Pub. Health & Med. Pros. for Transparency v. FDA, No. 21-01058, 2025 WL 71816 (N.D. Tex. Jan. 10, 2025) (Pittman, J.)

Pub. Health & Med. Pros. for Transparency v. FDA, No. 21-01058, 2025 WL 71816 (N.D. Tex. Jan. 10, 2025) (Pittman, J.)

Re:  Request for records concerning approval of COVID-19 vaccine

Disposition:  Denying defendant’s motion to alter judgment

• Litigation Considerations, “Open America” Stays of Proceedings:  The court relates that “[t]he FDA argues that the Court should alter or amend its order for the FDA to produce the [Emergency Use Authorization (“EUA”)] file on or before June 30, 2025, because:  (1) the Court committed a manifest error by ‘never consider[ing] 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;’ (2) ‘exceptional circumstances exist given this Court’s production order in [another related case] and the agency’s other essential FOIA obligations;’ and (3) the 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.’”  The court finds that “[t]he FDA had the opportunity, in its Response, to explain why it should not be ordered to produce the documents so expeditiously, but it wholly failed to do so.”  “Consequently, because the FDA’s Motion does not present an intervening change in the controlling law or newly discovered evidence that was previously unavailable, the Court would be justified in denying this Motion because it presents numerous arguments and claims ‘that could, and should, have been made before the judgment issued.’”  Of note, the court relates that “the FDA essentially argues that exceptional circumstances exist because – in an age where the length of rules and regulations number not in the hundreds but the hundreds of thousands – the agency tasked with processing and producing responsive documents for the Nation’s FOIA requests is staffed by ten people.”  The court finds that “despite representing that doing so would be unduly burdensome or impossible, the FDA has shown some of that same resiliency and thus far has risen to the challenge of complying with the Court’s orders.” “The Court is confident that it will do so again here.”  “Therefore, the Court finds that the FDA has failed to show exceptional circumstances that warrant indefinitely staying the production schedule.”