Case: 23-10362 Document: 543-1 Page: 59 Date Filed: 08/16/2023
stay is the temporary form of vacatur. Between vacatur and an injunction, the former is the “less drastic remedy.” Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139, 165 (2010). That is so because vacatur does not order the defendant to do anything; it only removes the source of the defendant’s authority. See Nken v. Holder, 556 U.S. 418, 428–29 (2009) (“[A] stay achieves this result by temporarily suspending the source of authority to act—the order or judgment in question—not by directing an actor’s conduct.”); see also Texas v. United States, 40 F.4th 205, 220 (5th Cir. 2022) (“Apart from the constitutional or statutory basis on which the court invalidated an agency action, vacatur neither compels nor restrains … agency decision-making.”).
Upon a successful APA claim, vacatur effectively rescinds the unlawful agency action. See Data Mktg. P’ship, LP v. U.S. Dep’t of Lab., 45 F.4th 846, 859 (5th Cir. 2022) (“Vacatur … retroactively undoes or expunges a past state action. … Unlike an injunction, which merely blocks enforcement, vacatur unwinds the challenged agency action.”) (quoting Driftless Area Land Conservancy v. Valcq, 16 F.4th 508, 522 (7th Cir. 2021)). Keeping with the preliminary-permanent injunction analogy, a stay temporarily voids the challenged authority.
Practically speaking, a stay means that—while the order is in effect—Danco will have legal authority to market and sell Mifeprex under the conditions that were in effect before 2016. Likewise, GenBioPro will have authority to market and sell the generic version of mifepristone under those same conditions—that is, those that appeared in the 2011 REMS. The in-person dispensing requirements, and FDA’s obligation to enforce them, will continue to apply.
In terms of enforcement, unlike with a preliminary injunction, a stay does not actively prohibit conduct, and so does not carry the same threat of contempt. Plaintiffs could move to enforce the stay in the unlikely event that
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