III. LAW AND ANALYSIS

(b) that the DHHS Secretary has succeeded in creating conditions, as required by § 360bbb–

3(e)(1)(A)(i)(II) and (ii)(II), that ensure that healthcare professionals and Vaccine candidates are

informed of the “significant known and potential [ ] risks” of the Vaccines, and (c) that the

DHHS Secretary has succeeded in creating conditions, as required by § 360bbb–3(e)(1)(A)(iii),

for the monitoring and reporting of adverse events; and (2) sealing Plaintiffs’ argument that the

FDA’s “citizen petition” process (discussed infra in section III(1)) is “inadequate and not

efficacious” and that its pursuit by Plaintiffs would have been a “futile gesture” by showing

Defendants’ bad faith. The evidence makes it irrefutable that Plaintiffs and others in the public

will suffer irreparable injury (discussed infra in section III(2)) if this Motion is denied. Finally,

the evidence tilts the balance of hardships and public interest (discussed infra in Section III(3)

decisively in favor of Plaintiffs.

III. LAW AND ANALYSIS

In the 11th Circuit, a district court may grant preliminary injunctive relief when:

“ a party establishes each of four separate requirements: (1) it has a substantial likelihood of success on the merits; (2) irreparable injury will be suffered unless the injunction issues; (3) the threatened injury to the movant outweighs whatever damage the proposed injunction may cause the opposing party; and (4) if issued, the injunction would not be adverse to the public interest.”

Jones v. Governor of Fla., 950 F.3d 795, 806 (11th Cir. 2020). However, the court has

“considerable discretion…in determining whether the facts of a situation require it to issue an

injunction.” eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006) (internal quotations

and citations omitted).

A. Likelihood of Success on the Merits

As a threshold matter, parties seeking a preliminary injunction “are not required to prove

their claim, but only to show that they [are] likely to succeed on the merits.” Glossip v. Gross,

135 S. Ct. 2726, 2792 (2015); Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 22 (2008).

While the burden of persuasion remains with the Plaintiffs, the “burdens at the

preliminary injunction stage track the burdens at trial.” Gonzales v. O Centro Espírita

Beneficente Uniã do Vegetal, 546 U.S. 418, 428–30 (2006). For the purposes of a preliminary

injunction, this burden of proof can be shifted to the party opposing the injunctive relief after a

prima facie showing, and the movant should be deemed likely to prevail if the non-movant fails

to make an adequate showing. Id.

(1) Plaintiffs Have Standing

Plaintiffs have standing to assert these claims. They have demonstrated that they have

“(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the

defendant, and (3) that it is likely to be redressed by a favorable decision.” Lujan v. Defs. of

Wildlife, 504 U.S. 555, 560-61 (1992).

Plaintiffs have alleged specific physical injuries caused by the Vaccines, death caused by

the Vaccines, actual and threatened loss of employment, and violations of their constitutionally

protected rights to personal autonomy, bodily integrity, and to work in a profession of their

choosing, each of which constitutes “an invasion of a legally protected interest” that is

“concrete,” “particularized,” and “actual or imminent, not conjectural or hypothetical” as

required under Spokeo, Inc. v. Robins, 136 S.Ct. 1540, 1548 (2016). Their pleadings are

supported by Declarations made under oath.

The participation of third parties in the chain of causation does not defeat Plaintiffs’

claims or their standing, since their injuries are “fairly traceable” to the Defendants. See Simon