Court Opinion

ID: 9926211
Source: CourtListenerOpinion
Date Created: 2024-01-24 01:00:40.022949+00
Date Added: 2024-06-11T09:22:11.465648
License: Public Domain

Case: 23-50167         Document: 00517041523             Page: 1      Date Filed: 01/23/2024

              United States Court of Appeals
                   for the Fifth Circuit
                                      ____________
                                                                                United States Court of Appeals
                                                                                         Fifth Circuit
                                        No. 23-50167
                                      ____________                                     FILED
                                                                                January 23, 2024
   Children’s Health Defense; Deborah L. Else; Sacha
                                                  Lyle W. Cayce
   Dietrich; Aimee Villella McBride; Jonathan Shour; Clerk
   Rebecca Shour,

                                                                   Plaintiffs—Appellants,

                                             versus

   Food & Drug Administration; Robert M. Califf,

                                               Defendants—Appellees.
                      ______________________________

                      Appeal from the United States District Court
                           for the Western District of Texas
                                USDC No. 6:22-CV-93
                      ______________________________

   Before Jones, Haynes, and Douglas, Circuit Judges.
   Per Curiam: *
          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-
          _____________________
          *
              This opinion is not designated for publication. See 5th Cir. R. 47.5.
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                                         No. 23-50167

   vaccine messaging. After finding that Plaintiffs lacked standing, the district
   court dismissed the suit. For the reasons that follow, we AFFIRM.
                                   I.     Background
           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 (authorizing
   the use of medical products in emergencies and justified threats).
           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

           _____________________
           1
             Specifically, the vaccines manufactured by Pfizer, Inc. and BioNTech
   Manufacturing GmbH were authorized for use in individuals 16 years of age and older and
   one manufactured by ModernaTX, Inc. was authorized for use in individuals 18 years of
   age and older. See 86 Fed. Reg. 5200, 5200, 5204, 5214 (Jan. 19, 2021) (providing notice of
   EUA issuance).

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   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
           _____________________
           2
              See FDA, Emergency Use Authorization, https://perma.cc/XKQ8-GUBN
   (listing EUAs). While the FDA has issued EUAs for an updated bivalent formula of both
   the Pfizer-BioNTech and Moderna vaccines, the monovalent formulas remain licensed but
   are no longer authorized for emergency use in the United States; they are thus only
   approved for use in individuals 12 years and older (Pfizer) or 18 years and older (Moderna).
   See generally FDA, FDA COVID-19 Vaccine News and Updates, https://perma.cc/E3VU-
   JDWF; FDA News Release, Coronavirus (COVID-19) Update: FDA Authorizes Changes
   to Simplify Use of Bivalent mRNA COVID-19 Vaccines (Apr. 18, 2023),
   https://perma.cc/WY2V-YLYU.
           3
             Plaintiffs allege that Elmo sent the message that children will “get sick if [they]
   don’t take the COVID-19 vaccine.” In doing so, Plaintiffs rely on a video that suggests
   otherwise. See Sesame Street: Elmo Gets the COVID-19 Vaccine, Sesame Street, available
   at https://www.youtube.com/watch?v=bwimt9n2JEk. In the video, Elmo’s father states
   that: “I had a lot of questions about Elmo getting the COVID vaccine. Was it safe? Was it
   the right decision? I talked to our pediatrician so I could make the right choice. I learned

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                                         No. 23-50167

   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).
                                II.     Discussion
           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, 422-
   23 (2021) (quoting Raines v. Byrd, 521 U.S. 811, 820 (1997)). “Under Article
   III, federal courts do not adjudicate hypothetical or abstract disputes” and

           _____________________
   that Elmo getting vaccinated is the best way to keep himself, our friends, neighbors and
   everyone else healthy and enjoying the things they love.” Id. Further, the video explains
   that “it’s okay to have questions about the COVID-19 vaccine for your kids. Get the latest
   facts by speaking with your pediatrician or healthcare provider.” Id.

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   “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.
                                     1. Injury in Fact
          “[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.

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          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

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   vaccine. Id. at *6 (finding that the child “made it clear that he is on the cusp
   of getting vaccinated”). 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 absent parental consent. 4 See e.g., Biden v. Feds for
   Med. Freedom, No. 23-60, 2023 WL 8531839, at *1 (U.S. Dec. 11, 2023)
   (explaining that an order granting a preliminary injunction against a vaccine
   mandate is moot because such mandate does not exist). By extension, there
   is also no “impending injury” arising from the parents’ fear of moving to

           _____________________
           4
              State laws establish vaccination requirements for school children. See Fla.
   Stat. 1014.06(1); N.C. Gen. Stat. § 90-21.5(a1); Tex. Family Code Ann. § 151.001(a)(6);
   see also Tex. Family Code Ann. § 32.101(b) (permitting certain specified non-parents to
   consent to immunization in limited circumstances where, among other things, the parents
   are “not available.”). To be sure, the Texas-based parents have alleged fears of a third-
   party authorizing vaccines to their children but, as they have noted, this occurs in limited
   circumstances. The parents neither identify any specific third party able to provide that
   authorization, nor do they allege that a third party wants to vaccinate their children, or that
   their children would consent on their own. Even if they did, the claim still fails for lack of
   imminency. As the district court explained, under Texas and Florida law, vaccination
   cannot be mandatory. Tex. Executive Order GA-40 (Oct. 11, 2021); Fla. Stat. § 381.00319.
   Moreover, under North Carolina law, individuals other than parents are not permitted to
   vaccinate a child. N.C. Gen. Stat. § 90-21.5(a1).

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   another state that might have a vaccine mandate in the future, as such a
   mandate has not materialized. 5 See e.g., TransUnion, 594 U.S. at 437-38
   (explaining that plaintiffs did not establish a concrete harm because
   “plaintiffs did not demonstrate that the risk of future harm materialized” and
   such risk was “too speculative”).
           Moreover, information in the public domain related to vaccines and
   general “pressure to receive the COVID-19 [vaccine] . . . from the media and
   other children” do not constitute a concrete injury. Plaintiffs rely on cases
   that find standing on similar theories as Booth, such as where a government
   agency allegedly exposed the plaintiff to, or increased the risk that the
   plaintiff would be exposed to, harmful products or drugs; 6 where an agency
   allegedly increased health-related uncertainty; 7 and where a parent’s medical
   control over her children’s care was allegedly impaired. 8 As the district court
   explained, however, those cases are neither binding, nor persuasive. To
   illustrate, in Baur, the plaintiff described how the alleged threat of harm
   directly arose from the agency’s action. See Baur, 352 F.3d at 634 (finding that
   enhanced risks in the “context of food and drug safety suits . . . are cognizable
   for standing purposes, where the plaintiff alleges exposure to potentially

           _____________________
           5
             To be clear, Plaintiffs fail to point to any states that require COVID-19 vaccines
   for children or adults. Even if they did, nothing in the amended complaint suggests that a
   vaccine mandate would present a threat to the parent or child that chooses not to seek the
   vaccine. Further, if a mandate existed, plaintiffs would need to bring a cause of action
   against the mandating entity (i.e., schools, employers, businesses), not FDA.
           6
           See Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003); Cutler v. Kennedy, 475 F. Supp.
   838 (D.D.C. 1979); Center for Food Safety v. Price, No. 17-cv-3833, 2018 WL4356730
   (S.D.N.Y. Sept. 12, 2018).
           7
               See New York Public Interest Research Grp. v. Whitman, 321 F.3d 316 (2d Cir. 2003).
           8
             See Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009) (explaining that under
   the challenged FDA action, parents are unable to legally obtain Plan B on behalf of their
   children).

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   harmful products.”). Baur clarifies that the injury must nonetheless be a
   “discrete, individual risk of personal harm from exposure[.]” Id. at 635.
           Unlike the plaintiffs in Baur, the Plaintiffs do not have a concrete or
   particularized injury. Instead, Plaintiffs merely allege that 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. These hypothetical dangers are untethered to the
   law. Even if the alleged harms were plausible, each are the result of a third-
   party action, not the FDA. See e.g., TransUnion, 594 U.S. at 438 (finding that
   plaintiffs failed to establish a future risk of harm by not showing “a sufficient
   likelihood that their individual credit information would be requested by
   third-party businesses and provided by [defendant] . . . [or] that there was a
   sufficient likelihood that [defendant] would otherwise intentionally or
   accidentally release their information to third parties.”). In other words, the
   EUAs do not put the parents at an imminent risk of harm or exposure because
   the parents are free to choose whether to consent to their children receiving
   the COVID-19 vaccine, and whether to restrict their children’s access to
   information related to the vaccine. 9 Thus, the parents fail to display any
   nonspeculative risk of harm based on a “possible future injury.” Clapper, 568
   U.S. at 409.
           In addition, Plaintiffs fail to argue how being marginalized by society
   and media campaigns based on vaccination status constitutes an injury in fact

           _____________________
           9
             “Under the EUA, there is an option to accept or refuse receiving this vaccine.
   Should you decide for your child not to receive this vaccine, it will not change the standard
   medical care.” See e.g., FOOD & DRUG ADMIN. Fact Sheet for Recipients and Caregivers
   about Pfizer-BioNTech COVID-19 Vaccine (2023 - 2024 Formula) which has Emergency
   Use Authorization (EUA) to Prevent Coronavirus Disease 2019 (COVID-19) in
   Individuals 6 Months through 11 Years of Age; 21 U.S.C. § 360bbb-3(c)(1)-(5).
   www.covid vaxoption.com.

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   to sue FDA. Plaintiffs simply point to a Sesame Street video saying that Elmo
   received the COVID-19 vaccine. 10 Because they do not explain on appeal how
   media or even societal norms may constitute an injury-in-fact, they forfeit any
   challenge to the district court’s conclusion that plaintiffs have not suffered
   an injury in fact at the hands of unidentified third parties or the media. See
   Owens v. Circassia Pharm., Inc., 33 F.4th 814, 824 n.4 (5th Cir. 2022); see also
   TransUnion, 594 U.S. at 424 (“[U]nder Article III, a federal court may
   resolve only ‘a real controversy with real impact on real persons.’”) (quoting
   American Legion v. American Humanist Assn., 139 S.Ct. 2067, 2103 (2019).
   Even if challenged, the district court correctly explained that Plaintiffs have
   not suffered an injury in fact because they have merely alleged a
   “psychological consequence” “produced by observation of conduct with
   which one disagrees.” Valley Forge Christian Coll. v. Am. United for
   Separation of Church & State, Inc., 454 U.S. 464, 485 (1982).
                         2. Organizational and Associational Standing
           We next consider whether CHD, as an organization or association,
   establishes standing. CHD first suggests that it has spent resources working
   with its members, addressing societal pressures, and educating the public
   regarding alleged dangers of vaccines. Then CHD asserts that it spent
   resources investigating FDA’s action to prepare for litigation and file a
   citizen petition.
           Organizations can satisfy injury-in-fact for standing under two
   theories: organizational standing and associational. OCA-Greater Houston v.
   Texas, 867 F.3d 604, 610 (5th Cir. 2017). “[A]n organization may establish
           _____________________
           10
              Misleadingly, Plaintiffs also allege that a federal vaccine mandate for students
   exists. The falsity of that allegation is demonstrated by Plaintiffs failure to cite any legal or
   factual support. Indeed, Plaintiffs do not identify any specific factual allegations that would
   support their claim of harassment related to their vaccination status.

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   injury in fact by showing that it had diverted significant resources to
   counteract the defendant’s conduct.” N.A.A.C.P. v. City of Kyle, 626 F.3d
   233, 238 (5th Cir. 2010). Thus, any diversion must be a specific response to
   the challenged law or action. It is not fairly traceable to defendants if the
   diversion responded not only to the defendants’ conduct but also to other
   forces. Texas State LULAC v. Elfant, 52 F.4th 248, 254 (5th Cir. 2022). “A
   “setback to [an] organization’s abstract social interests” is insufficient.
   Havens Realty Corp. v. Coleman, 455 U.S. 363, 379 (1982).
          Associational standing is derivative of an organization’s members.
   OCA-Greater Houston, 867 F.3d at 610. To have associational standing, the
   organization must show: (1) that its members independently possess Article
   III standing, (2) “the interests the association seeks to protect are germane
   to the purpose of the organization,” and (3) the claim and the relief requested
   does not require participation of the individual members. Ctr. for Biological
   Diversity v. U.S. EPA, 937 F.3d 533, 536 (5th Cir. 2019).
          We find that CHD has not established standing as it has not “diverted
   significant resources to counteract” the FDA’s EUAs. City of Kyle, 626 F.3d
   at 238. In particular, CHD has failed to show how the diversion of resources
   in response to the EUAs has “concretely and ‘perceptibly impaired’”
   CHD’s ability to carry out its purpose. CHD “ha[s] not identified any
   specific projects that [it] had to put on hold or otherwise curtail in order to
   respond to” the EUAs; instead, it has “only conjectured that the resources
   that [it] had devoted to” the EUAs “could have been spent on other
   unspecified [CHD] activities.” City of Kyle, 626 F.3d at 238-39.
   Furthermore, an organizational plaintiff—like any other plaintiff—cannot
   spend its way to standing through a lawsuit; instead, the organization must
   show that the injury increases the resources devoted to programs,
   “independent of its suit challenging the action.” Online Merchs. Guild v.
   Cameron, 995 F.3d 540, 547 (6th Cir. 2021) (quotation omitted); see also Steel

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   Co. v. Citizens for a Better Env’t, 523 U.S. 83, 107 (1998) (“Obviously, . . . a
   plaintiff cannot achieve standing to litigate a substantive issue by bringing suit
   for the cost of bringing suit.”). CHD fails to show how such previously
   incurred costs are redressable. Further, because the parents have not
   demonstrated an injury in fact, CHD has not established associational
   standing.
                              III.     Conclusion
          Because Plaintiffs fail to show that they have standing, we AFFIRM
   the district court and DISMISS the suit for lack of jurisdiction.

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