Court filing

Opposition Brief — CHD v. FDA

Record facts

Court	U.S. District Court for the Western District of Texas, Waco Division
Filed	2022-05-09

U.S. District Court for the Western District of Texas, Waco Division · No. 6:22-cv-00093-ADA-DTG · Doc. 21 · 2022-05-09 · Docket on CourtListener

Summary

Plaintiffs’ opposition to the defendants’ motion to dismiss in Children’s Health Defense, et al. v. Food and Drug Administration, et al., Case No. 6:22-cv-00093, in the U.S. District Court for the Western District of Texas, Waco Division, filed May 9, 2022 as Document 21. The brief responds to the motion at ECF No. 18, which sought dismissal for lack of subject-matter jurisdiction and failure to state a claim. It argues that Children’s Health Defense has organizational standing, that the individual plaintiffs Deborah L. Else and Sacha Dietrich have standing, and that the emergency use authorization is reviewable under the Administrative Procedure Act. The conclusion asks the court to vacate and remand the authorization of the Pfizer-BioNTech COVID-19 vaccine for children 5-11, citing 5 U.S.C. § 706(2)(A), and to deny the motion. The brief runs 26 pages.

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IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF TEXAS

CHILDREN’S HEALTH DEFENSE, et al.,
)

)

Plaintiffs,

)

) Case No. 6:22-cv-00093

)
FOOD and DRUG ADMINISTRATION, et al.
)

)

Defendants.

)
________________________________________ )

PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS

TO THE HONORABLE JUDGE OF THE COURT:

Plaintiffs Children’s Health Defense (“CHD”), Deborah L. Else, and Sacha Dietrich
(hereinafter collectively “Plaintiffs”), file this opposition to Defendants U.S. Food and Drug
Administration’s (“FDA”), Janet Woodcock's and Robert M. Califf’s, (hereinafter collectively
“Defendants’) Motion to Dismiss for Lack of Subject-Matter Jurisdiction and Failure to State a
Claim Upon Which Relief Can Be Granted (“Motion”) [ECF No. 18].

Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 1 of 26

TABLE OF CONTENTS
INTRODUCTION……………………………………………………………………………… 1
FACTUAL AND PROCEDURAL BACKGROUND………………………………………… 1
STANDARD OF REVIEW…………………………………………………………………….. 3
ARGUMENT…………………………………………………………………………………..... 3
I.
Plaintiffs Have Article III Standing……………………………………………….. 4
A. Plaintiff CHD Has Standing…………………………………………………… 5
i.
CHD Has Identified Members Who Have Standing to Sue
in Their Own Right.…………………………………………………. 8

ii.
CHD Aims to Protect Interests Germane to Its
Purpose……………………………………………………………….. 10

iii.
The Relief Sought By CHD Does Not Require the
Participation of Individual Members………………………………. 11

B. Plaintiffs Deborah L. Else and Sacha Dietrich Have
Standing as Individuals…………………..…………………………………… 12

II.
Sovereign Immunity Does Not Prevent this Challenge…………………………. 14
III.
Plaintiffs State Cognizable Claims on Which This Court Can Grant
Relief……………………………………………………………………………….. 16

A. Plaintiffs’ Challenge to the EUA is Reviewable……………………………... 17
B. Plaintiffs Successfully Allege that Defendants Violated the APA………….. 17
i.
FDA’s Arbitrary and Capricious Authorization………………….. 17
CONCLUSION………………………………………………………………………………... 20

Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 2 of 26

iii

TABLE OF AUTHORITIES
CONSTITUTION

U.S. Const. Art. III § 2…………………………………………………………………………… 4

CASES

Alabama-Coushatta Tribe of Texas v. United States,
757 F.3d 484 (5th Cir. 2014)…………………………………………………………… 14

Arenas v. United States,

322 U.S. 419 (1944)…………………………………………………………………….. 16

Associated Contractors of America v. Metropolitan Water Dist. Of S. Cal.,
159 F.3d 1178 (9th Cir. 1998)………………………………………………………….. 11

Bank of Am. Corp. v. City of Miami, Fla.,
137 S. Ct. 1296 (2017)………………………………………………………………… 5, 7

Barry v. Lyon,
834 F.3d 706 (2016)……………………………………………………………………… 5

Bell Atl. Corp. v. Twombly,
550 U.S. 544 (2007)……………………………………………………………………… 3

Burlington Truck Lines v. United States,
371 U.S. 156, 83 S. Ct. 239, 9 L.Ed.2d 207 (1962)…………………………………….. 18

Chamber of Commerce of the United States v. Reich,

74 F.3d 1322 (D.C. Cir. 1996)………………………………………………………….. 16

Citizens to Preserve Overton Park v. Volpe,

401 U.S. 402 (1971)…………………………………………………………………….. 17

Conley v. Gibson,
355 U.S. 41, 78 S. Ct. 99, 2 L.Ed. 2d 80 (1958)…………………………………………. 3

Dep't of Com. v. New York,
139 S. Ct. 2551, 204 L. Ed. 2d 978 (2019)……………………………………………... 15

El Rescate Legal Services, Inc. v. Executive Office of Immigration Review,
959 F.2d 742 (9th Cir. 1991)…………………………………………………………….. 6

F.C.C. v. Beach Commc’ns, Inc.,
508 U.S. 307 (1993)…………………………………………………………………….. 19
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 3 of 26

Friends of the Earth, Inc. v. Chevron Chem. Co.,
129 F.3d 826 (5th Cir. 1997)…………………………………………………………….. 8

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

Havens Realty Corp. v. Coleman,
455 U.S. 363 (1982)…………………………………………………………………… 5, 6

Hooker v. Weathers,
990 F.2d 913 (6th Cir. 1993)…………………………………………………………….. 6

Hunt v. Wash. State Apple Adver. Comm'n,
432 U.S. 333, 97 S.Ct. 2434, 53 L.Ed.2d 383 (1977)……………………………………. 8

Jenkins v. McKeithen,
395 U.S. 411 (1969)……….……………………………………………………………... 3

Lane v. Pena,
518 U.S. 187, 116 S.Ct. 2092, 135 L.Ed.2d 486 (1996)………………………………... 14

Lewis v. Casey,

518 U.S. 343, 116 S. Ct. 2174, 135 L.Ed. 2d 606 (1996)………………………………... 9

Lincoln v. Vigil,
508 U.S. 182, 113 S.Ct. 2024, 124 L.Ed.2d 101 (1993)………………………………... 15

Lujan v. Defenders of Wildlife,
504 U.S. 555, 112 S. Ct. 2130, 119 L. Ed. 2d 351 (1992) ……………………………..... 5

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).……………………………...…………………………… 15

Michigan v. E.P.A.,
576 U.S. 743 (2015)……………………………...……………………………............... 19

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)…………………………..……………………. 19

Motor Vehicle Mfrs. Ass’n v. State Farm Mutual Auto Ins. Co.,
463 U.S. 29 (1983)……………………………………………………………………… 19

Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 4 of 26

Patterson v. Rawlings,
287 F. Supp. 3d 632 (N.D. Tex. 2018)…………………………………………………... 5

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.,
318 U.S. 80 (1943)……………………………………………………………………… 19

Spann v. Colonial Village, Inc.,
899 F.2d 24 (DC Cir. 1990)……………………………………………………………… 6

Spokeo, Inc. v. Robins,

136 S. Ct. 1540, 194 L.Ed. 2d 635 (2016)…………………………………………… 9, 10

Summers v. Earth Island Inst.,
555 U.S. 488 (2009)…………………………………………………………………… 5, 8

Texans United for a Safe Econ. Educ. Fund v. Crown Cent. Petroleum Corp.,
207 F.3d 789 (5th Cir. 2000)…………………………………………………………….. 8

United States v. Nordic Vill. Inc.,
503 U.S. 30, 112 S. Ct. 1011, 117 L. Ed. 2d 181 (1992)……………………………….. 15

Valerio v. Limon,
533 F. Supp. 3d 439 (S.D. Tex. 2021)………………………………………………….. 15

Virginia v. American Booksellers Ass’n, Inc.,
484 U.S. 383 (1988)……………………………………………………………………… 8

Warth v. Seldin,
422 U.S. 490, 95 S. Ct. 2197, 45 L. Ed. 2d 343 (1975)………………………………….. 9

Waskul v. Washtenaw Cty. Cmty. Mental Health,
900 F.3d 250 (6th Cir. 2018)…………………………………………………………….. 9

Weyerhaeuser Co. v. United States Fish and Wildlife Serv.,
139 S.Ct. 361, 202 L.Ed.2d 269 (2018)………………………………………………… 15

Statutes
5 U.S.C. §

701……………………………………………………………………………. 5, 15, 17, 19
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 5 of 26

701(a)(2)………………………………………………………………………………... 15
702……………………………………………………………………………….. 4, 14, 17
706(2)(A)………………………………………………………………………… 4, 17, 20
706(2)(B)…………………………………………………………………………… 17, 19
706(2)(C)………………………………………………………………………… 4, 17, 19
706(2)(D)……………………………………………………………………………….. 19

21 U.S.C. §
360bbb-3……………………………………………………………………………….. 16
360bbb-3(a)(1)…………………………………………………………………………. 20
360bbb-3(e)(1)(A)(ii)(III)……………………………………………………………… 13

Rules
Fed. R. Civ. P 8(a)(2)…………………………………………………………………………… 3
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 6 of 26

INTRODUCTION

Defendants consider themselves to be above the law, claiming (1) no court has authority
over them for their actions in this matter; (2) that Congress’ plain limits under the APA do not
apply to them, and (3) that federal agencies are free to ignore the injuries their actions inflict.
The injury here is of the gravest variety, namely a foreseeable, coerced injection of a dangerous
and medically unnecessary experimental biologic. Plaintiffs Else and Dietrich experience fear,
intimidation and discriminatory treatment as their children refuse this experimental product.
Plaintiffs are members of a group that continues to grow as Defendants unlawfully make more
and more children eligible for their authorized biologic.
Defendants did not and cannot substantially defend the substance of their actions or
dispute the equitable grounds for an administrative stay under the Administrative Procedures Act
(“APA”). Hence, Plaintiffs' stay must be granted, and Defendants' motion to dismiss denied.
FACTUAL AND PROCEDURAL BACKGROUND
On October 29, 2021, the FDA granted an emergency use authorization (“EUA”) for the
Pfizer-BioNTech COVID-19 mRNA biologic for children ages 5-11. In doing so, the FDA
willfully ignored the overwhelming data, scientific studies, and case reports indicating not only
that the risks of the COVID-19 vaccines to children were significantly higher than the benefits,
but also that it was wholly unnecessary to vaccinate children between the ages of 5-11 against
COVID. Defendants here are intentionally fast-tracking a biologic via an authorization process
reserved for the most emergent and extreme circumstances. The FDA has exceeded the scope of
its authority allowed under the emergency use authorization statute. No emergency for children
ages 5-11 from COVID-19 existed or exists as healthy children in this age cohort have a
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 7 of 26

statistically zero risk of death from SARS-CoV-2 infection. By ignoring this fact, FDA has
abused its authority.
CHD’s prescience in confronting this unauthorized agency action is evidenced in CHD’s
Citizen Petition filed with the FDA on May 16, 2021. It was based on the FDA’s history of illicit
behavior regarding COVID-19 vaccines. In it, CHD requested that the FDA refrain from
licensing COVID-19 vaccines and revoke EUAs for the three existing COVID vaccines. Compl.
¶ 39. The FDA, by ignoring the evidence raised in the Citizen Petition and over 30,000
comments from interested persons, dismissed CHD’s concerns in its reply and continued forward
in its spree of authorizations and approvals. VAERS statistics1 bear out that what CHD feared
and warned of has now occurred.

The FDA’s decision to grant this EUA took on increasing importance when, as expected,
state governments and schools began preparing to or actually mandated COVID-19 vaccines as a
prerequisite for children's school attendance. These policies are natural, direct, and foreseeable
consequences of Defendants’ actions. Federal law incorporating the Nuremberg Code and
enshrined informed consent norms have been completely ignored due to FDA’s actions. The
FDA certainly had reasonable knowledge before authorizing this biologic that childhood vaccine
mandates would be implemented, as several states, school districts, and private businesses
promised to implement them as soon as the FDA granted the EUA.

Societal consequences for young children who remain unvaccinated against COVID-19
are far more critical to their mental and physical well-being than any danger they’d otherwise
face from COVID-19 itself. Discrimination, peer pressure and denial of medical treatment are

1 27,532 deaths and 51,163 Permanent Disabilities from COVID-19 vaccines reported to VAERS as of April 29,
2022, available at
https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=049432C0E3892D8E407DF2E0614F.
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 8 of 26

extremely prevalent. The known, negative health impacts of those children who have received
the Pfizer-BioNTech COVID-19 vaccines are distressing. The unknown, long-term injuries may
be horrific. FDA’s chicanery must be called out for what it is: unethical, illegal, and abusive.
STANDARD OF REVIEW
“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, 78 S. Ct. 99, 2 L.Ed. 2d 80 (1958)).
“To survive a motion to dismiss, a 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,
129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. at 570).
Furthermore, the allegations of the complaint must be taken as true. 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 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 is not above the law, the courts, the Constitution, or the citizens whom its
actions may injure. The Defendants’ argument asks this court to declare itself impotent, the
judiciary an empty chamber, the balance of powers permanently imbalanced, and the
Constitutional check on executive power just words on paper without effect. That was never the
law and is not the law. The court should deny Defendants’ motion to dismiss and issue the
requested remedial relief pending the remainder of the litigation. Such remedy must be granted
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 9 of 26

to prevent millions of children from losing their Constitutional rights to informed consent, a right
the world once considered so universal and sacred, as a jus cogens value, that the U.S. ordered
the execution of those who violated it at Nuremberg in 1947. The FDA is not above any law, any
court, or any citizen.

The Constitutional question regarding standing is answered since there is a “case or
controversy” here. “At the pleading stage, general factual allegations of injury resulting from the
defendant's conduct may suffice, for on a motion to dismiss we “presum[e] that general
allegations embrace those specific facts that are necessary to support the claim.” Lujan v. Defs. of
Wildlife, 504 U.S. 555, 561, 112 S. Ct. 2130, 119 L. Ed. 2d 351 (1992) (citing Lujan v. National
Wildlife Federation, 497 U.S. 871, 889, 110 S. Ct. 3177, 111 L.Ed.2d 695 (1990)).

First, the APA expressly authorizes standing for citizens 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).
I.
Plaintiffs Have Article III Standing
Art. III § 2 of the United States Constitution requires a “case” or “controversy.” “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). The Court construes this to mean that a plaintiff has a “personal interest at the
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 10 of 26

commencement of the litigation.” Barry v. Lyon, 834 F.3d 706 (2016); see Lujan v. Defenders of
Wildlife, 504 U.S. 555, 560, 112 S. Ct. 2130, 119 L. Ed. 2d 351 (1992).
An organization can demonstrate standing in two ways: (1) associational standing (“the
organization can assert representational standing on behalf of its members”) and (2)
organizational standing (“an organization may have standing on its own behalf.” ) Patterson v.
Rawlings, 287 F. Supp. 3d 632 (N.D. Tex. 2018). CHD clearly satisfies both theories of standing
to establish an injury-in-fact and to 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) Furthermore, Plaintiffs
Deborah L. Else and Sacha Dietrich satisfy Article III standing individually and on behalf of
their children.
a. Plaintiff CHD Has Standing
Organizational standing here clearly exists as CHD has Article III standing in its own
right (as opposed to suing as a representative of its members) since it is able to allege injury to its
organizational activities and a consequent drain on its resources. In Havens Realty Corp. v.
Coleman, 455 U.S. 363, 378 (1982) (“Havens Realty”), 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 - …” “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)
[an organization has standing to sue on its own behalf where it devotes resources to counteract a
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 11 of 26

defendant’s allegedly unlawful practices. See 455 U.S. at 379; Spann, 899 F.2d at 28; Cleburne
Living Ctr., Inc. v. City of Cleburne, 726 F.2d 191, 202-03 (5th Cir. 1984), affirmed in part and
vacated in part on other grounds, 473 U.S. 432 (1985)]. In El Rescate Legal Services, Inc. v.
Executive Office of Immigration Review, 959 F.2d 742, 748 (9th Cir. 1991), the Ninth Circuit
held:
“[T]he organizations involved in the present case were established to assist Central
American refugee clients, … in their efforts to obtain asylum and withholding of deportation in
immigration court proceedings. 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.)

The expenses associated with litigation that a plaintiff organization is required to expend
in pursuing a lawsuit are a drain on organizational resources sufficient to establish the
organization’s standing in its own right.

Decisions of other Circuit Courts affirm this same principle of an organization’s standing
in its own right under Article III, where its pre-litigation efforts to evaluate and challenge
government acts results in a drain on the organization’s resources. For example, in Hooker v.
Weathers, 990 F.2d 913, 915 (6th Cir. 1993) (“Hooker”), the Sixth Circuit found standing in its
own right as to an organizational plaintiff, the Fair Housing Contact Service, which was an
organization that worked to eliminate discriminatory housing practices, finding the organization
devoted resources to investigating the defendant trailer park’s practices and alleged in its
pleading that it had confirmed that the defendants discriminate on the basis of familial status.
Ibid.
Here, the allegations in the Complaint sufficiently pleaded that Plaintiff CHD had
organizational standing in its own right under Article III. First, on May 16, 2021, CHD filed a
19-page Citizen Petition with the FDA, requesting it to refrain from licensing COVID-19
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 12 of 26

vaccines and to revoke EUAs for the three existing vaccines. Compl. ¶ 39. CHD’s Citizen
Petition was the result of countless hours of work and effort by CHD personnel, including but
not limited to Meryl Nass, M.D. (Scientific Advisory Board member) and Robert F. Kennedy, Jr.
(Board Chair and Chief Litigation Counsel), requesting that the FDA revoke the EUA for
existing COVID-19 vaccines and refrain from approving and licensing them. Id. Additionally,
the Citizen Petition assembled and brought to the FDA’s attention a tremendous amount of
detailed factual findings and research regarding the risks to public health and safety,
effectiveness of vaccines (or rather lack thereof), the FDA’s misbranding of the vaccine
authorizations, and the serious injuries and consequences spawned by the FDA’s actions to CHD
members and their children.
As such, CHD has Article III standing in its own right because it was required to expend
a tremendous amount of manpower and work hours just to put together its Citizen Petition dated
May 16, 2021 alone. In addition, CHD was required to expend even more time, manpower and
expense in reviewing the FDA’s 52-page denial response, consult with the CHD’s members,
experts and legal counsel, follow and aggregate the massive amount of scientific research
regarding the consequences following the administration of the vaccine to individuals five years
of age and up, and then file the underlying civil action requesting the courts step in to review the
integrity of the FDA’s procedures under the APA.
CHD has diverted and continues to divert substantial resources, time, and manpower
from its current activities due to the threat that the FDA’s authorization poses to millions of
children, a risk that CHD has been predicting and warning about for months. Such resource
diversion is, in itself, grounds for standing. Bank of Am. Corp. v. City of Miami, Fla., 137 S. Ct.
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 13 of 26

1296, 1303 (2017). This substantial drain on CHD’s resources directly and proximately caused
by FDA's actions alone, confers Article III standing to CHD in its own right.
Finally, Supreme Court precedent holds that 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 so 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 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).
Plaintiff CHD also has associational standing to bring this suit. “ ‘Associational standing’
is derivative of the standing of an association’s members, requiring that they have standing and
that the interests the association seeks to protect be germane to its purpose.” OCA-Greater
Houston, 867 F.3d at 610. “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)
(citing Hunt v. Wash. State Apple Adver. Comm'n, 432 U.S. 333, 343, 97 S.Ct. 2434, 53 L.Ed.2d
383 (1977); Friends of the Earth, Inc. v. Chevron Chem. Co., 129 F.3d 826, 827–28 (5th Cir.
1997)). Indeed, it is “common ground that…organizations can assert the standing of their
members.” Summers, 555 U.S. at 494.

Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 14 of 26

i. CHD has Identified Members Who Have Standing to Sue In Their Own
Right

To satisfy this first element: “It generally suffices for an association to demonstrate ‘at
least one of [its] members would have standing to sue on his own.’" Waskul v. Washtenaw Cty.
Cmty. Mental Health, 900 F.3d 250 (6th Cir. 2018) (quoting Lewis v. Casey, 518 U.S. 343, 358
n.6, 116 S. Ct. 2174, 135 L.Ed. 2d 606 (1996)). Therefore, the organization must “show that one
of its named members ‘(1) suffered an injury in fact, (2) that is fairly traceable to the challenged
conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.'”
Waskul, 900 F.3d at 255 (quoting Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547, 194 L. Ed. 2d
635 (2016)). “If in a proper case the association seeks a declaration, injunction, or some other
form of prospective relief, it can reasonably be supposed that the remedy, if granted, will inure to
the benefit of those members of the association actually injured.” Warth v. Seldin, 422 U.S. 490,
515, 95 S. Ct. 2197, 45 L. Ed. 2d 343 (1975).
Defendants argue that CHD does not satisfy the first factor. Motion to Dismiss at 10.
However, CHD’s allegations satisfy associational standing because Deborah L. Else and Sacha
Dietrich, both 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.
Many of CHD’s members would have standing to sue in their own right because FDA’s
EUA injured all parents who have young children now threatened by the authorization at issue.
Plaintiffs Deborah L. Else and Sacha Dietrich chronicle imminent and irreparable harm
associated with coercion of children to take this dangerous biologic and encroaching mandates
that have resulted from FDA’s authorization.
Because of FDA's misrepresentation that the COVID-19 vaccine is beneficial to children,
Plaintiffs and their children experience pressure, coercion, and discrimination to have the
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 15 of 26

children take the vaccine. Plaintiff Deborah Else attests to enduring vaccine propaganda from
school administrators and pediatricians aimed at her children. Compl. ¶ 52; 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. Compl. ¶ 53; Dietrich Decl., ECF No 14-1. Plaintiffs’ children are subjected to an
inundation of pro-vaccine messaging via advertisements on television, radio shows,
announcements, and signage in stores and even promotion in children’s television programming.
The looming threat of being pushed out of society faces Plaintiffs’ children as the culture of mass
vaccination and medical mandates, now directed at children ages five through eleven,
perpetuates as a result of FDA’s actions. Injunctive relief that would stay the FDA’s five through
eleven EUA and prevent any further marketing or promotion of the biologic to children would
alleviate this harm facing Plaintiffs and countless other CHD members.
Because both Deborah L. Else and Sacha Dietrich individually satisfy the requirements of
Article III standing, CHD has identified members who have standing to sue in their own right.
Spokeo, Inc. v. Robins, 136 S. Ct. at 1547.
ii. CHD Aims to Protect Interests Germane to Its Purpose

Defendants do not contest that CHD clearly satisfies the other two criteria for
associational standing. Plaintiff CHD is a large organization that has millions of people
associated with it and continues to grow. While their members boast tens of thousands, CHD
reaches in the millions every month through their publications, TV channels and social media.
CHD provides that its mission is to “end childhood health epidemics by working aggressively to
eliminate harmful exposures, hold those responsible accountable, and to establish safeguards to
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 16 of 26

prevent future harm.”2 The organization goes on to state in its purpose statement that “the one
thing we all share is our passionate belief that we have public health policies and practices that
are harming our children. For the future good health of our children and planet, we call for more
research and transparency.”3 These goals pertain not only to actions that directly affect children,
but also those that will set long-lasting and dangerous precedents that will undoubtedly affect
future generations of youth. CHD is the voice for those oppressed by corporate capture of federal
agencies, as we have here.

The FDA’s EUA for children ages 5-11 affects CHD’s members and their children. The
current and imminent impact on children could hardly be more serious.
iii. The Relief Sought by CHD Does Not Require the Participation of
Individual Members

Finally, as the FDA does not contest in their motion, CHD’s claims do not require any
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
resolution of the action. Similarly, Plaintiffs’ Complaint contains no prayer for monetary
damages, only for the court to stay and vacate the FDA’s actions regarding the COVID vaccines
at issue in the action. Compl. Prayer for Relief. As such, individual participation by members
that are part of the CHD’s organization is not required.

2 https://childrenshealthdefense.org
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 17 of 26

CHD has standing to sue for injuries caused by Defendants to others for the same conduct
it imposes upon Plaintiffs Deborah L. Else and Sacha Dietrich, who submitted declarations in
support of Plaintiffs’ Motion to Stay.
b. Plaintiffs Deborah L. Else and Sacha Dietrich Have 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
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.
Defendants incorrectly allege that Plaintiffs Deborah L. Else and Sacha Dietrich lack
standing and therefore fail to establish this Court’s subject-matter jurisdiction. Motion to Dismiss
at 6. Plaintiffs Deborah L. Else and Sacha Dietrich 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, and injunctive relief will redress their injuries, which satisfies
Article III’s case-or-controversy requirement. Lujan 504 U.S. at 560-561.
Plaintiffs’ children have been subjected to continuous advertisements, pressure, and
coercive tactics to induce them to take the EUA COVID-19 vaccine. Their children face the risk
of expanding vaccine mandates, including those preventing them from receiving life-saving
transplants and medical treatment. Defendants’ note that Texas Governor Greg Abbott has
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 18 of 26

signed an executive order prohibiting vaccine mandates. Motion to Dismiss at 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.” Motion to Dismiss at 4; see 21 U.S.C. § 360bbb-
3(e)(1)(A)(ii)(III).
The threat of being denied life-saving treatment is not a remote risk, as Defendants
suggest. Motion to Dismiss at 7. No child is immune from the constant risk of an accidental
injury or emergency medical condition. Defendants hope to evade responsibility by claiming that
because Plaintiffs’ children have fortunately not yet suffered an emergency health situation and
required life-saving treatment, Defendants do not put them at any such risk. Furthermore,
Defendants would have the Court believe that coercive pressures and propaganda aimed at young
children to take a dangerous, experimental, mRNA gene therapy do not alone present an injury.
In fact, they do. Indeed, in granting a preliminary injunction prohibiting the enforcement of the
Minor Consent for Vaccinations Act Amendment of 2020 (which allowed a minor as young as
11 years old to consent to receiving a vaccine), the D.C. District Court held that there was
imminent injury when a young 13-year-old child felt “singled out for being unvaccinated against
COVID-19” and experienced substantial pressure to take the vaccine. Order Granting Plaintiffs’
Motion for Preliminary Injunction at 8-12, Booth et al v. Bowser et al, (No. 1:21-cv-01857-
TNM).
Furthermore, Defendants allege that “any injury deriving from the independently
developed messages of third parties, such as schools, pediatricians, or stores, cannot be fairly
traced to FDA.” Motion to Dismiss 9. However, FDA was aware of both government and
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 19 of 26

privately implemented vaccine mandates for individuals of all age cohorts who were eligible to
receive a vaccine. FDA also had reasonable knowledge that entities were preparing to implement
mandates as a direct result of FDA’s EUA. Without FDA’s action at issue here, none of the
presented injury would have occurred, and Plaintiffs would not be under current threat.
This injury, outlined in detail in Plaintiffs’ declarations filed along with their Motion to
Stay, is both concrete and particularized, and actual or imminent. The injury Plaintiffs and their
children sustained stems directly from FDA’s illicit authorization and the false representation
that this biologic is a “vaccine” that has been adequately tested for safety and confers benefit to
children.
The relief sought by Plaintiffs will immediately cure this injury and protect not only
Plaintiffs and their children, but all current and future children between the ages of 5-11 from
FDA’s arbitrary and capricious action.
II.
Sovereign Immunity Does Not Prevent this Challenge
Defendants incorrectly argue that the FDA here enjoys sovereign immunity and
Plaintiffs’ causes of action are beyond the APA’s scope of review. Motion to Dismiss at 12.
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. “In such
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 20 of 26

circumstances, where the Plaintiff is not seeking money damages, the APA acts as a waiver 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).
Plaintiffs clearly meet these criteria. Defendants incorrectly argue that their conduct is
somehow beyond the scope of APA accountability. Defendants claim Ass'n of Am. Physicians &
Surgeons v. United States FDA (“AAPS I”) as precedent to support Defendants’ argument that
its arbitrary and capricious conduct are exempt from review under the APA because FDA’s
action under 21 U.S.C. § 360bbb-3 is subject to agency discretion. Ass'n of Am. Physicians &
Surgeons v. United States FDA, No. 20-1784, 2020 U.S. App. LEXIS 30622 (6th Cir. Sep. 24,
2020). That case, still under appellate review, stands for no such proposition.
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).
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 21 of 26

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
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 that skip traditional safety protocols. Holding that the FDA is immune from
accountability here would deny citizens any proper recourse for addressing Defendants’ unlawful
operations.
III.
Plaintiffs State Cognizable Claims on Which This Court Can Grant Relief
The FDA does not have unlimited authority to release minimally tested and risk-heavy
medical products even in the most emergent of circumstances, particularly for children. The
FDA took the unprecedented step to authorize a biologic that is not a traditional “vaccine,” and is
neither safe nor effective for young children, who are least at risk from COVID-19. In doing so,
the FDA has created the illusion of safety and a false guarantee that this product confers some
level of protection. The FDA has actively deceived the public to the detriment of millions of
children and their families. This is reason sufficient to grant the stay.
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 22 of 26

CHD has sufficiently detailed the FDA’s wrongdoing. Plaintiffs gave fair notice of the
claim and sufficiently cited 5 U.S.C. § 701(2)(A), showing entitlement to relief for a single cause
of action with facts and verified, exhibit-supported harm. Not only are the facts true, but they
must also be accepted as true – something Defendants refuse to acknowledge.
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. It is important for
the Court to be aware of the scope of review it has when examining an administrative exercise of
discretion. The Supreme Court has indicated that a two-step procedure is required, entailing 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).
i. FDA’s Arbitrary and Capricious Authorization
To make a finding of “arbitrary” and “capricious” agency action, the Court must
undertake a "searching and careful" inquiry into the facts. Id. An agency’s action is “arbitrary
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 23 of 26

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 EUA for children ages 5-11 fails to meet
this standard. In its approval, the FDA:
1. failed to examine relevant data;
2. failed to articulate its standard for assessing the issue at hand;
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.
Defendants authorized Pfizer-BioNTech’s EUA for children ages 5-11 despite the
abundance of evidence indicating that the biologic poses a serious risk to young children and the
overwhelming lack of success of the administration of the same vaccines to individuals ages 12
and up. The FDA turned a blind eye to the reports of serious adverse effects, deaths and
warnings of severe long-term effects that have yet to be investigated. The FDA cannot hand-pick
which facts to utilize in its determination and which to ignore; it has a duty to examine the
totality of the evidence – a duty it has failed. The FDA granted this EUA knowing that the EUA
vaccine is liability-free, manufactured without good manufacturing practices required for
licensed products, and that the product would be mandated for some young children. The FDA
has capitulated to pharmaceutical and executive branch agendas, while disregarding the agency’s
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 24 of 26

purpose. Politics and industry pressure should play no role in the authorization process, yet they
obviously appear to have been central in the FDA’s decision-making process here.
Defendants 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 the authorization of this
vaccine. FDA’s EUA for children ages 5-11 violated the requirement of reasoned decision-
making detailing all the areas under 5 U.S.C. § 701 that were not followed. 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, Defendants’ actions
warrant vacatur and remand.
Furthermore, CHD successfully pleads Defendant FDA exceeded its statutory authority
when authorizing the EUA for children ages 5-11. “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 the conclusion that SARS-CoV-2 poses no “actual” or “potential” emergency for children
in this age cohort and therefore its action was not allowed under the emergency use statute. 21
Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 25 of 26

U.S.C. § 360bbb-3(a)(1). In several respects, FDA’s actions exceeded Defendants’ statutory
authority, which is reviewable under both the APA and pre-APA review.
CONCLUSION

Plaintiffs ask for this Court to vacate and remand the FDA’s decision to grant the EUA
for Pfizer-BioNTech’s COVID-19 vaccine for children 5-11 on the grounds that FDA’s action
violated the APA, 5 U.S.C. § 706(2)(A), was arbitrary and capricious, and exceeded the agency’s
statutory authority. For the foregoing reasons, this Court should deny Defendants’ Motion to
Dismiss and grant Plaintiffs’ motion to stay.

Dated: May 9, 2022

Respectfully submitted,

/s/ Robert E. Barnes

Robert E. Barnes, Esq.
Email: robertbarnes@barneslawllp.com
BARNES LAW
700 South Flower Street, Suite 1000
Los Angeles, California 90017
Telephone: (310) 510-6211

Robert F. Kennedy, Jr., Esq.
Children’s Health Defense
1227 N. Peachtree Pkwy, Suite 202
Peachtree City, GA 30269

Counsel for Plaintiffs CHILDREN’S
HEALTH DEFENSE, DEBORAH L. ELSE,
and SACHA DIETRICH

Case 6:22-cv-00093-ADA-DTG Document 21 Filed 05/09/22 Page 26 of 26

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