Military Mandate TRO Denial Florida (Doe v. Austin)
Military Mandate TRO Denial Florida (Doe v. Austin)
sixteen servicemembers sued the Secretary and others, challenging the mandate.
They then filed two separate preliminary injunction motions, one raising statutory
claims and the other raising constitutional claims. ECF Nos. 3, 10. The government
defendants responded, the plaintiffs replied, and there was a telephonic hearing. ECF
Nos. 31, 33, 45. Having carefully considered all the arguments, I now deny the
motions.
It is worth saying at the outset what this case is not about. For one, it is not
about vaccine mandates generally. The plaintiffs argue that the military’s vaccine
1
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for essentially all Americans,” ECF No. 11 at 8; see also ECF No. 10 at 2-3
(requesting “that this Court address the larger questions raised by federal vaccine
mandates”); ECF No. 3-2 at 23, but challenges to other mandates in other contexts
are not at issue here.1 This case addresses only the Secretary’s mandate, which
relates only to the affected servicemembers. Second, this case is not about the
vaccines. The plaintiffs argue that the mandate is imprudent and unwise—even
legal points (like arbitrariness under the APA), the issues presented here are not that
broad. Courts don’t serve to review the wisdom of the other branches’ policy
decisions. See Tenn. Valley Auth. v. Hill, 437 U.S. 153, 194 (1978) (explaining that
aside” and that “[o]nce the meaning of an enactment is discerned and its
The issue in this case is whether the mandate fails based on the specific APA
or constitutional claims these plaintiffs present. And the issue at this early stage of
1
For example, there is a recent OSHA requirement, see COVID-19
Vaccination and Testing, Emergency Temporary Standard, 86 Fed. Reg. 61,402
(Nov. 5, 2021) (to be codified at 29 C.F.R. pts. 1910, 1915, 1917, 1918, 1926, and
1928). That rule, which the Fifth Circuit stayed pending review, see BST Holdings,
LLC v. OSHA, No. 21-60845 (5th Cir. filed Nov. 6, 2021), is not at issue here.
2
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the case is whether the plaintiffs have shown they are entitled to preliminary
injunctive relief.
I.
remedy” and should never be granted unless the party seeking it “clearly
establishe[s]” entitlement. Siegel v. LePore, 234 F.3d 1163, 1176 (11th Cir. 2000)
(quoting McDonald’s Corp. v. Robertson, 147 F.3d 1301, 1306 (11th Cir. 1998));
see also Texas v. Seatrain Int’l, S.A., 518 F.2d 175, 179 (5th Cir. 1975) (“[W]e must
remember that granting a preliminary injunction is the exception rather than the
rule.”). To secure an injunction, the plaintiffs must clearly establish four factors: (1)
that they have “a substantial likelihood of success on the merits”; (2) that they will
suffer irreparable injury without an injunction; (3) that they face a threatened injury
that “outweighs whatever damage the proposed injunction may cause” the
government; and (4) that “the injunction would not be adverse to the public interest.”
Siegel, 234 F.3d at 1176. They must clearly establish all four; a failure on even one
prong dooms their motion. ACLU of Fla., Inc. v. Miami-Dade Cty. Sch. Bd., 557
2
The plaintiffs also seek an administrative stay under the APA, 5 U.S.C.
§ 705. See ECF No. 3-2 at 40. A similar analysis applies for administrative stays and
preliminary injunctions. Nken v. Holder, 556 U.S. 418, 434 (2009).
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II.
I will first consider plaintiffs’ APA claims against the FDA3 and DOD. In
vaccines, and the DOD by mandating their use. Before turning to those claims,
The parties do not agree on all the facts, but neither side requested an
undisputed.
vaccine starting in December 2020. ECF No. 1-6 at 2-3. An EUA is not a full FDA
license. It instead represents the FDA’s conclusion that a product may be effective
EUA drugs must include labeling and package inserts telling patients “of the option
3
The plaintiffs also include a claim against the Secretary of the Department
of Health and Human Services. ECF No. 3-2 at 14; see also ECF No. 1. But it is
unclear why HHS is an appropriate party. The FDA is part of HHS, but an order
against HHS is not necessary to effect the relief plaintiffs seek against the FDA.
4
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On August 23, 2021—roughly eight months after the EUA first became
a full FDA license to produce and distribute the vaccine and label it with its
proprietary name, “Comirnaty.” ECF No. 1-4 at 2-3. The BLA approval requires that
challenging the approval on various grounds. See generally ECF No. 1-12. But the
FDA denied that petition, explaining why the FDA felt evidence justified approving
In addition, the FDA concluded Comirnaty’s BLA approval did not eliminate
the grounds for extending the vaccine’s EUA. ECF No. 1-6 at 3. The FDA explained
that the EUA allows some third doses and use in children under 16, neither of which
the BLA approval allows. Id. at 5-6. The FDA also concluded that “there is not
in its entirety.” Id. at 6 n.9. Thus, Pfizer continues to produce vials of vaccine that
are labeled as an EUA drug with packaging material saying, “This product has not
been approved or licensed by the FDA . . . .” Id. at 12-13. And there “remains . . . a
significant amount of [Pfizer COVID-19 vaccine] that was manufactured and labeled
5
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approval, the FDA explained that some vials of EUA-labeled vaccine are still
approved facility. See ECF No. 1-5 at 28. For those lots, the FDA maintains that the
inapplicable for the BLA-approved use: the two-dose regimen for those over 16.
ECF No. 31-13 ¶ 13. (A batch produced in a non-BLA-approved facility can exist
as an EUA drug but is not BLA-compliant and cannot be labeled Comirnaty. ECF
No. 1-5 at 28.) To keep it all straight, FDA requires Pfizer to identify which lots it
considers BLA compliant and list them on the Internet. ECF No. 1-5 at 28.4
In short, what people think of as the Pfizer vaccine has two distinct FDA-
application in those 16 and older. But it is unlicensed and operating under an EUA—
that is, an emergency use authorization—for other applications, like for children
under 16 and for certain third shots. Nonetheless, the FDA describes the two as the
4
See RE: Pfizer-BioNTech COVID-19 IMPORTANT PRODUCT
INFORMATION, Pfizer (Aug. 23, 2021), https://webfiles.pfizer.com/half-lot-
number-letter-v3.
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“same formulation” and “interchangeabl[e]” for medical purposes. See ECF No. 1-
6 at 3 n.8.5
On August 9, two weeks before the FDA approved Pfizer’s Comirnaty BLA,
5
The plaintiffs question whether the two products are, in fact, chemically
identical. See, e.g., ECF No. 45 at 16:17-19. Indeed, the Summary Basis for
Regulatory Action lists a redacted excipient for BLA-approved Comirnaty that does
not appear on the ingredient list in the EUA letter. Compare ECF No. 1-5 at 9 (listing
11 components, including .450 ml per vial of a redacted excipient), with ECF No. 1-
6 at 7 (listing 10 components, all of which also appear on the Summary Basis list).
Excipients are “inactive” ingredients like “coatings, binders, and capsules,” but they
sometimes “may affect the safety and effectiveness of drug products.” United States
v. Generix Drug Corp., 460 U.S. 453, 454-55 (1983). In Generix, the Supreme Court
held that two products with the same active ingredients were nonetheless not the
same “drug” under the FDCA where the district court had found that their different
excipients created a reasonable possibility that the unlicensed drug was “less safe
and effective” than the licensed one. Id. at 455-57. But the Court expressly declined
to decide “whether two demonstrably bioequivalent products, containing the same
ingredients but different excipients, might under some circumstances be the same
‘drug.’” Id. at 461. Because an excipient is, by definition, an inactive ingredient—
and because the plaintiffs haven’t shown a “reasonable possibility” that excluding
.450 ml of the redacted excipient from a vial of the EUA vaccine makes it any “less
safe and effective” than Comirnaty, Generix, 460 U.S. at 455—I do not discount the
FDA’s conclusion that the two vaccines are medically interchangeable. See ECF
No. 1-6 at 3 n.8; ECF No. 31-13 at ¶¶ 7-9. Of course, that does not mean the two
vaccines are legally indistinguishable—the FDA concedes they are not. See ECF
No. 1-6 at 3 n.8. Still, EUA-labeled vials that Pfizer and the FDA “consider[] BLA
compliant,” ECF No. 1-5 at 28, presumably must include the redacted excipient to
meet Comirnaty’s licensing requirements. Cf. ECF No. 1-4 at 4 (“You must submit
information to your BLA for our review and written approval under 21 C.F.R.
601.12 for any changes in . . . the manufacturing [of Comirnaty].” (emphasis
added)).
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later than mid-September, . . . whichever [came] first.” ECF No. 31-1 at 2. Then, the
memorandum that announced the DOD-wide vaccination mandate. ECF No. 31-2 at
will only use COVID-19 vaccines that receive full licensure from the Food and Drug
Id.
With that background in mind, I now turn to the plaintiffs’ specific statutory
claims.
A.
1. First, the plaintiffs contend the DOD mandate is invalid because it did
not go through notice-and-comment rulemaking. ECF No. 3-2 at 17. Long before
the DOD mandate issued, an existing regulation—Army Reg. 40-562—set out the
military’s vaccine policy. That regulation allows medical exemptions for, among
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other “exemption codes,” see Army Reg. 40-562 app’x C-1.6 The new mandate,
Indeed, the DOD has explicitly stated that even those who already recovered from
The plaintiffs contend that because the mandate contradicts Army Reg. 40-
562, it essentially amends it. And, the plaintiffs argue, the Secretary cannot amend
Army Reg. 40-562 without notice-and-comment rulemaking. ECF No. 3-2 at 17-19;
rulemaking); Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87, 100 (1995) (noting
The problem for the plaintiffs is that the statute they rely on—5 U.S.C.
§ 553—is inapplicable “to the extent that there is involved . . . a military or foreign
affairs function of the United States.” Id. § 553(a)(1). The plaintiffs insist the
mandate is not really related to a “military function,” that the mandate is instead
“one piece in the larger federal administrative scheme to impose nearly universal
6
The regulation also allows servicemembers to submit religious exemption
requests. See Army Reg. 40-562 ¶ 2-6(b)(3). The plaintiffs here do not present any
claims based on religion. See ECF No. 1 at 2 n.1.
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Association of Nevada, Local No. 1 v. O’Leary, on which plaintiffs rely, does not
suggest otherwise. ECF No. 33 at 15-16 (citing 57 F.3d 766 (9th Cir. 1995)). The
issue in that case was whether certain civilian contract guards were performing a
comment-rulemaking claim.7
2. The plaintiffs next argue that the mandate is arbitrary and capricious
because it lacks any legitimate basis. ECF No. 3-2 at 19-20. They point to the fact
that the mandate issued the day after the FDA’s Comirnaty approval, which they say
shows a lack of meaningful consideration of the mandate. They also contend that
DOD did not support its decision with substantial evidence, “as there is no indication
in the record that the DOD considered any evidence at all in deciding to immediately
impose the mandate for all service members on the day following FDA approval,
7
In a footnote, the defendants argue a second statutory exception for
“matter[s] relating to agency management or personnel.” 5 U.S.C. § 553(a)(2) (cited
in ECF No. 31 at 23 n.9). Because the military-function exception applies, I need
not address this separate argument.
10
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to administrative decisions. See Dep’t of Com. v. New York, 139 S. Ct. 2551, 2569
(2019). There is substantial deference with most any agency decision, but this case
involves military affairs, where “the lack of competence on the part of the courts is
marked.” Rostker v. Goldberg, 453 U.S. 57, 65 (1981); accord id. at 66 (“The
Parties must show far more than that the agency made the wrong decision. As
noted at the outset, a federal court’s role is not to determine whether agencies made
the best or most prudent choice. The question is “whether the Secretary examined
the relevant data and articulated a satisfactory explanation for his decision, including
a rational connection between the facts found and the choice made.” Dep’t of Com.,
139 S. Ct. at 2569. At this stage, the plaintiffs have not shown that they are likely to
Next, to the extent plaintiffs rely on the administrative record to support their
claim (e.g., ECF No. 3-2 at 20 (“[T]here is no indication in the record . . . .”)), I note
that the administrative record is not before the court. Finally, the plaintiffs’ argument
that the mandate is arbitrary and capricious because it “relied on facially unlawful
11
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FDA actions” (ECF No. 3-2 at 20) cannot succeed because plaintiffs have not shown
those actions were facially unlawful. See infra. This is not to say that the plaintiffs’
challenge cannot ultimately succeed, but at this stage, they have not shown enough.
3. The plaintiffs next argue that the mandate violates their statutory right
to refuse an EUA vaccine. ECF No. 3-2 at 20-21. Under the EUA statute, recipients
§ 706(2)(C) (APA provision prohibiting agency action taken “in excess of statutory
U.S.C. § 1107a, “[i]n the case of the administration of [an EUA] product . . . to
members of the armed forces,” that statutory right to refuse “may be waived only by
the President only if the President determines, in writing, that complying with such
DOD acknowledges that the President has not executed a wavier under this section,
ECF No. 45 at 52:8-9, so as things now stand, the DOD cannot mandate vaccines
One problem with this argument is that the DOD’s guidance documents
explicitly say only FDA-licensed COVID-19 vaccines are mandated. See, e.g., ECF
COVID-19 will only use COVID-19 vaccines that receive full licensure from the
12
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[FDA] in accordance with FDA-approved labeling and guidance.”); and ECF No. 1-
regulation . . . .”), and on its face, the mandate does not require anyone to take an
EUA vaccine.
Notably, though, the plaintiffs have shown that the DOD is requiring
injections from vials not labeled “Comirnaty.” Indeed, defense counsel could not
even say whether vaccines labeled “Comirnaty” exist at all. ECF No. 45 at 48:5-7.
(Although the DOD’s response said it had an adequate Comirnaty supply, it later
clarified that it was mandating vaccines from EUA-labeled vials. See id. at 46:22-
47:3.) In the DOD’s view, this is fine because the contents of EUA-labeled vials are
chemically identical to the contents of vials labeled “Comirnaty” (if there are any
such vials). According to the DOD’s argument, this means servicemembers are not
§ 1107a(a)(1). Rather, the DOD argues that once the FDA licensed Comirnaty, all
EUA-labeled vials essentially became Comirnaty, even if not so labeled. ECF No.
45 at 60:1-3. Thus, the DOD argues, the “product” injected is a chemical formulation
13
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that has received full FDA licensure—not merely an EUA—so § 1107a does not
licensure does not retroactively apply to vials shipped before BLA approval. See 21
U.S.C. § 355(a) (“No person shall introduce . . . into interstate commerce any new
respect to such drug.” (emphasis added)). Thus, as a legal matter, vaccines sent
the Federal Food, Drug, and Cosmetic Act.” § 1107a(a)(1).9 Section 1107a’s explicit
cross-reference to the EUA provisions suggests a concern that drugs mandated for
BLA-approved drug. And the distinction is more than mere labeling: to be BLA
compliant, the drug must be produced at approved facilities, see ECF No. 1-4 at 2;
8
The plaintiffs also cite 10 U.S.C. § 1107, but the defendants correctly note
it does not apply. That statute covers “an investigational new drug or a drug
unapproved for its applied use,” and this vaccine (either under the EUA or the BLA)
is neither.
9
This distinction is the basis for the FDA’s comment that the BLA-compliant
vials and the EUA-compliant vials are “legally distinct,” even though their chemical
formulation is identical. See ECF No. 1-6 at 3 n.8. Thus, the DOD cannot rely on the
FDA to find that the two drugs are legally identical for § 1107a purposes.
14
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vials are from BLA-approved facilities.10 Moreover, the DOD concedes that some
of its current vials are not BLA-compliant, and that there is no policy to ensure that
is difficult to see how vials that the DOD admits are not BLA-compliant—and thus
administration.
likelihood of success on this APA claim. The FDA’s Summary Basis for Regulatory
Action approving Comirnaty explains that certain lots of EUA-labeled vials are
EUA-specific labeling when administering doses from those vials. ECF No. 1-5 at
doses that are EUA-labeled, and is using them.” ECF No. 30-14 ¶ 18. If the DOD is,
10
The FDA’s Comirnaty approval letter redacts the approved manufacturing
locations, see ECF No. 1-4 at 2, and the EUA extension letter does not identify which
facilities were “identified and agreed upon” in Pfizer’s EUA application, ECF No. 1-
6 at 8. The Summary Basis for Regulatory Action suggests that not all Pfizer
facilities are BLA compliant, because it contemplates that not all EUA-labeled lots
will contain BLA-compliant vials. See ECF No. 1-5 at 28.
15
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dose or offered only a dose from a non-BLA-compliant vial. Because the plaintiffs
have not shown they are (or will be) required to receive an EUA-labeled, non-BLA-
B.
The plaintiffs’ APA claims against the FDA do not fare better. These claims
break down into three categories. First, plaintiffs contend the FDA’s Comirnaty
approval is invalid because the FDA did not follow the Food, Drug & Cosmetic Act
(FDCA) and the Public Health Service Act (PHSA). Second, the plaintiffs argue that
the FDA wrongfully determined that EUA drugs and Comirnaty are interchangeable.
11
The plaintiffs argue that the FDA cannot allow BLA-compliant vaccine
doses to bear an EUA label. ECF No. 33 at 24-25. But they cite no legal authority
for this proposition, and they do not dispute that the FDA’s Summary Basis for
Regulatory Action specifically included certain EUA-labeled lots under the BLA
approval. Regardless, the plaintiffs do not present this claim against the FDA.
Still, the statutes leave unclear what FDA labeling decisions are discretionary.
The FDA’s Comirnaty approval letter says that the labeling on Comirnaty vials
“must be identical” to what Pfizer submitted in its application, ECF No. 1-4 at 4, but
this label does not appear to be identical to an EUA label, see ECF No. 1-5 at 28.
And federal regulations require the FDA commissioner to initiate license revocation
proceedings if he determines that a licensed product is “misbranded with respect to
any [of its intended uses]” or “fails to conform to the applicable standards established
in the license . . . designed to ensure the continued safety, purity, and potency” of
the product. 21 C.F.R. § 601.5(b)(1)(iv), (vi). These provisions could be read to
prohibit distributing a fully licensed drug with an EUA-specific label and package
insert rather than those its BLA approval require.
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Third, the plaintiffs argue that the FDA illegally extended the EUA for the vaccine
1. First, the government’s papers argued with some force that plaintiffs
lacked standing to challenge the FDA’s approval. ECF No. 31 at 32-33. The
plaintiffs would have standing only if relief against the FDA would redress their
injury, and the government argued that any injury was “not caused by FDA’s actions,
fact, the government argued, the DOD was going to impose a vaccine requirement
with or without Comirnaty’s full licensure. Id. at 33. But at the hearing, the
government’s counsel acknowledged that if the FDA’s licensure were set aside, that
would (at least for now) redress plaintiffs’ injuries because the DOD could not
§ 1107a(a)(1), which has not happened. Thus, at this stage, the plaintiffs have shown
enough as to standing. But they still have not shown enough for preliminary
injunctive relief.
12
Although based on alleged FDCA and PHSA violations, the plaintiffs’
claims are APA claims. The plaintiffs have not identified a private cause of action
under the FDCA or PHSA. Cf. Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1284 n.10
(11th Cir. 2002). But the APA provides that a court may set aside agency action that
is “in excess of statutory jurisdiction, authority, or limitations, or short of statutory
right.” 5 U.S.C. § 706(2)(C); see also ECF No. 1 ¶¶ 126, 131. Here, the plaintiffs
have not shown a likelihood of success on their APA claim because they have not
shown a likelihood the FDA violated the FDCA or PHSA.
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For one thing, there are procedural hurdles the plaintiffs have not overcome.
There is the “record rule,” which generally provides that courts reviewing agency
action should limit their review to “the administrative record already in existence,
not some new record made initially in the reviewing court.” Camp v. Pitts, 411 U.S.
138, 142 (1973); accord Pres. Endangered Areas of Cobb’s History, Inc. v. U.S.
Army Corps of Engineers, 87 F.3d 1242, 1246 (11th Cir. 1996) (“The role of the
court is not to conduct its own investigation and substitute its own judgment for the
administrative agency’s decision. Rather, the task of the reviewing court is to apply
the appropriate standard of review to the agency decision based on the record the
agency presents to the reviewing court.” (cleaned up)); see also Dep’t of Com. v.
New York, 139 S. Ct. 2551, 2573 (2019) (“In reviewing agency action, a court is
of the existing administrative record. That principle reflects the recognition that
expert affidavits.
The plaintiffs’ extra-record evidence does not appear to fall within the narrow
exceptions to the record rule. While the FDA’s decisions ordinarily may be
challenged “solely on the basis of the administrative record,” citizens who “wish[]
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submit a citizen petition asking the FDA “Commissioner . . . to modify the action.”
21 C.F.R. § 10.45(f). In their filings, the plaintiffs introduce materials that the FDA
did not receive for consideration as part of the citizen petition challenging
Comirnaty’s licensure. See generally ECF No. 1-12 (citizen petition that does not
incorporate the rest of plaintiffs’ exhibits). Thus, the plaintiffs have not pursued an
available administrative route available to force the FDA to consider the materials
they submit here. As the defendants point out, ECF No. 31 at 36, “[u]nder ordinary
principles of administrative law, a reviewing court will not consider arguments that
v. USDA, 485 F.3d 1247, 1254-55 (11th Cir. 2007) (quoting Sims v. Apfel, 530 U.S.
103, 114 (2000) (Breyer, J., dissenting)). The plaintiffs respond by assuring the court
that their experts are well-qualified, see ECF No. 33 at 26-27, but they do not explain
how they can clear the procedural hurdles to challenge FDA action on the basis of
On the merits, the plaintiffs haven’t made a substantial showing that the FDA
within the FDA’s “area of special expertise.” Balt. Gas & Elec. Co. v. Nat. Res. Def.
Council, Inc., 462 U.S. 87, 103 (1983). Thus, even if the plaintiffs’ expert
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declarations were properly before the court, they would need to overcome “an
extreme degree of deference” to the FDA. Nat’l Mining Ass’n v. Sec’y, U.S. Dep’t
of Lab., 812 F.3d 843, 866 (11th Cir. 2016) (quoting Kennecott Greens Creek Mining
Co. v. Mine Safety & Health Admin., 476 F.3d 946, 954 (D.C. Cir. 2007)). The
defendants have submitted their own expert declaration contesting many of the
plaintiffs’ scientific claims, ECF No. 31-13 ¶ 25, and the FDA also responded in
detail to the citizen petition challenging Comirnaty’s licensure, see ECF No. 1-13.
At most, the plaintiffs have shown that some experts disagree with the FDA’s
conclusions about Comirnaty’s safety and efficacy. But that does not create a
substantial likelihood of success on their APA claim. See Marsh v. Oregon Nat. Res.
Council, 490 US. 360, 378 (1989) (“When specialists express conflicting views, an
agency must have discretion to rely on the reasonable opinions of its own qualified
experts even if, as an original matter, a court might find contrary views more
persuasive.”).
The plaintiffs also argue that the FDA had improper motivations in approving
Comirnaty as quickly as it did. ECF No. 3-2 at 30-32. Normally, “a court may not
reject an agency’s stated reasons for acting simply because the agency might also
Administration’s priorities.” Dep’t of Com., 139 S. Ct. at 2573. To get around this
principle, the plaintiffs must provide a “strong showing of bad faith or improper
20
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behavior,” id. (quoting Citizens to Pres. Overton Park v. Volpe, 401 U.S. 402, 420
(1971)). They rely on the FDA’s short timeframe, and they claim the license was a
pretext to allow for vaccine mandates. ECF No. 3-2 at 30-31. But the timeframe is
of course susceptible to other explanations, and it is not itself evidence of bad faith—
Com., 139 S. Ct. at 2573. And the claims of pretext are supported at this stage only
by conjecture.
2. The plaintiffs also argue that the FDA acted unlawfully when it issued
Comirnaty “to provide the vaccination series without presenting any safety or
effectiveness concerns.” ECF No. 1-6 at 3 n.8; see also ECF No. 3-2 at 36. In the
plaintiffs’ view, the FDA determined that the two were “interchangeable” under 42
U.S.C. § 262(i)(3) without requiring Pfizer to go through the proper channels. ECF
No. 3-2 at 36. In their view, the EUA letter was an “attempt to retroactively license
the EUA vaccine, solely for the purpose of enabling the mandate.” Id. at 38.
determination. If the FDA’s goal were to “retroactively license” the EUA vaccine, it
had an odd way of doing so—in the same footnote describing the EUA vaccine and
Comirnaty as “interchangeabl[e],” the FDA clarifies that the two products are
“legally distinct.” ECF No. 1-6 at 3 n.8. More to the point, the FDA nowhere claims
21
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that EUA vaccine had been licensed as “interchangeable” with Comirnaty, the
process described in the statute the plaintiffs rely on. See 42 U.S.C. § 262(k)(4); ECF
No. 3-2 at 37. And because the DOD hasn’t mandated that the plaintiffs receive
anything other than “COVID-19 vaccines that receive full licensure from the Food
and Drug Administration,” ECF No. 1-3 at 2, the plaintiffs cannot show that they are
Even if the plaintiffs could show injury from the FDA’s interchangeability
determination, they still have not shown a substantial likelihood that the FDA acted
unlawfully. The plaintiffs insist that the FDA “must be presumed” to have used the
word “interchangeably” in the sense that 41 U.S.C. § 262(i)(3) defines it. ECF No. 3-
2 at 37. But, the plaintiffs argue, the FDA may only make a statutory
for licensure on the basis that its drug is “biosimilar” to an already-licensed drug.
What the plaintiffs overlook is that the FDA used the word “interchangeably”
in a practical sense, not a legal one. The EUA letter explains that the EUA drug and
effectiveness concerns,” but clarifies that they are “legally distinct.” ECF No. 1-6 at
3 n.8. That is most plausibly interpreted as a factual, medical claim rather than a
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regulatory claim.13 The best evidence of this is that, as noted above, the FDA was
not considering whether to grant full approval to the EUA product on the basis that
it was “interchangeable” with Comirnaty in the statutory sense. Rather, the FDA was
that expressly requires Pfizer to indicate that EUA vaccines “ha[ve] not been
to issue an EUA for a drug that is chemically identical to a drug with full FDA
approval (like Comirnaty), because the existence of an approved drug entails the
existence of an “available alternative” to the EUA drug. ECF No. 3-2 at 27. But the
plaintiffs have not shown at this stage that EUA decisions are even reviewable. Cf.
Ass’n of Am. Physicians & Surgeons v. USDA, 2020 WL 5745974, at *3 (6th Cir.
13
At any rate, the PHSA’s definition of “interchangeable” describes a drug
that can be substituted for a licensed “reference product without the intervention of
the healthcare provider who prescribed the reference product,” 42 U.S.C.
§ 262(i)(3), because it is “biosimilar” and “can be expected to produce the same
clinical result as the reference product,” 42 U.S.C. § 262(k)(4). For example, a
pharmacy might fill a doctor’s prescription for a name-brand drug with an alternative
the FDA has determined is “interchangeable,” even though the pharmacy does not
seek reapproval from the prescribing physician. Cf., e.g., Greentech, Inc. v. Immunex
R.H. Corp., 964 F.3d 1109 (Fed Cir. 2020) (addressing dispute between cancer
treatment manufacturer and competitor who submitted a biosimilar product for
licensure under § 262). But because healthcare providers administer COVID-19
vaccines directly, there is no scenario in which a patient would receive an EUA
vaccine as substitute to Comirnaty without his healthcare provider’s intervention or
approval.
23
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Sept. 24, 2020) (“[E]mergency-use authorizations are exempt from review under the
APA.”); and compare 5 U.S.C. § 701(a)(2) (APA does not apply to agency actions
EUA framework) (“Actions under the authority of this section . . . are committed to
agency discretion.”). The plaintiffs argue that 5 U.S.C. § 701(a)(2) doesn’t apply
because the FDCA provides “meaningful standards of review” for EUA approvals.
ECF No. 34 at 13 (citing Weyerhauser Co. v. U.S. Fish & Wildlife Servs., 139 S. Ct.
361, 370 (2018)). But the statute at issue here—unlike the statute in Weyerhauser—
explicitly says that EUA decisions “are committed to agency discretion.” 21 U.S.C.
§ 360bbb-3(i).
Regardless, even if the EUA decision were reviewable, the plaintiffs have not
shown a substantial likelihood of success on this claim. For one, they are not required
to take an EUA-only drug, so even without the EUA determination, the Comirnaty
decision would survive. Second, given the applicable deference and the absence of
the full administrative record here, they have not shown a likelihood of success on
the merits anyway. Finally, the plaintiffs have not shown that the FDCA itself
must be informed “of alternatives to the product that are available.” 21 U.S.C.
24
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* * *
The plaintiffs have not shown a likelihood of success on any of their statutory
claims.
III.
claims: Substantive Due Process, the unconstitutional conditions doctrine, and Equal
Protection. ECF No. 11 at 21, 26, 27 . (The constitutional claims are against the
military defendants only, not the FDA.) But they have not shown a substantial
A.
The parties contest the applicable standard of review. The plaintiffs want strict
scrutiny, ECF No. 11 at 24-25, while the DOD urges rational-basis review, ECF
No. 31 at 48. To justify strict scrutiny, the plaintiffs must show that the case involves
a suspect class or some fundamental right. Panama City Med. Diagnostic, Ltd. v.
Williams, 13 F.3d 1541, 1545 (11th Cir. 1994) (considering equal protection claim);
see also Doe v. Moore, 410 F.3d 1337, 1343 (11th Cir. 2005) (explaining that
substantive due process challenges merit strict scrutiny only if the plaintiff identifies
25
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“careful description of the fundamental interest at issue” and show that the interest
is “deeply rooted in this Nation’s history and tradition, and implicit in the concept
of ordered liberty, such that neither liberty nor justice would exist if [it] were
sacrificed.” Doe v. Moore, 410 F.3d 1337, 1344 (11th Cir. 2005) (quoting Williams
v. King, 543 U.S. 1152, 1239 (2005)). Because substantive due process involves
v. Glucksberg, 521 U.S. 702, 720 (1997) (quoting Collins v. City of Harker Heights,
14
The plaintiffs claim that mandating vaccines for servicemembers but not for
illegal immigrants constitutes alienage-based discrimination, ECF No. 11 at 28, but
they do not get far with this argument. Equal Protection “keeps governmental
decisionmakers from treating differently persons who are in all relevant respects
alike.” Nordlinger v. Hahn, 505 U.S. 1, 10 (1992). (The Fourteenth Amendment’s
Equal Protection Clause refers only to the States, but it “has been ‘reverse-
incorporated’ into the Fifth Amendment’s Due Process Clause” to apply against the
federal government too. Nat’l Parks Conservation Ass’n v. Norton, 324 F.3d 1229,
1241 n.4 (11th Cir. 2003) (citing Bolling v. Sharpe, 347 U.S. 497, 499-500 (1954)).)
It is true that alienage can trigger strict scrutiny in an Equal Protection analysis. See
Graham v. Richardson, 403 U.S. 365, 376 (1971). But the DOD mandate—the only
policy at issue in this case—doesn’t differentiate based on alienage. It applies to all
servicemembers, regardless of alienage.
26
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issue. They explicitly disclaim any general constitutional right to refuse vaccinations
or other medications.15 ECF No. 11 at 23. And although they point to end-of-life and
assisted-suicide cases, id. at 21-22 (citing Cruzan v. Dir., Mo. Dep’t of Health, 197
U.S. 261, 278 (1990), and Glucksberg, 521 U.S. at 722 n.17), they have not asserted
the specific rights identified in those inapposite decisions. The plaintiffs’ best effort
at specificity is their argument that the Constitution protects military personnel from
vaccine.” ECF No. 45 at 69:17-18. But they have not pointed to any legal authority
showing that such a right is “deeply rooted in this Nation’s history and tradition.”
Glucksberg, 521 U.S. at 721 (quoting Moore v City of E. Cleveland, 431 U.S. 494,
503 (1977) (plurality op.)). Even if they had, now that Comirnaty is FDA-approved,
aside—if Pfizer’s vaccines existed only under an EUA, there would only be a
15
That framing distinguishes the legal issues here from Jacobson v.
Massachusetts, 197 U.S. 11, 28 (1905) (holding that state smallpox vaccine mandate
did not violate constitutional liberty interests).
16
Once a drug receives an EUA, it is no longer considered under “clinical
investigation” under the PHSA or the FDCA. 21 U.S.C. § 360bbb-3(k). The
27
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policy question left for the military to decide as a personnel matter, not for a court
(1973) (“It would be difficult to think of a clearer example [than military affairs] of
the type of governmental action that was intended by the Constitution to be left to
the political branches . . . [or one] in which the courts have less competence.”).
Because the plaintiffs have identified no clearly defined fundamental right “deeply
rooted in this Nation’s history and tradition,” they have not triggered heightened
scrutiny. Moore, 410 F.3d at 1134. Nor have they cited a single case applying strict
scrutiny to a vaccine mandate. See contra Klassen v. Tr. of Ind. Univ., 7 F.4th 592,
593 (7th Cir. 2021), emergency application for relief denied, No. 21A15 (Barrett, J.,
mandate)).17
B.
Because strict scrutiny doesn’t apply, we are left with rational-basis review.
This is a “highly deferential” review, under which plaintiffs have the burden of
“negat[ing] every conceivable basis that might support [the DOD mandate], even if
that basis has no foundation in the record.” Leib v. Hillsborough Cnty. Pub. Transp.
Comm’n, 558 F.3d 1301, 1306 (11th Cir. 2009). In other words, there must be no
“reasonably conceivable state of facts that could provide a rational basis for the”
mandate. Williams v. Pryor, 240 F.3d 944, 948 (11th Cir. 2001) (quoting FCC v.
Beach Commc’ns, Inc., 508 U.S. 307, 314 (1993)) (cleaned up). And “[a] statute
survives rational basis review even if it seems unwise or if the rationale for it seems
tenuous.” Locke v. Shore, 634 F.3d 1185, 1196 (11th Cir. 2011) (quoting Romer v.
The plaintiffs have not met their extraordinary burden of showing the mandate
lacks any rationality. They note the absence of certain vaccine justifications in the
record, but the defendants have no evidentiary burden in this regard; they can base
Beach Commc’ns, 508 U.S. at 315. And it matters not that the defendant’s decision
may be the wrong one, so long as there is at least some arguable basis for it.
The plaintiffs also argue that “[t]he DOD mandate also violates equal
protection insofar as it singles out, and discriminates against, Plaintiffs based on their
medical history, disabilities and/or medical conditions.” ECF No. 11 at 22. They do
not fully develop this argument, but it apparently relates to their complaint that
military personnel previously infected with COVID-19 will not receive exemptions
29
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from the vaccine mandate. See ECF No. 11 at 18, ECF No. 3-2 at 10-11. To the
extent they argue that the mandate is irrational because it treats servicemembers with
natural immunity the same as those without—it requires vaccination even for those
because this is a facial challenge. They have to show more than an unconstitutional
mandate is constitutional. Doe v. Sullivan, 938 F.2d 1370, 1383 (D.C. Cir. 1991). So
although the plaintiffs point to the medical consensus that natural immunity provides
greater protection than vaccination alone, that is insufficient to sustain their facial
challenge. Relatedly, policies survive this standard even when they are “significantly
At bottom, the plaintiffs have not met the heavy burden of showing facial
irrationality.
C.
Finally, the plaintiffs have not shown any likelihood of success on their
unconstitutional conditions claim. It is true that “the government may not deny a
Water Mgmt. Dist., 570 U.S. 595, 604 (2013) (quoting Regan v. Tax’n With
Representation of Wash., 461 U.S. 540, 545 (1983)). But there is no conditioned
30
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benefit in this case; the whole basis of the plaintiffs’ lawsuit is that the DOD requires
them to be vaccinated, not that the DOD is “coercing [the plaintiffs] into giving []
up” a constitutional right in exchange for extra benefits. Id. Even if continued
employment in the military were a conditional benefit for the purposes of the
Acad. & Inst. Rts., Inc., 547 U.S. 47, 59-60 (2006). As discussed above, plaintiffs
have not shown a likelihood of success on their claim that the DOD mandate cannot
IV.
In conclusion, the plaintiffs have not shown they are entitled to the
preliminary injunctive relief they seek.18 Because they have not shown a likelihood
18
The defendants have raised certain alternative arguments that need not be
addressed. Their ripeness argument is jurisdictional, but in denying preliminary
injunctive relief, I have not determined that the court does have jurisdiction. It is
plaintiffs’ burden to show the court has jurisdiction, and the nature of their burden
depends on the stage of the proceedings. Lujan v. Defs. of Wildlife, 504 U.S. 555,
561 (1992). Because we are still at the pleading stage, and because the complaint
itself does not show any lack of ripeness, I have proceeded to consider the motion.
Cf. id. Of course, if the plaintiffs could not establish a likelihood that their claims
are ripe, they could not show a likelihood of success on the merits. Cf. Food & Water
Watch, Inc. v. Vilsack, 808 F.3d 905, 913 (D.C. Cir. 2015) (“[A] party who seeks a
preliminary injunction must show a substantial likelihood of standing.”). But if they
did not, that would only be a basis for denying preliminary injunctive relief—not
dismissing the case at this stage. And because I am denying preliminary injunctive
relief on other grounds, I have not further addressed ripeness.
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of success on the merits, I need not evaluate the other preliminary injunction factors.
s/ Allen Winsor
United States District Judge
32