 vaccine-related records and collectively have required ALFOI to produce records at rates
totaling 90,000 to 110,000 pages per month from July 2023 to November 2023 and at least 180,000
pages per month beginning in December 2023. See Burk Decl. ¶¶ 6, 19, 21 (App’x 002–003, 010–
011). Throughout this time, ALFOI has faced an increase in FOIA requests and lawsuits. See id.
¶¶ 6, 15–18 (App’x 003, 008–010). These increases have further strained the agency’s limited
resources and ability to perform the requisite careful, line-by-line and word-by-word review of all
records as required by law. See id. ¶¶ 7, 10, 33 (App’x 003, 006, 019) (noting line-by-line review
process); id. ¶ 24 (App’x 012–013) (describing new-employee training process); Decl. of Suzann
Burk ¶ 5, App’x in Support of Def.’s Brief in Advance of Scheduling Conference, ECF No. 23,
Ex. A (describing ALFOI’s litigation-related responsibilities).

To the government’s knowledge, this Court’s 2022 Orders in this case required the agency
to process records at a rate that was many orders of magnitude greater than anything any agency
had ever encountered in a FOIA order, and was soon surpassed by an even more extraordinary
Order by this Court in PHMPT II. Id. ¶ 22 (App’x 011–012); see ICAN v. FDA, Civ. A. No. 23-
3282 (ABJ) (D.D.C.), ECF No. 23 at 3 (Oct. 11, 2024 Order) (“[T]he [PHMPT II production]
order from the Northern District of Texas bears no relationship to the FOIA orders ordinarily
issued in this courthouse, even in cases of equal public importance.”); Hr’g Tr. Jan. 28, 2022 at
9:19–23, ECF No. 58 (this Court stating that “not only is this unprecedented, but it appears to me
the FDA is taking some unprecedented steps in order to comply”). Moving forward, to meet the
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 16 of 30 PageID 2778

Court’s June 2025 deadline in PHMPT II, ALFOI will need to produce an average of more than
230,000 pages per month. Burk Decl. ¶ 6 (App’x 003). The Court’s December 6, 2024 Order in
this case adds, at a minimum, 589,600 pages to ALFOI’s processing obligations through June
2025—an additional burden that the agency cannot meet while concurrently complying with the
Court’s PHMPT II production Order. Id. ¶¶ 6, 29, 34 (App’x 003, 018–020).
This comes amidst a backdrop of other increased workload obligations, including an
increase in FOIA requests and FOIA litigation, stemming, in large part, from requests related to
FDA’s work pertaining to the COVID-19 pandemic. Id. ¶ 6 (App’x 003). Before the 2022
production Orders in this case, ALFOI was able to keep its FOIA queues relatively low and stable
with nine regular staff and one branch chief. Id. ¶ 15 (App’x 008). From fiscal years 2015 to
2018, the number of FOIA requests received by CBER each year ranged from 255 to 343, and the
number of FOIA requests pending at the end of each year ranged from 39 to 54. Id. (App’x 008).
The number and complexity of FOIA requests began to increase in FY 2019. Id. ¶ 16 (App’x
008). By FY 2021, CBER began to receive more than 500 requests annually, with 509 requests
in FY 2021 and 633 requests in FY 2022. Id. (App’x 008). By the end of FY 2022, the number
of pending FOIA requests grew to 532. Id. (App’x 009). By the end of FY 2023, although the
number of FOIA requests received declined to 487, the number of requests closed also declined
to 336, while the number of pending requests increased to 679. Id. (App’x 009).
Moreover, starting in FY 2020, FOIA suits added significantly to ALFOI’s workload. Id.
(App’x 008). Before FY 2020, few suits involving ALFOI were filed; today, it is involved in
twenty active litigation cases, including this one. Id. ¶ 17 (App’x 009–010). The Burk Declaration
provides two tables summarizing the trends related to the increases in ALFOI’s FOIA workload
obligations. Id. ¶¶ 15–16 (App’x 008–009); see also id. ¶ 17 (App’x 009–010). The data collected
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 17 of 30 PageID 2779

as of the end of FY 2023 show that the number of pending FOIA requests has continued to grow
under the strain of increased requests and increased FOIA litigation, which demands ALFOI’s
attention. Id. ¶ 16 (App’x 009); see also Burk Decl. ¶ 5, App’x in Support of Def.’s Brief in
Advance of Scheduling Conference, ECF No. 23, Ex. A (describing ALFOI’s litigation-related
responsibilities). As of December 31, 2024, the number of pending FOIA requests increased to
844. Id. ¶ 18 (App’x 010).
In this case, the Court ordered FDA to produce records beginning in March 2022 at an
average rate of 55,000 pages per month. Id. ¶ 20 (App’x 010). Given that the production rate
ordered in this case far exceeded FOIA production rates typically ordered by courts (as
acknowledged by this Court as well, Hr’g Tr. Jan. 28, 2022 at 9:19–23, ECF No. 58), the agency
implemented immediate and sweeping organizational and work process changes including, among
other things, hiring contractors and additional full-time employees at a substantial expense,
reorganizing staff, and diverting resources from processing other FOIA matters. Id. (App’x 010–
011).
While the agency’s extraordinary efforts to marshal resources to comply with the PHMPT
I Orders were ongoing, FDA was sued in PHMPT II. Id. ¶ 21 (App’x 011). In PHMPT II, this
Court imposed an even more intense monthly production schedule. See PHMPT II, ECF No. 38.
From July 2023 to November 2023, ALFOI was required to produce 90,000 to 110,000 pages per
month in PHMPT I and PHMPT II collectively. Id. ¶ 21(A) (App’x 011). Then, beginning in
December 2023, after initial production in this case had concluded, the agency has been required
to produce 180,000 pages per month in PHMPT II. Id. ¶ 21(B) (App’x 011). Because of PHMPT
II and an increase in FOIA litigation, the agency once again reallocated its staff, leaving only a
handful of staff working on all non-PHMPT FOIA requests. Id. ¶ 22 (App’x 011). The agency
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 18 of 30 PageID 2780

hired six new employees between June 2023 and December 2023, five new employees between
January 2024 and May 2024, and three new employees between October and December 2024. Id.
¶ 22 (App’x 011). However, it takes approximately two years for new staff to be fully trained,
and the training process initially slows the pace of processing outstanding requests because senior
employees must review new employees’ work to ensure records are being correctly reviewed for
necessary redactions. Id. ¶¶ 24, 27 (App’x 012–013, 017). Even if agency production in PHMPT
II had concluded, and new staff were available to process the responsive EUA file pursuant to this
Court’s December 6, 2024 Order in this case, many likely would not have the appropriate training
to do so and would require close supervision. Id. ¶ 27 (App’x 017) (noting that CBER’s entire
Special Disclosure Unit staff, all of whom are assisting with the PHMPT II production, have less
than two years training and require close supervision; half have six months or less).
This Court’s large production Orders, along with the backdrop of substantially increased
FOIA litigation and requests, far exceed a “predictable” agency workload and thus constitute the
“exceptional circumstances” that justify a stay. See Elec. Frontier Found., 517 F. Supp. 2d at 119
(finding “exceptional circumstances” because the agency established more than a “predictable” or
“routine” backlog based on a one-third increase in FOIA requests and inadequate numbers of staff
available to handle the increased volume).
Indeed, even prior to this Court’s December 6, 2024 Order, several courts have already
held that these circumstances—most notably, this Court’s prior production Orders in this case and
in PHMPT II—constitute “exceptional circumstances” justifying a stay. See, e.g., ICAN v. FDA,
Civ. A. No. 24-1761(CJN), ECF No. 18 at 2 (D.D.C.) (Nov. 20, 2024 Order) (“This
unprecedentedly demanding production schedule—which has prompted the FDA to hire new
employees and substantially reallocate its existing staff—far exceeds a “predictable” agency
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 19 of 30 PageID 2781

workload and thus constitutes “exceptional circumstances” within the meaning of FOIA.”); ICAN
v. FDA, Civ. A. No. 23-3282 (ABJ) (D.D.C.), ECF No. 23 at 4 (Oct. 11, 2024 Order) (“These
unprecedented production orders and subsequent agency efforts to meet its FOIA obligations far
exceed a ‘predictable’ agency workload and constitute the ‘exceptional circumstances’ and due
diligence justifying a stay”); ICAN v. FDA, Civ. A. No. 23-3675 (JMC) (D.D.C.) (Sept. 4, 2024,
Min. Order) (“FDA has shown both exceptional circumstances and due diligence justifying an
Open America stay”); Children’s Health Def. v. FDA, Civ. A. No. 23-2316 (LLA) (D.D.C.) (Dec.
13, 2023 Min. Order) (“FDA has shown both exceptional circumstances and due diligence”), (Dec.
23, 2024 Min. Order) (keeping stay in place based on a continued finding of exceptional
circumstances and due diligence); ICAN v. FDA, Civ. A. No. 23-0219 (RBW) (D.D.C.), ECF No.
27 (Nov. 21, 2023 Mem. Op. & Order) (vacating all pending deadlines and setting conference in
six months because FDA “has shown exceptional circumstances exist and that the agency . . . is
exercising due diligence” in responding to plaintiff’s FOIA request); Children’s Health Def. v.
FDA, Civ. A. No. 23-0220 (RDM), 2024 WL 147851, at *3 (D.D.C. Jan. 12, 2024) (“The
unprecedented rate at which the PHMPT orders require the FDA to produce records is exceptional,
and it is, if anything more overwhelming that the extraordinary increase in FOIA workloads that
past decisions have found sufficient to warrant stays”); John Solomon v. Dep’t of Health & Hum.
Servs., Civ. A. No. 24-0572 (RBW) (D.D.C.), ECF No. 25 (Oct. 25, 2024 Order) (granting stay
because the agency “has ‘show[n] exceptional circumstances exist and that the agency . . . is
exercising due diligence”).
2.
FDA is Exercising “Due Diligence.”
As described in the Burk Declaration, ALFOI has a multi-track process for handling FOIA
requests, where requests are placed in one or more of six queues based on volume, complexity,
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 20 of 30 PageID 2782

and/or subject matter, and requests in each queue are generally assigned to reviewers for
processing on a first-in, first-out basis. Burk Decl. ¶ 8–9 (App’x 004–005). This alone is sufficient
to show “due diligence.” Energy Future Coal., 200 F. Supp. 3d at 162 (finding “due diligence”
based on a “multi-track” processing system separating “simple” and “complex” requests). But, as
detailed below, FDA can demonstrate extraordinary efforts to comply with its production orders
while continuing to process FOIA requests that far exceed what is necessary to show “due
diligence.”
To comply with the 2022 Orders in PHMPT I, ensure compliance with the current
production Order in PHMPT II, and fulfill its other responsibilities stemming from increased
FOIA requests and litigation, CBER’s FOIA office has undertaken immediate and aggressive
efforts to hire additional staff and contractors, seek funding, and reorganize its resources. Burk
Decl. ¶¶ 20, 22–23, 26–27 (App’x 010–012, 014–017). As noted above, prior to this Court’s first
production Orders in this case, ALFOI consisted of nine staff supervised by one branch chief. Id.
¶ 15 (App’x 008). After this Court’s 2022 production Orders, ALFOI made large-scale changes
to its staff and work processes. Among other things, ALFOI hired contractors (nine full-time and
one part-time) to focus on processing records for this case. Id. ¶ 20 (App’x 010). The estimated
cost of contractors alone for processing records in PHMPT I totaled approximately $3.5 million
through October 2023. Id. (App’x 011). Between February 2, 2022 and November 1, 2023,
ALFOI was also able to assign nine full-time employees to focus primarily on the PHMPT I
production, leaving a smaller team of six full-time employees to assume primary responsibility
for all other FOIA requests. Id. (App’x 010).
When the initial PHMPT I production concluded in November 2023, ALFOI was required
to ramp up to 180,000 pages per month in December 2023 for the PHMPT II production, although
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 21 of 30 PageID 2783

it will need to produce an average of more than 230,000 pages per month to meet the Court’s June
30, 2025 deadline in that case. Id. ¶ 21(B), (C) (App’x 011). Since the PHMPT II Order issued,
ALFOI once again reallocated staffing and left only a handful of staff working on all other FOIA
requests. Id. ¶ 22 (App’x 011). It also increased the number of full-time employees. Id. ¶¶ 22,
27 (App’x 011, 017). ALFOI brought on board six new employees between June–December 2023,
five new employees in between January–May 2024, and three new employees between October-
December 2024, all of whom are currently being trained. Id. ¶ 22 (App’x 011). Of these fourteen
employees, twelve are part of the newly established Special Disclosure Units (“Units”)—which
are currently focused primarily on the PHMPT II matter—and two have been assigned to process
FOIA requests unrelated to PHMPT II litigation. Id. (App’x 011).
CBER continues to carefully consider the number of employees and contractors needed
for these productions, while ALFOI is working diligently to train additional staff who will be
critical to ensuring that FDA can comply with the existing PHMPT II production Order going
forward. See id. ¶¶ 23–24 (App’x 012–013). Determining the number of employees/contractors
needed for these enormous productions while factoring in the availability of necessary financial
resources, requires ongoing, complex discussions with entities within and outside CBER
(particularly during a time of budgetary uncertainty). Id. (App’x 012).
Importantly, while CBER’s hiring and ongoing training efforts demonstrate the agency’s
“due diligence” and good-faith investment to comply with production mandates by this Court and
address the existing backlog of FOIA requests, its efforts have been limited by the lengthy ramp-
up period for hiring new employees and training new employees and contractors. Id. ¶ 24 (App’x
012). Thus, even if CBER is awarded additional resources, receiving funds and hiring are merely
the first steps in a labor-intensive process needed to onboard employees and contractors so that
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 22 of 30 PageID 2784

they can contribute to the Branch’s disclosure efforts. Id. (App’x 012). The process of advertising,
recruiting, interviewing, and conducting administrative onboarding of new employees alone takes
several months (assuming a qualified candidate is found). Id. (App’x 012). While new employees
and contractors are in training, current staff must spend time partnering with them to provide
training and oversight. Id. (App’x 012). Staff must review new employees and contractors’ work
to ensure that personal privacy, trade secrets, and other protected information is not inadvertently
disclosed. Id. (App’x 012). All told, after onboarding, it takes approximately two years for an
employee or contractor to be fully trained so that he or she can meaningfully contribute to the
Branch’s disclosure efforts. Id. (App’x 012); see also id. ¶ 27 (App’x 017).
CBER recently restructured its FOIA office creating new full-time employee positions and
onboarding new employees. As of January 2025, the CBER has added three supervisory positions
and thirteen staff level positions. Id. ¶ 27 (App’x 017). Two of the new supervisory positions
head the newly formed Units, which consist of six staff positions each. Id. (App’x 017).
Currently, a total of twelve staff have been onboarded and assigned to the Units, all of whom are
relatively (or brand) new and are receiving training. Id. (App’x 017). All Unit employees are
assisting with PHMPT II productions. Id. ¶¶ 3, 27 (App’x 002, 017).
The extraordinary efforts ALFOI has undertaken in significantly expanding its numbers of
staff, training new employees, and reorganizing staff resources, all while complying with
unprecedented production Orders and managing multi-track queues of FOIA requests, more than
demonstrate the “due diligence” needed for a stay of the June 30, 2025 production deadline. See
supra at 15–16 (citing multiple recent cases in which courts have granted a stay, finding that FDA
is exercising due diligence).

Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 23 of 30 PageID 2785

B.
Landis Also Supports the Court Altering or Amending the December 6, 2024 Order
by Granting the Request to Stay.

This Court may also exercise its inherent, equitable authority to grant a stay of the June
30, 2025 production deadline under Landis. “[T]he power to stay proceedings is incidental to the
power inherent in every court to control the disposition of the causes on its docket with economy
of time and effort for itself, for counsel, and for litigants.” Landis, 299 U.S. at 254. This “calls
for the exercise of judgment, which must weigh competing interests and maintain an even
balance.” Id. at 254–55. A stay is appropriate when the movant’s need “overrides the injury to
the party being stayed.” Belize Soc. Dev. Ltd. v. Gov’t of Belize, 668 F.3d 724, 732 (D.C. Cir.
2012) (cleaned up). Thus, courts consider: (1) the hardship imposed on the moving party if the
litigation proceeds without a stay, (2) any prejudice to the non-movant in granting a stay, and (3)
the interests of judicial economy. See Brown v. Lumpkin, Civ. A. No. 19-2301, 2021 WL 3847491,
at *17 n.11 (N.D. Tex. Aug. 27, 2021). All three factors militate in favor of granting a stay here.

First, FDA will suffer serious hardship if the June 30, 2025 production deadline set forth
in the Court’s December 6, 2024 Order is not stayed. As described in the preceding sections and
the Burk Declaration, the agency already is triaging its limited resources and working at full
capacity to address the extraordinary workload brought on by PHMPT II and other essential
obligations. The Court’s December 6, 2024 Order adds, at a minimum, 589,600 pages to the
agency’s processing obligations through June 30, 2025. Burk Decl. ¶ 6 (App’x 003). The agency
understands that Plaintiff wants to receive the remaining records responsive to its FOIA request
as quickly as possible, and ALFOI is committed to processing the responsive EUA file as ordered
by this Court. Id. ¶ 34 (App’x 019). However, given the substantial effect that this Court’s Orders
in this case and PHMPT II have had on ALFOI’s workload since January 2022, the significant
likelihood that ALFOI will be unable to comply with the current production deadline in PHMPT
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 24 of 30 PageID 2786

II absent a stay, and the fairness to other FOIA requesters currently positioned ahead of Plaintiff’s
request (i.e. requests in the agency’s Complex Track that preceded the FOIA request in this case),
ALFOI cannot concurrently process and produce the responsive EUA file as contemplated by the
Court in its December 6, 2024 Order and also meet the requirements of the Court’s PHMPT II
Order. Id. ¶ 34 (App’x 019–020).

Second, Plaintiff—who has already received approximately 4.5 million records in response
to its FOIA Requests here and in PHMPT II, id. ¶ 19 (App’x 010)—will not be prejudiced by the
requested stay. Indeed, the requested stay is necessary to allow the agency to meet this Court’s
existing and ongoing production Order in PHMPT II. As explained above, ALFOI cannot
concurrently process and produce the responsive EUA file and satisfy the Court’s Order in
PHMPT II. Given the agency’s limited bandwidth, Plaintiff would not be materially prejudiced
by having the remaining processing of one of its FOIA requests stayed while the agency finishes
processing another one of Plaintiff’s FOIA requests, particularly given that both requests relate to
COVID-19 vaccines. Moreover, even if prejudice to Plaintiff PHMPT were a possibility, it would
not outweigh the hardship faced by FDA if a stay were not granted. See Children’s Health Def.
v. CDC, Civ. A. No. 23-0431 (TNM), 2024 WL 3521593, at *6 (D.D.C. July 24, 2024) (“If the
Court denies a stay, . . . FDA “may be forced to violate a court-mandated processing order given
the reality of its limited resources.”).

Third, a stay will promote judicial economy by discouraging a further onslaught of FOIA
litigation. See id. at *5–6 (granting Landis stay and explaining that “forcing FDA to move . . .
documents to the head of the line would encourage every well-heeled FOIA requester to litigate
for a fast pass, all to the detriment of every other requester in the queue”).

Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 25 of 30 PageID 2787

C.
FDA Must Exercise Due Care in its Processing of Potentially Responsive Records.

FDA cannot take shortcuts or simply release records to relieve a backlog or complete
processing of a particularly burdensome request. To the contrary, as the Supreme Court
emphasized, FOIA exemptions serve “important interests” and are “as much a part of FOIA’s
purposes and policies as the statute’s disclosure requirement.” Food Mktg. Inst. v. Argus Leader
Media, 588 U.S. 427, 439 (2019). Here, FDA must take the time and have the resources necessary
to carefully process potentially responsive records and determine whether any FOIA exemptions
apply. FDA may need to protect privacy interests discussed in the records (i.e., withhold personal
identifiable information). Furthermore, FDA may need to protect proprietary information, such
as trade secrets and confidential commercial information, under Exemption 4 that provides
“private parties with sufficient assurances about the treatment of their proprietary information so
they will cooperate in federal programs and supply the government with information vital to its
work.” Argus Leader, 139 S. Ct. at 2366; see also Burk Decl. ¶ 31 (App’x 018) (noting that
ALFOI will need to re-engage with Pfizer to identify sections of the responsive EUA file that
Pfizer believes do not contain any information subject to FOIA Exemption 4). FOIA requesters,
through the collective burden of their voluminous requests that could overwhelm an agency’s
FOIA processing capabilities, should not be able to subvert the FOIA exemptions’ “important
interests.” Argus Leader, 139 S. Ct. at 2366.
D.
Alteration or Amendment of the December 6, 2024 Order is Appropriate to Correct
Clear Error and/or Prevent Manifest Injustice.

Most fundamentally, in imposing the June 30, 2025 production deadline for the responsive
EUA file in this case, this Court did not consider the timing necessary to search for and process
further records, the availability of agency resources, nor the agency’s other processing obligations
and responsibilities under FOIA. See supra at 3. Instead, the parties briefed (and the Court was
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 26 of 30 PageID 2788

asked to decide) whether FDA’s search was adequate, particularly insofar as it excluded the EUA
file. See ECF Nos. 90–101. Neither party briefed the feasibility of meeting a June 30, 2025
production deadline.
Additionally, as relayed above, FDA has taken, and continues to take, extraordinary efforts
to comply with this Court’s prior Orders in this case and in PHMPT II. See supra Part IV.A.
During the period where CBER has been complying with this Court’s aforementioned Orders,
there have been substantial increases in FOIA requests and litigation for CBER records, and there
are numerous FOIA requests in the Complex Track to process. See supra at 13–14. Several courts
have recognized these realities and have stayed CBER-related FOIA litigations. See supra at 4–
6, 15–16. In fact, as of November 15, 2024, there are 135 requests pending in the Complex Track
that were received by CBER before Plaintiff’s FOIA Request in this case.1 Burk Decl. ¶ 32 (App’x
019). Echoing the agency’s concern with fairness to other requesters, see id. ¶¶ 7, 34 (App’x 003,
019–020), at least one court has commented on this Court’s mandated out-of-order processing,
see Hr’g Tr. Oct. 4, 2024 in Children’s Health Def. v. FDA, Civ. A. No. 23-0220 (RDM) (D.D.C.),
at 18:10-19:5 (App’x 039–040) (court noting he has “been deferential to the judge in Texas” but
stating “I want my order in place before his next one, if there is one coming, if it relates to FOIA
requests that came before whatever FOIA requests . . . that came in later so they are all jumping
the queue. . . . [C]omity runs two ways.”). Strict fairness would dictate that Plaintiff’s Request in
this case wait its turn in the Complex Track; however, as a show of good faith, the agency here is
merely requesting that the Court stagger (and not further compound) its outstanding production

1 Among the 135 requests in the Complex Track ahead of PHMPT’s Request in this case, are two
requests that are the subject of litigation: ICAN v. FDA, Civ. A. No. 24-1761 (CJN) (D.D.C.) and
ICAN v. FDA, Civ. A. No. 24-1905 (JDB) (D.D.C.). Burk Decl. ¶ 17 (App’x 009). In both cases,
FDA has sought litigation stays. Id. ¶ 26 (App’x 016) (also noting that the court granted an
approximately eight-month stay in Civ. A. No. 24-1761).
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 27 of 30 PageID 2789

mandates in the two cases before it.
V.
CONCLUSION

For the foregoing reasons, the Court should grant Defendant’s Motion to Alter or Amend
Judgment Pursuant to Federal Rule of Civil Procedure 59(e), such that the June 30, 2025
production deadline set forth in the Court’s December 6, 2024 Order is stayed until the completion
of production in PHMPT v. FDA, No. 4:22-cv-915-P (N.D. Tex.), and the Court should further
order the parties to file a joint status report within 14 days of completion of production in PHMPT
II, advising the Court and setting forth a proposed processing schedule at a rate of 55,000 pages
per month for the responsive EUA file.
Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 28 of 30 PageID 2790

Dated: January 3, 2025

Respectfully submitted,

BRIAN M. BOYNTON
Principal Deputy Assistant Attorney General

ELIZABETH J. SHAPIRO
Deputy Director, Federal Programs Branch

/s/ Andrew F. Freidah

ANDREW F. FREIDAH
Trial Attorney
United States Department of Justice

Civil Division, Federal Programs Branch
1100 L Street, N.W.
Washington, DC 20005
Tel.: (202) 305-0879
Email: andrew.f.freidah@usdoj.gov

Attorneys for Defendant

OF COUNSEL:

PATRICIA ZETTLER
Deputy General Counsel
U.S. Department of Health and Human Services

MARK RAZA
Chief Counsel
U.S. Food and Drug Administration

WENDY S. VICENTE
Deputy Chief Counsel, Litigation
U.S. Food and Drug Administration

JACLYN E. MARTINEZ RESLY
MAGGIE R. REDDEN
Associate Chief Counsel
Office of the Chief Counsel
U.S. Food and Drug Administration
10903 New Hampshire Ave.
White Oak 31
Silver Spring, MD 20993-0002

Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 29 of 30 PageID 2791

CERTIFICATE OF SERVICE

I hereby certify that on January 3, 2025, I electronically filed this document with the
Clerk of the Court for the United States District Court for the Northern District of Texas by using
the CM/ECF system. Counsel in the case are registered CM/ECF users and service will be
accomplished by the CM/ECF system.

/s/ Andrew F. Freidah
ANDREW F. FREIDAH
Trial Attorney
United States Department of Justice

Case 4:21-cv-01058-P Document 104 Filed 01/03/25 Page 30 of 30 PageID 2792

File and source

File: gov.uscourts.txnd.353278.104.0.pdf
Size: 321,414 bytes
SHA-256: b1ced3a2bebdfa33fe4345bd932767dceb85c0e687fe276d883261b95a616284
Our copy: gov.uscourts.txnd.353278.104.0.pdf
Original: archive.org

FDA brief supporting Rule 59(e) motion to alter judgment — PHMPT v. FDA

Record facts

Summary

Full text

File and source

Related records