Children's Health Def. v. Food & Drug Admin.
| Docket Number | 23-50167 |
| Decision Date | 23 January 2024 |
| Parties | Children's Health Defense; Deborah L. Else; SacLhyale W. Cayce Dietrich; Aimee Villella McBride; Jonathan Shour; Clerk Rebecca Shour, Plaintiffs-Appellants, v. Food & Drug Administration; Robert M. Califf, Defendants-Appellees. |
| Court | U.S. Court of Appeals — Fifth Circuit |
Before JONES, HAYNES, and DOUGLAS, Circuit Judges.
Five parents and one organization challenged the Food and Drug Administration's issuance of emergency use authorizations covering COVID-19 vaccines for children. Specifically, the parents allege fears of a third party vaccinating their children without parental consent, harassing or marginalizing their children for their unvaccinated status, and pushing pro vaccine messaging. After finding that Plaintiffs lacked standing, the district court dismissed the suit. For the reasons that follow, we AFFIRM.
The Food and Drug Administration ("FDA"), an agency within the U.S. Department of Health and Human Services ("HHS"), and FDA Commissioner Califf are tasked with protecting the public's health by ensuring the safety, efficacy, and security of drugs and biological products, among other things. In February 2020, the Secretary of HHS declared a "public health emergency . . . that involves a novel (new) coronavirus," known as SARS-CoV-2, the virus that causes COVID-19. 85 Fed.Reg. 7316 7317 (Feb. 7, 2020). Subsequently, the Secretary of HHS determined that the circumstances surrounding the COVID-19 pandemic justified "the authorization of emergency use of drugs and biological products." 85 Fed.Reg. 18250 18250-51 (Apr. 1, 2020); see 21 U.S.C. § 360bbb-3 ().
In December 2020, FDA issued two emergency use authorizations ("EUAs") for administering COVID-19 vaccines to individuals over age 16.[1]In May 2021, October 2021, and June 2022, FDA revised the Pfizer EUA to expand the authorization to include additional age groups: first, individuals 12 through 15 years old; second, individuals 5 through 11 years old; and third, individuals 6 months through 4 years old. And in June 2022, FDA revised the Moderna EUA to authorize administration of the vaccine to those between 6 months and 17 years old. [2]
In May 2021, Plaintiff Children's Health Defense ("CHD") filed a petition with FDA asking the agency to revoke the existing EUAs for the COVID-19 vaccines. The FDA denied the petition, and the instant lawsuit followed in January 2022.
CHD is a nonprofit "organization that has tasked itself with protecting and promoting the health and wellbeing of children." The remaining Plaintiffs are parents that do not want their children to receive a COVID-19 vaccine. Some of the parents allege that they are at risk because their children may be coerced to receive the vaccine, may be forced to take the vaccine due to allegedly impending mandates, may receive the vaccine without parental consent, or may suffer adverse reactions should they be given the vaccine. Moreover, they complain of a "societal push toward vaccination" evidenced by, for example, "Sesame Workshop" which released a YouTube video announcing that Elmo had gotten the COVID-19 vaccine.[3] Plaintiffs claim that FDA failed to comply with the Administrative Procedure Act's ("APA") reasoned decision making requirements when it approved the COVID-19 vaccine for children and, as a result, request a stay, vacatur, and remand. Plaintiffs also seek an injunction against the marketing or promotion of the vaccines.
The district court dismissed the initial complaint, which included only the plaintiff parents from Texas. Plaintiffs filed an amended complaint, adding the plaintiff parents from North Carolina and Florida, who likewise do not want their children to receive COVID-19 vaccines. The district court again dismissed Plaintiffs' complaint for lack of standing, concluding that no plaintiff had adequately pled an injury in fact. This appeal followed. "We have jurisdiction to determine our own jurisdiction." Martin v. Halliburton, 618 F.3d 476, 481 (5th Cir. 2010).
We review standing de novo. See Shemwell v. City of McKinney, 63 F.4th 480, 483 (5th Cir. 2023). We may affirm a dismissal "'on any basis supported by the record.'" Collins v. Dep't of the Treasury, 83 F.4th 970, 978 (5th Cir. 2023) (quoting Asadi v. G.E. Energy U.S., L.L.C., 720 F.3d 620, 622 (5th Cir. 2013)).
A. Article III Standing
"'The law of Art. III standing is built on a single basic idea-the idea of separation of powers.'" TransUnion LLC v. Ramirez, 594 U.S. 413, 42223 (2021) (quoting Raines v. Byrd, 521 U.S. 811, 820 (1997)). "Under Article III, federal courts do not adjudicate hypothetical or abstract disputes" and "do not exercise general legal oversight of the Legislative and Executive Branches." Id.
Plaintiffs argue that the district court erred in its analysis of Article III standing on three grounds, including organizational standing, associational standing, and the APA. To begin, we must consider whether Plaintiffs satisfy the first requirement for Article III standing. Then, we consider whether CHD itself has standing.
"[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." TransUnion, 594 U.S. at 423 (citing Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-561 (1992)).
For an injury to be "'concrete,'" it must be "'real, and not abstract.'" Id. at 424 (quoting Spokeo, Inc. v. Robins, 578 U.S. 330, 340 (2016)). When evaluating whether a harm is "concrete," we consider "whether the alleged injury to the plaintiff has a 'close relationship' to a harm 'traditionally' recognized as providing a basis for a lawsuit in American courts." Id. (quoting Spokeo, 578 U.S. at 340). To be "imminent," "there must be at least a 'substantial risk' that the injury will occur." Stringer v. Whitley, 942 F.3d 715, 721 (5th Cir. 2019) (quoting Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014)).
Moreover, "allegations of possible future injury are not sufficient." Clapper v. Amnesty Int'l USA, 568 U.S. 398, 409 (2013) (quoting Whitmore v. Arkansas, 495 U.S. 149, 158 (1990)). Instead, "to ensure that the alleged injury is not too speculative," a plaintiff who wishes to rely on a threatened injury to establish standing must demonstrate that a concrete injury is "certainly impending." Id.
Plaintiffs contend that the injury-in-fact element is satisfied because a third party might vaccinate their children over their objections, and that such vaccine could allegedly injure them and their children. Additionally, Plaintiffs argue that any alleged advertising or disseminated information regarding the vaccine constitutes harm. In doing so, Plaintiffs note that "general factual allegations of injury" "may suffice" where, as here, the district court granted a motion to dismiss based on the pleadings. Be that as it may, we agree with the district court that Plaintiffs fail to demonstrate an injury in fact because the alleged injury is neither concrete nor imminent. "The party invoking federal jurisdiction bears the burden of establishing" the elements of standing, which "are not mere pleading requirements but rather an indispensable part of the plaintiff's case[.]" Lujan, 504 U.S. at 561.
Nothing in Plaintiffs' amended complaint or briefs suggest that the alleged injuries are nonspeculative or "certainly impending." Clapper, 568 U.S. at 409. To begin, it is insufficient that Plaintiffs allege that some hypothetical third party might, at some hypothetical point in the future and through some hypothetical means, will vaccinate their children against their wishes.
We are not persuaded by the out-of-circuit cases that Plaintiffs rely on to establish injury in fact. Take Booth v. Bowser, 597 F.Supp.3d 1 (D.D.C. 2022), which concluded that two sets of parents had sufficiently alleged an impending injury to establish standing. The parents in Booth challenged the District of Columbia's law permitting children at least eleven years old to get vaccinated without parental consent. Id. at *9. To determine whether the parents had standing, the court considered whether the complaint detailed allegations regarding the likelihood that the parents' children would soon seek vaccines. Id. For example, one child said he would take the vaccine if offered, and another child repeatedly told her parents that she needed the vaccine to participate in various school activities, so she wanted to get the vaccine. Id. at *6 (). Thus, the imminent injury for the parents in Booth arose from the D.C. law allowing children to seek vaccines absent parental consent, particularly when D.C. mandated vaccines for most students. Id. at *13.
In contrast, the parents in this case do not allege any facts establishing a similar likelihood that their children will seek or obtain a vaccine without parental consent. The parents do not allege that their children are or will be subject to any vaccine mandates that might be imposed by third parties. Nor do they allege that their children wish to receive a COVID-19 vaccine or have the means or opportunity to get it despite their parents' wishes. The parents' allegations are particularly speculative because there are no COVID-19 vaccine mandates, state or federal, and their states generally prohibit administering vaccines...
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