Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/37

From Wikisource
Jump to navigation Jump to search
This page has been proofread, but needs to be validated.

23-10362

argues that it may have to shut down absent relief. We have held that catastrophic financial losses “may be sufficient to show irreparable injury.” Wages & White Lion Investments, LLC v. FDA, 16 F.4th 1130, 1142 (5th Cir. 2021) (emphasis added) (quotation omitted). Of course, irreparable injury alone does not entitle Danco to a stay. See Virginian Ry. Co., 272 U.S. at 672.

And even if it did, neither FDA nor Danco articulates why this, or any other, injury would require a stay of all of the district court’s order, rather than only part. Recall that we may narrowly “tailor a stay” to impact “only some portion of the proceeding.” Int’l Refugee Assistance Project, 137 S. Ct. at 2087 (quotation omitted). The applicants’ arguments suggest, at best, that they require relief only from the district court’s treatment of the 2000 Approval. They make no argument as to why the district court’s treatment of the 2016 Major REMS Changes and later FDA activity irreparably harms anyone.

Applicants’ forfeiture of this contention is understandable because the world operated under the 2000 Approval for sixteen years, apparently without problems. And neither applicant contends that it’ll be irreparably injured without a stay so long as the 2000 Approval and its associated REMS remain in effect. Thus, the irreparable injury factor counsels against a stay.

B.

The next Nken factor asks whether “issuance of the stay will substantially injure the other parties interested in the proceeding.” 556 U.S. at 434 (quoting Hilton, 481 U.S. at 776); see also Ala. Ass’n of Realtors, 141 S. Ct. at 2487 (same); Planned Parenthood v. Abbott, 134 S. Ct. 506, 506–08 (2013) (mem.) (opinions of seven Justices using the same standard). This language again focuses on harm from the stay, not the injunction. Cf. Whole Woman’s Health, 141 S. Ct. at 2495 (using less specific “balance of the equities” language). To succeed on this prong, applicants must show that the

37