Case docket
Children's Health Defense v. Food & Drug Administration — W.D. Tex., Waco, No. 6:22-cv-00093-ADA
Children's Health Defense, et al. v. Food & Drug Administration, et al. — 3 court filings in the archive from U.S. District Court for the Western District of Texas (Waco Division), filed between July 1, 2022 and January 12, 2023. Among them: 1 complaint, 1 response or reply and 1 order.
See also: — the same docket (docket No. 6:22-cv-00093) under another case page, 12 public filings.
Case facts
| Court | U.S. District Court for the Western District of Texas (Waco Division) |
|---|---|
| Filings | 3 public filings |
| Filed | 2022-07-01 – 2023-01-12 |
| Document types | complaint (1), response or reply (1), order (1) |
| Original PDFs | 3 of 3 |
Case summary
Children's Health Defense and five individual plaintiffs sued the Food and Drug Administration and Commissioner Robert M. Califf in the U.S. District Court for the Western District of Texas, Waco Division, No. 6:22-cv-00093-ADA, on January 24, 2022. The first amended complaint pleads two causes of action, violation of the Administrative Procedure Act and declaratory relief, over the emergency use authorisations for the Pfizer-BioNTech and Moderna COVID-19 vaccines for children, and asks the court to enjoin further marketing to children, to stay and vacate the authorisations and to remand them to the agency. On January 12, 2023, after a hearing on November 18, 2022, the court granted the defendants' motion to dismiss for lack of subject-matter jurisdiction, held that all plaintiffs lack standing and dismissed the case with prejudice.
Case at a glance
| Parties | Plaintiffs, as captioned: Children's Health Defense, Deborah L. Else, Sacha Dietrich, Aimee Villella McBride, Jonathan Shour and Rebecca Shour. Defendants: Food & Drug Administration and Robert M. Califf, FDA Commissioner |
|---|---|
| Court and docket | U.S. District Court for the Western District of Texas, Waco Division, Case No. 6:22-cv-00093-ADA (also styled 6:22-cv-00093-ADA-DTG) |
| Program | Not named in the filings on this page. The subject is the FDA's emergency use authorisations for COVID-19 vaccines, issued after the March 27, 2020 determination that circumstances justified emergency use of drugs and biological products during the pandemic |
| 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 asks the court to enjoin further marketing or promotion of the Pfizer-BioNTech and Moderna COVID-19 vaccines to children, to stay the authorisations for children aged five to eleven and for infants and toddlers aged six months to four years, to vacate and remand those decisions, and to award fees and costs under 28 U.S.C. § 2412 |
| Disposition or status | Dismissed with prejudice. On January 12, 2023 the court granted the defendants' motion to dismiss for lack of subject-matter jurisdiction, concluding that all plaintiffs lack standing to sue, and did not rule on the motion to dismiss for failure to state a claim |
What did the court decide?
It granted the motion to dismiss for lack of subject-matter jurisdiction, concluded that all plaintiffs lack standing to sue, declined to reach the failure-to-state-a-claim ground, and dismissed the case with prejudice. On the organisational plaintiff the order states that the alleged procedural harm is not concrete and particularised to Children's Health Defense but is the same harm suffered by the public at large.
What does the amended complaint allege?
That the defendants abused their emergency powers, denied Children's Health Defense its procedural right to seek redress by citizen petition, redefined the term "vaccine" in violation of procedural due process, failed to articulate standards for assessing safety, efficacy and necessity, and promoted marketing of a biologic targeted at children, in violation of the Administrative Procedure Act. It asks for a declaratory judgment and for the defendants' return to the regular biologic licensure process.
What is the procedural history?
The order records that the FDA issued emergency use authorisations for the Pfizer-BioNTech and Moderna vaccines in December 2020, revised the Pfizer authorisation for children five to eleven on October 29, 2021 and for children six months to four years on June 17, 2022; that Children's Health Defense petitioned the FDA in May 2021 to revoke the existing authorisations and the petition was denied; and that the court granted an earlier motion to dismiss for lack of subject-matter jurisdiction without prejudice at a hearing on May 17, 2022.
Summary written from the documents on this page; every sentence is sourced.
Filings
3 public filings from this case, in filing-date order.
Court, dates and docket numbers are as recorded on the filings.