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Child.’s Health Def. v. FDA, No. 23-220, 2024 WL 147851 (D.D.C. Jan. 12, 2024) (Moss, J.)


Child.’s Health Def. v. FDA, No. 23-220, 2024 WL 147851 (D.D.C. Jan. 12, 2024) (Moss, J.)

Re:  Request for records concerning safety monitoring of COVID-19 vaccines through the Vaccine Adverse Event Reporting System database

Disposition:  Granting in part and denying in part defendant’s motion to stay

  • Litigation Considerations, “Open America” Stays of Proceedings:  The court relates that “the FDA contends that [two orders in other cases] have overwhelmed the agency’s production capabilities to such an extent that the orders present ‘exceptional circumstances’ as contemplated by § 552(a)(6)(C)(i).”  “The Court agrees.”  The court relates that “[i]n an order issued on January 6, 2022, [the U.S. District Court for the Northern District of Texas] directed the FDA to ‘produce . . . documents at a rate of 55,000 pages every 30 days, with the first production . . . due on or before March 1, 2022, until production is complete.’”  “By way of comparison, the FDA had proposed that it produce approximately 12,000 pages in four productions over several months and to produce 500 pages each month thereafter.”  “The FDA’s requested production rate was consistent with the range of production rates that this Court typically requires, even in cases involving substantial public interest; the court-ordered production rate far exceeded what is typical in this Court.”  “As of December 19, 2023, the FDA had fulfilled its obligations pursuant to that first order . . . .”  “But completion of production in [that case] has not relieved the FDA of an extraordinary production obligation because a second order in another case before [the same court] (involving the same plaintiffs and a similar FOIA request) has replaced it.”  “[The] second order has imposed on the FDA a production rate that the FDA characterizes – without contradiction – as ‘many orders of magnitude greater than anything any agency has ever encountered in a FOIA production order.’”  “Although the [first] order required the FDA to produce 55,000 pages per month, the [second] order requires the FDA to produce 360,000 pages per month from January 2024 onward – a more than six-fold increase of what was already an extraordinary burden.”  “To comply with this court-mandated rate of production, the FDA ‘implemented sweeping organizational and work process changes, including, among other things, hiring contractors and additional full-time employees, . . . reorganizing staff, and diverting resources from processing other FOIA matters.’”  “But despite this additional manpower and reorganization, the FDA remains hard pressed to meet its production obligations.” 

    The court finds that “[a]lthough the cases that apply Open America to find ‘exceptional circumstances’ typically do so in the context of a rising number of FOIA requests, . . . the Court sees no reason why Open America’s logic should not apply with equal force to a single court-ordered production schedule that has ‘deluge[d]’ the agency’s limited resources and has thus limited the agency’s ability to respond to other FOIA requests . . . .”  “The unprecedented rate at which the [other two case] orders require the FDA to produce records is exceptional, and it is, if anything more overwhelming than the extraordinary increase in FOIA workloads that past decisions have found sufficient to warrant stays.”  “Moreover, the insufficiency of even the extraordinary steps the FDA has taken to devote increased resources to respond to [the other two cases’] requests – [defendant] has almost doubled its full-time staff – shows that the agency’s existing resources are inadequate to respond to the ‘deluge’ that the [other two case] orders have imposed on it.”  “For these reasons, the Court agrees that the FDA has shown that ‘exceptional circumstances’ are present.”  “The Court appreciates that it might seem unfair to the plaintiff in this case (as well as to other FOIA requesters) to see the bulk of the agency’s resources devoted to satisfying the demands of a single requester, who obtained an extraordinary court order before others were able to obtain more limited judicial relief.”  “But that order is in place, and it is beyond the jurisdiction or proper role of this Court to review a decision rendered by another district court.”  “Nor would it be in the interests of comity or respect for the law for this Court to enter an order that would, at least in practical effect, conflict with the order entered by another district court.”  “This Court must – and can only – take the record as it exists.”  “Seen in that light, the Court can only conclude that the FDA is facing a Herculean undertaking that, despite the agency’s best efforts, precludes it from processing Plaintiff’s FOIA request in the usual course.”  “The FDA explains that it has exercised such diligence by taking the ‘aggressive’ steps described earlier:  hiring both contractors and full-time staff, reorganizing existing resources, and seeking additional funding to continue to ramp up production even more.”  “In addition, the FDA notes that in processing FOIA requests, [defendant] uses a ‘multi-track’ system in which ‘requests are placed in one or more of six queues based on volume, complexity, and/or subject matter, and requests in each queue are generally assigned to reviewers on a first-in, first-out basis.’”  “Both the onboarding and reassignment of new staff, as well as the first-in, first-out multi-track system for processing requests have been found sufficient to establish due diligence in other cases . . . and are sufficient here.”  “With respect to Plaintiff’s FOIA requests specifically, the FDA has also demonstrated that it has been diligent.”  “It has explained that, to date, the FDA has completed its search for records responsive to two of the items in Plaintiff’s FOIA requests . . . and that it reviewed 1,300 records that were potentially responsive to another item in those requests . . . .”  “Although the FDA has yet to complete searches for the remaining two items in Plaintiff’s FOIA requests . . . and the agency has yet to review approximately 150 potentially responsive records, . . . this progress on Plaintiff’s broad request for vaccine information indicates that the FDA is exercising due diligence in processing the requests.”  “Accordingly, the Court finds that the FDA has demonstrated that it has exercised due diligence in responding to Plaintiff’s FOIA requests.” 

    “In opposing the stay, Plaintiff advances two arguments, neither of which the Court finds persuasive.”  “First, it contends that ‘[t]he production burden [defendant] faces in the [Northern District of Texas] litigation is . . . not a surprise, because . . . FDA’s own regulations provide unambiguous notice that when the FDA approves a vaccine, licensing information must be disclosed quickly and as a matter of course.’”  “This argument, however, misunderstands the basis for the Court’s exceptional-circumstances finding:  the FDA has shown that it has already taken extraordinary steps to comply with a court-ordered production schedule that is, in the words of the FDA, ‘many orders of magnitude greater than anything any agency has ever encountered’ . . . .”  “Although it is conceivable that the FDA might have anticipated that it would face vaccine-related FOIA requests following its approval of COVID vaccines to combat the global pandemic then-raging, it could not have anticipated that a court would order it to produce records in response to COVID-vaccine-related FOIA requests at a rate that vastly outpaces what has ever been required of the FDA (or any other agency) in other FOIA cases.”  “Next, Plaintiff contends that the burdens [defendant] faces are a problem of the FDA’s own making because the agency decided ‘to assign the substantial work of processing vaccine-related FOIA requests to [one branch] without providing [that branch] sufficient staff to shoulder that load.’”  “But ‘as a general matter, it is not the role of the judiciary to question how executive agencies request and allocate resources’ . . . .”  “Here, Plaintiff has not provided any evidence that the FDA has acted in bad faith or in derogation of its FOIA obligations by assigning vaccine-related requests to [one branch] or otherwise.”

    “That said, the Court is mindful of the FOIA’s purpose in mandating the ‘efficient, prompt, and full disclosure of information’ by agencies . . . .”  “Accordingly, although the Court will grant the FDA’s request for a stay, it will not do so for the eighteen-month period the agency requests.”  “Instead, the Court will grant a six-month stay, subject to further consideration as events unfold.”  “To the extent that the FDA maintains that the burden it faces in the Texas litigation is excessive, it should take it up with that court.”  “It is not this Court’s role to second guess another district court.”
Court Decision Topic(s)
District Court opinions
Litigation Considerations, “Open America” Stays of Proceedings
Updated February 15, 2024