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Children's Health Defense v. Food & Drug Administration — W.D. Tex., Waco Division, No. 6:22-cv-00093

Children's Health Defense v. Food & Drug Administration — W.D. Tex., Waco Division, No. 6:22-cv-00093 — 15 documents in the archive, dated January 24, 2022 to January 12, 2023.

Case facts

CourtU.S. District Court for the Western District of Texas, Waco Division
Docket numberNo. 6:22-cv-00093 — main docket · CourtListener docket 1159970
Filings15 public filings
Filed2022-01-24 – 2023-01-12
Original PDFs15 of 15

Case summary

Children's Health Defense, Deborah L. Else and Sacha Dietrich filed this action on January 24, 2022 in the U.S. District Court for the Western District of Texas, Waco Division, No. 6:22-cv-00093-ADA, against the Food & Drug Administration and Janet Woodcock, acting commissioner of Food & Drugs. The complaint challenges the FDA's Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine for children aged five through eleven and pleads two causes of action: violation of the Administrative Procedure Act and declaratory relief. The plaintiffs moved on April 15, 2022 for an administrative stay of the authorisation pending judicial review; the defendants moved to dismiss the complaint on April 25, 2022 and the amended complaint on July 29, 2022. No ruling on those motions is among the filings on this page. The last filing is an order of January 11, 2023 vacating the referral to a magistrate judge.

Case at a glance

PartiesPlaintiffs, as captioned on the complaint: Children's Health Defense, Deborah L. Else and Sacha Dietrich. The January 2023 order names the plaintiffs as Children's Health Defense, Deborah L. Else, Sacha Dietrich, Aimee Villella McBride, Jonathan Shour and Rebecca Shour. Defendants: Food & Drug Administration and Janet Woodcock, acting commissioner of Food & Drugs, named in the January 2023 order as Robert M. Califf
Court and docketU.S. District Court for the Western District of Texas, Waco Division, No. 6:22-cv-00093, appearing on the filings as 6:22-cv-00093-ADA-JCM, 6:22-cv-00093-ADA-DTG and W-22-CV-00093-ADA (District Judge Alan D Albright; referred to U.S. Magistrate Judge Derek T. Gilliland until January 11, 2023)
ProgramNot named in the filings on this page. The measure at issue is the FDA's Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine for minor children ages five through eleven
ClaimsCause of Action I: violation of the Administrative Procedure Act. Cause of Action II: declaratory relief under 28 U.S.C. § 2201. The prayer for relief asks the court to enjoin further marketing or promotion of the drug to children and to stay the FDA's decision to grant the Emergency Use Authorization
Current statussee Children's Health Defense v. Food & Drug Administration — W.D. Tex., Waco, No. 6:22-cv-00093-ADA
Disposition or statusDismissed with prejudice January 12, 2023, when the court granted the defendants' motion to dismiss for lack of subject-matter jurisdiction; the plaintiffs appealed on March 3, 2023, and the court of appeals' judgment and mandate was entered on the district docket on February 14, 2024. The plaintiffs' motion of April 15, 2022 asks for an administrative stay of the Emergency Use Authorization pending judicial review; the defendants opposed it on April 29, 2022 and the plaintiffs replied on May 6, 2022. The defendants moved to dismiss the complaint on April 25, 2022, supported by a declaration from an FDA official and two exhibits, and moved to dismiss the amended complaint on July 29, 2022; the plaintiffs opposed both. No order on the stay or on either motion to dismiss is among the filings, and no judgment is on this page. The last filing is an order of January 11, 2023 vacating the referral of the case to a magistrate judge
Status checked2026-09-23 · against the order granting the motion to dismiss; docket entries 36 and 39, the notice of appeal and the court of appeals' judgment and mandate

What does the complaint allege?

That the FDA, by claiming emergency powers, authorized the Pfizer-BioNTech COVID-19 vaccine for children as young as five without a notice-and-comment period, without acting on citizen petitions, and in a way the plaintiffs say exceeds express legislative limits and is not beyond judicial review. Cause of Action I pleads violation of the Administrative Procedure Act, including the right to petition an agency, and Cause of Action II seeks a declaratory judgment that the defendants cannot use the emergency power as they did.

What relief did the plaintiffs ask for?

The prayer for relief asks the court to enjoin any further marketing or promotion of the drug to children and to stay the FDA's decision to grant the Emergency Use Authorization. A separate motion of April 15, 2022 asks for an administrative stay of the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine for minor children ages five through eleven pending judicial review of the complaint, and the complaint also asks for vacatur and remand of the agency's action.

What did the defendants file?

A motion to dismiss the complaint on April 25, 2022, supported by a declaration of the Director of the Division of Disclosure and Oversight Management in the FDA's Center for Biologics Evaluation and Research, and two exhibits: the FDA's Emergency Use Authorization letter to Pfizer Inc. of January 3, 2022 and an FDA fact sheet for recipients. They opposed the stay on April 29, 2022 and moved to dismiss the amended complaint on July 29, 2022. No order resolving these motions is on this page.

Docket

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

No. 6:22-cv-00093

  1. Complaint — CHD v. FDAEntry 1
  2. —Entries 2, 4–8 and 10–13 are not in the archive; entries 3 and 9 are listed under More documents below
  3. Motion to Stay — CHD v. FDAEntry 14
  4. —Entries 15–17 are not in the archive
  5. Motion to Dismiss — CHD v. FDAEntry 18
  6. Declaration — CHD v. FDAEntry 18, attachment 1
  7. Exhibit (FDA EUA Authorization Letter) — CHD v. FDAEntry 18, attachment 2
  8. Exhibit (FDA Fact Sheet) — CHD v. FDAEntry 18, attachment 3
  9. Opposition Brief — CHD v. FDA (Doc. 19, filed 2022-04-29)Entry 19
  10. Reply Brief — CHD v. FDAEntry 20
  11. Opposition Brief — CHD v. FDA (Doc. 21, filed 2022-05-09)Entry 21
  12. —Entries 22–25 are not in the archive
  13. First Amended Complaint — Children's Health Defense v. FDAEntry 26
  14. —Entries 27–28 are not in the archive
  15. Motion to Dismiss Amended Complaint — CHD v. FDAEntry 29
  16. Opposition Brief — CHD v. FDA (filed 2022-08-26)Entry 30
  17. Reply in support of motion to dismiss the First Amended Complaint — Children's Health Defense v. FDA (W.D. Tex.)Entry 31
  18. —Entries 32–33 are not in the archive
  19. Order Vacating Referral — CHD v. FDAEntry 34
  20. Order Granting Motion to Dismiss — Children's Health Defense v. FDA (W.D. Tex.)Entry 35

More documents from this case’s dockets

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

  1. representing a party, please submit a motion requesting the Court’s permission to appear in the aboveClerk of Court letter on pro hac vice admission, Children's Health Defense et al v. Food & Drug Administration, No. 6:22-cv-00093 (W.D. Tex.).
  2. [Proposed] Order Denying Plaintiffs’ Motion to Stay
  3. Summons in a Civil Action — Children's Health Defense v. Food & Drug Administration (Dkt. 3)Source documentAO 440 summons forms, Children's Health Defense v. Food & Drug Administration, No. 6:22-cv-00093-ADA-JCM (W.D. Tex.), Doc. 3, filed 01/26/22.
  4. Deficiency Notice — Children's Health Defense v. Food & Drug Administration (Dkt. 9)Source documentDeficiency Notice, Children's Health Defense v. Food & Drug Administration, No. 6:22-cv-00093-ADA-JCM (W.D. Tex.), February 24, 2022.

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

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