Motion to Dismiss — 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. 18 · 2022-04-25 · Docket on CourtListener

Summary

The defendants' motion to dismiss for lack of subject-matter jurisdiction and failure to state a claim upon which relief can be granted in Children's Health Defense, et al. v. Food & Drug Administration, et al., Case No. 6:22-cv-00093-ADA-DTG, in the U.S. District Court for the Western District of Texas, Waco Division, filed April 25, 2022 as Document 18. It argues that no plaintiff has standing to challenge the emergency use authorization FDA issued in October 2021 for the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11, and that Children's Health Defense has shown neither representational nor organizational standing. It argues that sovereign immunity bars the claims because Congress committed authorizations under 21 U.S.C. § 360bbb-3 to agency discretion. It further argues the claims are implausible under Fed. R. Civ. P. 12(b)(1) and 12(b)(6). The document is 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 for Lack of Subject-Matter Jurisdiction  
and Failure to State a Claim Upon Which Relief Can Be Granted 
 
 
 
  
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TABLE OF CONTENTS 
INTRODUCTION ............................................................................................................................... 1 
BACKGROUND ................................................................................................................................ 2 
I. 
FDA’s issuance of the Pfizer EUA for children aged 5 to 11 ..................................... 2 
II. 
CHD’s opposition to COVID-19 vaccines, and this lawsuit ...................................... 4 
LEGAL STANDARD .......................................................................................................................... 5 
ARGUMENT ..................................................................................................................................... 6 
I. 
Plaintiffs fail to establish this Court’s subject-matter jurisdiction ............................ 6 
A. 
No Plaintiff has standing .......................................................................................... 6 
1. 
With no actual or imminent injury to themselves or their children, Else  
and Dietrich lack standing .................................................................................... 7 
2. 
With no injury to an identified member or to the group itself, CHD lacks 
standing ................................................................................................................. 10 
B. 
Sovereign immunity bars Plaintiffs’ causes of action ......................................... 12 
II. 
Even if this Court has jurisdiction, Plaintiffs’ claims are implausible ................... 15 
CONCLUSION ................................................................................................................................ 20 
 
 
 
 
 
 
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TABLE OF AUTHORITIES 
Cases 
Ashcroft v. Iqbal, 
556 U.S. 662 (2009) .......................................................................................................... passim 
Ass’n for Retarded Citizens of Dall. v. Dall. Cty. Mental Health & Mental Retardation Ctr., 
19 F.3d 241 (5th Cir. 1994) ..................................................................................................... 11 
Ass’n of Am. Physicians & Surgeons v. FDA, 
2020 WL 5745974 (6th Cir. Sept. 24, 2020) .......................................................................... 13 
Aviles v. Blasio, 
No. 20 CIV. 9829 (PGG), 2021 WL 796033 (S.D.N.Y. Mar. 2, 2021) ................................... 4 
Baldwin v. Daniels, 
250 F.3d 943 (5th Cir. 2001) ................................................................................................... 16 
Balt. Gas & Elec. Co. v. Nat. Res. Def. Council, 
462 U.S. 87 (1983) .................................................................................................................... 15 
Bell Atl. Corp. v. Twombly, 
550 U.S. 544 (2007) ................................................................................................................ 5, 6 
Blanchett v. DeVos, 
490 F. Supp. 3d 26 (D.D.C. 2020) .......................................................................................... 15 
Block v. Cmty. Nutrition Inst., 
467 U.S. 340 (1984) .................................................................................................................. 13 
Borough of Duryea v. Guarnieri, 
564 U.S. 379 (2011) .................................................................................................................. 16 
Brownback v. King, 
141 S. Ct. 740 (2021) .................................................................................................................. 5 
Camp v. Pitts, 
411 U.S. 138 (1973) (per curiam) ........................................................................................... 19 
Carr v. Saul, 
141 S. Ct. 1352 (2021) .............................................................................................................. 19 
Children’s Health Def. v. FDA, 
No. 121CV00200DCLCCHS, 2021 WL 5756085 (E.D. Tenn. Nov. 30, 2021) ................ 4, 9 
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) ............................................................................................. 12, 16 
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Clapper v. Amnesty Int’l USA, 
568 U.S. 398 (2013) ................................................................................................................ 7, 9 
Clark v. Edwards, 
468 F. Supp. 3d 725 (M.D. La. 2020) ..................................................................................... 11 
Coal. for Mercury-Free Drugs v. Sebelius, 
671 F.3d 1275 (D.C. Cir. 2012) ................................................................................................. 8 
Collins v. Morgan Stanley Dean Witter, 
224 F.3d 496 (5th Cir. 2000) ..................................................................................................... 3 
Corley v. United States, 
556 U.S. 303 (2009) .................................................................................................................. 14 
Crane v. Johnson, 
783 F.3d 244 (5th Cir. 2015) ............................................................................................... 9, 11 
Ctr. for Biological Diversity v. U.S. EPA, 
937 F.3d 533 (5th Cir. 2019) ................................................................................................... 10 
DaimlerChrysler Corp. v. Cuno, 
547 U.S. 332 (2006) .................................................................................................................... 5 
Delta Found., Inc. v. United States, 
303 F.3d 551 (5th Cir. 2002) ................................................................................................... 19 
Dep’t of Army v. Blue Fox, Inc., 
525 U.S. 255 (1999) .................................................................................................................. 12 
Dep’t of Commerce v. New York, 
139 S. Ct. 2551 (2019) ........................................................................................................ 19, 20 
Defs. Wildlife v. Perciasepe, 
714 F.3d 1317 (D.C. Cir. 2013) ............................................................................................... 12 
Diamond v. Charles, 
476 U.S. 54 (1986) ...................................................................................................................... 9 
Drake v. Panama Canal Comm’n, 
907 F.2d 532 (5th Cir. 1990) ....................................................................................... 12, 13, 14 
FCC v. Prometheus Radio Project, 
141 S. Ct. 1150 (2021) .............................................................................................................. 15 
FDIC v. Bank of Coushatta, 
930 F.2d 1122 (5th Cir. 1991) ........................................................................................... 14, 15 
FDIC v. Meyer, 
510 U.S. 471 (1994) .................................................................................................................... 6 
Fla. Power & Light Co. v. Lorion, 
470 U.S. 729 (1985) .................................................................................................................. 19 
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Fleming v. U.S. Dep’t of Agric., 
987 F.3d 1093 (D.C. Cir. 2021) ............................................................................................... 19 
Gaar v. Quirk, 
86 F.3d 451 (5th Cir. 1996) ............................................................................................... 12, 20 
Gentilello v. Rege, 
627 F.3d 540 (5th Cir. 2010) ................................................................................................... 16 
Glennborough Homeowners Ass’n v. U.S. Postal Serv., 
21 F.4th 410, 415 (6th Cir. 2021) .............................................................................................. 9 
Haitian Refugee Ctr., Inc. v. Baker, 
953 F.2d 1498 (11th Cir. 1992) ............................................................................................... 13 
Havens Realty Corp. v. Coleman, 
455 U.S. 363 (1982) .................................................................................................................. 10 
Hayward v. U.S. Dep’t of Labor, 
536 F.3d 376 (5th Cir. 2008) ................................................................................................... 18 
Hishon v. King & Spalding, 
467 U.S. 69 (1984) ...................................................................................................................... 6 
Hollingsworth v. Perry, 
570 U.S. 693 (2013) .................................................................................................................... 6 
Keener v. Cong. of U.S., 
467 F.2d 952 (5th Cir. 1972) ................................................................................................... 16 
Kingdomware Techs., Inc. v. United States, 
579 U.S. 162 (2016) .................................................................................................................. 14 
Koehler v. United States, 
153 F.3d 263 (5th Cir. 1998) ................................................................................................... 12 
Lamie v. U.S. Trustee, 
540 U.S. 526 (2004) .................................................................................................................. 13 
Lincoln v. Virgil, 
508 U.S. 182 (1993) .................................................................................................................. 17 
Lujan v. Defs. of Wildlife, 
504 U.S. 555 (1992) ............................................................................................................ 6, 7, 8 
Miller ex rel. Miller v. HCA, Inc., 
118 S.W.3d 758 (Tex. 2003) .................................................................................................. 8, 9 
Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 
463 U.S. 29 (1983) .................................................................................................................... 18 
NAACP v. City of Kyle, 
626 F.3d 233 (5th Cir. 2010) ............................................................................................. 10, 11 
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Neitzke v. Williams, 
490 U.S. 319 (1989) .............................................................................................................. 6, 15 
Newman-Green, Inc. v. Alfonzo-Larrain, 
490 U.S. 826 (1989) .................................................................................................................... 3 
Null v. FDA, 
No. CV 09-1924 (RBW), 2009 WL 10744069 (D.D.C. Nov. 10, 2009) ................................. 9 
Offiiong v. Holder, 
864 F. Supp. 2d 611 (S.D. Tex. 2012) .................................................................................... 20 
Palacios v. Dep’t of Homeland Sec., 
434 F. Supp. 3d 500 (S.D. Tex. 2020) .................................................................................... 15 
Palm Valley Health Care, Inc. v. Azar, 
947 F.3d 321 (5th Cir. 2020) ................................................................................................... 20 
Patients for Customized Care v. Shalala, 
56 F.3d 592 (5th Cir. 1995) ..................................................................................................... 17 
Pena v. City of Rio Grande City, 
56 F.3d 592, 595 (5th Cir. 1995) ............................................................................................. 17 
Pros. & Patients for Customized Care v. Shalala, 
879 F.3d 613 (5th Cir. 2018) ................................................................................................... 15 
Residents Against Flooding v. Reinvestment Zone No. Seventeen, 
260 F. Supp. 3d 738 (S.D. Tex. 2017) .................................................................................... 15 
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) ................................................................................................... 12 
Sierra Club v. Glickman, 
156 F.3d 606 (5th Cir. 1998) ................................................................................................... 12 
Simon v. E. Ky. Welfare Rights Org., 
426 U.S. 26 (1976) ...................................................................................................................... 9 
Spokeo, Inc. v. Robins, 
578 U.S. 330 (2016) .............................................................................................................. 7, 11 
Steel Co. v. Citizens for a Better Env’t, 
523 U.S. 83 (1998) .................................................................................................................. 5, 7 
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 
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Summers v. Earth Island Inst., 
555 U.S. 488 (2009) ............................................................................................................ 10, 11 
Tenth St. Residential Ass’n v. City of Dall., 
968 F.3d 492 (5th Cir. 2020) ................................................................................................. 5, 8 
TransUnion LLC v. Ramirez, 
141 S. Ct. 2190 (2021) ............................................................................................................ 6, 7 
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, 12 
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). ................................................................................................... 12 
Webster v. Doe, 
486 U.S. 592 (1988) ...................................................................................................... 13, 14, 15 
Williams v. Parker, 
843 F.3d 617 (5th Cir. 2016) ................................................................................................... 11 
Yosowitz v. Covidien LP, 
182 F. Supp. 3d 683 (S.D. Tex. 2016) ...................................................................................... 3 
Zinermon v. Burch, 
494 U.S. 113 (1990) .................................................................................................................. 16 
Statutes 
5 U.S.C. § 
 553(b) ........................................................................................................................................ 17 
 701(a) ........................................................................................................................................ 14 
 701(a)(1) ............................................................................................................................. 13, 14 
 701(a)(2) ............................................................................................................................. 13, 14 
 702............................................................................................................................................. 12 
21 U.S.C. §  
 360bbb-3 ........................................................................................................................... passim 
 360bbb-3(a)(1) ..................................................................................................................... 2, 14 
  360bbb-3(b) .......................................................................................................................... 2, 14 
  360bbb-3(b)(1) ......................................................................................................................... 14 
  360bbb-3(b)(1)(C) ..................................................................................................................... 2 
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 360bbb-3(c) ................................................................................................................... 2, 14,  17 
 360bbb-3(c)(3) ......................................................................................................................... 19 
 360bbb-3(d) ............................................................................................................................. 17 
 360bbb-3(e)(1)(A).................................................................................................................... 14 
 360bbb-3(e)(1)(A)(ii)(III) ...................................................................................................... 4, 7 
 360bbb-3(e)(1)(A)-(B) ............................................................................................................. 14 
 360bbb-3(e)(4) ......................................................................................................................... 17 
 360bbb-3(g)(2) ......................................................................................................................... 14 
 360bbb-3(i) ..................................................................................................................... 2, 13, 14 
28 U.S.C. § 
 1331........................................................................................................................................... 12 
 2201........................................................................................................................................... 12 
42 U.S.C. §  
 262(a) .................................................................................................................................... 2, 17 
 262(i)(1) ...................................................................................................................................... 2 
50 U.S.C. § 1622 .................................................................................................................... 15, 16 
Tex. Fam. Code Ann. § 151.001(6).......................................................................................... 8, 9 
Tex. Gov’t Code § 418.012 ........................................................................................................... 8 
Regulations and Rules 
21 C.F.R. §    
 10.25(a) ............................................................................................................................... 17, 19 
10.30.......................................................................................................................................... 19 
 10.45(f)...................................................................................................................................... 19 
Fed. R. Civ. P. 
12(b)(1) ....................................................................................................................................... 5 
12(b)(6) ................................................................................................................................. 5, 16 
12(h)(3) ....................................................................................................................................... 5 
25(d) ........................................................................................................................................... 5 
 
Other Authorities 
85 Fed. Reg. 7316 (Feb. 7, 2020) .................................................................................................. 2 
85 Fed. Reg. 18,250 (Apr. 1, 2020) ........................................................................................ 2, 16 
86 Fed. Reg. 5200 (Jan. 19, 2021) ................................................................................................. 3 
86 Fed. Reg. 28,608 (May 27, 2021) ............................................................................................ 3 
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INTRODUCTION 
In October 2021, the U.S. Food and Drug Administration (“FDA”) issued an 
emergency use authorization for administration of the Pfizer-BioNTech COVID-19 
vaccine to children aged 5 to 11 (“the Pfizer EUA”). Since then, many American parents 
have chosen to vaccinate their children against the virus that causes COVID-19. And 
many other parents have not, as they are free to decide.  
Plaintiffs Deborah Else and Sacha Dietrich belong to the latter camp. But Else, 
Dietrich, and the advocacy group to which Else belongs—Children’s Health Defense 
(“CHD”)—are not content for American parents to make their own decisions about 
vaccination. Instead, Plaintiffs seek to invalidate the Pfizer EUA as it applies to all 
children aged 5 to 11. Their quest is legally baseless and should be dismissed. 
For starters, this Court lacks subject-matter jurisdiction for two reasons. First, no 
Plaintiff has standing. Else and Dietrich lack standing because none of their children 
faces an imminent threat of harm from the Pfizer EUA’s mere existence. Because Else 
lacks standing, CHD cannot establish representational standing through any identified 
member. And the Complaint does not plausibly show any injury to CHD itself, the 
prerequisite for organizational standing. 
Second, even if any plaintiff possessed standing, sovereign immunity deprives this 
Court of jurisdiction. Both claims in the 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. Not subject to the APA’s waiver of sovereign immunity (or any other similar 
waiver), 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 
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precedent, and their factual challenges are refuted by the face of FDA’s documents that 
are attached to or incorporated by reference in the Complaint. These claims fail as a 
matter of law. 
BACKGROUND 
I. FDA’s issuance of the Pfizer EUA for children aged 5 to 11 
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 must determine 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, 
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18,250–51 (Apr. 1, 2020). FDA subsequently issued EUAs for COVID-19 vaccines 
manufactured by Pfizer-BioNTech, ModernaTX, Inc., and Janssen Biotech, Inc. See 86 
Fed. Reg. 5200 (Jan. 19, 2021) (initial Pfizer and Moderna EUAs); 86 Fed. Reg. 28,608 
(May 27, 2021) (initial Janssen EUA). Only the Pfizer EUA is relevant to this case. Ex. 1, 
Burk Decl. (“January Letter”)1; see Compl., ECF No. 1, at ¶ 22.  
On October 29, 2021, “FDA concluded that it [was] reasonable to believe that 
Pfizer-BioNTech COVID-19 Vaccine may be effective in individuals 5 through 11 years 
of age.”2 January Letter 7. The agency also concluded, “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 
aged 5 through 11 years. Id. In reaching those conclusions, FDA reviewed extensive 
safety and effectiveness data, including data from a clinical trial involving “4,695 
participants 5 through 11 years of age.” Id.; see generally Ex. 5, EUA Mem., ECF No. 1, at 
178–225. The agency also considered the vote, by the Vaccines and Related Biological 
Products Advisory Committee, “in agreement with” these conclusions. January Letter 7; 
see EUA Mem., ECF No. 1, at 219–20. 
The Pfizer EUA requires vaccination providers to make available an approved 
“Fact Sheet for Recipients and Caregivers,” in hardcopy or online. January Letter 14–15, 
                                                 
1 The operative EUA on the Complaint’s filing date was the January 3, 2022 reissuance. 
Burk Decl. ¶¶ 5–6; see Newman-Green, Inc. v. Alfonzo-Larrain, 490 U.S. 826, 830 (1989) 
(“[F]ederal jurisdiction ordinarily depends on the facts as they exist when the complaint 
is filed.”). The Court may consider the January Letter for this motion to dismiss because 
it is the operative agency action challenged by and discussed in the Complaint. See, e.g., 
Collins v. Morgan Stanley Dean Witter, 224 F.3d 496, 498–99 (5th Cir. 2000). Also, “judicial 
notice of publicly-available documents . . . produced by the FDA, which were matters of 
public record directly relevant to the issue at hand is appropriate.” Yosowitz v. Covidien 
LP, 182 F. Supp. 3d 683, 688 (S.D. Tex. 2016) (quotation omitted); see Burk Decl. ¶ 6. 
2 Although the Pfizer EUA encompasses administration for all individuals aged 5 and 
above, see January Letter 10–12, only the portion related to children aged 5 through 11 is 
at issue here, see, e.g., Compl. ¶¶ 22, 201. 
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18. The Fact Sheet, which is publicly available on FDA’s website, informs parents and 
other caregivers that “there is an option to accept or refuse receiving the vaccine.” Ex. 2, 
Burk Decl. (“Fact Sheet”), at 5. 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) (among 
other conditions of authorization, “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 Georgia-based advocacy group that opposes the COVID-19 vaccines. See 
Compl. ¶ 5. In May 2021, CHD petitioned FDA to “refrain from licensing COVID-19 
vaccines and to revoke EUAs for the three existing COVID-19 vaccines.” Id. ¶ 39; see Ex. 
2, Citizen Pet., ECF No. 1, at 64–83. Three months later, FDA provided a detailed 
response of more than 50 pages. See Compl. ¶ 40; Ex. 3, Citizen Pet. Resp., ECF No. 1, at 
84–137. The agency denied CHD’s petition because it lacked “facts demonstrating any 
reasonable grounds for the requested action.” Citizen Pet. Resp., ECF No. 1, at 86. 
CHD also has pursued (unsuccessfully) its objections to COVID-19 vaccines 
through the courts. See Children’s Health Def. v. FDA, No. 121CV00200DCLCCHS, 2021 
WL 5756085, at *1, 6 (E.D. Tenn. Nov. 30, 2021) (dismissing CHD’s challenge to Pfizer’s 
COVID-19 vaccine for lack of standing), appeal docketed No. 21-6203 (6th Cir. Dec. 17, 
2021); 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 motion for a preliminary 
injunction 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 school COVID-19 policy). 
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On January 24, 2022, CHD returned to court and, alongside Else and Dietrich, filed 
this suit against FDA and Robert M. Califf, M.D., Commissioner of Food and Drugs.3 
Plaintiffs challenge FDA’s issuance of the Pfizer EUA for children aged 5 to 11, alleging 
one APA claim and another for declaratory relief. See Compl. ¶¶ 155–207. Defendants 
now move to dismiss the Complaint under Federal Rule of Civil Procedure 12(b)(1) and 
(b)(6) for lack of subject-matter jurisdiction and failure to state a claim upon which relief 
can be granted.  
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 
“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). “In deciding a motion to dismiss for lack of subject matter 
jurisdiction, a court may consider (1) the complaint alone; (2) the complaint 
supplemented by undisputed facts; or (3) the complaint supplemented by undisputed 
facts plus the court’s resolution of disputed facts.” Tenth St. Residential Ass’n v. City of 
Dall., 968 F.3d 492, 498–99 (5th Cir. 2020). 
“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 
                                                 
3 Dr. Califf automatically substitutes as defendant for his predecessor, Janet Woodcock, 
M.D., Acting Commissioner of Food and Drugs. Fed. R. Civ. P. 25(d). 
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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. Plaintiffs fail to establish this Court’s subject-matter jurisdiction 
Two bedrock jurisdictional precepts require the dismissal of this case. 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, 570 U.S. 693, 704 (2013)—do not properly invoke Article III 
jurisdiction. Lacking any cognizable injury, 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 
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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 three Plaintiffs has standing.  
1. With no actual or imminent injury to themselves or their children, Else 
and Dietrich lack standing 
Beginning with the two individual plaintiffs, Else and Dietrich 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). Else 
and Dietrich aver an “imminent risk of immediate harm” to their children if they were 
to receive the Pfizer vaccine. Compl. ¶¶ 6–7.4 “For a threatened future injury to satisfy 
the imminence 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. 
Consistent with the underlying statutory authority, see 21 U.S.C. § 360bbb-
3(e)(1)(A)(ii)(III), the Pfizer EUA does not compel any individual to receive the vaccine 
nor any parent to consent to administration to their child, see generally January Letter. 
Rather, as the caregiver Fact Sheet expressly states, “there is an option to accept or 
refuse receiving the vaccine. Should you decide for your child not to receive it, it will 
                                                 
4 Although the Complaint alleges “[c]hildren in Texas are being denied medical 
services, including transplants, without vaccination,” Compl. ¶ 127, Else’s and 
Dietrich’s children are not claimed to be among them. 
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not change your child’s standard of medical care.” Fact Sheet 5. Texas law also affords 
Else and Dietrich the right to consent, or “not to consent,” to their children’s medical 
care, including whether to receive the Pfizer EUA vaccine. Miller ex rel. Miller v. HCA, 
Inc., 118 S.W.3d 758, 766 (Tex. 2003); see Tex. Fam. Code Ann. § 151.001(6) (West). So by 
simply continuing to withhold consent, Else and Dietrich 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) (Kavanaugh, J.) (“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.”). 
Dietrich nonetheless suggests a risk to her children arises from unspecified “local 
and school mandates” and “directives to receive the COVID-19 biologic.” Compl. ¶¶ 7, 
186. She correctly does not suggest that FDA could “mandate vaccines for the general 
public.” EUA Mem., ECF No. 1, at 220. Nor could state or local authorities in Texas, 
where she and Else reside, Compl. ¶¶ 6–7, issue such a COVID-19 vaccine mandate. By 
executive order, the governor has 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.”). Given the executive order’s prohibition, “[s]uch a 
remote possibility of harm” from hypothetical local or school vaccine mandates “fails 
[standing’s] imminence requirement.” Tenth Street, 968 F.3d at 501; see id. (no standing 
when city ordinance prohibited funding the feared demolition of homes). 
Even if Dietrich fears a potential rescission of the executive order and imposition of 
a state vaccination mandate for children aged 5 through 11, such “unadorned 
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speculation will not suffice to invoke the federal judicial power.” Simon v. E. Ky. Welfare 
Rights Org., 426 U.S. 26, 44 (1976). And should it materialize, any injury therefrom 
would be traceable to the “decisions of independent actors,” i.e. state or local 
authorities, not FDA’s issuance of the Pfizer EUA. Clapper, 568 U.S. at 414; see Children’s 
Health Def., 2021 WL 5756085, at *5 (no standing to challenge FDA’s issuance of Pfizer 
EUA because “[t]he vaccine mandates, and the potential consequences for refusing 
those mandates, are not fairly traceable to the specific actions of the FDA”); Null v. FDA, 
No. CV 09-1924 (RBW), 2009 WL 10744069, at *3 (D.D.C. Nov. 10, 2009). The Pfizer EUA, 
again, compels no action whatsoever from any parent or child. 
Otherwise, Else and Dietrich object to “advertisements and societal pressures 
encouraging their children to receive” the Pfizer EUA vaccine. Compl. ¶ 184; see id.  
¶¶ 3, 185–86. But “the purported indignity of receiving a” 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 Diamond v. Charles, 476 U.S. 54, 62 (1986) (“The 
presence of a disagreement, however sharp and acrimonious it may be, is insufficient by 
itself to meet Art. III’s requirements.”). Else and Dietrich also fail to allege how such 
pressures can plausibly override their legal right to withhold consent for their children 
to receive the EUA vaccine. See Miller, 118 S.W.3d at 766; Tex. Fam. Code Ann.  
§ 151.001(6); Fact Sheet 5. Moreover, any injury deriving from the independently 
developed messages of third parties, such as schools, pediatricians, or stores, cannot be 
fairly traced to FDA. See, e.g., Clapper, 568 U.S. at 414. 
At bottom, Else and Dietrich 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 the Pfizer vaccine 
over their objection “is not supported by any facts” and “purely speculative.” Crane v. 
Johnson, 783 F.3d 244, 252 (5th Cir. 2015). Accordingly, they lack standing and “may not 
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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). 
2. With no injury to an identified member or to the group itself, CHD 
lacks standing 
CHD asserts both associational standing, on behalf of its members, and 
organizational standing, on its own behalf. Compl. ¶ 5; 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). Else is the only CHD member identified in the 
Complaint, and, as discussed above, she lacks 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 original mission in public education 
and protection of children to correct this critical error and try to protect the members 
and mission of CHD.” Compl. ¶ 5; see id. ¶ 13. “Not every diversion of resources to 
counteract the defendant’s conduct, however, establishes an injury in fact.” City of Kyle, 
626 F.3d at 238. Only a “diversion of resources” that “concretely and ‘perceptibly 
impaired’ [CHD’s] ability to carry out its purpose” suffices for standing. Id. at 239 
(quoting Havens Realty, 455 U.S. at 379).  
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CHD failed to “clearly allege facts” that demonstrate a perceptible impairment of 
its mission. Spokeo, 578 U.S. at 338 (cleaned up). CHD has not “identified any specific 
projects” it “had to put on hold or otherwise curtail in order to respond to the” Pfizer 
EUA. City of Kyle, 626 F.3d at 238. If the group intends to rely on litigation expenses, 
such costs are “fundamentally self-inflicted” and thus “insufficient to satisfy the injury-
in-fact requirement.” Williams v. Parker, 843 F.3d 617, 621 (5th Cir. 2016); Ass’n for 
Retarded Citizens of Dall. v. Dall. Cty. Mental Health & Mental Retardation Ctr., 19 F.3d 241, 
244 (5th Cir. 1994) (“The mere fact that an organization redirects some of its resources to 
litigation and legal counseling in response to actions or inactions of another party is 
insufficient to impart standing upon the organization.”). CHD also has not explained 
how this litigation—ostensibly filed to protect “minor children,” Compl. ¶ 1—
“detract[s] or ‘differ[s] from its routine [] activities,’” City of Dall., 968 F.3d at 500 
(quoting City of Kyle, 626 F.3d at 238). After all, CHD’s self-described mission is the 
“protection of children.” Compl. ¶ 5; 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”). Because 
CHD’s claim of resource diversion “is not supported by any facts,” the alleged “injury 
is purely speculative” and does not “establish standing.” Crane, 783 F.3d at 252.5 
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. Compl. ¶ 5. Ignoring for the moment the underlying flaws with these allegations, 
see infra pages 16–17, 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 
                                                 
5 Far from a financial drain, CHD’s advocacy against COVID-19 vaccines apparently has 
proved quite a boon. See Michelle R. Smith, AP, How a Kennedy built an anti-vaccine 
juggernaut amid COVID-19 (Dec. 15, 2021), https://bit.ly/3Dhr9qt. 
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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 supposed 
“inability to comment effectively or fully” on the Pfizer EUA could not, in and of itself, 
establish standing. Defs. of Wildlife v. Perciasepe, 714 F.3d 1317, 1325 (D.C. Cir. 2013); see 
Compl. ¶ 5. But 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 right to petition and procedural rights under the APA. 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). Ultimately, like Else and Dietrich, CHD 
must be dismissed for lack of standing. Valley Forge, 454 U.S. at 475–76. 
B. Sovereign immunity bars Plaintiffs’ causes of action 
Even if the Court were to find that Plaintiffs have 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 Compl. ¶¶ 10, 157.6 But the APA’s waiver is not 
absolute.  
                                                 
6 Although Plaintiffs invoke the general federal-question statute, 28 U.S.C. § 1331, and 
Declaratory Judgment Act, 28 U.S.C. § 2201, see Compl. ¶¶ 11, 207, neither waives 
sovereign immunity, see, e.g., 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 Compl. ¶ 11. 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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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, 
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) is implicated when the relevant 
statutory “language” and “structure” indicate “that its implementation was ‘committed 
to agency discretion by law.’” Webster, 486 U.S. at 600. And sometimes, given the 
analytical overlap, both section 701(a)(1) and (a)(2) equally support exemption from the 
APA’s waiver of sovereign immunity. See Haitian Refugee Ctr., Inc. v. Baker, 953 F.2d 
1498, 1507–08 (11th Cir. 1992). 
The Pfizer EUA was expressly issued “pursuant to” 21 U.S.C. § 360bbb-3. January 
Letter 1, 9–11. 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 
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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 
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 Pfizer EUA 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 [this] decision[] under the APA.” 
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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. 
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). “Judicial review under that standard is 
deferential . . . . 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). Judicial review also is “at its most deferential” when a case involves “scientific 
determination[s]” and “predictions” by FDA that are “within its area of special 
expertise.” Balt. Gas & Elec. Co. v. Nat. Res. Def. Council, 462 U.S. 87, 103 (1983).  
Although the Complaint advances numerous arguments, nowhere do Plaintiffs set 
forth a plausible APA claim. First, Plaintiffs contend that “FDA has based its emergency 
authorization authority” on 50 U.S.C. § 1622 and fault Congress for failing “to consider 
whether the COVID-19 emergency should continue.” Compl. ¶¶ 168–71. Plaintiffs’ first 
prong is factually wrong and the second is legally unavailing. The EUA was issued 
expressly under 21 U.S.C. § 360bbb-3. See January Letter 1, 9–10. The Secretary’s public-
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health emergency declaration under 21 U.S.C. § 360bbb-3, see 85 Fed. Reg. at 18,250–51, 
is distinct from a national-emergency declaration by the President under 50 U.S.C. § 
1622. And whatever their dissatisfaction with Congress, “no cause of action lies to 
compel Congress to exercise its discretion to legislate on a purely political question.” 
Keener v. Cong. of U.S., 467 F.2d 952, 953 (5th Cir. 1972).  
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.” Compl. p. 50. 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 on May 16, 2021.” Compl. ¶ 176 
(emphasis added); see Citizen Pet., ECF No. 1, at 64–83. FDA then responded, in great 
detail, a few months later. See Citizen Pet. Resp., ECF No. 1, at 84–137. Plaintiffs may 
not like that FDA disagreed with them, but “[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 
violation of procedural due process.” Compl. ¶ 180. For a procedural due-process claim, 
Plaintiffs “must first identify a protected life, liberty or property interest and then prove 
that governmental action resulted in a deprivation of that interest.” Baldwin v. Daniels, 
250 F.3d 943, 946 (5th Cir. 2001). Although “required to point to some” constitutionally 
protected interest, Plaintiffs 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 constitutionally 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 
“citizen participation or a notice-and-comment process when [FDA] labeled the 
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COVID-19 biologics as vaccines.” Compl. ¶ 181. But as the Complaint’s exhibits attest, 
see Citizen Pet. & Resp., ECF No. 1, at 64–137, FDA’s petition process allows citizens to 
submit their views and request “administrative action,” 21 C.F.R. § 10.25(a). And 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. 
Compl. ¶ 45. 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, although Plaintiffs object to FDA’s “market[ing] this emergency use only 
drug to children,” Compl. ¶ 183, FDA does not itself market any EUA vaccine or any 
other vaccine. The agency may “establish conditions on advertisements and other 
promotional descriptive matter” for EUAs, 21 U.S.C. § 360bbb-3(e)(4), which it has done 
for the Pfizer EUA, see January Letter 19. Plaintiffs do not challenge these conditions. 
The Complaint also lacks any facts supporting “the reasonable inference that [FDA] is 
liable for” any COVID-19 vaccine marketing, Iqbal, 556 U.S. at 678, including 
“advertisements on television, radio shows, announcements and signage in stores,” 
Compl. ¶ 185. Rather, it only describes independent recommendations of third parties 
like “[p]ediatricians,” “school[s],” “stores,” and a television program. Id. ¶¶ 185–86. 
Fifth, Plaintiffs argue that FDA’s consideration and explanation of several issues 
was inadequate. See Compl. ¶¶ 159–66, 187–97. But each alleged deficiency is refuted by 
agency documents, which establish on their face that Plaintiffs have not plausibly 
alleged 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 
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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 justify its conclusion that children ages 5–11 
face an emergency” warranting the Pfizer EUA. Compl. ¶¶ 162, 194. Not so. 
The agency first concluded that SARS-CoV-2 “can cause a serious or life-
threatening disease or condition,” i.e. COVID-19. EUA Mem., ECF No. 1, at 
185–87, 220; see January Letter 10. Although “the overall burden of COVID-
19 is lower in children 5-11 years of age compared with adults,” FDA found 
it still presents significant health risks. EUA Mem., ECF No. 1, at 185–86, 
215–16. And “given the uncertainty of the COVID-19 pandemic and 
likelihood of continued SARS-CoV-2 transmission,” the Pfizer vaccine “will 
likely have a substantial effect on COVID-19 associated morbidity and 
mortality in” the 5–11 age group due to the vaccine’s effectiveness, the 
limitations of mitigation measures, and other factors. Id. at 216–21.  
 Plaintiffs allege “FDA failed to articulate any standard for assessing an 
individualized, stratified risk for children between the ages of 5 and 11,” and 
its risk assessment methodology “is still shrouded in mystery.” Compl.  
¶¶ 188, 190. 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 make such a standard” in the first instance, 
Compl. ¶ 188. Furthermore, the agency fully explained its risk assessment 
methodology, including “a quantitative benefit-risk assessment” for 
“children 5-11 years of age” with six different scenarios. EUA Mem., ECF 
No. 1, at 217-19. 
 Plaintiffs allege FDA “failed to address” Pfizer’s “clinical trials.” Compl.  
¶ 193. In fact, the agency scrutinized the trials’ structure and results in 
depth. See EUA Mem., ECF No. 1, at 196–211. 
 Plaintiffs allege FDA “ignored adverse events that have been documented 
through the [Vaccine Adverse Events Reporting System] database.” Compl. 
¶ 196. On the contrary, FDA “queried” that database “for adverse event (AE) 
reports following administration of the Pfizer-BioNTech COVID-19 
Vaccine,” and analyzed the results. EUA Mem., ECF No. 1, at 192-93. 
 Plaintiffs allege FDA “dismissed the effectiveness of alternative treatments.” 
Compl. ¶ 197. 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 
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19 
 
cleared by FDA,” on an “indication-specific” basis, qualify under 21 U.S.C. 
§ 360bbb-3(c)(3). Citizen Pet. Resp., ECF No. 1, at 113 & n.82. 
Sixth, Plaintiffs seek to introduce new arguments from a news article about 
purported “inadequacies regarding [Pfizer] clinical trials” and whether “mRNA 
COVID-19 vaccines” are “gene therapies.” Compl. ¶¶ 191, 193. But the “focal point” for 
APA review is “the administrative record already in existence, not some new record 
made initially in the reviewing court.” Camp v. Pitts, 411 U.S. 138, 142 (1973) (per 
curiam); see Fla. Power & Light Co. v. Lorion, 470 U.S. 729, 744 (1985). Because the Court is 
“limited to evaluating the agency’s contemporaneous explanation in light of the existing 
administrative record,” Dep’t of Commerce v. New York, 139 S. Ct. 2551, 2573 (2019), it 
necessarily “could not conclude that a decision by the [agency] was arbitrary and 
capricious in failing to identify, raise, and resolve sua sponte an issue never presented 
to” it, Fleming v. U.S. Dep’t of Agric., 987 F.3d 1093, 1100 (D.C. Cir. 2021); see Delta Found., 
Inc. v. United States, 303 F.3d 551, 562–63 (5th Cir. 2002) (during APA review, 
“disregard[ing]” arguments not previously raised “at the administrative level”).  
That outcome reflects the long-standing “general rule that courts should not topple 
over administrative decisions unless the administrative body . . . has erred against 
objection made at the time appropriate under its practice.” United States v. L.A. Tucker 
Truck Lines, Inc., 344 U.S. 33, 37 (1952). This rule—“known as 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). Indeed, 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 have not plausibly alleged that, when deciding to issue the Pfizer EUA for 
individuals aged 5 to 11, the issues discussed in the media article or of gene therapy 
Case 6:22-cv-00093-ADA-DTG   Document 18   Filed 04/25/22   Page 27 of 29

20 
 
were part of the “administrative record” before the decisionmaker and should have 
been addressed sua sponte. Dep’t of Commerce, 139 S. Ct. at 2573. Plaintiffs also eschewed 
the available administrative process to present these issues to the agency. 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 issue. Palm Valley Health Care, Inc. v. Azar, 947 F.3d 321, 327–
28 (5th Cir. 2020). Thus, Plaintiffs’ new arguments cannot afford a basis to overturn the 
Pfizer EUA under the APA. See Velez-Duenas v. Swacina, 875 F. Supp. 2d 1372, 1379 (S.D. 
Fla. 2012) (dismissing, as “improper,” an APA claim where the plaintiff asked the court 
“to consider documents that were not a part of the administrative record”).7 
Lastly, without a plausible APA claim, Plaintiffs cannot proceed solely based on the 
Declaratory Judgment Act. See Compl. ¶¶ 206–07. That Act does not “provide an 
independent basis for federal court review.” Offiiong v. Holder, 864 F. Supp. 2d 611, 626–
27 (S.D. Tex. 2012). Rather, “the relevant cause of action must arise under some other 
federal law.” Gaar, 86 F.3d at 453. No such cause of action exists here. 
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. 
  
 
 
 
 
                                                 
7 Even if they were not waived, these arguments could not resuscitate the APA claim. 
For example, Plaintiffs summarily allege that FDA failed to meet its own standards for 
regulating gene therapy products, Compl. ¶ 61, but they critically do not identify any 
specific standard that FDA failed to apply in granting the Pfizer EUA, see Iqbal, 556 U.S. 
at 678–79 (“legal conclusions” are not presumed true). 
Case 6:22-cv-00093-ADA-DTG   Document 18   Filed 04/25/22   Page 28 of 29

21 
 
April 25, 2022 
 
OF COUNSEL: 
 
DANIEL BARRY 
Acting 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 18   Filed 04/25/22   Page 29 of 29

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