U.S. Court in Texas Tosses Action Against FDA over COVID Vaccine Authorization for Children
- January 20, 2023
A federal court in Texas dismissed January 12 a lawsuit challenging the Food and Drug Administration’s (FDA’s) decision to authorize emergency use of the COVID-19 vaccine for children.
The U.S. District Court for the Western District of Texas held that both the individual plaintiff parents and the Children’s Health Defense (CHD) lacked standing to bring the lawsuit, which alleged the FDA failed to comply with the Administrative Procedure Act (APA) when it approved the COVID-19 vaccine for children pursuant to an emergency use authorization (EUA). Plaintiffs asked the court to vacate the FDA’s EUA.
The individual plaintiffs have not suffered an injury in fact as a result of the vaccine EUA, the court said. Plaintiffs failed to show a credible threat of harm from vaccination by a non-parent or impending vaccine mandates, the court noted.
The FDA’s EUA specifically state that receiving the vaccine is optional, nor do state laws in Texas, Florida, and North Carolina, where the individual plaintiffs reside, mandate vaccination.
Plaintiffs also failed to show they suffered an injury in fact from pro-vaccine advertising or from losing confidence in FDA decision making.
As to pro-vaccine messaging, “[p]laintiffs have merely alleged a ‘psychological consequence’ ‘produced by observation of conduct with which one disagrees,’” which is insufficient to confer standing.
Plaintiffs’ loss of confidence in the FDA also could not establish standing because they failed to allege that loss of confidence would alter any of their purchasing decisions of FDA-regulated products, the court said.
In addition, the court found CHD lacked associational standing—because the individual plaintiff members lacked standing—and organizational standing—because the group did not demonstrate that the FDA's conduct caused a serious diversion of its resources.
“CHD has [ ] failed to show how its efforts in response to the FDA's EUAs differ from its ordinary activities,” nor did it demonstrate how the ability to carry out its purpose has been impaired, the court said.
CHD’s bare assertion of a procedural violation under the APA was “merely a generalized grievance” that also could not confer standing, the court held.
Children’s Health Defense v. Food and Drug Admin., No. Case No. 6:22-CV-00093-ADA (W.D. Tex. Jan. 12, 2023).