U.S.C.A. 5th Cir.

“ The district court nevertheless found timely the plaintiffs’ challenges to the 2000 Approval and the 2016 Petition Denial. How? First, the district court held that FDA “reopened” those decisions in 2016 and 2021, thus restarting the statute of limitations. Second—and alternatively—the district court decided plaintiffs were entitled to equitable tolling.
We consider each justification in turn.
First, reopening. “The reopen [ing] doctrine allows an otherwise untimely challenge to proceed where an agency has—either explicitly or implicitly—undertaken to reexamine its former choice.” ”

“ Chemical abortion drugs will not effectually end an ectopic pregnancy because they exert their effects on the uterus, which leaves women at risk of severe harm from hemorrhage due to tubal rupture, in need of emergent surgery or potentially at risk of death. Failure to perform an ultrasound prior to prescribing abortion drugs will cause some women to remain undiagnosed and at high risk for these adverse outcomes. ”

“ Again, we need not speculate because the 2016 Major REMS Changes, the 2021 Petition Denial, and the 2023 Mail-Order Decision all allow non-doctors to prescribe mifepristone. The women who use this drug cannot possibly go back to their non-doctor-prescribers for surgical abortions, so again, as the “Patient Agreement Form” itself says, they must instead seek “emergency care” from a qualified physician. ”

“ That’s because FDA has removed almost all of mifepristone’s REMS and thus enabled women to (1) get the drug without ever talking to a physician, (2) take the drug without ever having a physical exam to ensure gestational age and/or an ectopic pregnancy, and (3) attempt to complete the chemical abortion regimen at home; FDA has also (4) directed the hundreds of thousands of women who have complications to seek “emergency care” from the plaintiffs and plaintiffs’ hospitals. ”

“ We find that FDA and Danco succeed only in part.
III.
Regarding likelihood to succeed on the merits, the stay applicants raise four arguments. They contend (A) plaintiffs are unlikely to defend the district court’s stay because they lack standing. They next contend (B) plaintiffs’ claims are untimely. Then they claim (C) plaintiffs’ claims are unexhausted. Finally, applicants contend (D) FDA’s actions are not arbitrary, capricious, or otherwise contrary to law. We consider each in turn. ”

“ See, e.g., PI App. 218 (“I spent a significant amount of time that day working to save her life from unnecessary complications due to the irresponsible administration and use of mifepristone and misoprostol. As a result of the significant time that I devoted to that patient, my time and attention was taken away from other patients, who also need my care.”) ; PI App. 867 (“Because more women [who take mifepristone] are unnecessarily presenting in the emergency department, more of my time and attention is taken away from other patients who need it.”) ”

“ Since plaintiffs already prevail on most Nken factors concerning most of the agency items effectively enjoined by the district court’s order, we need not definitively interpret the Comstock Act to resolve this stay application. *** As the stay applicants, defendants bear the burden of showing why “extraordinary circumstances” demand that we exercise discretion in their favor. To the extent the defendants make any such showing, they do so only with respect to the 2000 Approval—not the plaintiffs’ alternative arguments challenging FDA’s 2016 Major REMS Changes and all subsequent actions. ”

“ Several doctors testified that they have seen an increasing number of women coming to the emergency room with complications from chemical abortions due to FDA’s virtual elimination of controls on the dispensing and administration of the drugs. PI App. 194, 205, 215, 866. And given how many women these doctors have seen in emergency departments in the past, these doctors quite reasonably know with statistical certainty—again, a statistic estimated on Mifeprex’s own “Patient Agreement Form”—that women will continue needing plaintiffs’ “emergency care.” ”

“ It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.
These actions make it unlikely that plaintiffs’ arbitrary-and-capricious challenges will fail on the merits, at least as far as they challenge FDA’s decisions including and following the 2016 Major REMS Changes.
IV.
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 ”

“ We begin with Article III standing. To bring their claims in federal court, plaintiffs must satisfy the familiar tripartite test: they must show they suffered an injury in fact, that’s fairly traceable to the defendants, and that’s likely redressable by a favorable decision. ”

“ As to those alternative arguments, plaintiffs’ claims are timely. Defendants have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, and as more fully explained below, defendants’ motions for a stay pending appeal are DENIED IN PART. Defendants’ alternative motions for an administrative stay are DENIED AS MOOT. Plaintiffs’ motion to dismiss the appeal is DENIED. The appeal is EXPEDITED to the next available Oral Argument Calendar. ”

“ The speed of our review does not permit conclusive exploration of this topic. To the extent the Comstock Act introduces uncertainty into the ultimate merits of the case, that uncertainty favors the plaintiffs because the applicants bear the burden of winning a stay. ”

“ The Supreme Court has explicitly instructed this court to review a new agency action finalized after litigation commenced and while the appeal was pending because this decision was a “final agency action” for purposes of 5 U.S.C. § 704. Biden v. Texas, 142 S. Ct. 2528, 2544-45 (2022) (quotation omitted) . ↑ As both parties recognize, this order would have the practical effect of an injunction because it would remove mifepristone from the market. ”

“ Although no factor is dispositive, the likelihood of success and irreparable injury factors are “the most critical.” Nken, 556 U.S. at 434. Success on either factor requires that the stay seeker make a strong not merely “possib [le] ” showing. ”

“ Finally, in January 2023, FDA approved a modified REMS for mifepristone lifting the in-person dispensing requirement. See REMS Single Shared System for Mifepristone 200 mg (Jan. 2023) , https://perma.cc/MJT5-35LF (the “2023 Mail-Order Decision”) . [2]
C.
In November 2022, plaintiffs (physicians and physician organizations) filed this suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs first challenged FDA’s 2000 Approval of the drug. But they also requested multiple grounds of alternative relief for FDA’s subsequent actions. ”

“ The result is the same under the second reopening test. Recall that under the second test, “ [a] constructive reopening occurs if the revision of accompanying regulations significantly alters the stakes of judicial review as the result of a change that could have not been reasonably anticipated.” Sierra Club, 551 F.3d at 1025 (quotation omitted) .
Sierra Club is the seminal case. In 1994, EPA adopted a rule that exempted major sources of air pollution from the Clean Air Act’s emission standards during startups, shutdowns, and malfunctions (the “SSM exemption”) . ”

“ Nat’l Wildlife Fed’n, 497 U.S. 871 (1990) . Importantly, only one plaintiff needs to have standing to present a valid case or controversy. See Rumsfeld v. Forum for Acad. & Institutional Rts., Inc., 547 U.S. 47, 52 n.2 (2006) .
Plaintiffs and the district court offered numerous theories of standing. At this preliminary, emergency stage, we are unpersuaded by applicants’ contentions that all of these theories fail to create a justiciable case or controversy. We need only consider two: (1) injuries to doctors and (2) injuries to the plaintiff medical associations. [4]
1. ”

“ In this way, “ [t] he FDA’s actions have created a culture of chaos for emergency room physicians.” PI App. 867. And we’re capable of redressing plaintiffs’ injuries by restoring the 2000 Approval’s REMS. Accordingly, at this stage, applicants have not shown that all of the plaintiffs lack standing.
We hasten to emphasize the narrowness of this holding. We do not hold that doctors necessarily have standing to raise their patients’ claims. ”

“ Here, the plaintiff-doctors have “‘set forth’ by affidavit or other evidence ‘specific facts’” that they are certain to see more patients. Clapper, 568 U.S. at 411 (quoting Lujan v. Defs. of Wildlife, 504 U.S. 555, 561 (1992) ) . ”