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Case docket

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

PHMPT v. Food and Drug Administration — U.S. District Court, N.D. Tex. — 47 documents in the archive, dated September 16, 2021 to January 10, 2025.

Case facts

CourtU.S. District Court for the Northern District of Texas (20 filings); UNITED STATES DISTRICT COURT (7 filings)
Docket numberNo. 4:21-cv-01058 — main docket · CourtListener docket 353278
Filings47 public filings
Filed2021-09-16 – 2025-01-10
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.

Docket

47 documents in docket-entry order; attachments follow their entry. Gaps name the entries we do not have.

No. 4:21-cv-01058

  1. Complaint for Declaratory and Injunctive Relief — PHMPT v. FDAEntry 1
  2. FOIA request (Exhibit A to complaint) — PHMPT v. FDAEntry 1, attachment 1
  3. —Entries 2–13 are not in the archive
  4. FDA's answer to complaint — PHMPT v. FDAEntry 14
  5. —Entry 15 is not in the archive
  6. Order setting scheduling conference — Phmpt v. FDA (N.D. Tex.)Entry 16
  7. —Entry 17 is not in the archive
  8. First Joint Report — PHMPT v. FDAEntry 18
  9. —Entry 19 is not in the archive
  10. Second Joint Report — PHMPT v. FDAEntry 20
  11. —Entry 21 is not in the archive
  12. FDA brief in advance of scheduling conference — PHMPT v. FDAEntry 22
  13. —Entry 23 is not in the archive
  14. Plaintiff's brief in support of timely production — PHMPT v. FDAEntry 24
  15. —Entry 25 is not in the archive
  16. undatedBrief in Support of Timely Production — PHMPT v. FDAEntry 26
  17. Appendix in Support of Brief for Timely Production — PHMPT v. FDAEntry 27
  18. —Entry 28 is not in the archive
  19. FDA reply brief in advance of scheduling conference — PHMPT v. FDAEntry 29
  20. —Entries 30–34 are not in the archive
  21. Scheduling order (production schedule) — PHMPT v. FDAEntry 35
  22. FDA's motion to partially modify scheduling order — PHMPT v. FDAEntry 36
  23. FDA memorandum supporting motion to modify scheduling order — PHMPT v. FDAEntry 37
  24. Second Declaration of Suzann Burk (FDA) — PHMPT v. FDAEntry 38
  25. —Entry 39 is not in the archive
  26. Pfizer Motion for Leave to Intervene — PHMPT v. FDAEntry 40
  27. Pfizer memorandum supporting motion to intervene — PHMPT v. FDAEntry 41
  28. —Entries 42–43 are not in the archive
  29. Plaintiff's Memorandum in Opposition to Motion to Modify Scheduling Order — PHMPT v. FDAEntry 44
  30. —Entry 45 is not in the archive
  31. FDA Response to Pfizer Motion to Intervene — PHMPT v. FDAEntry 46
  32. Plaintiff's response to Pfizer's motion to intervene — PHMPT v. FDAEntry 47
  33. —Entries 48–50 are not in the archive
  34. Order resetting hearing time — PHMPT v. FDAEntry 51
  35. FDA reply supporting motion to modify scheduling order — PHMPT v. FDAEntry 52
  36. Transcript of December 14, 2021 scheduling conference (Exhibit C) — PHMPT v. FDAEntry 53
  37. —Entry 54 is not in the archive
  38. Joint status report on agreed production terms — PHMPT v. FDAEntry 55
  39. Order modifying production schedule — Phmpt v. FDA (N.D. Tex.)Entry 56
  40. Order holding Pfizer's motion to intervene in abeyance — PHMPT v. FDAEntry 57
  41. —Entry 58 is not in the archive
  42. Joint Status Report (May 2022) — PHMPT v. FDAEntry 59
  43. —Entries 60–61 are not in the archive
  44. Joint Status Report (June 2022) — Phmpt v. FDA (N.D. Tex.)Entry 62
  45. —Entry 63 is not in the archive
  46. Joint Status Report (August 2022) — Phmpt v. FDA (N.D. Tex.)Entry 64
  47. Joint status report — PHMPT v. FDA (Doc. 65, filed 2022-12-24)Entry 65
  48. —Entry 66 is not in the archive
  49. Joint status report — PHMPT v. FDA (Doc. 67, filed 2023-03-24)Entry 67
  50. —Entry 68 is not in the archive
  51. Joint status report — PHMPT v. FDA (Doc. 69, filed 2023-06-22)Entry 69
  52. —Entries 70–73 are not in the archive
  53. Joint status report — PHMPT v. FDA (Doc. 74, filed 2023-09-20)Entry 74
  54. —Entry 75 is not in the archive
  55. Joint status report — PHMPT v. FDA (Doc. 76, filed 2024-03-18)Entry 76
  56. —Entries 77–78 are not in the archive
  57. Joint Status Report (June 2024) — Phmpt v. FDA (N.D. Tex.)Entry 79
  58. Joint Status Report (August 2024) — Phmpt v. FDA (N.D. Tex.)Entry 80
  59. —Entries 81–82 are not in the archive
  60. Joint letter on adequacy-of-search dispute — PHMPT v. FDAEntry 83
  61. —Entries 84–86 are not in the archive
  62. Letter re Waiving Redaction Challenges — PHMPT v. FDAEntry 87
  63. Joint status report on search-adequacy dispute — PHMPT v. FDAEntry 88
  64. —Entries 89–90 are not in the archive
  65. FDA's brief in support of motion for summary judgment — PHMPT v. FDAEntry 91
  66. Appendix supporting FDA's motion for summary judgment — PHMPT v. FDAEntry 92
  67. —Entries 93–94 are not in the archive
  68. PHMPT's combined opposition and cross-motion for summary judgment — PHMPT v. FDAEntry 95
  69. —Entries 96–100 are not in the archive
  70. Memorandum Opinion and Order — PHMPT v. FDAEntry 101
  71. —Entries 102–103 are not in the archive
  72. FDA brief supporting Rule 59(e) motion to alter judgment — PHMPT v. FDAEntry 104
  73. Appendix to FDA Rule 59(e) Motion to Alter or Amend Judgment — PHMPT v. FDAEntry 105
  74. —Entry 106 is not in the archive
  75. Plaintiff's Opposition to Motion to Alter or Amend Judgment — PHMPT v. FDA (N.D. Tex.)Entry 107
  76. Opinion and Order denying FDA's motion to alter judgment — Phmpt v. FDA (N.D. Tex.)Entry 108

More documents from this case’s dockets

1 more document linked to this case’s dockets is in the archive and not in the docket above.

  1. Summons — Public Health and Medical Professionals v. FDAAO 440 summons to the FDA in Public Health and Medical Professionals for Transparency v. FDA, No. 4:21-cv-01058-P (N.D. Tex.), September 16, 2021.

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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