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Case docket

PHMPT v. Food and Drug Administration — U.S. District Court, N.D. Tex.

Public Health and Medical Professionals for Transparency v. Food and Drug Administration — 47 court filings in the archive, mostly from U.S. District Court for the Northern District of Texas, filed between September 16, 2021 and June 4, 2025. Among them: 5 orders, 2 opinions and 1 complaint.

Case facts

CourtU.S. District Court for the Northern District of Texas (20 filings); UNITED STATES DISTRICT COURT (7 filings)
Filings47 public filings
Filed2021-09-16 – 2025-06-04
Document typesorders (5), opinions (2), complaint (1), exhibit (3), letter (1), response or reply (2)
Original PDFs47 of 47

Case summary

Public Health and Medical Professionals for Transparency filed a complaint for declaratory and injunctive relief on September 16, 2021 in the U.S. District Court for the Northern District of Texas, No. 4:21-cv-01058-P, over a Freedom of Information Act request to the Food and Drug Administration. The request sought all data and information for the Pfizer-BioNTech COVID-19 vaccine enumerated in 21 C.F.R. § 601.51(e), apart from publicly available Vaccine Adverse Events Reporting System reports. After the FDA said it sought up to seventy-five years to produce the documents, the court set an expedited production schedule on January 6, 2022. The FDA has since produced some 1,200,874 pages. On December 6, 2024 the court granted the plaintiff summary judgment and ordered the emergency use authorization file produced; on January 10, 2025 it denied the FDA's Rule 59(e) motion and its request for an indefinite stay.

Case at a glance

PartiesPlaintiff: Public Health and Medical Professionals for Transparency. Defendant: Food and Drug Administration
Court and docketU.S. District Court for the Northern District of Texas, No. 4:21-cv-01058-P; the June 4, 2025 joint notice on this page is captioned in a related case, No. 4:22-cv-00915-P
ProgramNot named in the filings on this page
ClaimsFreedom of Information Act, 5 U.S.C. § 552, for all data and information for the Pfizer vaccine enumerated in 21 C.F.R. § 601.51(e), with declaratory and injunctive relief
Disposition or statusExpedited production schedule ordered January 6, 2022, partially modified February 2, 2022; plaintiff's cross-motion for summary judgment granted and the FDA's denied December 6, 2024, with the emergency use authorization file ordered produced by June 30, 2025; FDA's Rule 59(e) motion and request for an indefinite stay denied January 10, 2025; production of further files continuing under a party agreement described in 2025 filings
Status checked2026-09-23 · against DOJ press releases through 2026-09-22; court docket not yet read

What did the FOIA request seek?

All data and information for the Pfizer vaccine enumerated in 21 C.F.R. § 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Events Reporting System. The complaint cites the regulation's provision that after a license has been issued, all safety and effectiveness data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.

What did the court decide in December 2024?

That the emergency use authorization file is disclosable data as requested by the plaintiff and defined in 21 C.F.R. § 601.51, being at a minimum an "other related submission" with regard to the biologics license application and also submitted with or incorporated by reference in it. The court granted the plaintiff's cross-motion for summary judgment and denied the FDA's.

How much has been produced?

Some 1,200,874 pages of responsive records as of the December 6, 2024 opinion. The production schedule required the FDA to produce 80,000 pages on or before May 2, June 1 and July 1, 2022; 70,000 pages on or before August 1, 2022; and 55,000 pages on or before the first business day of each month thereafter, with joint status reports every ninety days.

Summary written from the documents on this page; every sentence is sourced.

Filings

47 public filings from this case, in filing-date order.

  1. Complaint for Declaratory and Injunctive Relief — PHMPT v. FDAComplaint · PDF
  2. FOIA request (Exhibit A to complaint) — PHMPT v. FDAPDF
  3. FDA's answer to complaint — PHMPT v. FDAPDF
  4. Order setting scheduling conference — Phmpt v. FDA (N.D. Tex.)Order · PDF
  5. First Joint Report — PHMPT v. FDAPDF
  6. Second Joint Report — PHMPT v. FDAPDF
  7. Plaintiff's brief in support of timely production — PHMPT v. FDAPDF
  8. FDA brief in advance of scheduling conference — PHMPT v. FDAPDF
  9. Appendix in Support of Brief for Timely Production — PHMPT v. FDAExhibit · PDF
  10. FDA reply brief in advance of scheduling conference — PHMPT v. FDAPDF
  11. Scheduling order (production schedule) — PHMPT v. FDAOrder · PDF
  12. FDA memorandum supporting motion to modify scheduling order — PHMPT v. FDAPDF
  13. FDA's motion to partially modify scheduling order — PHMPT v. FDAPDF
  14. Second Declaration of Suzann Burk (FDA) — PHMPT v. FDAPDF
  15. Pfizer memorandum supporting motion to intervene — PHMPT v. FDAPDF
  16. Pfizer Motion for Leave to Intervene — PHMPT v. FDAPDF
  17. FDA Response to Pfizer Motion to Intervene — PHMPT v. FDAPDF
  18. Plaintiff's Memorandum in Opposition to Motion to Modify Scheduling Order — PHMPT v. FDAPDF
  19. Plaintiff's response to Pfizer's motion to intervene — PHMPT v. FDAResponse or reply · PDF
  20. FDA reply supporting motion to modify scheduling order — PHMPT v. FDAPDF
  21. Order resetting hearing time — PHMPT v. FDAOrder · PDF
  22. Transcript of December 14, 2021 scheduling conference (Exhibit C) — PHMPT v. FDATranscript · PDF
  23. Joint status report on agreed production terms — PHMPT v. FDAPDF
  24. Order modifying production schedule — Phmpt v. FDA (N.D. Tex.)Order · PDF
  25. Order holding Pfizer's motion to intervene in abeyance — PHMPT v. FDAOrder · PDF
  26. Joint Status Report (May 2022) — PHMPT v. FDAPDF
  27. Joint Status Report (June 2022) — Phmpt v. FDA (N.D. Tex.)PDF
  28. Joint Status Report (August 2022) — Phmpt v. FDA (N.D. Tex.)PDF
  29. Joint status report — PHMPT v. FDAPDF
  30. Joint status report — PHMPT v. FDAPDF
  31. Joint status report — PHMPT v. FDAPDF
  32. Joint status report — PHMPT v. FDAPDF
  33. Joint status report — PHMPT v. FDAPDF
  34. Joint Status Report (June 2024) — Phmpt v. FDA (N.D. Tex.)PDF
  35. Joint Status Report (August 2024) — Phmpt v. FDA (N.D. Tex.)PDF
  36. Joint letter on adequacy-of-search dispute — PHMPT v. FDAPDF
  37. Letter re Waiving Redaction Challenges — PHMPT v. FDALetter · PDF
  38. Joint status report on search-adequacy dispute — PHMPT v. FDAPDF
  39. Appendix supporting FDA's motion for summary judgment — PHMPT v. FDAExhibit · PDF
  40. FDA's brief in support of motion for summary judgment — PHMPT v. FDAPDF
  41. PHMPT's combined opposition and cross-motion for summary judgment — PHMPT v. FDAPDF
  42. Memorandum Opinion and Order — PHMPT v. FDAOpinion · PDF
  43. Appendix to FDA Rule 59(e) Motion to Alter or Amend Judgment — PHMPT v. FDAExhibit · PDF
  44. FDA brief supporting Rule 59(e) motion to alter judgment — PHMPT v. FDAPDF
  45. Plaintiff's Response in Opposition to FDA Rule 59(e) Motion — Phmpt v. FDA (N.D. Tex.)Response or reply · PDF
  46. Opinion and Order denying FDA's motion to alter judgment — Phmpt v. FDA (N.D. Tex.)Opinion · PDF
  47. Joint Notice of Clarification — PHMPT v. FDA

More documents from this docket

1 more document from the same CourtListener docket (gov.uscourts.txnd.353278) is in the archive but is not among the 47 filings above.

  1. on the plaintiff an answer to the attached complaint or a motion under Rule 12 of the Federal

Other cases in the archive from U.S. District Court for the Northern District of Texas.

Court, dates and docket numbers are as recorded on the filings.

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