Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/36

 Beyond likelihood of success on the merits, we also must consider the other three factors for granting a stay. Those are “[A] whether the applicant will be irreparably injured absent a stay; [B] whether issuance of the stay will substantially injure the other parties interested in the proceeding; and [C] where the public interest lies.” Nken, 556 U.S. at 434 (quotation omitted). We address each in turn. And we (D) discuss how the Comstock Act, 18 U.S.C. §§ 1461, 1462 affects the stay inquiry. Outside of the 2000 Approval, we find that the applicants fail to make a strong showing on any of these factors for a stay.

Of the remaining three factors, irreparable injury matters most. See Nken, 556 U.S. at 434. FDA argues that the plaintiffs fail to show irreparable injury. But the irreparable injury factor asks whether “the [stay] applicant will be irreparably injured” absent a stay, not whether the plaintiff would be irreparably injured absent an injunction. Ibid. (emphasis added) (quotation omitted). Similarly, FDA’s assertion that the district court’s injunction will harm pregnant women or other members of the public does not speak to the irreparable injury factor (although it may speak to other factors), because those persons are not stay applicants in this case.

Since FDA does not articulate any irreparable harm that FDA will suffer absent a stay, it makes no showing on this “critical” prong. Ibid. We may not need to address the merits of the applicants’ stay request any further, because failure to show irreparable injury often “decides the [stay] application.” Whalen v. Roe, 423 U.S. 1313, 1318 (1975) (Marshall, J., in chambers).

Danco by contrast does claim it will suffer irreparable injury, albeit in just one paragraph. Danco notes that mifepristone is its sole product and