Case: 23-10362 Document: 543-1 Page: 1 Date Filed: 08/16/2023
`
`United States Court of Appeals
`for the Fifth Circuit
`____________
`
`No. 23-10362
`____________
`
`Alliance for Hippocratic Medicine; American
`Association of Pro-Life Obstetricians &
`Gynecologists; American College of Pediatricians;
`Christian Medical & Dental Associations; Shaun
`Jester, D.O.; Regina Frost-Clark, M.D.; Tyler Johnson,
`D.O.; George Delgado, M.D.,
`
`
`United States Court of Appeals
`Fifth Circuit
`
`FILED
`August 16, 2023
`
`Lyle W. Cayce
`Clerk
`
`Plaintiffs—Appellees,
`
`
`
`versus
`
`
`U.S. Food & Drug Administration; Robert M. Califf,
`Commissioner of Food and Drugs; Janet Woodcock, M.D., in her
`official capacity as Principal Deputy Commissioner, U.S. Food and Drug
`Administration; Patrizia Cavazzoni, M.D., in her official capacity as
`Director, Center for Drug Evaluation and Research, U.S. Food and Drug
`Administration; United States Department of Health and
`Human Services; Xavier Becerra, Secretary, U.S. Department of
`Health and Human Services,
`
`
`Defendants—Appellants,
`
`
`
`versus
`
`
`Danco Laboratories, L.L.C.,
`
`
`
`
`
`
`Intervenor—Appellant.
`
`

`

`Case: 23-10362 Document: 543-1 Page: 2 Date Filed: 08/16/2023
`
`
`
`
`
`______________________________
`
`Appeal from the United States District Court
`for the Northern District of Texas
`USDC No. 2:22-CV-223
`______________________________
`
`
`Before Elrod, Ho, and Wilson, Circuit Judges.
`Jennifer Walker Elrod, Circuit Judge:
`
`This complicated administrative law appeal concerns the regulation of
`mifepristone, a drug used to cause abortion. The United States Food and
`Drug Administration approved mifepristone for use in 2000 under the brand
`name Mifeprex. At the same time, FDA imposed a number of conditions de-
`signed to prevent the drug from causing serious medical side effects. FDA
`amended those conditions in 2016, generally lightening the prior protections.
`It then approved a generic version in 2019. And in 2021, FDA announced
`that it would not enforce an agency regulation requiring mifepristone to be
`prescribed and dispensed in person. The agency ultimately removed that re-
`quirement from mifepristone’s conditions for use.
`
`The subject of this appeal is those four actions: the 2000 Approval,
`2016 Amendments, 2019 Generic Approval, and 2021 Non-Enforcement De-
`cision. They are challenged by the Alliance for Hippocratic Medicine—an
`association of doctors who research, teach, and advocate for ethical medical
`practices—several similar organizations, and several individual doctors. At
`bottom, the Medical Organizations and Doctors contend that FDA over-
`looked important safety risks in approving mifepristone and amending its re-
`strictions. They assert that FDA’s actions were unlawful under the Admin-
`istrative Procedure Act.
`
`The Organizations seek relief on behalf of their members, many of
`whom are OB/Gyns or emergency-room doctors. Many women face severe
`complications as a result of taking mifepristone. The Doctors allege that they
`
`2
`
`

`

`Case: 23-10362 Document: 543-1 Page: 3 Date Filed: 08/16/2023
`
`No. 23-10362
`
`are harmed when they treat those kinds of patients.
`
`According to the Doctors, when they treat women who are experienc-
`ing complications after taking mifepristone, they are required to perform or
`complete an abortion, or otherwise required to participate in a process that
`facilitates abortion. They maintain that personally conducting those proce-
`dures violates their sincerely held moral beliefs. The Doctors also contend
`that treatment of mifepristone patients diverts time and resources away from
`their ordinary patients, causes substantial mental and emotional distress, and
`exposes them to heightened malpractice risk and increased insurance costs.
`
`Seeking to prevent those alleged injuries, the Medical Organizations
`and Doctors moved for preliminary injunctive relief. The district court
`granted the motion, but rather than entering a traditional injunction, the
`court stayed the effective date of each of the challenged actions under 5
`U.S.C. § 705. FDA appealed, as did Intervenor Danco Laboratories, LLC,
`the pharmaceutical company that distributes Mifeprex.
`
`After extensive briefing and oral argument, we hold that the district
`court’s stay order should be VACATED in part and AFFIRMED in part.
`We conclude that the Medical Organizations and Doctors’ claim as to the
`2000 Approval is likely barred by the statute of limitations. Accordingly, that
`component of the district court’s order must be VACATED. This means
`that, until final judgment, Mifeprex will remain available to the public under
`the conditions for use that existed in 2016.
`
`We also VACATE the portion of the order relating to the 2019 Ge-
`neric Approval because the Medical Organizations and Doctors have not
`shown that they are injured by that particular action. The generic version of
`mifepristone will also be available under the same conditions as Mifeprex.
`
`We AFFIRM the components of the stay order that concern the 2016
`Amendments and the 2021 Non-Enforcement Decision. Those agency ac-
`
`3
`
`

`

`Case: 23-10362 Document: 543-1 Page: 4 Date Filed: 08/16/2023
`
`No. 23-10362
`
`tions—which generally loosen the protections and regulations relating to the
`use of mifepristone—will be stayed during the pendency of this litigation.
`
`Finally, we note that our holding is subject to the prior order of the
`Supreme Court, which stayed the district court’s order pending resolution of
`this appeal and disposition of any petition for writ of certiorari. Danco Lab’ys,
`LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) (mem.).
`
`I. Background
`
`This case arises under the Federal Food, Drug, and Cosmetic Act and
`related amendments. 21 U.S.C. ch. 9. The Department of Health and Hu-
`man Services is charged with responsibility for implementing that law, and
`has delegated that obligation to FDA, its subagency. Id. § 393. The relevant
`events center on the particular duty of approving new drugs.
`
`The approval process begins with a new drug application. Id. § 355(a).
`At this stage, it is the applicant’s burden to prove that the proposed drug is
`safe and effective. The Act directs FDA to deny a new drug application if,
`among other reasons, the applicant fails to include tests and data that show
`that the drug “is safe for use under the conditions prescribed, recommended,
`or suggested in the proposed labeling”; if “any other information” before
`FDA tends to show that the drug is not safe; or if “there is a lack of substan-
`tial evidence that the drug will have the effect it purports or is represented to
`have under the conditions for use prescribed, recommended, or suggested in
`the proposed labeling thereof.” Id. § 355(d); see 21 C.F.R. § 314.125 (regula-
`tions expanding on those requirements).
`
`Certain new drug applications may be designated for “accelerated ap-
`proval.” 21 C.F.R. § 314 subpt. H. This category applies to drugs treating
`“serious or life-threatening illnesses” and that “provide meaningful thera-
`peutic benefit to patients over existing treatments.” Id. § 314.500. The reg-
`ulations also require FDA to impose “postmarketing restrictions” where
`
`4
`
`

`

`Case: 23-10362 Document: 543-1 Page: 5 Date Filed: 08/16/2023
`
`No. 23-10362
`
`necessary to ensure the drug is used safely. Id. § 314.520(a). Relevant here,
`the agency may mandate that the drug be administered at “certain facilities
`or [by] physicians with special training or experience,” or that “specified
`medical procedures” be used. Id. § 314.520(a)(1), (a)(2).
`
` FDA has explained that it will consider accelerated approval in two
`situations: where the agency can reliably estimate effectiveness using a “sur-
`rogate endpoint”; and where FDA “determines that a drug, effective to the
`treatment of a disease, can be used safely only if distribution or use is modi-
`fied or restricted.” 57 Fed. Reg. 58942, 58942 (Dec. 11, 1992). The agency
`has understood approval under Subpart H as also satisfying the general ap-
`proval conditions provided by the Food, Drug, and Cosmetic Act. See id.
`(“Drugs or biological products approved under these procedures will have
`met the requisite standards for safety and effectiveness under the [Act] . . .
`and, thus, will have full approval for marketing.”).
`
`In March of 1996, an entity known as the Population Council applied
`for FDA to approve mifepristone as a new drug, as part of a two-drug regimen
`designed to cause abortion.1 The regimen works like this: First, a pregnant
`woman takes mifepristone, which suppresses the production of the hormone
`progesterone. Progesterone is needed for the pregnancy to continue; it pre-
`pares and maintains the uterine lining and stimulates the production of nutri-
`ents. After taking mifepristone, a patient takes misoprostol, which causes the
`uterus to cramp and expel its contents.
`
`As part of the new drug application, the Population Council relied on
`three clinical studies, one conducted in the United States and two conducted
`
`_____________________
`
`1 The Population Council is a non-profit organization. Roussel Uclaf—the French
`pharmaceutical company that originally developed mifepristone—donated the American
`patent rights to the Population Council in 1994. The Population Council then granted
`Danco an exclusive license to manufacture and distribute Mifeprex in the United States.
`
`5
`
`

`

`Case: 23-10362 Document: 543-1 Page: 6 Date Filed: 08/16/2023
`
`No. 23-10362
`
`in France. The studies purported to show that mifepristone was effective in
`the majority of cases, under the conditions imposed in each study. Those
`conditions included: an ultrasound to verify gestational age and diagnose ec-
`topic pregnancies; that prescribing physicians have experience performing
`surgical abortions and have admitting privileges at a nearby hospital; that the
`testing facilities be located close to a local hospital; and a four-hour monitor-
`ing period after taking misoprostol.
`
`Although mifepristone was effective for most patients, the studies
`showed a trend of adverse events for some women. According to FDA, “sur-
`gical intervention” was required in 7.9% of the subjects in the American trial
`and 4.5% of subjects in the French trials. The reasons for surgery included
`heavy bleeding, infection, incomplete abortion, and ongoing pregnancy—
`meaning that the embryo or fetus continued to grow and develop.
`
`FDA approved the new drug application in September 2000. The let-
`ters that the agency sent to the Population Council explained that the ap-
`proval was “under Subpart H.” FDA Approval Memorandum to Population
`Council at 6 (Sept. 28, 2000). This was for two reasons. First, FDA under-
`stood Mifeprex to be a drug that treated a serious or life threatening illness.
`Id. (“FDA has determined that the termination of an unwanted pregnancy is
`a serious condition within the scope of Subpart H. The meaningful therapeu-
`tic benefit over existing surgical abortion is the avoidance of a surgical proce-
`dure.”). And second, Subpart H was required because Mifeprex could not
`be administered safely without imposing certain use restrictions. Id. (“Sub-
`part H applies when FDA concludes that a drug product shown to be effec-
`tive can be safely used only if distribution or use is restricted . . . .”).
`
`In order to address the safety risks discussed above, FDA imposed
`several safeguards. First, it required the following black-box warning:
`
`6
`
`

`

`Case: 23-10362 Document: 543-1 Page: 7 Date Filed: 08/16/2023
`
`No. 23-10362
`
`If Mifeprex results in incomplete abortion, surgical interven-
`tion may be necessary. Prescribers should determine in ad-
`vance whether they will provide such care themselves or
`through other providers. Prescribers should also give patients
`clear instructions of whom to call and what to do in the event
`of an emergency following administration of Mifeprex.
`
`Approval Memorandum at 2. FDA also set the following controls on the use
`and prescription of Mifeprex:
` Only women whose pregnancies have a gestational age of
`forty-nine days or less are eligible;
` Only physicians can prescribe Mifeprex;
` All prescribing physicians must be able to assess gestational
`age, diagnose ectopic pregnancies, and “provide surgical
`intervention in cases of incomplete abortion or severe
`bleeding” or have arranged for another physician to provide
`such care;
` Prescription must occur in person; and
` Prescribers must report any “hospitalization, transfusion,
`or other serious event[] to the sponsor.”
`
`Id. at 1, 6. Finally, FDA required three doctor’s-office visits, which are sum-
`marized as follows. The patient first takes mifepristone at the doctor’s office.
`Three days later, she returns to the office to take misoprostol. Finally, the
`patient visits the doctor for a follow-up appointment, to determine whether
`the drug has successfully terminated the pregnancy and to screen for any ad-
`verse effects.
`
`In August of 2002, the American Association of Pro-Life Obstetri-
`cians and Gynecologists (a party to the instant case) and several other similar
`organizations filed a citizen petition, asking FDA to revoke its approval of
`mifepristone. See 21 C.F.R. § 10.30. The petition argued that mifepristone
`was not safe to use under the approved conditions. FDA reviewed the peti-
`
`7
`
`

`

`Case: 23-10362 Document: 543-1 Page: 8 Date Filed: 08/16/2023
`
`No. 23-10362
`
`tion over the next fourteen years, ultimately denying it in 2016.
`
` Two significant developments occurred in the meantime. First, in
`2007, Congress amended the Food, Drug, and Cosmetic Act. See Food and
`Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, tit. IX,
`§ 901, 121 Stat. 823, 922–43. The amendment authorizes FDA to require a
`“risk evaluation and mitigation strategy” (REMS) if it determines that such
`a strategy is “necessary to ensure that the benefits of the drug outweigh the
`risks of the drug.” 21 U.S.C. § 355-1(a)(1). The Act further allowed FDA to
`impose use restrictions via the REMS, like physician qualifications or report-
`ing requirements. Id. § 355-1(f). The law also regarded all drugs approved
`before the Act as having an approved REMS. See Amendments Act § 909(b),
`121 Stat. at 950 (“A drug that was approved before the effective date of this
`Act is . . . deemed to have in effect an approved risk evaluation and mitigation
`strategy under section 505-1 of the [Act].”).
`
`Then in 2011, FDA approved a REMS for mifepristone, imposing es-
`sentially the same restrictions as those FDA required when it approved Mif-
`eprex in 2000. The REMS included four essential parts: a general summary,
`medication guide, prescriber agreement, and patient agreement. The medi-
`cation guide explains how to use mifepristone and the risks associated with
`doing so. Mifepristone REMS at 4–6 (June 8, 2011). The prescriber agree-
`ment requires prescribers to promise to follow FDA’s restrictions. Id. at 7–
`8. And the patient agreement is a form that women must sign prior to using
`mifepristone; it obliges a patient to confirm that she meets the conditions for
`using mifepristone and acknowledge the risk of adverse events. Id. at 9–10.
`The mifepristone REMS was later amended in several respects. But its gen-
`eral form—the summary, medical guide, prescriber’s agreement, and patient
`agreement—remains the same.
`
`In 2016, FDA addressed Mifeprex in two respects. First, it denied the
`
`8
`
`

`

`Case: 23-10362 Document: 543-1 Page: 9 Date Filed: 08/16/2023
`
`No. 23-10362
`
`2002 citizen petition, defending Mifeprex’s safety and effectiveness as ap-
`proved in 2000. Second, FDA approved a supplemental new drug applica-
`tion by Danco. That application requested a number of amendments to Mif-
`eprex’s REMS that FDA described as “major” and “interrelated.” FDA
`Summary Review of 2016 Amendments at 5 (Mar. 29, 2016). Those changes
`included:
` Increasing the maximum gestational age from forty-nine
`days to seventy days;
` Allowing non-physicians to prescribe mifepristone;
` Removing the requirement that the administration of miso-
`prostol and the subsequent follow-up appointment be con-
`ducted in person;
` Eliminating prescribers’ obligation to report non-fatal ad-
`verse events;
` Switching the method of administration for misoprostol
`from oral to buccal; and
` Changing the dose of mifepristone (600 mg to 200 mg) and
`misoprostol (400 mcg to 800 mcg).
`
`Id. at 2, 26. FDA also pointed to a number of studies as evidence that Mif-
`eprex would be safe and effective despite the amendments. Id. at 5–17.
`
`Several years later, in 2019, the American Association of Pro-Life Ob-
`stetricians and Gynecologists and American College of Pediatricians filed a
`citizen petition challenging the 2016 Amendments. The petition generally
`requested that FDA restore the restrictions it imposed in 2000. Separately,
`in April of 2019, FDA approved an “abbreviated new drug application” by
`GenBioPro, Inc. for a generic version of mifepristone. To assess whether the
`drug was safe, the agency relied on the same data that it had relied upon for
`the 2000 Approval and 2016 Amendments regarding Mifeprex.
`
`9
`
`

`

`Case: 23-10362 Document: 543-1 Page: 10 Date Filed: 08/16/2023
`
`No. 23-10362
`
`FDA then took several notable steps in 2021. In April, it announced
`that, in connection with the COVID-19 pandemic, the agency would not en-
`force the in-person dispensing requirement. Effectively, this allowed mife-
`pristone to be prescribed remotely and sent via mail.
`
`[FDA] intends to exercise enforcement discretion during the
`COVID-19 [pandemic] with respect to the in-person dispens-
`ing requirement of the Mifepristone REMS Program, including
`any in-person requirements that may be related to the Patient
`Agreement Form. Further . . . [FDA] intends to exercise en-
`forcement discretion during the COVID-19 [pandemic] with
`respect to the dispensing of mifepristone through the mail ei-
`ther by or under the supervision of a certified prescriber, or
`through a mail-order pharmacy when such dispensing is done
`under the supervision of a certified prescriber.
`
`FDA Letter to American College of Obstetricians and Gynecologists at 2
`(Apr. 12, 2021). Later that year, FDA stated that it would adopt the change
`on a permanent basis. It then amended mifepristone’s REMS (which applies
`to Mifeprex and the generic version) in January of 2023 to formalize the re-
`moval of the in-person dispensing requirement. FDA Br. at 11.
`
`Finally, in December of 2021, FDA denied the 2019 citizen petition.
`According to FDA, the agency “undertook a full review of the Mifepristone
`REMS Program” and ultimately concluded that the drug was safe to use as
`amended. FDA Denial Letter to American College of Obstetricians and Gy-
`necologists at 6 (Dec. 16, 2021). FDA specifically addressed its reasons for
`removing the in-person dispensing requirement. Id. at 25–36.
`
`*
`
`*
`
`*
`
`Against this background, the Medical Organizations and Doctors filed
`the instant complaint in district court. As relevant here, they alleged that
`each FDA action—the 2000 Approval, 2016 Amendments, 2019 Generic
`
`10
`
`

`

`Case: 23-10362 Document: 543-1 Page: 11 Date Filed: 08/16/2023
`
`No. 23-10362
`
`Approval, and 2021 Non-Enforcement Decision—violates the Administra-
`tive Procedure Act. Danco intervened to represent its interest as the manu-
`facturer and distributor of Mifeprex in the United States. GenBioPro filed
`an amicus brief before this court but did not intervene or otherwise participate
`in the litigation, either in the district court or on appeal.
`
`The Medical Organizations and Doctors filed a motion for a prelimi-
`nary injunction. The district court held a hearing on the matter and granted
`the motion in part. All. for Hippocratic Med. v. FDA, __ F. Supp. 3d __, 2023
`WL 2825871 (N.D. Tex. Apr. 7, 2023). For relief, the court “stayed” the
`“effective date” of FDA’s actions under 5 U.S.C. § 705.
`
`FDA and Danco appealed and moved to stay the district court’s order
`pending appeal. A motions panel of this court stayed the district court’s or-
`der in part. All. for Hippocratic Med. v. FDA, No. 23-10362, 2023 WL 2913725
`(5th Cir. Apr. 12, 2023). The panel stayed the portion of the district court’s
`order relating to the 2000 Approval but did not disturb the other components
`of the order—regarding the 2016 Amendments, 2019 Generic Approval, and
`2021 Non-Enforcement Decision. FDA and Danco then applied to the Su-
`preme Court for a full stay of the district court’s order, which was granted.
`Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) (mem.).
`The Court further provided that its stay of the district court’s order would
`extend through the request for a petition for certiorari, if any:
`
`The April 7, 2023 order of the United States District Court for
`the Northern District of Texas, case No. 2:22–cv–223, is
`stayed pending disposition of the appeal in the United States
`Court of Appeals for the Fifth Circuit and disposition of a peti-
`tion for a writ of certiorari, if such a writ is timely sought.
`Should certiorari be denied, this stay shall terminate automati-
`cally. In the event certiorari is granted, the stay shall terminate
`upon the sending down of the judgment of this Court.
`
`11
`
`

`

`Case: 23-10362 Document: 543-1 Page: 12 Date Filed: 08/16/2023
`
`No. 23-10362
`
`Id. at 1075. The parties then fully briefed the ultimate question of whether
`the district court erred in issuing the stay order. Over thirty amici filed sepa-
`rate briefs on various topics. Oral argument was held on May 17, 2023, in
`which each side was allowed forty minutes to present its argument, double
`the ordinary allotted time. We now consider the merits of the appeal.
`
`II. Standing
`
`Before considering the Medical Organizations and Doctors’ claims,
`we must determine whether they have standing to assert them; an injunction
`is always improper if the district court lacked jurisdiction. Cruz v. Abbott,
`849 F.3d 594, 598–99 (5th Cir. 2017). At this stage, it is the plaintiffs’ burden
`to “make a ‘clear showing’ that they have standing to maintain the prelimi-
`nary injunction.” Barber v. Bryant, 860 F.3d 345, 352 (5th Cir. 2017) (quoting
`Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 22 (2008)). And so the
`Medical Organizations and Doctors must satisfy the three basic elements of
`standing: injury, traceability, and redressability. Lujan v. Defs. of Wildlife,
`504 U.S. 555, 560 (1992).
`
`Standing in this appeal turns principally on the “injury” prong. The
`Medical Organizations and Doctors seek prospective relief, so they must es-
`tablish future injury. To do that, they must show that “the threatened injury
`is ‘certainly impending,’ or there is a ‘substantial risk’ that the harm will oc-
`cur.” Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014) (quoting
`Clapper v. Amnesty Int’l USA, 568 U.S. 398, 414 n.5 (2013)). As those stand-
`ards indicate, the plaintiffs must show that the threat of future injury is suffi-
`ciently likely. The Supreme Court has thus rejected standing theories that
`rely “on a highly attenuated chain of possibilities” or that “require guess-
`work as to how independent decisionmakers will exercise their judgment.”
`Clapper, 568 U.S. at 410, 413.
`
`Even so, a “substantial risk” does not require that the threatened in-
`
`12
`
`

`

`Case: 23-10362 Document: 543-1 Page: 13 Date Filed: 08/16/2023
`
`No. 23-10362
`
`jury be “literally certain.” Id. at 414 n.5; see Lujan, 504 U.S. at 564 n.2 (ac-
`knowledging that imminence “is concededly a somewhat elastic concept”);
`Babbitt v. United Farm Workers Nat’l Union, 442 U.S. 289, 298 (1979) (re-
`quiring that the plaintiff “demonstrate a realistic danger of sustaining a direct
`injury”); Kolender v. Lawson, 461 U.S. 352, 355 n.3 (1983) (“a credible
`threat”); Frame v. City of Arlington, 657 F.3d 215, 235 (5th Cir. 2011) (“a suf-
`ficiently high degree of likelihood”). Instead, a plaintiff seeking prospective
`relief need only show that future injury is “fairly likely.” Crawford v. Hinds
`Cnty. Bd. of Supervisors, 1 F.4th 371, 376 (5th Cir. 2021); accord Arcia v. Fla.
`Sec’y of State, 772 F.3d 1335, 1341 (11th Cir. 2014) (“a realistic probability”).
`
`In assessing whether the threatened injury is fairly likely to occur, ev-
`idence of prior injury is especially probative. See Crawford, 1 F.4th at 376
`(citing Los Angeles v. Lyons, 461 U.S. 95, 102 (1983)). Said another way, it “is
`not unduly conjectural” to use the “predictable effect” of the defendant’s
`prior actions as a method to predict what will happen in the future. Apple Inc.
`v. Vidal, 63 F.4th 1, 17 (Fed. Cir. 2023) (quoting Dep’t of Com. v. New York,
`139 S. Ct. 2551, 2566 (2019)). Injuries that are “one-off” instances or “epi-
`sodic” in nature do not move the needle much. Crawford, 1 F.4th at 376. But
`where the causes that produced the first injury remain in place, past-injury
`evidence bears strongly “on whether there is a real and immediate threat of
`repeated injury.” O’Shea v. Littleton, 414 U.S. 488, 496 (1974); see Crawford,
`1 F.4th at 376; accord In re Navy Chaplaincy, 697 F.3d 1171, 1176–77 (D.C. Cir.
`2012) (“The prospect of future injury becomes significantly less speculative
`where, as here, plaintiffs have identified concrete and consistently-imple-
`mented policies claimed to produce such injury.”).
`
`Finally, a group of plaintiffs need not show that more than one of them
`is likely to be injured. “If at least one plaintiff has standing, the suit may
`proceed.” Biden v. Nebraska, 143 S. Ct. 2355, 2365 (2023) (citing Rumsfeld
`v. F. for Acad. and Institutional Rts., Inc., 547 U.S. 47, 52 n.2 (2006)).
`
`13
`
`

`

`Case: 23-10362 Document: 543-1 Page: 14 Date Filed: 08/16/2023
`
`No. 23-10362
`
`A. Associational Standing
`
`1. Factual Predicate
`
`The Medical Organizations and Doctors chiefly rely on associational
`standing. That is, the organizations contend that they have standing because
`their members are likely to sustain injuries as a result of FDA’s actions. See
`Hunt v. Wash. State Apple Adv. Comm’n, 432 U.S. 333, 343 (1977). We con-
`clude that the Medical Organizations and Doctors have made a “clear show-
`ing” that their members face injury with sufficient likelihood to support en-
`tering a preliminary injunction. Barber, 860 F.3d at 352.
`
`The standing theory forwarded here rests on several basic premises,
`which are recited as follows. Mifepristone causes adverse effects for a certain
`percentage of the women who take it. Those adverse events are traceable to
`FDA because it approved the drug. And hundreds of the Medical Organiza-
`tions’ members are OB/Gyns or emergency-room doctors who treat women
`who experience severe adverse effects.
`
`The Doctors are allegedly injured when they treat mifepristone pa-
`tients. They offer four reasons why that is so. First, when a doctor treats a
`woman suffering from a mifepristone complication, he or she will often be
`required to perform or complete an abortion. And even if not, the doctor
`must participate in the medical treatment that facilitates an abortion. The
`Doctors allege that being made to provide this treatment conflicts with their
`sincerely held moral beliefs and violates their rights of conscience.
`
`Second, treating mifepristone patients imposes mental and emotional
`strain above what is ordinarily experienced in an emergency-room setting.
`Third, providing emergency treatment forces the Doctors to divert time and
`resources away from their ordinary patients, hampering their normal prac-
`tice. And fourth, the Doctors allege that mifepristone patients involve more
`risk of complication than the average patient, and so expose the Doctors to
`
`14
`
`

`

`Case: 23-10362 Document: 543-1 Page: 15 Date Filed: 08/16/2023
`
`No. 23-10362
`
`heightened risk of liability and increased insurance costs.
`
`The Organizations reason that, given the millions of women who take
`mifepristone, the number of women who experience complications from tak-
`ing the drug, and the high number of the Organizations’ members who treat
`such women, their members are likely to continue to treat women suffering
`complications as a result of mifepristone. For the reasons listed above,
`providing that treatment will injure the Doctors. Thus, the Medical Organi-
`zations (via their members) are likely to be injured by FDA’s actions. We
`first examine the evidence supporting those contentions.
`
`a. Adverse Effects
`
`FDA and Danco do not dispute that a significant percentage of women
`who take mifepristone experience adverse effects. From Mifeprex’s initial
`approval to subsequent amendments to the REMS, FDA has acknowledged
`that a certain fraction of patients would require surgery due to miscellaneous
`complications. Approval Memorandum at 1; see also 2011 Mifepristone
`REMS at 5 (“[A]bout 5-8 out of 100 women taking Mifeprex will need a sur-
`gical procedure to end the pregnancy or to stop too much bleeding.”). Sim-
`ilarly, as explained by the motions panel, the required patient agreement dis-
`closes that “the treatment will not work” in “about 2 to 7 out of 100 women”
`who use mifepristone. All. for Hippocratic Med., 2023 WL 2913725, at * 5.
`
`To be sure, not every woman who experiences complications will pre-
`sent to the emergency room or require surgery and/or some other form of
`urgent care. But many will. According to the most updated REMS medica-
`tion guide, in studies conducted in the United States, between 2.9% and 4.6%
`of women visited the emergency room after taking mifepristone. Mifeprex
`Prescribing Information at 8 tbl.2 (Jan. 2023). Some women experience es-
`pecially severe conditions, such as sepsis (.02%) or hospitalization relating to
`abortion (.04% to .06%), and some women require a blood transfusion because
`
`15
`
`

`

`Case: 23-10362 Document: 543-1 Page: 16 Date Filed: 08/16/2023
`
`No. 23-10362
`
`of heavy bleeding (.03% to .05%). Id.2
`
`The data FDA cited in its 2000 approval memo is similar. For the
`American clinical trial, surgical intervention was required for 7.9% of women
`(4.5% for the French studies). Approval Memorandum at 1. Of that percent-
`age, 1.2% of women required surgery due to heavy bleeding (.3% for France)
`and .12% required a blood transfusion (.11% for France). Id. FDA and Danco
`agree that over five million women have taken Mifeprex since it was first ap-
`proved. These figures show that thousands of women, and as many as hun-
`dreds of thousands, have experienced serious adverse effects as a result of
`taking the drug, and required surgery or emergency care to treat those effects.
`
`The Medical Organizations contend that their members treat women
`who suffer serious complications after taking mifepristone. These doctors
`submitted declarations testifying to their experience giving this sort of emer-
`gency care. For example, Dr. Christina Francis recounted an instance where
`a patient took mifepristone at approximately ten weeks gestation. The
`woman experienced serious complications and the doctor was forced to per-
`form a surgical abortion because the drug failed to terminate the pregnancy:
`
`[T]he patient presented back at our emergency room with
`heavy vaginal bleeding and unstable vital signs as a result of tak-
`ing chemical abortion drugs. One of my partners was able to
`detect a fetal heartbeat. Due to the amount of bleeding that she
`was experiencing and evidence of hemodynamic instability,
`however, my partner had no choice but to perform an emer-
`
`_____________________
`
`2 To be clear, we do not understand the Medical Organizations and Doctors’ stand-
`ing theory as applying only to women who present to the emergency room with severe com-
`plications such as those listed above. Rather, they also contend that they are injured by
`treating women who experience less urgent medical side-effects because such treatment
`forces the doctor to participate in the abortion process.
`
`16
`
`

`

`Case: 23-10362 Document: 543-1 Page: 17 Date Filed: 08/16/2023
`
`No. 23-10362
`
`gency D&C. The patient needed to be hospitalized overnight
`for close observation after the D&C.
`Not only did my partner need to provide several hours of criti-
`cal care for this patient, but my partner also needed to call in a
`back-up physician