Combined Memorandum Of Law In Support Of

Date: 2021-12-17

Full text

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

AMERICA’S FRONTLINE
DOCTORS, et al.,

Plaintiffs,

UNITED STATES OF AMERICA, et
al.,

Defendants.

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

COMBINED MEMORANDUM OF LAW IN SUPPORT OF
DEFENDANTS’ MOTION TO DISMISS THE AMENDED COMPLAINT,
AND IN OPPOSITION TO PLAINTIFFS’ MOTION FOR A
PRELIMINARY INJUNCTION

FILED
2021 Dec-17 PM 07:56
U.S. DISTRICT COURT
N.D. OF ALABAMA
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TABLE OF CONTENTS
INTRODUCTION ............................................................................................................ 1
BACKGROUND ............................................................................................................. 3
I.
The Federal Government’s Responses to the COVID-19 Pandemic ......... 3
A.
HHS Secretary’s Emergency Declaration .................................................. 3
B.
FDA’s Issuance of EUAs for COVID-19 Vaccines ................................... 4
C.
FDA’s Approval of the Pfizer COVID-19 Vaccine. .................................. 6
D.
President Biden Orders COVID-19 Safety Measures for Federal
Employees and Contractors. ....................................................................... 7
II.
Procedural History ...................................................................................... 9
ARGUMENT ............................................................................................................... 10
I.
This Case Should Be Dismissed for Lack of Subject Matter
Jurisdiction. ............................................................................................... 10
A.
Legal Standard .......................................................................................... 10
B.
The Court Lacks Jurisdiction to Review the Actions Taken Under the
EUA Statute (Counts I, III–VI). ............................................................... 11
1. Standing .................................................................................................... 11
2. Counts I, III, and IV Are Unreviewable Under the APA. ........................ 14
3. Neither the Mandamus Statute (Count V) nor the Declaratory
Judgment Act (Count VI) Supplies Jurisdiction. ..................................... 15
C.
The Court Lacks Jurisdiction over the Claims Related to the
Executive Orders (Counts II, VI). ............................................................ 17
1. The President Should Be Dismissed as a Defendant................................ 17
2. Standing, Ripeness, and the Civil Service Reform Act Bar Plaintiffs’
Challenge to EO 14043. ........................................................................... 18
3. No Plaintiff Properly Challenges EO 14042. ........................................... 21
II.
The Amended Complaint Should Be Dismissed for Failure to
State a Claim. ............................................................................................ 23
A.
Legal Standard .......................................................................................... 23
B.
Defendants Untethered to Any Count Must Be Dismissed. ..................... 24
C.
Counts I, III, and IV Fail to State a Claim that the Emergency
Declaration and EUAs Are Unlawful Under the APA. ............................ 24
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iii

1. Plaintiffs Do Not Challenge HHS’s Contemporaneous Explanations
in Light of the Existing Administrative Record. ...................................... 24
2. Plaintiffs’ Remaining Arguments Fail. .................................................... 26
D.
Counts II and VI Fail to State a Claim that the Executive Orders Are
Unlawful. .................................................................................................. 30
1. Plaintiffs Have Not Plausibly Alleged that the Executive Orders Are
Unconstitutional. ...................................................................................... 30
2. Plaintiffs Have Not Plausibly Alleged that the Executive Orders
Exceed the President’s Statutory Authority. ............................................ 34
III.
Plaintiffs’ Preliminary Injunction Motion Should Be Denied. ................ 38
A.
Legal Standard .......................................................................................... 38
B.
Plaintiffs Are Not Likely to Succeed on the Merits. ................................ 38
C.
Plaintiffs Have Not Shown Imminent, Irreparable Harm. ....................... 42
D.
Neither the Equities nor the Public Interest Favors an Injunction. .......... 44
CONCLUSION ............................................................................................................. 45

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INTRODUCTION
The United States remains in the midst of a serious public health crisis. To
date, the virus that causes COVID-19 has infected more than 50 million Americans,
hospitalized more than 3.5 million, and killed over 800,000.1 Fortunately, a key tool
for ending this crisis is readily available: vaccination. Beginning in December 2020,
the U.S. Food and Drug Administration (“FDA”) issued Emergency Use
Authorizations (“EUAs”) to COVID-19 vaccines manufactured by Pfizer, Inc. and
BioNTech Manufacturing GmbH (“Pfizer”), ModernaTX, Inc. (“Moderna”), and
Johnson & Johnson/Janssen Biotech, Inc. (“Janssen”). In August 2021, FDA
approved the Pfizer vaccine.
In September 2021, the President sought to mitigate the impact of COVID-19
on federal operations through two executive orders (“EOs”). In EO 14043, the
President “determined that ensuring the health and safety of the Federal workforce
and the efficiency of the civil service” required “COVID-19 vaccination for all
Federal employees, subject to such exceptions as required by law.” 86 Fed. Reg.
50,989 (Sept. 14, 2021). EO 14042 sought to “promote[] economy and efficiency in
Federal procurement” by directing agencies to include a clause in certain contracts
requiring federal contractors to comply with “workplace safety guidance” regarding
COVID-19, provided that the guidance is approved by the Director of the Office of
Management and Budget (“OMB”). 86 Fed. Reg. 50,985 (Sept. 14, 2021).

1 See Centers for Disease Control and Prevention (“CDC”), COVID Data Tracker Weekly Review
(updated Dec. 17, 2021), https://go.usa.gov/xFU9U.
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Plaintiffs object to these sound measures to protect the health and safety of
federal employees and contractors. Their objections verge on the conspiratorial—
e.g., that there is no public health emergency and that the American people have been
psychologically manipulated. To resolve this motion to dismiss, however, the Court
need not engage with those objections, but need only apply well-established
jurisdictional principles and pleading standards.
Plaintiffs’ six claims may be grouped into two categories. First, Counts I, III,
IV, V, and VI challenge actions taken under the EUA statute, 21 U.S.C. § 360bbb-3,
specifically the Secretary of Health and Human Services’ (the “HHS Secretary”)
declaration of a public health emergency and FDA’s issuance of EUAs for COVID-
19 vaccines. But Plaintiffs do not have standing to assert these claims, and Congress
expressly exempted actions under the EUA statute from review under the
Administrative Procedure Act (“APA”). Even if the Court reaches the merits,
Plaintiffs have not stated plausible APA claims.
Second, Counts II and VI challenge EOs 14042 and 14043 (collectively, the
“Executive Orders”). But Plaintiffs have not established standing or that their claims
are ripe. No Plaintiff is threatened with forcible vaccination or imminent adverse
employment action from refusing vaccination. The federal-employee Plaintiffs
(Leahy and Nelson) have accommodation requests pending with their employer. If
they were subjected to an adverse action, the Civil Service Reform Act would
deprive this Court of jurisdiction. The federal-contractor Plaintiffs (Makowski,
Millen, Bloom, and Sobczak) have not even shown that EO 14042 applies to them,
let alone that their employers denied any accommodation requests.
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Even if the Court reaches the merits, the Amended Complaint does not
plausibly allege that the Executive Orders are unlawful. They do not deprive
Plaintiffs of substantive due process, and they fall within the President’s statutory
authority over federal employment and the federal procurement process.2
At a minimum, Plaintiffs are not entitled to the extraordinary relief of
preliminarily enjoining the Executive Orders. Besides no likelihood of success on
the merits, Plaintiffs have not shown they will suffer any imminent, irreparable harm
before this case is resolved on the merits. Any employment-related injuries are
generally redressable through back pay and reinstatement. Finally, given the federal
government’s compelling interest in stemming the spread of COVID-19 and the
public interest in effective government administration, the balance of hardships and
the public interest weigh heavily against the requested injunction.
BACKGROUND
I.
The Federal Government’s Responses to the COVID-19 Pandemic
A. HHS Secretary’s Emergency Declaration
In the EUA statute, Congress authorized the HHS Secretary to determine that
a “public health emergency . . . affects, or has a significant potential to affect,
national security or the health and security of United States citizens living abroad.”
21 U.S.C. § 360bbb-3(b)(1)(C). The Secretary may then further declare that
circumstances exist justifying the marketing of FDA-regulated products “intended

2 Defendants acknowledge that the Southern District of Georgia has issued a nationwide
preliminary injunction enjoining enforcement of EO 14042, though this decision has been
appealed. Georgia v. Biden, No. 1:21-CV-163, 2021 WL 5779939, at *12 (S.D. Ga. Dec. 7, 2021),
appeal filed, No. 21-14269 (11th Cir. Dec. 10, 2021).
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for use” in responding to the emergency. Id. § 360bbb-3(a)(1), (b). Congress
expressly committed these decisions to the Secretary’s discretion. Id. § 360bbb-3(i).
Under that authority, the HHS Secretary determined on February 4, 2020 that
a public health emergency existed involving the virus SARS-CoV-2, which causes
COVID-19. Determination of Public Health Emergency, 85 Fed. Reg. 7316, 7317
(Feb. 7, 2020) (“Emergency Declaration”). On March 27, 2020, the Secretary
declared that “circumstances exist justifying the authorization of emergency use of
drugs and biological products during the COVID-19 pandemic.” Emergency Use
Authorization Declaration, 85 Fed. Reg. 18,250, 18,250–51 (Apr. 1, 2020).
B. FDA’s Issuance of EUAs for COVID-19 Vaccines
Normally, a manufacturer of a biological product, such as a vaccine, may
market it “only if the FDA has licensed it” pursuant to the Public Health Service Act.
Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1670 (2017); see 42 U.S.C. § 262(i)(1).
But when the Secretary has made the required declarations under the EUA statute,
FDA may issue an EUA for a vaccine intended for use in responding to the
emergency. 21 U.S.C. § 360bbb-3(c). FDA’s decision to issue an EUA is committed
to agency discretion. Id. § 360bbb-3(i).3
FDA has issued EUAs for COVID-19 vaccines manufactured by Pfizer,
Moderna, and Janssen. See ECF Nos. 40-6; 40-14; 40-20.4 Based on its review of

3 Issuance of an EUA does not constitute approval of the product. See 21 U.S.C. § 360bbb-3(a)(3).
4 Subject matter jurisdiction is determined as of the time at which the Amended Complaint was
filed. See Rockwell Int’l Corp. v. United States, 549 U.S. 457, 473–74 (2007). For that reason, this
brief cites the FDA documents that were in effect when the Court permitted the corrected Amended
Complaint to be filed on November 5, 2021. See ECF No. 33. Like other information on
government websites cited herein, these exhibits were “publicly available on FDA’s website,” ECF
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extensive safety and efficacy data, including clinical trials with tens of thousands of
participants, see ECF Nos. 40-7; 40-8; 40-9; 40-10; 40-11; 40-15; 40-16; 40-17; 40-
21; 40-22; see also 21 U.S.C. § 360bbb-3(c), FDA found 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. 40-6, at 9; 40-14, at 6; 40-20, at 4–5.
The EUAs require vaccination providers to give recipients a “Fact Sheet for
Recipients and Caregivers” (collectively, the “Fact Sheets”), either in hardcopy or
online. ECF Nos. 40-6, at 13–14, 17; 40-14, at 8, 12; 40-20, at 6–7, 10; see, e.g.,
ECF No. 40-3, at 15–16.5 The Fact Sheets advise that “[i]t is your choice to receive
or not receive” the vaccine. E.g., ECF No. 40-1, at 7. The Moderna and Janssen Fact
Sheets 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” product and is authorized based on a determination
that it “may be effective to prevent COVID-19.” E.g., ECF No. 40-12, at 3–4, 7. The
Fact Sheets disclose the vaccines’ potential side effects and warn that other “[s]erious
and unexpected side effects may occur.” E.g., ECF No. 40-1, at 5–6.

No. 40, at ¶ 6, and are subject to judicial notice, 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).
5 This paragraph cites the Pfizer fact sheets, but except as otherwise noted, the same information
is also in the Moderna and Janssen fact sheets. See ECF Nos. 40-12; 40-13; 40-18; 40-19.
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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.” HHS, About VAERS, https://go.usa.gov/xFEc6 (last visited Dec. 17,
2021); see ECF Nos. 40-6, at 15–18; 40-14, at 10, 12; 40-20, at 8, 10. 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 (updated Nov. 9, 2021).
C. FDA’s Approval of 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. ECF No. 41-1. FDA’s decision was based on effectiveness data from
approximately 20,000 vaccine recipients and 20,000 placebo recipients, which
showed that the vaccine was over 91% effective in preventing COVID-19 and
between 95% and 100% effective in preventing severe COVID-19. See ECF Nos.
41, at ¶ 16; 41-7, at 7–14. FDA also relied on safety data from approximately 12,000
vaccine recipients monitored for at least six months and from the millions of vaccine
doses administered under the EUA, which showed that the product was safe. ECF
No. 41-7, at 13. Although Comirnaty is now approved for individuals ages 16 and
older to receive the standard two-dose series, the Pfizer EUA remains in effect,
including for individuals ages 5 and older and to provide a third dose to certain
individuals. See ECF No. 41-2.
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On December 16, 2021, FDA approved a second formulation of Comirnaty.
Notably, the two formulations of Comirnaty are the same as the two formulations
authorized under the Pfizer EUA. ECF No. 41, at ¶ 11–12. Although the approved
and EUA-authorized products are legally distinct with certain differences, such as in
labeling, the products are “medically interchangeable.” Id. ¶ 13. For individuals ages
12 and older, FDA has determined that both formulations of Comirnaty and the
EUA-authorized Pfizer vaccine, “when prepared according to their respective
instructions for use, can be used interchangeably without presenting any safety or
effectiveness concerns.” Id. ¶ 12.
D. President Biden Orders COVID-19 Safety Measures for Federal
Employees and Contractors.
On September 9, 2021, President Biden issued EOs 14042 and 14043,
addressing COVID-19 safety measures for federal civilian employees and
contractors. Neither Executive Order is self-effectuating; rather, both require
additional implementing actions from federal agencies.
In EO 14043, the President “determined that ensuring the health and safety of
the Federal workforce and the efficiency of the civil service” requires “COVID-19
vaccination for all Federal employees, subject to such exceptions as required by
law.” 86 Fed. Reg. at 50,989. Accordingly, EO 14043 directs each federal agency to
implement a COVID-19 vaccination program for its employees, and directs the Safer
Federal Workforce Task Force (“Task Force”) to issue guidance to agencies on the
implementation of EO 14043. Id. at 50,990.
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The Task Force guidance, like EO 14043, recognizes that federal employees
may be eligible for “a reasonable accommodation” if they “communicate to the
agency that they are not vaccinated against COVID-19 because of a disability or
because of a sincerely held religious belief, practice, or observance.” See Task Force,
Vaccinations Frequently Asked Questions, https://go.usa.gov/xe9CV (last visited
Dec. 17, 2021) (“Employee FAQs”). The guidance advises each agency to “follow
its ordinary process to review and consider what, if any, accommodation it must
offer.” Id. Although federal employees should have been vaccinated by November
22, 2021, the guidance advises that they should not face discipline if they have
“received an exception” or if the agency is considering their exception request. Id.
EO 14042 “promotes economy and efficiency in Federal procurement by
ensuring that the parties that contract with the Federal Government provide adequate
COVID-19 safeguards to their workers performing on or in connection with a
Federal Government contract.” 86 Fed. Reg. at 50,985. The order instructs Executive
departments and agencies, “to the extent permitted by law,” to incorporate a COVID-
19 safety clause into certain new contracts. Id. That clause requires that contractors
and subcontractors comply with guidance developed by the Task Force and approved
by the OMB Director after she concludes that adherence to the provisions “will
promote economy and efficiency in Federal contracting.” Id. The clause would be
included in new contracts executed after October 15, 2021, and in existing contracts
upon an extension or modification event. Id. at 50,987.
On November 10, 2021, the Acting OMB Director approved the issuance of
the Task Force’s current guidance based on “OMB’s expert opinion that the
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[g]uidance will promote economy and efficiency in Federal Government
procurement.” OMB Determination, 86 Fed. Reg. 63,418, 63,423 (Nov. 16, 2021).6
The guidance provides that “covered contractor employees” must be fully vaccinated
by January 18, 2022, unless they are “legally entitled to an accommodation.” Id. at
63,420; see id. at 63,419. Contractors “may be required to provide an
accommodation” if an employee communicates that she is not vaccinated “because
of a disability (which would include medical conditions) or because of a sincerely
held religious belief, practice, or observance.” Id. The contractor must “review and
consider what, if any, accommodation it must offer.” Id.
II.
Procedural History
On May 19, 2021, Plaintiffs filed a motion for a Temporary Restraining Order
to enjoin the extension of the EUAs to children under the age of 16, ECF No. 1,
which the Court denied sua sponte, ECF No. 3. Plaintiffs later filed their initial
complaint, seeking invalidation of the Emergency Declaration and EUAs. See ECF
No. 10. They then moved for a preliminary injunction to invalidate the EUAs and
enjoin FDA from approving the vaccines. ECF No. 15. On September 16, 2021,
Defendants opposed Plaintiffs’ preliminary injunction motion and moved to dismiss
the complaint under Federal Rule of Civil Procedure 12(b)(1), (b)(3), and (b)(6). See
ECF Nos. 23–25. Plaintiffs then withdrew their preliminary injunction motion and
received an extension of time to amend their complaint. See ECF Nos. 27, 29.

6 This OMB determination “rescind[ed] and supersede[d]” a prior determination by the OMB
Acting Director. 86 Fed. Reg. at 63,418.
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On November 5, 2021, the Court allowed Plaintiffs to file the operative
Amended Complaint. Am. Compl., ECF No. 32-1; see ECF No. 33. Plaintiffs raise
claims regarding the Emergency Declaration, EUAs, and Executive Orders under
the APA, substantive due process, 28 U.S.C. § 1361 (mandamus), and the
Declaratory Judgment Act. Am. Compl. ¶¶ 169–92. On November 19, 2021,
Plaintiffs filed a new motion for a preliminary injunction. PI Mot., ECF No. 37.
Defendants now move to dismiss the Amended Complaint under Federal Rule of
Civil Procedure 12(b)(1) and (b)(6), and oppose the preliminary injunction motion.
ARGUMENT
I. This Case Should 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). Subject matter jurisdiction must “be
established as a threshold matter.” Steel Co. v. Citizens for a Better Env’t, 523 U.S.
83, 94–95 (1998). The Court “presume[s]” to “lack jurisdiction” unless Plaintiffs
meet their “burden of establishing it.” DaimlerChrysler Corp. v. Cuno, 547 U.S. 332,
342 n.3 (2006) (quotations omitted)); see Brownback v. King, 141 S. Ct. 740, 749
(2021) (plaintiff “must plausibly allege all jurisdictional elements”).
Where, as here, Defendants factually attack subject matter jurisdiction, the
Court does not “presum[e] the truthfulness of the plaintiff’s allegations.” Makro
Cap. of Am., Inc. v. UBS AG, 543 F.3d 1254, 1258 (11th Cir. 2008) (quotation
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omitted). Rather, it “may consider extrinsic evidence,” including declarations, and
“weigh the evidence” to determine whether it has jurisdiction. Id.
B. The Court Lacks Jurisdiction to Review the Actions Taken Under the
EUA Statute (Counts I, III–VI).
Counts I, III, IV, V, and VI challenge actions taken under the EUA statute. For
several reasons, however, the Court lacks jurisdiction over each count.
1. Standing
To show standing, Plaintiffs “must clearly allege . . . facts demonstrating”
(1) an injury in fact that is “concrete, particularized, and actual or imminent”;
(2) “fairly traceable” to Defendants’ challenged actions; and (3) likely “redressable
by a favorable ruling.” Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016); Clapper v.
Amnesty Int’l USA, 568 U.S. 398, 409 (2013). Plaintiffs “must demonstrate standing
for each claim . . . and for each form of relief.” TransUnion LLC v. Ramirez, 141 S.
Ct. 2190, 2208 (2021). Here, Plaintiffs lack standing for all claims and requested
relief related to the Emergency Declaration or EUAs.
America’s Frontline Doctors (“AFLDS”) alleges no concrete injury to itself
from the mere existence of the Emergency Declaration and EUAs. See Jacobson v.
Fla. Sec’y of State, 974 F.3d 1236, 1249–50 (11th Cir. 2020). Likewise, AFLDS
lacks standing “to bring suit on behalf of its members” because it has not shown any
member “would otherwise have standing to sue in their own right.” Ga. Republican
Party v. SEC, 888 F.3d 1198, 1203 (11th Cir. 2018) (quoting Friends of the Earth,
Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 181 (2000)); see Am. Compl.
¶ 13. AFLDS must, among other things, “make specific allegations establishing that
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at least one identified member has suffered or will suffer harm,” and “self-
descriptions of its membership” are insufficient. Ga. Republican Party, 888 F.3d at
1203 (cleaned up); see Jacobson, 974 F.3d at 1249.
AFLDS does not identify a member who suffered a “concrete, particularized,
and actual or imminent” injury. Muransky v. Godiva Chocolatier, Inc., 979 F.3d 917,
925 (11th Cir. 2020) (en banc). It alleges only that unidentified members object to
(1) an American Medical Association (“AMA”) “ethical opinion”; (2) the possibility
that their unknown employers will adopt the AMA’s view; (3) unspecified vaccine
mandates by unknown employers; and (4) hypothetical complaints in the National
Physicians Database. Am. Compl. ¶¶ 7–9, 11. These allegations impermissibly rely
on a “speculative chain of possibilities,” Clapper, 568 U.S. at 414, before any injury
could become “real,” Muransky, 979 F.3d at 925. And none are “fairly traceable” to
Defendants’ conduct, which is entirely separate from the independent actions of the
AMA, AFLDS members’ employers, or the database complainants. Clapper, 568
U.S. at 409; Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992) (injury must not
result from “the independent action of some third party not before the court”
(quotations omitted)). Accordingly, AFLDS lacks standing.
Dr. Calderwood also lacks standing to represent his patient Makowski. Absent
an “injury in fact” to himself, Dr. Calderwood lacks “a sufficiently concrete interest
in the outcome of the issue in dispute” for third-party standing. Powers v. Ohio, 499
U.S. 400, 411 (1991) (quotations omitted); see Am. Comp. ¶ 14. And Makowski—
a plaintiff himself—is not hindered in his “ability to protect” his “own interests.”
Powers, 499 U.S. at 411.
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The remaining individual Plaintiffs also have not suffered an injury traceable
to the mere existence of the Emergency Declaration or EUAs. Muransky, 979 F.3d
at 925–26, 928; see Children’s Health Defense v. FDA, No. 1:21-cv-00200-DCLC-
CHS, 2021 WL 5756085, at *4 (E.D. Tenn. Nov. 30, 2021) (no standing to challenge
FDA’s procedures in approving Comirnaty and reissuing EUA). For example, no
individual Plaintiff was injured by an EUA vaccine.7 Rather, the Amended
Complaint implies (without explanation) that they might fear a future injury.
Plaintiffs, though, cannot meet the “high standard,” subject to “robust
judicial” scrutiny, of showing “a material risk of harm” traceable to the challenged
actions. Muransky, 979 F.3d at 927–28; see Elend v. Basham, 471 F.3d 1199, 1207
(11th Cir. 2006) (“a real and immediate threat of future harm” is necessary for
“injunctive and declaratory relief”). At most, Plaintiffs may fear future exposure to
an EUA vaccine, but they “do not claim that they intend to receive [an EUA vaccine]
in the future.” Coal. for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275, 1280 (D.C.
Cir. 2012). And the Court may not “create jurisdiction by embellishing a deficient
allegation of injury.” DiMaio v. Democratic Nat. Comm., 520 F.3d 1299, 1301 (11th
Cir. 2008) (quotation omitted).
Moreover, even if Plaintiffs received a COVID-19 vaccine in the future, it
could be the Pfizer vaccine from lots that were “manufactured in compliance with
the BLA” and that are “not subject to the EUA requirements when used for the
approved indication.” ECF No. 41, at ¶ 15; see Coal. for Mercury-Free Drugs, 671

7 Although Plaintiffs’ preliminary injunction motion states that certain individuals have been
injured by vaccines, PI Mot. 5–6, none of those individuals is currently a plaintiff.
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F.3d at 1280 (no standing to challenge “thimerosal-preserved vaccines” when
“thimerosal-free” version available); Norris v. Stanley, No. 1:21-CV-756, 2021 WL
3891615, at *2 (W.D. Mich. Aug. 31, 2021) (“should Plaintiff be offered the FDA-
approved Pfizer Comirnaty vaccine, her argument under the EUA statute would be
moot”). Thus, the individual Plaintiffs have not satisfied the “high standard,”
Muransky, 979 F.3d at 927, to show an “injury they will suffer” that “is ‘fairly
traceable’” to the Emergency Declaration or EUAs, California v. Texas, 141 S. Ct.
2104, 2113 (2021).
At bottom, Plaintiffs raise only an impermissible “generally available
grievance” challenging the wisdom of the Emergency Declaration and EUAs. Lujan,
504 U.S. at 573–74; see Diamond v. Charles, 476 U.S. 54, 66–67 (1986). But
“Article III standing is not to be placed in the hands of concerned bystanders, who
will use it simply as a vehicle for the vindication of value interests.” Hollingsworth
v. Perry, 570 U.S. 693, 707 (2013) (quotations omitted). And federal courts lack “a
general authority to conduct oversight of” the Executive Branch. California, 141 S.
Ct. at 2116. Thus, Counts I, III, IV, V, and VI must be dismissed for lack of standing.
2. Counts I, III, and IV Are Unreviewable Under the APA.
Even if Plaintiffs had standing, the Court lacks jurisdiction over the APA
claims in Counts I, III, and IV because the Emergency Declaration and EUAs are
“committed to agency discretion by law.” 5 U.S.C. § 701(a)(2); see Lenis v. U.S.
Att’y Gen., 525 F.3d 1291, 1293–94 (11th Cir. 2008). The EUA statute states that
HHS’s “[a]ctions under the authority of this section . . . are committed to agency
discretion.” 21 U.S.C. § 360bbb-3(i). The Emergency Declaration and EUAs were
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issued expressly under the EUA statute’s authority. See 85 Fed. Reg. at 7317; ECF
Nos. 40-6, at 2–4, 9–10; 40-14, at 2–3, 5–6; 40-20, at 2, 4–5. Thus, the Sixth Circuit
has recognized that EUAs “are exempt from review under the APA.” Ass’n of Am.
Physicians & Surgeons v. FDA, 2020 WL 5745974, at *3 (6th Cir. Sept. 24, 2020)
(citing 5 U.S.C. § 701(a)(2)); see also Lamie v. U.S. Trustee, 540 U.S. 526, 534
(2004) (“[W]hen the statute’s language is plain,” courts should enforce the statute
“according to its terms.” (quotations omitted)). The Emergency Declaration and
EUAs are committed to agency discretion and unreviewable under the APA.
3. Neither the Mandamus Statute (Count V) nor the Declaratory
Judgment Act (Count VI) Supplies Jurisdiction.
Regarding Count V, “[t]he test for jurisdiction is whether mandamus would
be an appropriate means of relief,” which requires that “the defendant owes [the
plaintiff] a clear nondiscretionary duty” and that the plaintiff “exhausted all other
avenues of relief.” Cash v. Barnhart, 327 F.3d 1252, 1257–58 (11th Cir. 2003)
(quotations omitted). Despite Plaintiffs’ bare allegation of a duty “to ensure the
faithful implementation of” the EUA statute, Am. Compl. ¶ 188, HHS does not owe
Plaintiffs “a clear nondiscretionary duty” to act, Cash, 327 F.3d at 1257–58. Rather,
all of HHS’s “[a]ctions under the authority of” the EUA statute, including issuing an
emergency declaration or an EUA or imposing conditions on an EUA, are
“committed to agency discretion.” 21 U.S.C. § 360bbb-3(i). The operative
provisions of the EUA statute reinforce this point. For example, the Secretary “may”
declare “that the circumstances exist justifying” an EUA and “may” issue an EUA.
21 U.S.C. §§ 360bbb-3(a)(1), (b)(1), (c); see Kingdomware Techs., Inc. v. United
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States, 136 S. Ct. 1969, 1977 (2016) (“the word ‘may’ . . . implies discretion”).
HHS’s decisions under the EUA statute, moreover, involve weighing scientific
evidence to make complex judgments about the safety and efficacy of medical
products. See 21 U.S.C. § 360bbb-3(c). Such decisions are the opposite of “clear
nondiscretionary dut[ies].” Cash, 327 F.3d at 1257–58.
Plaintiffs also have not “exhausted all other avenues of relief.” Id. FDA
regulations require parties to follow an administrative citizen petition process before
challenging FDA’s action in court.8 See 21 C.F.R. §§ 10.25(a), 10.45; see also Ass’n
of Am. Physicians & Surgeons, Inc. v. FDA, 539 F. Supp. 2d 4, 21 (D.D.C. 2008),
aff’d, 358 F. App’x 179 (D.C. Cir. 2009) (per curiam). Plaintiffs have not done so.
For all these reasons, this case is not among “the clearest and most compelling of
cases” warranting the “extraordinary remedy” of mandamus, and the Court therefore
lacks jurisdiction over Count V. Cash, 327 F.3d at 1257–58.
Regarding Count VI, the Declaratory Judgment Act “does not enlarge the
jurisdiction of the federal courts.” Wendy’s Int’l, Inc. v. City of Birmingham, 868
F.2d 433, 435 (11th Cir. 1989). A “party seeking declaratory relief must satisfy” the
standard jurisdictional requirements, including standing. Id.; DiMaio, 520 F.3d at
1301. For the same reasons Plaintiffs cannot establish jurisdiction over their other
claims related to the EUA statute, they also cannot establish the Court’s jurisdiction
to issue the declaratory relief requested in Count VI regarding the EUA statute.

8 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. See 21 C.F.R. §§ 10.25(a), 10.30.
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C. The Court Lacks Jurisdiction over the Claims Related to the
Executive Orders (Counts II, VI).
Count II seeks to enjoin “any mandate or action that would lead to the mandate
of [EUA-authorized] COVID-19 vaccines” on substantive due process grounds. Am.
Compl. ¶¶ 179–81. Count VI further requests a “declaration that EOs 14042 and
14043 are invalid to authorize compulsory EUA vaccinations.” Id. ¶ 192. Like the
other counts, these counts have numerous jurisdictional defects.
1. The President Should Be Dismissed as a Defendant.
Plaintiffs sue the President, but the Court may not issue either injunctive or
declaratory relief against him. In 1866, the Supreme Court disclaimed jurisdiction
“to enjoin the President in the performance of his” non-ministerial, “official duties.”
Mississippi v. Johnson, 71 U.S. 475, 501 (1866). The Court reaffirmed that principle
in Franklin v. Massachusetts, 505 U.S. 788 (1992); see id. at 802–03 (plurality
opinion); id. at 829 (Scalia, J., concurring) (“we have no power” to “order[]
declaratory or injunctive relief against appellant President Bush”); Made in the USA
Found. v. United States, 242 F.3d 1300, 1310 n.25 (11th Cir. 2001). The D.C. Circuit
has applied this principle to declaratory relief, Swan v. Clinton, 100 F.3d 973, 976–
77 n.1 (D.C. Cir. 1996), and explained that “courts do not have jurisdiction to enjoin
[the President], and have never submitted the President to declaratory relief,”
Newdow v. Roberts, 603 F.3d 1002, 1013 (D.C. Cir. 2010). Indeed, the Executive
Orders at issue here “are discretionary,” not “ministerial,” and thus the Court lacks
jurisdiction to issue injunctive or declaratory relief against President Biden. McCray
v. Biden, No. CV 21-2882 (RDM), 2021 WL 5823801, at *7 (D.D.C. Dec. 7, 2021);
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 20 of 51

see Navy Seal 1 v. Biden, No. 8:21-CV-2429-SDM-TGW, 2021 WL 5448970, at *2
(M.D. Fla. Nov. 22, 2021); Rydie v. Biden, No. CV DKC 21-2696, 2021 WL
5416545, at *3 (D. Md. Nov. 19, 2021); see also Ctr. for Democracy & Tech. v.
Trump, 507 F. Supp. 3d 213, 226 (D.D.C. 2020). The President must therefore be
dismissed as a defendant.
2. Standing, Ripeness, and the Civil Service Reform Act Bar
Plaintiffs’ Challenge to EO 14043.
Only Plaintiffs Leahy and Nelson allegedly fall within the ambit of EO 14043.
See Am. Compl. ¶ 19. But “[t]wo related doctrines of justiciability”—standing and
ripeness—deprive the Court of jurisdiction over their claims. Trump v. New York,
141 S. Ct. 530, 535 (2020) (per curiam).
To show standing, Leahy and Nelson must demonstrate “an injury that is
concrete, particularized, and imminent rather than conjectural or hypothetical.” Id.
(quotation omitted). But Nelson has conceded that his and Leahy’s religious
accommodation requests remain “pending.” ECF No. 37-4; see ECF No. 39, at ¶¶ 7,
10. And while their requests remain pending, they face no adverse employment
action. ECF No. 39, at ¶¶ 8, 11. Nor is any action imminent under NASA’s process,
which involves evaluation of the request by the Vaccine Exception Agency Review
Team, advice to senior NASA officials, a decision by those officials, as well as the
option for reconsideration by a different senior official. Id. ¶ 12. Thus, Leahy and
Nelson have not shown the actual or imminent injury necessary for standing. See
Children’s Health Def., 2021 WL 5756085 at *4 (no standing when plaintiff’s
religious accommodation request remained pending).
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Leahy’s and Nelson’s claims are also not ripe, because they depend on
“contingent future events that may not occur as anticipated, or indeed may not occur
at all.” Trump, 141 S. Ct. at 535 (quotation omitted). Ripeness is a “threshold
jurisdictional question,” Elend, 471 F.3d at 1204, and it is Plaintiffs’ burden to
establish it. Ralston v. LM Gen. Ins. Co., No. 616CV1723ORL37DCI, 2016 WL
6623728, at *3 (M.D. Fla. Nov. 9, 2016). “Any prediction how” NASA will resolve
Leahy’s and Nelson’s religious accommodation requests “is no more than conjecture
at this time.” Trump, 141 S. Ct. at 535 (quotation omitted). Even if their
accommodation requests are denied, it is uncertain how these Plaintiffs would
respond; they might decide to get vaccinated. See ECF No. 39, at ¶ 4 (discussing
employee counseling period). Thus, these Plaintiffs’ claims are “riddled with
contingencies and speculation that impede judicial review.” Trump, 141 S. Ct. at
535; see McCray, 2021 WL 5823801, at *8 (plaintiff’s challenge to the Executive
Orders was not ripe because his “purported injury is contingent upon his employers
denying his application for a medical exemption”).
Furthermore, “[w]hen a court is asked to review decisions of administrative
agencies, it is hornbook law that courts must exercise patience and permit the
administrative agenc[ies] the proper time and deference for those agencies to
consider the case fully.” Nat’l Advert. Co. v. City of Miami, 402 F.3d 1335, 1339
(11th Cir. 2005); see Elend, 471 F.3d at 1211. When, as here, employees’ “exemption
requests are still under consideration by the agencies,” the issues are “unfit for
judicial review.” Church v. Biden, No. CV 21-2815 (CKK), 2021 WL 5179215, at
*9 (D.D.C. Nov. 8, 2021).
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Meanwhile, “withholding adjudication at this time” will cause Leahy and
Nelson no hardship. Pittman v. Cole, 267 F.3d 1269, 1280 (11th Cir. 2001). The
“source of any injury to the plaintiffs is the action that” NASA “might take in the
future” to implement EO 14043, not the Executive Order “itself in the abstract.”
Trump, 141 S. Ct. at 536 (quotation omitted). And NASA will not take any adverse
action while their exception requests are pending. See ECF No. 39, at ¶¶ 8, 11. Thus,
Nelson and Leahy have not shown why adjudication of their claims may not be
“withheld until a more mature case can be presented.” Pittman, 267 F.3d at 1281;
see Church, 2021 WL 5179215, at *10 (no “immediate and significant hardship” to
federal employee by allowing agency process to conclude).
In addition to these standing and ripeness problems, another jurisdictional
infirmity looms on the horizon: preclusion under the Civil Service Reform Act
(“CSRA”), which “established a comprehensive system for reviewing personnel
action taken against federal employees.” Elgin v. Dep’t of Treasury, 567 U.S. 1, 5
(2012) (quotations omitted). “When a covered employee appeals a covered adverse
action,” the Merit Systems Protection Board (“MSPB”) has initial “jurisdiction over
the appeal,” and the Federal Circuit has “exclusive jurisdiction over appeals from a
final decision of the MSPB.” Id. at 6, 20 (citing 5 U.S.C. § 7703). This review
framework is exclusive, with no “additional avenue of review in district court,”
including for constitutional claims. Elgin, 567 U.S. at 12, 21; see Stephens v. Dep’t
of Health & Hum. Servs., 901 F.2d 1571, 1575–76 (11th Cir. 1990); Rydie, 2021 WL
5416545, at *2 (federal employees challenging “future terminations” related to EO
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14043 “likely have to proceed through the CSRA process, even though they assert
constitutional challenges”).
Both Nelson and Leahy are covered by the CSRA. ECF No. 39, at ¶¶ 6, 9; see
Elgin, 567 U.S. at 5. Thus, if they faced a “reviewable action,” including termination,
they would need to follow the CSRA’s review process, and this Court would not
have jurisdiction. See Elgin, 567 U.S. at 5–6 (citing 5 U.S.C. § 7512).9
3. No Plaintiff Properly Challenges EO 14042.
Plaintiffs Makowski, Millen, Bloom, and Sobczak allege that, due to EO
14042, they “confront[] the vaccine mandate in November, 2021.” Am. Compl.
¶¶ 15-18.10 But beyond an abstract “confront[ation],” these Plaintiffs allege no “real”
or particularized injury that they have incurred or will imminently incur. Muransky,
979 F.3d at 925–26. Makowski has conceded that his request for “medical and/or
religious exemptions” remains pending, ECF No. 37-3, at 2, and the other federal-
contractor Plaintiffs have not plausibly shown their accommodation requests were
denied. Cf. Makro Cap., 543 F.3d at 1258. Thus, the federal-contractor Plaintiffs’
claims are not justiciable because any injury is “dependent on contingent future
events that may not occur as anticipated, or indeed may not occur at all.” Trump, 141
S. Ct. at 535 (quotation omitted); see Children’s Health Def., 2021 WL 5756085.11

9 The CSRA also sets forth “prohibited personnel practices,” 5 U.S.C. § 2302, and any challenge
to such practices must be submitted “in the first instance to the [Office of Special Counsel] for
review,” Ferry v. Hayden, 954 F.2d 658, 661 (11th Cir. 1992). A failure to do so “precludes judicial
review” of any allegedly “improper agency action.” Id.
10 AFLDS vaguely alludes to members “currently facing COVID vaccine mandates,” Am. Compl.
¶ 9, but does not tie those supposed mandates to EOs 14042 or 14043.

11 As noted above, EO 14042 is currently enjoined by a nationwide preliminary injunction, which
has been appealed. See Georgia, 2021 WL 5779939, at *12.
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Moreover, the federal-contractor Plaintiffs have not established that EO 14042
even applies to them. EO 14042 provides that “new contracts” after October 15,
2021, as well as “extensions or renewals of existing contracts,” shall include a clause
requiring the contractor to follow Task Force guidance about COVID-19 workplace
safety. 86 Fed. Reg. at 50,987. Contractors can choose whether to accept the term or
decline to perform. See 86 Fed. Reg. at 63,419. If the clause has been incorporated
into a contract, the guidance applies only to “covered contractor employees.” 86 Fed.
Reg. at 63,419. To plausibly allege an injury traceable to EO 14042, therefore, the
federal-contractor Plaintiffs must “clearly allege facts” showing that they are
“covered contractor employees.” Spokeo, 578 U.S. at 338 (cleaned up).
They have failed to do so. Although Makowski alleges that his employer has
required him to “receive a COVID vaccine by December 8, 2021, if [he is] not
granted a medical and/or religious exemption,” and that “[t]his requirement is
imposed because of [EO] 14042,” he acknowledges that he will not imminently be
required to be vaccinated because “[t]he dates are currently fluid and dependent upon
the guidance from the government customer.” ECF No. 37-3; see Hollis v. Biden,
No. 1:21-CV-163-GHD-RP, 2021 WL 5500500, at *4 (N.D. Miss. Nov. 23, 2021)
(dismissing for lack of standing plaintiffs who “have not adequately demonstrated
that they are currently or imminently will be subject to the vaccine requirement set
forth in E.O. 14042”); McCray, 2021 WL 5823801, at *9.
Finally, even if Plaintiffs had shown their accommodation requests were
denied under a workplace policy adopted due to EO 14042, those denials still would
be traceable to (and redressable by) their employers, not Defendants. It is the
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responsibility of contractor-employers, not Defendants, to “review and consider
what, if any, [religious or medical] accommodation [they] must offer.” 86 Fed. Reg.
at 63,420; cf. Hollis, 2021 WL 5500500, at *5. Thus, if the federal-contractor
Plaintiffs’ employers deny their accommodation requests, Am. Compl. ¶¶ 16–18,
their recourse would be against those employers, not against Defendants. See Lewis
v. Governor of Ala., 944 F.3d 1287, 1301 (11th Cir. 2019); Navy Seal 1, 2021 WL
5448970, at *2.12
II.
The Amended Complaint Should Be Dismissed for Failure to State a
Claim.
A. Legal Standard
The Court must dismiss the Amended Complaint under Rule 12(b)(6) unless
Plaintiffs have “state[d] a plausible claim for relief.” Ashcroft v. Iqbal, 556 U.S. 662,
679 (2009). They must plead sufficient “factual content that allows the court to draw
the reasonable inference that 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 Plaintiffs’ “well-pleaded factual allegations,” but it need not
accept as true “conclusory statements” or “legal conclusions.” Id. at 678–79.

12 Even if the Court finds that any Plaintiff has standing to challenge one of the Executive Orders,
that Plaintiff would still lack standing to challenge the Public Health Emergency Declaration and
the EUAs. See TransUnion, 141 S. Ct. at 2208 (plaintiffs “must demonstrate standing for each
claim . . . and for each form of relief”).
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B. Defendants Untethered to Any Count Must Be Dismissed.
A plaintiff must plausibly allege “that the defendant is liable for the
misconduct alleged.” Id. at 678 (emphasis added). But Dr. Fauci, CDC, NIH, NIAID,
and Does I-X are untethered to any claim for relief. See Am. Compl. ¶¶ 169–92.
Thus, these Defendants must be dismissed.
C. Counts I, III, and IV Fail to State a Claim that the Emergency
Declaration and EUAs Are Unlawful Under the APA.
Counts I, III, and IV assert APA claims challenging the Emergency
Declaration and HHS’s alleged failure to satisfy the EUA issuance criteria and the
EUAs’ required conditions. Even if the Court had jurisdiction over these claims, they
should be dismissed for failure to state a claim.
1. Plaintiffs
Do
Not
Challenge
HHS’s
Contemporaneous
Explanations in Light of the Existing Administrative Record.
The “focal point” for arbitrary-and-capricious 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
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
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 27 of 51

of the administrative record” and that “information or views not included in the
administrative record shall” be submitted “to the Commissioner with a new [Citizen
Petition] to modify the action.” 21 C.F.R. § 10.45(f); see id. §§ 10.25, 10.30.
“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 permit the agency to exercise its discretion or apply
its expertise” and to “conserve scarce judicial resources.” Mahon, 485 F.3d at 1255.
FDA’s regulations allow any “interested person [to] petition the Commissioner to
issue, amend, or revoke a regulation or order, or to take or refrain from taking any
other form of administrative action” by filing “a citizen petition.” 21 C.F.R.
§ 10.25(a); see id. § 10.30.
Here, Counts I, III, and IV 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 Review Memoranda, which discuss the extensive data
supporting FDA’s conclusions.13
The Amended Complaint does not plausibly allege that HHS’s
contemporaneous explanations were unreasonable “in light of the existing

13 See 85 Fed. Reg. 7316; 85 Fed. Reg. 18,250; ECF Nos. 40-6; 40-7; 40-8; 40-9; 40-10; 40-11;
40-14; 40-15; 40-16; 40-17; 40-20; 40-21; 40-22.
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administrative record.” Dep’t of Commerce, 139 S. Ct. at 2573. Nor does it allege
that Plaintiffs ever presented their allegations to HHS, such as by filing a citizen
petition. See Mahon, 485 F.3d at 1254–55; 21 C.F.R. §§ 10.25(a), 10.30. Instead, it
attacks the Emergency Declaration and EUAs based on evidence that is not alleged
to be in the administrative record or to have been presented to HHS. For example,
the Amended Complaint vaguely asserts that Plaintiffs “have accumulated and will
present expert medical and scientific evidence” supporting their contentions, without
alleging whether such evidence was ever presented to HHS. Am. Compl. ¶ 176; see
also id. ¶ 79–116. And for Count IV, Plaintiffs dispute whether vaccination providers
and recipients “are being informed” of the information described in the EUA statute,
id. ¶¶ 185–87, but do not contest FDA’s contemporaneous explanation (i.e., at the
time the EUAs were issued) for why the content of the Fact Sheets satisfied
appropriate conditions designed to ensure that vaccination providers and recipients
are informed about the vaccines, see 21 U.S.C. § 360bbb-3(e)(1)(A). Thus, Plaintiffs
fail to state APA claims for Counts I, III, and IV. See Dep’t of Commerce, 139 S. Ct.
at 2573; Mahon, 485 F.3d at 1254–55; see also Velez-Duenas v. Swacina, 875 F.
Supp. 2d 1372, 1379 (S.D. Fla. 2012) (dismissing complaint because plaintiff asked
the Court “to consider documents that were not a part of the administrative record,”
which “would be improper”).
2. Plaintiffs’ Remaining Arguments Fail.
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
(1924), support their reliance on facts postdating the issuance of the Emergency
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Declaration, Am. Compl. ¶¶ 169–77. 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, but 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 on 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.14
Regarding Count III, even if Plaintiffs’ allegations were properly before the
Court, they do not plausibly show the EUA 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.” Am. Compl. ¶ 183. But over 800,000 Americans, of all ages,
have died from COVID-19. And Plaintiffs fail to address the risks of other serious
conditions, short of death, that FDA found to support the EUAs, see, e.g., ECF Nos.
40-7, at 9, 50–56; 40-8, at 7–8, 39–42; 40-15, at 9–10, 56–61; 40-21, at 9–10, 60–

14 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 360bbb-3(b)(2)(A).
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66. Additionally, Plaintiffs allege there are “adequate, approved, and available
alternative[s]” to the vaccines, 21 U.S.C. § 360bbb-3(c)(3); Am. Compl. ¶ 183, but
they misinterpret this standard. It is immaterial that alternatives have been “approved
by physicians as meeting the standard of care among similarly situated medical
professionals,” id. ¶ 183, because alternative treatments are only “approved” when
approved by FDA, 21 U.S.C. § 360bbb-3(a)(2).15 When FDA issued the EUAs, the
vaccines had no adequate, approved, and available alternatives. See ECF Nos. 40-7,
at 9–10; 40-15, at 10; 40-21, at 10.16
In Count IV, Plaintiffs’ allegations that vaccination providers and recipients
received inadequate information about the vaccines, Am. Compl. ¶ 186—even if
cognizable under the APA—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. 40-6, at 13–14, 17; 40-14, at 8, 12; 40-20, at 6–7, 10; see, e.g., ECF Nos. 40-3,
at 15–16. These Fact Sheets disclose all the information that must be provided to

15 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.
16 That remains true today for all three vaccines. See ECF No. 41-2, at 10 & n.18.
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 31 of 51

vaccination providers and recipients, respectively, under the EUAs. See ECF Nos.
40-1; 40-2; 40-3; 40-4; 40-5; 40-12; 40-13; 40-18; 40-19.
Plaintiffs do not dispute this, but instead allege that vaccination providers and
recipients “are not,” in fact, being informed of the information that they claim must
be given. Am. Compl. ¶ 186. 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 and that “psychological[] manipulat[ion]” and
coercive “rewards and penalties” render “the ‘option to [] refuse’ meaningless.” Am.
Compl. ¶¶ 50, 140-44, 186. But Plaintiffs do not plausibly allege that HHS is
responsible for the alleged censorship, manipulation, or coercion, which it attributes
to “the media,” id. ¶¶ 50, 142; state or foreign governments, id. ¶¶ 142–43; or private
businesses and employers, id. ¶ 143. As with their prior claims, Plaintiffs fail to
plausibly allege any arbitrary or capricious decision or statutory violation by HHS.17
Finally, Plaintiffs allege that “only a fraction (as low as 1%) of adverse events
are reported to VAERS by physicians fearing liability.” Am. Compl. ¶ 186. But this
doubtful allegation of underreporting, see ECF No. 41, at ¶ 17, is not plausibly linked

17 The Amended Complaint alleges that the vaccine recipients “are participants in a large scale,
ongoing non-consensual human experiment.” Am. Compl. ¶ 144; see id. ¶¶ 128–44. But 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).
Moreover, the informed consent requirements in 45 C.F.R. Part 46 are inapplicable because they
apply only to “research involving human subjects.” 45 C.F.R. § 46.101(a). Administration of an
EUA-authorized vaccine for clinical care is not “research.” 45 C.F.R. § 46.102(l).
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 32 of 51

to any challenged HHS action, 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, Am. Compl. ¶ 186, because the EUA statute does
not require that. Instead, FDA’s actions in establishing “[a]ppropriate conditions for
the monitoring and reporting of adverse events” are “committed to agency
discretion.” 21 U.S.C. § 360bbb-3(e)(1)(A)(iii), (i). Plaintiffs have not plausibly
alleged any APA violation related to the monitoring or reporting of adverse events.
D. Counts II and VI Fail to State a Claim that the Executive Orders Are
Unlawful.
Counts II and VI challenge the issuance of EOs 14042 and 14043. Plaintiffs
stated that “[a]ll counts in the amended complaint,” including Counts II and VI, “are
predicated on 5 U.S.C. §702”—the APA. PI Mot. 41. But Executive Orders “are not
reviewable under the APA” because “the President is not an ‘agency.’” Dalton v.
Specter, 511 U.S. 462, 470 (1994). Even assuming the Executive Orders were
reviewable, Plaintiffs have not plausibly alleged that they are inconsistent with the
Constitution or the President’s statutory authority.
1. Plaintiffs Have Not Plausibly Alleged that the Executive Orders
Are Unconstitutional.
Count II alleges that the Executive Orders violate Plaintiffs’ “fundamental
right to bodily integrity” and thus deprive them of substantive due process. Am.
Compl. ¶ 179; see also id. ¶ 192 (Count VI). But courts have repeatedly held that
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 33 of 51

vaccine mandates do not violate the fundamental right to bodily integrity, that they
are subject to rational basis review, and that they easily pass this test.
Courts “must analyze a substantive due process claim by first crafting a
‘careful description of the asserted right.’”18 Doe v. Moore, 410 F.3d 1337, 1343
(11th Cir. 2005) (quoting Reno v. Flores, 507 U.S. 292, 302 (1993)). Although
Plaintiffs allege that the Executive Orders violate their “fundamental right to bodily
integrity,” courts have repeatedly held that this is not an accurate description of the
interest implicated by COVID-19 vaccine mandates. For example, in Bauer v.
Summey, No. 2:21-CV-02952-DCN, 2021 WL 4900922 (D.S.C. Oct. 21, 2021), the
court held that the challenged vaccine mandate did not violate the plaintiff’s right to
“bodily integrity,” and that “a more appropriate description is plaintiffs’ interest in
continued employment with defendants while unvaccinated for COVID-19.” Id. at
*9–10; see also Kheriaty v. Regents of Univ. of Cal., No. SACV 21-1367 JVS
(KESx), 2021 WL 5238586, at *5 (C.D. Cal. Sept. 29, 2021). Here, similarly, what
is at stake is Plaintiffs’ interest in holding federal or federal-contractor employment
while refusing to be vaccinated against a highly contagious virus.
The Executive Orders contrast sharply with the government actions that the
Supreme Court has discussed as implicating the “fundamental right to bodily
integrity”: “forced administration of life-sustaining medical treatment,” Cruzan ex
rel. Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 279 (1990), and “forced

18 Different substantive due process analyses apply depending on whether the challenged action is
executive or legislative in character. See McKinney v. Pate, 20 F.3d 1550, 1557 n.9 (11th Cir.
1994) (en banc). The Executive Orders are “broad-ranging executive regulations” and are thus
legislative in character. Id.
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administration of antipsychotic drugs,” Washington v. Harper, 494 U.S. 210, 236
(1990). Unlike these actions, the Executive Orders do not force anyone to receive
medical care, but instead allow federal employees and contractors to seek medical
and religious exemptions or pursue other employment. See, e.g., Klaassen v. Trs. of
Ind. Univ., 2021 WL 3073926, at *25 (N.D. Ind. July 18, 2021) (public university’s
COVID-19 vaccination requirement was “a far cry” from forcible provision of
medical care); Bridges, 2021 WL 2399994, at *2 (similar).
After crafting a “careful description of the asserted right,” the Court “must
determine whether the asserted right is one of those fundamental rights and liberties
which are, objectively, deeply rooted in this Nation’s history and tradition, and
implicit in the concept of ordered liberty, such that neither liberty nor justice would
exist if they were sacrificed.” Doe, 410 F.3d at 1343 (quotations omitted). The
interest at stake here is not such a fundamental right. As the court explained in Bauer,
the Supreme Court “expressly rejected the idea of a fundamental right to
refuse vaccination” in Jacobson v. Massachusetts, 197 U.S. 11, 26–27 (1905), which
“upheld a state law allowing cities and towns to implement vaccine mandates in
order to contain smallpox outbreaks,” Bauer, 2021 WL 4900922, at *9; see also
Prince v. Massachusetts, 321 U.S. 158, 166–67 (1944) (the Constitution does not
provide “freedom from compulsory vaccination”).19 Accordingly, within the past

19 Plaintiffs argue that Planned Parenthood v. Casey, 505 U.S. 833 (1992), “largely overturned
Jacobson.” Am. Compl. ¶ 2. Not so. Casey cited Jacobson with approval. Casey, 505 U.S. at 857.
Since then, courts have continued to cite Jacobson. See, e.g., Klaasen, 7 F.4th at 593; Phillips v.
City of N.Y., 775 F.3d 538, 542 (2d Cir. 2015); Bauer, 2021 WL 4900922, at *9 n.6 (“[T]he
majority of courts considering challenges to state and local COVID-19 restrictions have
respected Jacobson’s precedential value, and the court follows suit today.”).
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several months, federal courts have repeatedly held that vaccine mandates do not
violate a fundamental right. See Bauer, 2021 WL 4900922, at *10.20
“When a challenged law does not infringe upon a fundamental right, [courts]
review substantive due process challenges under the rational basis standard.”
Fresenius Med. Care Holdings, Inc. v. Tucker, 704 F.3d 935, 945 (11th Cir. 2013).21
“The rational basis test is highly deferential to government action, and the regulation
can only be invalidated if it is so unrelated to the achievement of any combination
of legitimate purposes that we can only conclude that the legislature’s actions were
irrational.’” Ga. Elec. Life Safety & Sys. Ass’n, 965 F.3d at 1275 (quotations
omitted). “[T]hese requirements are generally easily met.” Id. (quotations omitted).
The Executive Orders easily survive rational basis review. “Stemming the
spread of COVID-19 is unquestionably a compelling interest.” Roman Cath. Diocese
of Brooklyn, 141 S. Ct. at 67; see Florida v. Dep’t of Health & Hum. Servs., No. 21-
14098-JJ, 2021 WL 5768796, at *17 (11th Cir. Dec. 6, 2021). The Executive Orders
are rationally related to that compelling interest.22 See Rydie, 2021 WL 5416545, at
*4 (“There is a long tradition of upholding mandatory vaccination laws under
rational basis scrutiny because they were necessary to the public health.”); Bauer,

20 See, e.g., Klaassen, 7 F.4th 592; Smith v. Biden, No. 1:21-cv-19457, 2021 WL 5195688 (D.N.J.
Nov. 8, 2021); Rodriguez-Vélez v. Pierluisi-Urrutia, No. 21-1366, 2021 WL 5072017, at *15
(D.P.R. Nov. 1, 2021); Johnson v. Brown, No. 3:21-CV-1494-SI, 2021 WL 4846060, at *13 (D.
Or. Oct. 18, 2021); Dixon v. De Blasio, 2021 WL 4750187, at *8 (E.D.N.Y. Oct. 12, 2021); Norris
v. Stanley, No. 1:21-CV-756, 2021 WL 4738827, at *2 (W.D. Mich. Oct. 8, 2021); Kheriaty, 2021
WL 5238586, at *6; Valdez v. Grisham, No. 21-CV-783 MV/JHR, 2021 WL 4145746, at *5
(D.N.M. Sept. 13, 2021).
21 Justice Gorsuch explained that “[a]lthough Jacobson pre-dated the modern tiers of scrutiny,”
the Supreme Court “essentially applied rational basis review” to a government-imposed
vaccination requirement. Roman Cath. Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 70 (2020)
(Gorsuch, J., concurring).
22 Indeed, Plaintiffs have not argued that the Executive Orders lack a rational basis.
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2021 WL 4900922, at *10–11 (“numerous courts have recognized that preventing
the spread of COVID-19 provides a rational justification for vaccine mandates”).
Moreover, “the Government has a much freer hand in dealing with citizen employees
than it does when it brings its sovereign power to bear on citizens at large.” NASA v.
Nelson, 562 U.S. 134, 148 (2011) (quotations omitted). “Like private individuals and
businesses, the Government enjoys the unrestricted power . . . to determine those
with whom it will deal, and to fix the terms and conditions upon which it will make
needed purchases.” Perkins v. Lukens Steel Co., 310 U.S. 113, 127 (1940). Thus,
Plaintiffs have failed to state a substantive due process claim.
2. Plaintiffs Have Not Plausibly Alleged that the Executive Orders
Exceed the President’s Statutory Authority.
The Amended Complaint alleges that EO 14042 is not authorized by the
Federal Property and Administrative Services Act (“Procurement Act”), 40 U.S.C.
§ 101, et seq.; that EO 14043 is not authorized by 5 U.S.C. §§ 3301, 3302 and 7301;
and that both Executive Orders violate the EUA statute. Am. Compl. ¶¶ 159, 166,
192. But none of these statutes waive the federal government’s sovereign immunity
or authorize a private right of action here. See, e.g., Guilfoyle v. Beutner, No. 2:21-
cv-5009, 2021 WL 4594780, at *27 (C.D. Cal. Sept. 14, 2021). Although Larson v.
Domestic and Foreign Commerce Corp., 337 U.S. 682 (1949), may permit an action
against a government official who acts outside his statutory authority, id. at 689–90,
Larson is a doctrine “of last resort intended to be of extremely limited scope.”
Terveer v. Billington, 34 F. Supp. 3d 100, 123 (D.D.C. 2014) (quoting Griffith v. Fed.
Labor Relations Auth., 842 F.2d 487, 493 (D.C. Cir. 1988)). An officer acts ultra
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vires “only when he acts ‘without any authority whatever.’” Pennhurst State Sch. &
Hosp. v. Halderman, 465 U.S. 89, 101–02 n.11 (1984) (citation omitted). As
explained below, this standard is not satisfied for either of the Executive Orders.
EO 14042 is authorized by the Procurement Act, which broadly empowers the
President to “prescribe policies and directives that the President considers necessary
to carry out” the Act’s provisions, so long as they are “consistent” with the Act. 40
U.S.C. § 121(a). This requires that they be “reasonably related to the Procurement
Act’s purpose of ensuring efficiency and economy in government procurement.”
Liberty Mut. Ins. Co. v. Friedman, 639 F.2d 164, 170 (4th Cir. 1981). “Efficiency”
and “economy” are “not narrow terms,” AFL-CIO v. Kahn, 618 F.2d 784, 789 (D.C.
Cir. 1979) (en banc), and the statute gives the President “necessary flexibility and
‘broad-ranging authority’” to carry out its goals, UAW-Labor Emp. & Training Corp.
v. Chao, 325 F.3d 360, 366 (D.C. Cir. 2003); see also Chamber of Com. v. Reich, 74
F.3d 1322, 1333 (D.C. Cir. 1996) (providing examples of Executive Orders
authorized by the Procurement Act); Kahn, 618 F.2d at 788.
EO 14042 easily satisfies this “lenient” standard. See Chao, 325 F.3d at 367.
As a proprietor like “private individuals and businesses,” the federal government
may “determine those with whom it will deal, and to fix the terms and conditions
upon which it will make needed purchases.” Perkins, 310 U.S. at 127. The President,
as ultimate manager of procurement operations, determined that workplace
safeguards aimed at preventing the spread of COVID-19 will “decrease worker
absence, reduce labor costs, and improve the efficiency of contractors and
subcontractors at sites where they are performing work for the Federal Government.”
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86 Fed. Reg. at 50,985. Slowing the spread of COVID-19 promotes efficiency and
economy for the simple reason that federal procurement—like any other business
endeavor—suffers when the employees of entities the government contracts with get
sick and miss work. See Florida, 2021 WL 5768796, at *12 (explaining, in the
context of a healthcare worker COVID-19 vaccine mandate, that it is “highly
inefficient for facility employees to be out sick with COVID-19”). Thus, EO 14042
is within the President’s authority under the Procurement Act.23
EO 14043 is authorized by 5 U.S.C. §§ 3301, 3302 and 7301. Am. Compl.
¶ 166. Section 3301 broadly authorizes the President to “prescribe such regulations
for the admission of individuals into the civil service in the executive branch as will
best promote the efficiency of that service.” Section 3302 authorizes the President
to “prescribe rules governing the competitive service,” and section 7301 authorizes
him to “prescribe regulations for the conduct of employees in the executive branch.”
See Clarry v. United States, 85 F.3d 1041, 1047 (2d Cir. 1996) (“The President has
broad authority pursuant to 5 U.S.C. §§ 3301 and 7301 to regulate employment
matters . . . .”). These statutes authorize EO 14043, which is based on the President’s
“determin[ation] that to promote the health and safety of the Federal workforce and
the efficiency of the civil service, it is necessary to require COVID-19 vaccination
for all Federal employees, subject to [required] exceptions.” 86 Fed. Reg. at 50,989.

23 Two district courts have found to the contrary in the preliminary injunction context. Georgia,
2021 WL 5779939; Kentucky v. Biden, No. 3:21-CV-00055-GFVT, 2021 WL 5587446 (E.D. Ky.
Nov. 30, 2021), appeal filed, No. 21-6147 (6th Cir. Dec. 6, 2021). But those decisions are
inconsistent with longstanding precedent holding that the Procurement Act gives the President
“necessary flexibility and ‘broad-ranging authority,’” Chao, 325 F.3d at 366, to carry out its goals
of “ensuring efficiency and economy in government procurement,” Liberty Mut. Ins. Co., 639 F.2d
at 170.
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Finally, Plaintiffs have not plausibly alleged that the Executive Orders violate
the provisions of the EUA statute directing FDA to establish “[a]ppropriate
conditions designed to ensure that [vaccine recipients] are informed” of certain
information, including “the option to accept or refuse administration of the” vaccine.
21 U.S.C. § 360bbb-3(e)(1)(A)(ii); Am. Compl. ¶ 167. Federal employees and
contractors might receive the Pfizer vaccine from lots that were “manufactured in
compliance with the [BLA]” and that are “not subject to the EUA requirements”
because they are “used for the approved indication.” ECF No. 41 ¶ 15. Any dispute
regarding the EUA statute is therefore moot. See Norris v. Stanley, No. 1:21-cv-756,
2021 WL 3891615, at *2 (W.D. Mich. Aug. 31, 2021). Moreover, the EUA statute
does not prohibit the government from requiring vaccination with an EUA product
as a condition of continued employment. Instead, it directs HHS to establish
“[a]ppropriate conditions designed to ensure that [vaccine recipients] are informed”
of certain information, 21 U.S.C. § 360bbb-3(e)(1)(A)(ii), which is satisfied by the
Fact Sheets. As numerous courts have held, this informational requirement does not
prevent any entity (including the government) from imposing workplace discipline,
including termination, on employees who choose not to receive an EUA vaccine.24

24 See Bridges, 2021 WL 2399994, at *2; Valdez, 2021 WL 4145746, at *4; Norris v. Stanley, No.
1:21-cv-756, 2021 WL 4738827, at *3 (W.D. Mich. Oct. 8, 2021); Johnson v. Brown, No. 3:21-
cv-1494, 2021 WL 4846060, at *18 (D. Or. Oct. 18, 2021); Pelekai v. Hawaii, No. 1:21-cv-343,
2021 WL 4944804, at *6 n.9 (D. Haw. Oct. 22, 2021).
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III.
Plaintiffs’ Preliminary Injunction Motion Should Be Denied.
A. Legal Standard
A preliminary injunction is “the exception rather than the rule.” Brown v.
Sec’y, U.S. Dep’t of Health & Hum. Servs., 4 F.4th 1220, 1224 (11th Cir. 2021).
Plaintiffs must establish that (1) they are “likely to succeed on the merits,” (2) they
are “likely to suffer irreparable harm in the absence of preliminary relief,” (3) “the
balance of equities tips in [their] favor,” and (4) “an injunction is in the public
interest.” Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008). The Court
may not grant this “extraordinary and drastic remedy” unless Plaintiffs “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). Plaintiffs have
not met their burden on any of these factors.
B. Plaintiffs Are Not Likely to Succeed on the Merits.
As discussed above, the Amended Complaint must be dismissed because
Plaintiffs have not plausibly alleged subject matter jurisdiction or stated 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).”).
Additionally, Plaintiffs seek “a preliminary injunction enjoining enforcement
of EOs 14042 and 14043, and every rule, directive, and guidance based thereon.” PI
Mot. 43. Yet “injunctive relief must relate in some fashion to the relief requested in
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the complaint” and must be “of the same character as that which may be granted
finally.” Alabama v. U.S. Army Corps of Eng’rs, 424 F.3d 1117, 1134 (11th Cir.
2005). Because the Amended Complaint does not challenge any “rule, directive, [or]
guidance based” on the Executive Orders, those actions may not be the subject of a
preliminary injunction.
Properly construed, Plaintiffs’ motion seeks to enjoin only the Executive
Orders. But Plaintiffs stated that “[a]ll counts in the amended complaint are
predicated on 5 U.S.C. § 702,” PI Mot. 41, and Executive Orders “are not reviewable
under the APA” because “the President is not an ‘agency.’” Dalton, 511 U.S. at 470.
Thus, Plaintiffs cannot show a likelihood of success on the merits.
Plaintiffs argue that the issuance of the EUAs violated the misbranding statute,
21 U.S.C. § 352(j). PI Mot. 34–37. But Plaintiffs’ motion does not seek to enjoin the
EUAs. Moreover, Plaintiffs fail to identify any evidence in “the existing
administrative record,” Dep’t of Commerce, 139 S. Ct. at 2573; see Mahon, 485 F.3d
at 1254–55, showing the vaccines are “dangerous to health when used” according to
the FDA-approved labeling, 21 U.S.C. § 352(j).
Plaintiffs’ motion also impermissibly asserts new claims that were not alleged
in the Amended Complaint. For example, Plaintiffs’ motion argues for the first time
that the Executive Orders violate the separation of powers and the nondelegation
doctrine25 and that the federal government has infringed on the states’ prerogative to

25 In support of this new argument, Plaintiffs cite Alabama Association of Realtors v. Department
of Health & Human Services, 141 S. Ct. 2485 (2021); PI Mot. 31–32, which addressed whether
the Public Health Service Act, 42 U.S.C. § 264(a), authorized CDC’s eviction moratorium due to
the COVID-19 pandemic. That case is inapposite because it addressed whether a different
government action was authorized under a different statute. Unlike the Executive Orders,
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regulate the practice of medicine. PI Mot. 25–37. To obtain a preliminary injunction,
however, a plaintiff must show “it has a substantial likelihood of success on the
merits of the underlying case when the case is ultimately tried.” U.S. Army Corps of
Eng’rs, 424 F.3d at 1128; 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).
Plaintiffs here cannot show a likelihood of success on the merits based on the claims
they raise for the first time in their preliminary injunction motion.
Even if the Court reached the merits of these new arguments, they would fail.
To show an impermissible delegation of legislative authority, Plaintiffs must show
that Congress failed to “lay down by legislative act an intelligible principle to which
the person or body authorized to [act] is directed to conform.” Whitman v. Am.
Trucking Ass’ns, 531 U.S. 457, 472 (2001) (quotations omitted). But the Supreme
Court has “almost never felt qualified to second-guess Congress regarding the
permissible degree of policy judgment that can be left to those executing or
applying the law,” and it has even “found an ‘intelligible principle’ in various
statutes authorizing regulation in the ‘public interest.’” Id. at 474–75 (quotations

moreover, CDC’s eviction moratorium did not implicate the federal government’s “much freer
hand in dealing with citizen employees,” Nelson, 562 U.S. at 148, and its “unrestricted power . . .
to determine those with whom it will deal, and to fix the terms and conditions upon which it will
make needed purchases,” Perkins, 310 U.S. at 127.
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omitted). The statutes authorizing the Executive Orders provide at least as much of
an “intelligible principle” as regulation in the “public interest.” Plaintiffs also cannot
succeed on their claim that the federal government has intruded on the states’
prerogative to regulate the practice of medicine because neither the Executive
Orders, nor the EUAs, nor any liability protections for entities involved in vaccine
administration regulate the practice of medicine.
Finally, Exhibits 5 and 6 to Plaintiffs’ motion do not show a likelihood of
success on the merits. Relying on Exhibit 5, Plaintiffs contend that FDA and
manufacturers “ignored” several “probable harms” of the EUA vaccines. PI Mot. 35.
But this argument blatantly misconstrues the public record. Exhibit 5 is an excerpt
from a slide deck used at an October 22, 2020, public meeting of FDA’s vaccines
advisory committee, during which CDC and FDA discussed plans to monitor for
“possible adverse event outcomes of interest” for “any new COVID-19 vaccine.”
Mtg. Tr. at 122, https://go.usa.gov/xemdx; see id. at 96–99, 121. The agencies also
shared draft working lists of possible surveillance events, which would be refined
after reviewing “sponsor safety data submitted to FDA,” “the literature and
regulatory experience with these vaccines,” and “other relevant data.” Id. at 121; see
CDC Presentation, https://go.usa.gov/xemdp (slides 31–32); FDA Presentation,
https://go.usa.gov/xemdP (slide 16). Accordingly, the slide in Exhibit 5 is titled,
“FDA Safety Surveillance of COVID-19 Vaccines: Draft Working list of possible
adverse event outcomes ***Subject to change***.” Far from a conspiracy to
suppress information, Exhibit 5 simply reflects FDA’s transparent process to devise
a useful surveillance system for vaccine adverse events.
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Exhibit 6 purports to provide “Data from [the] Medicare System” showing
that “51,100 beneficiaries died within 14 days after the COVID‐19 vaccine.” See PI
Mot. 14. The exhibit does not identify where Plaintiffs obtained these data, and
Plaintiffs did not respond to Defendants’ November 29, 2021, email requesting this
information. There is thus no way to verify or evaluate the data. Even taking Exhibit
6 on face value, it does not identify the Medicare beneficiaries’ cause of death, let
alone show that they died because of the vaccine. As Dr. Marks explained, VAERS
“reports alone cannot be used to determine if a vaccine caused or contributed to an
adverse event or illness” because “vaccination providers are required to report to
VAERS serious adverse events following vaccination with the COVID-19 vaccines
‘irrespective of attribution to vaccination.’” ECF No. 41, at ¶ 17. In short, Plaintiffs
have not met their burden of showing a likelihood of success on the merits.
C. Plaintiffs Have Not Shown Imminent, 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 Brown, 4 F.4th
at 1225. Preventing future irreparable harm is “the sine qua non of injunctive relief.”
U.S. Army Corps of Eng’rs, 424 F.3d at 1133.
As an initial matter, the Southern District of Georgia has issued a nationwide
preliminary injunction enjoining enforcement of EO 14042. Georgia, 2021 WL
5779939, at *12. Plaintiffs therefore cannot show that they would suffer future
imminent, irreparable harm from EO 14042 before this case can be resolved on the
merits. See Wreal, 840 F.3d at 1248.
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Plaintiffs’ irreparable harm argument is based entirely on their contention that
the Executive Orders deprive them of substantive due process by violating their
fundamental right to bodily integrity. PI Mot. 37–38. But this contention fails. See
supra pp. 30–34. Even looking beyond Plaintiffs’ erroneous framing of their
argument, Plaintiffs still fail to show irreparable harm. They argue that they will be
forced “to take a shot against their will.” PI Mot. 38. But no one has been—or will
be—vaccinated “against their will” under the Executive Orders. The individual
Plaintiffs face no imminent risk of any harm, moreover, because they may request
medical or religious accommodations and avoid any adverse employment actions
while their requests are pending. See ECF No. 39, at ¶¶ 8, 11; Church, 2021 WL
5179215, at *13. An injunction is thus unnecessary to protect them from harm
“before [this] case can be resolved on its merits.” Wreal, 840 F.3d at 1248; see
Rodden v. Fauci, No. 3:21-CV-317, 2021 WL 5545234, at *2 (S.D. Tex. Nov. 27,
2021) (finding it “too speculative to say that the plaintiffs who have claimed an
exemption [from EO 14043] are in imminent danger of irreparable harm” because
“[t]here is little to suggest either how soon the exemption claims will be resolved or
how likely the claimants are to prevail”); Church, 2021 WL 5179215, at *13.26
No more irreparable are any adverse employment consequences, including
termination, that Plaintiffs may face if their accommodation requests are denied and
they choose to remain unvaccinated. The loss of employment does not normally

26 Plaintiffs also baselessly assert that “the vaccines as first developed and tested were more
dangerous than those being used today.” PI Mot. 25. But even if true, it would undermine
Plaintiffs’ irreparable harm argument because Plaintiffs’ purported evidence of past harms from
the vaccines would not be probative of future harms. See U.S. Army Corps of Eng’rs, 424 F.3d at
1133 (preventing future irreparable harm is “the sine qua non of injunctive relief’”).
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 46 of 51

constitute irreparable harm. See Sampson v. Murray, 415 U.S. 61, 90, 92 n.68 (1974).
If Plaintiffs are right on the merits, they may seek appropriate relief, such as back
pay and reinstatement, for any unlawful workplace discipline. See id. at 90–91;
Rydie, 2021 WL 5416545, at *5 (no irreparable harm to federal employees
challenging EO 14043); Church, 2021 WL 5179215, at *15 (same).
D. Neither the Equities nor the Public Interest Favors an Injunction.
“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 (quotations omitted).
The balance of equities and the public interest strongly favor Defendants
because enjoining the Executive Orders would greatly harm the public. COVID-19
has already infected over 50 million Americans, hospitalized over 3.5 million, and
killed over 800,000.27 “Stemming the spread of COVID-19 is unquestionably a
compelling interest.” Roman Cath. Diocese of Brooklyn, 141 S. Ct. at 67. As
President Biden observed, CDC “has determined that the best way to slow the spread
of COVID-19 and to prevent infection by the Delta variant or other variants is to be
vaccinated.” 86 Fed. Reg. 50989. Any “injunction affecting the Pfizer-BioNTech
vaccine EUA would greatly harm the public,” “call into question” FDA’s scientific
determination that Pfizer’s EUA vaccine and Comirnaty “are safe and effective,”
create “considerable public and administrative confusion” given that Pfizer’s EUA
vaccine and Comirnaty are “medically interchangeable,” and exacerbate “vaccine
hesitancy.” ECF No. 41, at ¶ 19. Accordingly, the federal government’s compelling

27 CDC, COVID Data Tracker Weekly Review, https://go.usa.gov/xFU9U.
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 47 of 51

interest in stemming the spread of COVID-19 “would be impeded by [the requested]
injunction.” Rydie, 2021 WL 5416545, at *5.
Furthermore, “[t]he effective administration of the federal government, in
which Defendants and the public have a deep and abiding interest, would likely be
hampered by an injunction.” Id. As President Biden reasonably determined, the
Executive Orders are necessary “to promote the health and safety of the Federal
workforce and the efficiency of the civil service” and to promote “economy and
efficiency in Federal procurement.” 86 Fed. Reg. 50989; 86 Fed. Reg. 50985.
Notably, the Executive Orders do not force anyone to receive a vaccine, but
instead allow federal employees and contractors to seek medical and religious
exemptions or pursue other employment. Thus, the Executive Orders strike a careful
balance between the federal government’s compelling interest in stemming the
spread of COVID-19 and certain individuals’ medical or religious reasons for
declining vaccination. The balance of equities and the public interest, therefore,
strongly oppose the requested injunction.
Finally, if an injunction is granted, it should be limited to the Executive Orders
as applied to Plaintiffs. See Gill v. Whitford, 138 S. Ct. 1916, 1934 (2018) (“A
plaintiff’s remedy must be tailored to redress the plaintiff’s particular injury.”).
CONCLUSION
For the foregoing reasons, the Court should dismiss Plaintiffs’ Amended
Complaint pursuant to Federal Rule of Civil Procedure 12(b)(1) and (b)(6) and deny
Plaintiffs’ motion for a preliminary injunction.

Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 48 of 51

Dated: December 17, 2021

OF COUNSEL:
DANIEL BARRY
Acting General Counsel
U.S. Department of Health and Human
Services
WENDY VICENTE
Acting Deputy Chief Counsel,
Litigation
JAMES ALLRED
Associate Chief Counsel
Office of the Chief Counsel
U.S. Food and Drug Administration
10903 New Hampshire 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/ James W. Harlow

ISAAC C. BELFER
Trial Attorney
JAMES W. HARLOW
Senior Trial Attorney
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
Case 2:21-cv-00702-CLM Document 42 Filed 12/17/21 Page 49 of 51

Fax: (204) 244-2171
Email: Don.Long2@usdoj.Gov

Counsel for Defendants the United
States of America; Joseph R. Biden, Jr.,
President of the United States; Xavier
Becerra, Secretary of Health and
Human Services; Dr. Anthony Fauci,
Director of the National Institute of
Allergy and Infectious Diseases; Dr.
Janet Woodcock, Acting Commissioner
of Food and Drugs; 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 42 Filed 12/17/21 Page 50 of 51

CERTIFICATE OF SERVICE
I hereby certify that on December 17, 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 42 Filed 12/17/21 Page 51 of 51

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