Combined Memorandum of Law in Support of Defendants’

Date: 2021-09-16

Full text

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION

AMERICA’S FRONTLINE
DOCTORS, et al.,

Plaintiffs,

XAVIER BECERRA, et al.,

Defendants.

CIVIL ACTION NO.
2:21-CV-702-CLM
OPPOSED

COMBINED MEMORANDUM OF LAW IN SUPPORT OF DEFENDANTS’
MOTION TO DISMISS FOR LACK OF JURISDICTION, IMPROPER
VENUE, AND FAILURE TO STATE A CLAIM, AND IN OPPOSITION TO
PLAINTIFFS’ MOTION FOR A PRELIMINARY INJUNCTION

FILED
2021 Sep-16 PM 05:12
U.S. DISTRICT COURT
N.D. OF ALABAMA
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 1 of 49

TABLE OF CONTENTS
INTRODUCTION ............................................................................................................ 1
BACKGROUND ............................................................................................................. 5
I. Statutory and Regulatory Background ............................................................... 5
A. In Public Health Emergencies, FDA Has Discretion to Permit the
Distribution of Unapproved Products Through EUAs. .................................. 5
B. After Reviewing Extensive Scientific Data, FDA Exercised Its
Discretion to Issue EUAs for the COVID-19 Vaccines. .............................. 7
C. FDA Approved the Pfizer COVID-19 Vaccine. ......................................... 10
II. Procedural History .......................................................................................... 11
ARGUMENT ............................................................................................................... 12
I. This Case Must Be Dismissed for Lack of Subject Matter Jurisdiction. ......... 12
A. Legal Standard ............................................................................................. 12
B. Plaintiffs Lack Standing. ............................................................................. 13
C. The Emergency Declaration and EUAs Are Unreviewable Under the
APA. ............................................................................................................ 25
D. The Court Lacks Jurisdiction over Plaintiffs’ Mandamus Claim
(Count VI). .................................................................................................. 27
II. The Complaint Should Be Dismissed for Failure to State a Claim. ............... 29
A. Legal Standard ............................................................................................. 29
B. Counts I–III Fail to State a Claim that the Emergency Declaration and
EUAs Are Unlawful Under the APA. ......................................................... 30
C. Count IV Fails to State a Claim Under Customary International Law. ...... 38
D. Count V Fails to State a Claim Under 45 C.F.R. Part 46. .......................... 39
E. Count VI Fails to State a Mandamus Claim. ............................................... 39
III. Plaintiffs’ Motion for a Preliminary Injunction Should Be Denied. ............. 40
A. Legal Standard ............................................................................................. 40
B. Plaintiffs Are Not Likely to Succeed on the Merits. ................................... 41
C. Plaintiffs Have Not Shown Irreparable Harm. ............................................ 43
D. Plaintiffs Have Not Shown that the Balance of Equities Favors Them
or that an Injunction Is in the Public Interest. ............................................. 44
CONCLUSION ............................................................................................................. 45
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 2 of 49

INTRODUCTION
Since the COVID-19 pandemic began in the United States in early 2020, over
40.5 million Americans have been infected, over 2.8 million Americans have been
hospitalized, and over 652,000 Americans have died. These numbers continue to
rise: over the past week, there was an average of over 136,000 new infections per
day, over 11,700 hospital admissions per day, and over 1000 deaths per day. COVID-
19 affects both children and adults: over 4.4 million children age 17 and under have
been infected, over 57,600 have been hospitalized, and over 500 have died.1
To protect themselves from COVID-19, millions of Americans have chosen
to receive one of the COVID-19 vaccines manufactured by Pfizer, Inc. (“Pfizer”),
ModernaTX, Inc. (“Moderna”), or Johnson & Johnson/Janssen Biotech, Inc.
(“Janssen”) (collectively, the “COVID-19 vaccines”), which received Emergency
Use Authorizations (“EUAs”) from the U.S. Food and Drug Administration
(“FDA”). The Pfizer vaccine was recently approved by FDA for persons ages 16 and
older.2
Over 210 million Americans have received at least one dose of a COVID-19
vaccine (over 63% of Americans), and over 179 million Americans are now fully
vaccinated (over 54% of Americans). 3 Nonetheless, millions of Americans have not

1 Centers for Disease Control and Prevention (“CDC”), COVID Data Tracker Weekly Review:
Interpretive Summary for Sept. 10, 2021, https://go.usa.gov/xFU9U; CDC, Demographic Trends
of COVID-19 Cases and Deaths in the US Reported to CDC, https://go.usa.gov/xFU9t (posted
Sept. 15, 2021); CDC, New Hospital Admissions, https://go.usa.gov/xFU9K (last updated Sept.
15, 2021).

2 Comirnaty BLA Approval (Aug. 23, 2021), https://go.usa.gov/xM3nZ.

3 CDC, COVID-19 Vaccinations in the United States, https://go.usa.gov/xFQXD (posted Sept. 15,
2021). Americans ages 12 and older are eligible to receive at least one of the COVID-19 vaccines.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 3 of 49

yet received a vaccine, and more than half a million vaccine doses were administered
in the last week alone. Plaintiffs America’s Frontline Doctors (“AFLDS”)—a not-
for-profit healthcare advocacy organization comprising “hundreds of member
physicians that come from across the country,” Compl. ¶ 12—and 24 individuals
seek to deprive Americans of the opportunity to get vaccinated.
Plaintiffs oppose the vaccines and dispute that the country is even in a public
health emergency. AFLDS members and the individual Plaintiffs allegedly do not
want to be vaccinated themselves, do not want their families to be vaccinated, and
do not want others to receive the vaccines. The Complaint does not allege, though,
that they or their families will imminently be required to receive the vaccines or that
they will imminently be required to encourage others to receive them, let alone that
such a requirement is traceable to any challenged action of Defendants. Plaintiffs
can avoid any purported injury by refusing the vaccines for themselves and their
families and declining to encourage others to receive them.
Not content to avoid injury to themselves, Plaintiffs ask the Court to invalidate
the vaccine EUAs nationwide and prohibit FDA from fully approving the vaccines.
This relief would prevent millions of Americans who have not yet received a vaccine
and who are not parties to this litigation from receiving one. Every week, hundreds
of thousands of Americans are choosing to receive a vaccine to protect themselves
from COVID-19,4 and Plaintiffs seek to take this choice away from them.

See Vaccine Information Fact Sheet for Recipients and Caregivers About Comirnaty (COVID-19
Vaccine, mRNA) and Pfizer-BioNtech COVID-19 Vaccine to Prevent Coronavirus Disease 2019
(COVID-19), at 1, https://go.usa.gov/xFvry (last revised Aug. 23, 2021).

4 COVID Data Tracker Weekly Review: Interpretive Summary for Sept. 10, 2021.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 4 of 49

Plaintiffs undoubtedly may advocate against the vaccines and submit their
arguments in a Citizen Petition to FDA. But to obtain an order from this Court
invalidating the vaccine EUAs and blocking the vaccines’ approval, Plaintiffs must
plausibly allege that this Court has subject matter jurisdiction. Plaintiffs have failed
to meet this burden for three reasons.
First, Plaintiffs have not set forth allegations sufficient to establish Article III
standing to seek injunctive relief. Plaintiffs have not alleged, as they must, that they
are subject to any actual or imminent vaccine mandate traceable to Defendants’
challenged conduct. Moreover, the only potential bases for venue in this District are
the claims by the eight Plaintiffs who reside in Alabama—Lyle and Julie Bloom,
Greenslade, McFarlane, Miller, Roth, and Jody and Deborah Sobczak (the “Alabama
Plaintiffs”)—but each of these Plaintiffs lacks standing, so this case can be dismissed
for improper venue without reaching the standing of the other Plaintiffs.
Second, the EUAs and related Public Health Emergency Declaration
(“Emergency Declaration”) are unreviewable under the Administrative Procedure
Act (“APA”), 5 U.S.C. §§ 701–706, because 21 U.S.C. § 360bbb-3(a)(1) (the “EUA
statute”) expressly commits decisions under its authority to agency discretion.
Finally, the Court does not have jurisdiction over Plaintiffs’ mandamus claim
because Defendants do not have a clear duty to act and Plaintiffs have an alternative
remedy in the form of a Citizen Petition.
Even if the Court reached the merits, Plaintiffs have failed to state plausible
claims for relief. Plaintiffs’ APA claims (Counts I–III) rely on allegations that are
beyond the scope of the existing administrative record and were never presented to
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 5 of 49

FDA before filing suit. These allegations thus cannot show that the decisions to issue
the Emergency Declaration and EUAs were arbitrary and capricious. Plaintiffs’
claim for a violation of customary international law (Count IV) fails for lack of a
private right of action. Finally, Plaintiffs fail to state a claim under 45 C.F.R. Part 46
(Count V) because the use of the vaccines for clinical care under the EUAs is not a
clinical investigation, and Plaintiffs fail to state a mandamus claim (Count VI)
because Defendants do not have a clear duty to act and Plaintiffs have an alternative
Citizen Petition remedy.
Plaintiffs have also failed to show they are entitled to the extraordinary
remedy of a mandatory preliminary injunction. They are not likely to succeed on the
merits because they have not established the Court’s subject matter jurisdiction and
they failed to state a plausible claim for relief. Nor can they assert new claims and
seek new relief in their preliminary injunction motion. Plaintiffs have not shown
irreparable harm because they do not face an imminent risk of future harm; indeed,
they delayed for months before seeking a preliminary injunction. Finally, the balance
of equities and the public interest oppose an injunction: whereas Plaintiffs do not
face imminent irreparable harm absent an injunction, the public would be severely
harmed by the requested relief, which would deprive millions of Americans of the
opportunity to be vaccinated against COVID-19.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 6 of 49

BACKGROUND
I.
Statutory and Regulatory Background
A. In Public Health Emergencies, FDA Has Discretion to Permit the
Distribution of Unapproved Products Through EUAs.
The Public Health Service Act governs the approval and marketing of
“biological product[s],” which include vaccines. 42 U.S.C. § 262(i)(1). Normally, a
“manufacturer of a biologic may market the drug only if the FDA has licensed it
pursuant to either of two review processes set forth in [section] 262” of the Public
Health Service Act. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1670 (2017). But in
certain cases of “an actual or potential emergency,” Congress empowered FDA to
authorize the marketing of biological products (and other FDA-regulated products)
“intended for use” in responding to the emergency. 21 U.S.C. § 360bbb-3(a)(1).
The EUA process begins when the Secretary declares that an EUA is justified
based on a determination of emergency or threat, such as the Secretary’s
determination that “there is a public health emergency.” Id. § 360bbb-3(b). Once the
Secretary makes such a declaration, FDA may issue an EUA for use of an FDA-
regulated product if certain criteria are met. First, the biological or other agent
underlying the emergency declaration “can cause a serious or life-threatening
disease or condition.” Id. § 360bbb-3(c)(1). Second, “based on the totality of
scientific evidence available to the Secretary, . . . it is reasonable to believe” that (1)
the authorized product “may be effective in diagnosing, treating, or preventing” that
“disease or condition” and (2) “the known and potential benefits of the product,
when used to diagnose, prevent, or treat such disease or condition, outweigh the
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 7 of 49

known and potential risks of the product.” Id. § 360bbb-3(c)(2). Third, “there is no
adequate, approved, and available alternative to the product for diagnosing,
preventing, or treating such disease or condition.” Id. § 360bbb-3(c)(3).
The issuance of an EUA does not constitute approval of the product. See id.
§ 360bbb-3(a)(3). However, the individual use of a product under an EUA “shall not
be considered to constitute a clinical investigation” for purposes of specified statutes
governing clinical investigations. Id. § 360bbb-3(k).
For an emergency use of an unapproved product, such as the COVID-19
vaccines5 (except the Pfizer vaccine administered to persons ages 16 and older,
which has been approved), FDA shall, “to the extent practicable given the applicable
circumstances,” establish “[a]ppropriate conditions,” as FDA finds “necessary or
appropriate to protect the public health,” for the use of EUA products. Id. § 360bbb-
3(e)(1)(A). These include conditions designed to ensure that the people
administering and receiving the product are informed “(I) that [FDA] has authorized
the emergency use of the product; (II) of the significant known and potential benefits
and risks of the emergency use of the product, and of the extent to which such
benefits and risks are unknown; and (III) of the alternatives to the product that are
available, and of their benefits and risks.” Id. § 360bbb-3(e)(1)(A)(i). They also
include conditions to ensure that the product’s recipients are informed “of the option
to accept or refuse administration of the product.” Id. § 360bbb-3(e)(1)(A)(ii). And

5 Letter of Authorization from FDA to Pfizer Inc. (May 10, 2021), ECF No. 24-3, at 3, 11; Letter
of Authorization from FDA to ModernaTX, Inc. (Feb. 25, 2021), ECF No. 24-8, at 2, 10; Letter of
Authorization from FDA to Janssen Biotech, Inc. (June 10, 2021), ECF No. 24-12, at 2, 10.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 8 of 49

they include “conditions for the monitoring and reporting of adverse events
associated with the emergency use of the product.” Id. § 360bbb-3(e)(1)(A)(iii).
The EUA statute provides that all “[a]ctions under [its] authority . . . are
committed to agency discretion.” Id. § 360bbb-3(i).
B. After Reviewing Extensive Scientific Data, FDA Exercised Its
Discretion to Issue EUAs for the COVID-19 Vaccines.
In February 2020, the Secretary determined that a public health emergency
existed involving COVID-19. Determination of Public Health Emergency, 85 Fed.
Reg. 7316, 7317 (Feb. 7, 2020). In March 2020, the Secretary issued an additional
declaration based on his February 2020 determination, declaring that “circumstances
exist justifying the authorization of emergency use of drugs and biological products
during the COVID-19 pandemic.” Emergency Use Authorization Declaration, 85
Fed. Reg. 18,250, 18,250–51 (Apr. 1, 2020).6
In December 2020, FDA issued EUAs for the Pfizer and Moderna vaccines.
See ECF Nos. 24-3, 24-8.7 The Pfizer EUA was initially for persons ages 16 and
older, and in May 2021, the EUA was extended to persons ages 12 and older. See
ECF No. 24-3, at 2–5. The Moderna EUA is for persons ages 18 and older. See ECF

6 Count I of the Complaint challenges the Secretary’s February 2020 declaration, but not his March
2020 declaration. See Compl. ¶ 258. This brief will refer to the Secretary’s February 2020
declaration as the “Emergency Declaration.”

7 Because “standing must be determined as of the time at which the plaintiff’s complaint is filed,”
Focus on the Fam. v. Pinellas Suncoast Transit Auth., 344 F.3d 1263, 1275 (11th Cir. 2003),
through the Burk Declaration, ECF No. 24, this brief cites the versions of the relevant documents
that were in effect when Plaintiffs filed the Complaint on June 10, 2021. For this motion to dismiss,
the Court may take judicial notice of these exhibits—all of which were “publicly available on
FDA’s website,” ECF No. 24, at ¶ 6— and other information available on government websites.
See Tellabs, Inc. v. Makor Issues & Rts., Ltd., 551 U.S. 308, 322–23 (2007); Eternal Word
Television Network, Inc. v. Sebelius, 935 F. Supp. 2d 1196, 1209 n.12 (N.D. Ala. 2013). The
exhibits also are central to Plaintiffs’ claims, and their authenticity is indisputable. See U.S. ex rel.
Osheroff v. Humana Inc., 776 F.3d 805, 811 (11th Cir. 2015); see also Fed. R. Evid. 201(b).
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 9 of 49

No. 24-8, at 2–4. In February 2021, FDA issued an EUA for the Janssen vaccine for
persons ages 18 and older. See ECF No. 24-12, at 2–4.
The EUAs were based on FDA’s review of extensive safety and efficacy data.
The Pfizer EUA was based on a clinical trial with approximately 46,000 participants,
including 2,260 participants ages 12 to 15. ECF No. 24-3, at 3–4. The Moderna EUA
was based on a clinical trial with approximately 30,000 participants; Janssen
involved a clinical trial with approximately 43,000 participants. ECF Nos. 24-8, at
3; 24-12, at 3. After reviewing the data from these trials, FDA concluded that “it is
reasonable to believe that the [vaccines] may be effective in preventing COVID-19,
and that, when used under the conditions described in [the EUAs], the known and
potential benefits of the [vaccines] when used to prevent COVID-19 outweigh [their]
known and potential risks.” ECF Nos. 24-3, at 3; 24-8, at 2; 24-12, at 2.
The EUAs require vaccination providers to give each vaccine recipient a “Fact
Sheet for Recipients and Caregivers” (collectively, the “Fact Sheets”), either in
hardcopy or online, and to communicate information from the Fact Sheets.8 ECF
Nos. 24-3, at 6, 10; 24-8, at 5, 9; 24-12, at 5, 9; see Pfizer Provider Fact Sheet, ECF
No. 24-2, at 9; Moderna Provider Fact Sheet, ECF No. 24-7, at 5–6; Janssen Provider
Fact Sheet, ECF No. 24-11, at 5. The Fact Sheets advise potential recipients that “[i]t
is your choice to receive or not receive” the vaccine. Pfizer Recipient Fact Sheet,

8 The EUAs also require vaccination providers to “participate [in] and comply with the terms and
training required by CDC’s COVID-19 Vaccination Program,” which mandates that vaccination
providers give a Fact Sheet to each vaccine recipient. ECF No. 24-3, at 10; ECF No. 8, at 9; ECF
No. 12, at 9; CDC, COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheets for
Recipients and Caregivers, https://go.usa.gov/xFQ9A (last reviewed Aug. 6, 2021).

Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 10 of 49

ECF No. 24-1, at 5; Moderna Recipient Fact Sheet, ECF No. 24-6, at 5; Janssen
Recipient Fact Sheet, ECF No. 24-10, at 5.9 They explain that the vaccine is
“unapproved” and is authorized “under an Emergency Use Authorization,” meaning
it “has not undergone the same type of review as an FDA-approved or cleared
product” and is authorized based on a determination that it “may be effective to
prevent COVID-19.” ECF Nos. 24-1, at 2–4, 7; 24-6, at 2–3, 6; 24-10, at 2–3, 7.
The Fact Sheets disclose the potential side effects of the vaccines. For
example, they disclose that the vaccines “could cause a severe allergic reaction,”
manifesting in symptoms such as “[d]ifficulty breathing,” “[d]izziness and
weakness,” and that other side effects may include “fatigue, headache, muscle pain,
joint pain, chills, nausea and vomiting, and fever.” ECF Nos. 24-1, at 4; 24-6, at 4;
24-10, at 4–5. They warn that other “[s]erious and unexpected side effects may
occur.” ECF Nos. 24-1, at 4; 24-6, at 3; 24-10, at 4. The Pfizer and Moderna Fact
Sheets also disclose that the vaccines include “messenger ribonucleic acid
(mRNA).” ECF Nos. 24-1, at 3; 24-6, at 3. Finally, all the Fact Sheets provide
websites and telephone numbers to obtain more information about the vaccines. ECF
Nos. 24-1, at 6; 24-6, at 5–6; 24-10, at 5.
The EUAs also require vaccine manufacturers and providers to report serious
adverse events to the Vaccine Adverse Event Reporting System (“VAERS”)—“a
national early warning system to detect possible safety problems in U.S.-licensed
vaccines.”
U.S.
Dep’t
of
Health
&
Human
Servs., About VAERS,

9 This brief will cite the Fact Sheets that were in effect when Plaintiffs filed the Complaint. See
Focus on the Fam., 344 F.3d at 1275.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 11 of 49

https://go.usa.gov/xFEc6 (last visited Sept. 16, 2021); see ECF Nos. 24-3, at 8, 10;
24-8, at 7, 9; 24-12, at 7, 9. CDC has also developed a second reporting system
known as V-safe, which “is a smartphone-based tool” for vaccine recipients to report
side
effects.
CDC,
V-safe
After
Vaccination
Health
Checker,
https://go.usa.gov/xFvgR (last updated Sept. 3, 2021); see also Compl. ¶ 270(e).
C. FDA Approved the Pfizer COVID-19 Vaccine.
On August 23, 2021, FDA approved Pfizer’s Biologics License Application
(“BLA”) for its COVID-19 vaccine, named Comirnaty, for persons ages 16 and
older. Comirnaty BLA Approval (Aug. 23, 2021), https://go.usa.gov/xM3nZ. FDA
determined that the vaccine was over 91% effective in preventing COVID-19 disease
and between 95% and 100% effective in preventing severe COVID-19 disease,
based on effectiveness data from approximately 20,000 vaccine recipients and
20,000 placebo recipients. Comirnaty Approved Prescribing Information, at 15–18,
https://go.usa.gov/xM3nG (last revised 8/2021). FDA also determined that the
product was safe based on data from approximately 12,000 vaccine recipients, each
of whom was monitored for at least six months. Id. at 12. Although the Pfizer vaccine
is now approved for individuals ages 16 and older to receive the standard two-dose
series, the Pfizer EUA remains in effect for individuals ages 12 and older and to
provide a third dose to certain immune-compromised individuals. See Re-issued
Pfizer EUA Letter of Authorization (Aug. 23, 2021), https://go.usa.gov/xMBXr .10

10 Although Comirnaty is approved to prevent COVID-19 in individuals 16 years of age and older,
FDA has not revoked the Pfizer EUA because the agency found that “there is not sufficient
approved vaccine available for distribution to this population in its entirety” at the time of
Comirnaty’s approval, and because the Pfizer EUA covers individuals age 12 through 15 and the
provision of an additional dose to the immunocompromised population. Id. at 5 n.9.

Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 12 of 49

II.
Procedural History
On May 19, 2021, Plaintiffs filed a motion for a Temporary Restraining Order
against Xavier Becerra, Secretary of Health and Human Services, and the U.S.
Department of Health and Human Services to enjoin the extension of the COVID-
19 vaccine EUAs to children under the age of 16. ECF No. 1. On May 24, the Court
denied Plaintiffs’ motion because it found “no specific facts in the motion or attached
affidavits that ‘clearly show that immediate and irreparable injury, loss, or damage
will result to the [Plaintiffs] before [the Government Defendants] can be heard in
opposition.’” ECF No. 3 (quoting Fed. R. Civ. P. 65(b)(1)(A)).
On June 10, 2021, Plaintiffs filed their Complaint, seeking invalidation of the
Emergency Declaration and COVID-19 vaccine EUAs based on the APA, customary
international law, 45 C.F.R. Part 46, and 28 U.S.C § 1361. See Compl., ECF No. 10,
at ¶¶ 257–85. These claims are asserted against the U.S. Department of Health and
Human Services; FDA; CDC; the National Institutes of Health; the National Institute
of Allergies and Infectious Diseases (“NIAID”); and, in their official capacities,
Secretary Becerra; Dr. Anthony Fauci, Director of NIAID; and Dr. Janet Woodcock,
Acting Commissioner of Food and Drugs (collectively, “HHS”).11

11 Plaintiffs’ “claims for injunctive or declaratory relief . . . are considered to be official capacity
claims against” HHS. Edwards v. Wallace Cmty. Coll., 49 F.3d 1517, 1524 n.9 (11th Cir. 1995).
The Complaint also asserts a claim for money damages against Secretary Becerra, Dr. Fauci, and
Dr. Woodcock in their individual capacities (Count VII). See Compl. ¶¶ 286–96. On August 28,
2021, Plaintiffs filed a Notice of Voluntary Dismissal of Count VII pursuant to Fed. R. Civ. P.
41(a). ECF No. 21. On September 3, 2021, the Court rejected Plaintiffs’ Notice on the grounds
that “Rule 41(a) is not an appropriate vehicle to dismiss a single claim without dismissing the
entire lawsuit,” and it “invite[d]” Plaintiffs to “seek leave to amend their Complaint under Rule
15.” ECF No. 22. Although Plaintiffs have not yet sought leave to amend their Complaint, it is
HHS’s understanding that Plaintiffs still intend not to pursue Count VII.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 13 of 49

On July 19, 2021, Plaintiffs moved for a preliminary injunction to invalidate
the vaccine EUAs and enjoin FDA from approving the vaccines. PI Mot., ECF No.
15. HHS now moves to dismiss the Complaint under Federal Rules of Civil
Procedure 12(b)(1), (3), and (6), and opposes the preliminary injunction motion.
ARGUMENT
I. This Case Must Be Dismissed for Lack of Subject Matter Jurisdiction.
A. Legal Standard
“Article III of the Constitution limits the jurisdiction of federal courts to
‘Cases’ and ‘Controversies.’” Susan B. Anthony List v. Driehaus, 573 U.S. 149, 157
(2014) (quoting U.S. Const., Art. III, § 2). When “a federal court concludes that it
lacks subject-matter jurisdiction, the court must dismiss the complaint in its
entirety.” Arbaugh v. Y&H Corp., 546 U.S. 500, 514 (2006); see also Steel Co. v.
Citizens for a Better Env’t, 523 U.S. 83, 94–95 (1998) (subject matter jurisdiction
must “be established as a threshold matter”). The Court “presume[s]” to “lack
[subject matter] jurisdiction” unless the plaintiff meets its “burden of establishing
it.” DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 342 n.3 (2006) (internal quotation
marks omitted)). If a plaintiff cannot meet this burden, then the Court has “no
business deciding” the case. Id. at 341, 342 n.3.
Where, as here, defendants assert a “facial attack” on subject matter
jurisdiction, the Court must “look and see if the plaintiff has sufficiently alleged a
basis of subject matter jurisdiction.” Stalley ex rel. U.S. v. Orlando Reg’l Healthcare
Sys., Inc., 524 F.3d 1229, 1232 (11th Cir. 2008). A plaintiff “must plausibly allege
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 14 of 49

all jurisdictional elements.” Brownback v. King, 141 S. Ct. 740, 749 (2021); see also
City of Pembroke Pines, Fla. v. Fed. Emergency Mgmt. Agency, 494 F. Supp. 3d
1272, 1281–82 (S.D. Fla. 2020). The complaint’s factual allegations “are taken as
true for the purposes of the motion,” but conclusory statements and legal conclusions
are not. Stalley, 524 F.3d at 1232–33.
Here, the Court lacks subject matter jurisdiction for three reasons. First,
Plaintiffs lack standing. Second, Plaintiffs’ claims are unreviewable under the APA.
Finally, Plaintiffs have not plausibly alleged the Court’s jurisdiction over their
mandamus claim. The Complaint must therefore be dismissed.
B. Plaintiffs Lack Standing.
For standing, a plaintiff must establish (1) an injury in fact that is “concrete,
particularized, and actual or imminent”; (2) “fairly traceable to the challenged
action” of the defendant; and (3) likely “redressable by a favorable ruling.” Clapper
v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013); see TransUnion LLC v. Ramirez,
141 S. Ct. 2190, 2203–07 (2021). At the pleading stage, a plaintiff “must clearly
allege . . . facts demonstrating each element” of standing. Spokeo, Inc. v. Robins, 136
S. Ct. 1540, 1547 (2016). Because “standing is not dispensed in gross,” a plaintiff
“must demonstrate standing for each claim . . . and for each form of relief.”
TransUnion, 141 S. Ct. at 2208.
To seek “injunctive or declaratory relief,” which is all that Plaintiffs seek
against HHS, a plaintiff must plausibly allege a “material” risk of future injury.
Muransky v. Godiva Chocolatier, Inc., 979 F.3d 917, 927 (11th Cir. 2020) (en banc);
see also Malowney v. Fed. Collection Deposit Grp., 193 F.3d 1342, 1346 (11th Cir.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 15 of 49

1999) (“a plaintiff must allege facts from which it appears there is a substantial
likelihood that he will suffer injury in the future”). The plaintiff’s threatened injury
must be “certainly impending.” Jacobson v. Fla. Sec’y of State, 974 F.3d 1236,
1245–46 (11th Cir. 2020) (quoting Clapper, 568 U.S. at).
Here, the Alabama Plaintiffs have not plausibly alleged standing, and thus the
Complaint can be dismissed for improper venue without reaching the standing of the
remaining individual Plaintiffs and AFLDS. But even if the Court considers those
other Plaintiffs, they have also failed to plausibly allege standing.
1. The Alabama Plaintiffs Lack Standing, and Thus This Entire Case
Should Be Dismissed for Improper Venue.
A court “shall dismiss” a case filed in the wrong venue unless “the interest of
justice” requires transfer “to any district or division in which [the case] could have
been brought.” 28 U.S.C. § 1406(a); see Fed. R. Civ. P. 12(b)(3). Here, the only
potential bases for venue in this District are the claims by the Alabama Plaintiffs.
See Compl. ¶ 144 (asserting venue under 28 U.S.C. § 1391(e)(1) because “at least
one Plaintiff resides in this District”). But all Alabama Plaintiffs lack standing, so
this case should be dismissed in its entirety for improper venue.
Plaintiffs Lyle and Julie Bloom (id. ¶¶ 116–18), Greenslade (id. ¶¶ 120–21),
McFarlane (id. ¶ 119), Miller (id. ¶ 58), and Jody and Deborah Sobczak (id. ¶¶ 65–
66) fear that they, their children, or their grandchildren will be required to receive a
vaccine and will suffer side effects. But the Complaint does not clearly allege facts
demonstrating that any Plaintiffs, their children, or their grandchildren are currently
required to receive the vaccines or will imminently be required to do so. Indeed,
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 16 of 49

Alabama enacted legislation in May 2021 that prohibits state and local government
entities, including schools, from requiring COVID-19 vaccinations as a condition of
receiving government services or entry into a government building. See Ala. SB267
(Act No. 2021-493), §§ 1(b)–(c).12
Although the Complaint alleges that certain unnamed local governments have
“eliminate[d] the requirement for parental consent, and even parental knowledge, of
medical treatments administered to children,” Compl. ¶ 239, it does not allege that
Plaintiffs’ children or grandchildren live in such a jurisdiction. There is thus no
indication that Plaintiffs’ children or grandchildren face any risk, let alone a material
risk, of being vaccinated over Plaintiffs’ objections. See Clapper, 568 U.S. at 420
(no standing based on “mere conjecture about possible governmental actions”);
Muransky, 979 F.3d at 927.
Moreover, those hypothetical injuries would not be traceable to the challenged
actions of HHS here; rather, they would be “the independent action of some third
party not before the court.” Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992);
see also Clapper, 568 U.S. at 414 n.5. Indeed, the Complaint does not allege that the
challenged actions will require or pressure anyone to get vaccinated, but instead that
children will face “social and school pressure” to get vaccinated, Compl. ¶ 119; see
id. ¶ 65, or pressure from “friends, parents of friends, sports organizations, summer
camps, schools and colleges,” id. ¶ 58. Similarly, “just because the federal
government approved [the] vaccine as safe for human” use, any state or local

12 Available at http://alisondb.legislature.state.al.us/ALISON/SearchableInstruments/2021RS/
PrintFiles/SB267-enr.pdf.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 17 of 49

vaccination requirement would be an “action independently taken by a separate
sovereign” and not traceable to HHS’ conduct challenged here. Null v. FDA, No. CV
09-1924 (RBW), 2009 WL 10744069, at *3 (D.D.C. Nov. 10, 2009).13
Finally, Dr. Roth alleges that he is afraid the vaccines could harm his young
patients. Compl. ¶¶ 122–27.14 But to bring a claim on behalf of a third party, Dr.
Roth (1) “must have suffered an injury in fact, thus giving [him] a sufficiently
concrete interest in the outcome of the issue in dispute”; (2) “must have a close
relation to the third party”; and (3) “there must exist some hindrance to the third
party’s ability to protect his or her own interests.” Powers v. Ohio, 499 U.S. 400, 411
(1991). Here, Roth has not alleged an injury in fact; at most he has an “abstract
concern” about the vaccines that is not cognizable under Article III. See Diamond v.
Charles, 476 U.S. 54, 66–67 (1986); see also infra § I.B.2.a. Furthermore, Roth has
not alleged any hindrance to his patients’ ability to protect their own interests, even
assuming he could demonstrate his patients opposed the vaccine and were being
compelled to get vaccinated. Thus, he cannot assert standing on his patients’ behalf.
In sum, the Alabama Plaintiffs have not plausibly alleged standing. The
Complaint should therefore be dismissed for improper venue. See Atl. Marine Const.
Co. v. U.S. Dist. Ct. for W. Dist. of Texas, 571 U.S. 49, 55–56 (2013); Ga. Republican
Party v. Sec. & Exch. Comm’n, 888 F.3d 1198, 1205 (11th Cir. 2018).

13 Plaintiffs’ citation to Simon v. Eastern Kentucky Welfare Rights Organization, 426 U.S. 26, 45
n.25 (1976), PI Mot. at 43–44, is inapposite here because the Emergency Declaration, EUAs, and
any vaccine approvals do not themselves authorize any third parties to require anyone to get
vaccinated or to permit children to get vaccinated over their parents’ objection.
14 The Complaint does not state where in Alabama Dr. Roth resides. Compl. ¶ 122. But even if he
resides in the Northern District, venue remains improper because Dr. Roth lacks standing.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 18 of 49

2. The Remaining Individual Plaintiffs Lack Standing.
The individual Plaintiffs who reside outside Alabama allege abstract
objections to the vaccines, past injuries, and feared future injuries. None of these is
sufficient for standing.
a. The Individual Plaintiffs Do Not Have Standing Based on Their
Abstract Objections to the Vaccines.
The individual Plaintiffs allege several abstract objections to the
administration of the vaccines. For example, Geyer “has strong objections to the
experimental COVID-19 Vaccine for children,” Compl. ¶ 94, and McCrae is
concerned that vaccination sites are not ensuring that recipients give informed
consent, id. ¶¶ 70–72. But those “abstract concern[s],” “claim[s] of conscientious
objection,” and “nonconcrete interest[s] in the proper administration of the laws” do
“not provide a judicially cognizable interest.” Diamond, 476 U.S. at 66–67;
Summers v. Earth Island Inst., 555 U.S. 488, 497 (2009).
b. The Individual Plaintiffs’ Alleged Past Injuries Do Not Confer
Standing to Seek Their Requested Injunctive Relief.
“[P]ast exposure to illegal conduct does not in itself show a present case or
controversy regarding injunctive relief . . . if unaccompanied by any continuing,
present adverse effects.” City of Los Angeles v. Lyons, 461 U.S. 95, 102 (1983). The
requirement of future injury implicates both the injury-in-fact element—the plaintiff
must be “likely to suffer future injury”—and the redressability element—the relief
sought must “likely prevent such injury from occurring.” Cone Corp. v. Fla. Dep’t
of Transp., 921 F.2d 1190, 1203–04 (11th Cir. 1991). When a plaintiff “alleges only
past infractions” and “not a continuing violation or the likelihood of a future
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 19 of 49

violation, injunctive relief will not redress its injury.” Steel Co., 523 U.S. at 109; see
also Malowney, 193 F.3d at 1346.
Although several Plaintiffs allegedly suffered past physical or economic
injuries, they have not plausibly alleged a likelihood of suffering future injury and
that the requested relief would prevent such injury. See Cone, 921 F.2d at 1203–04.
Plaintiffs Deselle (Compl. ¶ 78), Simmonds (id. ¶¶ 82–85), Vidiella (id. ¶ 92), and
Wood (id. ¶ 40) allegedly lost their jobs because of vaccine side effects or because
they refused to give the vaccines to children. But these past injuries are not likely to
recur or be redressable by the requested injunctive relief. See Clapper, 568 U.S. at
409. For instance, Plaintiffs do not contend they would be rehired if the Emergency
Declaration and EUAs were invalidated. See Cone, 921 F.2d at 1203–04.
Plaintiffs Boone (Compl. ¶¶ 60–64), Deselle (id. ¶¶ 73–80), Galvin (id. ¶¶ 46–
56), Estate of Dovi Sanders Kennedy (id. ¶¶ 109, 115), Mills (id. ¶¶ 67–68),
Simmonds (id. ¶¶ 81–85), and Vidiella (id. ¶¶ 87–90) allegedly suffered side effects
from the vaccines. As a threshold matter, the Countermeasures Injury Compensation
Program provides the exclusive remedy for all claims of loss related to
administration of a COVID-19 vaccine licensed or authorized by the EUAs, other
than willful misconduct. 42 U.S.C. §§ 247d-6d(a), 247d-6e(d)(4).15 Congress has
made the United States otherwise “immune from suit” on these claims, thereby
divesting the Court of subject matter jurisdiction and rendering these alleged injuries

15 These statutes apply here because the Secretary issued the declaration required by 42 U.S.C.
§ 247d-6d(b). See Declaration Under the Public Readiness and Emergency Preparedness Act for
Medical Countermeasures Against COVID–19, 85 Fed. Reg. 15,198 (Mar. 17, 2020), as amended.
The Secretary’s declaration is not subject to judicial review. 42 U.S.C. § 247d-6d(b)(7).
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 20 of 49

inadequate to support standing. Id. § 247d-6d(a), (d), (i)(2). Moreover, these alleged
past injuries are not likely to recur or be redressable by the requested injunctive
relief. See Clapper, 568 U.S. at 409; Cone, 921 F.2d at 1203–04. The Complaint
does not plausibly allege any material risk that these Plaintiffs, who now vehemently
oppose the vaccines, will imminently receive another vaccine dose. Muransky, 979
F.3d at 927; see, e.g., Compl. ¶ 57.
Finally, the Complaint alleges that the vaccines were administered to these
Plaintiffs without their receiving adequate information about the products. See, e.g.,
Compl. ¶¶ 56, 62, 176, 270. But the information Plaintiffs allege they should have
received is all in the Recipient Fact Sheets. The Fact Sheets disclose that “[i]t is your
choice to receive or not receive” the vaccines. ECF Nos. 24-1, at 5; 24-6, at 5; 24-
10, at 5. They explain that the vaccines are “unapproved” and authorized under
“Emergency Use Authorization[s],” which means they have “not undergone the
same type of review as an FDA-approved or cleared product” and are authorized
based on a determination that they “may be effective” to prevent COVID-19. ECF
Nos. 24-1, at 2–4, 7; 24-6, at 2–3, 6; 24-10, at 2–3, 7. The Fact Sheets also disclose
that the vaccines can have a variety of potentially serious side effects, such as “severe
allergic reaction[s]” manifesting in symptoms such as “[d]ifficulty breathing,”
“[d]izziness and weakness.” ECF Nos. 24-1, at 4; 24-6, at 4; 24-10, at 4–5. Finally,
the Pfizer and Moderna Fact Sheets disclose that the vaccines include messenger
ribonucleic acid (mRNA). ECF Nos. 24-1, at 3; 24-6, at 3, 5–6.
The EUAs and CDC’s COVID-19 Vaccination Program require vaccination
providers to give a Fact Sheet to each vaccine recipient, either in hardcopy or online.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 21 of 49

ECF Nos. 24-2, at 9; 24-7, at 5–6; 24-11, at 5. If Plaintiffs’ vaccination providers
furnished the information in the Recipient Fact Sheets, Plaintiffs did not “lack access
to information to which [they were] legally entitled” and thus cannot show a
“constitutionally cognizable informational injury.” Stacy v. Dollar Tree Stores, Inc.,
274 F. Supp. 3d 1355, 1363 (S.D. Fla. 2017). If Plaintiffs’ vaccination providers did
not disseminate the Fact Sheet information as required, those are “the independent
action of some third party not before the court” and not traceable to HHS. Lujan,
504 U.S. at 560–61; see also Clapper, 568 U.S. at 414 n.5.
The Complaint itself illustrates how third parties—not HHS—were
responsible for any failure to give Plaintiffs the Fact Sheets. For example, DeSelle
alleges that her employer provided her a consent form that appeared to be a standard
influenza consent form “with the word ‘influenza’ replaced with ‘COVID-19.’”
Compl. ¶ 80. Similarly, Simmonds alleges that the “local health department” failed
to provide the requisite Fact Sheet, id. ¶ 81, and Mills alleges that CVS failed to
provide adequate information about the vaccine, id. ¶¶ 67, 69. The alleged failure of
these providers to comply with the EUAs and CDC’s COVID-19 Vaccination
Program is not traceable to HHS. Moreover, far from denying Plaintiffs “access to
[vaccine] information to which [they were] legally entitled,” Stacy, 274 F. Supp. 3d
at 1363, FDA posted the Fact Sheets on its website, ECF No. 24, ¶¶ 5–6.
Finally, Plaintiffs cannot have been injured by any purported failure to comply
with the informed consent requirements in 45 C.F.R. Part 46 because that regulation
is inapplicable here. It applies to “research involving human subjects,” 45 C.F.R.
§ 46.101(a), but the administration of an EUA-authorized vaccine for clinical care
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 22 of 49

does not meet the regulation’s definition of “research.” 45 C.F.R. § 46.102(l).
Removing any doubt, the EUA statute prescribes that the use of a product within the
scope of an EUA “shall not be considered to constitute a clinical investigation” for
purposes of the statutes governing such investigations. 21 U.S.C. § 360bbb-3(k).
Additionally, although the VAERS and V-safe systems conduct vaccine surveillance
and facilitate adverse event reporting, “[p]ublic health surveillance activities” are
specifically excluded from the definition of “research.” 45 C.F.R. § 46.102(l)(2).
c. The Individual Plaintiffs’ Alleged Future Injuries Do Not
Establish Standing.
Plaintiff MacFarlane fears losing her job because she will refuse to receive or
administer the vaccine. Compl. ¶ 119. But this alleged injury is neither concrete nor
imminent because it is speculative whether MacFarlane’s employer will fire her.
Plaintiffs Boone (id. ¶¶ 60–64), Geyer (id. ¶¶ 94–95), Hibbard (id. ¶ 99), Hunt
(id. ¶ 107), Meyers (id. ¶ 96), Roberts (id. ¶ 102), and Schweder (id. ¶¶ 128–29) fear
that they, their children, or their grandchildren will be required to receive a vaccine
and will suffer side effects. For the reasons discussed above with respect to the
Alabama Plaintiffs, however, these Plaintiffs have not plausibly alleged standing
because they have not alleged a material risk of future injury, nor any injury that is
traceable to the challenged actions of HHS. See Clapper, 568 U.S. at 409; supra
§ I.B.1. Indeed, the Complaint does not allege that HHS’ challenged actions require
anyone to get vaccinated, but instead that the actions of third parties such as “public
school[s],” Compl. ¶ 99, or “summer camp,” id. ¶ 107, will do so, see Clapper, 568
U.S. at 409, 414 n.5; Lujan, 504 U.S. at 560–61.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 23 of 49

3. AFLDS Lacks Standing.
An organization can have standing under two theories: (1) organizational
standing, in which the organization sues on its own behalf, and (2) representational
standing, in which the organization sues on behalf of its members. See Ga.
Republican Party, 888 F.3d at 1201–05. AFLDS does not have standing under either.
a. AFLDS Lacks Organizational Standing.
Organizational standing is governed by “the same inquiry as in the case of an
individual.” Havens Realty Corp. v. Coleman, 455 U.S. 363, 378–79 (1982). It is
insufficient for an organizational plaintiff to have an “abstract concern” with an issue
in the litigation or “a desire to vindicate value interests,” and a “claim of
conscientious objection to [particular conduct] does not provide a judicially
cognizable interest.” Diamond, 476 U.S. at 66–67. Similarly, a “nonconcrete interest
in the proper administration of the laws” is not a cognizable injury. Summers, 555
U.S. at 497.
AFLDS’s objections to the Emergency Declaration and the EUAs, e.g.,
Compl. ¶ 16, are at most “abstract concern[s]” or “claim[s] of conscientious
objection” that “do[] not provide a judicially cognizable interest,” Diamond, 476
U.S. at 66–67. And its concern with ensuring compliance with the EUA statute and
informed consent laws, e.g., Compl. ¶¶ 230–49, is a “nonconcrete interest in the
proper administration of the laws” that also does not amount to injury in fact,
Summers, 555 U.S. at 497. The Complaint does not allege that AFLDS will suffer
any concrete, imminent injury from the Emergency Declaration or EUAs, such as
the need to divert its resources from other projects “to counteract those [allegedly]
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 24 of 49

illegal acts.” Ga. Republican Party, 888 F.3d at 1203. Thus, AFLDS has not
plausibly alleged organizational standing.
b. AFLDS Lacks Representational Standing.
“An association has standing to bring suit on behalf of its members when its
members would otherwise have standing to sue in their own right, the interests at
stake are germane to the organization’s purpose, and neither the claim asserted nor
the relief requested requires the participation of individual members in the
lawsuit.” Id. (quoting Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,
528 U.S. 167, 181 (2000)). An organization must “make specific allegations
establishing that at least one identified member ha[s] suffered or [will] suffer harm,”
and its “self-descriptions of [its] membership” are insufficient. Id. (quoting
Summers, 555 U.S. at 498–99); see also Jacobson, 974 F.3d at 1249.
The Complaint does not identify any member of AFLDS, let alone “make
specific allegations establishing that at least one identified member ha[s] suffered or
[will] suffer harm.” Ga. Republican Party, 888 F.3d at 1203. Although the Complaint
describes AFLDS’s members generally, these “self-descriptions of [its]
membership” are insufficient. Id.
Furthermore, the abstract objections to the vaccine of AFLDS members, e.g.,
Compl. ¶ 16 (claiming “it is unethical even to advocate for Covid-19 vaccine
administration to persons under the age of 50”), are not cognizable under Article III.
Also unavailing are the allegations that unidentified members fear losing their jobs
because employers might follow an American Medical Association ethics opinion,
which states that doctors “have an ethical responsibility to encourage patients to
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 25 of 49

accept immunization when the patient can do so safely” and health care “institutions’
responsibility may extend to requiring immunization of staff.” Id. ¶ 22; see also id.
¶¶ 18–23. These allegations rely on an impermissible “speculative chain of
possibilities,” Clapper, 568 U.S. at 414: the members’ employers would have to (1)
adopt the AMA’s ethics opinion; (2) require their employees to receive or encourage
their patients to receive the vaccines; and (3) discipline or terminate AFLDS’s
members for failing to do so rather than, for example, making an accommodation
for their beliefs. Similarly deficient is the alleged fear of job loss based on
anonymous reports to the National Physician’s Database, Compl. ¶¶ 26, 28, because
it “rest[s] on mere speculation about the decisions of third parties,” Dep’t of Com. v.
New York, 139 S. Ct. 2551, 2566 (2019), i.e., the decisions of unknown parties to
file anonymous reports to the database and the decisions of employers to take
adverse action in response to those reports.16
Even if the threat of being disciplined or fired was a cognizable injury to
AFLDS members, “the independent action[s] of” employers, which are “third
part[ies] not before the court,” are not plausibly traceable to HHS’ challenged
conduct. Lujan, 504 U.S. at 560–61; see also Clapper, 568 U.S. at 414 n.5; Ass’n of
Am. Physicians & Surgeons v. FDA, 2021 WL 4097325, at *11 (6th Cir. Sept. 9,
2021) (rejecting standing theory that “rests on pure guesswork about the decisions

16 Although the Complaint alleges that unnamed doctors have lost their jobs because they refused
to support the administration of the vaccines, Compl. ¶ 18, it does not allege those doctors are
AFLDS members or even have the same employers as AFLDS members. Thus, there is no
indication that AFLDS members face a material risk of imminently losing their jobs.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 26 of 49

of parties not before the court”). Thus, AFLDS has not met its burden to plausibly
allege standing.
In sum, none of the Plaintiffs have plausibly alleged standing. The Complaint
should therefore be dismissed for lack of subject matter jurisdiction.
C. The Emergency Declaration and EUAs Are Unreviewable Under the
APA.
Even if Plaintiffs had standing, they still failed to plausibly allege subject
matter jurisdiction over their APA claims. Agency action is unreviewable under the
APA when it “is committed to agency discretion by law.” 5 U.S.C. § 701(a)(2). This
provision is jurisdictional. Lenis v. U.S. Att’y Gen., 525 F.3d 1291, 1294 (11th Cir.
2008).
The EUA statute provides that HHS’s “[a]ctions under the authority of this
section . . . are committed to agency discretion.” 21 U.S.C. § 360bbb-3(i). Following
this plain statutory language, the Sixth Circuit has held that “emergency-use
authorizations are exempt from review under the APA.” Ass’n of Am. Physicians &
Surgeons v. FDA, 2020 WL 5745974, at *3 (6th Cir. Sept. 24, 2020) (citing 5 U.S.C.
§ 701(a)(2); 21 U.S.C. § 360bbb-3(i)); see Lamie v. U.S. Trustee, 540 U.S. 526, 534
(2004) (“when the statute’s language is plain,” courts should enforce the statute
“according to its terms” (internal quotation marks omitted)).
The Emergency Declaration and vaccine EUAs state that they were issued
under the authority of the EUA statute. Emergency Declaration, 85 Fed. Reg. at
7317; ECF Nos. 24-3, at 2, 4; 24-8, at 2–3; 24-12, at 1–2. Thus, these actions are
committed to agency discretion and unreviewable under the APA.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 27 of 49

Although the plain meaning of 21 U.S.C. § 360bbb-3(i) is dispositive, the
statute’s purpose and structure confirm that HHS’s actions related to an EUA are
committed to agency discretion. See Webster v. Doe, 486 U.S. 592, 600–01 (1988)
(considering statute’s purpose and structure in finding actions were committed to
agency discretion). The EUA statute was part of the Project BioShield Act of 2004.
Pub. L. No. 108-276, 118 Stat. 835. That Act provided for the development and
acquisition of new medical countermeasures against chemical, biological,
radiological, or nuclear agents that might be used against the United States, and
included various new authorities to protect the United States from harm caused by
such agents. Id. at 835. Congress provided EUA authority to FDA specifically to
“streamlin[e] . . . the approval process of countermeasures.” Id.
The EUA statute grants discretion to HHS at key steps of the authorization
process. The Secretary “may” declare “that the circumstances exist justifying” an
EUA, 21 U.S.C. § 360bbb-3(b)(1); “may” issue an EUA, id. §§ 360bbb-3(a)(1), (c);
“may” place “conditions on an authorization” that are “necessary and appropriate to
protect the public health,” id. § 360bbb-3(e)(1)(B); and “may revise or revoke” an
EUA, id. § 360bbb-3(g)(2); see Kingdomware Techs., Inc. v. United States, 136 S.
Ct. 1969, 1977 (2016) (noting that “the word ‘may’ . . . implies discretion”). Thus,
the EUA statute “fairly exudes deference to” HHS, Webster, 486 U.S. at 600, and
reflects Congress’s desire to make HHS’s substantive decisions unreviewable. The
EUA statute’s purpose and structure, therefore, confirm what is clear from its plain
text: The Emergency Declaration and vaccine EUAs are committed to agency
discretion and unreviewable under the APA.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 28 of 49

D. The Court Lacks Jurisdiction over Plaintiffs’ Mandamus Claim
(Count VI).
“The test for jurisdiction is whether mandamus would be an appropriate
means of relief. Mandamus relief is only appropriate when: (1) the plaintiff has a
clear right to the relief requested; (2) the defendant has a clear duty to act; and (3) no
other adequate remedy is available.” Cash v. Barnhart, 327 F.3d 1252, 1257–58
(11th Cir. 2003) (citations omitted) (cleaned up). In other words, a writ
of mandamus “is intended to provide a remedy for a plaintiff only if he has exhausted
all other avenues of relief and only if the defendant owes him a clear
nondiscretionary duty.” Id. (quoting Heckler v. Ringer, 466 U.S. 602, 616 (1984)).
“[M]andamus is an extraordinary remedy which should be utilized only in the
clearest and most compelling of cases.” Id.
HHS does not owe Plaintiffs “a clear nondiscretionary duty” to act. Cash, 327
F.3d at 1257–58 (quoting Heckler, 466 U.S. at 616). To the contrary, the decisions to
issue an emergency declaration or an EUA are expressly “committed to agency
discretion.” 21 U.S.C. § 360bbb-3(i). Indeed, the duty to “ensure the faithful
implementation” of the EUA statute and 45 C.F.R. Part 46, Compl. ¶ 283, is not the
sort of “clear nondiscretionary duty” that a writ of mandamus may compel.
Furthermore, 45 C.F.R. Part 46 does not apply here because the clinical use of a
product within the scope of an EUA is not a clinical investigation, and the clinical
use of such a product and the accompanying adverse event reporting systems are not
“research.” See 21 U.S.C. § 360bbb-3(k); 45 C.F.R. § 46.102(l)(2); supra § I.B.2.b.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 29 of 49

Plaintiffs also have not “exhausted all other avenues of relief” because another
“adequate remedy is available.” Cash, 327 F.3d at 1257–58 (quoting Heckler, 466
U.S. at 616). FDA regulations set out an administrative Citizen Petition process and
require that challenges to FDA action be brought through that process before being
asserted in court.17 21 C.F.R. §§ 10.25(a), 10.45; see infra § II.B.1..
Contrary to Plaintiffs’ argument, PI Mot. at 49–54, Plaintiffs are not excused
from filing a Citizen Petition. “Exhaustion may be excused if a litigant can show:
(1) that requiring exhaustion will result in irreparable harm; (2) that the
administrative remedy is wholly inadequate; or (3) that the administrative body is
biased, making recourse to the agency futile.” Ga. by & through Ga. Vocational
Rehab. Agency v. U.S. by & through Shanahan, 398 F. Supp. 3d 1330, 1343 (S.D.
Ga. 2019). First, Plaintiffs are not at risk of imminent irreparable harm. See infra
§ III.C. Second, a Citizen Petition would not be “wholly inadequate” because, in
response to such a petition, FDA could revoke the vaccine EUAs or the Pfizer
vaccine approval. Finally, Plaintiffs’ speculation about the prospects of any citizen
petition they file, see PI Mot. at 49–54, is insufficient to show the futility of
undertaking that administrative process.18 See Lanfear v. Home Depot, Inc., 536 F.3d

17 Although the Emergency Declaration was issued by the Secretary, not FDA, Plaintiffs could still
challenge it in a Citizen Petition, such as by arguing that the EUAs are improper because the
Emergency Declaration is improper.

18 Notably, FDA continues to evaluate and respond to Citizen Petitions regarding the COVID-19
vaccines. See, e.g., Citizen Petition Response, Dkt. No. FDA-2020-P-1770-0037 (Dec. 14, 2020),
https://go.usa.gov/xMDyP (responding to requests for FDA to take certain actions prior to issuing
EUAs for COVID-19 vaccines); Citizen Petition Responses, Dkt. Nos. FDA-2021-P-0460-30085
(Aug. 23, 2021), https://go.usa.gov/xMDVY (responding to request for FDA to take certain actions
prior to approving a BLA for a COVID-19 vaccine); FDA-2021-P-0529-1077 (Aug. 23, 2021),
https://go.usa.gov/xMDV8 (same).
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 30 of 49

1217, 1225 (11th Cir. 2008) (“[T]he futility exception is about meaningful access to
administrative proceedings, not a potential conflict of interest of the
decisionmakers.”); Bickley v. Caremark RX, Inc., 461 F.3d 1325, 1330 (11th Cir.
2006) (plaintiff’s “claim of futility is merely speculative because he did not even
attempt to pursue the administrative procedure available,” and thus exhaustion was
required).19 As the Eleventh Circuit has emphasized, mandamus must “remain[] an
extraordinary form of relief and not a strategy for avoiding administrative
exhaustion.” Lifestar Ambulance Serv., Inc. v. United States, 365 F.3d 1293, 1298
(11th Cir. 2004).20
In sum, none of the three requirements for mandamus are met. This case is
plainly not among “the clearest and most compelling of cases” that warrant the
“extraordinary remedy” of mandamus. Cash, 327 F.3d at 1257–58.
II.
The Complaint Should Be Dismissed for Failure to State a Claim.
A. Legal Standard
The Court must dismiss the Complaint under Rule 12(b)(6) unless Plaintiffs
have “state[d] a plausible claim for relief.” Iqbal, 556 U.S. at 679. They must plead
sufficient “factual content that allows the court to draw the reasonable inference that

19 If the Court were to find the Emergency Declaration and the EUAs are reviewable under the
APA, it would provide an adequate remedy for Plaintiffs and defeat their mandamus claim. See
Hollywood Mobile Ests. Ltd. v. Seminole Tribe of Fla., 641 F.3d 1259, 1267–68 (11th Cir. 2011).

20 Plaintiffs’ citation of 21 U.S.C. § 355(q)(1)(A), PI Mot. at 48–50, is inapposite because that
provision regulates when the Secretary may “delay approval of a pending application” for new
drug approval or biological product licensure. It is also irrelevant that 21 C.F.R. § 10.30 and the
EUA statute do not expressly reference each other. PI Mot. at 50. FDA regulations require that
“request[s] that the Commissioner take or refrain from taking any form of administrative action,”
including action under the EUA statute, be brought through the Citizen Petition process before
being asserted in court. 21 C.F.R. § 10.45(b).
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 31 of 49

the defendant is liable for the misconduct alleged.” Id.; see also Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 555 (2007) (“Factual allegations must be enough to raise a
right to relief above the speculative level.”). “Threadbare recitals of the elements of
a cause of action” or “unadorned, the-defendant-unlawfully-harmed-me
accusation[s]” do not suffice. Iqbal, 556 U.S. at 678. The Court accepts as true the
Complaint’s “well-pleaded factual allegations,” but it need not accept as true
“conclusory statements” or “legal conclusions.” Id. at 678–79.
B. Counts I–III Fail to State a Claim that the Emergency Declaration and
EUAs Are Unlawful Under the APA.
Counts I–III assert APA claims challenging, respectively, the Emergency
Declaration, the alleged failure to satisfy the criteria for issuance of the vaccine
EUAs, and the alleged failure to satisfy the required conditions of the EUAs. Even
if the Court had jurisdiction over these claims, see supra §§ I.B. and I.C., Counts I–
III still must be dismissed for failure to state a claim. The Complaint does not
challenge HHS’s contemporaneous explanations for the Emergency Declaration and
EUAs in light of the existing administrative record; instead, it impermissibly relies
on alleged evidence that postdates those actions and that was never presented to
HHS. The Complaint thus fails to plausibly allege that those actions were arbitrary
and capricious. Plaintiffs’ remaining arguments are no more convincing.
1. Plaintiffs
Do
Not
Challenge
HHS’s
Contemporaneous
Explanations in Light of the Existing Administrative Record.
“To state a proper claim under the APA,” Plaintiffs “must allege facts that, if
true, plausibly establish that the agency action is arbitrary and capricious.” Blanchett
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 32 of 49

v. DeVos, 490 F. Supp. 3d 26, 32 (D.D.C. 2020); see 5 U.S.C. § 706(2). The Court’s
review of agency action under 5 U.S.C. § 706(2)(A) is “deferential” and “narrow.”
Dep’t of Commerce, 139 S. Ct. at 2569 (quoting Motor Vehicle Mfrs. Ass’n of U.S.
v. State Farm Mut. Automobile Ins. Co., 463 U.S. 29, 43 (1983)). The Court “may
not substitute its own policy judgment for that of the agency,” but “simply ensures
that the agency has acted within a zone of reasonableness and, in particular, has
reasonably considered the relevant issues and reasonably explained the decision.”
FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021). The Court’s review
here is “at its most deferential” because the challenged actions involve “scientific
determination[s]” that are “within [HHS’s] area of special expertise.” Balt. Gas &
Elec. Co. v. Nat. Res. Def. Council, Inc., 462 U.S. 87, 103 (1983). Moreover, “courts
owe significant deference to the politically accountable entities with the
‘background, competence, and expertise to assess public health.’” FDA v. Am. Coll.
of Obstetricians & Gynecologists, 141 S. Ct. 578, 579 (2021) (Roberts, C.J.,
concurring in grant of application for stay).
The “focal point for judicial review” under the APA “should be the
administrative record already in existence, not some new record made initially in the
reviewing court.” Camp v. Pitts, 411 U.S. 138, 142 (1973) (per curiam); Fla. Power
& Light Co. v. Lorion, 470 U.S. 729, 744 (1985) (“The reviewing court is not
generally empowered to conduct a de novo inquiry into the matter being reviewed
and to reach its own conclusions based on such an inquiry.”); Pres. Endangered
Areas of Cobb’s Hist., Inc. v. U.S. Army Corps of Eng’rs, 87 F.3d 1242, 1246 (11th
Cir. 1996). This Court is therefore “limited to evaluating the agency’s
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 33 of 49

contemporaneous explanation in light of the existing administrative record.” Dep’t
of Commerce, 139 S. Ct. at 2573. FDA regulations reflect this principle, providing
that “the validity of [an administrative] action must be determined solely on the basis
of the administrative record” and that “[a]n interested person who wishes to rely
upon information or views not included in the administrative record shall submit
them to the Commissioner with a new [Citizen Petition] to modify the action.” 21
C.F.R. § 10.45(f).
“Under ordinary principles of administrative law,” moreover, “a reviewing
court will not consider arguments that a party failed to raise in timely fashion before
an administrative agency.” Mahon v. U.S. Dep’t of Agric., 485 F.3d 1247, 1254–55
(11th Cir. 2007); see also Drummond Co., Inc. v. Dir., OWCP, 650 F. App’x 690,
693–94 (11th Cir. 2016). This issue exhaustion requirement serves numerous
important policies, including to protect the orderly operation of administrative
processes, “to permit the agency to exercise its discretion or apply its expertise,” and
to “conserve scarce judicial resources.” Mahon, 485 F.3d at 1255.
Here, Counts I–III assert APA challenges to the Emergency Declaration and
EUAs. HHS’s contemporaneous explanations for these actions are contained in the
Secretary’s February 2020 and March 2020 declarations, the EUAs, and the related
FDA Decision Memoranda, which discuss the extensive data supporting FDA’s
conclusions. See Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Review
Memorandum (May 10, 2021), ECF No. 24-5; Pfizer-BioNTech COVID-19 Vaccine
Emergency Use Authorization Review Memorandum (Dec. 11, 2020), ECF No. 24-
4; Moderna COVID-19 Vaccine Emergency Use Authorization Review
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 34 of 49

Memorandum (Dec. 18, 2020), ECF No. 24-9; Janssen COVID-19 Vaccine
Emergency Use Authorization Review Memorandum (Feb. 27, 2021), ECF No. 24-
13. These contemporaneous explanations, based on “scientific determination[s]” that
are “within [HHS’s] area of special expertise,” are entitled to a high degree of
deference. Balt. Gas & Elec. Co., 462 U.S. at 103.
The Complaint does not plausibly allege that HHS’s “contemporaneous
explanations” were unreasonable “in light of the existing administrative record.”
Dep’t of Commerce, 139 S. Ct. at 2573. Instead, it attacks the Emergency Declaration
and EUAs based on evidence that is not in the administrative record. For Count I,
the Complaint challenges the Emergency Declaration based on evidence dating from
after it was issued in February 2020, see, e.g., Compl. ¶¶ 154 & n.7, 163–64, or
based on undated studies, see, e.g., id. ¶¶ 157, 161. And it vaguely asserts that
Plaintiffs “have accumulated and will present expert medical and scientific evidence
further supporting” their contentions, without alleging when this purported evidence
is from or whether it was ever presented to HHS. Id. ¶ 264.
For Count II, which challenges the issuance of the EUAs, the Complaint again
relies on evidence generated after the EUAs were issued, see, e.g., id. ¶¶ 167–68, or
on undated studies, see, e.g., id. ¶¶ 168–72. It also summarizes the purported
findings of “AFLDS medico-legal researchers [who] have analyzed the accumulated
COVID-19 Vaccine risk data,” id. ¶ 181, though it does not allege that these findings
predate the issuance of the EUAs or that they were ever presented to HHS.
Finally, Count III challenges whether the EUAs met the required conditions
to ensure that vaccination providers and recipients are appropriately informed about
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 35 of 49

the vaccines. See 21 U.S.C. § 360bbb-3(e)(1)(A). But Plaintiffs do not contest
FDA’s contemporaneous explanation (i.e., at the time the EUAs were issued) for
why these conditions were met. Instead, the Complaint disputes whether, in fact,
vaccination providers and recipients “are being informed” of the information they
must be provided under the EUA statute. Compl. ¶¶ 269–71. These allegations
necessarily postdate the issuance of the EUAs and do not disturb HHS’s
contemporaneous explanation for how the required conditions were met. The
Complaint also does not allege that its allegations were ever presented to HHS.
Because
the
Complaint
does
not
plausibly
allege
that
HHS’s
“contemporaneous explanations” for the Emergency Declaration and EUAs were
unreasonable “in light of the existing administrative record,” Plaintiffs fail to state
APA claims for Counts I–III. Dep’t of Commerce, 139 S. Ct. at 2573; see also Velez-
Duenas v. Swacina, 875 F. Supp. 2d 1372, 1379 (S.D. Fla. 2012) (dismissing
complaint for failure to state a claim because plaintiff “ask[ed] th[e] Court to
consider documents that were not a part of the administrative record,” which “would
be improper”). Plaintiffs also do not allege that they ever presented their allegations
to HHS, which confirms that they may not rely on these allegations to support Counts
I–III. See Mahon, 485 F.3d at 1254–55. This Court cannot excuse Plaintiffs’ failure
to present their allegations to HHS by conducting a “de novo inquiry” and creating
a new record. Fla. Power & Light Co., 470 U.S. at 744; Camp, 411 U.S. at 142.
2. Plaintiffs’ Remaining Arguments Are Unconvincing.
In Count I, Plaintiffs argue that Home Building & Loan Association v.
Blaisdell, 290 U.S. 398 (1934), and Chastleton Corp. v. Sinclair, 264 U.S. 543
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 36 of 49

(1924), support their reliance on facts postdating the issuance of the Emergency
Declaration, Compl. ¶¶ 257–65. But those cases are inapposite because they
addressed a court’s duty to determine whether an emergency still exists when
evaluating whether emergency laws violate the Constitution. See Blaisdell, 290 U.S.
at 415–16; Chastleton, 264 U.S. at 546. Count I does not assert a constitutional
violation, only an APA challenge to the Emergency Declaration under the EUA
statute. Moreover, the APA, which postdates both Blaisdell and Chastleton, provides
the operative framework for an aggrieved party to challenge a final agency action,
emergency and non-emergency alike. And the APA requires Plaintiffs to show that
HHS’s “contemporaneous explanation” for the Emergency Declaration was
unreasonable “in light of the existing administrative record,” Dep’t of Commerce,
139 S. Ct. at 2573, not based a new record they attempt to create before the court,
see Fla. Power & Light Co., 470 U.S. at 744. Plaintiffs have not done so.21
Regarding Count II, even if Plaintiffs’ allegations were properly before the
Court, they still do not plausibly show the issuance criteria were not met. Plaintiffs
allege that COVID-19 is “not ‘a serious or life-threatening disease or condition’ for
99% of the population.” Compl. ¶ 267(a). But apart from the known risk of death
from COVID-19, Plaintiffs fail to address the risks of other serious conditions that
FDA found to support the EUAs, see ECF Nos. 24-5, at 7–8, 39–42; 24-4, at 9, 50–

21 Although Plaintiffs may not challenge the issuance of the Emergency Declaration under the
APA by alleging that a public health emergency no longer exists, the EUA Statute expressly
accounts for when circumstances change and there is no longer a public health emergency. It
provides that an emergency declaration terminates, inter alia, upon “a determination by the
Secretary … that the [public health emergency] ha[s] ceased to exist.” 21 U.S.C. § 360bbb-
3(b)(2)(A). Plaintiffs have not alleged, however, that that the Secretary was required to make a
determination under section (b)(2)(A).

Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 37 of 49

56; 24-9, at 9–10, 56–61; 24-13, at 9–10, 60–66. Additionally, Plaintiffs allege that
there are “adequate, approved, and available alternative[s]” to the vaccines, 21
U.S.C. § 360bbb-3(c)(3); see Compl. ¶ 267(e), but they misinterpret this standard. It
is immaterial that alternatives have allegedly been “approved by physicians as
meeting the standard of care among similarly situated medical professionals,” id.
¶ 267, because alternative treatments are only “approved” when approved by FDA,
21 U.S.C. § 360bbb-3(a)(2).22 When FDA issued the EUAs, there was no adequate,
approved, and available alternative to the vaccines. See ECF Nos. 24-4, at 9–10; 24-
9, at 10; 24-13, at 9. (That remains true today. See Re-issued Pfizer EUA Letter of
Authorization, at 5 n.9, https://go.usa.gov/xMBXr.).
In Count III, Plaintiffs’ allegations (even if cognizable under the APA) that
vaccination providers and recipients received inadequate information about the
vaccines, Compl. ¶ 270, do not show that HHS violated the EUA statute. Consistent
with the EUA statute, FDA has established “appropriate conditions designed to
ensure” that vaccination providers and recipients are informed of the specified
information. 21 U.S.C. § 360bbb-3(e)(I)(A)(i)–(ii). The EUAs require local health
authorities to give vaccination providers a Fact Sheet for Healthcare Providers
Administering Vaccine, and require vaccination providers to give vaccine recipients
a Fact Sheet for Recipients and Caregivers, in hardcopy or online. ECF Nos. 24-2,
at 9; 24-3, at 6, 10; 24-7, at 5–6; 24-8, at 5, 9; 24-11, at 5; 24-12, at 5, 9. These Fact

22 FDA has clarified that the term “approved” in the EUA statute refers solely to FDA approval.
See Response Letter to Citizen Petition from FDA CBER to Children’s Health Defense, FDA-
2021-P-0460-30085, at 29 & n.83 (Aug. 23, 2021), https://go.usa.gov/xMZNu; FDA, Emergency
Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other
Stakeholders at 3 n.7 (Jan. 2017), https://go.usa.gov/xMaKg.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 38 of 49

Sheets disclose all the information that must be provided to vaccination providers
and recipients, respectively, under the EUAs. See id.
Plaintiffs do not dispute this, but instead allege that vaccination providers and
recipients “are not,” in fact, being informed of the information they must be given.
Compl. ¶¶ 269–71. This allegation is irrelevant, however, to the question of whether
FDA has established “appropriate conditions designed to ensure” that vaccination
providers and recipients are informed of the specified information. 21 U.S.C.
§ 360bbb-3(e)(I)(A)(i)–(ii) (emphasis added).
Plaintiffs also make conclusory allegations that there is an “effort to censor
information” about the vaccines’ efficacy and risks and that “psychological[]
manipulat[ion]” and coercive “rewards and penalties” render “the ‘option to []
refuse’ meaningless.” Compl. ¶¶ 153, 246–49, 270. But the Complaint does not
plausibly allege that HHS is responsible for such censorship, manipulation, or
coercion, which it alternately attributes to “the media,” id. ¶¶ 153, 247; state or
foreign governments, id. ¶¶ 247–48; and private businesses and employers, id. ¶ 248.
As with their prior claims, Plaintiffs fail to plausibly allege any arbitrary or
capricious decision or statutory violation by HHS.
Finally, Plaintiffs allege that “only a fraction (as low as 1%) of adverse events
are reported to VAERS by physicians fearing liability.” Compl. ¶ 270(e). But this
alleged underreporting is not plausibly linked to any challenged action of HHS, and
it does not show that HHS failed to establish “[a]ppropriate conditions for the
monitoring and reporting of adverse events.” 21 U.S.C. § 360bbb-3(e)(1)(A)(iii).
Similarly, it is irrelevant that the public allegedly cannot access reports to V-safe,
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 39 of 49

Compl. ¶ 270(e), because the EUA statute does not require public access to the
adverse event reporting system. Instead, the EUAs establish “[a]ppropriate
conditions for the monitoring and reporting of adverse events,” 21 U.S.C. § 360bbb-
3(e)(1)(A)(iii), and FDA’s actions in establishing those conditions are “committed
to agency discretion,” id. § 360bbb-3(i). Plaintiffs have not plausibly alleged any
APA violation related to the monitoring or reporting of adverse events.
C. Count IV Fails to State a Claim Under Customary International Law.
Count IV alleges that HHS has violated the customary international law norm
requiring informed consent for human medical experimentation, as expressed in the
Declaration of Helsinki and the Nuremberg Code. But “there is no private right of
action for an alleged violation of international law for the protection of human
research subjects under the Declaration of Helsinki and the Nuremberg Code.”
Robertson ex rel. Robertson v. McGee, No. 01CV60, 2002 WL 535045, at *3 (N.D.
Okla. Jan. 28, 2002); see Hoover v. W. Va. Dep’t of Health & Hum. Res., 984 F. Supp.
978, 980 (S.D.W. Va.), aff’d, 129 F.3d 1259 (4th Cir. 1997). Customary international
law is controlling only “where there is no treaty and no controlling executive or
legislative act or judicial decision.” Garcia-Mir v. Meese, 788 F.2d 1446, 1453 (11th
Cir. 1986) (quoting The Paquete Habana, 175 U.S. 677, 700 (1900)) (internal
quotation marks omitted); see also Lee-Lewis v. Kerry, No. 2:13-CV-80, 2017 WL
498717, at *1 (S.D. Ga. Feb. 6, 2017). As Plaintiffs concede, Compl. ¶ 235, the norm
against medical experimentation on non-consenting human subjects is implemented
by 45 C.F.R. Part 46, see, e.g., 45 C.F.R. § 46.116 (“General Requirements for
Informed Consent”). It is “unnecessary to look to international law when human
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 40 of 49

research standards have been effectively promulgated here in the Code of Federal
[Regulations].” Keller v. Strauss, No. 1:10-CV-3282-RWS, 2011 WL 2470631, at *6
(N.D. Ga. June 17, 2011), aff’d, 480 F. App’x 552 (11th Cir. 2012) (citing 45 C.F.R
§§ 46.116 et seq.); see Robertson, 2002 WL 535045, at *3.
The only case about customary international law cited in the Complaint,
Abdullahi v. Pfizer, Inc., 562 F.3d 163 (2d Cir. 2009), is inapposite because it
addressed the Alien Tort Statute, which creates jurisdiction over “any civil action by
an alien for a tort only, committed in violation of the law of nations or a treaty of the
United States.” 28 U.S.C. § 1350; see Abdullahi, 562 F.3d at 172–89. Here, Plaintiffs
do not assert a claim under the Alien Tort Statute.
D. Count V Fails to State a Claim Under 45 C.F.R. Part 46.
Count V alleges that HHS violated 45 C.F.R. Part 46, which implements the
customary international law norm requiring informed consent for human medical
experimentation. As discussed above, however, that regulation is inapplicable here
because the use of a product for clinical care within the scope of an EUA and the
accompanying adverse event reporting systems are not a “clinical investigation” or
“research.” 21 U.S.C. § 360bbb-3(k); see supra § I.B.2.b.
E. Count VI Fails to State a Mandamus Claim.
As discussed above in the context of jurisdiction, mandamus would not “be
an appropriate means of relief.” Cash, 327 F.3d at 1257–58; supra § I.D. Thus,
Plaintiffs have failed to state a mandamus claim.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 41 of 49

III.
Plaintiffs’ Motion for a Preliminary Injunction Should Be Denied.
A. Legal Standard
“A plaintiff seeking a preliminary injunction must establish [1] that he is likely
to succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence
of preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an
injunction is in the public interest.” Winter v. Nat. Res. Def. Council, Inc., 555 U.S.
7, 20 (2008). “[A] preliminary injunction is an extraordinary and drastic remedy not
to be granted unless the movant clearly established the ‘burden of persuasion’ as to
each of the four prerequisites.” Siegel v. LePore, 234 F.3d 1163, 1176 (11th Cir.
2000) (en banc) (per curiam); see also Brown v. Sec’y, U.S. Dep’t of Health & Hum.
Servs., 4 F.4th 1220, 1224 (11th Cir. 2021) (a preliminary injunction is “the
exception rather than the rule”). “Because the government is the party opposing
a preliminary injunction here, its interest and harm merge with the public interest, so
[the Court] may consider the third and fourth factors together.” Brown, 4 F.4th at
1224 (internal quotation marks omitted).
Plaintiffs seek the mandatory relief of invalidating the EUAs and prohibiting
vaccine approval. “[W]hen a plaintiff applies for a mandatory preliminary
injunction, such relief should not be granted except in rare instances in which the
facts and law are clearly in favor of the moving party.” Exhibitors Poster Exch., Inc.
v. Nat’l Screen Serv. Corp., 441 F.2d 560, 561–62 (5th Cir. 1971) (internal quotation
marks omitted).23 Plaintiffs have not met their burden of persuasion on any of the
prerequisites for a preliminary injunction. See Siegel, 234 F.3d at 1176.

23 See Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir. 1981) (en banc) (adopting as
precedent all decisions of the former Fifth Circuit that were issued up to September 30, 1981).
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 42 of 49

B. Plaintiffs Are Not Likely to Succeed on the Merits.
As discussed above, the Complaint must be dismissed because Plaintiffs have
not met their burden of plausibly alleging subject matter jurisdiction and claims upon
which relief can be granted. For the same reasons, Plaintiffs have not shown a
likelihood of success on the merits. See Klay v. United Healthgroup, Inc., 376 F.3d
1092, 1097–98 (11th Cir. 2004) (“For a traditional injunction to be even theoretically
available, a plaintiff must be able to articulate a basis for relief that would withstand
scrutiny under Fed. R. Civ. P. 12(b)(6).”). And like the Complaint, Plaintiffs’ motion
relies on evidence that is beyond the scope of “the existing administrative record,”
Dep’t of Commerce, 139 S. Ct. at 2573, and that Plaintiffs “failed to raise” before
HHS, Mahon, 485 F.3d at 1254–55; see Velez-Duenas, 875 F. Supp. 2d at 1379.
Plaintiffs’ motion also impermissibly asserts new claims against HHS that are
not rooted in the Complaint. To obtain a preliminary injunction, a plaintiff must show
“it has a substantial likelihood of success on the merits of the underlying case when
the case is ultimately tried.” Alabama v. U.S. Army Corps of Eng’rs, 424 F.3d 1117,
1128 (11th Cir. 2005); see id. at 1134 (plaintiff “must demonstrate a substantial
likelihood of prevailing on at least one of the causes of action he has asserted”). “A
district court should not issue an injunction” that “is not of the same character, and
deals with a matter lying wholly outside the issues in the suit.” Kaimowitz v.
Orlando, 122 F.3d 41, 43 (11th Cir. 1997), opinion amended on reh’g, 131 F.3d 950
(11th Cir. 1997)); see also Bruce v. Reese, 431 F. App’x 805, 806 n.1 (11th Cir. 2011).
Here, Plaintiffs seek a preliminary injunction to protect the “constitutional
right[s] to personal autonomy and bodily integrity.” PI Mot. at 61. But the Complaint
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 43 of 49

asserts those rights only in Count VII, which seeks money damages against Secretary
Becerra, Dr. Fauci, and Dr. Woodcock in their individual capacities, see Compl.
¶¶ 286–96—a count Plaintiffs intend to abandon. The Complaint does not assert
those rights as a basis for injunctive relief against HHS, and thus Plaintiffs cannot
show “a substantial likelihood of success on the merits of the underlying case.” U.S.
Army Corps of Eng’rs, 424 F.3d at 1128.
Plaintiffs’ motion also impermissibly seeks relief that is not requested in the
Complaint. “[I]njunctive relief must relate in some fashion to the relief requested in
the complaint” and must be “of the same character as that which may be granted
finally.” Id. at 1134 (citing Klay, 376 F.3d at 1097–98; Kaimowitz, 122 F.3d at 43).
Here, Plaintiffs ask the Court to bar FDA from approving the vaccines, PI Mot. at
65–66, but the Complaint does not request this relief; instead, it focuses on the
Emergency Declaration and vaccine EUAs. FDA approvals of vaccines are new
agency actions governed by a different statutory standard than EUAs, see 42 U.S.C.
§ 262(a); 21 C.F.R. § 601.2, and would need to be challenged through new APA
claims. Moreover, because FDA has already approved Pfizer’s vaccine, Plaintiffs’
request to enjoin such approval is moot. Plaintiffs would need to plead a separate
claim that FDA was required to revoke Pfizer’s license, which is governed by a
different statutory standard than granting a license in the first instance. See 42 U.S.C.
§ 262(a)(2)(A); 21 C.F.R. § 601.5(b). Thus, Plaintiffs cannot show a substantial
likelihood of success regarding their request to enjoin the vaccine approvals.
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 44 of 49

C. Plaintiffs Have Not Shown Irreparable Harm.
A preliminary injunction is designed to protect a plaintiff from future
irreparable harm it would suffer “before a case can be resolved on its merits.” Wreal,
LLC v. Amazon.com, Inc., 840 F.3d 1244, 1248 (11th Cir. 2016); see also Brown v.
Sec’y of Health & Hum. Servs., 4 F.4th 1220, 1225 (11th Cir. 2021). Preventing
future irreparable harm is “the sine qua non of injunctive relief.’” U.S. Army Corps
of Eng’rs, 424 F.3d at 1133.
Plaintiffs’ irreparable harm argument is based on the alleged injuries of
Boone, Deselle, the Estate of Dovi Sanders Kennedy, Galvin, Mills, Simmonds, and
Vidiella. See PI Mot. at 61–64. These Plaintiffs allegedly suffered side effects from
the vaccines and did not receive adequate information about them. See id. But they
do not face irreparable harm in the future, let alone in the period between when they
filed the preliminary injunction motion and when this case could be resolved on the
merits. See Wreal, 840 F.3d at 1248.
Plaintiffs attempt to bootstrap irreparable harm through supposed “harm to the
public.” PI Mot. at 63. But this argument is foreclosed by the Supreme Court’s
admonition that a plaintiff must show “he is likely to suffer irreparable harm” absent
an injunction. Winter, 555 U.S. at 20 (emphasis added); see also Siegel, 234 F.3d at
1176 n.9. For the same reason, Plaintiffs cannot show irreparable harm based on
alleged harm to Diana Hallmark, a non-party. See PI Mot. at 61–64.
Finally, courts “have found that a party’s failure to act with speed or urgency
in moving for a preliminary injunction necessarily undermines a finding
of irreparable harm.” Wreal, 840 F.3d at 1248. A delay of “even only a few
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 45 of 49

months . . . militates against a finding of irreparable harm” because “[a] preliminary
injunction requires showing ‘imminent’ irreparable harm.” Id. (quoting Siegel, 234
F.3d at 1176–77). Here, Plaintiffs delayed almost two months after the Court denied
their TRO motion on May 24 before requesting a preliminary injunction on July 19.
This delay “necessarily undermines a finding of irreparable harm.” Id.
D. Plaintiffs Have Not Shown that the Balance of Equities Favors Them
or that an Injunction Is in the Public Interest.
The balance of equities and the public interest strongly favor HHS because
Plaintiffs’ requested relief would greatly harm the public. “Stemming the spread of
COVID-19 is unquestionably a compelling interest.” Roman Cath. Diocese of
Brooklyn v. Cuomo, 141 S. Ct. 63, 67 (2020). COVID-19 has already infected over
40.5 million Americans, hospitalized over 2.8 million, and killed over 652,000. The
vaccines have been shown to be effective at protecting people from COVID-19,
especially severe illness and death, and at reducing the risk of spreading the virus
that causes COVID-19. So far, over 210 million Americans have received at least
one dose of a COVID-19 vaccine, and over the past week, an average of over half a
million Americans per day received a vaccine.24 There is a compelling public interest
in ensuring that Americans who want to get vaccinated continue to have access to
the vaccine.

24 COVID Data Tracker Weekly Review: Interpretive Summary for Sept. 10, 2021,
https://go.usa.gov/xFU9U; New Hospital Admissions, https://go.usa.gov/xFU9K (last updated
Sept. 15, 2021); CDC, Benefits of Getting a COVID-19 Vaccine, https://go.usa.gov/xFPes (last
updated Aug. 16, 2021); COVID-19 Vaccinations in the United States, https://go.usa.gov/xFQXD
(posted Sept. 15, 2021).
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 46 of 49

Although several Plaintiffs have decided not to get vaccinated, they do not ask
merely to be exempt from a hypothetical vaccine mandate. Instead, they seek to
invalidate the EUAs and prevent FDA from approving the vaccines, which would
deprive millions of Americans of the opportunity to get vaccinated against COVID-
19 and would interfere with HHS’s efforts to combat the pandemic. The balance of
equities and the public interest strongly oppose the requested injunction.
CONCLUSION
For the foregoing reasons, the Court should dismiss all of Plaintiffs’ claims
pursuant to Federal Rules of Civil Procedure 12(b)(1), 12(b)(3), and 12(b)(6), and
should deny Plaintiffs’ motion for a preliminary injunction.

Dated: September 16, 2021

OF COUNSEL:
DANIEL BARRY
Acting General Counsel
U.S. Department of Health and Human
Services
PERHAM GORJI
Deputy Chief Counsel, Litigation
JAMES ALLRED
Associate Chief Counsel
Office of the Chief Counsel
U.S. Food and Drug Administration
10903 New Hampshire Avenue
White Oak 31
Silver Spring, MD 20993-0002

Respectfully submitted,

BRIAN M. BOYNTON
Acting Assistant Attorney General

ARUN G. RAO
Deputy Assistant Attorney General
GUSTAV W. EYLER
Director
HILARY K. PERKINS
Assistant Director
/s/ Isaac C. Belfer

ISAAC C. BELFER
Trial Attorney
/s/ James W. Harlow

JAMES W. HARLOW
Senior Trial Attorney
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 47 of 49

Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, DC 20044-0386
Tel: (202) 305-7134 (Belfer)
Tel: (202) 514-6786 (Harlow)
Fax: (202) 514-8742
Email: Isaac.C.Belfer@usdoj.gov
Email: James.W.Harlow@usdoj.gov

PRIM F. ESCALONA
United States Attorney
DON B. LONG, III
Assistant United States Attorney
United States Attorney’s Office
Northern District of Alabama
1801 Fourth Avenue North
Birmingham, Alabama 35203
Tel: (205) 244-2106
Fax: (204) 244-2171
Email: Don.Long2@usdoj.Gov

Counsel for Defendants Xavier Becerra,
Secretary of Health and Human
Services, in his official capacity only;
Dr. Anthony Fauci, Director of the
National Institute of Allergy and
Infectious Diseases, in his official
capacity only; Dr. Janet Woodcock,
Acting Commissioner of Food and
Drugs, in her official capacity only; the
U.S. Department of Health and Human
Services; the Food and Drug
Administration; the Centers for Disease
Control and Prevention; the National
Institutes of Health; and the National
Institute of Allergy and Infectious
Diseases
Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 48 of 49

CERTIFICATE OF SERVICE
I hereby certify that on September 16, 2021, I electronically filed the
foregoing with the Clerk of the Court using the CM/ECF system, which will send
notification of such filing to counsel of record.

/s/ James W. Harlow

JAMES W. HARLOW
Senior Trial Attorney

Case 2:21-cv-00702-CLM Document 25 Filed 09/16/21 Page 49 of 49

File and source

File: gov.uscourts.alnd.177186.25.0.pdf
Size: 295,323 bytes
SHA-256: 1db3a184e17e96f556e06cb8895e0a38e79de56726a89020570d04b6f83b8395
Our copy: gov.uscourts.alnd.177186.25.0.pdf
Original: archive.org

Combined Memorandum of Law in Support of Defendants’

Full text

File and source

Related records