Professional Documents
Culture Documents
PI Motion-Main
PI Motion-Main
JOSHUA WILSON, et al §
§
Plaintiffs,
§
v. Case No. 4:22-cv-438-ALM
§
LLOYD AUSTIN, III, et al., §
§
Defendants. §
Pursuant to Rule 65 of the Federal Rules of Civil Procedure (“FRCP”), Plaintiffs Joshua
Wilson, et al., by and through counsel, move this court for a Preliminary Injunction in limine in
accordance with this Court’s July 1, 2022 Order. The Feres doctrine – and the Supreme Court’s
reaffirmation of it in United States v. Stanley, 483 U.S. 669 (1987) – prohibits military members
from suing for monetary damages under the Federal Tort Claims Act (“FTCA”). A preliminary
injunction is necessary “to preserve the court’s ability to later order meaningful relief.” Drew v.
Liberty Mut. Ins., 480 F.2d 69, 72, 74 (5th Cir. 1973). The injunctive relief sought is consistent
with the Supreme Court’s directive in Austin v. U.S. Navy SEALs 1-26, 142 S.Ct. 1301 (2022),
because it does not seek to preclude consideration of Plaintiffs’ “vaccination status in making
deployment, assignment, and other operational decisions.” Therefore, unless the Court issues a
preliminary injunction, Plaintiffs will suffer harms that cannot be otherwise remedied. A proposed
1. On May 23, 2022, plaintiffs filed a class action complaint that included 14 named
plaintiffs and the Members of the Armed Forces for Liberty (“MAFL”), an unincorporated
1
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association with over 500 service member plaintiffs. See ECF 1. The facts and allegations stated
in Plaintiffs’ Complaint are hereby incorporated into and made a part of this motion for preliminary
2. Defendants’ actions are the latest iteration in a long institutional history of policies,
procedures, and practices using service members for medical experimentation without their
knowledge or informed consent. Congress has held many hearings condemning such practices
and programs because of the obvious criminality of such actions.1 From Atomic Veterans and so-
called “Man-Break” tests using mustard and lewisite gases in World War 2, to MKULTRA (using
LSD on unwitting military members) during the Cold War (1952-1964), to the use of the defoliant
“Agent Orange” during the Vietnam War, all the way to Gulf War illness resulting from the use
of unlicensed and experimental drugs and vaccines as prophylaxes against possible enemy chem-
bio weapons, Defendant DOD’s illegal and unethical experiments have harmed millions of
American service members.2 Congress (eventually) stepped in and explicitly prohibited Defendant
DOD from doing this anymore by statute, in part because taxpayers ultimately have to foot the bill
for the service-related disabilities that have resulted from Defendants’ prior instances of unlawful
medical experimentation.
1
See, e.g., “Human Experimentation, An Overview on Cold War Era Programs,” U.S. General
Accounting Office (GAO), Sep. 28, 1994, GAO/T-NSIAD-94-266; Is Military Research
Hazardous to Veterans' Health? Lessons from World War II, the Persian Gulf War, and Today,
Senate Committee on Veterans’ Affairs, 103rd Cong. May 6, 1994; see also Veterans at Risk: The
Health Effects of Mustard Gas and Lewisite, Pechura, C.M. & Rall, D.P. (Eds.) Institute of
Medicine, National Academy Press (Washington, DC, 1993) at 3-4, 6-8, 50-52, 224-226.
2
See Compl., ¶¶ 45-52; Ex. 2, Efthimios Parasidis, Justice and Beneficence in Military Medicine
and Research, 73 Ohio St. L.J. 723, 732-39 & 759-60 (2012); see also U.S. Senate, Human Drug
Testing by the CIA, 1977: Hearings Before the Subcommittee on Health and Scientific Research,
Committee on Human Resources at 169 (Sept. 20-21, 1977).
2
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3. Abuses in illegally testing vaccines first during the Gulf War, and then with the
anthrax vaccine in the runup to the second Gulf War, led Congress to pass 10 U.S.C. §1107 in
1997 in order to prohibit the Defendant DOD from compelling members of the All-Volunteer
Force (AVF) to use unlicensed (“investigational”) products. Despite this, Defendant DOD began
the anthrax vaccine immunization program (AVIP) right in the shadow of Congress’ actions, so
Congress strengthened 10 U.S.C. §1107 repeatedly through 2000, and in 2004 Congress added 10
U.S.C. § 1107a, prohibiting the mandate of Emergency Use Authorization (“EUA”) drugs or
vaccines after the passage of the 2004 Project BioShield Safety Act (21 U.S.C. §360bbb-3).
Comprehensive Toxics (“PACT”) Act of 2022—providing $280 billion to cover health costs for
veterans exposed to Agent Orange, burn pits and other toxins after DOD and DOJ (and even the
Veterans Administration) fought against it in court for decades, DOD is creating the next veterans’
health disaster that we will all be paying for in decades to come, with Plaintiffs paying the heaviest
Administration’s other illegal vaccine mandates and DOD’s systematic violations of service
members’ rights in executing the DOD Mandate. In September 2021, President Biden announced
the issuance of a series of executive orders and other vaccine mandates that would require all or
nearly all U.S. citizens and lawful residents to be vaccinated as a condition for employment,
education, or participation in the Nation’s social or economic life. With the exception of the DOD
3
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Mandate, the five other federal mandates were quickly enjoined by the Courts.3 Several courts
have found that the DOD’s implementation of the Mandate to be unlawful insofar as DOD and the
other Armed Services have refused to grant any religious accommodation requests (“RARs”)
6. Plaintiffs have pursued all available military remedies, including requests for
religious accommodations5 and medical exemptions (“ME”), which have been denied or ignored.6
All Plaintiffs face adverse employment or disciplinary actions, up to and including separation,
3
See Nat'l Fed'n of Indep. Bus. v. OSHA, 142 S. Ct. 661 (2022) (“OSHA”) (enjoining OSHA
mandate, which was subsequently withdrawn); Feds for Medical Freedom v. Biden, --- F.Supp.3d
---, 2022 WL 188329 (S.D. Tex. Jan. 21, 2022) (nation-wide stay of federal employee mandate),
vacated and remanded 30 F.4th 503 (5th Cir. Apr. 7, 2022), reh’g en banc granted and vacated -
-- F.4th ---, 2022 WL 2301458 (5th Cir. June 27, 2022) (reinstating nationwide stay); Georgia, v.
Biden, --- F.Supp.3d ---, 2021 WL 5779939 (S.D. Ga. Dec. 7, 2021) (nation-wide stay of federal
contractor mandate); Texas v. Becerra, --- F.Supp.3d ---, 2021 WL 6198109 (N.D. Tex. Dec. 31,
2021) & Louisiana v. Becerra, --- F.Supp.3d ---, 2022 WL 16571 (W.D. La. Jan. 1, 2022) (staying
Head Start Mandate in 25 states). The Healthcare Mandate was stayed nationwide in Louisiana v.
Becerra, ––– F. Supp. 3d ––––, 2021 WL 5609846 (W.D. La. Nov. 30, 2021), but that injunction
was dissolved and the case remanded by the Supreme Court in Biden v. Missouri, 142 S. Ct. 647,
654–55 (2022). The healthcare worker mandate is now back before the district court to consider
constitutional challenges not addressed in the Supreme Court’s decision.
4
See generally U.S. Navy SEALs 1-26 v. Biden, --- F.Supp.3d. ---, 2022 WL 34443 (N.D. Tex. Jan.
3, 2022) (“Navy SEALs 1-26”), stay denied, 27 F.4th 346 (5th Cir. Feb. 28, 2022) (“Navy SEALs
1-26 Stay Order”). See also cases cited Plaintiffs’ Complaint, ECF 1, FN 64.
5
The Complaint does not include any claims that Plaintiffs have under the Religious Freedom
Restoration Act (“RFRA”) or other violations of their religious liberties, although more than 450
of the named Plaintiffs and MAFL members have submitted religious accommodation requests
(“RAR”) that have been uniformly denied.
6
See, e.g., ECF 3-4, Brown Decl., ¶11 (denied ME for lack of vaccine supply); ECF 3-5, Wilson
Decl., ¶ 8 (ME despite documented allergy to vaccine, recommendation from two doctors and
previous documented infections); ECF 3-6 Groothousen Decl., ¶¶ 9-12 (permanent ME denied
despite history cancer, Bell’s palsy, migraines and high blood pressure and temporary ME for
participating in clinical trial withdrawn); ECF 4-6, Gibson Decl., ¶ 7-8 (1 ME request ignored, a
second denied, despite doctor’s concurrence with ME).
4
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discharge for “misconduct,” court martial, loss of postseparation veterans’ benefits, and permanent
damage to their reputation and employment prospects resulting from less than an “honorable”
discharge, which all Plaintiffs have unquestionably earned by their service thus far, many in
combat.7 In the meantime, they are non-deployable and prohibited from travel, training, permanent
change of station (“PCS”), promotion, and new assignments.8 They have faced these adverse
actions even while their RAR or MEs were pending and/or FDA-licensed vaccines were
unavailable, in flagrant violation of service regulations claiming to prohibit adverse actions during
LEGAL STANDARD
Ladd v. Livingston, 777 F.3d 286, 288 (5th Cir. 2015). Courts may employ “a sliding scale” to
“balance the hardships … with the degree of likelihood of success on the merits.”10
7
See ECF 3-4, Brown Decl., ¶ 9 (will be involuntarily separated by July 1, 2022 with less
“Honorable” discharge); ECF 3-9, Puckett Decl., ¶¶ 12-16 (faces loss of benefits & recoupment of
benefits that may render her homeless after separation); ECF 4-2, Fields Decl., ¶¶ 17-18 (selected
for Colonel (O-6) but will be forced to retire as Lt Col and faces “misconduct” discharge or
placement into Inactive Ready Reserve (“IRR”)); ECF 4-5, Gross Decl., ¶ 12 (denied ME and
opportunity to see doctor while on deployment).
8
See, e.g., ECF 4-6, Gibson Decl., ¶¶ 8-9; ECF 4-5, Gross Decl., ¶ 11.
9
See ECF 3-4, Brown Decl., ¶ 8; ECF 3-5, Wilson Decl., ¶¶ 7-8.
10
Fla. Med. Ass’n, Inc. v. U. S. Dep’t of Health, Ed. & Welfare, 601 F.2d 199, 203 n.2 (5th Cir.
1979)(citation and quotation marks omitted). See also Knights of Ku Klux Klan, Realm of La. v. E.
Baton Rouge Par. Sch. Bd., 578 F.2d 1122, 1125 (5th Cir. 1978) (“Where one or more of the
5
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Although civilian courts have traditionally been reluctant to intervene in the conduct of
military affairs, Courts will hear servicemembers claims that meet the two-part justiciability test
set forth in Mindes v. Seaman, 453 F.2d 197, 201 (5th Cir. 1971) (“Mindes”). Plaintiffs’ claims
satisfy the Mindes tests for largely the same reasons as those in Navy SEALs 1-26 and other cases
enjoining enforcement of the DoD Mandate.11 Mindes allows judicial review if there is (1) an
allegation that the military has violated service members’ statutory or constitutional rights, or that
it “has acted in violation of applicable statutes or its own regulations,” and (2) “exhaustion of
available intra service corrective measures.” Id. at 201. Plaintiffs meet those tests because they
allege constitutional, statutory, and regulatory violations, and because they have exhausted, or are
exempt from exhaustion of, military remedies to the extent remedies are actually available at all.
For plaintiffs who meet the threshold criteria, the Court must then weigh four factors to
(1) the nature and strength of the plaintiffs’ challenge; (2) the potential injury to the
plaintiffs if review is refused; (3) the type and degree of anticipated interference
with the military function; and (4) the extent to which military expertise or
discretion is involved.
factors is very strongly established, this will ordinarily be seen as compensating for a weaker
showing as to another or others.”).
11
See supra note 4.
6
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To the extent that military remedies are available—and generally speaking they are not—
Plaintiffs have exhausted those remedies. Certain Plaintiffs have unsuccessfully challenged the
lawfulness of the DoD Mandate and/or sought medical exemptions that have been categorically
eliminated (i.e., for previous documented infections, vaccine injuries, or medical conditions
To the extent that any Plaintiffs or other class members are deemed not to have exhausted
military remedies, they each qualify for one or more exemptions from exhaustion based on: (1)
futility; (2) inadequacy; (3) irreparable harm; or (4) substantial constitutional questions. See Navy
SEALs 1-26, at *6 (discussing Von Hoffburg v. Alexander, 615 F.2d 633, 638-40 (5th Cir. 1980)).12
In the context of RFRA and First Amendment claims, several courts have found that the military’s
No Accommodation Policy is unlawful and amounts to little more than “theater.” Navy SEALs 1-
26, 2022 WL 34443, at *1; Air Force Officer, 2022 WL 468799, at *1. Their outcome (denial) is
This applies a fortiori to the military remedies for challenging the unlawful orders at issue
here. The only military “remedy” potentially available to Plaintiffs was to seek a medical
exemptions in his August 24, 2021 memo, except for those participating in clinical trials. See ECF
12
With respect to Plaintiffs’ APA-based claims for violations of the Informed Consent Laws and
APA, there is no exhaustion requirement. APA review requires exhaustion of remedies only where
“the statute or rule clearly mandates” exhaustion. Darby v. Cisneros, 509 U.S. 137, 113 S.Ct. 2539
(1993). Neither the APA nor 10 U.S.C. §1107a mandate exhaustion.
7
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4-12 at 1. As Plaintiffs such as LCDR Groothousen demonstrate, even that exemption is subject to
revocation at the whim of Defendants’ agents who are pressured to obtain 100% vaccination rates,
regardless of what exemptions are available, necessary, or medically prudent. Being required to
pursue a medical exemption that has been categorically eliminated is the definition of a futile and
inadequate remedy. Plaintiffs also qualify for exemptions based on the threat of irreparable harm
absent review, see infra Section III, and because their claims raise substantial constitutional
questions (i.e., satisfy the first Mindes factor). See infra Section I.A.2.
In other proceedings, the DoD has claimed that service members must exhaust remedies
up to and through the Boards of Correction of Military Records (“BCMR”). This defense is based
BCMRs may make recommendations, but “the Service Secretary always has the final say over
[BCMR] decisions[.]” Hodges v. Callaway, 499 F.2d 417, 423 (5th Cir. 1974).
First, review is favored where, as here, Plaintiffs raise constitutional claims “founded on
infringement of specific constitutional rights,” like Defendants’ violations of the Fifth Amendment
rights to procedural due process, substantive due process, and equal protection. See Navy SEALs
1-26, at *7 (citation omitted). Plaintiffs’ statutory claims are also strong, as they are identical to
13
Glines v. Wade, 586 F.2d 675, 678 (9th Cir. 1978), rev'd on other grounds sub nom. Brown v.
Glines, 444 U.S. 348 (1980); see also Adair v. England, 183 F.Supp.2d 31, 55 (D.D.C. 2002)
(“resolving a claim founded solely upon a constitutional right is singularly suited to a judicial
forum and clearly inappropriate to an administrative board.” (citation omitted).
8
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the those addressed in the Doe v. Rumsfeld series of cases,14 where the D.C. District court enjoined
the same violation of the same statutes (i.e., the APA and the Informed Consent Laws) by the same
Defendants (DoD, FDA, and HHS) for the same class of plaintiffs as present here.Indeed, it is
Plaintiffs’ contention that the Defendants’ DOD and FDA are estopped by the doctrine of collateral
estoppel/issue preclusion from even arguing that they can mandate an EUA vaccine to
Second, Plaintiffs face irreparable harm from the infringement of their rights under the
Fifth Amendment and the Informed Consent Laws. See infra Section III. They also face harm from
discharge; loss of veterans’ benefits; medical coverage; retirement eligibility; obstacles to civilian
employment; and severe family disruptions, including being involuntary transferred away from
their current jobs, homes, and families, or by being indebted for previously transferred Post-9/11
A Marine who has not been fully vaccinated is not considered worldwide
deployable and shall be assigned or reassigned, locally, to billets which account for
health risks to the unvaccinated Marine and those working in proximity to the
Marine…
14
John Doe No. 1 v. Rumsfeld, 297 F. Supp. 2d 119, 135 (D.D.C. 2003) (“Rumsfeld I”), modified
sub nom. John Doe No. 1 v Rumsfeld, 341 F. Supp. 2d 1 (D.D.C. 2004) (“Rumsfeld II”), modified
sub nom. John Doe No. 1 v. Rumsfeld, 2005 WL 774857 (D.D.C. Feb. 6, 2005) (“Rumsfeld III”).
15
MARADMIN 612/21, ¶¶3c, 3h. Available here: http://tinyurl.com/42sbmcfb
9
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Third, judicial review would not interfere with military functions. Nearly 98% of active-
duty service members are “vaccinated.”16 Permitting a small number of servicemembers to remain
unvaccinated would not interfere with military functions because it makes no difference with
regard to the central justification for mandating a vaccine: prohibiting transmission of the virus.
Fourth, the constitutional issues in this case do not implicate “[t]he complex[,] subtle, and
professional decisions” that “are essentially professional military judgments.” Air Force Officer,
*8 (citations omitted). While “judges don’t make good generals,” id. (citing Orloff v. Willoughby,
345 U.S. 83, 93, 73 S.Ct. 534 (1953)), “Generals don’t make good judges—especially when it
comes to nuanced constitutional issues.” Id. Whether the DOD Mandate can withstand judicial
scrutiny “doesn’t require ‘military judgment. … Such an issue is purely a legal matter” appropriate
for judicial review. Air Force Officer, at * 8 (quoting Mindes, 453 F.2d at 201).
injury that is “actual or imminent”; (2) “fairly traceable to the challenged conduct”; and
(3) “likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. Robbins, 578 U.S.
Each of these requirements are easily met. Plaintiffs will suffer an “actual and imminent”
16
See, e.g., Dept. Air Force, DAF COVID-19 Statistics – June 2022, available at:
https://tinyurl.com/mrx7kvnd (last visited June 20, 2022) (98.5% vaccination rate); Dept. Navy,
NAVADMIN 225/21 (Oct. 13, 2021) (over 98% of active-duty sailors vaccinated as of October
13, 2021), available at: http://tinyurl.com/4c236sre (last visited June 20, 2022); Peter Aitken,
Army Nears 100% Vaccination, Claims Only 1% Refusal Among Troops, Fox News (May 22,
2022), available at: http://tinyurl.com/46un8w4w (last visited June 20, 2022).
10
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“concrete and particularized” injury” due to the unlawful and unconstitutional DOD Mandate
and related challenged final, agency actions. Several named Plaintiffs have already faced adverse
personnel or disciplinary actions, see supra ¶ 6, and a full catalog of the harms suffered by the
entire group of Plaintiffs would require this Motion to be submitted in separate volumes. Courts
have routinely granted standing to service members challenging a new vaccine mandate
applicable to them. See generally Rumsfeld I and Rumsfeld II. Plaintiffs also satisfy the Article
III “injury-in-fact” standing requirement due to the “increased risk of future harm” they face if
they take the vaccine.17 Because they face a “severe” threat, i.e., death or permanent injury,18
they need only show a “relatively modest increment of risk.” Beaty, 853 F.Supp.2d at 36 (citation
The latter two elements, traceability and redressability, normally “overlap as two sides of
the causation coin.” Dynalantic Corp. v. DoD, 115 F.3d 1012, 1017 (D.C. Cir. 1997). Where, as
here, the plaintiff “is the object of the challenged agency action, there is usually little doubt of
causation.”19 Plaintiffs’ injury is directly traceable to the actions of the DOD in adopting the DOD
17
Beaty v. FDA, 853 F.Supp.2d 30, 36 (D.D.C. 2012) (“Beaty”), aff’d in part, vacated in part sub.
nom. Cook v. FDA, 733 F.3d 1 (D.C. Cir. 2013) (“Cook”).
18
See Compl., ¶¶ 116-118 (12,000 deaths, including 119 service members, 13,000 permanently
disabled, including 300 service members). By Defendant HHS’ own legally required
pharmacovigilance data (VAERS), 119 “military” died from the current mRNA shots as of Feb.
11, 2022. See ECF 5-13, Long Decl., at 13. The DOD’s expert has averred in written testimony
that “[i]n total, 31 active-duty service members have died from COVID-19 as of the end of
February 2022.” ECF 3-1, Rans Decl., at 11 & Table. The government’s data demonstrates that
the “vaccines” killed four times as many service members in 6 months as the Covid-19 virus itself
killed in (at least) 23 months of prevalence (using March 2020 as a starting point).
19
Teva Pharmaceuticals USA, Inc. v. FDA, 514 F.Supp.3d 66, 91 (D.D.C. 2020) (“Teva”) (citing
Lujan v. Defs. of Wildlife, 504 U.S. 555, 561-62, 112 S. Ct. 1230 (1992) (“Lujan”)).
11
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Plaintiffs also have standing for their claims against the FDA and HHS because the DOD
Mandate and elimination of medical exemptions are traceable to FDA and HHS actions. Courts
have permitted service members to challenge FDA approval of a vaccine where the FDA’s
approval provided the legal basis for a DOD mandate.20 Just as in Rumsfeld I and II, this case
alleges the interconnected actions of multiple agencies, not merely a single decision by the DoD
on its own. Plaintiffs seek both declaratory judgment and injunctive relief because each the DoD,
FDA, and HHS acted in concert by failing to adhere to statutes and regulations governing the exact
U.S.C. §1107a—and their coordinated actions are the cause of Plaintiffs’ injuries, which would be
affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to
judicial review thereof.” Lujan, 497 U.S. 871 at 882 (quoting 5 U.S.C. § 702). The “zone of
interests” tests for standing “is not meant to be especially demanding and is applied in keeping
with Congress’s evident intent when enacting the APA to make agency action presumptively
reviewable.”21 Plaintiffs easily meet the APA standing requirements. See Rumsfeld I and II.
Plaintiffs have standing under the Informed Consent Laws because they are the subject
20
See Doe #1-#14 v. Austin, 2021 WL 5816632, at *7 (N.D. Fla. Nov. 12, 2021) (“Austin”) (finding
that “plaintiffs have shown enough as to standing” for FDA claims because DoD Mandate
traceable to FDA); Rempfer v. Eschenbach, 535 F.Supp.2d 99, 101 (D.D.C. 2008) (“Rempfer”),
aff’d sub. nom, Rempfer v. Sharfstein, 583 F.3d 860 (D.C. Cir. 2009).
21
Match-E-Be-Nash-She-Wish Band of Pottawatomi Indians v. Patchak, 567 U.S. 209, 224, 132
S.Ct. 2199 (cleaned up).
12
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of the challenged agency action. See Teva, 514 F.Supp.3d at 91. They meet the other requirements
for standing for the same reasons as set forth above and in Austin, Rumsfeld I, Rumsfeld II, and
Rempfer. While the “zone of interests” does not require Congress to have enacted a statutory
provision “specifically intend[ing] to benefit the plaintiff,” Nat’l Credit Union Admin. v. First
Nat’l Bank & Trust Co., 522 U.S. 479, 118 S.Ct. 927, 935 (1998), 10 U.S.C. § 1107a was
specifically intended to benefit service members like Plaintiffs by codifying their right to refuse
Plaintiffs also have standing under the PHSA, as they are in the class of (involuntary)
consumers that these statutes are intended to protect. The requirements violated by the FDA
include the specific approval requirements for biologics (which were misapplied to mRNA gene
therapy products), the “interchangeability” requirements adopted to protect consumers, and the
“When determining ripeness, we must balance the fitness of the issues for judicial decision
with the hardship to the parties of withholding court consideration.” Pearson v. Holder, 624 F.3d
682, 684 (5th Cir. 2010). Plaintiffs’ claims do not “rest[] upon contingent future events that may
not occur as anticipated, or may not occur at all.” Texas v. United States, 523 U.S. 296, 300, 118
S.Ct. 1257 (1998) (internal quotations omitted). Nor is there any risk of “premature adjudication”
22
See, e.g., Washington Legal Found. v. Kessler, 880 F.Supp. 26 (D.D.C. 1995) (“WLF”) (public
interest group had standing to challenge FDA misbranding policy that restricted information
available to consumers and doctors similar to EUA Fact Sheets at issue here); Stauber v. Shalala,
895 F.Supp. 1178, 1187-88 (W.D. Wis. 1995) (finding that consumers had standing under the
FDCA to sue FDA because “plaintiffs’ injury is their exposure to a potentially dangerous drug
whose safety has not been demonstrated in accordance with the act.”).
13
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or “entangling” the court in “abstract disagreements over administrative policies” that “have not
been formalized and its effects felt in a concrete way by the challenging parties.” Abbott
Instead, Plaintiffs challenge discrete, final agency actions that set forth Defendants’
consistent and unchanging policy since the DOD Mandate was issued August 24, 2021. There are
Secretary has placed these novel mRNA shots on the “Required Vaccines” list for service in the
military; Plaintiffs will not be exempted. Defendant DOD’s service components have issued a wide
range of orders and regulations that make anyone not getting these shots “non-deployable” and
subject to a wide array of adverse actions including being ineligible for command, transfer,
continuing education in their specialty, etc. (See, e.g., MARADMIN 612/21, ¶3c-3h, supra, p. 8).
Plaintiffs have suffered a wide range of adverse actions, many with career-ending consequences.
See Compl., ¶¶ 124-127. There is no question as to the likelihood that Plaintiffs will suffer injury
or hardship; they have and they will. Accordingly, there is no “benefit from any further factual
development,” and “the court would be in no better position to adjudicate these [legal] issues in
the future than it is now.” Pearson, 624 F.3d at 684 (citation and quotation omitted).
Immunization Program” (July 23, 2019). It defines “vaccination” and “vaccine” as follows:
The mRNA shots being forced on the Plaintiffs do not meet the DoD’s own requirements
to be “vaccines.” The first and second clause establish an identity relationship between the
“biological agent” administered (i.e., mRNA) and “that agent” against which the vaccine “induces
a protective immune response.”23 The identity relationship presents a binary choice—either the
agent in [1] the same as “that agent” in [2], or is it not—with no space in between for ambiguity.
The mRNA shots do not “contain” a single molecule of the COVID-19 virus; they are not the same
The mRNA treatments also fail to satisfy the FDA and CDC definitions. In recognition of
this fact, the CDC had to radically change the definition of “vaccine” to eliminate the word
“immunity” to encompass these treatments just 8 days after the DoD issued its mandate on August
24, 2021, without any legal or scientific basis or any public notice or comment. See Compl., ¶¶
84-86. Prior to approval, Defendant FDA considered mRNA products as gene therapies. Other
jurisdictions still treat mRNA products as gene therapies, as acknowledged by BioNTech and
Moderna SEC filings. See id., ¶¶90-91. These gene therapy products are not “vaccines” because
they do not provide immunity, nor do they prevent infection or transmission, as the FDA and other
23
That is to say, vaccination involves the administration of weakened, killed or fragmented
disease-causing biological agents or toxins, to “induc[e] immunity” against that same disease-
causing biological agent or toxin. The mRNA shots do not induce immunity against mRNA;
instead, they seek to induce a response against COVID-19—instructing the recipient’s immune
system to produce a similar spike protein—that is an entirely distinct biological agent from the
mRNA administered. See Compl., ¶¶ 87-88.
15
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public health agencies acknowledge. See id., ¶89. The limited protection they do provide wanes
rapidly over time, see id, ¶¶107-109, and Pfizer’s CEO has acknowledged that the mandated two-
dose regimen offers “very limited protection, if any, against the Omicron variant.” Id., ¶108
(citation omitted).
The premise for the unique constitutional treatment of vaccines—and vaccine mandates—
is that they actually stop the spread of the disease and can even (potentially) eradicate the disease,
as has been the case with smallpox or polio vaccine. There is no dispute that these gene therapy
products do not prevent infection or transmission, and thus fail this test. Instead, the mRNA shots
provide only “protection from the worst effects” of COVID-19. In other words, they are a treatment
This Court does not owe Defendants any deference on matters of constitutional
constitutional right when reviewing agency decision-making.” Porter v. Califano, 592 F.2d 770,
780 (5th Cir. 1979).24 Agencies cannot eliminate constitutional rights simply by redefining the
words that stake out the boundaries of those rights, yet that is what Defendants have done by
redefining “vaccines” to encompass products that are excluded by their own pre-Mandate
regulations and the centuries-old understanding of that term by doctors, legislators, regulators, the
courts, and the public upon which the Jacobson decision was based. See infra note 33. Deference
24
Courts cannot defer to agency interpretations of their own regulations, like DoDI 6205.02,
“unless the regulation is genuinely ambiguous. … If uncertainty does not exist, there is no plausible
reason for deference.” Kisor v. Wilkie, 139 S.Ct. 2400, 2415 (2019).
16
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to agency decisions abridging constitutional rights is all the more impermissible here given the
pattern of illegality and lawless agency behavior surrounding COVID-19 mandates and the DoD
Mandate, see supra ¶¶ 2-5, which eliminates any “presumption of regularity” they might otherwise
One of the most fundamental principles of Anglo-American law is the right to bodily
autonomy and informed consent. It is arguably the oldest and most cherished right that there is—
At common law, even the touching of one person by another without consent and
without legal justification was a battery. Before the turn of the century, this Court
observed that [n]o right is held more sacred, or is more carefully guarded, by the
common law, than the right of every individual to the possession and control of his
own person, free from all restraint or interference of others, unless by clear and
unquestionable authority of law. This notion of bodily integrity has been embodied
in the requirement that informed consent is generally required for medical
treatment. … Every human being of adult years and sound mind has a right to
determine what shall be done with his own body; and a surgeon who performs an
operation without his patient’s consent commits an assault, for which he is liable in
damages. The informed consent doctrine has become firmly entrenched in
American tort law.
Cruzan v. Director, Mo. Dept. of Health, 497 U.S. 261, 269 (1990) (“Cruzan”)(citations and
quotation marks omitted) (emphasis added). This interest also includes the concomitant right to
refuse a particular treatment or drug: “[t]he logical corollary of the doctrine of informed consent
is that the patient generally possesses the right not to consent, that is, to refuse treatment.” Cruzan,
497 U.S. at 270 (emphasis added). The Cruzan decision concludes that “[t]he principle that a
competent person has a constitutionally protected liberty interest in refusing unwanted medical
17
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treatment may be inferred from our prior decisions.”25 The Court subsequently confirmed that the
right to “bodily integrity” is a “fundamental right,” and assumed that “the traditional right to refuse
unwanted … medical treatment” is as well. Washington v. Glucksberg, 521 U.S. 702, 720, 117
Because the injections are treatments, and not vaccines, heightened or strict scrutiny
applies. In reviewing violations of this fundamental right, the Supreme Court applies a standard
that is functionally the same as strict scrutiny, even if it has labeled it as such.26 Thus, where the
government burdens a person’s liberty interest in bodily integrity, the government must:
(1) “adequately demonstrate a compelling need for the intrusion,” (2) “a lack of reasonable
alternatives,” and (3) appropriate “procedural and medical safeguards.”27 The DoD Mandate does
But the DoD Mandate cannot and does not further that compelling interest. It is undisputed that
the Pfizer/BioNTech and Moderna mRNA treatments cannot prevent infection or transmission,
25
Id. at 279. See also id. at 278-79 (discussing Washington v. Harper, 494 U.S. 210, 223, 110 S.
Ct. 1028 (1990) (“[t]he forcible injection of medication into a nonconsenting person’s body
represents a substantial interference with that person’s liberty.”) and Vitek v. Jones, 445 U. S. 480,
445 U. S. 494 (1980) (recognition of general liberty interest in refusing medical treatment)).
26
Lower courts have applied strict scrutiny analysis to violations of the fundamental rights
protected by the Substantive Due Process Clause. See, e.g., Democracy North Carolina v. North
Carolina State Bd. of Elections, 476 F.Supp.3d 158, 220 (M.D.N.C. 2020); U.S. v. Juvenile Male,
670 F.3d 999, 1012 (9th Cir. 2012).
27
Planned Parenthood Southwest Ohio Region v. DeWine, 696 F.3d 490, 506 (6th Cir. 2012)
(discussing Riggins v. Nevada, 504 U.S. 127, 135-36, 112 S.Ct. 1810 (1992)).
18
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and they have been rendered “obsolete” by the Delta and Omicron variants, see ECF 3-3,
The DoD has never considered any alternatives to requiring 100% vaccination, as revealed
by the administrative record materials produced in a related case, see infra Section II.3, and their
uniform denials of Plaintiffs exemption requests. Treating all servicemembers the same, regardless
of their individual medical status, risk factors, and natural immunity is not “narrowly tailored.”
The blanket mandate ignores individual factors increasing or decreasing the risks that the plaintiffs
pose to themselves or to others.28 Several courts have found the DoD’s failure to consider any
alternatives, or to perform any individualized assessment for service members, failed to satisfy the
similar less restrictive means analysis under RFRA and the First Amendment. See supra note 4.
Finally, the Defendants have eliminated medical or procedural safeguards. DoD has
ensure that no exemptions will be granted (in particular, by removing the discretion of treating
physicians to grant exemptions, which now must be granted by a flag officer). See, e.g., Compl.
¶19. Defendant FDA licensed the mRNA treatments without any exceptions (or contraindications)
for key populations (e.g., those with previous infections, pregnant/nursing women, or those with
other medical conditions that may face higher risks of adverse effects), despite the fact that these
key populations were not included or specifically studied in the ongoing clinical trials for these
shots.
28
For example, many of the Plaintiffs are fighter pilots or crew in aircraft that use individual
oxygen, such that some of these plaintiffs do not even share the same air with anyone else while
performing their duties. Nor did DoD give any consideration to the fact that Plaintiffs have
successfully performed their missions and duties over the last two years while unvaccinated.
19
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First, the Jacobson court grounded its decision in the State police power to regulate the
health of those within its borders through the legislature.29 Defendant DoD is not a state legislature,
but a federal agency run by a political appointee, who is acting directly contrary to the governing
statute and the DoD’s own regulations. Second, the Court specifically noted that its justification
was in large part predicated on the lethality of smallpox30 that is orders of magnitude more deadly
than Covid-19. The mortality rate for smallpox is about 30%.31 By contrast, the mortality rate for
COVID-19 is less than 1%, and approximately 0.02% (i.e., one out of 5,000) for fit citizens who
are culled from among the general populace and required to maintain high levels of fitness and
body composition for military service.32 Third, and perhaps most fatal to Defendants mandate, is
that relying on Jacobson means being bound by that Court’s understanding of what constituted a
“vaccination.” Defendants cannot simultaneously claim Jacobson for the sweeping language
29
Jacobson, 197 U.S. at 38 (“The safety and the health of the people of Massachusetts are, in the
first instance, for that Commonwealth to guard and protect. They are matters that do not ordinarily
concern the National Government.”)
30
See, e.g., Jacobson, 197 U.S. at 37-38 (“We are not prepared to hold that a minority, residing or
remaining in any city or town where smallpox is prevalent… may thus defy the will of its
constituted authorities, acting in good faith for all, under the legislative sanction of the State… [if
the Court did allow such opt-outs] the spectacle would be presented of the welfare and safety of
an entire population being subordinated to individual concerns.”).
31
See Ellner, P.D. Smallpox: Gone but not forgotten, Infection 26, 263–269 (1998) (same),
available at: https://doi.org/10.1007/BF02962244 (last visited June 20, 2022). Accord.Klaassen v.
Trustees of Ind. Univ., 549 F.Supp.3d 836, 2021 WL 3073926, at *17 (N.D. Ind. July 18, 2021);
see also id. (smallpox has killed at least 300 million people in the 20th Century alone).
32
According to the DOD, as of June 10, 2022 there have been 415,956 “Military” cases, with a
total of 95 deaths. See, e.g., DoD, Coronavirus: DOD Response, DOD COVID-19 Cumulative
Totals, available at: https://www.defense.gov/Spotlights/Coronavirus-DOD-Response/.
20
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regarding government authority to mandate a vaccine, but then try to simultaneous hide from the
fact that mRNA gene therapy products are not “vaccines” as that term was understood by the
Jacobson court and for centuries by legislators, regulators, and the general public up until
September 2021.33 Finally, the Jacobson Court explicitly exempted, even from state legislative
mandates, those who faced serious risk of injury or death from vaccination. See Jacobson, 197
U.S. at 39. There are a number of Plaintiffs in the case such as LCDR Groothousen that clearly
would fit in this rubric under any reasonable consideration of their cases, but Defendant DOD has
eliminated these medical safeguards and exemptions. See Compl., ¶¶ 119-122 & ECF 5-13, Long
Decl., at 6.
Defendants have violated Plaintiffs’ Procedural Due Process Rights insofar as their actions
have deprived, or threaten to deprive, Plaintiffs of protected life, liberty and property interests.
There is no question that the DoD Mandate “substantially burden[s]” the constitutionally protected
“liberty interests” of Plaintiffs “put to a choice between their job(s) and their jab(s).” BST
Holdings, LLC v. OSHA, 17 F.4th 604, 618 (5th Cir. 2021) (“OSHA”).34
33
The Jacobson opinion quotes the trial judge’s jury instruction “that for nearly a century, most
of the members of the medical profession have regarded vaccination… as a preventive of smallpox;
that… the risk of such an injury too small to be seriously weighed as against the benefits coming
from the discreet and proper use of the preventive[.]” Jacobson at 23-24.
34
Plaintiffs face not only face the loss of the current employment, but also will be barred from
employment by the federal government or federal contractors—the largest employers of former
services members—and will also face significantly difficulties with private employers and local
and state government due to their vaccination and discharge status and loss of security clearances
for “misconduct.” They also face significant risk of death and permanent disability from these
treatments—at least four times greater than from the disease itself, see supra note 18, while the
Vaccine Injury Plaintiffs have already suffered injuries—and loss of protected property interests
21
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Plaintiffs, along with all other class members and U.S. citizens, were deprived of their
procedural due process rights through Defendants’ actions, both unilateral and in concert, to
Pfizer/BioNTech and Moderna mRNA treatments that would have been expressly excluded by
those definitions (and current definitions in the case DoDI 6205.02). See supra Section
Pfizer/BioNTech and Moderna mRNA Products Are Gene Therapy Treatments, Not
Vaccines.I.A.1. That they did so contemporaneously with the FDA approval of Comirnaty and
the issuance of the DoD Mandate eliminates any doubt as to the purpose: to enable vaccine
mandates and to circumvent constitutional and statutory prohibitions on mandating treatments and
to deprive them of their constitutional rights defined by the Cruzan line of cases and 10 U.S.C. §
1107a. Plaintiffs, like all other Americans, had no notice or hearing before Defendants unilaterally
changed the pre-Mandate definitions through unaccountable and, in their view, unreviewable
administrative fiat.
The Equal Protection Clause is violated where a government regulation treats similarly
situated persons differently based on their membership in a suspect class frequently accompanied
by the deprivation of a fundamental right. This includes members of “politically unpopular” groups
where the adverse impact, and the class itself, is based on membership in a disfavored group
from loss of government benefits, in particular those with over 18 years of service who should be
protected by sanctuary rules and permitted to reach 20 years for full retirement benefits.
22
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apply “heightened rational basis review,” a more searching inquiry into motives and evidence than
While vaccination status has not historically been a “suspect class” or the unvaccinated a
demonized minority, the COVID-19 pandemic and the hysteria has been cynically manipulated by
politicians to create one and to use this classification to deny the unvaccinated fundamental rights
and to purge them from the Armed Services and other public institutions. Further, there is 90-
100% overlap between the members of this new class the government seeks to disenfranchise
through vaccine mandates and the class of those whose objections are protected by the First
The RFRA cases prove that hostility to religion is one of the primary motives driving the mandate.
See supra note 4. Such animus, whether by the military or civilian authorities is due no deference.
If this does not seem plausible at first glance, consider the following:
• In September 2021, President Biden announced a sweeping series of vaccine mandates that
would require nearly all U.S. citizens or lawful residents to be vaccinated as a condition for
employment, public service, education, or participation in the Nation’s cultural, social or
economic life, based on false claims that we faced a “pandemic of the unvaccinated,” and his
“anger” and “frustration” with the unvaccinated. see Ex. 4, Biden Statement, at 2 & 6;
35
See, e.g., Plyler v. Doe, 457 U.S. 202, 102 S.Ct. 2382 (1982) (non-citizen children); Romer v.
Evans, 517 U.S. 620, 116 S.Ct. 1620 (1996) (sexual orientation); Lawrence v. Texas, 539 U.S.
558, 123 S.Ct. 2472 (2003) (same); United States v. Windsor, 570 U.S. 744, 133 S. Ct. 2675 (2013)
(gay marriage); Jimenez v. Weinberger, 417 U.S. 628, 94 S.Ct. 2496 (1974) (illegitimate children);
USDA v. Moreno, 413 U.S. 528, 93 S.Ct. 2821 (1973) (low-income housing).
36
See, e.g., Bishop v. Smith, 760 F.3d 1070, 1099 (10th Cir. 2014) (Holmes, J.,
concurring)(surveying cases employing heightened rational basis review). See also Swanson v.
City of Plano, Texas, 2020 WL 7060817, at *3 n.2 (E.D. Tex. Dec. 3, 2020) (discussing “ordinary
rational basis” scrutiny and “heightened rational basis review,” noting that the Fifth Circuit has
not addressed the issue, but concluding that any regulation “impelled by animus is a poisoned and
poisonous one.”) (citation omitted).
23
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• Five of the six federal vaccine mandates were found to likely violated federal law and enjoined,
see supra ¶ 5;
• The coordinated effort by federal agencies to suppress and censor “disinformation” regarding
vaccination spread by U.S. citizens slandered as “extremists” or even terrorists;37
• The coordinated effort between federal agencies and social media companies like Twitter to
suppress and censor any alternative views regarding COVID-19 vaccine, id. at 18 (describing
efforts to coordinate with Twitter to counter vaccine “disinformation”);
• An unprecedented purge of the Armed Services that, based on the current number of RARs (at
least 25,000, not including the Army) and the approval rate (0.0%), will result in the expulsion
of tens of thousands of service members for refusal to take a drug, see Compl., ¶¶ 102-105 &
Table 1, at the same time as we face the prospect of a multi-front war with Russia, China, and
their proxies in Iran and North Korea;
• Recruiting and retention are in “crisis”38 based in part on the unfortunately accurate perception
that the military is hostile to people of faith and to those who have traditionally served;
The foregoing facts demonstrate that Defendants, acting in coordination with other
agencies and private media companies, have taken actions to define the demonized group of
vaccine “refusers” or “deniers” and sought to deprive this group of employment, education and
their fundamental rights. This class has a 90% or greater overlap with a group those who object to
vaccine mandates based on protected First Amendment rights. This should trigger strict scrutiny
or at least the heightened rational basis scrutiny applicable to classifications defined by irrational
animus, prejudice, or political demonization. See supra note 35. Where such heightened review is
triggered, the Court must engage in a more searching inquiry as to whether the regulation is
37
See Ex. 5, Sen. Grassley Letter to DHS Secretary Mayorkas (June 7, 2022) & DHS
Memorandum, DHS Efforts to Counter Disinformation (Sept. 13, 2021) (DHS efforts to counter
“disinformation” related to “effects of COVID-19 vaccines” used by “domestic violent
extremists”).
38
See, e.g., Thomas Novelly, et al. , Military Throwing Cash at Recruiting Crisis as Troops Head
for Exits, Military News (May 13, 2022), available at: http://tinyurl.com/2bjmmnhs (last visited
June 22, 2022).
24
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motivated by an impermissible purpose and the factual evidence presented by the parties. See, e.g.,
Plyler, 457 U.S. at 228-30. The purpose and effect of the federal vaccine mandates is the same as
that in Plyler, namely, to create[e] and perpetuat[e] … a subclass” that will be barred from military
service, employment and education, based on their religious views and/or medical conditions.
“military readiness”—with its actual effects conclusively demonstrates that the stated purposes are
a mere pretext. Over the last two years, there have been a total of 95 military deaths from COVID-
19, see supra note 32, and 30-something among active-duty service members. See ECF 3-1, Rans
Decl., ¶ 11 & Table. Yet the DoD and the Armed Service will discharge at least 25,000 for religious
objections alone, see Compl., Table 1, and likely a multiple of that because those numbers include
only a small number from the Army or those who have not sought religious accommodations.39
Each of these unvaccinated service members will be discharged for a 100% permanent loss (i.e.,
as opposed to spending a few days in quarantine or even hospital). This Court should treat a claim
by the military that a policy that will intentionally result in the permanent loss of hundreds for each
one “saved” the same as one by a doctor testifying that a medical procedure that kills hundreds of
his patients for each life saved is justified: with extreme skepticism of that doctor’s judgement and
expertise, accompanied by demands extraordinary proof and an inquiry into the real motive for
39
See, e.g., Lolita C. Baldor, Army Guard Troops Risk Dismissal as Vaccine Deadline Looms,
Army Times (June 26, 2022) (“40,000 Army National Guard soldiers” are unvaccinated, and “at
least 14,000 … could be forced out” now that June 30 deadline has passed), available at:
http://tinyurl.com/yc5v7drh (last visited June 30, 2022).
25
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While the hysteria among the general public appears to be fading, it is not among politicians
and federal agencies, who must be the subject of any inquiry into government animus toward
“disfavored groups.” The United States has already been through multiple cycles of war or
pandemic hysteria used to demonize politically unpopular groups40 and many more cycles of
abusing service members in illegal experiments. See supra ¶ 2. This Court can put this cycle on
hold until we regain their senses and stop trying to scapegoat conscientious objectors.
The Natural Immunity Plaintiffs’ Equal Protection rights under the Fourteenth Amendment
are violated by the Defendants’ arbitrary, unscientific, unsupportable distinctions between Natural
Immunity Plaintiffs and other similarly situated military members who have only artificially
induced immunity through mRNA treatments. The scientific evidence shows that vaccines (a) do
not stop reinfection among the vaccinated, and (b) do not stop spread of the virus by the vaccinated.
See Compl.,¶¶ 120-124. Thus, there is no impact on good order and discipline or the health of the
Total Force by Plaintiffs who have already had COVID-19 remaining unvaccinated. Accordingly,
the policy cannot satisfy either rational basis review, much less the strict or intermediate scrutiny
that should be applied here. Moreover, the fact that Defendants target those with natural immunity
and disregard their medical exemptions proves Defendants’ policy is driven by improper animus
against the small minority (1-2% for active-duty personnel) of servicemembers who are
40
See, e.g., Dr. A v. Hochul, 142 S.Ct. 552, 558-59 (2021) (Gorsuch, J., dissenting) (discussing
the Supreme Courts cycles of allowing persecution against disfavored groups and subsequent
course corrections in wars and pandemics).
26
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express statutory provisions the Informed Consent Laws and the Public Health Safety Act and/or
As an initial matter, Defendants are not due deference on statutory interpretation, where
the statutory language is clear and unambiguous. See, e.g., Gulf Fishermens Assoc. v. NMFS, 968
F.3d 454, 460 (5th Cir. 2020). Nor will courts “defer to an agency interpretation that is inconsistent
with the design and structure of the statute as a whole.” Id. (citations internal quotation marks
from statutory requirements—does not create ambiguity or “gaps” for the agency to fill. “This …
argument presumes power given if not excluded,” id. at 462, which would grant agencies “virtually
limitless hegemony, a result plainly out of keeping with Chevron and quite likely with the
Constitution as well.” Id. at 461 (quoting Texas, 809 F.3d at 186). Nor are they due any
coordination among Defendants for same, the proven lawlessness of federal COVID-19 vaccine
mandates generally, and the implementation of the DoD Mandate in particular. See supra ¶ 2.
41
These statutes do not include an express private right of action. Plaintiffs, who have been harmed
by Defendant agency actions for which there is no other adequate remedy, bring these actions
under 5 U.S.C. § 704 for violations of 5 U.S.C. § 706(2)(C). See, e.g., Austin, at *2 & *7 n.12
(informed consent violations are “APA claims”). It is well-settled that, where a statute does not
expressly provide a cause of action, plaintiffs may enforce agency violations of the statute’s
substantive requirements through the judicial review provisions of the APA. See, e.g., Dunn-
McCampbell Royalty Int., Inc. v. Nat'l Park Serv., 112 F.3d 1283, 1286 (5th Cir. 1997).
27
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The Supreme Court has recently and repeatedly struck down agency rules, and denied
agencies deference, where they acted ultra vires in excess of their statutory authority or acted
outside the specific area of expertise in seeking to enact “public health” measures using emergency
authorities.42 The Court is particularly skeptical of agency actions with vast significance affecting
millions of people where “the agency has no comparative expertise.” EPA, slip op. at 25 (citation
and quotation marks omitted). The DoD Mandate, and the other challenged agency actions, must
be considered as just one part of the Biden Administration’s efforts to impose universal vaccine
mandates on all U.S. citizens and lawful residents immediately after FDA approval of Comirnaty
on August 23, 2021, through illegal agency actions and executive orders.43 See supra ¶ 5. The DoD
Mandate is thus part of a “broad public health regulation” beyond its comparative expertise, rather
than a specific measure to promote military readiness. The DoD did the same in going beyond the
FDA and treating EUA and licensed products as legally, rather than medically, interchangeable.
Deference also is not due where Congress has repeatedly debated the matter in question yet
declined to take action the matter. See EPA, slip op. at 27-28. Congress has spent trillions of dollars
and passed several pieces of major legislation to address COVID-19, but it has expressly declined
to impose any federal vaccine mandates. Further, Congress has spoken directly to the issue of
42
The Supreme Court summarized these cases and the criteria it applies in West Virginia v. EPA,
No. 20-1530 (June 30, 2022) (“EPA”). See id. slip op. at 17-18 (discussing OSHA, 142 S.Ct. 661
(staying OSHA Mandate because it was a “broad public health regulation”); Alabama Assn. of
Realtors v. HHS, 141 S.Ct. 2485 (2021) (striking down CDC rent moratorium)
43
Chief Justice Roberts in the OSHA oral argument suggested that the “government is trying to
work across the waterfront and it’s just going agency by agency. … [T]his has been referred to …
as a workaround, and I’m wondering what it is you’re trying to work around.” Ex. 6, NFIB v.
OSHA Oral Argument Transcript, at 79:21-25
28
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military vaccine mandates: 10 U.S.C. § 1107a prohibits for EUA products without a Presidential
were not available when the DOD Mandate was issued and that the DOD has systematically
mandated unlicensed EUA vaccines that prominently bear EUA labels. See, e.g., Austin, 2021 WL
5816632, at *7. The Informed Consent Laws prohibit the mandatory administration of an EUA
product. See 10 U.S.C. § 1107a and 21 U.S.C. § 360bbb-3. Defendants seek to circumvent this
express statutory prohibition on mandating an EUA product through guidance documents asserting
that any EUA vaccine “should” be used interchangeably with, or “as if” it were an FDA-licensed
vaccine.44 While Congress and the President have delegated the Secretary of Defense broad
authority, they have expressly withheld the authority to mandate an EUA vaccine without
Presidential waiver, which Secretary Austin has neither received nor requested. Apart from
Presidential approval, there are no exceptions, or even any criteria for discretionary grants of
exceptions. Nor is there any ambiguity in the statutory text, or any “gap” to fill. Just silence. “This
44
See, e.g., ECF 4-7, Aug. 23, 2021 EUA Re-Issuance Letter, at 2 n.8 ; Compl., ECF 5-2,
September 14, 2021 Adirim Memo, at 1; ECF 5-9, Sept. 3, 2021 Air Force Mandate, § 3.1.1; see
also Ex. 8, ¶ 10 (June 2, 2022 Response in Coker v. Austin). Defendant FDA compounds this
violation exercising its “enforcement discretion” to not require the inclusion of the EUA Fact
Sheet. See ECF 5-3, Marks Decl., ¶13. This factsheet is a required part of the required “labeling”
that informs recipients of their statutory “option to accept or refuse,” 10 U.S.C. § 1107a(a)(1) and
21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III) & 360bbb-3(e)(2)(A). This violation of statutory labeling
requirements is discussed in the following section.
29
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460; see also EPA, slip op. at 27-28. Accordingly, this Court owes no deference to agency
Defendants’ interpretations of the statutes that permit what the statutory text expressly prohibits.
The FDA documents relied on by Defendants expressly state that the EUA and the licensed
product are “legally distinct” and acknowledge that there are “certain differences” between these
products. These legal distinctions include the fact that the EUA BioNTech Vaccine is subject to
the laws governing EUA products, including the statutory right of informed consent (i.e., the
“option to accept or refuse”), to be labeled as an unlicensed, EUA product, and the requirement to
inform recipients that the product is not licensed and that he or she has an “option to accept or
refuse.” See Compl., ¶¶ 81-82.45 Plaintiffs do not advance solely a legal argument on this point,
either.
The New England Journal of Medicine published a study on this exact issue of nearly
identical mRNA shots and Defendants are undoubtedly aware of it – because the study is a part of
the ongoing experiment for the licensure of BNT162b2. The NEJM made an explicit comparison
of BioNTech BNT-162b1 and BNT162b2 and found that despite their similarity, that they are NOT
identical. The comparison makes clear that even these “chemically similar” products are different
and produce different effects when injected into the human body.46
The reason for the lower reactogenicity of BNT162b2 than of BNT162b1 is not
certain, given that the two vaccine candidates share the same modRNA platform,
45
While the FDA initially asserted that EUA products and the FDA-licensed products are
interchangeable because they have the “same formulation,” while admitting that there are “certain
differences” between them, the FDA subsequently expanded the scope of interchangeable products
to encompass products with different formulations that are chemically distinct but “analytically
comparable.” Cf. Compl., ECF 4-7, Aug. 23, 2021 Pfizer/BioNTech EUA Re-Issuance Letter &
ECF 5-4, March 29, 2022 Pfizer/BioNTech EUA Re-Issuance Letter.
46
See “Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates,” N. Engl.
J. Med. 2020; 383:2439-50. https://www.nejm.org/doi/full/10.1056/NEJMoa2027906
30
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It is, therefore, an extraordinary – and illicit – claim by both Defendants to base the mandate
of an unlicensed product in place of a licensed one on the use of an entirely novel adjective –
“medically interchangeable” – while simultaneously ignoring the actual statutory requirements for
“interchangeable” products mandated by Congress under the PHSA. See sub-para. 2 below.
The final aspect of the informed consent violations by Defendants concerns the precedent
established by the first EUA vaccine that Defendant FDA ever granted: the anthrax vaccine in
2005. In that prior case, both the Defendants DoD and FDA took the opposite legal position from
that which they are taking right now. As the Fifth Circuit recently noted in issuing a Preliminary
After the D.C. District Court initially enjoined the Defendant DoD’s anthrax vaccine
program,49 the Defendants DoD and FDA both took various actions to continue Secretary Cohen’s
1998 anthrax mandate. See Doe v. Rumsfeld, 341 F.Supp.2d 1 (D.D.C. 2004). After being enjoined
47
Id., at 2449 (emphasis added).
48
BST Holdings, LLC v. OSHA, No. 21-60845, p. 12 (5th Cir. 2021)(citations omitted)(emphasis
added).
49
297 F. Supp. 2d 119 (D.D.C. 2003)
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again, and facing a permanent injunction, the Defendant DoD filed an emergency motion to
Modify the Injunction because Defendant FDA had reclassified the anthrax vaccine as an EUA
product – the first time any vaccine had ever been granted that status.
Defendants have now filed an Emergency Motion to Modify the Injunction, seeking
clarification that there exists a third option - an alternative to informed consent or
a Presidential waiver - by which defendants can administer AVA to service
members even in the absence of FDA approval of the drug: that is, pursuant to an
Emergency Use Authorization (“EUA”) under the Project BioShield Act of 2004,
21 U.S.C.A. § 360bbb-3.”50
The FDA placed several conditions on the EUA grant to DOD, but only one is important
to this litigation. Noting that 21 USC 360bbb-3(e)(1)(A)(ii)(III) contains not only an informed
consent requirement, but also a requirement that individuals to whom the product is administered
be informed of the option to accept or refuse administration of the product, the FDA determined
that an option to refuse vaccination meant that DOD’s AVIP could not be mandatory, and that
there could be no disciplinary or other punitive measures taken against service members, civilian
With respect to condition (3), above, relating to the option to accept or refuse
administration of AVA, the AVIP will be revised to give personnel the option to
refuse vaccination. Individuals who refuse anthrax vaccination will not be
punished. Refusal may not be grounds for any disciplinary action under the
Uniform Code of Military Justice. Refusal may not be grounds for any adverse
personnel action. Nor would either military or civilian personnel be considered
non-deployable or processed for separation based on refusal of anthrax
vaccination. There may be no penalty or loss of entitlement for refusing anthrax
vaccination.
50
The Doe v. Rumsfeld order is attached as Ex. 7.
32
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Doe v. Rumsfeld may not be binding precedent on this Court, but it is a binding
determination on these same Defendants on the same issue and, therefore, these Defendants are
estopped from re-litigating the issue against the Plaintiffs. These two Defendants have already had
a full and fair opportunity to litigate the same exact issue in the first instance when the statute was
just passed and the doctrines of judicial estoppel and issue preclusion both prohibit these
Defendants from now claiming the exact opposite in fundamentally the same litigation against an
The Doe v. Rumsfeld series of decisions is, therefore, directly relevant on multiple levels:
(1) it has obvious factual relevance because it involved injunctive relief by servicememembers
against a mandatory vaccination program; (2) it was the first vaccine ever granted EUA status by
the FDA; (3) both the Defendants FDA and DoD took public, official positions exact contrary on
the same legal issue in the instant case – whether or not servicemembers could refuse an EUA
product without penalty – and is therefore relevant to whether or not the agency has abused its
discretion record; (4) both Supreme Court and 5th Circuit precedent direct the courts to consider
the “reliance interests” that attended a prior policy; and (5) both Defendants were part of a consent
order and took record positions 17 years ago to NOT do what they are now doing – violating the
informed consent rights of military servicemembers – in keeping with their long history of
abrogating the rights of members of the Armed Forces and using them as human guinea pigs.
51
See, generally, New Hampshire v. Maine, 532 U.S. 742 (2001).
33
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The PHSA expressly prohibits the sale of any biologic product in interstate commerce
unless the package is “plainly marked with” “the proper name of the biological product,” (i.e.,
Comirnaty or Spikevax) and “the name, address and applicable license number of the
discretionary.52 The FDA has stated that it has exercised its “enforcement discretion”53 not to
enforce labeling requirements—or the requirement to provide the EUA factsheet that includes the
“option to accept or refuse” the EUA vaccine—so that unlicensed, EUA vaccines may be treated
“as if” they were licensed vaccines and eliminating the statutory right to informed consent. The
FDA’s action disregards the express, non-waivable statutory requirements. The FDA has illegally
abandoned enforcement of a huge swath of the Act it has been chartered by Congress to enforce,
42 U.S.C. §262 and 21 U.S.C. § 360bbb-3, as well asthe marketing and labeling requirements in
its own regulations, and the criminal laws against mislabeling and misbranding of regulated
products.
52
See 21 C.F.R. § 610.60(a)(1)(2) (directing that the “proper name” and “license number” “shall
appear on the label” of biological product); see also 21 C.F.R. § 207.37(a)(2) (a product is “deemed
… misbranded” if labeling codes used to “denote or imply FDA approval of [an unapproved] drug.
53
See ECF 5-3, Marks Decl., ¶13 (“FDA is exercising its enforcement discretion with respect to
certain labeling requirements, in that FDA is not taking enforcement with respect to vials that bear
the EUA label,” and not requiring providers to provide “the Fact Sheet for Recipients, which
advises recipients that ‘under the EUA, it is your choice to receive or not receive the vaccine’”).
While in the Marks Declaration, the FDA purports to limit this exercise of “enforcement
discretion” only to “BLA-compliant” lots, there is no record evidence supporting this limitation,
and all other public available record materials indicate that the FDA treated all EUA-labeled
products “as if” they were FDA-licensed products.
34
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In doing so, the FDA went far beyond permissible agency enforcement discretion, which
action confers a legal benefit and a heightened legal status—FDA licensure of an unlicensed EUA
product—and deprives servicemembers and other Americans the right to refuse the EUA treatment
(i.e., the right to informed consent). As such, the FDA’s decision is equivalent to an affirmative,
violates statutes it enforces.54 It is not within the FDA’s discretion to confer a legal benefit for a
product (i.e., licensure), or to exempt an unlicensed products from labeling and other requirements
applicable to them, when Congress has already established an “intricate process,” Texas, 809 F.3d
at 179, governing licensure and the benefits thereof in the PHSA. Moreover, this is not an isolated
instance, as the FDA has applied the same policy to Pfizer/BioNTech and Moderna.
The FDA’s mix of actions and inactions are similar to the FDA “enforcement discretion”
policy that the D.C. Circuit found to have violated mandatory provisions of the Food, Drug and
Cosmetics Act (“FDCA”), as well as the APA, in Beaty and Cook. There, the court emphasized
that the FDCA provision in question, like 42 U.S.C. § 262(a) here (“no person shall …”), used
mandatory language “shall,” which “generally indicates a command that admits of no discretion.”
Beaty, 853 F.Supp.2d at 37 (citation omitted). As with 42 U.S.C. § 262(a), the FDCA provision
did not provide for exceptions or other language suggesting FDA enforcement discretion. Also as
54
See, e.g., Texas v. U.S., 809 F.3d 134, 166-69 (5th Cir. 2015) (“Texas”), aff’d 136 S.Ct. 2271
(2016) (agency action was not immune from review as exercise of enforcement discretion where
it adopted general policy conferring legal status and benefits); see also id. at 166-67 (agency action
“need not directly confer … benefits” to be “more than nonenforcement; instead “removing a
categorical bar on receipt of [governmental] benefits and thereby making a class … newly eligible”
for such benefits).
35
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here, the FDA’s purported nonenforcement decision amounted to “affirmative acts of approval”—
treating unlicensed, misbranded products as if they were licensed and labeled in accordance with
FDA regulations— “rather than refusal to take enforcement action.” Cook, 733 F.3d at 7. The same
analysis applies to the FDA’s decision not to require the statutorily mandated EUA Fact Sheet
The FDA acknowledges that it has never made a “statutory interchangeability determination”
because the PHSA’s requirements have not been satisfied, and instead describes its actions as
finding that the two are “medically interchangeable.” Compl., ¶ 81 & ECF 5-3, Marks Decl., ¶ 11.
The PHSA grants the FDA the authority only to make “statutory” interchangeability
determinations,56 which is governed by an “intricate process,” Texas, 809 F.3d at 179, set forth by
Congress in the PHSA. The PHSA does not authorize the FDA to create new, alternative categories
or criteria for “interchangeable” products. As such, the FDA’s action must be held unlawful as
ultra vires. Because FDA has not made a “statutory” determination, then the two products are not
“legally interchangeable” and cannot be the basis for the DOD’s position that an unlicensed, EUA
55
The FDA’s actions here also have the same additional defects relied on in Beaty, see id., at 41-
43, namely: (1) the FDA’s actions violated the FDA’s own regulations, see Compl., ¶ 55
(discussing FDA violations of 21 C.F.R. § 610.60(a)(1)(2) and § 207.37(a)(2); (2) departed from
long-standing policy prohibiting mandate of EUA products, see, e.g., Rumsfeld III (conditioning
EUA grant on requirement that anthrax vaccine would only be voluntarily administered); and (3)
it undermines the purpose of the PHSA to protect consumers and ensure that no mislabeled
products are permitted to be distributed in interstate commerce.
56
Notably, the FDA has never made a statutory interchangeability determination, whether for
Comirnaty or any other product. The FDA “Purple Book” lists biological products licensed under
the PHSA, and the on-line database includes a blank column for “interchangeable” products. See
FDA, Purple Book Database of Licensed Biological Products, available at:
https://purplebooksearch.fda.gov/.
36
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“vaccine” can be substituted – much less mandated – in the place of a licensed, unavailable
vaccine. Either the FDA and DOD have both violated the PHSA, or only the DOD has; either way,
Plaintiffs have been unlawfully mandated EUA products and face discipline and discharge for
then the courts do not owe the agency deference to which it would otherwise be due. Nor are
courts required to bury their head in the sand and “defer” to the agency’s pretextual explanations
for its actions and decisionmaking. See, e.g., Dep’t of Commerce v. New York, 139 S. Ct. 2551,
2574-76 (2019) (“Our review is deferential, but we are ‘not required to exhibit naivete from which
ordinary citizens are free.’”) (citation omitted). Where, as here, there is significant evidence of
improper purposes, political interference, and significant departures from normal decisionmaking
processes, this constitutes evidence of the agency’s “bad faith that renders its decision arbitrary
The entirety of the DOD Mandate is a two-page memorandum from the Secretary of
Defense that cites no statute, regulation, executive order or other legal authority, and indeed in
many places appears to patently exceed his authority, insofar as it seeks to regulate State
Guardsman. Secretary Austin’s sole statement justification is a conclusory statement that the
Secretary has “determined that mandatory vaccination against [COVID-19] is necessary to protect
the Force and defend the American people.” ECF 4-12, SECDEF Memo at 1. Given that the DOD
Mandate was issued on the very next day after FDA Comirnaty Approval, it is apparent the DoD
37
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either blindly relied on the FDA approval and out-of-context FDA statements regarding
interchangeability or was fully involved in a scheme to commit fraud upon members of the Armed
Forces by denying them their Constitutional and statutory rights and obviate the Congressional
The DOD Mandate is also arbitrary and capricious because it constitutes an unannounced
and unexplained departure from a prior policy. See supra, II“[A]gencies must typically provide a
detailed explanation for contradicting a prior policy that has engendered serious reliance interests.”
BST Holdings, LLC v. OSHA, 17 F.4th 604, 614 (5th Cir. 2021). Such “reversal[s]” on a “pretextual
basis” as have occurred here “are all hallmarks of unlawful agency actions.” Id.
The DoD and Army administrative records provide further confirmation that Defendants
acted arbitrarily and capriciously in enacting the mandate because Defendants failed altogether to
consider any alternatives to 100% vaccination, including measures that had been effectively
employed over the previous two years prior to the mandate (e.g., masking, social distancing,
testing, quarantine, etc.). Nor did Defendants provide any explanation in the record as to why these
alternatives were inadequate or consider the relative costs and benefits of alternative measures.
This is confirmed by the findings of the five U.S. district courts in the RFRA context that the DOD
and other Armed Services failed to consider any alternative less restrictive measures. See, e.g.,
57
Defendants also purport to rely on the CDC’s recommendations in adopting the two-dose
regimen, but have ignored the CDC’s unanimous recommendation that all eligible adults should
receive a third booster shot. See CDC, CDC Expands Eligibility for COVID-19 Booster Shots to
All Adults, CDC Media Statement (Nov. 19, 2021), available at:
https://www.cdc.gov/media/releases/2021/s1119-booster-shots.html. Such selective picking and
choosing of which recommendations to follow, without any explanation, is the essence of
arbitrary and capricious decision-making.
38
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Navy SEAL 1, at *18; Air Force Officer, *10. Where an agency like DOD “provide[d] little or no
explanation for the [its] choices,” “omit[s] explanation for rejecting alternatives,” and did “not
address alternative (or supplementary) requirements,” its order is arbitrary and capricious and must
be vacated. Health Freedom Def. Fund v. Biden, 2022 WL 1134138, at *18-19 (M.D. Fla. Apr.
Finally, the DOD Mandate and Armed Services Guidance are arbitrary and capricious, and
for previous documented infections under AR 40-562, or to consider natural immunity in its
religious exemption decisions. See, e.g., Navy SEAL 1, at *16 & n.10; Navy SEALs 1-26, at *10;
Air Force Officer, at *10. In doing so, Defendants have “entirely failed to consider an important
time, unquestionably constitutes irreparable injury.” Elrod v. Burns, 427 U.S. 347, 373 (1976).
This applies to violations of the right to privacy, which includes the right to bodily integrity,
because “once an infringement has occurred it cannot be undone by monetary relief.” Deerfield
Med. Ctr. v. City of Deerfield Beach, 661 F.2d 328, 338 (5th Cir. 1981) (citation omitted).
Violations of constitutional rights to due process and equal protection of the laws also
presumptively cause irreparable harm. See, e.g., DeLeon v. Perry, 975 F.Supp.2d 632, 663 (W.D.
Tex. 2014).
the vaccine—is an injury that cannot be undone and will permanently prevent Plaintiffs from
39
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exercising their right to refuse unwanted experimental medical treatment. “[R]equiring a person
harm for which there is no monetary relief.” Rumsfeld I, 297 F.Supp.2d at 135.
A preliminary injunction is proper when “the balance of equities tips in [its] favor, and that
an injunction is in the public interest.” Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20, 129
S.Ct. 365 (2008). “These factors merge when the Government is the opposing party.” Nken v.
Holder, 556 U.S. 418, 435, 129 S.Ct. 1749 (2009). “[I]t is always in the public interest to prevent
the violation of a party's constitutional rights.” Campaign for S. Equal. v. Mississippi Dep't of
Hum. Servs., 175 F. Supp. 3d 691, 711 (S.D. Miss. 2016) (citation and quotation marks omitted).
That is true even though COVID-19 is involved. Cf. Cuomo, 141 S. Ct. at 68 (“[E]ven in a
There is also a strong public interest in ensuring the rights of informed consent, and that
citizens are not subject to unwanted, unnecessary and unproven experimental medical treatment.
Informed consent fosters trust and support in the doctor-patient relationship. It is also in the
public interest for those seeking vaccines to receive accurate, truthful, complete information, and
that they give informed consent—or refusal—to experimental treatments. Conversely, the DOD
has no legitimate interest whatsoever in forcing Plaintiffs to receive an experimental shot that
doesn’t provide immunity from the virus, doesn’t stop transmission of the virus, and in ¼ the
time has likely killed four times the number of members of this particular population cohort.
these plaintiffs deserve an opportunity to have the merits of their claims adjudicated in this Court.
40
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V. CONCLUSION
This Court should grant the preliminary injunction and adopt the Proposed Order.
Respectfully submitted,
41