Motion to Dismiss Amended Complaint — CHD v. FDA

Record facts

U.S. District Court for the Western District of Texas, Waco Division · No. 6:22-cv-00093-ADA-DTG · Doc. 29 · 2022-07-29 · Docket on CourtListener

Summary

Defendants' motion to dismiss the first amended complaint for lack of subject-matter jurisdiction and failure to state a claim in Children's Health Defense v. Food & Drug Administration, No. 6:22-cv-00093-ADA-DTG, filed July 29, 2022 as Document 29 in the U.S. District Court for the Western District of Texas, Waco Division. Brought under Rule 12(b)(1) and 12(b)(6), it argues no individual plaintiff has shown actual or imminent injury and that Children's Health Defense lacks associational and organizational standing. It further argues sovereign immunity bars the claims because Congress committed issuance of an emergency use authorization to agency discretion under 21 U.S.C. § 360bbb-3(i). The background recounts the authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines, including the June 17, 2022 expansions, and the brief runs 29 pages.

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UNITED STATES DISTRICT COURT 
FOR THE WESTERN DISTRICT OF TEXAS 
WACO DIVISION 
 
 
Children’s Health Defense, et al., 
 
 
 
 
 
Plaintiffs, 
 
 
v. 
 
Food & Drug Administration, et al., 
 
 
 
 
 
Defendants. 
 
 
 
 
Case No. 6:22-cv-00093-ADA-DTG 
Defendants’ Motion to Dismiss the First Amended Complaint  
for Lack of Subject-Matter Jurisdiction and Failure to State a Claim  
 
 
 
  
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TABLE OF CONTENTS 
INTRODUCTION ............................................................................................................................... 1 
BACKGROUND ................................................................................................................................ 2 
I. 
FDA’s issuance of the Pfizer and Moderna EUAs ...................................................... 2 
II. 
CHD’s opposition to COVID-19 vaccines, and this lawsuit ...................................... 3 
LEGAL STANDARD .......................................................................................................................... 4 
ARGUMENT ..................................................................................................................................... 5 
I. 
This Court still lacks subject-matter jurisdiction ......................................................... 5 
A. 
No Plaintiff has standing .......................................................................................... 6 
1. 
With no actual or imminent injury to themselves or their children, the 
individual plaintiffs lack standing ...................................................................... 6 
2. 
CHD lacks associational and organizational standing ................................... 11 
B. 
Sovereign immunity bars Plaintiffs’ causes of action ......................................... 13 
II. 
Even if this Court has jurisdiction, Plaintiffs’ claims are implausible ................... 16 
CONCLUSION ................................................................................................................................ 20 
 
 
 
 
 
 
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TABLE OF AUTHORITIES 
Cases 
Ashcroft v. Iqbal, 
556 U.S. 662 (2009) ........................................................................................................ 5, 18, 20 
Ass’n of Am. Physicians & Surgeons v. FDA, 
2020 WL 5745974 (6th Cir. Sept. 24, 2020) .......................................................................... 14 
Aviles v. Blasio, 
No. 20 CIV. 9829 (PGG), 2021 WL 796033 (S.D.N.Y. Mar. 2, 2021) ................................... 4 
Balt. Gas & Elec. Co. v. Nat. Res. Def. Council, 
462 U.S. 87 (1983) .................................................................................................................... 16 
Bell Atl. Corp. v. Twombly, 
550 U.S. 544 (2007) .................................................................................................................... 5 
Blanchett v. DeVos, 
490 F. Supp. 3d 26 (D.D.C. 2020) .......................................................................................... 16 
Block v. Cmty. Nutrition Inst., 
467 U.S. 340 (1984) .................................................................................................................. 14 
Borough of Duryea v. Guarnieri, 
564 U.S. 379 (2011) .................................................................................................................. 17 
Brownback v. King, 
141 S. Ct. 740 (2021) .................................................................................................................. 5 
Carr v. Saul, 
141 S. Ct. 1352 (2021) ........................................................................................................ 19, 20 
Children’s Health Def. v. FDA, 
No. 21-6203, 2022 WL 2704554 (6th Cir. July 12, 2022) ............................................. 4, 7, 10 
Children’s Health Def. v. Rutgers State Univ. of N.J., 
No. CV2115333ZNQTJB, 2021 WL 4398743 (D.N.J. Sept. 27, 2021) .................................. 4 
City of Hearne v. Johnson, 
929 F.3d 298 (5th Cir. 2019) ............................................................................................. 13, 17 
Clapper v. Amnesty Int’l USA, 
568 U.S. 398 (2013) .............................................................................................................. 7, 10 
Clark v. Edwards, 
468 F. Supp. 3d 725 (M.D. La. 2020) ..................................................................................... 12 
Coal. for Mercury-Free Drugs v. Sebelius, 
671 F.3d 1275 (D.C. Cir. 2012) ................................................................................................. 7 
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Corley v. United States, 
556 U.S. 303 (2009) .................................................................................................................. 14 
Crane v. Johnson, 
783 F.3d 244 (5th Cir. 2015) ............................................................................................. 10, 12 
Ctr. for Biological Diversity v. U.S. EPA, 
937 F.3d 533 (5th Cir. 2019) ................................................................................................... 11 
Defs. of Wildlife v. Perciasepe,  
714 F.3d 1317 (D.C. Cir. 2013). ........................................................................................ 13, 14 
DaimlerChrysler Corp. v. Cuno, 
547 U.S. 332 (2006) .................................................................................................................... 5 
Delta Found., Inc. v. United States, 
303 F.3d 551 (5th Cir. 2002) ................................................................................................... 20 
Dep’t of Army v. Blue Fox, Inc., 
525 U.S. 255 (1999) .................................................................................................................. 13 
Dep’t of Commerce v. New York, 
139 S. Ct. 2551 (2019) .............................................................................................................. 20 
Drake v. Panama Canal Comm’n, 
907 F.2d 532 (5th Cir. 1990) ....................................................................................... 13, 14, 15 
El Paso Cnty. v. Trump, 
982 F.3d 332 (5th Cir. 2020) ............................................................................................. 11, 12 
Ex parte McCardle 
74 U.S. 506 (1868) .................................................................................................................... 13 
FCC v. Prometheus Radio Project, 
141 S. Ct. 1150 (2021) .............................................................................................................. 16 
FDIC v. Bank of Coushatta, 
930 F.2d 1122 (5th Cir. 1991) ................................................................................................. 15 
FDIC v. Meyer, 
510 U.S. 471 (1994) .................................................................................................................... 6 
Fleming v. U.S. Dep’t of Agric., 
987 F.3d 1093 (D.C. Cir. 2021) ............................................................................................... 20 
Gaar v. Quirk, 
86 F.3d 451 (5th Cir. 1996) ............................................................................................... 13, 20 
Gentilello v. Rege, 
627 F.3d 540 (5th Cir. 2010) ................................................................................................... 18 
Glennborough Homeowners Ass’n v. U.S. Postal Serv., 
21 F.4th 410 (6th Cir. 2021) ...................................................................................................... 7 
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Palm Valley Health Care, Inc. v. Azar, 
947 F.3d 321 (5th Cir. 2020) ................................................................................................... 20 
Pena v. City of Rio Grande City, 
879 F.3d 613 (5th Cir. 2018) ................................................................................................... 16 
Pros. & Patients for Customized Care v. Shalala, 
56 F.3d 592 (5th Cir. 1995) ..................................................................................................... 18 
Residents Against Flooding v. Reinvestment Zone No. Seventeen, 
260 F. Supp. 3d 738 (S.D. Tex. 2017) .................................................................................... 16 
Sandoz Inc. v. Amgen Inc., 
137 S. Ct. 1664 (2017) ................................................................................................................ 2 
Shrimpers & Fishermen of RGV v. Tex. Comm’n on Env’t Quality, 
968 F.3d 419 (5th Cir. 2020) ................................................................................................... 13 
Sierra Club v. Glickman, 
156 F.3d 606 (5th Cir. 1998) ................................................................................................... 13 
Simon v. E. Ky. Welfare Rights Org., 
426 U.S. 26 (1976) .................................................................................................................. 8, 9 
Spokeo, Inc. v. Robins, 
578 U.S. 330 (2016) ...................................................................................................... 6, 8, 9, 12 
Steel Co. v. Citizens for a Better Env’t, 
523 U.S. 83 (1998) .................................................................................................................. 4, 6 
Stockman v. Fed. Election Comm’n, 
138 F.3d 144 (5th Cir. 1998) ................................................................................................... 13 
Stringer v. Whitley, 
942 F.3d 715 (5th Cir. 2019) ............................................................................................... 7, 10 
Summers v. Earth Island Inst., 
555 U.S. 488 (2009) ............................................................................................................ 11, 12 
Tenth St. Residential Ass’n v. City of Dall., 
968 F.3d 492 (5th Cir. 2020) ........................................................................................... 8, 9, 12 
TransUnion LLC v. Ramirez, 
141 S. Ct. 2190 (2021) ............................................................................................................ 5, 6 
United States v. L.A. Tucker Truck Lines, Inc., 
344 U.S. 33 (1952) .................................................................................................................... 19 
United States v. Mitchell, 
463 U.S. 206 (1983) .................................................................................................................... 6 
Valley Forge Christian Coll. v. Ams. United for Separation of Church & State, Inc., 
454 U.S. 464 (1982) .................................................................................................................. 10 
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Velez-Duenas v. Swacina, 
875 F. Supp. 2d 1372 (S.D. Fla. 2012) ................................................................................... 20 
Walmart Inc. v. U.S. Dep’t of Just., 
21 F.4th 300 (5th Cir. 2021) .................................................................................................... 13 
Webster v. Doe, 
486 U.S. 592 (1988) ...................................................................................................... 13, 14, 15 
Williams v. Parker, 
843 F.3d 617 (5th Cir. 2016) ................................................................................................... 12 
Zinermon v. Burch, 
494 U.S. 113 (1990) .................................................................................................................. 18 
Statutes 
5 U.S.C. §  
 553(b) ........................................................................................................................................ 18 
 701(a) ........................................................................................................................................ 15 
 701(a)(1) ....................................................................................................................... 13, 14, 15 
 701(a)(2) ....................................................................................................................... 13, 14, 15 
 702............................................................................................................................................. 13 
21 U.S.C. §  
 360bbb-3 ............................................................................................................................. 14, 15 
 360bbb-3(a)(1) ..................................................................................................................... 2, 15 
 360bbb-3(b) ................................................................................................................................ 2 
 360bbb-3(b)(1) ................................................................................................................... 15, 16 
 360bbb-3(b)(1)(C) ..................................................................................................................... 2 
 360bbb-3(c) ...................................................................................................................... passim  
 360bbb-3(c)(1) ......................................................................................................................... 17 
 360bbb-3(c)(2) ......................................................................................................................... 17 
 360bbb-3(c)(3) ......................................................................................................................... 19 
 360bbb-3(d) ............................................................................................................................. 18 
 360bbb-3(e)(1)(A).................................................................................................................... 15 
 360bbb-3(e)(1)(A)(ii)(III) ...................................................................................................... 3, 7 
 360bbb-3(i) ..................................................................................................................... 2, 14, 15 
 360bbb-3(g)(2) ......................................................................................................................... 15 
28 U.S.C. §  
1331........................................................................................................................................... 13 
1361........................................................................................................................................... 13 
2201........................................................................................................................................... 13 
42 U.S.C. §  
 262(a) .................................................................................................................................... 2, 18 
 262(i)(1) ...................................................................................................................................... 2 
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Fla. Stat. § 381.00319 .................................................................................................................... 9 
N.C. Gen. Stat. § 90-21.5(a1) ..................................................................................................... 10 
Tex. Fam. Code § 32.101(b) ......................................................................................................... 8 
Tex. Fam. Code § 151.001(6) ....................................................................................................... 8 
Tex. Gov’t Code § 418.012 ........................................................................................................... 8 
Regulations and Rules  
21 C.F.R. §  
 10.25.........................................................................................................................................  20 
    10.25(a) ..................................................................................................................................... 18 
 10.30.........................................................................................................................................  20 
 10.45(f)...................................................................................................................................... 20 
Fed. R. Civ. P.  
12(b)(1) ....................................................................................................................................... 4 
12(b)(6) ............................................................................................................................. 4, 5, 16 
12(h)(3) ....................................................................................................................................... 5 
Other Authorities 
85 Fed. Reg. 18,250 (Apr. 1, 2020) ........................................................................................ 2, 17 
86 Fed. Reg. 5200 (Jan. 19, 2021) ................................................................................................. 2 
86 Fed. Reg. 7316 (Feb. 7, 2020) .................................................................................................. 2 
 
 
 
 
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INTRODUCTION 
Plaintiffs oppose the U.S. Food and Drug Administration’s (“FDA”) issuance of 
emergency use authorizations for administration of the Pfizer-BioNTech (“the Pfizer 
EUA”) and Moderna (“the Moderna EUA”) COVID-19 vaccines to children aged 6 
months through 11 years. But no matter how fervent their policy disagreement—about 
the prospects of “pharmapocalypse” or any other issue—it does not amount to an 
Article III case or controversy. On this basis, their Amended Complaint should be 
dismissed.  
Despite adding three plaintiffs and pages of allegations, Plaintiffs have done 
nothing to address the fundamental standing defects that prompted dismissal of their 
first Complaint. No individual plaintiff has shown any actual or imminent threat of 
harm to self or child that is fairly traceable to the EUAs’ existence. And Children’s 
Health Defense (“CHD”) still cannot establish representational standing through an 
injured member or organizational standing via injury to itself. 
Were any plaintiff to possess standing, sovereign immunity also deprives this 
Court of jurisdiction. Both claims in the Amended Complaint depend on the 
Administrative Procedure Act’s (“APA”) waiver of sovereign immunity. But FDA’s 
issuance of an EUA ranks among the class of agency actions that Congress exempted 
from review under the APA. Absent an applicable waiver of sovereign immunity, 
Plaintiffs’ challenge cannot proceed. 
Finally, even if Plaintiffs could establish this Court’s subject-matter jurisdiction, 
they still have not plausibly alleged any claim upon which relief can be granted. 
Plaintiffs’ APA and Declaratory Judgment Act claims are unsupported by statute or 
precedent, and their factual challenges are refuted by the face of FDA’s documents that 
are attached to or incorporated by reference in the Amended Complaint. These claims 
fail as a matter of law. 
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BACKGROUND 
I. FDA’s issuance of the Pfizer and Moderna EUAs 
Ordinarily, a manufacturer of a biological product, including a vaccine, may 
market the product “only if the FDA has licensed it” pursuant to the Public Health 
Service Act. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1670 (2017); see 42 U.S.C. § 262(a), 
(i)(1). But in times of “an actual or potential emergency,” Congress empowered the 
Secretary of Health and Human Services (“the Secretary”) to authorize the introduction 
into interstate commerce of biological products (and other FDA-regulated products) 
“intended for use” in responding to the emergency. 21 U.S.C. § 360bbb-3(a)(1).  
The Secretary first determines that a “public health emergency . . . affects, or has a 
significant potential to affect, national security or the health and security of United 
States citizens living abroad.” Id. § 360bbb-3(b)(1)(C). The Secretary then may declare 
that circumstances exist justifying the marketing of FDA-regulated products “intended 
for use” in responding to the emergency. Id. § 360bbb-3(a)(1), (b). Following those 
declarations, FDA may issue an EUA for a vaccine intended for use in diagnosing, 
treating, or preventing the disease or condition that created the emergency. Id. 
§ 360bbb-3(c). Congress expressly committed all these decisions to agency discretion. Id. 
§ 360bbb-3(i). 
On February 4, 2020, the Secretary determined, under 21 U.S.C. § 360bbb-3(b)(1)(C), 
that a public health emergency existed involving the virus SARS-CoV-2, which causes 
COVID-19. 85 Fed. Reg. 7316, 7317 (Feb. 7, 2020). On March 27, 2020, the Secretary 
declared that “circumstances exist justifying the authorization of emergency use of 
drugs and biological products during the COVID-19 pandemic.” 85 Fed. Reg. 18,250, 
18,250–51 (Apr. 1, 2020). FDA subsequently issued EUAs for COVID-19 vaccines 
manufactured by Pfizer-BioNTech and ModernaTX, Inc. See 86 Fed. Reg. 5200 (Jan. 19, 
2021) (initial Pfizer and Moderna EUAs). 
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On October 29, 2021, FDA revised the Pfizer EUA to authorize administration of 
the Pfizer vaccine to individuals 5 through 11 years of age. ECF No. 26-1, at 106, 110. 
Then on June 17, 2022, FDA expanded the Pfizer EUA to include administration to 
individuals aged 6 months through 4 years. Id. at 107. Both times, the agency concluded 
that it was “reasonable to believe that Pfizer-BioNTech COVID-19 Vaccine may be 
effective in” those age groups, and “based on the totality of the scientific evidence 
available, that the known and potential benefits of Pfizer-BioNTech COVID-19 Vaccine 
outweigh the known and potential risks of the vaccine” for those groups. Id. at 110, 114. 
FDA also drew the same conclusions for the Moderna EUA on June 17, 2022, to 
authorize administration to individuals 6 months through 17 years. ECF No. 26-2, at 86. 
The Pfizer and Moderna EUAs require vaccination providers to make available an 
approved “Fact Sheet for Recipients and Caregivers,” in hardcopy or online. ECF No. 
26-1, at 123; ECF No. 26-2, at 94. These Fact Sheets, which are publicly available on 
FDA’s website, inform parents and other caregivers that “there is an option to accept or 
refuse receiving the vaccine.” Pfizer Fact Sheet for 6 Months Through 4 Years, at 5 (June 
28, 2022), https://perma.cc/M3V7-RF2Z.1 A decision “not to receive” the vaccine “will 
not change [the] child’s standard medical care.” Id.; see 21 U.S.C. § 360bbb-
3(e)(1)(A)(ii)(III) (“individuals to whom the product is administered are informed . . . of 
the option to accept or refuse administration of the product”). 
II. CHD’s opposition to COVID-19 vaccines, and this lawsuit 
CHD is a New Jersey-based advocacy group that opposes the COVID-19 vaccines. 
See Am. Compl., ECF No. 26, at ¶ 8. In May 2021, CHD petitioned FDA to “refrain from 
licensing COVID-19 vaccines and to revoke EUAs for the three existing COVID-19 
 
1 See also Pfizer Fact Sheet for 5 Through 11 Years, at 5 (June 28, 2022), 
https://perma.cc/E7US-7JU4; Moderna Fact Sheet for 6 Months Through 5 Years, at 4 
(June 17, 2022), https://perma.cc/4G3N-Q5DX; Moderna Fact Sheet for 6 Through 11 
Years, at 4 (June 17, 2022), https://perma.cc/V826-EBUX. 
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vaccines.” Id. ¶ 146. Three months later, FDA provided a detailed response of more than 
50 pages, ultimately denying CHD’s petition because it lacked “facts demonstrating any 
reasonable grounds for the requested action.” See id. ¶ 148; ECF No. 26-3, at 63. 
CHD also has pursued (unsuccessfully) its objections to COVID-19 vaccines 
through the courts. See Children’s Health Def. v. FDA, No. 21-6203, 2022 WL 2704554, at 
*1 (6th Cir. July 12, 2022) (affirming dismissal for lack of standing in challenge to 
“FDA’s licensure of Pfizer’s Comirnaty COVID-19 vaccine and FDA’s reauthorization of 
the” Pfizer EUA); Children’s Health Def. v. Rutgers State Univ. of N.J., No. 
CV2115333ZNQTJB, 2021 WL 4398743, at *1, 8 (D.N.J. Sept. 27, 2021) (denying CHD’s 
preliminary injunction motion against university COVID-19 vaccination policy); see also 
Aviles v. Blasio, No. 20 CIV. 9829 (PGG), 2021 WL 796033, at *16 (S.D.N.Y. Mar. 2, 2021) 
(dismissing CHD, for lack of standing, from challenge to New York City schools’ 
COVID-19 policy). 
On January 24, 2022, CHD returned to court and, alongside two individuals, filed 
this suit against FDA and Robert M. Califf, M.D., Commissioner of Food and Drugs. See 
Compl., ECF No. 1. On May 21, 2022, this Court granted Defendants’ motion to dismiss, 
finding Plaintiffs lacked standing. On July 1, 2022, CHD filed a First Amended 
Complaint, challenging FDA’s issuance of the Moderna and Pfizer EUAs for children 
aged 6 months through 11 years. See Am. Compl. ¶¶ 33–34. The Amended Complaint 
alleges one APA claim and another for declaratory relief. See Am. Compl. ¶¶ 213–250. 
Defendants renew their motion to dismiss under Federal Rule of Civil Procedure 
12(b)(1) and (b)(6) for lack of subject-matter jurisdiction and failure to state a claim.  
LEGAL STANDARD 
A motion to dismiss under Federal Rule of Civil Procedure 12(b)(1) challenges the 
Court’s subject-matter jurisdiction, which must “be established as a threshold matter.” 
Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83, 94–95 (1998). The Court “presume[s]” to 
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“lack jurisdiction” unless Plaintiffs meet their “burden of establishing it.” 
DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 342 n.3 (2006) (quotations omitted)); see 
Brownback v. King, 141 S. Ct. 740, 749 (2021) (plaintiff “must plausibly allege all 
jurisdictional elements”). If the burden is not met, the Court “must dismiss the action.” 
Fed. R. Civ. P. 12(h)(3).  
“To survive a motion to dismiss” under Rule 12(b)(6), Plaintiffs’ “complaint must 
contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is 
plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. 
Twombly, 550 U.S. 544, 570 (2007)). The Court need not accept as true “conclusory 
statements” or “legal conclusions.” Iqbal, 556 U.S. at 678–79. The complaint must 
“allow[] the court to draw the reasonable inference that the defendant is liable for the 
misconduct alleged,” Iqbal, 556 U.S. at 678, and “raise a right to relief above the 
speculative level,” Twombly, 550 U.S. at 555. “[I]f as a matter of law ‘it is clear that no 
relief could be granted under any set of facts that could be proved consistent with the 
allegations,’ a claim must be dismissed, without regard to whether it is based on an 
outlandish legal theory or on a close but ultimately unavailing one.” Neitzke v. Williams, 
490 U.S. 319, 326–27 (1989) (quoting Hishon v. King & Spalding, 467 U.S. 69, 73 (1984)). 
ARGUMENT 
I. This Court still lacks subject-matter jurisdiction 
The same two bedrock jurisdictional precepts that required dismissal of the original 
Complaint apply as forcefully to the Amended Complaint. First, “[u]nder Article III, 
federal courts do not possess a roving commission to publicly opine on every legal 
question” and “do not exercise general legal oversight of the Legislative and Executive 
Branches.” TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2203 (2021). Litigants “raising 
only a generally available grievance about government,” Lujan v. Defs. of Wildlife, 504 
U.S. 555, 573–74 (1992)—“however sharp” their disagreement, Hollingsworth v. Perry, 
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570 U.S. 693, 704 (2013)—do not properly invoke Article III jurisdiction. Lacking any 
cognizable injury traceable to the challenged conduct, Plaintiffs are not proper litigants. 
Second, “[i]t is axiomatic that the United States may not be sued without its consent 
and that the existence of consent is a prerequisite for jurisdiction.” United States v. 
Mitchell, 463 U.S. 206, 212 (1983). Accordingly, “[a]bsent a waiver, sovereign immunity 
shields the Federal Government and its agencies from suit.” FDIC v. Meyer, 510 U.S. 471, 
475 (1994). Plaintiffs’ claims are not covered by a requisite waiver. 
A. No Plaintiff has standing 
The standing “doctrine limits the category of litigants empowered to maintain a 
lawsuit in federal court” only to those who “have (1) suffered an injury in fact, (2) that is 
fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be 
redressed by a favorable judicial decision.” Spokeo, Inc. v. Robins, 578 U.S. 330, 338 
(2016); see Lujan, 504 U.S. at 560–61. This “triad of injury in fact, causation, and 
redressability constitutes the core of Article III’s case-or-controversy requirement.” Steel 
Co., 523 U.S. at 103–04. Because “standing is not dispensed in gross,” Plaintiffs “must 
demonstrate standing for each claim that they press and for each form of relief that they 
seek.” TransUnion, 141 S. Ct. at 2208. None of the Plaintiffs has standing.  
1. With no actual or imminent injury to themselves or their children, the 
individual plaintiffs lack standing 
The five individual plaintiffs, see Am. Compl. ¶¶ 9–12, must establish an injury-in-
fact “that is ‘concrete and particularized’ and ‘actual or imminent, not conjectural or 
hypothetical.’” Spokeo, 578 U.S. at 339 (quoting Lujan, 504 U.S. at 560). The individuals 
all aver an “imminent risk” of harm to their children from the Pfizer and Moderna 
EUAs. Am. Compl. ¶¶ 9–12.2 “For a threatened future injury to satisfy the imminence 
 
2 Plaintiffs also cursorily allege that their children have been exposed to so-called “pro 
vaccine messaging,” Am. Compl. ¶ 96, but “the purported indignity of receiving a” 
 
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requirement, there must be at least a ‘substantial risk’ that the injury will occur.” 
Stringer v. Whitley, 942 F.3d 715, 721 (5th Cir. 2019). “[A]llegations of possible future 
injury are not sufficient,” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013), because 
they are “too speculative for Article III purposes,” Stringer, 942 F.3d at 721 (quotations 
omitted). That is the situation here. 
As an initial matter, “FDA does not mandate vaccines for the general public.” ECF 
No. 26-1, at 97; accord Children’s Health Def., 2022 WL 2704554, at *4 (“FDA has not 
required the general public to be vaccinated.”). Consistent with that broad proposition 
and the specific statutory authority at issue here, see 21 U.S.C. § 360bbb-
3(e)(1)(A)(ii)(III), neither EUA compels any individual to receive the vaccine or any 
parent to consent to administration to their child, see generally ECF No. 26-1, at 104–29; 
ECF No. 26-2, at 77–101. Rather, as the caregiver Fact Sheets expressly state, “there is an 
option to accept or refuse receiving the vaccine. Should you decide for your child not to 
receive it, it will not change your child’s standard of medical care.” Pfizer Fact Sheet for 
6 Months Through 4 Years, at 5. By simply opting against vaccination, the individual 
plaintiffs will prevent the future injury they fear from manifesting. In these 
circumstances—“an injury at some indefinite future time, and the acts necessary to 
make the injury happen are at least partly within the plaintiff’s own control”— 
imminence “has been stretched beyond the breaking point.” Lujan, 504 U.S. at 564 n.2; 
see Coal. for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275, 1280 (D.C. Cir. 2012) (“In light 
of plaintiffs’ avowed intention to refuse thimerosal-preserved vaccines, plaintiffs cannot 
show that they face a ‘certainly impending,’ or even likely, risk of future physical injury 
from thimerosal in vaccines.”). 
 
message with which one disagrees is “a psychic injury [that] falls well short of a 
concrete harm needed to establish Article III standing.” Glennborough Homeowners Ass’n 
v. U.S. Postal Serv., 21 F.4th 410, 415 (6th Cir. 2021); see Hein v. Freedom From Religion 
Found., 551 U.S. 587, 634 (2007) (Scalia, J., concurring) (“mental angst” generally not a 
cognizable injury). 
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But even setting aside the lack of imminent injury traceable to the EUAs, the 
individual plaintiffs do not plead an impending injury from any source. Deborah Else 
and Sacha Dietrich live with their children in Texas. Am. Compl. ¶¶ 9–10. Texas law 
affords them the right to consent, or “not to consent,” to their children’s medical care, 
including whether to receive an EUA vaccine. Miller ex rel. Miller v. HCA, Inc., 118 
S.W.3d 758, 766 (Tex. 2003); see Tex. Fam. Code § 151.001(6). They do not deny this right 
to “make medical decisions” for their children, Am. Compl. ¶ 99, rendering irrelevant 
all allegations about the Department of Family and Protective Service’s Permanent 
Managing Conservatorship program, see id. ¶¶ 99–111.  
Else and Dietrich fear that “any consenting adult” might authorize immunization 
of their children “against the[ir] wishes and consent” or “without their . . . knowledge.” 
Id. ¶¶ 115–16. But the law they cite precludes that possibility if the parent is “available” 
or when the parent “has expressly refused to give consent to the immunization.” Tex. 
Fam. Code § 32.101(b)–(c); see Am. Compl. ¶ 112 & n.5. Else and Dietrich also fail to 
“clearly allege” any “facts” showing that the event they fear—future immunization of 
their children due to an unknown third-party’s actions and over their objection—is 
imminent. Spokeo, 578 U.S. at 338. Absent that, their “unadorned speculation will not 
suffice” for standing. Simon v. E. Ky. Welfare Rights Org., 426 U.S. 26, 44 (1976).  
To contrive an imminent risk that her children will be vaccinated, Dietrich next 
invokes the specter of social “pressure” and “impending mandates.” Am. Compl. ¶ 10. 
(Else more realistically describes them as “recommendations.” Id. ¶ 128.) But any risk of 
vaccination over their objection was eliminated when the governor prohibited any 
“entity in Texas” from “compel[ing] receipt of a COVID-19 vaccine by any individual,  
. . . who objects to such vaccination for any reason of personal conscience, based on a 
religious belief, or for medical reasons,” Executive Order GA-40 (Oct. 11, 2021); see Tex. 
Gov’t Code § 418.012 (“Executive orders . . . have the force and effect of law.”); see also 
Tenth St. Residential Ass’n v. City of Dall., 968 F.3d 492, 501 (5th Cir. 2020) (no standing 
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when city ordinance prohibited funding the feared demolition of homes). The 
Amended Complaint generally avers that Texas children are “being denied medical 
services” due to lack of vaccination, Am. Compl. ¶ 119, yet again offers no facts 
demonstrating that Else and Dietrich’s children will imminently be denied medical 
services, see Spokeo, 578 U.S. at 339 (“a plaintiff must show that he or she” will suffer the 
requisite injury in fact) (emphasis added). The only story they cite covers a single 
instance and declares that the hospital in question “Denies Requiring COVID-19 Vaccine 
for Organ Transplant Patients.” Am. Compl. ¶ 119 n.55 (emphasis added). At bottom, 
the “remote possibility of harm” to Else and Dietrich’s children “fails [standing’s] 
imminence requirement.” Tenth Street, 968 F.3d at 501. 
The next individual plaintiff, Amy Villella, lives with her children in Florida. Am. 
Compl. ¶ 11.3 Florida law prohibits “an educational institution or elected or appointed 
local official” from “impos[ing] a COVID-19 vaccination mandate for any student.” Fla. 
Stat. § 381.00319. Plaintiffs further acknowledge that Florida’s Department of Health 
“recommend[s] against healthy children” aged 17 and younger receiving a COVID-19 
vaccine. Am. Compl. ¶ 82 (emphasis added). Against this backdrop, Villella does not 
“clearly allege facts” as she must, Spokeo, 578 U.S. at 338 (cleaned up), to render 
plausible her conclusory claim of an “imminent risk of harm” from the EUAs’ issuance, 
Am. Compl ¶ 11. Like Else and Dietrich, Villella offers nothing but “unadorned 
speculation” as a basis for standing. Simon, 426 U.S. at 44. 
So too for the last individual plaintiffs, Jonathan and Rebecca Shour, who reside 
with their children in North Carolina. Am. Compl. ¶ 12. That state prohibits a health 
care provider from “administering any vaccine that has been granted emergency use 
authorization and is not yet fully approved by the United States Food and Drug 
Administration to an individual under 18 years of age”—which would include the 
 
3 She also claims to reside in North Carolina, id. ¶ 131, but the outcome is no different. 
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Pfizer and Moderna EUAs— without previously “obtaining written consent from a 
parent or legal guardian.” N.C. Gen. Stat. § 90-21.5(a1). Guaranteed the right to 
withhold consent for the EUA vaccines in North Carolina, the Shours hypothesize that 
they might be “relocated around the country” for work and that unknown state might 
have a vaccine mandate for children and that unknown mandate in that unknown state 
might not accommodate “their religious objections to the COVID-19 vaccine.” Am. 
Compl. ¶ 130. Relying on a triple layer of conjecture to create an “imminent risk from 
FDA’s EUA[s],” Am. Compl. ¶ 12, is far “too speculative for Article III purposes,” 
Stringer, 942 F.3d at 721 (quotation omitted). 
Even if a cognizable injury materialized for any individual, it would be traceable to 
the “decisions of independent actors,” not FDA’s mere issuance of the Pfizer and 
Moderna EUAs. Clapper, 568 U.S. at 414; see Children’s Health Def., 2022 WL 2704554, at 
*3–4 (any alleged injuries from vaccine mandates are “not fairly traceable to FDA’s 
actions” in authorizing the Pfizer COVID-19 vaccine); Null v. FDA, No. CV 09-1924 
(RBW), 2009 WL 10744069, at *3 (D.D.C. Nov. 10, 2009). The challenged EUAs, again, 
compel no action whatsoever from any parent or child. Thus, any injury derived from 
the independent actions of third parties—from the unknown persons who Else and 
Dietrich worry might consent to vaccinate their children to the hypothetical state 
authorities who set vaccination policies disagreeable to the Shours—could not support 
standing against the defendants here. See, e.g., Clapper, 568 U.S. at 414. 
Ultimately, the individual plaintiffs have not borne “the burden of pleading . . . 
concrete facts showing that [FDA’s] actual action has caused the substantial risk of 
harm.” Clapper, 568 U.S. at 414 n.5. The fear that their children might receive an EUA 
vaccine over their objection “is not supported by any facts” and is “purely speculative.” 
Crane v. Johnson, 783 F.3d 244, 252 (5th Cir. 2015). Accordingly, they lack standing and 
“may not litigate as suitors in the courts of the United States.” Valley Forge Christian Coll. 
v. Ams. United for Separation of Church & State, Inc., 454 U.S. 464, 475–76 (1982). 
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2. CHD lacks associational and organizational standing 
CHD asserts both associational standing, on behalf of its members, and 
organizational standing, on its own behalf. Am. Compl. ¶ 8; NAACP v. City of Kyle, 626 
F.3d 233, 237–38 (5th Cir. 2010). It has neither. 
Associational standing requires that one of CHD’s members “independently” 
possess Article III standing. Ctr. for Biological Diversity v. U.S. EPA, 937 F.3d 533, 536 (5th 
Cir. 2019). Among other things, CHD must “make specific allegations establishing that 
at least one identified member had suffered or would suffer harm.” Summers v. Earth 
Island Inst., 555 U.S. 488, 498 (2009). The only identified CHD members—Else, Dietrich, 
and the Shours4—lack standing. Thus, CHD lacks associational standing. See, e.g., City of 
Kyle, 626 F.3d at 237 (rejecting “NAACP’s associational-standing claim” given “no 
evidence in the record showing that a specific member of the NAACP” had standing). 
Organizational standing requires that CHD exhibit a “concrete and demonstrable 
injury to [its] activities—with the consequent drain on [its] resources,” not “simply a 
setback to [its] abstract social interests.” Havens Realty Corp. v. Coleman, 455 U.S. 363, 
379 (1982). CHD first alleges that “FDA’s conduct toward children . . . caused a serious 
diversion of the organization’s resources from its mission to correct this critical error 
and try to protect the members and mission of CHD.” Am. Compl. ¶ 8. “However, an 
organization does not automatically suffer a cognizable injury in fact by diverting 
resources in response to a defendant’s conduct.” El Paso Cnty. v. Trump, 982 F.3d 332, 
343–44 (5th Cir. 2020). Only a “diversion of resources” that “concretely and ‘perceptibly 
impaired’ [CHD’s] ability to carry out its purpose” suffices for standing. City of Kyle, 626 
F.3d at 239 (quoting Havens Realty, 455 U.S. at 379).  
A “vague, conclusory assertion” that CHD “had to divert resources is insufficient 
to establish” a perceptible impairment of CHD’s mission. El Paso, 982 F.3d at 344. Yet 
 
4 Villella is a CHD “employee,” not a member. Am. Compl. ¶ 11. Regardless, she too 
lacks standing and cannot support CHD’s associational standing. 
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the Amended Complaint offers nothing more than that, see Am. Compl. ¶ 162, failing to 
“clearly allege facts” that support standing, Spokeo, 578 U.S. at 338 (cleaned up). 
Tellingly, CHD has not “identified any specific projects” it “had to put on hold or 
otherwise curtail in order to respond to the” EUAs. City of Kyle, 626 F.3d at 238; see, e.g., 
El Paso, 982 F.3d at 344–45 (organization lacked standing because it “does not identify 
any particular projects that suffered because of the diversion of resources”). 
CHD lists several actions taken in response to or anticipation of the EUAs, 
including filing a Citizen Petition with FDA, discussing its views with members, and 
engaging in public outreach. See Am. Compl. ¶¶ 156–59. But CHD “has tasked itself 
with protecting and promoting the health and wellbeing of children.” Am. Compl. ¶ 
162. So none of these undertakings “detract or ‘differ from its routine [] activities.’” 
Tenth Street, 968 F.3d at 500 (quoting City of Kyle, 626 F.3d at 238); see Clark v. Edwards, 
468 F. Supp. 3d 725, 746–47 (M.D. La. 2020) (finding no “significant diversion of 
resources” when the alleged injury “seems consistent with [the organizations’] general 
activities and mission”). Apart from the costs of bringing this suit—which do not 
“satisfy the injury-in-fact requirement,” Williams v. Parker, 843 F.3d 617, 621 (5th Cir. 
2016)—the Amended Complaint contains “only conjecture[] that the resources” CHD 
devoted to addressing the EUAs “could have been spent on other unspecified . . . 
activities,” City of Kyle, 626 F.3d at 239. Because CHD’s claim of resource diversion and 
mission impairment “is not supported by any facts,” the alleged “injury is purely 
speculative” and does not “establish standing.” Crane, 783 F.3d at 252. 
CHD also advances a procedural-injury theory, citing denial of “its right to 
petition, the chance at notice-and-comment, and its procedural remedies under the” 
APA. Am. Compl. ¶ 162. Beyond the underlying flaws with these allegations, see infra 
pages 17–18, a “bare procedural violation, divorced from any concrete harm,” cannot 
“satisfy the injury-in-fact requirement of Article III,” Spokeo, 578 U.S. at 341; see 
Summers, 555 U.S. at 496. That is, CHD still “must show an injury that is both concrete 
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and particular, as opposed to an undifferentiated interest in the proper application of 
the law.” Sierra Club v. Glickman, 156 F.3d 606, 613 (5th Cir. 1998). Its claimed “inability 
to comment effectively or fully” on the EUAs could not, by itself, establish standing. 
Defs. of Wildlife v. Perciasepe, 714 F.3d 1317, 1325 (D.C. Cir. 2013). The only other hint of 
concrete, organizational harm is the inadequate allegation of diverted resources. Thus, 
because CHD’s “claimed procedural injury does not impact any concrete interest,” it 
lacks standing to challenge the purported denial of its petition and APA procedural 
rights. City of Hearne v. Johnson, 929 F.3d 298, 302 (5th Cir. 2019); see Shrimpers & 
Fishermen of RGV v. Tex. Comm’n on Env’t Quality, 968 F.3d 419, 425–26 (5th Cir. 2020). 
When no plaintiff has standing, the Court “announc[es] the fact and dismiss[es] the 
cause.” Ex parte McCardle, 74 U.S. 506, 514 (1868). 
B. Sovereign immunity bars Plaintiffs’ causes of action 
Even if Plaintiffs had standing, “[t]o bring a claim against a sovereign,” Plaintiffs 
also must show the “sovereign has waived its immunity from suit.” Walmart Inc. v. U.S. 
Dep’t of Just., 21 F.4th 300, 307 (5th Cir. 2021). Such a waiver is “strictly construed, in 
terms of its scope, in favor of the sovereign.” Dep’t of Army v. Blue Fox, Inc., 525 U.S. 255, 
261 (1999). The APA, 5 U.S.C. § 702, is Plaintiffs’ only potential source of a waiver. See 
Am. Compl. ¶¶ 15, 215.5 But the APA’s waiver is not absolute.  
The APA does not apply when “statutes preclude judicial review” or when 
“agency action is committed to agency discretion by law.” 5 U.S.C. § 701(a)(1)–(2); see 
Webster v. Doe, 486 U.S. 592, 599 (1988); Stockman v. Fed. Election Comm’n, 138 F.3d 144, 
 
5 Neither 28 U.S.C. § 1331 nor 28 U.S.C. § 2201, see Am. Compl. ¶¶ 16, 250, waives 
sovereign immunity, see Koehler v. United States, 153 F.3d 263, 266 n.2 (5th Cir. 1998); 
Gaar v. Quirk, 86 F.3d 451, 453 (5th Cir. 1996). Plaintiffs also cite the mandamus statute, 
28 U.S.C. § 1361, but plead no mandamus claim, see Am. Compl. ¶ 16. Regardless, 
because Plaintiffs do not demand FDA “perform a ministerial duty imposed on it by 
law” but instead seek to require FDA to “alter its decision on the merits of their claims,” 
they exceed “the function of mandamus” and any waiver of sovereign immunity in that 
statute. Drake v. Panama Canal Comm’n, 907 F.2d 532, 534–35 (5th Cir. 1990). 
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152 (5th Cir. 1998). For 5 U.S.C. § 701(a)(1), the Court examines whether “a particular 
statute precludes judicial review” by “its express language, . . . the structure of the 
statutory scheme, its objectives, its legislative history, and the nature of the 
administrative action involved.” Block v. Cmty. Nutrition Inst., 467 U.S. 340, 345 (1984). If 
“the congressional intent to preclude judicial review is ‘fairly discernible in the 
statutory scheme,’” Drake, 907 F.2d at 535 (quoting Block, 467 U.S. at 351), section 
701(a)(1) applies. Alternatively, 5 U.S.C. § 701(a)(2) looks to the relevant statutory 
“language” and “structure” to ask if “its implementation was ‘committed to agency 
discretion by law.’” Webster, 486 U.S. at 600. Given the analytical overlap, section 
701(a)(1) and (a)(2) may both support exemption from the APA’s sovereign immunity 
waiver. See Haitian Refugee Ctr., Inc. v. Baker, 953 F.2d 1498, 1507–08 (11th Cir. 1992). 
The Pfizer and Moderna EUAs were expressly issued “pursuant to” 21 U.S.C.  
§ 360bbb-3. ECF No. 26-1, at 104–07, 115–16; ECF No. 26-2, at 77–80, 87–88. And 21 
U.S.C. § 360bbb-3(i) states that “[a]ctions under the authority of this section by the 
Secretary . . . are committed to agency discretion.” That language tracks section 
701(a)(2)’s exception to APA review when “agency action is committed to agency 
discretion by law.” Because the language of 21 U.S.C. § 360bbb-3(i) “is plain,” the Court 
must enforce the statute “according to its terms.” Lamie v. U.S. Trustee, 540 U.S. 526, 534 
(2004) (quotations omitted). Indeed, the Sixth Circuit concluded this language means 
that EUAs “are exempt from review under the APA.” Ass’n of Am. Physicians & Surgeons 
v. FDA, 2020 WL 5745974, at *3 (6th Cir. Sept. 24, 2020) (citing 5 U.S.C. § 701(a)(2)).  
The Sixth Circuit’s conclusion is bolstered by the “basic interpretive canon[]” that 
“a statute should be construed so that effect is given to all its provisions, so that no part 
will be inoperative or superfluous, void or insignificant.” Corley v. United States, 556 U.S. 
303, 314 (2009) (cleaned up). Apart from committing actions to agency discretion, 21 
U.S.C. § 360bbb-3(i) contains no other language. Thus, it functionally serves no other 
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purpose than summoning the APA’s exemption in 5 U.S.C. § 701(a). A failure to apply 
the exemption would impermissibly render 21 U.S.C. § 360bbb-3(i) meaningless. 
Although the statute’s plain meaning is dispositive, its purpose and structure 
confirm that FDA’s issuance of the EUAs is “unreviewable” under section 701(a). FDIC 
v. Bank of Coushatta, 930 F.2d 1122, 1129 (5th Cir. 1991); see Webster, 486 U.S. at 600–01. 
The EUA statute was largely enacted as part of the Project BioShield Act of 2004, Pub. L. 
No. 108-276, 118 Stat. 835, which granted FDA authority to issue EUAs to “streamlin[e]  
. . . the approval process of countermeasures” against chemical, biological, radiological, 
or nuclear agents that might be used against the United States. And agency discretion 
permeates the authorization process. For example, the Secretary “may” declare “that the 
circumstances exist justifying” an EUA, 21 U.S.C. § 360bbb-3(b)(1); “may” issue an 
EUA, id. § 360bbb-3(a)(1), (c); “may” impose conditions that are “necessary and 
appropriate to protect the public health,” id. § 360bbb-3(e)(1)(B); and “may revise or 
revoke” an EUA, id. § 360bbb-3(g)(2); see Kingdomware Techs., Inc. v. United States, 579 
U.S. 162, 171 (2016) (“the word ‘may’ . . . implies discretion”). Indeed, even when the 
statute directs the agency to establish conditions on EUA products, it includes 
discretionary caveats. See 21 U.S.C. § 360bbb-3(e)(1)(A) (“to the extent practicable given 
the applicable circumstances” and “such conditions . . . as the Secretary finds necessary 
or appropriate to protect the public health”).  
Thus, through the language, structure, and purpose of 21 U.S.C. § 360bbb-3, 
Congress’s intent to preclude judicial review of FDA’s decision to issue EUAs under 5 
U.S.C. § 701(a)(1) is “fairly discernible.” Drake, 907 F.2d at 535. Alternatively, because 
the “language and structure” of 21 U.S.C. § 360bbb-3 “fairly exudes deference to” FDA, 
5 U.S.C. § 701(a)(2) “precludes judicial review of [these] decision[s] under the APA.” 
Webster, 486 U.S. at 600–01; see Bank of Coushatta, 930 F.2d at 1129. Either way, the result 
is the same: no waiver of sovereign immunity and no subject-matter jurisdiction. 
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II. Even if this Court has jurisdiction, Plaintiffs’ claims are implausible  
Even if Plaintiffs could establish this Court’s jurisdiction, their suit still should be 
dismissed for failure to plausibly state a claim for relief. “Rule 12(b)(6) requires 
dismissal whenever a plaintiff’s claim is based on an invalid legal theory.” Residents 
Against Flooding v. Reinvestment Zone No. Seventeen, 260 F. Supp. 3d 738, 803 (S.D. Tex. 
2017); see Neitzke, 490 U.S. at 326–27. Dismissal also is required when the facts pleaded 
in the complaint do not “plausibly support each element” of the alleged cause of action. 
Pena v. City of Rio Grande City, 879 F.3d 613, 621 (5th Cir. 2018). 
“To state a proper claim under the APA,” Plaintiffs “must allege facts that, if true, 
plausibly establish that the agency action is arbitrary and capricious.” Blanchett v. 
DeVos, 490 F. Supp. 3d 26, 32 (D.D.C. 2020); see, e.g., Palacios v. Dep’t of Homeland Sec., 
434 F. Supp. 3d 500, 506 (S.D. Tex. 2020). “A court simply ensures that the agency has 
acted within a zone of reasonableness and, in particular, has reasonably considered the 
relevant issues and reasonably explained the decision.” FCC v. Prometheus Radio Project, 
141 S. Ct. 1150, 1158 (2021). Review also is “at its most deferential” because the case 
involves “scientific determination[s]” and “predictions” by FDA “within its area of 
special expertise.” Balt. Gas & Elec. Co. v. Nat. Res. Def. Council, 462 U.S. 87, 103 (1983).  
None of Plaintiffs’ numerous arguments amounts to a plausible APA claim. First, 
Plaintiffs contend that “FDA failed to justify its conclusion that children ages 6 months 
through 11 years face an emergency” to support “an EUA declaration.” Am. Compl.  
¶¶ 218–19 (citing 21 U.S.C. § 360bbb-3(b)(1)). But that muddles the legal criteria and 
neglects the agency’s public reasoning. Under 21 U.S.C. § 360bbb-3(b)(1), the Secretary 
“may make a declaration that the circumstances exist justifying” an emergency 
authorization “for a product.” The Secretary did so, determining that a public health 
emergency exists involving the virus “SARS–CoV–2, which causes the illness COVID–
19,” and that “circumstances exist justifying the authorization of emergency use of . . . 
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biological products during the COVID–19 pandemic.” 85 Fed. Reg. at 18,250–51. This 
declaration thus resolved whether a public-health emergency exists. 
FDA then may issue an EUA for a specific product if it concludes certain criteria are 
met, as the agency did here. See 21 U.S.C. § 360bbb-3(c) (setting forth criteria). FDA 
found that “SARS-CoV-2 can cause a serious or life-threatening disease or condition, 
including severe respiratory illness [i.e., COVID-19], to humans infected by this virus.” 
ECF No. 26-1, at 115; ECF No. 26-2, at 87; see 21 U.S.C. § 360bbb-3(c)(1). Data about the 
consequences of COVID-19 include “COVID-19-associated hospitalizations and deaths 
[that] have occurred in children,” as well as symptoms that linger “for weeks to months 
after the[] initial illness.” ECF No. 26-2, at 9. The agency further found that the Pfizer 
and Moderna EUA vaccines “may be effective in preventing COVID-19, and that, when 
used under the conditions” of authorization, “the known and potential benefits of” the 
EUA vaccines “when used to prevent COVID-19 outweigh [the] known and potential 
risks.” ECF No. 26-1, at 115; ECF No. 26-2, at 87; see 21 U.S.C. § 360bbb-3(c)(2); ECF No. 
26-2, at 64–69 (analyzing risks and benefits). Thus, FDA’s public explanations belie any 
plausible claim that the agency did not justify its conclusions. 
Second, Plaintiffs aver that FDA “denied CHD its procedural right to seek redress 
via citizen petition, a right conforming to the right to petition under the First 
Amendment.” Am. Compl. ¶ 224. The First Amendment’s “Petition Clause protects the 
right of individuals to appeal to courts and other forums established by the government 
for resolution of legal disputes.” Borough of Duryea v. Guarnieri, 564 U.S. 379, 387 (2011). 
“CHD exercised that right by filing a citizen petition,” Am. Compl. ¶ 226 (emphasis 
added), to which FDA responded, in great detail, a few months later, see ECF No. 26-3, 
at 62–114. Although FDA disagreed with CHD, “[t]he First Amendment does not 
mandate a result once such petitions are received.” City of Hearne, 929 F.3d at 301. 
Third, Plaintiffs believe that “FDA and CDC have altered the traditional definitions 
of ‘vaccine’ and ‘vaccination’ to encompass the COVID-19 biologics,” supposedly “in 
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violation of procedural due process.” Am. Compl. ¶ 230. Plaintiffs must “point to 
some” interest protected by the due process clause, but they do not and thus fail “to 
state a due process claim.” Gentilello v. Rege, 627 F.3d 540, 545 (5th Cir. 2010). Even if 
they had, deprivation of a protected interest “is not in itself unconstitutional; what is 
unconstitutional is the deprivation of such an interest without due process of law.” 
Zinermon v. Burch, 494 U.S. 113, 125 (1990). Plaintiffs allege a denial of “a citizen 
participation or notice-and-comment process when [FDA] labeled the COVID-19 
biologics as vaccines.” Am. Compl. ¶ 231. Yet Plaintiffs undeniably availed themselves 
of FDA’s petition process to submit their views and request “administrative action.” 21 
C.F.R. § 10.25(a); see ECF No. 26-3, at 42–114. Further, notice-and-comment is not 
required by the statutes governing issuance of EUAs, 21 U.S.C. § 360bbb-3(c)–(d), and 
approval of biological products like vaccines, 42 U.S.C. § 262(a).  
As for the supposedly altered definitions, the only specific definitions cited in the 
Complaint are from a CDC informational webpage and The Free Dictionary online. Am. 
Compl. ¶¶ 135–36. No factual allegations show FDA’s responsibility for this Internet 
content. See Iqbal, 556 U.S. at 678. Moreover, neither the CDC webpage nor The Free 
Dictionary qualifies as a “substantive rule,” with “the force of law,” that triggers notice-
and-comment under 5 U.S.C. § 553(b). Pros. & Patients for Customized Care v. Shalala, 56 
F.3d 592, 595 (5th Cir. 1995); see Lincoln v. Virgil, 508 U.S. 182, 196 (1993). 
Fourth, Plaintiffs argue that FDA’s consideration and explanation of several issues 
was inadequate. See Am. Compl. ¶¶ 233–43. But each alleged deficiency is refuted by 
agency documents, which undercut any plausible allegation that FDA “entirely failed to 
consider an important aspect of the problem” or “offered an explanation for its decision 
that runs counter to the evidence before the agency.” Motor Vehicle Mfrs. Ass’n of U.S., 
Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). 
 Plaintiffs allege “FDA failed to articulate any standard for assessing an 
individualized, stratified risk for children between the ages of 6 months and 
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11 years,” and its risk assessment methodology “is still shrouded in 
mystery.” Am. Compl. ¶¶ 234, 236. However, “[a]gencies are not required to 
proceed by set standards in order to avoid a finding that their actions are 
arbitrary and capricious,” Hayward v. U.S. Dep’t of Labor, 536 F.3d 376, 382 
(5th Cir. 2008), so FDA was not “obligat[ed] to create such a standard” in the 
first instance, Am Compl. ¶ 234. Regardless, the agency fully explained its 
risk assessment and methodology. See ECF No. 26-2, at 62–67. 
 Plaintiffs allege FDA “failed to address the inadequacies regarding clinical 
trials,” including “adverse events.” Am. Compl. ¶ 239. In fact, the agency 
scrutinized the trials’ results and safety in depth. See ECF No. 26-2, at 18–59. 
 Plaintiffs allege “FDA ignored data on the high recovery rate of children 
diagnosed with COVID-19 and the high rates of natural immunity.” Am. 
Compl. ¶ 240. Actually, FDA noted both that “[m]ost children with COVID-
19 recovered within 1 to 2 weeks” and that COVID-19 vaccine data “have 
demonstrated an added benefit of vaccination to protection conferred by 
natural immunity.” ECF No. 26-2, at 9, 65. 
 Plaintiffs allege FDA “ignored adverse events that have been documented 
through the [Vaccine Adverse Events Reporting System] database.” Am. 
Compl. ¶ 241. On the contrary, FDA “queried” that database for adverse 
event “reports following the Pfizer-BioNTech COVID-19 Vaccine,” and 
analyzed the results. ECF No. 26-2, at 13-14. 
 Plaintiffs allege FDA should not have granted EUAs under 21 U.S.C. 
§ 360bbb-3(c)(3) because there are alternative treatments available, and FDA 
“dismissed the effectiveness of alternative treatments.” Am. Compl. ¶ 242. 
But Plaintiffs concede these “alternative treatments” have not “been 
recognized,” i.e. approved, by FDA for the prevention or treatment of 
COVID-19. Id. And only products that have been “approved, licensed, or 
cleared by FDA,” on an “indication-specific” basis, qualify under 21 U.S.C. 
§ 360bbb-3(c)(3). ECF No. 26-2, at 90 & n.82. 
Fifth, Plaintiffs seek to introduce new arguments from a news article about 
“allegations of fraud in Pfizer’s clinical trials” and whether “mRNA COVID-19 
vaccines” are “gene therapies.” Am. Compl. ¶¶ 235, 237. But the long-standing rule of 
“issue exhaustion . . . require[s] parties to give the agency an opportunity to address an 
issue before seeking judicial review of that question.” Carr v. Saul, 141 S. Ct. 1352, 1358 
(2021); see United States v. L.A. Tucker Truck Lines, Inc., 344 U.S. 33, 37 (1952). Indeed, 
Case 6:22-cv-00093-ADA-DTG   Document 29   Filed 07/29/22   Page 27 of 29

20 
 
FDA regulations require that any challenger “who wishes to rely upon information or 
views not included in the administrative record shall submit them to the Commissioner 
with a new petition to modify the action.” 21 C.F.R. § 10.45(f); see id. §§ 10.25, 10.30; see 
also Carr, 141 S. Ct. at 1358 (“issue-exhaustion rules” may be “creatures of . . . 
regulation”). Plaintiffs eschewed that process to present these new issues. Nor have 
they plausibly alleged that these issues were part of the “administrative record” for the 
challenged actions. Dep’t of Commerce v. New York, 139 S. Ct. 2551, 2573 (2019).  
Because a “federal court reviewing an agency determination will not ordinarily 
consider arguments that a litigant could have raised before the agency but chose not 
to,” Plaintiffs have waived the issues. Palm Valley Health Care, Inc. v. Azar, 947 F.3d 321, 
327–28 (5th Cir. 2020); see Delta Found., Inc. v. United States, 303 F.3d 551, 562–63 (5th Cir. 
2002) (“disregard[ing]” arguments not previously raised “at the administrative level”). 
And these new arguments cannot comprise a plausible APA claim. See Fleming v. U.S. 
Dep’t of Agric., 987 F.3d 1093, 1100 (D.C. Cir. 2021) (court “could not conclude that” an 
agency decision “was arbitrary and capricious in failing to identify, raise, and 
resolve sua sponte an issue never presented”); Velez-Duenas v. Swacina, 875 F. Supp. 2d 
1372, 1379 (S.D. Fla. 2012).6 Without a plausible APA claim, Plaintiffs cannot proceed 
solely under the Declaratory Judgment Act, see Am. Compl. ¶¶ 249–50, which does not 
“provide an independent basis for federal court review.” Offiiong v. Holder, 864 F. Supp. 
2d 611, 626–27 (S.D. Tex. 2012); see Gaar, 86 F.3d at 453. 
CONCLUSION 
For the foregoing reasons, the Court should dismiss this case for lack of subject-
matter jurisdiction and failure to state a claim upon which relief can be granted. 
 
6 Even if preserved, these arguments could not resuscitate the APA claim. For example, 
although alleging that FDA failed to meet standards for regulating gene therapy 
products, Am. Compl. ¶ 143, Plaintiffs do not identify any specific standard that FDA 
failed to apply, see Iqbal, 556 U.S. at 678–79 (“legal conclusions” are not presumed true). 
Case 6:22-cv-00093-ADA-DTG   Document 29   Filed 07/29/22   Page 28 of 29

21 
 
July 29, 2022 
 
OF COUNSEL: 
 
SAMUEL R. BAGENSTOS 
General Counsel 
U.S. Department of Health and Human 
Services 
 
MARK RAZA 
Chief Counsel 
 
WENDY VICENTE 
Acting Deputy Chief Counsel, Litigation 
 
JAMES ALLRED 
Associate Chief Counsel 
Office of the Chief Counsel 
U.S. Food and Drug Administration 
10903 New Hampshire Ave. 
White Oak 31, Room 4564 
Silver Spring, MD  20993-0002 
Respectfully submitted, 
 
BRIAN M. BOYNTON 
Principal Deputy Assistant Attorney 
General 
 
ARUN G. RAO 
Deputy Assistant Attorney General 
  
GUSTAV W. EYLER 
Director 
 
HILARY K. PERKINS 
Assistant Director 
 
/s/ James W. Harlow 
JAMES W. HARLOW 
Senior Trial Attorney 
Consumer Protection Branch 
Civil Division 
U.S. Department of Justice 
P.O. Box 386 
Washington, DC  20044-0386 
(202) 514-6786 
(202) 514-8742 (fax) 
james.w.harlow@usdoj.gov 
 
Case 6:22-cv-00093-ADA-DTG   Document 29   Filed 07/29/22   Page 29 of 29

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