Case 2:21-cv-00702-CLM Document 15 Filed 07/19/21 Page 42 of 67
(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).
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