Of late, the Fifth Circuit has come in for some criticism over rulings involving science, the FDA, and medicines.  But apparently even it has its limits—and Article III standing is one.

In Children’s Health Defense v. FDA, No. 23-50167, 2024 U.S. App. LEXIS 1528, 2024 WL 244938 (5th Cir. 1/23/24), a non-profit and several parents challenged the FDA’s emergency use authorization (EUA) that permits the administration of COVID-19 vaccines to children.  In essence, the plaintiffs sought to have the FDA’s regulatory decision overturned on the ground that the Agency failed to follow the Administrative Procedures Act, and to enjoin the FDA from “marketing or promoting” COVID-19 vaccines.

So what was the alleged harm in Children’s Health Defense that might allow these plaintiffs to overturn an FDA regulatory decision?  How had the FDA’s issuance of an EUA during the COVID-19 pandemic caused a legally cognizable injury to these plaintiffs?

According to the plaintiffs, their injury was that they feared “a third party may vaccinate their children without their consent, that a third party might harass their children for being unvaccinated, and that their children may be exposed to pro-vaccine messaging,” such as a Sesame Street segment about Elmo getting vaccinated.     

You might be thinking that these alleged injuries sound pretty speculative, as well as attenuated from the FDA activity of issuing a COVID-19 vaccine EUA, and you would be right. 

In legal terms, the issue was whether these plaintiffs have standing, something required by Article III of the U.S. Constitution:

[T]o establish standing, a plaintiff must show (i) that he suffered an injury in fact that is concrete, particularized, and actual or imminent; (ii) that the injury was likely caused by the defendant; and (iii) that the injury would likely be redressed by judicial relief.

Children’s Health Defense, 2024 WL 244938 at *2.

As the Fifth Circuit acknowledged, speculation “that some hypothetical third party might, at some hypothetical point in the future and through some hypothetical means, [ ] vaccinate their children against their wishes” was neither a concrete nor an imminent alleged injury.  As to the exposure to a viewpoint with which the plaintiffs disagreed, the Fifth Circuit recognized it is not an injury in fact to allege a “psychological consequence produced by observation of conduct with which one disagrees.”  Id. at *4 (internal citation and quotes omitted).

In addition, the connection to the FDA was missing:  “Even if the alleged harms were plausible,” each would be “the result of a third-party action, not the FDA.”   In other words, even if there was an imminent risk that someone might help one of the plaintiff’s children obtain the vaccine against the parent’s wishes, the solution would be to seek an injunction against that person—it is not to try to upend the FDA regulatory decision authorizing the vaccine in the first place.