Memorandum Opinion and Order — Calderwood v. United States (N.D. Ala.)
- Date
- 2022-08-25
Summary
A Memorandum Opinion and Order entered August 25, 2022 as Document 54 in Dr. David Calderwood, et al. v. The United States of America, et al., Case No. 2:21-cv-00702-CLM, in the U.S. District Court for the Northern District of Alabama, Southern Division, signed by United States District Judge Corey L. Maze. The plaintiffs challenge HHS and FDA actions under the Emergency Use Authorization statute, 21 U.S.C. § 360bbb-3, and Executive Orders 14042 and 14043 imposing vaccine mandates on federal contractors and federal employees. The opinion reviews the EUA statute, the executive orders and the nationwide injunctions against them, and the six counts of the amended complaint. The Court holds that it lacks subject-matter jurisdiction, grants the motion to dismiss (doc. 38), dismisses the amended complaint without prejudice, and allows a Third Amended Complaint.
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Case 2:21-cv-00702-CLM Document 54 Filed 08/25/22 Page 1 of 25 FILED
2022 Aug-25 PM 01:54
U.S. DISTRICT COURT
N.D. OF ALABAMA
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION
Dr. David Calderwood,
Joseph Makowski, Michael
Nelson, and Joseph Leahy,
Plaintiffs,
v. Case No. 2:21-cv-702-CLM
The United States of America,
Xavier Becerra, Secretary of the
U.S. Department of Health and
Human Services, U.S. Department
of Health and Human Services,
Dr. Janet Woodcock, Acting
Commissioner of the Food and
Drug Administration, and Food
and Drug Administration,
Defendants.
MEMORANDUM OPINION AND ORDER
This case is about emergency authorization for COVID-19 vaccines
and executive orders that imposed vaccine mandates on federal
contractors and federal employees. Two federal civilian employees, a
federal contractor’s employee, and a physician sued to challenge several
agency actions of the Secretary of the Department of Health and Human
Services and of the Food and Drug Administration under the Emergency
Use Authorization statute, 21 U.S.C. § 360bbb-3. They also seek to
challenge the constitutional and statutory validity of the President’s
Executive Orders 14042 (the federal-contractor mandate) and 14043 (the
federal-employee mandate).
But the Court cannot address the merits of these COVID-related
actions because, as explained below, the Court lacks subject-matter
jurisdiction over the plaintiffs’ claims. So the Court grants the defendants’
motion to dismiss (doc. 38) and dismisses the plaintiffs’ operative
amended complaint (doc. 32-1).
Case 2:21-cv-00702-CLM Document 54 Filed 08/25/22 Page 2 of 25
BACKGROUND
The Court lays out this case in three parts. First, the EUA statute
and the defendants’ actions under it. Second, the executive orders that
imposed vaccine mandates on federal contractors and federal employees.
And third, the factual and procedural histories.
I. The Emergency Use Authorization statute
Under the Public Health Service Act, “[a] manufacturer of a
biologic” such as a vaccine “may market the drug only if the FDA has
licensed it pursuant to either of two review processes set forth in § 262.”
Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1670 (2017) (referring to 42
U.S.C. § 262). But “[n]otwithstanding” the PHSA’s licensing
requirements, the Emergency Use Authorization statute permits the HHS
Secretary to authorize the immediate marketing of “biological product[s]
intended for use in an actual or potential emergency” under limited
circumstances. 21 U.S.C. § 360bbb-3(a)(1).1 Three EUA-statute provisions
warrant discussion: the emergency-declaration provision; the criteria-for-
issuance provision; and the conditions-of-authorization provisions.2
A. The emergency-declaration provision. The EUA statute
authorizes the HHS Secretary to determine “that there is a public health
emergency . . . that affects, or has a significant potential to affect, national
security or the health and security of United States citizens living abroad”
and “involves a biological . . . agent or agents, or a disease or condition
that may be attributable to such agent or agents.” Id. § 360bbb-3(b)(1)(C).
And that may serve as “the basis of” the HHS Secretary’s declaration that
“circumstances exist justifying the authorization” of biological products
such as vaccines. Id. § 360bbb-3(b)(1).
The HHS Secretary determined in February 2020 “that there is a
public health emergency” based on SARS-CoV-2, which causes COVID-19.
Determination of Public Health Emergency, 85 Fed. Reg. 7,316, 7,317
1 “FDA’s licensing authority under 21 U.S.C. § 262 and its EUA authority under 21 U.S.C. §
360bbb-3 are independent of each other; FDA’s licensing authority does not affect its EUA
authority and vice versa.” Children’s Health Defense v. U.S. Food & Drug Administration, No.
21-6203, 2022 WL 2704554, at *1 (6th Cir. July 12, 2022).
2 Also relevant is the provision that the Secretary’s “[a]ctions under the authority of” the EUA
statute “are committed to agency discretion.” 21 U.S.C. § 360bbb-3(i).
2
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(Feb. 7, 2020). The next month, 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 (April 1, 2020).
B. The criteria-for-issuance provision. The Secretary may issue
an EUA for a specific product “only if” three criteria (as relevant here) are
satisfied:
(1) that an agent referred to in a declaration under subsection (b)
can cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to the
Secretary, including data from adequate and well-controlled clinical
trials, if available, it is reasonable to believe that—
(A) the product may be effective in diagnosing, treating, or
preventing—
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition
caused by a product authorized under this section,
approved or cleared under this chapter, or licensed
under section 351 of the Public Health Service Act, for
diagnosing, treating, or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product, taking
into consideration the material threat posed by the agent or
agents identified in a declaration under subsection (b)(1)(D),
if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition . . . .
21 U.S.C. § 360bbb-3(c)(1)–(3).
3
Case 2:21-cv-00702-CLM Document 54 Filed 08/25/22 Page 4 of 25
C. The conditions-of-authorization provision. Finally, the
EUA statute requires “the Secretary, to the extent practicable given the
applicable circumstances,” to establish “appropriate conditions” for EUA
products as “the Secretary finds necessary or appropriate to protect the
public health.” Id. § 360bbb-3(e)(1)(A). Those include conditions that
ensure healthcare professionals and vaccine recipients receive certain
information about the product. Id. § 360bbb-3(e)(1)(A)(i)–(ii). And also
“conditions for the monitoring and reporting of adverse events associated
with the emergency use of the product.” Id. § 360bbb-3(e)(1)(A)(iii).
Beginning in December 2020, the FDA issued EUAs for vaccines
from Pfizer, Moderna, and Janssen. (Docs. 40-6, 40-14, 40-20). And in
August 2021, the FDA approved Pfizer’s biologics license application for
its COVID-19 vaccine, Comirnaty, for persons 16 and older. (Doc. 41-1).3
II. The executive orders imposing vaccine mandates
On his first day in office, President Biden issued Executive Order
13991 establishing the Safer Federal Workforce Task Force. Protecting
the Federal Workforce and Requiring Mask-Wearing, 86 Fed. Reg. 7,045
(Jan. 25, 2021). That executive order explained that the SFWTF’s mission
would be to “provide ongoing guidance to heads of agencies on the
operation of the Federal Government, the safety of its employees, and the
continuity of Government functions during the COVID-19 pandemic.” Id.
at 7,046. And that order set the stage for the vaccine mandates.
Months later, President Biden announced several measures “to
require more Americans to be vaccinated.”4 One was Executive Order
14042, the federal-contractor mandate. Another was Executive Order
14043, the federal-employee mandate.
A. Executive Order 14042 (federal-contractor mandate)
President Biden issued Executive Order 14042 on September 9,
2021. Ensuring Adequate COVID Safety Protocols for Federal
3 Despite full authorization under the PHSA for Comirnaty, the Pfizer EUA persists for a two-
dose series for individuals 5 and older, and for a third dose for certain individuals. (Doc. 41-2).
4 Remarks by President Biden on Fighting the COVID-19 Pandemic, White House (Sept. 9,
2021), https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/09/remarks-by-
president-biden-on-fighting-the-covid-19-pandemic-3/ (last visited Aug. 25, 2022).
4
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Contractors. 86 Fed. Reg. 50,985 (Sept. 14, 2021). The President stated
that the order would “promote[] 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 or
contract-like instrument.” Id. at 50,985 § 1.
Executive Order 14042 directs departments and agencies, “to the
extent permitted by law,” to include a clause in federal contracts that
requires compliance with guidance that the SFWTF would publish and
the Office of Management and Budget’s director would approve. Id. § 2(a).
On September 24, the SFWTF issued the contemplated guidance.5
That guidance imposed a vaccine mandate: “Covered contractors must
ensure that all covered contractor employees are fully vaccinated for
COVID-19, unless the employee is legally entitled to an accommodation.”
SFWTF EO 14042 Guidance at 5. It also ordered compliance with CDC
guidance on masking and physical distancing, id. at 6, and the designation
of a person who would oversee the workplace-safety-protocol
implementation, id. at 7–8. The OMB Acting Director approved the
guidance after determining that it “will improve economy and efficiency
by reducing absenteeism and decreasing labor costs for contractors and
subcontractors working on or in connection with a Federal Government
contract.” Determination of the Promotion of Economy and Efficiency in
Federal Contracting Pursuant to Executive Order No. 14042, 86 Fed. Reg.
53,691, 53,692 (Sept. 28, 2021).6
5 Safer Federal Workforce Task Force, COVID-19 Workplace Safety: Guidance for Federal
Contractors and Subcontractors (“SFWTF EO 14042 Guidance”) (Sept. 24, 2021),
https://www.saferfederalworkforce.gov/downloads/Draft%20contractor%20guidance%20doc_20
210922.pdf (last visited Aug. 25, 2022).
6 The SFWTF issued revised (but substantially similar) guidance that included the vaccine
mandate on November 10. Safer Federal Workforce Task Force, COVID-19 Workplace Safety:
Guidance for Federal Contractors and Subcontractors (Nov. 10, 2021),
https://www.saferfederalworkforce.gov/downloads/Guidance%20for%20Federal%20Contractors
_Safer%20Federal%20Workforce%20Task%20Force_20211110.pdf (last visited Aug. 25, 2022).
And the OMB Acting Director approved the revised version on November 16. Determination of
the Acting OMB Director Regarding the Revised Safer Federal Workforce Task Force Guidance
for Federal Contractors and the Revised Economy & Efficiency Analysis, 86 Fed. Reg. 63,418,
63,423 (Nov. 16, 2021). The Court assumes that November 5 is the relevant time for Article III
standing purposes, so the Court will rely on the September 24 SFWTF guidance.
5
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After the federal-contractor vaccine mandate went into effect, a
federal district court entered a nationwide injunction barring enforcement
of “the vaccine mandate for federal contractors and subcontractors in all
covered contracts in any state or territory of the United States of
America.” See Georgia v. Biden, 574 F. Supp. 3d 1337, 1357 (S.D. Ga.
2021), appeal docketed, No. 21-14269 (Dec. 10, 2021). The Eleventh
Circuit denied the motion to stay the injunction and expedited the case.
Georgia v. Biden, No. 21-14269 (11th Cir. Dec. 17, 2021). So the federal-
contractor mandate remains enjoined nationwide.
B. Executive Order 14043 (federal-employee mandate)
President Biden also issued Executive Order 14043 on September
9. Requiring Coronavirus Disease 2019 Vaccination for Federal
Employees, 86 Fed. Reg. 50,989 (Sept. 14, 2021). The order directs
agencies to “implement, to the extent consistent with applicable law, a
program to require COVID-19 vaccination for all of its Federal employees,
with exceptions only as required by law.” Id. at 50,990 § 2. And it ordered
the SFWTF to issue guidance on implementation. Id.
A federal district court has enjoined the government from enforcing
Executive Order 14043 nationally. See Feds for Med. Freedom v. Biden,
No. 3:21-cv-356, 2022 WL 188329, at *8 (S.D. Tex. Jan. 21, 2022). A Fifth
Circuit motions panel declined to stay the injunction pending appeal. 25
F.4th 354, 355 (5th Cir. 2022) (mem.) (carrying the motion with the case
and expediting the appeal). Then a merits panel vacated the district
court’s injunction after holding that the Civil Service Reform Act, 5 U.S.C.
§ 1101 et seq., precluded the district court’s subject-matter jurisdiction. 30
F.4th 503, 511 (5th Cir. 2022). But before the panel’s mandate issued, the
full Fifth Circuit vacated the panel’s opinion and ordered rehearing en
banc. 37 F.4th 1093 (5th Cir. 2022) (en banc) (mem.). So the federal-
employee mandate remains enjoined nationwide.
III. Factual and procedural backgrounds
The Court begins this section by discussing the plaintiffs’ claims.
Then it covers the plaintiffs’ background allegations. And then the
defendants’ factual attacks on justiciability.
6
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A. The plaintiffs’ claims
The plaintiffs raise six claims in the operative amended complaint.
(Doc. 32-1).
Count I is an APA challenge to the HHS Secretary’s ongoing
emergency declaration. (Doc. 32-1 at 57). See 21 U.S.C. § 360bbb-
3(b)(1)(C). The plaintiffs allege that the circumstances that supported the
Secretary’s February 2020 emergency declaration no longer exist (and
they imply that the circumstances never justified the original declaration).
(Id. at 58–59 ¶¶ 176–77). And they appear to allege that the Court should
terminate the emergency declaration and the EUAs. (Id. at 59 ¶ 177).
Count II is a substantive-due-process constitutional challenge to
Executive Orders 14042 and 14043. (Id. at 59). They request injunctive
and declaratory relief barring “any mandate or action that would lead to
the mandate of the COVID-19 vaccines.” (Id. at 60 ¶ 181).
Count III is an APA challenge to the EUAs based on the
defendants’ failure to comply with the criteria-for-issuance provision. (Id.
at 60). The plaintiffs allege that: (1) COVID-19 is not “a serious or life-
threatening disease or condition”; (2) the Secretary didn’t rely on
“adequate and well-controlled clinical trials”; (3) it was not “reasonable to
believe” that the vaccines “may be effective”; (4) it was not “reasonable to
believe” that “the known and potential benefits of the product . . . outweigh
the known and potential risks of the product”; and (5) there were
“adequate, approved, and available alternative[s] to the product for
diagnosing, preventing, or treating” COVID-19. (Doc. 32-1 at 60–61 ¶
183). See 21 U.S.C. § 360bbb-3(c).7 Based on these allegations, they seek
a declaration that the EUAs are invalid. (Doc. 32-1 at 61 ¶ 184).
Count IV is an APA challenge to the EUAs based on the
defendants’ failure to comply with the conditions-of-authorization
provision. (Id. at 61). See 21 U.S.C. § 360bbb-3(e). The plaintiffs allege
that the defendants have arbitrarily and capriciously failed to provide
7 The plaintiffs’ complaint doesn’t make clear whether they are trying to allege that those
criteria were not satisfied at the times the defendants issued the relevant EUAs or, instead, that
those findings proved later to be incorrect. In an APA challenge to agency action, the Court’s
review is “limited to evaluating the agency’s contemporaneous explanation in light of the
existing administrative record.” Dep’t of Commerce v. New York, 139 S. Ct. 2551, 2573 (2019).
7
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healthcare professionals and vaccine recipients with information about
the vaccines. (Doc. 32-1 at 61–62 ¶ 186). And that the defendants have not
established appropriate conditions for monitoring and reporting adverse
events. (Id.). Based on these allegations, the plaintiffs seek a declaration
that the EUAs are invalid. (Doc. 32-1 at 62–63 ¶ 187).
Count V seeks a writ of mandamus “compelling the individual
federal defendants to perform the duties owed to them” under the EUA
statute. (Id. at 63 ¶ 190). See 21 U.S.C. § 360bbb-3.
Count VI seeks two declarations. (Doc. 32-1 at 64). The first is a
declaration that the executive orders “are invalid to authorize compulsory
EUA vaccinations.” (Id. ¶ 192). The second is a declaration that the EUA
statute and the “constitutional right to bodily integrity” include a right “to
refuse without adverse consequences any EUA vaccine.” (Id.).
These six counts fit into three categories. First, Counts I, III, IV,
and part of VI challenge the HHS Secretary’s and the FDA’s actions under
the EUA statute. Second, Counts II and the other part of VI challenge the
executive orders on constitutional and statutory grounds. And third,
Count V seeks a writ of mandamus compelling the defendants to comply
with the EUA statute.
B. The plaintiffs’ background allegations
Thirty-one plaintiffs have participated in this lawsuit at one point
or another.8 Four remain: Joseph Makowski, Michael Nelson, Joseph
Leahy, and Dr. David Calderwood.9 The Court discusses these plaintiffs
below.
Joseph Makowski “works for a federal contractor that provides
services on a federal installation.” (Id. at 6 ¶ 15). Makowski’s physician,
co-plaintiff Dr. Calderwood, advised him “that because of his medical
problems, he should not take any Vaccine.” (Id.). And his employer “issued
a mandate declaring that he must be vaccinated no later than November
8, 2021.” (Id.). The complaint does not explain whether Makowski is a
“covered contractor employee” or whether his employer is a “covered
contractor” under the SFWTF guidance that imposed the federal-
8 (Docs. 1, 10, 32-1).
9 (Docs. 32-1, 50, 51).
8
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contractor vaccine mandate. See SFWTF EO 14042 Guidance at 3–5. Nor
does it identify who his employer is or explain whether his employer’s
mandate is based on the federal-contractor vaccine mandate.
Dr. David Calderwood is Makowski’s doctor. (Id. at 6 ¶ 14). He
“advised Makowski to not take any of the vaccines at issue in this
complaint due to his health condition(s).” (Id.). He claims authority to
assert his Makowski’s rights. (Id.).
Michael Nelson works “at the Marshall Space Flight Center.”
(Doc. 32-1 at 7 ¶ 19). As a federal employee, he was set to “confront the
vaccine mandate” from Executive Order 14043 in November 2021. (Id.).
Joseph Leahy also works “at the Marshall Space Flight Center” as
a federal civilian employee (Id.). So he was also set to “confront the vaccine
mandate” from Executive Order 14043 in November 2021. (Id.).
C. The defendants’ factual attacks on justiciability
The defendants have moved to dismiss under Rule 12(b)(1)
(jurisdiction) and under Rule 12(b)(6) (failure to state a claim). (Doc. 38).
Among other things, the defendants attack jurisdiction by arguing that
none of the four plaintiffs has Article III standing. (See doc. 42 at 2).
To challenge standing, the defendants present a “factual attack”
that “challenge[s]” jurisdiction “irrespective of the pleadings.” Makro
Capital of Am., Inc. v. UBS AG, 543 F.3d 1254, 1258 (11th Cir. 2008)
(citation omitted). “In resolving a factual attack, the district court ‘may
consider extrinsic evidence such as testimony and affidavits.’” Id. (quoting
Morrison v. Amway Corp., 323 F.3d 920, 925 n.5 (11th Cir. 2003)).
The defendants’ “motion implicates the fundamental question of
[the] trial court’s jurisdiction,” and the “court is free to weigh the evidence
and satisfy itself as to the existence of its power to hear the case without
presuming the truthfulness of the plaintiff’s allegations.” Id. (citation and
quotation marks omitted). In other words, the Court will “apply a
summary judgment standard when ruling on the motion to dismiss as a
factual attack on subject matter jurisdiction.” Miccosukee Tribe of Indians
of Fla. v. EPA, 105 F.3d 599, 603 (11th Cir. 1997).
9
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For the EUA-statute claims, the defendants argue that plaintiffs
Makowski, Nelson, and Leahy did not and do not face any material risk of
harm traceable to the EUA-statute actions. (Doc. 42 at 13–14).10 And for
the executive-order claims, the defendants argue that there was never a
material risk that these three plaintiffs would have to take a COVID-19
vaccine (based on the ready availability of exemption processes). (Id. at
18, 22–23). To support these arguments, the defendants rely on affidavits
about vaccine-authorization processes (doc. 41 at 7 ¶ 15) and the plaintiffs’
efforts to obtain exemptions (docs. 37-3, 37-4, 39).
D. The procedural history of this case
This case began when several individual plaintiffs and America’s
Frontline Doctors moved in May 2021 for a temporary restraining order.
(Doc. 1). They sought to enjoin the vaccine EUAs for children under 16.
(Id.). The Court denied it. (Doc. 3).
After that, the plaintiffs filed their complaint in June 2021, seeking
to invalidate the emergency declaration and EUAs. (Doc. 10). They moved
for a preliminary injunction. (Doc. 15). But the defendants responded with
a motion to dismiss. (Doc. 23). So the plaintiffs withdrew their injunction
motion and sought leave to amend. (Docs. 26, 27, 28, 29).
The plaintiffs filed an amended complaint on October 29, 2021. (Doc.
30). On November 4, they asked for leave to file a “revised amended
complaint” that would fix typos and drop one claim. (Doc. 32). And they
attached the revised amended complaint. (Doc. 32-1). The Court treats the
revised amended complaint as the operative pleading. (Id.).11
With new allegations and claims, the plaintiffs again sought a
preliminary injunction. (Doc. 37). And the defendants sought dismissal for
lack of jurisdiction and failure to state a claim. (Doc. 38). With full briefing
on the preliminary-injunction motion and the motion to dismiss, the Court
10 The defendants oppose Dr. Calderwood’s third-party standing by pointing out that Makowski
(his only known patient) is not hindered in his “ability to protect” his “own interests.” See Powers
v. Ohio, 499 U.S. 400, 411 (1991). (Doc. 42 at 12).
11 After they sought leave to file the “revised amended complaint,” (doc. 32), the Court granted
the plaintiffs leave on November 5 to do so and ordered them “to file the corrected amended
complaint (doc. 32-1) as a separate docket entry.” (Doc. 33). They never did. But the defendants
treated the revised amended complaint as operative. (Doc. 42 at 4 n.4). The Court will too.
10
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heard argument. (Doc. 49). After the hearing, the plaintiffs withdrew their
preliminary-injunction motion. (Doc. 50). And the parties jointly moved to
dismiss several parties. (Id.).
The Court turns now to decide whether this case is justiciable.
DISCUSSION
Article III of the Constitution limits the federal judicial power to
“Cases” and “Controversies.” U.S. CONST. art. III, § 2. This means “[a]t all
stages of litigation, a plaintiff must maintain a personal interest in the
dispute.” Uzuegbunam v. Preczewski, 141 S. Ct. 792, 796 (2021). It also
“prevent[s] the federal courts from issuing advisory opinions.” Carney v.
Adams, 141 S. Ct. 493, 498 (2020). And “[f]ederal courts have an
independent obligation to ensure that subject-matter jurisdiction exists
before reaching the merits of a dispute.” Jacobson v. Fla. Sec’y of State,
974 F.3d 1236, 1245 (11th Cir. 2020).
This case is not justiciable. The Court explains why in three parts.
First, the plaintiffs lack standing to pursue their challenges to the EUA-
statute actions (Counts I, III, IV, and VI in part) and the executive orders
(Counts II and the VI’s other part). Second, the Court doesn’t have
jurisdiction over the plaintiffs’ request for mandamus relief (Count V)
because the plaintiffs have not shown that their “right to the writ is clear
and indisputable.” Serrano v. U.S. Att’y Gen., 655 F.3d 1260, 1263 (11th
Cir. 2011). And third, reaching the merits would require the Court to write
an impermissible advisory opinion.
I. The plaintiffs lack Article III standing.
“[A]n essential and unchanging part of the case-or-controversy
requirement of Article III” is that the plaintiff must establish standing.
Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992). To establish standing,
the plaintiff must show “(1) that he or she suffered an injury in fact that
is concrete, particularized, and actual or imminent, (2) that the injury was
caused by the defendant, and (3) that the injury would likely be redressed
by the requested judicial relief.” Thole v. U.S. Bank N.A., 140 S. Ct. 1615,
1618 (2020). Put another way, the plaintiff must establish “personal
injury fairly traceable to the defendant’s allegedly unlawful conduct and
11
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likely to be redressed by the requested relief.” DaimlerChrysler Corp. v.
Cuno, 547 U.S. 332, 342 (2006).
“The type of relief sought also bears on whether the plaintiff has
standing.” Attala Cnty., Miss. Branch of NAACP v. Evans, 37 F.4th 1038,
1042 (5th Cir. 2022). “[W]hen plaintiffs seek prospective relief to prevent
future injuries, they must prove that their threatened injuries are
‘certainly impending.’” Jacobson, 974 F.3d at 1245 (quoting Clapper v.
Amnesty Int’l USA, 568 U.S. 398, 401 (2013)). In other words, the plaintiff
must establish “a material risk” of future harm. Muransky v. Godiva
Chocolatier, Inc., 979 F.3d 917, 928 (11th Cir. 2020) (en banc).12
Here, the plaintiffs seek prospective declaratory and injunctive
relief, so they must establish “a real and immediate threat of future
harm.” Elend v. Basham, 471 F.3d 1199, 1207 (11th Cir. 2006) (citing City
of Los Angeles v. Lyons, 461 U.S. 95, 105 (1983)).13
The plaintiffs bear the burden to establish standing. Lujan, 504
U.S. at 561. And they cannot do so “in gross,” Davis v. Fed. Elec. Comm’n,
554 U.S. 724, 734 (2008). To the contrary, “a plaintiff must demonstrate
standing for each claim he seeks to press and for each form of relief that
is sought.” Id. (quotation marks omitted).
With that framework, the Court proceeds in three parts. First, the
Court explains why it assumes November 5, 2021, is the date on which
the plaintiffs must have had standing. Second, the Court explains why the
plaintiffs lack standing to challenge the executive orders. And third, the
Court explains why the plaintiffs lack standing to challenge the
defendants’ EUA-statute actions.
12 The plaintiffs do not have to show “that it is literally certain that the harms they identify will
come about,” but they must do more than make mere “allegations of possible future injury.”
Clapper, 568 U.S. at 409, 414 n.5 (quotation marks and alteration omitted).
13 A past wrong is relevant to “whether there is a real and immediate threat of repeated injury,”
but “[p]ast exposure to illegal conduct does not in itself show a present case or controversy
regarding injunctive relief, however, if unaccompanied by any continuing, present adverse
effects.” O’Shea v. Littleton, 414 U.S. 488, 495–96 (1974).
12
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A. The Court assumes that November 5, 2021, is the
relevant date for establishing Article III standing.
The Court must first decide the date on which to judge the plaintiffs’
Article III standing: June 10, 2021, when the plaintiffs filed their original
complaint (doc. 10) or November 5, 2021, when the Court granted the
plaintiffs’ motion to accept their revised amended complaint, making it
operative (docs 32-1, 33). The Court assumes the latter: November 5th.
It’s well established that Plaintiffs must have had standing when
they filed their original complaint. See, e.g., Lujan, 504 U.S. at 569 n.4
(“The existence of federal jurisdiction ordinarily depends on the facts as
they exist when the complaint is filed.”); Friends of the Earth, Inc. v.
Laidlaw Ent’l Servs. (TOC), Inc., 528 U.S. 167, 180 (2000) (courts have
“an obligation to assure ourselves that [the plaintiff] had Article III
standing at the outset of the litigation”).
But also well-established is the “general rule” that “an amended
complaint supersedes and replaces the original complaint unless the
amendment specifically refers to or adopts the earlier pleading.” Varnes
v. Local 91, Glass Bottle Blowers Ass’n, 674 F.2d 1365, 1370 n.6 (11th Cir.
1982); see also Pintando v. Miami-Dade Hous. Agency, 501 F.3d 1241,
1243 (11th Cir. 2007). And the Supreme Court (although in a different
context) has stated that “when a plaintiff files a complaint in federal court
and then voluntarily amends the complaint, courts look to the amended
complaint to determine jurisdiction.” Rockwell Int’l Corp. v. United States,
549 U.S. 457, 473–74 (2007); id. at 474 n.6 & 475 (holding that the plaintiff
“plead[ed] away jurisdiction” by abandoning the original factual basis for
jurisdiction). As Justice Scalia, who later wrote Rockwell, put it: “We have
repeatedly recognized that what is required for litigation to continue is
essentially identical to what is required for litigation to begin: There must
be a justiciable case or controversy as required by Article III.” Friends of
the Earth, 528 U.S. at 212 (Scalia, J. dissenting).
This Court has not found a definitive answer to this question from
the Supreme Court or the Eleventh Circuit, and the parties did not
meaningfully brief it. So the Court will use the date of the operative
complaint (November 5, 2021) from this point on to determine whether
13
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the plaintiffs present a justiciable case or controversy as required by
Article III. That said, the Court would reach the same conclusion if it used
the date the complaint was filed (June 10, 2021) because, at the time, the
risk that the defendants’ actions would harm the plaintiffs was
exceedingly “speculative.” Clapper, 568 U.S. at 401.
B. The plaintiffs lack standing to challenge Executive
Order 14042 and Executive Order 14043.
The plaintiffs challenge the executive orders constitutionally (Count
II) and statutorily (Count VI in part). But the plaintiffs lack standing
because they have not shown that they faced a “certainly impending” risk
of vaccine-mandate enforcement. Id.
1. The individual defendants lack standing.
In the operative amended complaint, the individual plaintiffs allege
that each of them “fac[es] a COVID vaccine mandate.” (Doc. 32-1 at 1 ¶ 1).
According to that complaint, Makowski works for a federal contractor who
“issued a mandate,” merely implying that his employer issued the
mandate under Executive Order 14042. (Id. at 6 ¶ 15). And both Nelson
and Leahy are federal employees who were set to “confront” a mandate
under Executive Order 14043. (Id. at 7 ¶ 19). The two future injuries the
plaintiffs allege are forced vaccination and threats to their continued
employment. (Doc. 32-1 at ¶¶ 1, 15, 19, 32, 181, 192).
The defendants make a “factual attack” on the individual plaintiffs’
standing, so the Court “may consider extrinsic evidence such as testimony
and affidavits.” Makro, 543 F.3d at 1258. Based on available evidence, the
Court finds that the ready availability of exemptions from the vaccine
mandates (including Nelson’s and Leahy’s submitting exemption
requests) forecloses a personal stake in the legality of the orders.
To begin, the orders contemplated exemptions. Executive Order
14042 directed departments and agencies to include a compliance clause
in contracts “to the extent permitted by law.” 86 Fed. Reg. at 50,985 § 2(a).
And the SFWTF’s guidance made room for exemptions: “Covered
contractors must ensure that all covered contractor employees are fully
vaccinated for COVID-19, unless the employee is legally entitled to an
accommodation.” SFWTF EO 14042 Guidance at 5 (emphasis added).
14
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Likewise, Executive Order 14043 directed agencies “to require COVID-19
vaccination for all of its Federal employees, with exceptions only as
required by law.” 86 Fed. Reg. at 50,990 § 2 (emphasis added).
i. Nelson and Leahy
At the time of the operative complaint, Nelson and Leahy had
submitted religious-exemption requests. The defendants submitted a
declaration from those plaintiffs’ employer (NASA) explaining that Nelson
submitted an exemption request on October 15 and that “as long as [his]
exception request remains pending,” Nelson “will not be disciplined for
being unvaccinated.” (Doc. 39 at 3–4 ¶¶ 10–11). The declaration similarly
explained that Leahy submitted an exemption request on September 20
and that he “will not be disciplined for being unvaccinated” before NASA
processes his request. (Id. at 3 ¶¶ 7–8).
Nelson and Leahy don’t dispute these facts. Rather, Nelson
submitted his own declaration saying that he and Leahy submitted
exemption requests and, on November 19, both requests remained
pending. (Doc. 37-4 at 2).14 So both were pending on November 5.
Based on these undisputed facts, the plaintiffs have not carried
their burden to establish that they faced a “certainly impending” threat of
forced vaccination or any adverse employment action. See Clapper, 568
U.S. at 401. And any fear that their exemption requests would be denied
and that they would then face either forced vaccination or an adverse
employment action relies on a “speculative” and “attenuated chain of
possibilities” that “does not satisfy the requirement that threatened injury
must be certainly impending.” Id. at 409–10. So Nelson and Leahy lack
14 In fact, their requests are still pending. Soon after the federal court enjoined EO 14043
enforcement, the SFWTF instructed agencies to stop enforcing the vaccine mandate and to pause
processing requests. (See doc. 44 at 7 n.5 (discussing SFWTF guidance as of January 24)). And
on August 17, the SFWTF issued updated guidance directing agencies, among other things, to
refrain from asking employees and potential employees about vaccination status; to not process
exemption requests; and to hold any pending disciplinary actions in abeyance. SFWTF,
Frequently Asked Questions Related to Compliance with the Applicable Preliminary
Nationwide Injunction on Implementation and Enforcement of the Vaccination Requirement
Pursuant to Executive Order 14043 (Aug. 17, 2022), https://www.saferfederalworkforce.gov/dow
nloads/FAQs_compliance_injunction_EO%2014043_20220124.pdf (last visited Aug. 25, 2022).
This guidance underscores the Court’s view that this case calls for an impermissible advisory
opinion. See Section III, infra, at 24.
15
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Article III standing to challenge Executive Order 14043’s federal-
employee mandate.
ii. Makowski
Assuming that Executive Order 14042 applies to Makowski, the
plaintiffs have not met their burden to establish that Makowski has
standing to seek prospective relief against the executive order.
On November 5, Makowski had reason to know that he would need
a medical exemption and that such exemptions were readily available.
The plaintiffs alleged in the operative complaint the “Makowski’s
physician, Dr. Calderwood, has advised that because of his medical
problems, he should not take any Vaccine.” (Doc. 32-1 at 6 ¶ 15).
Makowski suggested in his November 18 declaration that he intended to
seek “a medical and/or religious exemption.” (Doc. 37-3 at 3). And even
though he apparently didn’t seek an exemption until November 21, (doc.
43 at 13), he could have done so on or before November 5. After all, the
government had broadcasted the exemptions’ availability in Executive
Order 14042 and the SFWTF EO 14042 Guidance.15
Based on these undisputed facts, the Court finds that the plaintiffs
have not shown that Makowski faced a “certainly impending” threat of
forced vaccination or any adverse employment action. See Clapper, 568
U.S. at 401. And Makowski’s failure to seek an exemption at an earlier
stage does not change this outcome. See id. at 416 (explaining that parties
“cannot manufacture standing merely by inflicting harm on themselves
based on their fears of hypothetical future harm that is not certainly
impending”). So he lacks standing to challenge Executive Order 14042’s
federal-contractor mandate.
15 Makowski’s employer has granted his request for an exemption from the vaccine mandate.
(Doc. 43 at 13). According to the plaintiffs, Makowski’s employer exempted him from the
vaccination requirement but has required him to wear a mask and undergo weekly testing. (Id.).
16
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iii. The plaintiffs’ counterarguments are
unpersuasive.
The plaintiffs try to raise new injuries in their response to the
defendants’ motion to dismiss. (Doc. 43). Those arguments include that:
Makowski finds “wearing masks at work” to be “particularly
bothersome.” (Id. at 13).
Makowski’s “weekly testing consumes his time and also causes
inconvenience, stress and fear.” (Id.).
Makowski is concerned that he “may be subjected in the future to
another vaccine mandate.” (Id.).
Nelson must “wear masks at meetings” and “engage in social
distancing.” (Id. at 14).
Nelson “is ostracized by his fellow workers because he is not
vaccinated and is seeking a religious accommodation.” (Id.).
Nelson “had to investigate how to secure a vaccine exemption, draft
and present such to his superiors, and deal with everything that has
followed, all of which has consumed a substantial amount of time.”
(Id.).
Nelson “is concerned that even though he has requested an
exemption, it may be denied and he may very well lose his job.” (Id.).
Recall that the only two injuries the plaintiffs allege in the operative
complaint are forced vaccination and threats to their continued
employment. (Doc. 32-1 at ¶¶ 1, 15, 19, 32, 181, 192). The new injuries
they raise only in briefing do not support standing because they are found
nowhere in their complaint, and a plaintiff cannot amend his complaint
through counsel’s arguments in opposition to a motion to dismiss. Eiras v.
Florida, 239 F. Supp. 3d 1331, 1342 (M.D. Fla. 2017).16
Even if the plaintiffs had included these alleged injuries in their
pleading, they would still not support standing to seek prospective relief
against the vaccine mandates in Executive Order 14042 (and its
16 It is true that, as here, a district court may consider extrinsic evidence when evaluating a
“factual attack” on the “fundamental question” of whether subject-matter jurisdiction exists.
Makro, 543 F.3d at 1258. But the party invoking federal jurisdiction must always “plausibly
allege all jurisdictional elements.” Brownback v. King, 141 S. Ct. 740, 749 (2021). And that
includes “the burden of establishing” Article III standing. Lujan, 504 U.S. at 561.
17
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accompanying guidance) or Executive Order 14043. The Court will
explain why each injury falls short.
1. Makowski’s complaint that “wearing masks at work” is
“particularly bothersome” fails for three reasons. For one, that mask-
wearing is bothersome is not a concrete injury. “[P]urely psychic injuries
arising from disagreement with government action—for instance,
‘conscientious objection’ and ‘fear’—don’t qualify.” Gardner v. Mutz, 962
F.3d 1329, 1341 (11th Cir. 2020). Contrast those injuries with “physical
harms,” which are concrete. See TransUnion LLC v. Ramirez, 141 S. Ct.
2190, 2204 (2021) (emphasis added). But the plaintiffs didn’t explain how
the mask-wearing, while bothersome, causes a physical harm. For
another, even if this complaint were enough, there is no basis to say that
this mask-wearing injury is traceable the allegedly unlawful vaccine
mandate authorized by Executive Order 14042 and implemented by the
SFWTF EO 14042 Guidance. And lastly, even if this Court held the
vaccine mandate within the executive order and guidance to be unlawful,
that ruling wouldn’t likely redress the mask-wearing injury.
2. Makowski’s objection to “weekly testing” doesn’t support standing
to challenge the mandates within Executive Order 14042 and SFWTF
guidance because neither mentions testing. See 86 Fed. Reg. 50,985;
SFWTF EO 14042 Guidance. So this injury would not be “fairly traceable”
to any defendant’s “allegedly unlawful conduct.” See DaimlerChrysler, 547
U.S. at 342. Nor would this injury be redressable through claims that only
challenge the vaccine mandate’s legality. And even if weekly testing
“causes inconvenience, stress and fear,” (doc. 43 at 13), those feelings
aren’t concrete injuries. See Gardner, 962 F.3d at 1341.
3. Makowski’s concern that “he still may be subjected in the future
to another vaccine mandate,” (doc. 43 at 13), “is too speculative” to support
standing. Clapper, 568 U.S. at 401. It is merely an insufficient allegation
about “possible future injury.” Id. at 409.
4. Nelson’s complaint about being required to “wear masks at
meetings” and “engage in social distancing” don’t support standing to
challenge Executive Order 14043’s federal-employee vaccine mandate.
Neither the executive order itself nor any available implementing
18
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guidance mentions mask-wearing or social distancing. So these
complaints are not traceable to the Executive Order 14043—and not
traceable to the federal-employee vaccine mandate, itself.
5. Nelson’s being “ostracized by his fellow workers” doesn’t work
either. With few exceptions, federal courts skepticize “standing theories
that rest on speculation about the decisions of independent actors.”
Clapper, 568 U.S. at 414; see also Dep’t of Commerce v. New York, 139 S.
Ct. 2551, 2566 (2019) (explaining that, where causation between the
injury and the defendant’s challenged action turns on the decision of an
independent third party, the plaintiff must show that the third-party’s
action is a “predictable effect of [the] Government action”). The plaintiffs
never try to explain how coworker ostracism is a predictable effect of the
federal-employee mandate. So this injury is not traceable to the
defendants’ allegedly unlawful conduct. DaimlerChrysler, 547 U.S. at 342.
And there is no basis to conclude that favorable legal relief would redress
that ostracism. Id.
6. That Nelson “had to investigate how to secure a vaccine
exemption, draft and present such to his superiors, and deal with
everything that has followed, all of which has consumed a substantial
amount of time,” falls short, too. All these things happened before
November 5 (Nelson submitted his accommodation request on October
15). (Doc. 39 at 3 ¶ 10). So it cannot support standing for prospective relief.
Elend, 471 F.3d at 1207. And although a past injury is relevant to
“whether there is a real and immediate threat of repeated injury,” there
is no non-speculative risk that Nelson will bear these harms again in the
imminent future. See O’Shea, 414 U.S. at 496.
7. Nelson’s “concern[] that even though he has requested an
exemption, it may be denied and he may very well lose his job,” (doc. 32-1
at 14), “is too speculative” to support standing. Clapper, 568 U.S. at 401.
It is an insufficient allegation about “possible future injury.” Id. at 409.
19
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***
In sum, the plaintiffs have not met their burden to establish that,
on November 5, they faced a certainly impending harm that would be
traceable to the defendants’ vaccine mandates in the executive orders and
the corresponding SFWTF guidance and that the Court could redress.
DaimlerChrysler, 547 U.S. at 342. So the plaintiffs don’t have standing to
bring Count II or Count IV’s part about the mandates.
2. Dr. Calderwood lacks third-party standing
The plaintiffs allege that Dr. Calderwood “has advised Makowski to
not take any of the vaccines at issue in this complaint due to his health
condition(s).” (Doc. 32-1 at 6 ¶ 14). They assert that Dr. Calderwood can
assert Makowski’s rights. (Id.). And this third-party standing theory is
the plaintiffs’ only basis for Dr. Calderwood being in this case.
“In the ordinary course, a litigant must assert his or her own legal
rights and interests, and cannot rest a claim to relief on the legal rights
or interests of third parties.” Powers v. Ohio, 499 U.S. 400, 410 (1991). But
the Supreme Court has “characterized the rule” against third-party
standing “as a prudential rather than jurisdictional matter.” United
States v. Sineneng-Smith, 140 S. Ct. 1575, 1586 (2020) (Thomas, J.,
concurring). And the Court has crafted a narrow exception to the rule
against third-party standing where (1) the litigant has “suffered an ‘injury
in fact,’ thus giving him or her a ‘sufficiently concrete interest’ in the
outcome of the issue in dispute”; (2) the litigant has “a close relation to the
third party”; and (3) there is “some hindrance to the third party’s ability
to protect his or her interests.” Powers, 499 U.S. at 411.
Dr. Calderwood cannot pursue the vaccine-mandate claims (Counts
II and VI in part) because there is no “hindrance to” Makowski’s “ability
to protect his . . . interests.” Id. After all, Makowski is a co-plaintiff in this
lawsuit. So Dr. Calderwood lacks third-party standing.
C. The plaintiffs lack standing to challenge the
defendants’ actions under the EUA statute.
The plaintiffs challenge various actions by the HHS Secretary and
the FDA in Counts I, III, IV, and VI in part. The plaintiffs seek only
20
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prospective relief. So they must show a “certainly impending” threat of
future harm, Clapper, 568 U.S. at 401, that would be “fairly traceable to
the defendant’s allegedly unlawful conduct and likely to be redressed by
the requested relief,” DaimlerChrysler, 547 U.S. at 342. The plaintiffs
have not made that showing.
The EUA statute “neither require[s] nor forbid[s] any action” by the
plaintiffs. Summers v. Earth Island Inst., 555 U.S. 488, 493 (2009). So
standing “is ordinarily substantially more difficult to establish.” Id.
(quoting Lujan, 504 U.S. at 562) (quotation marks omitted). The plaintiffs
therefore “can demonstrate standing only if application of the [EUA
statute] by the Government will affect them.” Id. at 494.
The plaintiffs have not established that the defendants’ actions
under the EUA statute—that is, the emergency declaration and EUA
issuance without complying with the criteria-for-issuance provision or the
conditions-of-authorization provision—will affect them in any meaningful
way. So their claims don’t rely on a “certainly impending” future harm.
Clapper, 568 U.S. at 401. As explained in Section (I)(B), there was no
imminent risk on November 5 that Makowski, Nelson, or Leahy would be
forced to take any COVID-19 vaccine. And even if they had to take a
vaccine, it wouldn’t necessarily be an EUA vaccine. By November 5, they
could have received Pfizer’s Comirnaty vaccine that received FDA
approval “in compliance” with their Biologics License Application under
21 U.S.C. § 262, (see doc. 41 at 7 ¶ 15), which is an “independent”
authorization mechanism, Children’s Health Defense, 2022 WL 2704554,
at *1. So there was no non-speculative risk that the defendants’ EUA-
statute actions would harm them.17
The plaintiffs’ EUA-statute claims amount to “generalized
grievance[s]” that are “common to all members of the public.” Lujan, 504
U.S. at 575 (citation omitted). And “generalized grievances” do not satisfy
Article III. Carney, 141 S. Ct. at 498–99. So the Plaintiffs lack standing to
pursue Counts I, III, IV, and VI’s part aimed at EUA-statute actions.
17 Dr. Calderwood lacks third-party standing because there is no “hindrance” to Makowski’s
“ability to protect his . . . interests.” Powers, 499 U.S. at 411.
21
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II. The Court lacks jurisdiction over the mandamus claim.
In Count V, the plaintiffs seek a writ of mandamus “compelling the
individual federal defendants to perform the duties owed to them” under
the EUA statute, 21 U.S.C. § 360bbb-3. (Doc. 32-1 at 63). The Court lacks
jurisdiction over the request.
The Mandamus Act provides that “[t]he district courts shall have
original jurisdiction of any action in the nature of mandamus to compel
an officer or employee of the United States or any agency thereof to
perform a duty owed to the plaintiff.” 28 U.S.C. § 1361. “[M]andamus is
an extraordinary remedy which should be utilized only in the clearest and
most compelling of cases.” Cash v. Barnhart, 327 F.3d 1252, 1257 (11th
Cir. 2003) (quoting Carter v. Seamans, 411 F.2d 767, 773 (5th Cir. 1969)).
And “[a]lthough the issuance of a writ of mandamus is ‘a legal remedy, it
is largely controlled by equitable principles and its issuance is a matter of
judicial discretion.’” Id. at 1257–58 (quoting Carter, 411 F.2d at 773).
“[T]he test for mandamus jurisdiction is ‘whether mandamus would
be an appropriate means of relief.’” United States v. Salmona, 810 F.3d
806, 811 (11th Cir. 2016). Mandamus jurisdiction exists only if: “(1) the
plaintiff has a clear right to the relief requested; (2) the defendant has a
clear duty to act; and (3) ‘no other adequate remedy [is] available.’” Cash,
327 F.3d at 1258. “Put another way, a writ of mandamus ‘is intended to
provide a remedy for a plaintiff only if he has exhausted all other avenues
of relief and only if the defendant owes him a clear nondiscretionary
duty.’” Id. (quoting Heckler v. Ringer, 466 U.S. 602, 616 (1984)). “The party
seeking mandamus has the burden of demonstrating that his right to the
writ is clear and indisputable.” Serrano, 655 F.3d at 1263.
The plaintiffs have not shown that their “right to the writ is clear
and indisputable,” id., because they have not shown (and cannot show)
that the defendants owe them “clear nondiscretionary dut[ies]” under the
EUA statute, Cash, 327 F.3d at 1258. So the Court lacks jurisdiction over
the mandamus claim.
First, the EUA statute says that “[a]ctions under the authority of
this section by the Secretary”—which includes the emergency declaration
and the issuance of the EUAs—“are committed to agency discretion.” 21
22
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U.S.C. § 360bbb-3(i). And it “strains credulity for even the most casual
user of words,” McDonald v. City of Chicago, 561 U.S. 742, 811 (2010)
(Thomas, J., concurring in part and concurring in the judgment), to
suggest that decisions committed to agency discretion are
“nondiscretionary,” Cash, 327 F.3d at 1258. That independently precludes
mandamus jurisdiction.
Second, the individual EUA-statute provisions underlying the
defendants’ challenged actions also suggest that the defendants don’t owe
any “nondiscretionary” duties to the plaintiffs. Id. The emergency-
declaration provision explains that “[t]he Secretary may make a
declaration” that a public health emergency exists. 21 U.S.C. § 360bbb-
3(b)(1)(C) (emphasis added). And the criteria-for-issuance provision
explains that “[t]he Secretary may issue an authorization” if certain
criteria are met. Id. § 360bbb-3(c) (emphasis added). Under these
provisions, the Secretary enjoys discretion. See Kingdomware Techs., Inc.
v. United States, 579 U.S. 162, 171 (2016) (explaining that “the word ‘may’
. . . implies discretion”).
The conditions-of-authorization provision explains that “the
Secretary, to the extent practicable given the applicable circumstances
described in subsection (b)(1), shall . . . establish such conditions on an
authorization under this section as the Secretary finds necessary or
appropriate to protect the public health.” Id. § 360bbb-3(e)(1)(A)
(emphasis added). Although “the word ‘shall’ usually connotes a
requirement,” Kingdomware, 579 U.S. at 171, any duty that exists here is
qualified by the Secretary’s discretionary determination about whether
conditions would be “practicable,” “necessary,” and “appropriate.” Id.
§ 360bbb-3(e)(1)(A). So there is not a “clear nondiscretionary duty” to
establish any particular conditions. See Cash, 327 F.3d at 1258. And, at
the very least, the plaintiffs have not satisfied their “burden of
demonstrating that [their] right to the writ is clear and indisputable.”
Serrano, 655 F.3d at 1263. In fact, they did not even discuss mandamus
jurisdiction in their briefing. (See doc. 43).
In sum, the plaintiffs have not shown that their right to mandamus
relief is “clear and indisputable.” Serrano, 655 F.3d at 1263. So the Court
lacks jurisdiction over Count V.
23
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III. Any decision on the merits would be an advisory opinion.
This case is also nonjusticiable because any decision on the merits
would be an impermissible advisory opinion.
On justiciability, the Supreme Court has explained:
Under Article III, federal courts do not adjudicate
hypothetical or abstract disputes. Federal courts do not
possess a roving commission to publicly opine on every legal
question. Federal courts do not exercise general legal
oversight of the Legislative and Executive Branches, or of
private entities. And federal courts do not issue advisory
opinions.
TransUnion, 141 S. Ct. at 2203. At this point, any decision the Court
writes would violate every word of the Court’s admonition.
Presently, the government cannot enforce either vaccine mandate
because of nationwide injunctions. See Feds for Med. Freedom v. Biden,
No. 3:21-cv-356, 2022 WL 188329, at *8 (S.D. Tex. Jan. 21, 2022)18;
Georgia v. Biden, 574 F. Supp. 3d 1337, 1357 (S.D. Ga. 2021), appeal
docketed, No. 21-14269 (Dec. 10, 2021). And given that the EUA statute
“neither require[s] nor forbid[s] any action” by the plaintiffs, Summers,
555 U.S. at 493, and does not otherwise affect them, an enforceable
vaccine mandate appears to be necessary to justiciability.19 So facts that
developed after the plaintiffs filed their operative amended complaint
have, at this point, ensured that the plaintiffs have no ongoing “personal
interest in the dispute.” Uzuegbunam, 141 S. Ct. at 796.
18 The Feds for Medical Freedom case is pending review by the en banc Fifth Circuit. 37 F.4th
1093 (5th Cir. 2022) (en banc) (mem.).
19 Count V is nonjusticiable for its own reasons. See supra, at 22–23.
24
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***
For the reasons above, the Court grants the defendants’ motion to
dismiss because the Court lacks jurisdiction. (Doc. 38). The Court
dismisses the plaintiffs’ operative amended complaint without
prejudice. (Doc. 32-1). The plaintiffs may file a Third Amended
Complaint if, in that complaint, they can plausibly and in good faith allege
a justiciable controversy. The Court does not expect to allow more
amendments after the Third Amended Complaint.
DONE and ORDERED on August 25, 2022.
_________________________________
COREY L. MAZE
UNITED STATES DISTRICT JUDGE
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