Case docket
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 — 12 court filings in the archive from U.S. District Court for the Western District of Texas, Waco Division, filed between January 24, 2022 and January 11, 2023. Among them: 2 exhibits, 1 complaint and 1 motion.
See also: — the same docket (docket No. 6:22-cv-00093) under another case page, 3 public filings.
Case facts
| Court | U.S. District Court for the Western District of Texas, Waco Division |
|---|---|
| Filings | 12 public filings |
| Filed | 2022-01-24 – 2023-01-11 |
| Document types | exhibits (2), complaint (1), motion (1), declaration (1), response or reply (4), order (1) |
| Original PDFs | 12 of 12 |
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
| Parties | Plaintiffs, 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 docket | U.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) |
| Program | Not 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 |
| Claims | Cause 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 status | see Children's Health Defense v. Food & Drug Administration — W.D. Tex., Waco, No. 6:22-cv-00093-ADA |
| Disposition or status | Dismissed 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 checked | 2026-09-23 · 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.
Summary written from the documents on this page; every sentence is sourced.
Filings
12 public filings from this case, in filing-date order.
- Complaint — CHD v. FDAComplaint
- Motion to Stay — CHD v. FDAMotion · PDF
- Declaration — CHD v. FDADeclaration · PDF
- Motion to Dismiss — CHD v. FDAPDF
- Exhibit (FDA EUA Authorization Letter) — CHD v. FDAExhibit
- Exhibit (FDA Fact Sheet) — CHD v. FDAExhibit
- Opposition Brief — CHD v. FDAResponse or reply · PDF
- Reply Brief — CHD v. FDAResponse or reply
- Opposition Brief — CHD v. FDAResponse or reply · PDF
- Motion to Dismiss Amended Complaint — CHD v. FDAPDF
- Opposition Brief — CHD v. FDAResponse or reply · PDF
- Order Vacating Referral — CHD v. FDAOrder · PDF
More documents from this docket
2 more documents from the same CourtListener docket (gov.uscourts.txwd.1159970) are in the archive but are not among the 12 filings above.
Court, dates and docket numbers are as recorded on the filings.