Court Order (Partial Open America Stay) — Ican v. FDA, No. 1:24-cv-1761 (Nov. 20, 2024)

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UNITED STATES DISTRICT COURT · No. 1:24-cv-01761-CJN · Doc. 18 · 2024-11-20 · Docket on CourtListener

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UNITED STATES DISTRICT COURT 
FOR THE DISTRICT OF COLUMBIA 
 
INFORMED CONSENT ACTION 
NETWORK,  
Plaintiff, 
v. 
Civil Action No. 1:24-cv-1761 (CJN) 
FOOD AND DRUG ADMINISTRATION, 
et al., 
Defendants. 
 
ORDER 
This matter is before the Court on the FDA’s motion for an eighteen-month stay of its 
obligations to respond to Plaintiff’s FOIA request, which seeks clinical trial protocols related to 
the Boostrix vaccine against tetanus, diptheria, and pertussis.  See ECF No. 13 (Stay Mot.); ECF 
No. 1 (Compl.).  For the reasons discussed below, the Court will grant the motion in part and deny 
it in part. 
Generally, an agency that receives a FOIA request must “determine within 20 days . . . 
whether to comply with such request,” and then—if it decides to comply—make the requested 
records “promptly available.”  5 U.S.C. §§ 552(a)(6)(A)(i), (C)(i).  But “[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 jurisdiction and allow the agency additional time to complete 
its review of the records.”  Id. § 552(a)(6)(C)(i).  “‘[E]xceptional circumstances exist’ when an 
agency . . . is deluged with a volume of requests for information vastly in excess of that anticipated 
by Congress” and its “existing resources are inadequate to deal with the volume of such requests 
within the [otherwise applicable] time limits.”  Open Am. v. Watergate Special Prosecution Force, 
Case 1:24-cv-01761-CJN     Document 18     Filed 11/20/24     Page 1 of 4

547 F.2d 605, 616 (D.C. Cir. 1976).  And an agency can demonstrate its “due diligence” in 
complying with the requirements of FOIA by showing that it has a satisfactory “present procedure 
for processing FOIA requests”—such as one that categorizes requests by difficulty, seeks to 
proceed on a “first-in, first-out basis,” and is staffed by an adequate number of personnel.  Id. at 
612–13.   
The FDA has demonstrated that a stay under 5 U.S.C. § 552(a)(6)(C)(i), or an “Open 
America stay,” is warranted here.  In the past three years, the FDA received two court orders that 
together compelled it to produce approximately 5.7 million pages of COVID-19 vaccine records 
within a highly compressed timeframe.  See Pub. Health & Med. Professionals for Transparency 
v. FDA, Civ. A. No. 21-1058 (N.D. Tex.) (“PHMPT I”); Pub. Health & Med. Professionals for 
Transparency v. FDA, Civ. A. No. 22-915 (N.D. Tex.) (“PHMPT II”); see also ECF No. 13-1 
(Burk Decl.) ¶¶ 7, 22.  To satisfy the PHMPT I production order, the FDA was required to produce 
at least 90,000 pages per month from July 2023 to November 2023.  Burk Decl. ¶ 7.  And to satisfy 
the PHMPT II production order by the court’s June 2025 deadline, the FDA will need to produce 
at least 230,000 pages per month between now and then.  Id. ¶¶ 7, 25B.  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 workload and thus 
constitutes “exceptional circumstances” within the meaning of FOIA.  Elec. Frontier Found. v. 
Dep’t of Just., 517 F. Supp. 2d 111, 119 (D.D.C. 2007); see also Child.’s Health Def. v. FDA, 2024 
WL 147851, at *3 (D.D.C. Jan. 12, 2024) (describing the same schedule as “more overwhelming 
than the extraordinary increase in FOIA workloads that past decisions have found sufficient to 
warrant stays”); Burk Decl. ¶¶ 24, 26.  
Case 1:24-cv-01761-CJN     Document 18     Filed 11/20/24     Page 2 of 4

The FDA has also exercised due diligence in responding to the FOIA requests it receives.  
FOIA requests submitted to the FDA are placed into one of six “queues” based on their “volume, 
complexity, or subject matter,” and requests in each queue are generally processed in the order 
submitted.  Burk Decl. ¶¶ 12–13.  These standard protocols, in addition to the FDA’s efforts to 
hire new staff in the wake of the PHMPT I and PHMPT II orders, “have been found sufficient to 
establish due diligence in other cases . . . and are sufficient [to do so] here.”  Child.’s Health Def., 
2024 WL 147851, at *3. 
It is clear that an Open America stay of some duration is appropriate.  But the eighteen-
month stay sought by the FDA is too long, at least at present.  As Plaintiff notes, production in the 
PHMPT matters will be completed by June 2025, and the FDA should have a better sense of its 
capacity to process Plaintiff’s request after that time.  See ECF No. 15 (Opp.) at 1.  The Court will 
therefore stay this case only until the June 2025 deadline has passed, subject to further 
consideration with the benefit of new information following that date.  It is accordingly 
ORDERED that Defendants’ Motion to Stay, ECF No. 13, is GRANTED IN PART AND 
DENIED IN PART;  
ORDERED that this action is STAYED for approximately eight months, until and 
including July 21, 2025, with respect to any FDA processing of records (i.e., search, review, and 
redaction) for Plaintiff’s FOIA Request No. 2020-7656; and it is further 
ORDERED that the Parties shall file a joint status report on or before July 23, 2025, stating 
their positions on whether the stay should be lifted and, if so, proposing a schedule for further 
proceedings. If circumstances change while the case is stayed that warrant lifting the stay or 
otherwise affect the posture of this case, the parties may file a joint status report.   
SO ORDERED.  
Case 1:24-cv-01761-CJN     Document 18     Filed 11/20/24     Page 3 of 4

  
November 20, 2024   
 
 
 
 
_______________________ 
 
 
 
 
 
 
 
 
 
CARL J. NICHOLS 
 
 
 
 
 
 
 
 
 
United States District Judge 
Case 1:24-cv-01761-CJN     Document 18     Filed 11/20/24     Page 4 of 4

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