Doe v. Austin

• Decision Date: 12 November 2021
• Docket Number: Case No. 3:21-cv-1211-AW-HTC
• Parties: John DOE #1-#14 and Jane Doe #1-#2, Plaintiffs, v. Lloyd AUSTIN, III, in his official capacity as Secretary of Defense, et al., Defendants.
• Court: U.S. District Court — Northern District of Florida

572 F.Supp.3d 1224

John DOE #1-#14 and Jane Doe #1-#2, Plaintiffs,

v.Lloyd AUSTIN, III, in his official capacity as Secretary of Defense, et al., Defendants.

Case No. 3:21-cv-1211-AW-HTC

United States District Court, N.D. Florida, Pensacola Division.

Signed November 12, 2021

Brandon C. Johnson, Washington, DC, Ibrahim Reyes Gandara, Reyes Lawyers PA, Coral Gables, FL, for Plaintiffs.

Courtney D. Enlow, DOJ-CIV, Washington, DC, Andrew Evan Carmichael, Zachary A. Avallone, DOJ-CIV, Civil Division - Federal Programs Branch, Washington, DC, Amy E. Powell, DOJ-CIV, Federal Programs Branch, Raleigh, NC, for Defendants.

ORDER DENYING PRELIMINARY INJUNCTION MOTIONS

Allen Winsor, United States District Judge In August, Secretary of Defense Lloyd Austin issued a mandate requiring all military personnel to become vaccinated against COVID-19. Seven weeks later, 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 mandate should be viewed "as part of a larger effort by federal administrative agencies and the Executive Branch to impose unconstitutional vaccination

mandates 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 wisdom of the Secretary's decision—or whether the Secretary should mandate vaccines. The plaintiffs argue that the mandate is imprudent and unwise—even contrary to national security interests. Although those arguments relate to certain 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, 98 S.Ct. 2279, 57 L.Ed.2d 117 (1978) (explaining that a court's "individual appraisal of the wisdom or unwisdom" of a policy "is to be put aside" and that "[o]nce the meaning of an enactment is discerned and its constitutionality determined, the judicial process comes to an end").

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 the case is whether the plaintiffs have shown they are entitled to preliminary injunctive relief.

I.

A preliminary injunction is no small thing. It is "an extraordinary and drastic 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 F.3d 1177, 1198 (11th Cir. 2009).²

II.

I will first consider plaintiffs' APA claims against the FDA³ and DOD. In plaintiffs' view, those entities acted unlawfully—the FDA by approving the vaccines, and the DOD by mandating their use. Before turning to those claims, though, it is helpful to cover some relevant background.

The parties do not agree on all the facts, but neither side requested an evidentiary hearing. Regardless, many of the pertinent facts are essentially undisputed.

Pfizer developed a COVID-19 vaccine, for which the FDA issued an Emergency Use Authorization ("EUA"). This allowed Pfizer to distribute the 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 against a disease in a public health emergency where there is no "adequate, approved, and available alternative." See generally 21 U.S.C. § 360bbb-3(a) - (c). EUA drugs must include labeling and package inserts telling patients "of the option to accept or refuse administration of the product." Id. § 360bbb-3(e)(1)(A)(ii)(III).

On August 23, 2021—roughly eight months after the EUA first became effective—the FDA approved a Biologics License Application ("BLA") and issued 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 Pfizer produce Comirnaty only at approved locations, subject to specific manufacturing, packaging, and labeling requirements. Id. at 2

During the administrative process, several scientists filed a Citizens' Petition 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 the Comirnaty BLA. See generally ECF No. 1-13.

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 sufficient approved vaccine available for distribution to [the approved] population 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 in accordance with [the EUA]." Id. at 12.

In the Summary Basis for Regulatory Action regarding Pfizer's BLA approval, the FDA explained that some vials of EUA-labeled vaccine are still considered BLA-compliant—and are thus essentially Comirnaty—because they have the BLA-approved chemical composition and were produced at a BLA-approved facility. See ECF No. 1-5 at 28. For those lots, the FDA maintains that the EUA informed-consent provision, 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), is 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-approval statuses. It is licensed—that is, fully approved—for the two-dose 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 "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, the Secretary of Defense issued a memorandum announcing his intent to require vaccination

against COVID-19 either "immediately" upon FDA licensure or "no later than mid-September, ... whichever [came] first." ECF No. 31-1 at 2. Then, the day after Comirnaty's approval, the Secretary of Defense issued another memorandum that announced the DOD-wide vaccination mandate. ECF No. 31-2 at 2. The memorandum advised Pentagon leadership that "[m]andatory vaccination ... will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance." 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 other things, a "medical contraindication relevant to a specific vaccine or other medication." Army Reg. 40-562 ¶ 2-6(a). As an example of what might justify a medical exemption, it includes "[e]vidence of immunity based on serologic tests

, documented infection or similar circumstances," id. ¶ 2-6(a)(1)(b), along with many other "exemption codes," see Army Reg. 40-562 app'x C-1.⁶ The new mandate, notwithstanding Army Reg. 40-562, includes no exception for natural immunity. Indeed, the DOD has explicitly stated that even those who already recovered from COVID-19 must be vaccinated.

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; see also 5 U.S.C. § 553 (...