Opposition Brief — CHD v. FDA

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Plaintiffs' opposition to the defendants' motion to dismiss the First Amended Complaint, filed August 26, 2022 as ECF No. 30 in Children's Health Defense v. Food and Drug Administration, Case No. 6:22-cv-00093, in the U.S. District Court for the Western District of Texas, Waco Division. It responds to the motion at ECF No. 29, which sought dismissal for lack of jurisdiction and failure to state a claim. The brief argues that Children's Health Defense has organizational and associational standing, that the individual plaintiffs satisfy Article III standing, that sovereign immunity does not bar the challenge, and that the plaintiffs state reviewable claims under the APA, 5 U.S.C. § 701, and 21 U.S.C. § 360bbb-3. It asks the court to deny the motion and to allow review of the Pfizer-BioNTech COVID-19 vaccine authorization for children 6 months through 11 years. The brief is 27 pages.

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IN THE UNITED STATES DISTRICT COURT 
FOR THE WESTERN DISTRICT OF TEXAS 
Waco Division 
 
CHILDREN’S HEALTH DEFENSE, et al.  
) 
 
 
 
 
 
 
 
) 
 
 
Plaintiffs, 
 
 
 
) 
  
 
 
) 
Case No. 6:22-cv-00093 
 
 
v. 
 
 
 
 
) 
  
 
 
) 
FOOD and DRUG ADMINISTRATION, et al.,  
) 
 
 
 
 
 
 
 
) 
 
 
Defendants.   
 
 
) 
_________________________________________ ) 
 
PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS AMENDED 
COMPLAINT 
 
 
TO THE HONORABLE JUDGE OF THE COURT: 
 
 
 
Plaintiffs Children’s Health Defense (“CHD”), Deborah L. Else, Sacha Dietrich, Aimee 
Villella McBride, Jonathan Shour, and Rebecca Shour (hereinafter collectively “Plaintiffs”), file 
this opposition to Defendants U.S. Food and Drug Administration’s (“FDA”) and Robert M. 
Califf’s, (hereinafter collectively “Defendants’) Motion to Dismiss the First Amended Complaint 
[ECF No. 26] for Lack of Subject-Matter Jurisdiction and Failure to State a Claim (“MTD”) 
[ECF No. 29].  
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
INTRODUCTION……………………………………………………………………………… 1 
STANDARD OF REVIEW…………………………………………………………………….. 2 
ARGUMENT…………………………………………………………………………………..... 3 
I. 
This Case Creates A Constitutionally Cognizable Case or Controversy: Plaintiffs 
Have Article III Standing…………………………………………………………... 4 
A. Legal Standard: Organizational Standing……………………………………. 4 
B. Plaintiff CHD Presents a Case or Controversy: Organizational Standing…. 7 
C. Plaintiff CHD Presents a Case or Controversy: Associational Standing…... 10 
i. 
CHD Members Interests Create a Constitutionally Cognizable Case 
or Controversy: Associational Standing…………………………… 10 
 
ii. 
CHD Aims to Protect Interests Germane to Its Purpose..……….. 10 
iii. 
The Relief CHD Seeks Does Not Require Individual Member 
Participation…………………………………………………………. 11 
 
D. Plaintiffs Deborah L. Else, Sacha Dietrich, Aimee Villella McBride, Jonathan 
Shour, and Rebecca Shour Satisfy Article III Standing as Individuals……. 11  
 
II. 
Sovereign Immunity Does Not Prevent this Challenge…………………………. 16 
III. 
Plaintiffs State Cognizable Claims on Which This Court Can Grant 
Relief……………………………………………………………………………….. 18 
 
A. Plaintiffs’ Challenge to the EUA is Reviewable……………………………... 18 
B. Plaintiffs Successfully Allege that Defendants Violated the APA………….. 18 
i. 
Scope of Authority…………………………………………………... 19 
ii. 
FDA’s Arbitrary and Capricious Authorization………………….. 19 
CONCLUSION………………………………………………………………………………... 20 
 

 
iii
TABLE OF AUTHORITIES 
 
Cases 
Advocacy Ctr. V. La. Tech Univ.,  
2019 U.S. Dist. Lexis 47726……………………………………………………………... 5 
 
Alabama-Coushatta Tribe of Texas, v. United States,  
757 F.3d 484 (5th Cir. 2014)…………………………………………………………… 16 
 
Animal Legal Def. Fund v. Azar,  
No. 20-CV-03703-RS, 2021 WL 4477901 (N.D. Cal. Feb. 23, 2021)…………………. 13 
 
Arenas v. United States,  
322 U.S. 419 (1944)…………………………………………………………………….. 18 
 
Associated Contractors of America v. Metropolitan Water Dist. Of S. Cal.,  
159 F.3d 1178 (9th Cir. 1998)………………………………………………………….. 11 
 
Association of Community Orgs. For Reform Now v. Fowler,  
178 F.3d 350 (5th Cir. 1999)…………………………………………………………….. 5 
 
Bank of Am. Corp. v. City of Miami, Fla., 
137 S. Ct. 1296 (2017)………………………………………………………………… 4, 7 
 
Barry v. Lyon,  
834 F.3d 706 (2016)……………………………………………………………………… 4 
 
Bell Atl. Corp. v. Twombly,  
550 U.S. 544 (2007)……………………………………………………………………… 2 
 
Burlington Truck Lines v. United States,  
371 U.S. 156, 83 S. Ct. 239, 9 L.Ed.2d 207 (1962).……………………………………. 19 
 
Bustos v. Martini Club, Inc.,  
599 F.3d 458 (5th Cir. 2010)…………………………………………………………….. 3 
 
Chaney v. Heckler,  
718 F.2d 1174 (D.C. Cir. 1983).………………………………………………………... 16 
 
Chamber of Commerce of the United States v. Reich,  
74 F.3d 1322 (D.C. Cir. 1996)………………………………………………………….. 17 
 
Conley v. Gibson,  
355 U.S. 41, 78 S. Ct. 99, 2 L.Ed. 2d 80 (1958)…………………………………………. 2 

 
iv 
 
Ctr. for Food Safety v. Price,  
No. 17-CV-3833 (VSB), 2018 WL 4356730 (S.D.N.Y. Sept. 12, 2018)………………. 12 
 
Cutler v. Kennedy,  
475 F.Supp. 838 (D.D.C.1979)……………………………………………………... 12, 16 
 
Davidson v. Kimberley-Clark Corporation,  
873 F.3d 1103 (9th Cir. 2017)………………………………………………………….. 15 
 
Davidson v. Kimberly-Clark Corporation,  
No. 15-16173, 2018 U.S. App. LEXIS 12204 (9th Cir. May 9, 2018)…………………. 15 
 
Dep't of Com. v. New York,  
139 S. Ct. 2551, 204 L. Ed. 2d 978 (2019)……………………………………………... 17 
 
Duncan v. Muzyn,  
833 F.3d 567 (6th Cir. 2016)…………………………………………………………… 17 
 
El Rescate Legal Services, Inc. v. Executive Office of Immigration Review,  
959 F.2d 742 (9th Cir. 1991)…………………………………………………………….. 5 
 
F.C.C. v. Beach Commc’ns, Inc.,  
508 U.S. 307 (1993)…………………………………………………………………….. 20 
 
Friends of the Earth, Inc. v. Chevron Chem. Co.,  
129 F.3d 826 (5th Cir. 1997)…………………………………………………………… 10 
 
Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,  
528 U.S. 167, 120 S. Ct. 693, 145 L.Ed. 2d 610 (2000)………………………………... 12 
 
Gladstone Realtors v. Vill. of Bellwood,  
441 U.S. 91, 99 S. Ct. 1601, 60 L. Ed. 2d 66 (1979)…………………………………….. 6 
 
Havens Realty Corp. v. Coleman,  
455 U.S. 363 (1982)……………………………………………………………………… 5 
 
Hooker v. Weathers,  
990 F.2d 913 (6th Cir. 1993)…………………………………………………………….. 5 
 
Jenkins v. McKeithen,  
395 U.S. 411 (1969)……………………………………………………………………… 2 
 
Lane v. Pena,  
518 U.S. 187, 116 S. Ct. 2092, 135 L.Ed.2d 486 (1996)……………………………….. 16 
 

 
v
Lincoln v. Vigil,  
508 U.S. 182, 113 S.Ct. 2024, 124 L.Ed.2d 101 (1993)………………………………... 17 
 
Lujan v. Defs. of Wildlife,  
504 U.S. 555, 112 S. Ct. 2130, 119 L. Ed. 2d 351 (1992)……………………………….. 4 
 
Lujan v. National Wildlife Federation,  
497 U.S. 871, 110 S. Ct. 3177, 111 L.Ed.2d 695 (1990)………………………………… 4 
 
Lundeen v. Mineta,  
291 F.3d 300 (5th Cir. 2002)…………………………………………………………… 17 
 
Michigan v. E.P.A.,  
576 U.S. 743 (2015)…………………………………………………………………….. 20 
 
Monumental Task Comm., Inc. v. Chao,  
678 F. App'x 250 (5th Cir. 2017)……………………………………………………….. 19 
 
Monumental Task Comm., Inc. v. Foxx,  
157 F. Supp. 3d 573 (E.D. La. 2016)…………………………………………………… 19 
 
Motor Vehicle Mfrs. Ass’n v. State Farm Mutual Auto Ins. Co.,  
463 U.S. 29 (1983)………………………………………………………………….. 19, 20 
 
Natural Resources Defense Council, Inc. v. SEC,  
606 F.2d 1031 (D.C.Cir.1979)………………………………………………………… 5, 6 
 
OCA-Greater Houston v. Texas,  
867 F.3d 604 (5th Cir. 2017).……………………………………………………………. 4 
 
Pac. Legal Found. v. Goyan,  
500 F. Supp. 770 (D. Md. 1980), rev'd, 664 F.2d 1221 (4th Cir. 1981)………………… 6 
 
Patterson v. Rawlings,  
287 F. Supp. 3d 632 (N.D. Tex. 2018).………………………………………………….. 4 
 
Public Citizen v. Foreman,  
631 F.2d 969 (D.C.Cir.1980)………………………………………………………….. 5, 6 
 
Rumsfeld v. Forum for Academic & Institutional Rights, Inc.,  
547 U.S. 47 (2006).………………………………………………………………………. 4 
 
Scheuer v. Rhodes,  
416 U.S. 232, 94 S. Ct. 1683, 40 L. Ed. 2d 90 (1974)…………………………………… 3 
 
SEC v. Chenery Corp.,  

 
vi 
318 U.S. 80 (1943)……………………………………………………………………… 20 
 
Summers v. Earth Island Inst.,  
555 U.S. 488, 129 S. Ct. 1142, 173 L. Ed. 2d 1 (2009)………………………………….. 4 
 
Texans United for a Safe Econ. Educ. Fund v. Crown Cent. Petroleum Corp.,  
207 F.3d 789 (5th Cir. 2000)…………………………………………………………… 10 
 
United States v. Nordic Vill. Inc.,  
503 U.S. 30, 112 S. Ct. 1011, 117 L. Ed. 2d 181 (1992)……………………………….. 17 
 
United States v. SCRAP,  
412 U.S. 669, 93 S.Ct. 2405, 37 L.Ed.2d 254 (1973).………………………………….. 13 
 
Valerio v. Limon,  
533 F. Supp. 3d 439 (S.D. Tex. 2021)………………………………………………….. 17 
 
Weyerhaeuser Co. v. United States Fish and Wildlife Serv.,  
139 S.Ct. 361, 202 L.Ed.2d 269 (2018)………………………………………………… 17 
 
Rules 
 
Federal Rule of Civil Procedure 8(a)(2)…………………………………………………………. 2 
Statutes 
5 U.S.C. §  
701……………………………………………………………………………………….. 4  
701(a)(2)………………………………………………………………………………... 17 
702…………………………………………………………………………….. 7, 9, 16, 18 
703……………………………………………………………………………………….. 4 
704……………………………………………………………………………………….. 4 
705……………………………………………………………………………………….. 4 
706(2)(A)…………………………………………………………………………….. 9, 18 
706(2)(B)…………………………………………………………………………… 18, 19 
706(2)(C)………………………………………………………………………… 9, 18, 19 
706(2)(D)……………………………………………………………………………….. 19 
 
21 U.S.C. §  
360bbb-3………………………………………………………………………... 14, 17, 19 
360bbb-3(a)(1).…………………………………………………………………………. 19 
360bbb-3(e)(1)(A)(ii)(III).……………………………………………………………… 14 
 
 

 
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INTRODUCTION 
The FDA claims it is above the law and denies any remedy to those aged 6 months to 
eleven years, from its arbitrary and capricious authorization of COVID -19 injections, including 
those in foster care. The Constitution embraces judicial review of this extraordinarily 
consequential agency action as a cognizable case or controversy. Indeed, for the Constitution's 
tripartite system of checks and balances to function, this court has the precise power it needs to 
recognize Plaintiffs’ injuries that have arisen from inadequate agency review and decision 
making, and subsequent false advertising of COVID-19 shots. The injuries Plaintiffs suffer 
include their inability to rely on FDA marketing any longer; resultant health uncertainty for their 
children; risk of involuntary childhood injection of dangerous biologics; and enormous costs to 
CHD to correct FDA’s misinformation.  This case or controversy urgently demands judicial 
oversight.   
FDA claims immunity from suit on grounds everything it did was an "emergency power." 
The problem with that argument is four-fold: first, falsely claiming an emergency exists for 
young children from COVID-19 is itself challenged in this suit; second, falsely claiming a drug 
is safe for little children is not an emergency power; third, falsely claiming a drug is effective for 
little children is not an emergency power; and fourth, redefining the word vaccine itself to relabel 
a drug that is not a vaccine a "vaccine" is not an emergency power. All such agency actions are 
subject to judicial review. The FDA's marketing of this drug is not an emergency use 
authorization power even if they disguise it all under their "emergency use authorization." This 
case is about the misuse and misappropriation of emergency powers to market an unsafe, 
dangerous drug to little kids to deny them informed consent. CHD and parent Plaintiffs suffer 
ongoing injury from the mismarketing of this drug to little kids. The Constitution intended courts 

 
2
to address precisely this kind of "case or controversy". The FDA's motion to dismiss at this 
pleading stage should be denied. The least protected, most vulnerable lives depend upon it.  
STANDARD OF REVIEW 
Without discovery or trial, the FDA seeks to dismiss this case of extraordinary public 
importance. Yet to do so, the FDA must show that no facts exist, whether alleged, possibly 
alleged in an amendment, or discoverable, that provide a basis for any claim or cause of action. 
The FDA cannot do this. “Even if it seems ‘almost a certainty to the court that the facts alleged 
cannot be proved to support the legal claim,’ the claim may not be dismissed so long as the 
complaint states a claim.” Clark v. Amoco Prod. Co., 794 F.2d 967, 970 (5th Cir. 1986) (quoting 
Boudeloche v. Grow Chem. Coatings Corp., 728 F.2d 759, 762 (5th Cir. 1984); see also U.S. ex 
rel. Riley v. St. Luke’s Episcopal Hosp. 355 F.3d 370, 376 (5th Cir. 2004). “A claim will not be 
dismissed on a Rule 12(b)(6) motion unless it appears to a certainty that no relief can be granted 
under any set of facts provable in support of its allegations”. Lowe v. Hearst Commc'ns, Inc., 414 
F. Supp. 2d 669 (W.D. Tex. 2006), aff'd, 487 F.3d 246, fn. 1 (5th Cir. 2007). 
 “Federal Rule of Civil Procedure 8(a)(2) requires only ‘a short and plain statement of the 
claim showing that the pleader is entitled to relief,’ in order to ‘give the defendant fair notice of 
what the . . . claim is and the grounds upon which it rests.’”  Bell Atl. Corp. v. Twombly, 550 
U.S. 544, 555 (2007) (citing Conley v. Gibson, 355 U.S. 41, 47 (1958)). Critically, at all times at 
this pleading stage of the case, the Court must accept as true all inferences, assumptions and facts 
of Plaintiffs’ complaint, including what amendments could provide and what discovery could 
show, against the FDA. Jenkins v. McKeithen, 395 U.S. 411, 421-422 (1969). “In passing on a 
motion to dismiss . . . for failure to state a cause of action, the allegations of the complaint should 

 
3
be construed favorably to the pleader. ” Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S. Ct. 1683, 40 
L. Ed. 2d 90 (1974); see also Bustos v. Martini Club, Inc., 599 F.3d 458, 461 (5th Cir. 2010).  
ARGUMENT 
The FDA mislabeled a dangerous biologic to toddlers and children as safe, effective, and 
a vaccine, when it is neither safe, effective, nor a vaccine. The FDA achieved this by ignoring 
the CHD’s Citizen Petition, skipping any participatory process such as notice-and-comment, 
colluding with social media platforms to censor and silence CHD, and using children’s icons like 
Big Bird and Elmo to market the product as a safe and effective vaccine, necessary in an 
emergency when no emergency for children even existed, and when the product poses more risk 
than benefit to children.  
The FDA’s actions caused CHD to undergo a complete revamping of its budgeted plans, 
reverse course entirely on its public educational focus, conduct massively detailed inquiries to do 
the job the FDA failed to do, incur unprecedented expense to educate the public on the risks the 
FDA failed to inform them of, discover completely new means of communication with the 
public, and seek new funds for this extraordinary expense the FDA caused. CHD member 
parents face complete collapse of confidence in the FDA, a dramatic surge in uncertainty for 
their children, and daily risk of involuntary childhood injections. 
The FDA is not above the law, the courts, the Constitution, or the citizens whom its 
actions may injure. The FDA denies Plaintiffs informed consent –a right the world once 
considered so universal and sacred, as a jus cogens norm, that the U.S. ordered the execution of 
those who violated it in Nuremberg, Germany in 1947. The FDA cannot be allowed to operate 
with no accountability for its role in causing vaccine injury to the most vulnerable amongst us – 
young children, too often without parental protection. The FDA asks this court to declare itself 

 
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powerless and the constitutional check on executive power mute. That is not the law, and this 
Court should say so. 
IV. 
THIS CASE CREATES A CONSTITUTIONALLY COGNIZABLE CASE OR 
CONTROVERSY: PLAINTIFFS HAVE ARTICLE III STANDING 
 
A. Legal Standard: Organizational Standing 
The Constitution empowers the judicial branch power to adjudicate any “case or 
controversy.” Article III § 2 of the United States Constitution. The Court construes this to apply 
whenever any plaintiff has any “personal interest at the commencement of the litigation.” Barry 
v. Lyon, 834 F.3d 706 (2016); see Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). At 
the pleading stage, courts must presume the complaint’s “general allegations embrace those 
specific facts that are necessary to support the claim.” Lujan v. Defs. of Wildlife, 504 U.S. 555, 
561 (1992) (citing Lujan v. National Wildlife Federation, 497 U.S. 871, 889 (1990)).  “The 
presence of one party with standing is sufficient to satisfy Article III's case-or-controversy 
requirement.” Rumsfeld v. Forum for Academic & Institutional Rights, Inc., 547 U.S. 47, 53, n2 
(2006).  
As an organization, CHD can demonstrate standing in two ways: (1) organizational 
standing (“an organization may have standing on its own behalf”); and (2) associational standing 
(“the organization can assert representational standing on behalf of its members”). Patterson v. 
Rawlings, 287 F. Supp. 3d 632 (N.D. Tex. 2018). CHD satisfies both to establish an injury-in-
fact and bring this suit. See e.g., 5 U.S.C. § 701-706; Bank of Am. Corp. v. City of Miami, Fla., 
137 S. Ct. 1296, 1303 (2017); Summers, 555 U.S. at 494; see also OCA-Greater Houston v. 
Texas, 867 F.3d 604, 610 (5th Cir. 2017).  Organizations enjoy standing whenever agency action 
causes a “consequent drain on the organization’s resources” originally budgeted toward other 

 
5
items to “counteract defendant’s alleged unlawful practices.” See Association of Community 
Orgs. For Reform Now v. Fowler, 178 F.3d 350, 360 (5th Cir. 1999).  
The Supreme Court held that an organization’s pleading sufficiently meets Article III 
standing where it alleges that a “concrete and demonstrable injury to the organization’s activities 
– with the consequent drain on the organization’s resources.” Havens Realty Corp. v. Coleman, 
455 U.S. 363, 378 (1982). “Ultimately, to establish standing in its own right, an organization 
must allege facts to show that it devoted resources to counteract defendant’s alleged unlawful 
practices.” Advocacy Ctr. V. La. Tech Univ., 2019 U.S. Dist. Lexis 47726 *8 (quoting 
Association of Community Orgs. For Reform Now v. Fowler, 178 F.3d 350, 360 (5th Cir. 1999).  
Decisions of sister Circuit Courts affirm this same principle of an organization’s standing 
under Article III, where its pre-litigation efforts to evaluate and challenge government acts result 
in a drain on the organization’s resources. See e.g., Abigail Alliance for Better Access to 
Developmental Drugs v. Eschenback, 469 F.3d 129 (D.C. Cir. 2006); Hooker v. Weathers, 990 
F.2d 913, 915 (6th Cir. 1993) (“Hooker”); El Rescate Legal Services, Inc. v. Executive Office of 
Immigration Review, 959 F.2d 742, 748 (9th Cir. 1991) (“El Rescate”); Public Citizen v. 
Foreman, 631 F.2d 969, fn. 12 (D.C.Cir.1980); Natural Resources Defense Council, Inc. v. SEC, 
606 F.2d 1031 (D.C.Cir.1979); Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461 (D. Md. 
2019). 
In El Rescate, the Ninth Circuit held: “The allegation that the [defendant government 
agency]’s policy frustrates these goals and requires the organizations to expend resources in 
representing clients they otherwise would spend in other ways is enough to establish standing.” 
(citing Havens Realty, supra, 455 U.S. at 379.) Equally, in Hooker, the Sixth Circuit found 
standing when agency actions forced an organizational plaintiff to devote resources to 

 
6
investigating what the agency failed to, then standing to sue existed. Ibid. Furthermore, the DC 
Circuit Court in Natural Resources Defense Council, Inc. v. SEC, 606 F.2d 1031 (D.C.Cir.1979) 
found that “organizations dedicated to inducing more responsive attitudes among American 
corporations towards the problems of environmental degradation and inequality of employment 
opportunity” also enjoyed standing to contest the failure of the SEC “to promulgate rules 
requiring comprehensive disclosures by corporations of their environmental and equal 
employment policies” because the plaintiff’s “interest was judicially cognizable, personal to 
them, and was arguably impaired” by defendants’ actions. 606 F.2d at 1036.  
An organization need not show an “overly burdensome” injury to satisfy standing. Public 
Citizen v. Foreman, 631 F.2d 969, fn. 12 (D.C.Cir.1980) (“Public Citizen”). In Public Citizen, 
the court held that a nonprofit public interest group and two of its members had standing against 
the government to seek a declaratory judgment that nitrates used in curing bacon are an “unsafe” 
food additive under the Federal Food, Drug, and Cosmetic Act (“FDCA”).  The Court found that 
because nitrite-free bacon “was not readily available at a reasonable price”, plaintiffs sustained 
an injury, even though they could abstain from eating bacon or purchase the more expensive 
nitrite-free bacon and the injury was not “overly burdensome.” Id. at fn. 12; see also Pac. Legal 
Found. v. Goyan, 500 F. Supp. 770 (D. Md. 1980), rev'd, 664 F.2d 1221 (4th Cir. 1981) (“an 
‘identifiable trifle’ can be enough for standing”). 
Finally, where a plaintiff sufficiently alleges actual injury to itself under certain federal 
statutes, the plaintiff is permitted to prove that the rights of others were also infringed and to seek 
relief on their behalf as well. Thus, in Gladstone, supra, 441 U.S. at 103, a municipality sued a 
real estate broker for violating the Civil Rights Act by steering prospective home buyers to 
different residential areas according to race. Because the city itself claimed actual injury (loss of 

 
7
racial balance and stability), it had standing to prove that the rights of others (prospective home 
buyers) were also infringed. See also Virginia v. American Booksellers Ass’n, Inc., 484 U.S. 383, 
392-393 (1988). This equally applies in statutory enforcement of the Administrative Procedures 
Act and to those aggrieved by agency action related thereto. See 5 U.S.C. § 702. 
B. Plaintiff CHD Presents a Case or Controversy: Organizational Standing 
The FDA mislabeled and falsely marketed a biologic for mass consumption by young 
children without real opportunity for their parents or guardians to give informed consent. CHD 
objected throughout the process, including through a Citizen Petition, but the FDA ignored 
CHD’s objections. Now, reports arise each day of injured children. FDA’s refusal to 
meaningfully address the Citizen Petition and amendments thereto, compounded by FDA’s 
collusion to censor CHD on precisely these issues on social media platforms, paved the path for 
FDA’s mass deception on the safety, efficacy, and nature of this product. FDA’s actions caused 
CHD a “consequent drain on the organization’s resources” to “counteract defendant’s alleged 
unlawful practices.” See Association of Community Orgs. For Reform Now v. Fowler, 178 F.3d 
350, 360 (5th Cir. 1999). Such resource diversion, by itself, creates a Constitutionally cognizable 
case or controversy. Bank of Am. Corp. v. City of Miami, Fla., 137 S. Ct. 1296, 1303 (2017). As 
a fellow federal court noted: “the FDA appears to be simply wrapping itself in the flag of law 
enforcement discretion to justify its authority and masquerade an otherwise seemingly callous 
indifference to the health consequences of those imminently facing” the harm. Beaty v. Food & 
Drug Admin., 853 F.Supp.2d 30 (D.D.C. 2012). 
When the risk of a drug or biologic is only possible due to FDA’s actions, then that risk 
constitutes a clearly cognizable Constitutional case or controversy for those affected. Beaty v. 
Food & Drug Admin., 853 F.Supp.2d 30 (D.D.C. 2012). Indeed, fellow federal courts found 

 
8
jurisdiction over an analogous suit concerning the same kind of organizational plaintiff and the 
same defendant. Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461 (D. Md. 2019). A group 
dedicated to educating people on public health issues incurred more costs in educating the public 
about health risks than they would have had the FDA done its job correctly. Id. Equally, fellow 
federal courts found that an organization akin to CHD pleaded plausible injury when the FDA’s 
actions impacted its advocacy, educational activities and the cost related thereto. Abigail Alliance 
for Better Access to Developmental Drugs v. Eschenback, 469 F.3d 129 (D.C. Cir. 2006).  
FDA’s mislabeling and mismarketing of these COVID injections injured CHD in the 
expenditure of resources necessary to “eliminate harmful exposures, hold those responsible 
accountable, and to establish safeguards to prevent future harm” to children.1 FDA directly 
targeted CHD by not only failing to address, but acting in direct contradiction to, CHD’s Citizen 
Petition. Am. Compl. ¶ 148. This follows a pattern of Defendants and others in government 
targeting CHD for adverse actions, by demanding major social media platforms prevent it from 
reaching the public2 and precluding it from raising funds online for its organizational efforts. In 
anticipation of the Emergency Use Authorization (“EUA”) for children ages 6 months through 5 
years, CHD again sent a letter to the FDA on June 10, 2022 outlining why the EUA was illicit 
agency action. Am. Compl. ¶ 152. Yet, the FDA did not pause, delay, or even reply to the letter. 
Defendants continuously denied CHD its procedural remedies under the Administrative 
Procedures Act (“APA”) and a satisfactory answer to its concerns. 
 
1 Children’s Health Defense Mission Statement, available at http://childrenshealthdefense.org. 
2 In fact, on August 17, 2022, CHD was censored and deplatformed without warning from 
Facebook and Instagram. Both accounts, which had amassed hundreds of thousands of followers, 
were permanently deactivated. See https://childrenshealthdefense.salsalabs.org/chd-censorship-
attack.  

 
9
Point in fact, FDA’s activities created several roles that CHD was forced to fill: (1) CHD 
devoted resources over the past 18 months to investigating the FDA’s actions, including its 
involvement in safety and efficacy studies, clinical trial oversight, interpretation of data, 
misrepresentation of data, rationale for authorization and approval of COVID-19 related 
biologics, abuse of emergency powers, and public statements and advertising of such biologics; 
(2) CHD worked with its members to address coercion and pressure to vaccinate, as well as 
discrimination that members and their families face. CHD has numerous members and 
employees whose children fall within the age cohorts that the FDA now authorizes to receive the 
Moderna and Pfizer-BioNTech vaccines; (3) CHD worked through its newsletters, online video 
news platforms, and live commentary to educate the public with real information necessary to 
satisfy informed consent and combat the misinformation that the FDA and CDC continue to 
promote. 
The APA creates judicially enforceable private interests in efficacious governance that 
protects the democratic guardianship of our Constitutional republic. The APA expressly 
authorizes standing for those injured by agency action: “a person suffering legal wrong because 
of agency action, or adversely affected or aggrieved by agency action within the meaning of a 
relevant statute, is entitled to judicial review thereof.” 5 U.S.C. § 702. Indeed, the entire purpose 
of the APA is to assure judicial review of agency action, specifically authorizing federal courts to 
“hold unlawful and set aside agency action findings, and conclusions found to be arbitrary, 
capricious, an abuse of discretion, or otherwise not in accordance with law” or “in excess of 
statutory jurisdiction, authority or limitations.” 5 U.S.C. § 706(2)(A), (C). 
Finally, CHD has standing as the organization seeks relief on behalf of classes of children 
who likely will experience injury due to FDA’s EUAs. In particular, CHD seeks to protect 

 
10
children between the ages of 6 months and 11 years of age under Texas state conservatorship 
who are not protected by a parent or guardian, who are being allowed to “consent” to a 
potentially dangerous medical procedure under state pressure, without the maturity to be able to 
appropriately weigh the risks and benefits. Am. Compl. ¶ 97-111; CHD, in alignment with its 
mission, represents these children who are subject to imminent threat of injury from these 
injections without parental consent in the Waco-McClennan area. Am. Compl. ¶ 113.  
C. Plaintiff CHD Presents a Case or Controversy: Associational Standing 
Plaintiff CHD’s associational standing also establishes a Constitutionally cognizable case 
or controversy. “An organization has standing to bring suit on behalf of its members when: (1) 
its members would otherwise have standing to sue in their own right; (2) the interests it seeks to 
protect are germane to the organization’s purpose; and (3) neither the claim asserted nor the 
relief requested requires the participation of individual members.” Texans United for a Safe 
Econ. Educ. Fund v. Crown Cent. Petroleum Corp., 207 F.3d 789, 792 (5th Cir. 2000); Friends 
of the Earth, Inc. v. Chevron Chem. Co., 129 F.3d 826, 827–28 (5th Cir. 1997)).  
i. 
CHD Members Interests Create a Constitutionally Cognizable Case 
or Controversy: Associational Standing  
 
CHD’s allegations satisfy associational standing because, as detailed supra, Deborah L. 
Else, Sacha Dietrich, Aimee Villella McBride, Jonathan Shour, and Rebecca Shour, all members 
of CHD, have been injured by FDA’s action and have individual standing. Thus, CHD has 
associational standing to bring suit on their behalf.  
ii. 
CHD Aims to Protect Interests Germane to Its Purpose 
Defendants do not contest that CHD satisfies the other two criteria for associational 
standing. While CHD boasts members in the tens of thousands, CHD reaches millions every 
month through publications, its TV channel and social media. CHD’s mission is to “end 

 
11
childhood health epidemics by working aggressively to eliminate harmful exposures, hold those 
responsible accountable, and to establish safeguards to prevent future harm.”3 The organization’s 
purpose seeks to address “public health policies and practices that are harming our children” and 
“call[s] for more research and transparency.”4 These goals pertain not only to actions that 
directly affect children, but also to those that will set long-lasting and dangerous precedents that 
will affect future generations. CHD is the voice for those oppressed by corporate capture of 
federal agencies, as is the case here.  
iii. 
The Relief CHD Seeks Does Not Require Individual Member 
Participation 
 
Finally, CHD’s claims do not require individual members to participate directly in the 
suit, and thus the third factor of associational standing is satisfied. In Associated Contractors of 
America v. Metropolitan Water Dist. Of S. Cal., 159 F.3d 1178, 1181 (9th Cir. 1998), the court 
held that the individual participation of an association of contractors was not required to assert 
standing where declaratory and injunctive relief were sought rather than monetary damages, and 
thus individualized proof was not necessary to the resolution of the action. Similarly, Plaintiffs’ 
Amended Complaint contains no prayer for monetary damages, only for the court to stay and 
vacate the FDA’s authorizations and misleading promotion of the COVID vaccines. Am. Compl. 
Prayer for Relief. As such, individual members’ participation is not required.  
D. Plaintiffs Deborah L. Else, Sacha Dietrich, Aimee Villella McBride, Jonathan 
Shour, and Rebecca Shour Satisfy Article III Standing as Individuals 
 
“To satisfy Article III’s standing requirements, a plaintiff must show (1) it has suffered 
an ‘injury in fact’ that is (a) concrete and particularized and (b) actual or imminent, not 
 
3 https://childrenshealthdefense.org  
4 Id. 

 
12
conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of the 
defendant; and (3) it is likely, as opposed to merely speculative, that the injury will be redressed 
by a favorable decision.” Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 
U.S. 167, 181, 120 S. Ct. 693, 145 L.Ed. 2d 610 (2000) (quoting Lujan, 504 U.S. at 560-561). “It 
can scarcely be doubted that for a plaintiff who is injured or faces the threat of future injury due 
to illegal conduct ongoing at the time of suit, a sanction that effectively abates that conduct and 
prevents its recurrence provides a form of redress.” Laidlaw, 528 U.S. at 185-86.  
Exposure to potentially harmful products constitutes a remedial injury for a 
Constitutionally cognizable case or controversy. Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003); 
see also Ctr. for Food Safety v. Price, No. 17-CV-3833 (VSB), 2018 WL 4356730, *6 (S.D.N.Y. 
Sept. 12, 2018). Agency actions that increase health-related uncertainty constitute a remediable 
injury for a Constitutionally cognizable case or controversy. New York Public Interest Research 
Group v. Whitman, 321 F.3d 316 (2d Cir. 2003). Impairing a parent’s medical control over her 
children’s care has previously been found to constitute a Constitutionally cognizable case or 
controversy. Tummino v. Torti, 603 F.Supp.2d 519 (E.D.N.Y. 2009).  
Furthermore, federal courts specifically allow consumers to bring suit against the FDA 
when the agency has “increased the risk that they will purchase and consume unsafe or 
ineffective drugs.”  Cutler v. Kennedy, 475 F.Supp. 838, 848 (D.D.C.1979). Noting that the focus 
of the standing inquiry is on the “fact, and not the amount or severity, of the injury,” the court 
held that: 
[I]f, as the plaintiffs contend on the merits, the FDA is authorizing drugs to be 
marketed in violation of the [FDCA], it has increased the risk that plaintiffs will 
be exposed to unsafe or ineffective drugs by depriving them of regulatory 
protection which the statute accords all drug consumers. This risk and deprivation 
itself constitutes a distinct and palpable injury to plaintiffs’ statutory interests as 
drug consumers.  

 
13
 
475 F.Supp. at 848-849; see also United States v. SCRAP, 412 U.S. 669, 688-89 & n.14, 93 S.Ct. 
2405, 37 L.Ed.2d 254 (1973); see also Animal Legal Def. Fund v. Azar, No. 20-CV-03703-RS, 
2021 WL 4477901, *3 (N.D. Cal. Feb. 23, 2021).  
Plaintiffs have shown that they have suffered an injury in fact that is (a) concrete and 
particularized, and (b) actual or imminent, the injury being fairly traceable to the FDA's actions, 
which satisfies Article III’s case-or-controversy requirement. Lujan 504 U.S. at 560-561. All 
individual parent Plaintiffs have children who are directly threatened by FDA’s authorizations 
and the false advertising of them. FDA’s misrepresentations have led to continuous coercion, 
propaganda, and advertisements aimed directly at children, to which Plaintiffs’ children are 
subjected daily. Plaintiffs’ children are bombarded with messaging encouraging them to take an 
improperly authorized vaccine via advertisements on television, radio shows, announcements, 
and signage in stores and even promotion in children’s television programming. Plaintiff 
Deborah Else attests to enduring vaccine propaganda from school administrators and 
pediatricians aimed at her children. Am. Compl. ¶ 128; Else Decl., ECF No. 14-1. Plaintiff Sacha 
Dietrich further asserts that her children experience constant harassment from directives and 
pressure to receive the COVID-19 biologic from the media and other children. Am. Compl. ¶ 53; 
Dietrich Decl., ECF No 14-1.  
Plaintiffs’ children face the looming threat of being pushed out of society as the culture 
of mass vaccination and medical mandates, now directed at children as young as 6 months, 
continues as a result of FDA’s actions.5 Their children also face the risk of expanding vaccine 
mandates, including those preventing them from receiving life-saving transplants and medical 
 
5 Most recently, Washington D.C. mandated that all students attending public or private schools 
be fully vaccinated for COVID-19 for the 2022-2023 school year.  

 
14
treatment. Am. Compl. ¶ 33. Defendants note that Texas Governor Greg Abbott has signed an 
executive order prohibiting vaccine mandates. MTD, p. 8. However, such an executive order has 
not prevented discriminatory and cruel treatment towards the unvaccinated –particularly 
children—which, as Defendants admit, is in direct violation of the assurance included in the 
EUA statute that a decision to not take the COVID-19 vaccine “will not change [the] child’s 
standard medical care.” MTD, p. 3; see 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).  
The threat of being denied life-saving treatment is not the remote risk Defendants would 
have this Court believe. MTD, p. 7. No child is immune from the danger of an accidental injury 
or emergency medical condition. Defendants hope to evade responsibility by claiming that 
because Plaintiffs’ children have not required life-saving treatment, Defendants do not put them 
at risk. Furthermore, Defendants would have the Court believe that coercive pressures, false 
advertising, and propaganda aimed at young children to take a dangerous, experimental, mRNA 
gene therapy do not alone present an injury. In fact, however, they do.  
Specifically, Plaintiffs Jonathan and Rebecca Shour are at risk from mandates around the 
country. As a member of the Navy, Chaplain Shour and his family relocate around the country 
without any say in their residence. Am. Compl. ¶ 130. At any time, Chaplain Shour could be 
stationed in a state that implements strict mandates and, as a result, his children could face 
discrimination and being ostracized from certain activities because of vaccination status. The 
Shours have already been ostracized due to their religious objections to the COVID-19 vaccine. 
 
In addition, Texas law puts Plaintiffs’ children at risk from being injected with this 
vaccine against parents’ wishes. Texas law, Am. Compl. Fn. 54, permits adults other than a 
child's parents or guardian to consent to the child being vaccinated.  While parents are intended 
to be the decision-makers for their children’s health, when an over-zealous family member, 

 
15
friend, or childcare provider can consent to potentially dangerous medical treatment, Plaintiffs 
are at risk of having their child unwillingly vaccinated. (Waco County’s consent form requires 
only an unspecified adult's signature for vaccination.) Plaintiffs, who have rightfully and 
conclusively decided that it is not in the best interest of their child to be vaccinated against 
COVID-19 have the palpable fear that their child may be vaccinated without their consent. Even 
if Plaintiffs’ children are not yet subject to mandates or faced with the necessity for life-saving 
treatment, they face constant threat of another adult consenting to their vaccination in Texas.  
Plaintiffs also have standing on the grounds that they are no longer able to rely on FDA 
representations now or in the future. The Ninth Circuit has held that there are scenarios in which 
the threat of future harm could be sufficient for standing, including the “consumer’s plausible 
allegations that she will be unable to rely on the product’s advertising or labeling in the future, 
and so will not purchase the product although she would like to.” Davidson v. Kimberley-Clark 
Corporation, 873 F.3d 1103 (9th Cir. 2017) (“Davidson I”). This was affirmed in Davidson v. 
Kimberly-Clark Corporation, No. 15-16173, 2018 U.S. App. LEXIS 12204 (9th Cir. May 9, 
2018) (“Davidson II”) when the Court held that “misled consumers may properly allege a threat 
of imminent or actual harm sufficient to confer standing to seek injunctive relief[.]” Plaintiffs are 
unable to rely on any future FDA attestations of safety and effectiveness. Defendants have 
injured Plaintiffs by permanently stripping them of any confidence in the FDA’s statements and 
authorization and approval process.  
Without FDA’s action at issue here, none of the presented injury would have occurred, 
and Plaintiffs would not be under current threat. The injury Plaintiffs and their children sustained 
stems directly from FDA’s unjustified authorization and the false representation that this biologic 
is a “vaccine” that has been adequately tested for safety. If this Court were to grant the relief 

 
16
Plaintiffs seek, the “risk would necessarily be eliminated” and would protect not only Plaintiffs 
and their children, but all current and future children between the ages of 6 months and 11 years 
from FDA’s arbitrary and capricious action.  Cutler v. Kennedy, 475 F. Supp. 838, 850 (D.D.C. 
1979), disapproved of by Chaney v. Heckler, 718 F.2d 1174 (D.C. Cir. 1983). 
V. 
SOVEREIGN IMMUNITY DOES NOT PREVENT THIS CHALLENGE 
FDA claims immunity from suit. The FDA treats emergency power as a Pandora’s Box 
of powers it can use to escape judicial review. The FDA goes further: the FDA claims it can 
unilaterally declare when it can open Pandora’s Box and whether any action it takes comes from 
Pandora’s Box. Thus, the FDA claims its false labeling of a biologic is magically an emergency 
power. But it isn’t. The FDA claims its ability to open Pandora’s Box is equally beyond judicial 
reach. But it isn’t. This case challenges the FDA’s mislabeling and prerogative to open Pandora’s 
Box in the first place, neither of which is beyond judicial reach.  
The FDA does not enjoy sovereign immunity, nor are Plaintiffs’ causes of action beyond 
the APA’s scope of review. MTD, p. 1. A waiver of sovereign immunity is “unequivocally 
expressed” in the APA. Lane v. Pena, 518 U.S. 187, 192, 116 S. Ct. 2092, 135 L.Ed.2d 486 
(1996). 5 U.S.C. § 702 presents two requirements for establishing a waiver of sovereign 
immunity: (1) the plaintiff must “identify some ‘agency action’ affecting him in a specific way, 
which is the basis of his entitlement for judicial review,” Alabama-Coushatta Tribe of Texas, v. 
United States, 757 F.3d 484 (5th Cir. 2014) (quoting 5 U.S.C. § 702), and (2) the plaintiff must 
demonstrate that she has “suffered legal wrong because of the challenged agency action, or is 
adversely affected or aggrieved by that action within the meaning of a relevant statute.” Lujan, 
497 U.S. at 883. “[W]here the Plaintiff is not seeking money damages, the APA acts as a waiver 

 
17
of the government’s sovereign immunity, allowing the plaintiff to proceed in federal court to 
rectify agency action.” Valerio v. Limon, 533 F. Supp. 3d 439, 450 (S.D. Tex. 2021).  
Exemptions from judicial review are rare and “not generally to be ‘liberally construed.’” 
United States v. Nordic Vill. Inc., 503 U.S. 30, 34, 112 S. Ct. 1011, 117 L. Ed. 2d 181 (1992). 
There is a “‘strong presumption’ that Congress intends that the federal courts review agency 
action.” Lundeen v. Mineta, 291 F.3d 300, 305 (5th Cir. 2002). Although 21 U.S.C. § 360bbb-3 
does give discretion to the Agency and the Secretary of Health and Human Services, this 
discretion is not without bounds. The 5 U.S.C. § 701(a)(2) exception to sovereign immunity for 
action delegated to agency discretion is read “quite narrowly, restricting it to ‘those rare 
circumstances where the relevant statute is drawn so that a court would have no meaningful 
standard against which to judge the agency's exercise of discretion.’” Weyerhaeuser Co. v. 
United States Fish and Wildlife Serv., 139 S.Ct. 361, 370, 202 L.Ed.2d 269 (2018) (quoting 
Lincoln v. Vigil, 508 U.S. 182, 191, 113 S.Ct. 2024, 124 L.Ed.2d 101 (1993)). FDA 
authorizations and approvals are not actions that are “traditionally committed to agency 
discretion.” Dep't of Com. v. New York, 139 S. Ct. 2551, 2568, 204 L. Ed. 2d 978 (2019). 
In any event, “nothing in the subsequent enactment of the APA altered the [pre-existing] 
doctrine of review.” Chamber of Commerce of the United States v. Reich, 74 F.3d 1322, 1328 
(D.C. Cir. 1996); see Duncan v. Muzyn, 833 F.3d 567, 578 (6th Cir. 2016) (recognizing the 
ongoing vitality of pre-APA review). As Prof. Davis put it shortly after the APA’s enactment, 
when review is cut off under the Act (i.e., the APA), “[t]he result is that the pre-Act law 
continues.” Kenneth Culp Davis, Nonreviewable Administrative Action, 96 U. PA. L.REV. 749, 
776 (1948). Under that pre-APA review, “if an official acts solely on grounds which 
misapprehend the legal rights of the parties, an otherwise unreviewable discretion may become 

 
18
subject to correction.” Arenas v. United States, 322 U.S. 419, 432 (1944). The FDA, acting as a 
government agency, cannot evade responsibility for arbitrary and capricious actions under the 
APA, especially considering the perilous nature of authorizing biologics for children that skip 
traditional safety protocols. Holding that the FDA is immune from accountability here would 
deny citizens any proper recourse for addressing such unlawful operations.  
VI. 
PLAINTIFFS STATE COGNIZABLE CLAIMS ON WHICH THIS COURT 
CAN GRANT RELIEF 
 
The FDA claims to be above the law. It is not.   
A. Plaintiffs’ Challenge to the EUA is Reviewable 
The APA expressly authorizes standing for citizens who are harmed by an agency’s 
unlawful activity: “a person suffering legal wrong because of agency action…is entitled to 
judicial review thereof.” 5 U.S.C. § 702. Indeed, the entire point of the APA was to assure 
judicial review of agency action, specifically authorizing federal courts to “hold unlawful and set 
aside agency action . . . found to be arbitrary, capricious, an abuse of discretion, or otherwise not 
in accordance with law; contrary to constitutional right, power, privilege, or immunity; [or] in 
excess of statutory jurisdiction, authority, or limitations.” 5 U.S.C. § 706(2)(A)-(C).  
B. Plaintiffs Successfully Allege that Defendants Violated the APA 
The APA affords Plaintiffs the right to challenge Defendants’ conduct. The Supreme 
Court has indicated that a two-step procedure is required when examining an administrative 
exercise of discretion: first, a determination whether the agency has acted within the scope of its 
statutory authority, and second, whether the actual choice made was "arbitrary, capricious, an 
abuse of discretion, or otherwise not in accordance with law." Citizens to Preserve Overton Park 
v. Volpe, 401 U.S. 402, 416 (1971).  

 
19
i. 
Scope of Authority 
CHD successfully pleaded that the FDA exceeded its statutory authority when 
mislabeling this biologic as a safe, effective vaccine for children ages 6 months through 11 years.  
“The reviewing court must also hold unlawful and set aside agency action that is contrary to 
constitutional right, in excess of statutory authority, or without observance of procedure required 
by law.” Monumental Task Comm., Inc. v. Foxx, 157 F. Supp. 3d 573 (E.D. La. 2016), aff'd sub 
nom. Monumental Task Comm., Inc. v. Chao, 678 F. App'x 250 (5th Cir. 2017) (citing 5 U.S.C. § 
706(2)(B)-(D)). The FDA does not contest that COVID-19 poses no “actual” or “potential” 
emergency for children in this age cohort; therefore, the emergency use statute, 21 U.S.C. § 
360bbb-3(a)(1), does not authorize its action. FDA’s actions exceeded its statutory authority, 
which this Court may review under both the APA and pre-APA review. 
ii. 
FDA’s Arbitrary and Capricious Authorization 
An agency’s action is “arbitrary and capricious” if it did not articulate any rational 
connection between the facts it found and the choices it made. Burlington Truck Lines v. United 
States, 371 U.S. 156, 168, 83 S. Ct. 239, 9 L.Ed.2d 207 (1962). Plaintiffs successfully pleaded 
that the FDA’s EUAs for children ages 6 months through 11 years fail to meet this standard. In 
its authorization, the FDA: (1) failed to examine relevant data; (2) failed to articulate its standard 
for assessment; (3) relied on factors not intended for it to consider; (4) failed to consider an 
important aspect of the problem; (5) offered an explanation that runs counter to the evidence; or 
(6) failed any aspect of reasoned decision-making in the process it utilized to come to its 
conclusions. Motor Vehicle, 463 U.S. at 43.  
The FDA mislabeled Pfizer-BioNTech’s biologic for children ages 6 months-11 years 
despite there being almost zero risk of serious injury or death from COVID-19. (Am. Compl. ¶ 

 
20
128). The FDA acted arbitrarily and capriciously by failing to engage in a pluralistic, critical, 
open, transparent and scientific dialogue with the public and medical community based on 
careful, deliberative evaluation of all relevant research before rushing this authorization. FDA’s 
actions did not conform with reasoned decision-making, which requires detailing all the areas 
under 5 U.S.C. § 701. Unlike rational-basis review, review of agency action is based on the 
record before the agency. Compare Motor Vehicle Mfrs. Ass’n v. State Farm Mutual Auto Ins. 
Co., 463 U.S. 29, 50 (1983) (APA); SEC v. Chenery Corp., 318 U.S. 80, 88 (1943) (pre-APA) 
with F.C.C. v. Beach Commc’ns, Inc., 508 U.S. 307, 315 (1993). The APA’s requirement of 
“reasoned decision making” is offended since the FDA “agency action is lawful only if it rests 
‘on a consideration of the relevant factors.’” Michigan v. E.P.A., 576 U.S. 743, 750 (2015) 
(citation omitted). As a result, plaintiffs state a cognizable claim for judicial review and remedy.  
CONCLUSION 
 
Plaintiffs’ First Amended Complaint properly asked this Court to vacate and remand the 
FDA’s mislabeling of the Pfizer-BioNTech’s COVID-19 vaccine for children 6 months through 
11 years on the grounds that FDA’s action was arbitrary and capricious, violated the APA, and 
exceeded the agency’s statutory authority. Plaintiffs request that this Court prohibit the FDA 
from advertising and misrepresenting the biologic as “safe and effective” until the FDA has 
performed the proper analyses, as the law requires. The FDA’s action cost substantial CHD 
resources, created health uncertainty for millions of children, and inflicted real risk of ongoing 
harm to Plaintiffs. This case is precisely what the Constitution intends when it empowers judicial 
review of a “case or controversy.” Millions of lives depend on this Court’s review. For the 
foregoing reasons, this Court should deny Defendants’ Motion to Dismiss.  
 
Dated: August 26, 2022 

21
Respectfully submitted, 
/s/ Robert E. Barnes 
Robert E. Barnes, Esq.  
Member of the Western District of Texas 
235919/CA 
Lexis Anderson, Esq. 
Subject to admission Pro Hac Vice 
Email: robertbarnes@barneslawllp.com 
BARNES LAW 
700 South Flower Street, Suite 1000 
Los Angeles, California 90017 
Telephone: (310) 510-6211 
Facsimile: (310) 510-6225  
Robert F. Kennedy, Jr., Esq. 
Mary S. Holland, Esq. 
Subject to admission Pro Hac Vice 
Children’s Health Defense 
852 Franklin Ave.  
Franklin Lakes, NJ 07417 
Counsel for Plaintiffs CHILDREN’S  
HEALTH DEFENSE, DEBORAH L. ELSE, 
SACHA DIETRICH, AIMEE VILLELLA 
MCBRIDE, JONATHAN SHOUR, and 
REBECCA SHOUR.

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