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Home Source documents Reply in Support of Motion to Dismiss — America's Frontline Doctors v. United States (N.D. Ala.)

Reply in Support of Motion to Dismiss — America's Frontline Doctors v. United States (N.D. Ala.)

Date
2022-01-28

Summary

A Reply in Support of Defendants' Motion to Dismiss the Amended Complaint, filed January 28, 2022 as Document 44 in America's Frontline Doctors, et al. v. United States of America, et al., Case 2:21-cv-00702-CLM, in the U.S. District Court for the Northern District of Alabama. The government defendants argue that plaintiffs conceded 15 of the 20 Defendants are not proper parties and did not defend the standing of five of the eight Plaintiffs. The reply contends the remaining plaintiffs lack standing, that actions under the EUA statute, 21 U.S.C. § 360bbb-3, are unreviewable under the APA, and that the Civil Service Reform Act channels federal-employee challenges. It also argues that Executive Orders 14042 and 14043 are lawful. The 27-page brief is signed by Department of Justice attorneys.

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     Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 1 of 27            FILED
                                                                      2022 Jan-28 PM 06:18
                                                                      U.S. DISTRICT COURT
                                                                          N.D. OF ALABAMA


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


AMERICA’S FRONTLINE
DOCTORS, et al.,

             Plaintiffs,
                                            CIVIL ACTION NO.
v.                                          2:21-CV-702-CLM
                                            OPPOSED
UNITED STATES OF AMERICA, et
al.,

             Defendants.


            REPLY IN SUPPORT OF DEFENDANTS’
        MOTION TO DISMISS THE AMENDED COMPLAINT
              Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 2 of 27




                                             TABLE OF CONTENTS
INTRODUCTION .....................................................................................................1
ARGUMENT .............................................................................................................4
   I.            Numerous Plaintiffs and Defendants should be dismissed at the
                 outset. ........................................................................................................4
   II.           Plaintiffs still have not met their burden of establishing this
                 Court’s jurisdiction. .................................................................................5
        A.       Several jurisdictional hurdles bar Plaintiffs’ challenges to
                 Defendants’ actions under the EUA statute (Counts I, III–VI). ........6
             1. Standing ....................................................................................................6
             2. Plaintiffs cannot overcome the statutory language rendering
                Counts I, III, and IV unreviewable under the APA............................9
             3. Plaintiffs concede the mandamus statute (Count V) and the
                Declaratory Judgment Act (Count VI) do not supply
                jurisdiction. .............................................................................................11
        B.       Plaintiffs have not established the Court’s jurisdiction over their
                 claims related to the Executive Orders (Counts II, VI). ...................11
             1. Standing and ripeness ...........................................................................11
             2. The CSRA precludes this Court from hearing any challenge by
                Nelson and Leahy to potential adverse employment actions
                reviewable under that statute. .............................................................16
   III.          Plaintiffs’ claims for relief remain implausible on the merits.........17
        A.       Counts I, III, and IV fail to state a claim that the Emergency
                 Declaration and EUAs are unlawful under the APA.......................17
        B.       Counts II and VI fail to state a claim that the Executive Orders are
                 unlawful. .................................................................................................19
             1. Plaintiffs fail to show that the Executive Orders are
                unconstitutional. ....................................................................................19
             2. Plaintiffs fail to show that the Executive Orders exceed the
                President’s statutory authority. ...........................................................20
CONCLUSION ........................................................................................................23

                                                                 ii
         Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 3 of 27




                                    INTRODUCTION
        Plaintiffs’ Opposition to Defendants’ Motion to Dismiss is notable more for

what it does not say than for what it does. Plaintiffs opted not to defend the standing

of five of the eight Plaintiffs. Likewise, they conceded that 15 of the 20 Defendants

are not proper parties. Right off the bat, 20 parties should be dismissed from the

case.

        The three remaining Plaintiffs lack standing. Defendants showed that none of

these Plaintiffs faces an imminent injury that is fairly traceable to the challenged

actions, and the concessions in Plaintiffs’ brief confirm that. Plaintiffs concede that

Makowski, the sole remaining federal-contractor Plaintiff, received a medical

accommodation1 that exempts him from any vaccination requirement based on

Executive Order (“EO”) 14042. Makowski may fear a hypothetical, future vaccine

mandate, but such fear is both speculative and beyond the allegations in the
Amended Complaint.2 As to Nelson and Leahy, the two remaining federal-employee

Plaintiffs, Plaintiffs concede that their accommodation requests remain pending.

Unless and until those requests are denied and they suffer adverse employment

consequences, their feared injuries are speculative and may never come to pass.

        Plaintiffs’ brief also fails to overcome the Amended Complaint’s many other

jurisdictional defects. Regarding Counts I and III–VI, Defendants showed that
actions taken under the emergency use authorization (“EUA”) statute, 21 U.S.C.

1
  The parties’ prior briefing referred to both “accommodations” and “exemptions” from
vaccination requirements, but for clarity, this brief will refer to “accommodations” throughout.
2
 Even if the Opposition had defended the standing of the other federal-contractor Plaintiffs
(Millen, Bloom, and Sobczak), they lack an imminent injury that is fairly traceable to EO 14042.
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 4 of 27




§ 360bbb-3, are exempt from review under the Administrative Procedure Act

(“APA”) based on the EUA statute’s and APA’s plain language. Plaintiffs cannot

show otherwise, and in fact concede that these actions “are subject to [Defendants’]

discretion” and “are not subject to judicial review.” Pls.’ Opp’n, ECF No. 43, at 25.3
Plaintiffs also have no response to Defendants’ explanation of why jurisdiction does

not lie under the mandamus statute (28 U.S.C. § 1361) or the Declaratory Judgment

Act (28 U.S.C. §§ 2201–02). Finally, Plaintiffs do not dispute Defendants’ argument
that this Court lacks jurisdiction over Counts II and VI because Nelson and Leahy

must follow the Civil Service Reform Act’s (“CSRA”) review process to challenge

potential adverse employment action reviewable under that statute, including

termination.

       Even if the Court reached the merits, Plaintiffs have failed to rebut

Defendants’ showing that the Amended Complaint fails to state a claim for relief.
Defendants explained that the APA claims in Counts I, III, and IV are not plausibly

alleged because they do not purport to challenge the Emergency Declaration and

EUAs in light of the agencies’ contemporaneous explanations and the existing

administrative record. Plaintiffs cannot state viable APA claims based on new

arguments and evidence that were never presented to the U.S. Department of Health

and Human Services (“HHS”). Plaintiffs’ brief provides no reason to doubt that these
critical deficiencies are fatal to Counts I, III, and IV.



3
  The citations to Defendants’ opening brief, ECF No. 42, and Plaintiffs’ Opposition, ECF No. 43,
refer to the page numbers at the bottom of each page. The citations to exhibits, e.g., ECF No. 43-
1, refer to the ECF page numbers at the top of each page.
                                                2
         Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 5 of 27




       Regarding Counts II and VI, Plaintiffs have no response to Defendants’

argument that EOs 14042 and 14043 (collectively, the “Executive Orders”) are not

reviewable under the APA because the President is not an “agency.” They also

ignore numerous cases cited by Defendants showing that the Executive Orders do

not deprive Plaintiffs of substantive due process. Finally, Plaintiffs fail to show that

the Executive Orders exceed the President’s statutory authority. They rely on

decisions that address vaccine mandates not at issue here, including injunctions that

have since been stayed by the Supreme Court. More fundamentally, they fail to rebut

Defendants’ explanation of why the text of the relevant statutes authorizes the

Executive Orders.4
       It is Plaintiffs’ burden to establish this Court’s jurisdiction, and their Amended

Complaint must state plausible claims for relief. Plaintiffs have failed on both

accounts. This case should therefore be dismissed.




4
 Defendants acknowledge that the Southern District of Texas has issued a nationwide
preliminary injunction enjoining enforcement of EO 14043, though this decision has been
appealed. Feds for Med. Freedom v. Biden, No. 3:21-CV-356, 2022 WL 188329, at *7–8 (S.D.
Tex. Jan. 21, 2022), appeal filed, No. 22-40043 (5th Cir. Jan. 26, 2022). This decision provides an
additional reason why Plaintiffs’ preliminary injunction motion should be denied, since Plaintiffs
cannot show that they would suffer imminent, irreparable harm from EO 14043 before this case
can be resolved on the merits. See Wreal, LLC v. Amazon.com, Inc., 840 F.3d 1244, 1248 (11th
Cir. 2016). Similarly, Defendants explained that Plaintiffs cannot show that they would suffer
imminent, irreparable harm from EO 14042 before this case can be resolved on the merits in light
of the nationwide preliminary injunction enjoining enforcement of EO 14042 issued in 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). ECF No. 42, at 42 (citing Wreal, 840 F.3d at 1248); see Feds for
Med. Freedom, 2022 WL 188329, at *1 (denying motion to preliminarily enjoin enforcement of
EO 14042 because that Executive Order “is already the subject of a nationwide injunction” that
“protects the plaintiffs from imminent harm”).
                                                3
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                                     ARGUMENT

I.     Numerous Plaintiffs and Defendants should be dismissed at the outset.
       Defendants expressly challenged the standing of all eight Plaintiffs. See Defs.’
 Mem., ECF No. 42, at 11–14, 18, 21–23. “[W]hen standing is questioned by . . . an

 opposing party, . . . the litigant must explain how the elements essential to standing

 are met.” Va. House of Delegates v. Bethune-Hill, 139 S. Ct. 1945, 1951 (2019).

 Rather than satisfy that obligation for all Plaintiffs, Plaintiffs’ brief “addresses just

 the circumstances of three of the Plaintiffs, Joseph Makowski . . . , Michael Nelson

 and Joseph Leahy.” Pls.’ Opp’n 2. Plaintiffs’ choice was deliberate and unaffected

 by space or time constraints (for example, Plaintiffs used only 28 of their allotted 45

 pages).

       By failing to defend the standing of America’s Frontline Doctors (“AFLDS”),
 Dr. Calderwood, Lyle Bloom, Ellen Millen, and Jody Sobczak, Plaintiffs concede

 these parties lack standing. See, e.g., Ctr. for Biological Diversity v. EPA, 937 F.3d

 533, 542 (5th Cir. 2019) (“Arguments in favor of standing, like all arguments in

 favor of jurisdiction, can be forfeited or waived.” (collecting cases)); Eternal World

 Television Network, Inc. v. Burwell, No. CIV.A. 13-0521-CG-C, 2014 WL 2738546,

 at *2 (S.D. Ala. June 17, 2014); Payne v. Gail Pittman, Inc., No. CV 06-B-0565-S,

 2006 WL 8437754, at *1–2 (N.D. Ala. Nov. 14, 2006) (“The court finds that

 plaintiffs have abandoned their claims against [defendant] because they failed

 to address these arguments for dismissal of their claims.”). Because Plaintiffs’
 failure to show standing cannot be remedied by the Court, see Whitmore v. Arkansas,

 495 U.S. 149, 155–56 (1990), AFLDS, Dr. Calderwood, Lyle Bloom, Ellen Millen,

                                            4
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  and Jody Sobczak should be dismissed for lack of standing, see Valley Forge

  Christian Coll. v. Ams. United for Separation of Church & State, Inc., 454 U.S. 464,

  475–76 (1982) (“Those who do not possess Art. III standing may not litigate as

  suitors in the courts of the United States.”).

        Regarding the named Defendants, Plaintiffs “do not object to releasing the

  President as a defendant.” Pls.’ Opp’n 18. Plaintiffs also do not respond to

  Defendants’ argument that Dr. Anthony Fauci, Centers for Disease Control and

  Prevention (“CDC”), National Institutes of Health (“NIH”), National Institute of

  Allergy and Infectious Diseases (“NIAID”), and Does I–X are untethered to any

  claim for relief and should be dismissed from this action. Defs.’ Mem. 24. Plaintiffs
  thus concede that these Defendants should be dismissed. See Eternal World

  Television Network, 2014 WL 2738546, at *2; Payne, 2006 WL 8437754, at *1–2.

II.     Plaintiffs still have not met their burden of establishing this Court’s
        jurisdiction.
        Plaintiffs fail to rebut Defendants’ arguments for why they have not

  established jurisdiction over any of their claims. Defs.’ Mem. 10–23. The Court does

  not have jurisdiction over Plaintiffs’ challenges to Defendants’ actions under the

  EUA statute (Counts I, III–VI) because Plaintiffs lack standing; Counts I, III, and IV

  are unreviewable under the APA based on the EUA statute’s and the APA’s plain

  language; and the mandamus statute (Count V) and the Declaratory Judgment Act

  (Count VI) indisputably do not supply jurisdiction. The Court also does not have
  jurisdiction over Plaintiffs’ claims related to the Executive Orders (Counts II, VI)

  because Plaintiffs have not shown standing or ripeness. Moreover, Nelson and Leahy

                                             5
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 8 of 27




must follow the CSRA’s review process to challenge potential adverse employment

action reviewable under that statute, including termination, and this Court lacks

jurisdiction.

      A. Several jurisdictional hurdles bar Plaintiffs’ challenges to Defendants’
         actions under the EUA statute (Counts I, III–VI).

          1. Standing
      Defendants explained why no Plaintiff has standing to challenge the existence

of the Emergency Declaration or EUAs. Defs.’ Mem. 13–14. Plaintiffs respond only

that “they have engaged in self-avoidance of imminent harm they fear can be caused

by the vaccines.” Pls.’ Opp’n 12. But this argument skips several links in the “chain

of possibilities” that would need to occur before Plaintiffs could actually be injured.

Clapper v. Amnesty Int’l USA, 568 U.S. 398, 410 (2013). Plaintiffs must show that
they face an imminent risk of suffering a “personal injury” that is “fairly traceable to

the . . . allegedly unlawful” issuance of the Emergency Declaration and EUAs.

California v. Texas, 141 S. Ct. 2104, 2113 (2021) (quotations omitted).

      The Emergency Declaration and EUAs “neither require nor forbid any action

on the part of” Plaintiffs, Summers v. Earth Island Inst., 555 U.S. 488, 493–94

(2009), so standing is “substantially more difficult to establish,” Lujan v. Defs. of

Wildlife, 504 U.S. 555, 562 (1992) (quotation omitted). The EUA “Fact Sheets

advise that ‘[i]t is your choice to receive or not receive’ the vaccine.’” Defs.’ Mem.

5 (quoting ECF No. 40-1, at 7). And as Defendants observed—without rebuttal—
Plaintiffs “do not claim that they intend to receive [an EUA vaccine] in the future.”

Defs.’ Mem. 13 (quoting Coal. for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275,

                                           6
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 9 of 27




1280 (D.C. Cir. 2012)). The imminence requirement “has been stretched beyond the

breaking point when, as here, the plaintiff alleges only an injury at some indefinite

future time, and the acts necessary to make the injury happen are at least partly

within the plaintiff’s own control.” Lujan, 504 U.S. at 564 n.2.

       To manufacture standing, Plaintiffs extend the “chain of possibilities” further

still, relying on their potential encounter with an EUA vaccine due to EOs 14042 or

14043. Clapper, 568 U.S. at 410. But there is no imminent risk that EOs 14042 or

14043 will force Makowski, Nelson, and Leahy to receive any COVID-19 vaccine,

let alone one issued under an EUA. Makowski’s medical accommodation request

was granted, so he need not be vaccinated. Pls.’ Opp’n 2, 13. Nelson’s and Leahy’s
accommodation requests remain pending,5 id. at 7, but even if they are denied, the

Court can only speculate whether Nelson and Leahy would choose to be vaccinated.

And even if one of them receives a COVID-19 vaccine in the future, they would not
necessarily need to receive an EUA vaccine. The U.S. Food and Drug Administration

(“FDA”) has approved the COVID-19 vaccine Comirnaty, and Plaintiffs do not

challenge that approval. See Defs.’ Mem. 13–14. All of these contingencies preclude


5
  In compliance with the nationwide preliminary injunction enjoining enforcement of EO 14043
issued in Feds for Med. Freedom v. Biden, 2022 WL 188329, the Safer Federal Workforce Task
Force has instructed federal agencies to “take no action to implement or enforce the COVID-19
vaccination requirement pursuant to [EO] 14043,” and specifically to pause the processing of
pending accommodation requests and not to “ask employees for additional information that may
be required to process” those requests. Safer Federal Workforce Task Force, Frequently Asked
Questions Related to Compliance with the Applicable Preliminary Nationwide Injunction on
Implementation and Enforcement of the Vaccination Requirement Pursuant to Executive Order
(E.O.) 14043: Guidance to Agencies as of January 24, 2022, at 1–2, https://go.usa.gov/xtNPR.
Consistent with those instructions, the National Aeronautics and Space Administration (“NASA”)
has paused the processing of Nelson’s and Leahy’s accommodation requests.

                                              7
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 10 of 27




Plaintiffs from satisfying the “high standard” of an imminent injury traceable to the

Emergency Declaration and EUAs. Defs.’ Mem. 14 (quoting Muransky v. Godiva

Chocolatier, Inc., 979 F.3d 917, 927 (11th Cir. 2020) (en banc)).6

       Plaintiffs cite MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), Pls.’
Opp’n 12, which held that a plaintiff in a patent dispute had standing to assert a

declaratory-judgment claim despite continuing to pay disputed royalties under a

patent license to avoid potentially catastrophic liability. MedImmune, 549 U.S. at

137.7 But whereas the MedImmune plaintiff risked liability if it ever stopped paying

the disputed royalties, here the accommodation process either already has prevented

or may in the future prevent Plaintiffs from ever suffering the injury required for
standing. Makowski’s medical accommodation request was granted, so he need not

be vaccinated and will never suffer the requisite injury. Pls.’ Opp’n 2, 13. Nelson’s

and Leahy’s accommodation requests remain pending. Id. at 7. If those requests are
granted, then (like Makowski) Nelson and Leahy will not need to be vaccinated and

will never suffer the requisite injury. If their accommodation requests are denied,

6
 Moreover, because the Executive Orders were issued by the President, any potential injuries to
Plaintiffs from the Executive Orders would not be fairly traceable to the challenged actions of
Defendants Secretary Becerra, Dr. Fauci, Acting Commissioner Woodcock, HHS, FDA, CDC,
NIH, NIAID, or Does I–X. See Children’s Health Def. v. Food & Drug Admin., No. 1:21-CV-
00200-DCLC-CHS, 2021 WL 5756085, at *5–6 (E.D. Tenn. Nov. 30, 2021), appeal filed, No.
21-6203 (6th Cir. Dec. 17, 2021) (“The [military] vaccine mandates, and the potential
consequences for refusing those mandates, are not fairly traceable to the specific actions of the
FDA” because they “result[ed] from the independent action of” the military—a “third party not
before the court[.]” (quoting Allen v. Wright, 468 U.S. 737, 757 (1984)) (internal quotation marks
omitted)).
7
  The Court explained that the traditional standing inquiry continued to apply: “whether plaintiff
is threatened with ‘imminent’ injury in fact ‘fairly . . . trace[able] to the challenged action of the
defendant.’” MedImmune, 549 U.S. at 128 n.8 (quoting Lujan, 504 U.S. at 560).

                                                  8
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 11 of 27




they still might never suffer the requisite injury because they might choose to be

vaccinated and might receive Comirnaty rather than an EUA vaccine. See Defs.’

Mem. 13–14. MedImmune is thus inapposite.8

           2. Plaintiffs cannot overcome the statutory language rendering
              Counts I, III, and IV unreviewable under the APA.
       Defendants explained that even if any Plaintiff had standing to challenge the

Emergency Declaration and EUAs, this Court still lacks jurisdiction because those

actions are “committed to agency discretion by law.” 5 U.S.C. § 701(a)(2); see Defs.’

Mem. 14–15. Plaintiffs appear to agree. They concede that “[a]ctions taken by
agency officials pursuant to [21 U.S.C. § 360bbb-3] are subject to the discretion of

these officials” and “are not subject to judicial review.” Pls.’ Opp’n 25.9

       For Count I, however, Plaintiffs baldly contend that “whether an emergency

exists is not a matter committed to the discretion of any agency, and is a matter that

a court can determine at any time when raised in litigation.” Pls.’ Opp’n 18. But

Plaintiffs cannot reconcile that position with Congress’s express statement that
“[a]ctions under the authority of” the EUA statute, such as the Emergency


8
  Plaintiffs present a hypothetical in which a man is about to be wrongfully executed, and they
assert that, under Defendants’ arguments, “an injunction could not be granted to stop the
execution” and that “the only remedy” would be a “wrongful death” lawsuit. Pls.’ Opp’n 3–4. This
assertion blatantly misrepresents Defendants’ position. Defendants acknowledged that standing
can be based on a future injury, but they explained that the future injury must be “concrete,
particularized, and imminent rather than conjectural or hypothetical.” Trump v. New York, 141 S.
Ct. 530, 535 (2020) (per curiam) (quotation omitted). Plaintiffs have not plausibly alleged any
such injury. Defs.’ Mem 11–14.
9
  Because the Emergency Declaration and EUAs are unreviewable under the APA, Plaintiffs’
quotations from Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 413–14 (1971),
and FCC v. Nextwave Personal Communications Inc., 537 U.S. 293, 300 (2003), for the APA’s
standard of review, see Pls.’ Opp’n 26, are inapplicable.
                                               9
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 12 of 27




Declaration and EUAs, “are committed to agency discretion.” 21 U.S.C. § 360bbb-

3(i).

        Plaintiffs again cite Chastleton Corp. v. Sinclair, 264 U.S. 543 (1924), and

Home Building and Loan Association v. Blaisdell, 290 U.S. 398 (1934). Pls.’ Opp’n

18. But they do not dispute Defendants’ arguments for why those cases are

inapposite. Defs.’ Mem. 26–27. As Defendants explained, both cases pre-dated the

APA and addressed only a court’s review of emergency laws for compliance with

the Constitution. See id. Count I does not challenge the Emergency Declaration

based on the Constitution; instead, it asserts an APA challenge under the EUA

statute, in the face of Congress’s express direction that no APA cause of action is
available. Similarly inapposite is Sterling v. Constantin, 287 U.S. 378 (1932), see

Pls.’ Opp’n 18, which held that “[w]hen there is a substantial showing that the

exertion of state power has overridden private rights secured by th[e] Constitution,

the subject is necessarily one for judicial inquiry.” Sterling, 287 U.S. at 398. Count

I, again, presents no constitutional question.

        Finally, in a last-ditch appeal to avoid dismissal, Plaintiffs assert that “the

possibility that serious wrongs have likely been committed” means judicial review

should not be “foreclosed.” Pls.’ Opp’n 28. But Congress declared that agency

actions “committed to agency discretion by law” are unreviewable under the APA,

5 U.S.C. § 701(a)(2), and it included within that category actions under the EUA

statute, 21 U.S.C. § 360bbb-3(i). Plaintiffs cannot manufacture an exception to

Congress’s command by merely arguing that “serious wrongs have likely been

committed”—an exception that would render 5 U.S.C. § 701(a)(2) a dead letter.
                                          10
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         3. Plaintiffs concede the mandamus statute (Count V) and the
            Declaratory Judgment Act (Count VI) do not supply jurisdiction.
      Defendants explained why jurisdiction does not lie under the mandamus

statute (28 U.S.C. § 1361) or the Declaratory Judgment Act (28 U.S.C. §§ 2201–02).

Defs.’ Mem. 15–16. Plaintiffs have no response and therefore concede the point. See
Ctr. for Biological Diversity, 937 F.3d at 542; Eternal World Television Network,

2014 WL 2738546, at *2; Payne, 2006 WL 8437754, at *1–2.

      B. Plaintiffs have not established the Court’s jurisdiction over their
         claims related to the Executive Orders (Counts II, VI).

         1. Standing and ripeness
      Defendants demonstrated that no Plaintiff has standing or ripe claims to

challenge EOs 14042 or 14043. See Defs.’ Mem. 18–23. Of the three Plaintiffs

whose standing is defended in the Opposition, only Makowski is allegedly a federal
contractor covered by EO 14042. But Makowski has received a medical

accommodation, Pls.’ Opp’n 2, 13, so he no longer “fac[es] a COVID vaccine

mandate,” ECF No. 32-1, at ¶ 1. Thus, he cannot show the injury necessary for

standing to challenge EO 14042 in Counts II and VI. See Carney v. Adams, 141 S.

Ct. 493, 499 (2020) (plaintiff “bears the burden of establishing standing as of the

time he brought this lawsuit and maintaining it thereafter”).
      Plaintiffs attach as Exhibit 1 an FAQ page from Raytheon Technologies. ECF

No. 43-1. On its face, the exhibit appears to be a document fragment. See id. at 3

(cutting off answer to Question 8 and possibly more FAQs). In any event, only
Plaintiff Millen works for Raytheon, Pls.’ Opp’n 10, and Plaintiffs chose not to

defend her standing, id. at 2. Moreover, no clearly alleged facts show that Millen is

                                         11
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a “covered contractor employee” for purposes of EO 14042, see Defs.’ Mem. 22,

that she could not avail herself of the accommodation process, or that an

accommodation request was denied, see ECF No. 43-1, at 3 (discussing

“accommodation for medical or religious reasons”).

      Plaintiffs’ argument that the federal-contractor Plaintiffs’ standing “is not

affected when the harm they suffer has been caused by third parties such as [their]

employers,” Pls.’ Opp’n 9, falls short. Defendants explained that, if the federal-

contractor Plaintiffs’ accommodation requests were wrongfully denied under a

workplace policy adopted due to EO 14042 (which, at least for Makowski, did not

happen), those denials would be traceable to (and redressable by) their employers—
not Defendants—because it is the employers’ responsibility to “review and consider

what, if any, [religious or medical] accommodation [they] must offer.” Defs.’ Mem.

23 (quoting 86 Fed. Reg. 63,418, 63,420 (Nov. 16, 2021)). Accommodation denials

would be an employer’s “independent action” and not fairly traceable to the

Executive Orders. Simon v. E. Ky. Welfare Rts. Org., 426 U.S. 26, 41–42 (1976).

Moreover, Plaintiffs have not shown that an accommodation denial “would have

been illegal without” Defendants’ challenged actions. Id. at 45 n.25; Pls.’ Opp’n 9

n.5; see Defs.’ Mem. 7–8.

      Turning to EO 14043, Plaintiffs concede that Nelson’s and Leahy’s

accommodation requests remain pending before NASA. Pls.’ Opp’n 7, 13–14. They

do not dispute that “while their requests remain pending, they face no adverse

employment action.” Defs.’ Mem. 18 (citing ECF No. 39, at ¶¶ 8, 11). And they

ignore the numerous cases cited by Defendants holding that employees’ claims are
                                        12
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not justiciable when their accommodation requests remain pending. See Defs.’ Mem.

18–22; see also Donovan v. Vance, No. 4:21-CV-5148-TOR, 2021 WL 5979250, at

*4–5 (E.D. Wash. Dec. 17, 2021) (where plaintiffs challenging EOs

14042 and 14043 were “in various stages of the exemption and accommodations
process,” their claims were “unripe for judicial review because [p]laintiffs’ fears [of

termination] may never come into fruition, and because delaying review will not

unduly burden the parties”); Am. Fed’n of Gov’t Emps. Loc. 501 v. Biden, No. 21-

23828-CIV, 2021 WL 6551602, at *7–8 (S.D. Fla. Dec. 22, 2021) (associational

plaintiffs challenging EO 14043 lacked standing because “it is entirely speculative

as to whether any of [their] members would be disciplined for failure to become
vaccinated because, for example, they may choose to become vaccinated or receive

an exemption”); Robert v. Austin, No. 21-CV-02228-RM-STV, 2022 WL 103374,

at *3 (D. Colo. Jan. 11, 2022) (dismissing challenge to military vaccine mandate for
lack of jurisdiction where plaintiffs’ exemption requests had been granted or were

pending, and thus where “[p]laintiffs’ contention that they may be subject to

discipline for refusing to take a vaccine appears to be based on nothing more than

speculation”).

      Plaintiffs cite U.S. Navy SEALs 1–26 v. Biden, No. 4:21-CV-01236-O, 2022

WL 34443 (N.D. Tex. Jan. 3, 2022), appeal filed, No. 22-10077 (5th Cir. Jan. 21,
2022), see Pls.’ Opp’n 14, but that decision, which reviewed the military’s

vaccination policy, did not address Article III standing at all. Rather, it examined the

justiciability of servicemembers’ Religious Freedom Restoration Act claims under
a Fifth Circuit-specific “test to determine whether a given military issue is
                                          13
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justiciable.” 2022 WL 34443, at *4. That legal framework is inapplicable here.

Moreover, although the court in U.S. Navy Seals found that “the record” in that case

indicated that “the denial of each [religious accommodation] request is

predetermined” such that the exhaustion of administrative remedies was futile, id.,

no similar facts are alleged here. Under the ordinary principles of Article III standing

and ripeness, Nelson’s and Leahy’s claims should be dismissed. See Defs.’ Mem.

18–19.

      Finally, Plaintiffs’ brief inappropriately raises new theories of injury,

including that Makowski finds mask-wearing “bothersome” and that Nelson spent

time submitting his accommodation request. See Pls.’ Opp’n 13–15. “It is axiomatic
that a plaintiff cannot amend the complaint by arguments of counsel made in

opposition to a motion to dismiss.” Kuhn v. Thompson, 304 F. Supp. 2d 1313, 1321

(M.D. Ala. 2004). The only injuries alleged in the Amended Complaint are threats

to Plaintiffs’ employment and to their bodily integrity from “COVID-19 vaccine

mandate[s].” Am. Compl. ¶¶ 1, 15–19, 32. Likewise, in Counts II and VI, Plaintiffs

challenge only those provisions of EOs 14042 and 14043 relating “to the mandate

of the COVID-19 vaccines.” Id. ¶¶ 181, 192. Because the only injuries alleged in the

Amended Complaint are Plaintiffs’ alleged injuries from the vaccine mandates,

Plaintiffs lack standing to challenge any other provisions of the Executive Orders.

See CAMP Legal Def. Fund, Inc. v. City of Atlanta, 451 F.3d 1257, 1273 (11th Cir.

2006) (plaintiffs must show injury-in-fact “as to each challenged [statutory]

provision”).


                                          14
       Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 17 of 27




      Despite having filed an original complaint, an amended complaint, and a

corrected amended complaint, Plaintiffs suggest they could file a fourth complaint

with new allegations. See Pls.’ Opp’n 15. Further amendment, however, would be

“futile” because “the complaint as amended [would] still [be] subject to dismissal.”

Archie v. Covington Cty., No. 2:19CV508-MHT, 2021 WL 4227027, at *1 (M.D.

Ala. Sept. 16, 2021) (quoting Bryant v. Dupree, 252 F.3d 1161, 1163 (11th Cir.

2001)); Hall v. United Ins. Co. of Am., 367 F.3d 1255, 1262–63 (11th Cir. 2004)

(internal quotations omitted); see also Fed. R. Civ. P. 15(a)(2). Specifically,

Plaintiffs’ newfound injuries would no more support standing than their presently

alleged ones.
      Makowski fears a hypothetical vaccine mandate “in the future,” Pls.’ Opp’n

13, but “unadorned speculation will not suffice to invoke the federal judicial power,”

Simon, 426 U.S. at 44. Although Makowski finds masks “bothersome,” Pls.’ Opp’n

13, that kind of “psychic injury” does not satisfy standing’s requirement of

concreteness, Gardner v. Mutz, 962 F.3d 1329, 1341 (11th Cir. 2020). Lastly,

Makowski’s objection to “weekly testing,” Pls.’ Opp’n 13, cannot be fairly traced to

EO 14042 or to the Safer Federal Workforce Guidance implementing EO 14042,

which do not mention testing, see 86 Fed. Reg. 50,985 (Sept. 9, 2021); Safer Federal

Workforce Task Force, COVID-19 Workplace Safety: Guidance for Federal

Contractors and Subcontractors, https://go.usa.gov/xtDVu (updated Nov. 10,

2021); see also Pls.’ Opp’n 5 & n.1 (referencing Guidance).

      Nelson’s concerns that his accommodation request “may be denied” and that

“he may very well lose his job,” Pls.’ Opp’n 14, are simply “allegations of possible
                                         15
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 18 of 27




future injury” that “are not sufficient” for standing, Clapper, 568 U.S. at 409.

Moreover, the time Nelson spent preparing his accommodation request is not “a real

and immediate threat of future harm,” as required for injunctive or declaratory relief,

Elend v. Basham, 471 F.3d 1199, 1207 (11th Cir. 2006) (emphasis added), and is not

redressable by such relief, see Kawa Orthodontics, LLP v. Sec’y, U.S. Dep’t of the

Treasury, 773 F.3d 243, 247–48 (11th Cir. 2014).10 Finally, Nelson’s purported

“ostraci[sm]” by his coworkers, Pls.’ Opp’n 14, results from his coworkers’
“independent action,” Simon, 426 U.S. at 41–42, and is not fairly traceable to

Defendants’ challenged actions.

           2. The CSRA precludes this Court from hearing any challenge by
              Nelson and Leahy to potential adverse employment actions
              reviewable under that statute.
       Defendants explained that the Amended Complaint faces a further

jurisdictional infirmity: preclusion under the CSRA. Defs.’ Mem. 20. Nelson and

Leahy—the only Plaintiffs allegedly subject to EO 14043—are both covered by the

CSRA. ECF No. 39, at ¶¶ 6, 9; see Elgin v. Dep’t of Treasury, 567 U.S. 1, 5 (2012).

To challenge potential adverse employment action reviewable under the CSRA,
including termination, they must follow the CSRA’s review process, and this Court

lacks jurisdiction. See Elgin, 567 U.S. at 5–6 (citing 5 U.S.C. § 7512); Rydie v.

Biden, No. CV DKC 21-2696, 2021 WL 5416545, at *2 (D. Md. Nov. 19, 2021),
appeal filed, No. 21-2359 (4th Cir. Dec. 7, 2021); Defs.’ Mem. 20–21. But see Feds


10
  For this reason, Plaintiffs’ reference to Losch v. Nationstar Mortgage LLC, 995 F.3d 937 (11th
Cir. 2021), is inapposite. Pls.’ Opp’n 14–15. Whereas the Losch plaintiff sought only damages,
995 F.3d at 941–42, Plaintiffs here seek declaratory and injunctive relief and thus must show a
material risk of future injury.
                                              16
          Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 19 of 27




   for Med. Freedom, 2022 WL 188329, at *2–3. Plaintiffs ignore this argument and

   thus concede it. See Ctr. for Biological Diversity, 937 F.3d at 542; Eternal World

   Television Network, 2014 WL 2738546, at *2; Payne, 2006 WL 8437754, at *1–2.

III.     Plaintiffs’ claims for relief remain implausible on the merits.
         Even if the Court reaches the merits, Defendants showed that the Amended

   Complaint should still be dismissed for failure to state a claim, Defs.’ Mem. 23–37,

   and Plaintiffs have not shown otherwise. Plaintiffs have not plausibly pleaded that

   the Emergency Declaration and EUAs violate the APA (Counts I, III, IV). Nor have

   they plausibly pleaded that the Executive Orders are unconstitutional or that they

   exceed the President’s statutory authority (Counts II, VI).

         A. Counts I, III, and IV fail to state a claim that the Emergency
            Declaration and EUAs are unlawful under the APA.
         Defendants explained that, even assuming jurisdiction over the APA claims

   in Counts I, III, and IV, they still are not plausibly alleged. Defs.’ Mem. 24–30. The

   APA requires plaintiffs to show that the agency’s contemporaneous explanations

   were unreasonable “in light of the existing administrative record,” Dep’t of Com. v.

   New York, 139 S. Ct. 2551, 2573 (2019), and courts “will not consider arguments

   that a party failed to raise in timely fashion before an administrative agency,” such

   as by filing a citizen petition with FDA, Mahon v. U.S. Dep’t of Agric., 485 F.3d

   1247, 1254–55 (11th Cir. 2007); see 21 C.F.R. §§ 10.25(a), 10.30, 10.45. The

   Amended Complaint, however, 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. Defs.’ Mem. 24–26. Plaintiffs’ brief confirms this deficiency,

                                            17
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 20 of 27




identifying nothing in “the existing administrative record” that shows the

contemporaneous explanations for the Emergency Declaration and EUAs were

unreasonable, and nowhere suggesting that Plaintiffs presented their arguments to

HHS before filing suit. See Pls.’ Opp’n 18, 25–27.11
       Instead, Plaintiffs argue that the vaccine manufacturers misbranded the

vaccines, and they insinuate, without specificity or support, that Defendants were

aware of “some problem.” Pls.’ Opp’n 26–28. Such speculation does not state a

plausible APA claim, which would require Plaintiffs to identify evidence in the

existing administrative record showing the vaccines are “dangerous to health when

used” according to the FDA-approved labeling. Defs.’ Mem. 39; see Ashcroft v.
Iqbal, 556 U.S. 662, 678–79 (2009). Neither the Amended Complaint nor Plaintiffs’

brief meets that burden.

       In support of their misbranding argument, Plaintiffs improperly attach the
Ealy Declaration, which suggests that the COVID-19 vaccines may have killed over

427,000 Americans—more than all Americans who died in World War II.12 Pls.’

Opp’n 27–28; ECF No. 43-5, at ¶ 25. This assertion defies common sense, and

Plaintiffs’ baseless speculation that Defendants were aware of this information and

did not act on it cannot overcome the presumption of regularity to which federal

officials are entitled. See U.S. Postal Serv. v. Gregory, 534 U.S. 1, 10 (2001). The

11
   Contrary to Plaintiffs’ belief, see Pls.’ Opp’n 25–26, Defendants did not purport to file the
complete administrative record as an exhibit to the motion to dismiss. Rather, Defendants filed
certain publicly available materials to demonstrate Plaintiffs’ complete failure to engage with the
scientific evidence that was actually before the agency. See Defs.’ Mem. 25–26.
12
  Approximately 405,000 Americans died in military service during World War II. See
Department of Veterans Affairs, America’s Wars, https://go.usa.gov/xtB8s.
                                               18
       Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 21 of 27




Ealy Declaration is also improper because Plaintiffs may not defeat a Rule 12(b)(6)

motion by adding new allegations in their brief. See Lee v. Sec. Check, LLC, No.

3:09-CV-421-J-12TEM, 2009 WL 3790455, at *2 (M.D. Fla. Nov. 9, 2009) (striking

“the exhibits and new factual assertions contained in [p]laintiff’s response to

[defendant]’s Motion to Dismiss” because “they attempt to insert new facts not

contained in [p]laintiff’s Second Amended Complaint” and thus “cannot support

denial of [defendant]’s Motion to Dismiss” (citations omitted)). Moreover, even if

the Ealy Declaration reflected the allegations in the Amended Complaint, it still

would not support an APA claim because its contents are untethered to the

contemporaneous administrative record and were never presented to the agency. See
Dep’t of Com., 139 S. Ct. at 2573; Mahon, 485 F.3d at 1254–55; 21 C.F.R. §§ 10.25,

10.30, 10.45.

       B. Counts II and VI fail to state a claim that the Executive Orders are
          unlawful.
       Defendants explained that the Executive Orders “are not reviewable under the

APA” because “the President is not an ‘agency.’” Dalton v. Specter, 511 U.S. 462,

470 (1994); Defs.’ Mem. 30. Plaintiffs ignore this argument and thus concede it. See

Eternal World Television Network, 2014 WL 2738546, at *2; Payne, 2006 WL

8437754, at *1–2. But even if the Executive Orders were reviewable, Counts II and

VI still fail to state plausible claims for relief.

          1. Plaintiffs fail to         show      that   the   Executive   Orders   are
             unconstitutional.
       Defendants explained that the Executive Orders do not deprive Plaintiffs of

substantive due process, citing numerous cases that Plaintiffs completely ignore.
                                             19
       Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 22 of 27




Defs.’ Mem. 30–34. Plaintiffs respond by simply invoking the “unconstitutional

conditions doctrine,” Pls.’ Opp’n 15–16, under which “the government may not deny

a benefit to a person on a basis that infringes his constitutionally protected” rights,

United States v. Am. Libr. Ass’n, 539 U.S. 194, 210 (2003) (quotation omitted).

      As an initial matter, Plaintiffs ignore that the only Plaintiffs whose standing

they defend—Makowski, Nelson, and Leahy—are not being “forced to choose

between” being vaccinated “or being terminated from their employment.” Pls.’

Opp’n 15. Makowski was granted an accommodation, and Nelson’s and Leahy’s

accommodation requests are pending. But even if Nelson’s and Leahy’s

accommodation requests are denied, the unconstitutional conditions doctrine does
not apply here because the Executive Orders do not “infringe[] [Plaintiffs’]

constitutionally protected” rights. Am. Libr. Ass’n, 539 U.S. at 210; see Defs.’ Mem.

30–34; Burcham v. City of Los Angeles, No. 221CV07296RGKJPR, 2022 WL

99863, at *8 n.4 (C.D. Cal. Jan. 7, 2022); Troogstad v. City of Chicago, No. 21 C

5600, 2021 WL 5505542, at *10 (N.D. Ill. Nov. 24, 2021), appeal filed, No. 21-3371

(7th Cir. Dec. 23, 2021); Doe v. Zucker, 520 F. Supp. 3d 217, 268 (N.D.N.Y. 2021),
appeal filed, No. 21-537 (2d Cir. Mar. 5, 2021).

          2. Plaintiffs fail to show that the Executive Orders exceed the
             President’s statutory authority.
      Defendants explained why both Executive Orders are within the President’s

statutory authority. Defs.’ Mem. 34–37. In opposition, Plaintiffs cite decisions
preliminarily enjoining enforcement of the vaccine policies imposed by the Centers

for Medicare and Medicaid Services (“CMS”) and the Occupational Safety and

                                          20
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 23 of 27




Health Administration (“OSHA”),13 but those decisions are inapposite because they
did not address EOs 14042 or 14043. See Donovan, 2021 WL 5979250, at *4

(decision regarding OSHA vaccine policy was not “persuasive or even instructive”

in challenge to EOs 14042 and 14043). Moreover, the Supreme Court recently

stayed the preliminary injunctions enjoining enforcement of the CMS policy on the

basis that “the Secretary’s rule falls within the authorities that Congress has

conferred upon him.” Biden v. Missouri, 142 S. Ct. 647, 652, 654–55 (2022).

       Regarding EO 14043, Plaintiffs trace the history of 5 U.S.C. §§ 3301, 3302,

and 7301, Pls.’ Opp’n 23–25, but fail to respond to Defendants’ explanation for why

the text of those statutes authorizes EO 14043, see Defs.’ Mem. 36; Rydie, 2021 WL
5416545, at *3 (explaining that 5 U.S.C. §§ 3301, 7301, and 7513 authorize EO

14043); Oklahoma v. Biden, No. CIV-21-1136-F, 2021 WL 6126230, at *10 (W.D.

Okla. Dec. 28, 2021) (“the court concludes that [EO 14043] is a permissible exercise

of executive authority . . . substantially for the reasons stated in Rydie v. Biden”); see

also Bostock v. Clayton Cty., 140 S. Ct. 1731, 1749 (2020) (“when the meaning of

the statute’s terms is plain,” a court’s “job is at an end”).14 Furthermore, EO 14043


13
  Pls.’ Opp’n 19–21 (citing BST Holdings, LLC v. Occupational Safety and Health Admin., 17
F.4th 604 (5th Cir. 2021); Louisiana v. Becerra, No. 21-30734, 2021 U.S. App. LEXIS 37035 (5th
Cir. Dec. 15, 2021); Louisiana v. Becerra, No. 3:21-CV-03970, 2021 U.S. Dist. LEXIS 229949
(W.D. La. Nov. 30, 2021); Missouri v. Biden, No. 4:21-cv-01329-MTS, 2021 U.S. Dist. LEXIS
227410 (E.D. Mo. Nov. 29, 2021)).
14
   The Southern District of Texas recently determined, in the preliminary injunction context, that
“the President was without statutory authority to issue” EO 14043. Feds for Med. Freedom, 2022
WL 188329, at *6. The government’s appeal of the district court’s decision in Feds for Med.
Freedom is pending. Defendants respectfully submit that this case was wrongly decided because
it is contrary to the text of 5 U.S.C. §§ 3301, 3302, and 7301 and the case law interpreting those
provisions, as explained in Defendants’ opening brief. See Defs.’ Mem. 36.
                                               21
        Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 24 of 27




is within the President’s authority because the President has independent

constitutional authority to act as CEO of the Executive Branch, even absent

confirming statutory authority from Congress. See U.S. Const. Art. II, § 1; Rydie,

2021 WL 5416545, at *3; Oklahoma, 2021 WL 6126230, at *10.

       Regarding EO 14042, Plaintiffs likewise trace the history of 3 U.S.C. § 301

and the Federal Property and Administrative Services Act (“Procurement Act”), 40

U.S.C. § 101, et seq., Pls.’ Opp’n 21–23, but fail to respond to Defendants’

explanation for why the text of those statutes authorizes EO 14042, see Defs.’ Mem.

35–36; see also Donovan, 2021 WL 5979250, at *6 (EO 14042 “easily satisfies” the

“lenient standard” for authorization under the Procurement Act). Although Plaintiffs
cite several cases (each of which has been appealed) finding in the preliminary

injunction context that EO 14042 likely exceeds the President’s authority under the

Procurement Act,15 they do not discuss those cases’ reasoning. For the reasons
explained in their opening brief, Defendants respectfully submit that those cases

were wrongly decided and that the Procurement Act authorizes EO 14042.

       In any event, the Eleventh Circuit has scheduled oral argument for the week
of April 4, 2022, in one appeal of a decision preliminarily enjoining enforcement of

EO 14042. Georgia v. President of the United States, No. 21-14269 (11th Cir.).




15
   Pls.’ Opp’n 19–20 (citing Georgia v. Biden, No. 1:21-cv-163, 2021 U.S. Dist. LEXIS 234032
(S.D. Ga. Dec. 7, 2021), appeal filed, No. 21-14269 (11th Cir. Dec. 10, 2021); Florida v. Nelson,
No. 8:21-cv-2524-SDM-TGW, 2021 U.S. Dist. LEXIS 246185 (M.D. Fla. Dec. 22, 2021), appeal
filed, No. 22-10165 (11th Cir. Jan. 13, 2022); Kentucky v. Biden, No. 3:21-cv-00055-GFVT, 2021
U.S. Dist. LEXIS 228316 (E.D. Ky. Nov. 30, 2021)), appeal filed, No. 21-6147 (6th Cir. Dec. 6,
2021)).
                                               22
       Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 25 of 27




Thus, this Court should defer any ruling on the merits of Plaintiffs’ statutory

challenge to EO 14042 until the Eleventh Circuit issues its decision in Georgia.

                                 CONCLUSION
      For the foregoing reasons, and those stated in Defendants’ opening brief, the

Court should dismiss Plaintiffs’ Amended Complaint pursuant to Federal Rule of

Civil Procedure 12(b)(1) and (b)(6).


Dated: January 28, 2022                  Respectfully submitted,

OF COUNSEL:                              BRIAN M. BOYNTON
                                         Acting Assistant Attorney General
DANIEL BARRY
Acting General Counsel                   ARUN G. RAO
U.S. Department of Health and Human      Deputy Assistant Attorney General
Services
                                         GUSTAV W. EYLER
WENDY VICENTE                            Director
Acting Deputy Chief Counsel,
Litigation                               HILARY K. PERKINS
                                         Assistant Director
JAMES ALLRED
Associate Chief Counsel                  /s/_ Isaac C. Belfer _____
Office of the Chief Counsel              ISAAC C. BELFER
U.S. Food and Drug Administration        Trial Attorney
10903 New Hampshire Avenue               JAMES W. HARLOW
White Oak 31, Rm 4564                    Senior Trial Attorney
Silver Spring, MD 20993-0002             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

                                        23
Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 26 of 27




                               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 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




                              24
       Case 2:21-cv-00702-CLM Document 44 Filed 01/28/22 Page 27 of 27




                          CERTIFICATE OF SERVICE
      I hereby certify that on January 28, 2022, 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/_ Isaac C. Belfer _____
                                             ISAAC C. BELFER
                                             Trial Attorney




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