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Apter v. Department of Health and Human Services — S.D. Tex., Galveston

Apter v. Department of Health and Human Services — S.D. Tex., Galveston — 69 documents in the archive, dated June 2, 2022 to March 22, 2024.

Case facts

CourtU.S. District Court for the Southern District of Texas, Galveston Division (34 filings); U.S. District Court for the Southern District of Texas (Galveston Division) (28 filings)
Docket numberNo. 3:22-cv-00184 — main docket · CourtListener docket 1875135
Filings69 public filings
Filed2022-06-02 – 2024-03-22
Original PDFs69 of 69
ProfilesXavier Becerra

Case summary

Three physicians, Robert L. Apter, Mary Talley Bowden and Paul E. Marik, filed a complaint for vacatur, declaratory and injunctive relief on June 2, 2022 in the U.S. District Court for the Southern District of Texas, Galveston Division, No. 3:22-cv-00184, against the Department of Health and Human Services, its Secretary, the Food and Drug Administration and its Commissioner. The complaint concerns FDA statements about the off-label use of ivermectin for COVID-19 and argues that the FDA cannot ban particular uses of approved human drugs or advise whether a patient should take one. The district court's judgment was reversed and the case remanded by the Fifth Circuit on October 24, 2023. The parties settled and stipulated to dismissal with prejudice on March 21, 2024.

Case at a glance

PartiesPlaintiffs: Robert L. Apter, M.D.; Mary Talley Bowden, M.D.; Paul E. Marik, MBBCh. Defendants: U.S. Department of Health and Human Services; Xavier Becerra, Secretary of Health and Human Services; U.S. Food and Drug Administration; Robert M. Califf, Commissioner of Food and Drugs, the individuals sued in their official capacities
Court and docketU.S. District Court for the Southern District of Texas, Galveston Division, No. 3:22-cv-00184, Judge Jeffrey V. Brown; appeal No. 22-40802 (5th Cir.)
ProgramNot named in the filings on this page
ClaimsVacatur, declaratory and injunctive relief, pleaded on the basis that the FDA generally cannot ban particular off-label uses of approved human drugs and cannot advise whether a patient should take an approved drug for a particular purpose
Disposition or statusDismissed with prejudice by stipulation under Rule 41(a)(1)(A)(ii) on March 21, 2024 following a settlement, with an order of dismissal entered March 22, 2024. Before that, the Fifth Circuit reversed the district court's judgment and remanded on October 24, 2023
Status checked2026-09-23 · against DOJ press releases through 2026-09-22; court docket not yet read

What did the Fifth Circuit decide?

It ordered that the judgment of the district court be reversed and the cause remanded for further proceedings in accordance with its opinion, each party to bear its own costs on appeal; the judgment was issued as the mandate on October 24, 2023.

What did the settlement provide?

That within 21 calendar days the defendants would retire the FDA Consumer Update "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19", while retaining the right to post a revised Consumer Update, and delete and not republish named FDA social media posts from August 21, 2021 and April 26, 2022 and other posts linking to that update, with all materials archived as required by federal law.

Did anyone admit liability?

No. The stipulation states that neither it nor the actions described in it constitute an admission or evidence of any issue of fact or law, wrongdoing, misconduct or liability on the part of any party.

Docket

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

No. 3:22-cv-00184

  1. Complaint — Apter v. HHSEntry 1
  2. Exhibit 1 — FDA Consumer Update on Ivermectin — Apter v. HHSEntry 1, attachment 1
  3. Exhibit 2 — FDA Ivermectin FAQ — Apter v. HHSEntry 1, attachment 2
  4. Exhibit 3 — FDA 'You Are Not a Horse' Tweet — Apter v. HHSEntry 1, attachment 3
  5. Exhibit 4 — FDA 'Hold Your Horses' Tweet — Apter v. HHSEntry 1, attachment 4
  6. Exhibit 5 — Declaration of Robert L. Apter, M.D. — Apter v. HHSEntry 1, attachment 5
  7. Exhibit 6 — Declaration of Mary Talley Bowden, M.D. — Apter v. HHS (S.D. Tex.)Entry 1, attachment 6
  8. Exhibit (complaint, Ex. 8) — Apter v. HHSEntry 1, attachment 8
  9. Exhibit 9 (Sentara COVID-19 Treatment Guidelines) — Apter v. HHSEntry 1, attachment 9
  10. Exhibit (WHO Report) — Apter v. HHSEntry 1, attachment 10
  11. Exhibit (complaint, Ex. 11) — Apter v. HHSEntry 1, attachment 11
  12. Exhibit (WHO VigiAccess ivermectin adverse-event data) — Apter v. HHS (S.D. Tex., 2022-06-02)Entry 1, attachment 12
  13. Exhibit 13 (Doc. 1): FDA Faers Ivermectin Adverse Events — Apter v. HHS (S.D. Tex.)Entry 1, attachment 13
  14. Exhibit (complaint, Ex. 14) — Apter v. HHSEntry 1, attachment 14
  15. Exhibit (FDA Consumer Update) — Apter v. HHSEntry 1, attachment 16
  16. Exhibit (complaint, Ex. 17) — Apter v. HHSEntry 1, attachment 17
  17. Exhibit 18 — FDA Letter to FSMB on Ivermectin — Apter v. HHSEntry 1, attachment 18
  18. Exhibit 20 — AMA/APhA/ASHP Joint Letter — Apter v. HHSEntry 1, attachment 20
  19. Exhibit 21 — Maine Board of Pharmacy Statement — Apter v. HHSEntry 1, attachment 21
  20. Exhibit 22 — Smith v. West Chester Hospital Memorandum — Apter v. HHS (S.D. Tex.)Entry 1, attachment 22
  21. Exhibit 23 — Congressional Letter on Ivermectin — Apter v. HHSEntry 1, attachment 23
  22. —Entries 3–7 and 9–11 are not in the archive; entries 2 and 8 are listed under More documents below
  23. Amended Complaint — Apter v. HHSEntry 12
  24. Exhibit 1 (FDA Ivermectin Consumer Update) — Apter v. HHSEntry 12, attachment 1
  25. Exhibit 2 (FDA FAQ on COVID-19 and Ivermectin) — Apter v. HHSEntry 12, attachment 2
  26. Exhibit 4 (FDA 'You Are Not a Horse' Tweet) — Apter v. HHSEntry 12, attachment 4
  27. Exhibit 5: FDA Internal Emails on ‘You Are Not a Horse’ Tweet — Apter v. HHS (S.D. Tex.)Entry 12, attachment 5
  28. Declaration of Dr. Robert L. Apter (Exhibit 8) — Apter v. HHSEntry 12, attachment 8
  29. Declaration of Dr. Mary Talley Bowden (Exhibit 9) — Apter v. HHSEntry 12, attachment 9
  30. Exhibit (curriculum vitae of Dr. Paul Marik) — Apter v. HHSEntry 12, attachment 10
  31. Exhibit (EVMS COVID-19 Management Protocol) — Apter v. HHSEntry 12, attachment 11
  32. Exhibit (Hospital Treatment Guidelines) — Apter v. HHSEntry 12, attachment 12
  33. Exhibit 13: WHO Essential Medicines List (Ivermectin) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 13
  34. Exhibit 14 (FDA Ivermectin Approval Package) — Apter v. HHSEntry 12, attachment 14
  35. Exhibit 15: WHO VigiAccess Ivermectin Adverse Events — Apter v. HHS (S.D. Tex.)Entry 12, attachment 15
  36. Exhibit 16 (FAERS Ivermectin Adverse Event Data) — Apter v. HHSEntry 12, attachment 16
  37. Exhibit (Doc. 12-17, updated pharmacovigilance data) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 17
  38. Exhibit 19 (Doc 12) — Archived FDA Consumer Update — Apter v. HHSEntry 12, attachment 19
  39. Exhibit 20 (Doc 12) — FDA 'Well Done!' Email — Apter v. HHSEntry 12, attachment 20
  40. Exhibit 21 — Horse-Bleep: How 4 Calls on Animal Ivermectin Launched a False FDA-Media Attack (Document 12-21)Entry 12, attachment 21
  41. FDA Letter to Federation of State Medical Boards re Ivermectin (Exhibit 22) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 22
  42. TikTok Screenshot — "Stop Prescribing Ivermectin" (Exhibit 23) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 23
  43. Twitter Screenshot — Dr. Bowden Hospital Suspension (Exhibit 24) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 24
  44. AMA/APHA/ASHP Joint Statement on Ivermectin (Exhibit 25) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 25
  45. Maine Board of Pharmacy Statement on Dispensing Ivermectin (Exhibit 26) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 26
  46. West Chester Hospital Opposition to Emergency Injunction re Ivermectin (Exhibit 27) — Apter v. HHS (S.D. Tex.)Entry 12, attachment 27
  47. Exhibit (congressional letter on ivermectin, Oct. 5, 2021) — Apter v. HHS (S.D. Tex., 2022-08-08)Entry 12, attachment 28
  48. —Entries 13–24 are not in the archive
  49. Defendants’ Motion to Dismiss — Apter v. HHSEntry 25
  50. Joint Discovery/Case Management Plan — Apter v. HHSEntry 26
  51. Plaintiffs’ Opposition to Defendants’ Motion to Dismiss — Apter v. HHS (S.D. Tex.)Entry 27
  52. —Entry 28 is not in the archive
  53. Motion for Leave to File Amicus Brief (AAPS) — Apter v. HHSEntry 29
  54. Amicus curiae brief — Apter v. HHSEntry 29, attachment 1
  55. Order Granting AAPS Amicus Motion — Apter v. HHSEntry 30
  56. Amicus curiae brief (AAPS) — Apter v. HHSEntry 31
  57. —Entries 32–34 are not in the archive
  58. Motion for leave to file amicus curiae brief — Apter v. HHSEntry 35
  59. Amicus curiae brief (America's Frontline Doctors) — Apter v. HHSEntry 35, attachment 1
  60. —Entry 36 is not in the archive
  61. Order Granting AFLDS Amicus Motion — Apter v. HHSEntry 37
  62. —Entries 38–41 are not in the archive
  63. Defendants' Reply in Support of Motion to Dismiss — Apter v. HHS (Oct. 21, 2022)Entry 42
  64. Hearing Transcript — Motion to Dismiss — Apter v. HHS (Nov. 1, 2022) (S.D. Tex.)Entry 43
  65. —Entry 44 is not in the archive
  66. Memorandum Opinion and Order — Motion to Dismiss Granted — Apter v. HHS (Dec. 6, 2022) (S.D. Tex.)Entry 45
  67. Notice of Appeal — Apter v. HHSEntry 46
  68. —Entries 47–49 are not in the archive
  69. Fifth Circuit judgment and mandate — Apter v. HHS (S.D. Tex.)Entry 50
  70. —Entry 51 is not in the archive
  71. Order Setting Status Conference — Apter v. HHSEntry 52
  72. —Entry 53 is not in the archive
  73. Joint Proposed Docket-Control Order — Apter v. HHS (S.D. Tex.)Entry 54
  74. Court Order — Apter v. HHSEntry 55
  75. —Entries 56–60 are not in the archive
  76. Plaintiffs' Opposition to Renewed Motion to Dismiss — Apter v. HHS (Jan. 12, 2024) (S.D. Tex.)Entry 61
  77. Defendants' Renewed Motion to Dismiss — Apter v. HHS (Jan. 19, 2024) (S.D. Tex.)Entry 62
  78. —Entries 63–66 are not in the archive
  79. Defendants' Reply in Support of Renewed Motion to Dismiss — Apter v. HHS (Feb. 14, 2024)Entry 67
  80. —Entries 68–73 are not in the archive
  81. Stipulation of Dismissal (Settlement) — Apter v. HHSEntry 74
  82. Order of dismissal (stipulated) — Apter v. HHS (S.D. Tex.)Entry 75

More documents from this case’s dockets

17 more documents linked to this case’s dockets are in the archive and not in the docket above.

  1. Civil Cover Sheet (Doc. 1-24) — Apter v. Department of Health and Human Services (S.D. Tex.), June 2, 2022Cover sheetCivil cover sheet, Case 3:22-cv-00184 (TXSD), June 2, 2022: physicians' APA challenge to FDA actions on ivermectin use against HHS and FDA.
  2. Summons in a Civil Action, Doc. 2-2 — Apter v. Department of Health and Human ServicesSummons or warrantSummons to HHS Secretary Xavier Becerra in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), dated June 2, 2022.
  3. Summons to Robert M. Califf (c/o Attorney General) — Apter v. Department of Health and Human ServicesSummons or warrantSummons to Robert M. Califf, c/o the Attorney General, in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), June 2, 2022.
  4. Summons in a Civil Action, Doc. 2-7 — Apter v. Department of Health and Human ServicesSummons or warrantSummons to the Food and Drug Administration in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), Document 2-7, June 2, 2022.
  5. Summons in a Civil Action, Doc. 2-8 — Apter v. Department of Health and Human ServicesSummons or warrantSummons to the Food and Drug Administration in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), dated June 2, 2022.
  6. Summons in a Civil Action, Doc. 2-6 — Apter v. Department of Health and Human ServicesSummons or warrantSummons to the Food and Drug Administration in care of the Attorney General, Apter v. HHS, No. 3:22-cv-184 (S.D. Tex.), Document 2-6, June 2, 2022.
  7. Summons in a Civil Action, Doc. 2-9 — Apter v. Department of Health and Human ServicesSummons or warrantSummons to HHS in care of the Attorney General, Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), Document 2-9, June 2, 2022.
  8. Summons in a Civil Action, Doc. 2-5 — Apter v. Department of Health and Human ServicesSummons or warrantSummons to Commissioner of Food and Drugs Robert M. Califf in Apter v. HHS, No. 3:22-cv-184 (S.D. Tex.), Document 2-5, issued June 2, 2022.
  9. Summons in a Civil Action to Xavier Becerra — Apter v. Department of Health and Human Services (S.D. Tex.)Summons or warrantSummons to HHS Secretary Xavier Becerra in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), filed June 2, 2022.
  10. Summons in a Civil Action to Robert M. Califf — Apter v. Department of Health and Human Services (S.D. Tex.)Summons or warrantSummons to Commissioner of Food and Drugs Robert M. Califf in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), June 2, 2022.
  11. Summons in a Civil Action, Doc. 2-10 — Apter v. Department of Health and Human ServicesSummons or warrantAO 440 summons in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), Document 2-10, filed June 2, 2022.
  12. Summons in a Civil Action, Doc. 2-11 — Apter v. Department of Health and Human ServicesSummons or warrantSummons to the Department of Health and Human Services in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), June 2, 2022.
  13. Summons to Xavier Becerra (c/o Attorney General) — Apter v. Department of Health and Human ServicesSummons or warrantSummons to Xavier Becerra, c/o the Attorney General, in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), June 2, 2022.
  14. Summons in a Civil Action, Doc. 8 — Apter v. Department of Health and Human ServicesSummons or warrantAO 440 summonses to federal officials in Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), Document 8, filed June 3, 2022.
  15. Civil Cover Sheet (Doc. 12-29) — Apter v. Department of Health and Human Services (S.D. Tex.), August 8, 2022Cover sheetCivil cover sheet, Document 12-29 in Case 3:22-cv-00184 (TXSD), August 8, 2022: physicians' APA challenge to FDA actions on ivermectin use.
  16. Complaint - P l a i n t i f f s , v. U.S. DEPARTMENT OF HEALTH (2022-06-02)MotionJoint motion for a briefing schedule on the government's motion to dismiss in Apter v. HHS, No. 3:22-cv-184 (S.D. Tex.), August 18, 2022.
  17. Notice of Appeal — Apter v. Department of Health and Human Services (S.D. Tex.)NoticeNotice of Appeal to the Fifth Circuit, Apter v. Department of Health and Human Services, No. 3:22-cv-184 (S.D. Tex.), filed December 12, 2022.

Other cases in the archive from U.S. District Court for the Southern District of Texas, Galveston Division.

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

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