Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/54

This page has been proofread, but needs to be validated.

Case: 23-10362 Document: 543-1 Page: 54 Date Filed: 08/16/2023

“for which there is no adequate remedy at law.” Louisiana v. Biden, 55 F.4th 1017, 1033–34 (5th Cir. 2022) (quoting Daniels Health Scis., LLC v. Vascular Health Scis., LLC, 710 F.3d 579, 585 (5th Cir. 2013)). No legal remedy can adequately redress the Doctors’ conscience and mental-distress injuries. And the economic injuries—the potential damage to their medical practice, heightened exposure to malpractice liability, and increased insurance costs—are irreparable too. Monetary harm cannot be remedied where, as here, the defendant is entitled to sovereign immunity. See Wages & White Lion Invs., LLC v. FDA, 16 F.4th 1130, 1142 (5th Cir. 2021).

This risk of irreparable harm must be weighed against any injury FDA and Danco would sustain as a result of the stay order, as well as against the public interest. Starting with FDA, we recognize that anytime the Government is enjoined from enforcing its statutes or regulations, “it suffers a form of irreparable injury.” Maryland v. King, 567 U.S. 1301, 1303 (2012) (Roberts, C.J., in chambers); accord Valentine v. Collier, 956 F.3d 797, 803 (5th Cir. 2020). But on the other hand, neither FDA nor the public has any interest in enforcing a regulation that violates federal law. Louisiana, 55 F.4th at 1035 (“There is generally no public interest in the perpetuation of unlawful agency action.”) (citations omitted).

In this regard, the government/public-interest analysis collapses with the merits. See Sierra Club v. U.S. Army Corps of Eng’rs, 990 F. Supp. 2d 9, 43 (D.D.C. 2013) (Jackson, J.) (explaining that “public interest arguments” are “derivative of … merits arguments and depend in large part on the vitality of the latter”) (citing Serono Lab’ys, Inc. v. Shalala, 158 F.3d 1313, 1326 (D.C. Cir. 1998)); see also Louisiana, 55 F.4th at 1035; League of Women Voters of U.S. v. Newby, 838 F.3d 1, 12 (D.C. Cir. 2016). The Medical Organizations and Doctors are likely to succeed on their claims as to the 2016 Amendments and 2021 Non-Enforcement Decision. It follows that FDA and the public will not be injured by an order staying those likely unlawful actions.

54