Abortion Pill Ruling 5th District
Abortion Pill Ruling 5th District
Abortion Pill Ruling 5th District
____________ FILED
August 16, 2023
No. 23-10362 Lyle W. Cayce
____________ Clerk
Plaintiffs—Appellees,
versus
Defendants—Appellants,
versus
Intervenor—Appellant.
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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
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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.
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* * *
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
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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-
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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)).
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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
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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.
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Fourth, such patients involve more risk than the average emergency-
room patient, which exposes the Doctors to greater malpractice liability and
increased insurance costs. See Dr. Barrows Declaration ¶ 23 (testifying that
providing emergency treatment to women suffering complications because of
taking mifepristone puts doctors in “riskier, emergent medical situations”);
Dr. Jester Declaration ¶ 20 (“These situations are naturally higher risk for
both the patient and for the physician providing care.”). The more mifepris-
tone patients the Doctors treat, the higher their liability and greater their in-
jury. See Dr. Barrows Declaration ¶¶ 21–24; Dr. Jester Declaration ¶¶ 20–
21; Dr. Johnson Declaration ¶ 15. Having examined the factual basis for the
Medical Organizations and Doctors’ claims, we now answer the question of
whether they have associational standing to assert those claims.
2. Analysis
a. Imminent Injury
We conclude that the Medical Organizations and Doctors have made
a “clear showing” of associational standing. Barber, 860 F.3d at 352. To
begin, it is “fairly likely” that the Doctors—both those who testified and
those who are members of the Medical Organizations but did not testify—
will continue treating women who experience severe complications after tak-
ing mifepristone. Crawford, 1 F.4th at 376. FDA’s own data shows that a
definite percentage of women who take mifepristone will require emergency-
room care, be it a blood transfusion, a surgery to complete a failed abortion
or ongoing pregnancy, or some other complication. The data further shows
that millions of women take mifepristone. And the Medical Organizations
testified that hundreds of their members are OB/Gyns and emergency-room
doctors who care for women in these circumstances. The Medical Organiza-
tions and Doctors therefore face a “substantial risk” of future injury. Susan
B. Anthony List, 573 U.S. at 158.
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That risk is supported by the fact that many Doctors have already been
required to treat patients experiencing complications due to mifepristone.
Lyons, 461 U.S. at 102. These are not merely “one-off” instances. Crawford,
1 F.4th at 376. On the contrary, FDA’s data and the Doctors’ testimony
show that women will continue to present to the emergency room after taking
mifepristone, requiring urgent treatment. That trend is not speculative—it
is “predictable” and “consistent[].” Vidal, 63 F.4th at 17; In re Navy Chap-
laincy, 697 F.3d at 1176. And it does not matter that the foundation of the
Doctors’ standing rests, in part, on “choices made by independent actors.”
Lujan, 504 U.S. at 562. That concern is alleviated where, as here, “third
parties will likely act in predictable ways.” Dep’t of Com., 139 S. Ct. at 2566.
It is worth repeating that the Medical Organizations and Doctors are
not required to show that it is “literally certain” that they will be injured.
Clapper, 568 U.S. at 414 n.5. They need only show a “substantial risk” that
injury will occur. Susan B. Anthony List, 573 U.S. at 158; see also United Farm
Workers, 442 U.S. at 298 (“a realistic danger”); Kolender, 461 U.S. at 356 n.3
(“a credible threat”); Arcia, 772 F.3d at 1341 (“a realistic probability”). At
this preliminary-injunction stage, they have carried their burden. All. for Hip-
pocratic Med., 2023 WL 2913725, at *8.
FDA and Danco’s primary objection to the Medical Organizations
and Doctors’ standing theory is that it is speculative and inconsistent with
the Supreme Court’s decision in Summers v. Earth Island Institute, 555 U.S.
488 (2009). We disagree. For one thing, testimony was offered from multi-
ple doctors who have personally given emergency care to women suffering
complications from mifepristone. Dr. Francis Declaration ¶¶ 12–13; Dr.
Skop Declaration ¶¶ 17–18, 22; Dr. Jester ¶ 17. Given those prior instances,
and given mifepristone’s continued availability, the Medical Organizations
reason that these members are reasonably likely to be injured again. The rec-
ord amply supports that claim.
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sue” once the case was before the Supreme Court. Id. at 491 (quoting Earth
Island Inst. v. Pengilly, 376 F. Supp. 2d 994, 999 (E.D. Cal. 2005)).
The plaintiffs attempted to continue their challenge to the regulation,
asserting that their other members were statistically likely to travel to one of
the many parks that would likely be affected by the regulation. To be sure,
the majority expressed skepticism with that theory. See id. at 497 (criticizing
the dissent’s “hitherto unheard-of test for organizational standing: whether
. . . there is a statistical probability that some of [the plaintiffs’] members are
threatened with concrete injury”). But its bigger concern was that plaintiffs
failed to prove their claims: they lacked evidence of the number of association
members who intended to visit the parks, and when:
A major problem with the dissent’s approach is that it accepts
the organizations’ self-descriptions of their membership, on
the simple ground that “no one denies” them. But it is well
established that the court has an independent obligation to as-
sure that standing exists, regardless of whether it is challenged
by any of the parties.
Id. at 499. A primary reason for the lack of evidence was the majority’s deci-
sion to not consider several affidavits offered after the district court entered
judgment—affidavits that would have made the required showing. See id. at
495 n.* (declining to consider the affidavits); cf. id. at 508–09 (Breyer, J., dis-
senting) (arguing that the Court should consider them). Without those affi-
davits, the majority understood itself as not having evidence of any other
member’s injury:
In part because of the difficulty of verifying the facts upon
which such probabilistic standing depends, the Court has re-
quired plaintiffs claiming an organizational standing to identify
members who have suffered the requisite harm—surely not a
difficult task here, when so many thousands are alleged to have
been harmed.
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2023 WL 2913725, at *6–7. And by the same token, the Doctors sustain a
concrete injury when mifepristone patients expose them to greater liability
and increased insurance costs. Dr. Barrows Declaration ¶¶ 21–24; Dr. Jester
Declaration ¶¶ 20–21; Dr. Johnson Declaration ¶ 15.
The Medical Organizations and Doctors also face a concrete injury
when they are forced to choose between following their conscience and
providing care to a woman experiencing complications as a result of taking
mifepristone. As recounted above, evidence was offered of a doctor who per-
sonally gave care in these circumstances. Dr. Skop Declaration ¶ 17 (“In my
practice, I have cared for at least a dozen women who have required surgery
to remove retained pregnancy tissue after a chemical abortion. Sometimes
this includes the embryo or fetus, and sometimes it is placental tissue that has
not been completely expelled.”). Another doctor testified about her partner,
who experienced the same thing. Dr. Francis Declaration ¶ 13 (“Due to the
amount of bleeding . . . my partner had no choice but to perform an emer-
gency D&C. . . . And because the preborn baby still had a heartbeat when the
patient presented, my partner felt as though she was forced to participate in
something that she did not want to be a part of—completing the abortion.”).
And other doctors testified of fear that they or fellow physicians will be forced
into similar situations. Dr. Barrows Declaration ¶ 26; Dr. Skop Declaration
¶ 34; cf. Dickerson Declaration ¶ 16.
FDA and Danco do not dispute that the Medical Organizations and
Doctors’ conscience injury is cognizable. But they defend FDA’s actions on
the ground that federal law would allow the Doctors to refuse care based on
a conscientious objection. FDA Br. at 26; Danco Br. at 21 (citing 42 U.S.C.
§§ 238n, 300a-7(c), (d)). The Medical Organizations and Doctors respond
by pointing out that the federal government has recently taken a contrary po-
sition. That is, in July 2022, the Department of Health and Human Services
issued a guidance document that interprets the Emergency Medical Treat-
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ment and Active Labor Act to require hospitals to provide care to, among
others, a woman with an “incomplete medical abortion,” irrespective of ob-
jections of conscience. Reinforcement of EMTALA Obligations Specific to
Patients Who Are Pregnant or Are Experiencing Pregnancy Loss, at 6, Cen-
ters for Medicare & Medicaid Services (July 11, 2022). A district court has
enjoined that guidance, and an appeal is proceeding before this court. Texas
v. Becerra, 623 F. Supp. 3d 696 (N.D. Tex. 2022) (entering preliminary in-
junction); Texas v. Becerra, No. 5:22-CV-185, 2023 WL 2467217 (N.D. Tex.
Jan. 10, 2023) (final judgment and permanent injunction).
At oral argument, counsel for FDA disputed that EMTALA binds in-
dividual doctors, arguing instead that the obligation to provide abortion-re-
lated care runs to hospitals. That is, individual doctors may assert conscience
objections so long as one doctor at the hospital can provide the required care.
This raises the question of what would happen if no other doctor were avail-
able—a situation that seems particularly likely in smaller clinics. But setting
that issue to the side, counsel’s argument appears to conflict with the Gov-
ernment’s position on appeal in the Texas case. See Br. for Appellants at 25,
Texas v. Becerra (5th Cir. May 1, 2023) (No. 23-10246) (“EMTALA requires
doctors to offer abortion care when that care is the necessary stabilizing treat-
ment for an emergency medical condition.”) (emphasis added); id. at 27
(“[W]hen pregnant women come to a Medicare-funded hospital with an
emergency medical condition, EMTALA obligates the treating physician to
provide stabilizing treatment, including abortion care.”) (quoting United
States v. Idaho, 623 F. Supp. 3d 1096, 1109 (D. Idaho 2022)).
We conclude that the federal laws Defendants cite do not alleviate the
Doctors’ conscience injury, at least for purposes of this preliminary posture.
The inconsistencies between the Government’s position in Texas v. Becerra
and FDA’s position here tend to rebut the notion that Doctors are free to
refuse treatment to mifepristone patients.
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We next address the Doctors’ argument that they will suffer an inde-
pendent injury by way of the “enormous stress and pressure” that is involved
with treating women suffering complications from taking mifepristone. Dr.
Wozniak Declaration ¶ 17. They maintain that FDA’s actions cause women
to present at the emergency room with complications that involve a unique
level of trauma and distress, due to the high amount of emotional and physical
strain often associated with the experience. Dr. Delgado Declaration ¶ 14;
Dickerson Declaration ¶ 14; Dr. Skop Declaration ¶ 33.
It is true that the Supreme Court has interpreted Article III to recog-
nize injuries that “significantly affect[]” a plaintiff’s “quality of life.” Sierra
Club v. Morton, 405 U.S. 727, 734–35 (1972). And several of our sister circuits
acknowledge standing that is predicated on “emotional or psychological
harm.” Maddox v. Bank of N.Y. Mellon Tr. Co., 19 F.4th 58, 65 (2d Cir. 2021)
(quoting TransUnion, 141 S. Ct. at 2211 n.7); see also Clemens v. ExecuPharm
Inc., 48 F.4th 146, 155 (3d Cir. 2022) (same). However, the mental and emo-
tional stress shown here is best understood as additional to the Doctors’ con-
science injuries, not independent from them. The threat of being forced to
violate a sincerely held moral belief is cognizable at least in part because the
event would involve acute emotional and psychological harm. Maddox, 19
F.4th at 65; Clemens, 48 F.4th at 155. The emotional and mental strain of
which the Doctors testify is of the same nature, albeit of an arguably lesser
magnitude. In this way, the “enormous stress and pressure” that the Medi-
cal Organizations and Doctors cite augment the Doctors’ conscience injuries,
but does not provide a separate basis for Article III standing.4
Danco argues that the Medical Organizations and Doctors’ standing
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4
We understand the Doctors’ conscience injuries as being supported by longstand-
ing precedent of the Supreme Court and this court. We thus do not discuss our colleague’s
thoughtful comments on other types of injuries that may be cognizable. Post at 67–70.
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argument is “limitless,” and worries that its logic would allow doctors to
challenge firearm laws based on the stress involved with treating gunshot vic-
tims. Danco Br. at 22–23 (citing E.T. v. Paxton, 41 F.4th 709, 721 (5th Cir.
2022)). But we see several limits. Foremost is the rigorous evidence needed
to prove traceability and redressability. The plaintiffs in Danco’s hypothet-
ical would lack standing unless they could prove that a particular law caused
there to be more gunshot victims, and that enjoining enforcement of the law
would cause there to be fewer. That is a tall order, to say the least. Equally
significant is the requirement that a plaintiff be threatened with injury akin to
being forced to violate his or her sincerely held conscience beliefs. That sort
of injury will be absent except in the most exceptional cases. We do not think
that our holding will open the floodgates to the litigation Danco describes.
c. Traceability
Standing to challenge mifepristone’s approval does not necessarily in-
clude standing to challenge FDA’s subsequent actions. That is so because
“standing is not dispensed in gross; rather, plaintiffs must demonstrate
standing for each claim that they press and for each form of relief that they
seek.” TransUnion, 141 S. Ct. at 2208. As we have said many times, standing
proceeds claim by claim. E.g., In re Gee, 941 F.3d 153, 170–71 (5th Cir. 2019);
Friends of St. Frances Xavier v. FEMA, 658 F.3d 460, 466 (5th Cir. 2011). The
Medical Organizations and Doctors are correct, then, to acknowledge that
they must show “harms to the plaintiff doctors and associations [that] flow
from each of the relevant FDA actions.” Alliance Br. at 22.
i. 2016 Amendments
The Medical Organizations and Doctors contend that the 2016
Amendments will increase the number of women who suffer complications
as a result of taking mifepristone. That is so for three reasons, they say. First,
the risk of complication increases with gestational age, and the Amendments
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increase the maximum permissible age from forty-nine days to seventy days.
See Dr. Skop Declaration ¶ 28 (asserting that taking mifepristone at later
stages of gestation increases the chance of “complications due to the in-
creased amount of tissue, leading to hemorrhage, infection and/or the need
for surgeries or other emergency care”); see also Dr. Barrows Declaration
¶ 22; Dr. Wozniak Declaration ¶ 10.
Second, the percentage of women who experience complications that
present to the emergency room (as opposed to their mifepristone provider)
will increase because the Amendments remove the requirement for a second
and third in-person visit. One doctor explained this phenomenon:
Under the current practice by those who prescribe and dis-
pense chemical abortion drugs like mifepristone and miso-
prostol, there is no follow-up or additional care provided to pa-
tients. Instead, with no established relationship with a physi-
cian, patients are simply left to report to the emergency room
when they experience adverse events.
Dr. Foley Declaration ¶ 11; see also Dr. Harrison Declaration ¶ 44 (testifying
that eliminating in-person evaluations and follow-up care “places our mem-
ber doctors at increased risk of being forced to violate their conscience
rights”); Dr. Frost-Clark Declaration ¶ 21 (similar).
Third, and relatedly, the percentage of women who present to the
emergency room will increase because the Amendments allow non-physi-
cians to prescribe mifepristone. As the motions panel explained, women who
receive the drug from someone other than a doctor “cannot possibly go back
to their non-doctor-prescribers for surgical abortions.” All. for Hippocratic
Med., 2023 WL 2913725, at *5. And multiple doctors testified that they have
seen or expect to see more women with serious complications resulting from
mifepristone. Dr. Harrison Declaration ¶ 26; Dr. Skop Declaration ¶¶ 20–
21; Dr. Wozniak Declaration ¶¶ 18, 29; Dr. Johnson Declaration ¶ 18; Dr.
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Frost-Clark Declaration ¶ 18; Dr. Jester Declaration ¶ 13. Given the already-
substantial risk of harm, the evidence of increased risk is sufficient to confer
standing to challenge the 2016 Amendments. See Nat. Res. Def. Council, Inc.
v. EPA, 464 F.3d 1, 6–7 (D.C. Cir. 2006) (holding that plaintiffs had standing
based on “increased risk” of developing skin cancer); Sutton v. St. Jude Med.
S.C., Inc., 419 F.3d 568, 570–75 (6th Cir. 2005) (holding that plaintiffs had
standing based on an “increased risk” of harm from a medical device).
ii. 2021 Non-Enforcement Decision
The Medical Organizations and Doctors have also shown that the
2021 Non-Enforcement Decision contributes to their injury. That decision
effectively removes the in-person dispensing requirement, allowing women
to request and take mifepristone without ever going to the doctor’s office.
Evidence was introduced that this change will cause additional severe com-
plications. Among other things, several doctors testified that supervision is
necessary to ensure patients’ safety:
The FDA’s actions harm women, including my patients, be-
cause clinics and physicians prescribing or dispensing chemical
abortion drugs, or websites that provide these drugs through
mail order delivery without any physician involvement, often
underprepare women for the severity and risks of chemical
abortion, and they often provide insufficient or no follow-up
care to those women.
Dr. Skop Declaration ¶ 27; see also Dr. Harrison Declaration ¶ 25 (“Mifepris-
tone and misoprostol are serious drugs that should not be administered with-
out medical supervision. The FDA’s actions to eliminate the necessary su-
pervision of these drugs harms women and obstetrics professionals . . . .”);
cf. Dickerson Declaration ¶ 12 (“[Mifepristone] can now be administered and
dispensed with no in-person examination or oversight by a physician.”).
Doctors also testified that, without in-person examination, the pre-
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* * *
Because we hold that the Medical Organizations and Doctors have as-
sociational standing, we need not consider whether they also have organiza-
_____________________
5
FDA initially appealed that ruling, but the parties dismissed the appeal after FDA
announced that it would decline to enforce the in-person dispensing and prescription re-
quirements. See Am. Coll. of Obstetricians & Gynecologists v. Indiana, No. 20-1784, 2021 WL
3276054 (4th Cir. May 19, 2021).
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tional or third-party standing. See generally ACORN v. Fowler, 178 F.3d 350,
356–57 (5th Cir. 1999); see also All. for Hippocratic Med., 2023 WL 2913725, at
*4 n.4. However, to the extent that it were necessary to consider third-party
standing, it is likely that emergency-room doctors have a sufficiently “close
relationship” with mifepristone patients. Kowalski v. Tesmer, 543 U.S. 125,
130 (2004); cf. June Med. Servs. LLC v. Russo, 140 S. Ct. 2103, 2118–19
(2020), overruled on other grounds, Dobbs v. Jackson Women’s Health Org., 142
S. Ct. 2228 (2022). Indeed, the Court has “long permitted abortion provid-
ers to invoke the rights of their actual or potential patients.” June Med.
Servs., 140 S. Ct. at 2118. We fail to see how this case is materially different.
FDA and Danco deny that third-party standing applies, saying that the
Doctors have a “diametrically opposed” or “antagonistic” relationship with
women experiencing severe complications as a result of taking mifepristone.
FDA Br. at 33; Danco Br. at 32. That is so, Defendants contend, because the
relief the Doctors seek would reimpose certain conditions of using mifepris-
tone. That dubious proposition misunderstands the nature of the would-be
representation. The Doctors pursue third-party standing to represent their
patients’ interest in avoiding or limiting the dangerous side effects that some-
times occur when a woman takes mifepristone.
Although we do not fulsomely consider the issue here, we suspect that
the Doctors—who have provided firsthand care to dozens of mifepristone
patients experiencing acute physical and emotional distress in an emergency
setting—have a relationship with their patients that is more than adequate to
support third-party standing. In many respects, such a relationship may be
closer than those previously recognized by the Supreme Court. June Med.
Servs., 140 S. Ct. at 2118–19; Whole Women’s Health v. Hellerstedt, 136 S. Ct.
2292, 2314 (2016); Gonzales v. Carhart, 550 U.S. 124, 133 (2007).
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ular degree of likelihood of success that is required in every case, the party
seeking a preliminary injunction must establish at least some likelihood of
success on the merits before the court may proceed to assess the remaining
requirements.”). A plaintiff need not prove “its entitlement to summary
judgment in order to establish a substantial likelihood of success on the mer-
its.” Byrum v. Landreth, 566 F.3d 442, 446 (5th Cir. 2009) (internal quota-
tion marks omitted). But at a minimum, it must “present a substantial case
on the merits.” Bryne, 847 F.2d at 1133(quoting Celestine, 823 F.2d at 77).
A. 2000 Approval
As explained above, the Medical Organizations and Doctors have
standing to challenge the 2000 Approval, the 2016 Amendments, and the
2021 Non-Enforcement Decision. Before addressing the merits of the chal-
lenge as to the 2000 Approval, we must consider a threshold issue: whether
that claim was timely asserted.
The Medical Organizations and Doctors admit that they did not raise
a claim as to FDA’s denial of their 2002 citizen petition within six years, as
required for civil actions filed against the United States. 28 U.S.C. § 2401.
They present two independent arguments for why their claim as to the 2000
Approval is nonetheless timely. The motions panel rejected both arguments.
All. for Hippocratic Med., 2023 WL 2913725, at *13–15. We do the same.
1. Reopening Doctrine
First, the Medical Organizations and Doctors point to a judge-made
exception to the statute of limitations called the “reopening doctrine.” Es-
sentially, this doctrine allows a plaintiff to challenge an agency action past the
ordinary timeline if the agency substantively reconsiders the original action
in a subsequent decision. See Nat’l Biodiesel Bd. v. EPA, 843 F.3d 1010, 1017
(D.C. Cir. 2016); Sierra Club v. EPA, 551 F.3d 1019, 1024 (D.C. Cir. 2008).
The Medical Organizations and Doctors maintain that the 2016 Amend-
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6
The Supreme Court has cast some doubt on whether the reopening doctrine is a
legitimate exception to a statute of limitations. See Biden v. Texas, 142 S. Ct. 2528, 2545
n.8 (2022) (“[T]his Court has never adopted [the reopening doctrine], and [it] appears to
be inapposite to the question of final agency action.”). But the parties both assume that the
doctrine is good law in this circuit. And in any event, we need not address that threshold
question because we ultimately conclude that the doctrine does not apply here.
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52 (5th Cir. 2021), rev’d on other grounds, 142 S. Ct. 2528 (2022). Actually,
the opposite is true. FDA took the restrictions imposed in 2000 as a given,
and considered only whether the REMS amendments were safe and effective.
As explained by the motions panel: “FDA’s 2016 decision to relax many of
the REMS was issued in response to Danco’s supplemental application re-
questing as much.” All. for Hippocratic Med., 2023 WL 2913725, at *13.
The Medical Organizations and Doctors respond that the 2016
Amendments were so significant as to constitute a change to the “basic reg-
ulatory scheme,” Nat’l Biodiesel Bd., 843 F.3d at 1017, thereby constructively
reopening the 2000 Approval. It is certainly true that the amendments mean-
ingfully altered the conditions under which mifepristone is prescribed and
taken. But a regulatory amendment, even a major one, is insufficient to sat-
isfy the reopening doctrine. Nat. Res. Def. Council, Inc. v. EPA, 571 F.3d 1245,
1265–66 (D.C. Cir. 2009); see also Nat’l Ass’n of Reversionary Prop. Owners v.
Surface Transp. Bd., 158 F.3d 135, 144–46 (D.C. Cir. 1998); United Transp.
Union-Ill. Legis. Bd. v. Surface Transp. Bd., 132 F.3d 71, 76 (D.C. Cir. 1998)
(Ginsburg, J.). To meet this high bar and trigger the reopening doctrine, the
amendment must fundamentally alter the nature of the regulation such that
it “could not have been reasonably anticipated.” Env’t Def. v. EPA, 467 F.3d
1329, 1334 (D.C. Cir. 2006).
The 2016 Amendments do not clear that bar. They do not alter
FDA’s basic assumption that mifepristone is safe and effective, subject to
certain conditions for use. To be sure, the amendments put the public on
notice of a significant change in the degree of mifepristone’s availability and
restriction. Disagreement with that decision would support challenging the
new amendments—and that is exactly what the Medical Organizations did.
But as to mifepristone’s approval per se, the 2016 Amendments tell the public
nothing they did not already know. As before, FDA approved a drug that
chemically induces abortion, with the knowledge that the drug causes medi-
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the 2021 Petition Denial reevaluated FDA’s decision in 2000 to approve mif-
epristone. The reopening doctrine therefore does not permit the Medical
Organizations and Doctors to challenge the 2000 Approval after the pre-
scribed limitations period.
2. Equitable Tolling
The Medical Organizations and Doctors also point to equitable tolling
as a justification for considering the 2000 Approval claim even though it is
untimely. But that is a very narrow exception. See Jones v. Lumpkin, 22 F.4th
486, 490 (5th Cir. 2022) (reiterating that equitable tolling “is warranted in
only ‘rare and exceptional circumstances’”) (quoting Davis v. Johnson, 158
F.3d 806, 811 (5th Cir. 1998)). It applies only if the plaintiff satisfies two con-
ditions: “(1) that he has been pursuing his rights diligently, and (2) that some
extraordinary circumstance stood in his way and prevented timely filing.”
Menominee Indian Tribe of Wis. v. United States, 577 U.S. 250, 255 (2016) (ci-
tation omitted).
Supposing that the Medical Organizations and Doctors could meet
the first condition, they cannot meet the second. This court has stressed that
equitable tolling does not apply if the party seeking its benefit could have
complied with the relevant deadline. Jones, 22 F.4th at 490 (“[A] peti-
tioner’s failure to satisfy the statute of limitations must result from external
factors beyond his control; delays of the petitioner’s own making do not qual-
ify.”) (quoting In re Wilson, 442 F.3d 872, 875 (5th Cir. 2006)). Here, the
Medical Organizations and Doctors offer no reason why they could not have
filed their lawsuit within the six-year limitations period. See All. for Hippo-
cratic Med., 2023 WL 2913725, at *15 (explaining that FDA’s delay in ruling
on the 2002 Citizen Petition “had no impact on the length of the statute-of-
limitations period or plaintiffs’ capacity to challenge the 2016 Petition De-
nial”). Their failure to do so forecloses any possibility of relief.
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* * *
For the reasons stated above, we conclude that the claim as to the
2000 Approval is untimely. Consequently, the Medical Organizations and
Doctors are not likely to succeed on that claim. And that means that we must
vacate the component of the district court’s order that stays the 2000 Ap-
proval. Willey v. Harris Cnty. Dist. Att’y, 27 F.4th 1125, 1129 (5th Cir. 2022).
B. 2016 Amendments
In addition to the 2000 Approval claim, which is not likely to succeed,
the Medical Organizations and Doctors challenge two other actions taken by
FDA: the 2016 Amendments to the mifepristone REMS and the 2021 deci-
sion to not enforce regulations requiring in-person prescription. The parties
agree that the claims as to the 2016 Amendments and the 2021 Non-Enforce-
ment decision are timely, so we proceed to the merits.
The Medical Organizations and Doctors ground their claims in the
Administrative Procedure Act. That law requires federal courts to “hold un-
lawful and set aside agency action, findings, and conclusions found to be ar-
bitrary, capricious, an abuse of discretion, or otherwise not in accordance
with the law.” 5 U.S.C. § 706(2)(A). The Supreme Court has explained that
the “arbitrary-and-capricious standard requires that agency action be reason-
able and reasonably explained.” FCC v. Prometheus Radio Project, 141 S. Ct.
1150, 1158 (2021). That standard of review is “deferential,” id., but “not
toothless.” Sw. Elec. Power Co. v. EPA, 920 F.3d 999, 1013 (5th Cir. 2019).
On the contrary, our review is “searching and careful.” Univ. of Texas
M.D. Anderson Cancer Ctr. v. U.S. Dep’t of Health and Hum. Servs., 985 F.3d
472, 475 (5th Cir. 2021) (quoting Marsh v. Or. Nat. Res. Council, 490 U.S.
360, 378 (1989)). Above all, an agency must “examine the relevant data and
articulate a satisfactory explanation for its action including a ‘rational con-
nection between the facts found and the choice made.’” Motor Vehicle Mfrs.
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Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quoting Bur-
lington Truck Lines v. United States, 371 U.S. 156, 168 (1962)). An agency
violates these rules where it “entirely fail[s] to consider an important aspect
of the problem,” or offers “an explanation for its decision that runs counter
to the evidence before the agency, or is so implausible that it could not be
ascribed to a difference in view or the product of agency expertise.” Id.; see
also Michigan v. EPA, 576 U.S. 743, 752 (2015); Mexican Gulf Fishing Co. v.
U.S. Dep’t of Com., 60 F.4th 956, 971 (5th Cir. 2023); Sw. Elec. Power Co.,
920 F.3d at 1018–19 (explaining that courts must set aside agency action
where there are “shortcomings in the agency’s explanations”).
With those standards in mind, we first address the 2016 Amendments
and hold that the Medical Organizations and Doctors are substantially likely
to succeed on the merits of that claim. Byrne, 847 F.3d at 1133. That is so for
two instances of the same defect: failing to consider an important aspect of
the problem. Michigan, 576 U.S. at 752; State Farm, 463 U.S. at 43.
First, FDA did not consider the cumulative effect of the 2016 Amend-
ments. Those changes include: increasing the maximum gestational age from
forty-nine days to seventy days; allowing non-physicians to prescribe mife-
pristone; removing the requirement that the administration of misoprostol
and the subsequent follow-up appointment be conducted in person; eliminat-
ing prescribers’ obligation to report non-fatal adverse 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). FDA Summary Review of 2016 Amendments at 2.
FDA admits that none of the studies it relied on examined the effect
of implementing all of those changes together. It studied the amendments
individually. FDA Medical Review of 2016 Amendments at 32–38 (Mar. 29,
2016) (gestational age); id. at 38–41 (in-person appointments); id. at 43–44
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_____________________
7
According to FDA, the causes of those events are as follows: ongoing pregnancy,
drug intoxication and death, death (unknown cause), sepsis and death, and pulmonary em-
bolism. 2021 Denial Letter at 26.
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time, but FDA concluded that there did not “appear to be a difference in
adverse events when in-person dispensing was and was not enforced.” Id.
Second, FDA considered published literature relating to remote pre-
scription of mifepristone. It determined that those studies were “not incon-
sistent with our conclusion that . . . mifepristone will remain safe and efficacy
will be maintained if the in-person dispensing requirement is removed from
the Mifepristone REMS Program.” Id. at 28. Based on these sources, FDA
concluded that “mifepristone will remain safe and effective if the in-person
dispensing requirement is removed.” Id. at 35.
1. Mootness
Defendants first raise a threshold question: whether the Medical Or-
ganizations and Doctors’ challenge to the 2021 non-enforcement policy is
moot. They contend that the 2023 modification of mifepristone’s REMS su-
persedes the 2021 policy, and also that the prior policy was tied to the Gov-
ernment’s COVID-19 public health emergency, which has since expired. For
these reasons, FDA and Danco say, there is no longer a live dispute as to the
2021 Non-Enforcement Decision.
Neither reason is availing. First, FDA is incorrect to say that it tied
its December 2021 decision not to enforce the in-person dispensing require-
ment to the COVID-19 pandemic. True, FDA cited the pandemic as a justi-
fication for taking the initial action. FDA Letter of April 2021 at 2 (“[FDA]
intends to exercise enforcement discretion during the COVID-19 [pandemic]
with respect to the in-person dispensing requirement of the Mifepristone
REMS Program . . . .”). But when FDA “directed mifepristone’s sponsors
to submit a proposed REMS modification,” several months later, it did so
without regard to pandemic conditions. FDA Br. at 11; see 2021 Denial Letter
at 6, 25–26. FDA simply did not tether its action in December of 2021 to the
continued existence of the public health emergency.
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to perhaps the best source of data: the prescribers. The agency is responsible
for its own inability to obtain probative data; it cannot then cite its lack of
information as an argument in favor of removing further safeguards. As the
motions panel aptly put it: “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.” All. for Hippocratic Med., 2023 WL 2913725, at *17.
Moreover, considerable evidence shows that FAERS data is insuffi-
cient to draw general conclusions about adverse events. Indeed, in describing
the database, FDA itself recognizes that “FAERS data cannot be used to cal-
culate the incidence of an adverse event or medication error in the U.S. pop-
ulation.” FDA admits that FAERS reporting is purely voluntary, FDA Br.
at 53; consequently, many adverse events will go unreported.
For example, one doctor testified that she obtained adverse-event data
from one provider (Planned Parenthood) and compared it to FAERS data for
the same time period. For 2010, the provider reported 1,530 adverse events,
whereas FAERS reported only 664 events for all providers nationwide. Dr.
Harrison Declaration ¶ 17; see also id. (“These discrepancies render FAERS
inadequate to evaluate the safety of mifepristone abortions.”).
In addition, the Doctors introduced evidence that many physicians do
not use FAERS, either because they are not aware of the system or because
they believe that using the system is difficult, and takes time away from their
ordinary medical practice:
Many doctors likely do not know about the need to report ad-
verse events related to chemical abortion to the FDA. Simi-
larly, many doctors likely do not know how to report adverse
events. . . . I personally know of practitioners . . . who have
tried to report adverse events related to chemical abortion
drugs to the FDA. The process is complicated, cumbersome,
and time-consuming. The adverse event reporting require-
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pristone would still be safe and effective even with a relaxed in-person dis-
pensing requirement,” Danco Br. at 48, but that is not what FDA said in
2021. On the contrary, FDA candidly acknowledged that the literature was
only “not inconsistent with [its] conclusion.” 2021 Denial Letter at 28. In
other words, the studies neither confirmed nor rejected the idea that mife-
pristone would be safe if the in-person dispensing requirement were re-
moved. In discussing the various studies, FDA recognized many significant
limitations:
We note that the ability to generalize the results of these stud-
ies to the United States population is hampered by differences
between the studies with regard to pre-abortion care (e.g., tel-
emedicine versus in-person). In addition, the usefulness of the
studies is limited in some instances by small sample sizes and
lack of follow-up information on outcomes with regard to both
safety and efficacy.
There are also factors which complicate the analysis of the dis-
pensing element alone. Some of these factors are: (1) only a
few studies have evaluated alternatives for in-person dispens-
ing of mifepristone in isolation (for example, most studies on
mail dispensing of mifepristone also include telemedicine con-
sultation); and (2) because most serious adverse events with
medical abortion are infrequent, further evaluation of changes
in dispensing would require studies with larger numbers of par-
ticipants. We did not find any large clinical studies that were
designed to collect safety outcomes in healthcare systems sim-
ilar to the United States.
Id. Given those limitations, FDA concluded that the studies were “not ade-
quate on their own to establish the safety of the model of dispensing mifepris-
tone by mail.” Id. at 35.
Especially in light of the unreliability of the adverse-event data, it was
not reasonable for FDA to depend on the published literature to support its
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decision. Courts must set aside agency action where there are “shortcomings
in the agency’s explanations” or where “[n]o record evidence affirmatively
makes” the agency’s case. Sw. Elec. Power Co., 920 F.3d at 1018–19; see also
State Farm, 463 U.S. at 56 (“While [an] agency is entitled to change its view
. . . it is obligated to explain its reasons for doing so.”). That is the case here.
In the face of concededly limited data, and lacking more probative in-
formation from prescribers, FDA fell back on studies that were merely “not
inconsistent” with its intended conclusion. It did not refer to any literature
that affirmatively supported the notion that mifepristone would remain safe
and effective even without the in-person dispensing requirement. We con-
clude that the Medical Organizations and Doctors are likely to succeed in
showing that this action violated the APA.8
IV. Irreparable Harm and Balance of the Equities
We now proceed to the remaining steps of the preliminary-injunction
analysis. First, we ask if the Medical Organizations and Doctors are likely to
sustain irreparable harm absent an injunction. Garcia, 910 F.3d at 190. If so,
we then balance the equities and consider whether an injunction serves the
public interest. Winter, 555 U.S. at 20. And where the government appeals
an injunction, its interests “merge” with the public interest. Tex. Democratic
Party v. Abbott, 961 F.3d 389, 412 (5th Cir. 2020) (quoting Veasey v. Abbott,
870 F.3d 387, 391 (5th Cir. 2017)).
We have already concluded that the Medical Organizations and Doc-
tors are likely to sustain injury; now we need only determine whether the
threatened injuries are irreparable. They are. An irreparable harm is one
_____________________
8
Given this holding, we do not consider the Medical Organizations and Doctors’
independent argument that the 2021 Non-Enforcement Decision violates the Comstock
Act of 1873.
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health risks to certain women, including those who use the drug to manage
miscarriage. Br. of American College of Obstetricians and Gynecologists et
al. at 21–26; Br. of Physicians for Reproductive Health at 18–27; Br. of Over
200 Reproductive Health, Rights, and Justice Organizations at 14–25; Br. of
Doctors for America et al. at 14–23; Br. of Advocates for Survivors of Inti-
mate Partner Violence at 18–26. Other amici argue that “disrupting access
to mifepristone” would burden state and local health-care systems. Br. of
New York et al. at 4; see also Br. of Local Governments at 24–26; Br. of the
City of New York et al. at 8–31; Br. of Medical Students for Choice at 3–22.
And still other amici say that staying FDA’s approval of mifepristone would
destabilize the pharmaceutical industry, especially research-and-develop-
ment sections. Br. of Pharmaceutical Companies, Executives, and Investors
at 3–4; Br. of Pharmaceutical Research and Manufacturers of America et al.
at 22–26; Br. of Patient and Provider Advocacy Organizations at 9–20.
These concerns are not insignificant. But they apply primarily (if not
wholly) to the challenge to the 2000 Approval—a claim that we have con-
cluded is not likely to succeed. All. for Hippocratic Med., 2023 WL 2913725,
at *20 (“[T]hese concerns center on the district court’s removal of mifepris-
tone from the market. [Defendants] make no arguments as to why the 2016
Major REMS Changes, the 2019 Generic Approval, or the 2021 and 2023
Mail Order Decisions are similarly critical to the public . . . .”). Insofar as
these concerns translate to the 2016 Amendments and 2021 Non-Enforce-
ment Decision, they are lessened by the fact that mifepristone would remain
available under the 2011 REMS, as would options for surgical abortion.
And of course, the public interest is disserved by a drug that does not
afford adequate protections to its users. See Deerfield Med. Ctr. v. City of
Deerfield Beach, 661 F.2d 328, 338 (5th Cir. 1981); Hill Dermaceuticals, Inc. v.
FDA, 524 F. Supp. 2d 5, 12 (D.D.C. 2007) (“[T]he public interest weighs
strongly in favor of preventing unsafe drugs from entering the market.”). To
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be clear, the evidence does not show that mifepristone is unsafe in all appli-
cations. But on this record and at this preliminary stage, the Medical Organ-
izations and Doctors have made a substantial showing that the 2016 Amend-
ments and 2021 Non-Enforcement Decision were taken without sufficient
consideration of the effects those changes would have on patients.
Weighing all of these considerations, we conclude that the balance of
the equities favors the Medical Organizations and Doctors. They face a sub-
stantial risk of irreparable harm to their medical practice, mental and emo-
tional health, and conscience. The limited relief affirmed by our judgment
threatens neither FDA nor Danco with substantial harm. Nor does it offend
the public interest. The Medical Organizations and Doctors therefore satisfy
the remaining preliminary-injunction factors. Winter, 555 U.S. at 20.
V. Form of Relief
Finally, FDA and Danco challenge the form of the relief entered by
the district court—a stay of the actions’ effective dates. FDA argues that the
Medical Organizations and Doctors were required to first seek an adminis-
trative stay, but failed to do so. See 21 C.F.R. § 10.45(c) (“A request that
administrative action be stayed must first be the subject of an administrative
decision based upon a petition for stay of action . . . before a request is made
that a court stay the action.”). It also contends that § 705 authorizes only
requests made at the same time the challenged action is enacted. Here, by
contrast, the Medical Organizations and Doctors seek a stay years after the
relevant policies took effect. And Danco maintains that injunctive relief is
categorically unavailable, reasoning that if the Medical Organizations and
Doctors prevailed, they would only be entitled to remand without vacatur.
We hold that the district court entered an appropriate form of relief.
To begin, consider the nature of a “stay” under § 705. In the same way that
a preliminary injunction is the temporary form of a permanent injunction, a
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FDA or Danco took some action to violate it. But of course, we have abso-
lutely no reason to believe that such a motion would be necessary. And we
should reiterate that the Supreme Court’s stay of the district court’s order
will remain in effect pending disposition of any petition for certiorari.
Turning to Danco’s objection to a stay, we do not agree that the Med-
ical Organizations and Doctors will be limited to remand without vacatur if
they obtain a favorable judgment. “[V]acatur of an agency action is the de-
fault rule in this Circuit.” Cargill v. Garland, 57 F.4th 447, 472 (5th Cir.
2023) (en banc) (plurality op.); Data Mktg. P’ship, 45 F.4th at 859; accord
United Steel v. Mine Safety & Health Admin., 925 F.3d 1279, 1287 (D.C. Cir.
2019) (“The ordinary practice is to vacate unlawful agency action.”). Given
that presumption, remand without vacatur is appropriate only if “there is at
least a serious possibility that the agency will be able to substantiate its deci-
sion given an opportunity to do so.” Texas v. United States, 50 F.4th 498, 529
(5th Cir. 2022) (quoting Texas Assn. of Mfrs. v. U.S. Consumer Prod. Safety
Comm’n, 989 F.3d 368, 389–90 (5th Cir. 2021)); accord Radio-Television News
Dirs. Ass’n v. FCC, 184 F.3d 872, 888 (D.C. Cir. 1999).
Remand without vacatur is likely not appropriate because “it is far
from certain” that FDA could cure its mistakes with further consideration.
Env’t Def. Fund v. FERC, 2 F.4th 953, 976 (D.C. Cir. 2021). FDA erred by
failing to consider the cumulative effects of the 2016 Amendments on mife-
pristone’s safety and by disregarding the lack of recent data on adverse events
when removing the in-person dispensing requirement. The record does not
tend to show that FDA would have arrived at the same decision if it had con-
sidered those things. See Oglala Sioux Tribe v. U.S. Nuclear Regul. Comm’n,
896 F.3d 520, 536 (D.C. Cir. 2018) (declining to remand without vacatur be-
cause of the “seriousness” of the action’s “deficiency”); Pollinator Steward-
ship Council v. EPA, 806 F.3d 520, 532 (9th Cir. 2015) (same); cf. Sierra Club
v. FERC, 68 F.4th 630, 652 (D.C. Cir. 2023) (remanding without vacatur be-
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cause it was possible that FERC could “adequately explain its decision” if
given another opportunity). If the Medical Organizations and Doctors suc-
ceed on the merits, it is likely that the default remedy—vacatur—will be ap-
propriate. And the temporary version of vacatur is a stay.
We are also unpersuaded by FDA’s contentions. First, FDA argues
Medical Organizations and Doctors cannot seek a stay before the district
court because they failed to seek one from the agency. But the record shows
that FDA would have denied any request for an administrative stay. See Gulf
Restoration Network v. Salazar, 683 F.3d 158, 176 (5th Cir. 2012). FDA une-
quivocally denied the 2019 citizen petition, rejecting the premise that 2016
Amendments made mifepristone less safe. It discussed the 2021 Non-En-
forcement Decision in the same document, and then formalized the policy in
2023. These pronouncements show that FDA was committed to implement-
ing these changes, and foreclose any notion that the agency would have
granted an administrative stay. Tesoro Refin. & Mktg. Co. v. FERC, 552 F.3d
868, 874 (D.C. Cir. 2009) (explaining that the exhaustion requirement does
not apply “when resort to administrative remedies [would be] clearly use-
less”) (citations omitted). That FDA denied a request to stay the 2000 Ap-
proval further aids this conclusion. See 2016 Denial Letter at 32 (“As de-
scribed above, we are denying your Petition. Therefore, your request for a
stay pending final action on your Petition is moot.”).
Second, FDA provides no authority for its assertion that § 705 of the
APA limits stays to contemporaneous agency actions. The text does not pro-
vide such a limitation. Instead, it empowers a reviewing court to “issue all
necessary and appropriate process to postpone the effective date of an agency
action or to preserve status or rights pending conclusion of the review pro-
ceedings.” 5 U.S.C. § 705. Circuit courts have interpreted this statute as
providing something akin to the general stay power recognized by Rule 18 of
the Federal Rules of Appellate Procedure, see Ohio v. Nuclear Regul. Comm’n,
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812 F.2d 288, 290 (6th Cir. 1987); In re GTE Serv. Corp., 762 F.2d 1024, 1026
(D.C. Cir. 1985), which weighs against construing § 705 as requiring that a
stay be issued concurrently with an agency action. We are disinclined to
reach a definitive answer on this question, given the cursory treatment by
both parties. But we strongly doubt that § 705 should be read to impose the
limit urged by FDA. Nothing about this argument persuades us that the dis-
trict court abused its discretion by entering this particular form of relief.
VI. Conclusion
For the foregoing reasons, the stay order entered by the district court
is VACATED in part and AFFIRMED in part. We vacate the component
of the order that stayed the effective date of the 2000 Approval and the 2019
Generic Approval. Mifeprex will remain available under the safety re-
strictions that were in effect prior to 2016. Generic mifepristone will also
remain available under those same restrictions.
We affirm the portions of the stay order regarding the 2016 Amend-
ments and the 2021 Non-Enforcement Decision. In loosening mifepristone’s
safety restrictions, FDA failed to address several important concerns about
whether the drug would be safe for the women who use it. It failed to consider
the cumulative effect of removing several important safeguards at the same
time. It failed to consider whether those “major” and “interrelated”
changes might alter the risk profile, such that the agency should continue to
mandate reporting of non-fatal adverse events. And it failed to gather evi-
dence that affirmatively showed that mifepristone could be used safely with-
out being prescribed and dispensed in person.
At this preliminary stage, the Medical Organizations and Doctors
have made a substantial showing that the 2016 Amendments and the 2021
Non-Enforcement Decision violate the APA. Accordingly, those actions will
be stayed pending final judgment. But to repeat, all of this relief is subject to
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the Supreme Court’s prior order, which stays the district court’s order until
the disposition of any petition for certiorari.
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[A] partner of mine and I cared for another patient who also
suffered complications from chemical abortion. I had taken
care of her when she was hospitalized . . . at 9 weeks 5 days
gestation. She was discharged home in good condition after
significant improvement with medications. During that
hospital stay, she had an ultrasound, which showed a healthy
pregnancy with no apparent complications and a strong fetal
heart rate. . . . Approximately one week after her discharge, the
patient presented back at our emergency room with heavy
vaginal bleeding and unstable vital signs as a result of taking
chemical abortion drugs.
Dr. Jester put Plaintiffs’ interest in unborn life this way: “When my
patients have chemical abortions, I lose the opportunity . . . to care for the
woman and child through pregnancy and bring about a successful delivery of
new life.” Dr. Jester Declaration ¶ 19. See Ctr. for Biological Diversity v. EPA,
937 F.3d 533, 541 (5th Cir. 2019) (recognizing judicially cognizable injury
where plaintiff experiences aesthetic harm at work).
The Supreme Court has recognized that “the person who observes or
works with a particular animal threatened by a federal decision is facing
perceptible harm, since the very subject of his interest will no longer exist.”
Lujan, 504 U.S. at 566. Every circuit, including our own, has concluded that,
when a federal agency authorizes third parties to harm flora or fauna that a
plaintiff intends to view or study, that satisfies all of the requirements for
Article III standing. See, e.g., Housatonic River Initiative v. EPA, _ F.4th_,
2023 WL 4730222, *9 (1st Cir. July 25, 2023); NRDC v. FAA, 564 F.3d 549,
555 (2nd Cir. 2009); Sierra Club v. EPA, 972 F.3d 290, 298–99 (3rd Cir.
2020); Sierra Club v. Dep’t of the Interior, 899 F.3d 260, 282–85 (4th Cir.
2018); Gulf Restoration Network v. Salazar, 683 F.3d 158, 166–68 (5th Cir.
2012); Meister v. Dep’t of Agriculture, 623 F.3d 363, 369–70 (6th Cir. 2010);
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Am. Bottom Conservancy, 650 F.3d at 656–60; Sierra Club v. Army Corps of
Engineers, 645 F.3d 978, 985–86 (8th Cir. 2011); Cottonwood Env’t Law Ctr.
v. Forest Service, 789 F.3d 1075, 1079–83 (9th Cir. 2015); WildEarth
Guardians v. EPA, 759 F.3d 1196, 1206–07 (10th Cir. 2014); Black Warrior
Riverkeeper, Inc. v. Army Corps of Engineers, 781 F.3d 1271, 1280–83 (11th Cir.
2015); Ctr. for Biological Diversity v. EPA, 56 F.4th 55, 66–69 (D.C. Cir.
2022).
In all of these cases, a federal agency approved some action—such as
developing land or using pesticides—that threatens to destroy the animal or
plant life that plaintiffs wish to enjoy. This injury is redressable by a court
order holding unlawful and setting aside the agency approval.
And so too here. The FDA has approved the use of a drug that
threatens to destroy the unborn children in whom Plaintiffs have an interest.
And this injury is likewise redressable by a court order holding unlawful and
setting aside approval of that abortifacient drug.
I see no basis for allowing Article III standing based on aesthetic injury
when it comes to animals and plants—but not unborn human life.
II.
I now turn specifically to Plaintiffs’ challenge to the FDA’s 2000
approval of mifepristone. The FDA contends that the challenge is untimely.
But it concedes that “the well-established reopening doctrine” is binding
precedent in this circuit. Texas v. Biden, 20 F.4th 928, 951 (5th Cir. 2021),
rev’d on other grounds, 142 S. Ct. 2528 (2022). And it accepts that, under that
doctrine, the clock for an APA claim restarts when an agency revises its
regulations in a manner that “significantly alters the stakes of judicial
review.” Sierra Club v. EPA, 551 F.3d 1019, 1025 (D.C. Cir. 2008). See also
NRDC v. EPA, 571 F.3d 1245, 1266 (D.C. Cir. 2009) (same).
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That standard is easily met here. It seems obvious that the 2016 and
2021 revisions significantly altered the regulatory landscape. Indeed, the
FDA recently told the Supreme Court that setting aside those revisions
would “upend the regulatory regime for mifepristone” and “unleash[]
regulatory chaos.” Application to Stay the Order Entered by the United
States District Court for the Northern District of Texas and for An
Administrative Stay, 2023 WL 3127519, at *2–3, FDA v. Alliance for
Hippocratic Medicine, 143 S. Ct. 1075 (2023). If switching from the 2016/2021
regime to the 2000-era regime significantly alters the “basic regulatory
scheme,” NRDC, 571 F.3d at 1266, then surely the reverse does, too.
So the district court was correct that “FDA’s 2016 and 2021 Changes
. . . significantly departed from the agency’s original approval of the abortion
regimen. FDA . . . altered its original decision by removing safeguards and
changing the regulatory scheme for chemical abortion drugs.” Alliance for
Hippocratic Medicine v. FDA, _ F. Supp. 3d _, 2023 WL 2825871, at *11 (N.D.
Tex. Apr. 7, 2023). As a result, the 2016 and 2021 revisions triggered the
reopening doctrine. Plaintiffs’ challenge to the 2000 approval is timely.
A.
Challenges to federal administrative action are subject to a six-year
statute of limitations. See 28 U.S.C. § 2401(a). This six-year clock initially
started ticking in March 2016, when the FDA denied Plaintiffs’ 2002 petition
objecting to the 2000 approval. See 21 C.F.R. § 10.45(d). Absent reopening,
Plaintiffs’ challenge to the 2000 approval would be barred by this six-year
statute of limitations, because Plaintiffs filed this suit after March 2022.
But under the administrative reopening doctrine, the agency can
restart the clock in two ways: (1) if “the agency opened the issue up anew,
and then reexamined and reaffirmed its prior decision,” NRDC, 571 F.3d at
1265 (cleaned up), or (2) “if the revision of accompanying regulations
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‘significantly alters the stakes of judicial review’ as the result of a change that
‘could have not been reasonably anticipated,’” id. at 1266 (quoting Sierra
Club v. EPA, 551 F.3d 1019, 1025 (D.C. Cir. 2008)).
This second type of reopening is called “constructive reopening.” Id.
I would hold that constructive reopening applies here, rendering Plaintiffs’
challenge to the 2000 approval timely.
“A constructive reopening occurs if the revision of . . . regulations
‘significantly alters the stakes of judicial review.’” Sierra Club, 551 F.3d at
1025 (quoting Kennecott Utah Copper Corp. v. Dep’t of the Interior, 88 F.3d
1191, 1227 (D.C. Cir. 1996)). The paradigmatic example of this is when the
agency unexpectedly removes “necessary safeguards,” thus giving “new
significance” to the original action. Id. at 1025–26.
In Sierra Club, the EPA’s initial 1994 rule exempted pollutant-
emitting plants from emission limits when the plants were starting up,
shutting down, or malfunctioning. See id. at 1022. To be eligible for the
exemption, a plant had to show it was doing its “reasonable best” to stay
under the emission limits. Id.
But in the early 2000s, new EPA rules removed this “reasonable best”
requirement. To qualify for the exemption, plants no longer had to show they
were doing their best to limit emissions. See id. at 1023. This elimination of
safeguards “significantly altered the stakes of judicial review” for the
environmental plaintiffs, thereby triggering reopening. Id. at 1025 (cleaned
up).
The same is true here. Just as the EPA initially authorized emissions
under certain safeguards to minimize harm, the FDA initially authorized
mifepristone under certain safeguards to minimize harm. Remove these
safeguards, and you’ve significantly altered the stakes of judicial review. The
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even if the ancien régime of 2000 “may not have been” on its own. Kennecott
Utah Copper Corp., 88 F.3d at 1227.
Indeed, the FDA itself has characterized the switch from one regime
to the other as a “sea change.” NRDC, 571 F.3d at 1266. Under the limited
stay issued by a previous panel of our court, the FDA was required to return
to the regulatory regime that existed between 2000 and 2016. See Alliance,
2023 WL 2913725, at *1. The FDA vigorously protested the substitution of
the 2016 and 2021 regime with the original 2000 regulations. It urged the
Supreme Court to restore the 2016 and 2021 regulations by granting a stay of
the entire district court order. Switching back to the 2000 restrictions, it
argued, would “upend the regulatory regime for mifepristone, with sweeping
consequences for the pharmaceutical industry, women who need access to
the drug, and FDA’s ability to implement its statutory authority.” FDA Stay
Application, 2023 WL 3127519, at *3. It would “unleash[] regulatory chaos”
for “patients, prescribers, and the health care delivery system.” Id. at *2, *4.
In sum, the FDA insisted that switching from one regime to the other
would “change the basic regulatory scheme.” NRDC, 571 F.3d at 1266. It
claimed that switching from the 2016/2021 scheme back to the 2000 scheme
counts as a sweeping change with huge stakes. The same must be true of
switching from 2000 to 2016/2021—that too “upend[ed] the regulatory
regime for mifepristone, with sweeping consequences.”
Plaintiffs’ challenge to the 2000 approval of mifepristone is timely.
III.
Turning to the merits, I would hold the 2000 approval unlawful. It’s
a longstanding principle that agencies must follow their own regulations. See
Arizona Grocery Co. v. Atchison, Topeka & Santa Fe Ry. Co., 284 U.S. 370, 386
(1932) (agency’s legislative rule “has the force of a statute”); Fort Stewart
Schools v. FLRA, 495 U.S. 641, 654 (1990) (“It is a familiar rule of
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administrative law that an agency must abide by its own regulations.”). The
FDA violated that principle when it approved mifepristone under Subpart
H—as even the drug’s sponsor, the Population Council, admitted in 2000.
A.
Subpart H authorizes the FDA to approve only those drugs that treat
“serious or life-threatening illnesses.” 21 C.F.R. § 314.500. See also 57 Fed.
Reg. 58958 (Dec. 11, 1992) (Accelerated Approval of New Drugs for Serious
or Life-Threatening Illnesses). It “applies to certain new drug products that
have been studied for their safety and effectiveness in treating serious or life-
threatening illnesses and that provide meaningful therapeutic benefit to
patients over existing treatments.” 21 C.F.R. § 314.500 (emphasis added).
Pregnancy is not an illness. An “illness” is a “[b]ad or unhealthy
condition of the body.” Oxford English Dictionary (2nd ed. 1989),
s.v. illness, sense 3. It’s a “disease, ailment, sickness, malady.” Id.
Pregnancy, by contrast, is when a woman is “with child.” Oxford
English Dictionary, s.v. pregnancy, sense II.3.a.
Pregnancy is not a bad or unhealthy condition of the body—it’s a
natural consequence of a healthy and functioning reproductive system. See,
e.g., Gudenkauf v. Stauffer Communications, Inc., 922 F. Supp. 465, 473 (D.
Kan. 1996) (“Being the natural consequence of a properly functioning
reproductive system, pregnancy cannot be called an impairment.”); Lacount
v. South Lewis, 2017 WL 319217, at *3 (N.D. Okla. Jan. 20, 2017) (same);
Whitaker v. Bosch Braking Sys. Div. of Robert Bosch Corp., 180 F. Supp. 2d 922,
928 (W.D. Mich. 2001) (pregnancy is “not a serious health condition”);
Brennan v. National Telephone Directory Corp., 850 F. Supp. 331, 343 (E.D.
Pa. 1994) (“it cannot be said that [a woman’s] reproductive system is
negatively affected” by pregnancy).
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The FDA notes that its statutory authority to approve drugs comes
from 21 U.S.C. § 355. But that doesn’t change the fact that the regulatory
path it chose was Subpart H. Section 355 gives the FDA the power to
approve drugs. And the agency exercised that power when it promulgated
Subpart H. The FDA did not have to adopt Subpart H in the first place. But
once it did, it was bound to follow it.
D.
As a final defense, the FDA contends that subsequent events cured
any defects in its initial 2000 approval. Specifically, the FDA points to the
2007 Food and Drug Administration Amendments Act and to the agency’s
2011 Risk Evaluation and Mitigation Strategy. It claims that both authorities
render any faults with the 2000 approval irrelevant.
First, the FDA argues that the 2007 Act “deemed” mifepristone to
be approved. But the statutory text contradicts this argument. The Act
makes clear that “[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 . . . if there are in effect on the effective date of this Act elements to
assure safe use . . . required under [21 C.F.R. §] 314.520.” Food and Drug
Administration Amendments Act of 2007, Pub. L. No. 110-85, tit. IX
§ 909(b)(1), 121 Stat. 823, 950 (emphasis added).
So the Act itself did not approve any drugs. It only approved any risk
evaluation and mitigation strategies for those drugs that the FDA had already
validly approved under § 314.520 of Subpart H. And as explained above, the
FDA’s attempted approval was invalid because it failed to comply with
Subpart H. The FDA’s reliance on the 2007 Act is entirely circular—it only
works if you assume that the agency had already validly approved
mifepristone in the first place.
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The FDA also points to its 2011 Risk Evaluation and Mitigation
Strategy, arguing that this too re-approved mifepristone and cured any
defects in its 2000 approval. It did not. To the contrary, the 2011 REMS
letter made clear that the agency continued to rely on Subpart H for its
approval of mifepristone—that it “is approved under the provisions of 21
CFR 314.520 (Subpart H).” FDA Supplemental Approval Letter to Danco
Labs at 1. Moreover, the letter only approved the Risk Evaluation and
Mitigation Strategy proposed in Danco’s 2008 Supplemental Application—
it did not re-approve the drug apart from Subpart H. In fact, the letter
recognized the need for continued compliance with the conditions “required
by” Subpart H. Id. at 2 (citing 21 C.F.R. § 314.550).
***
For these reasons, I would find that Plaintiffs are likely to succeed on
the merits of their challenge to the 2000 approval. Plaintiffs also satisfy the
remaining factors for equitable relief. The harm to Plaintiffs is irreparable.
No relief at law can adequately address Plaintiffs’ conscience injuries. See
BST Holdings, L.L.C. v. OSHA, 17 F.4th 604, 618 (5th Cir. 2021). Nor can
money damages remedy the destruction of life. Cf. Amoco Production Co. v.
Village of Gambell, 480 U.S. 531, 545 (1987). The balance of equities and
public interest also favor Plaintiffs. Plaintiffs seek to vindicate the “national
policy of discountenancing abortion as inimical to the national life,” as
reflected in Congressional enactments including the Comstock Act. Bours v.
United States, 229 F. 960, 964 (7th Cir. 1915). See 18 U.S.C. § 1461; id.
§ 1462. Cf. 19 U.S.C. § 1305(a).
IV.
With respect to the FDA’s 2016 and 2021 revisions, I agree with the
majority’s thoughtful analysis explaining how the FDA “entirely failed to
consider an important aspect of the problem” in 2016 and “offered an
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explanation for its decision that runs counter to the evidence before the
agency” in 2021. State Farm, 463 U.S. at 43. The agency thus acted
arbitrarily in violation of the APA.
I write separately to add that the 2021 revisions violate the Comstock
Act, 18 U.S.C. §§ 1461–62, and are “not in accordance with law” for that
reason as well. 5 U.S.C. § 706(2)(A).
A.
The text of the Comstock Act prohibits the mailing of abortifacient
drugs:
Every article or thing designed, adapted, or intended for
producing abortion . . . and [e]very article, instrument,
substance, drug, medicine, or thing which is advertised or
described in a manner calculated to lead another to use or apply
it for producing abortion . . . [i]s declared to be nonmailable
matter and shall not be conveyed in the mails or delivered from
any post office or by any letter carrier.
18 U.S.C. § 1461. This language derives from the original 1873 Comstock
Act. See Act of Mar. 3, 1873, ch. 258, § 2, 17 Stat. 598, 599 (“No . . . article
or thing designed or intended for the . . . procuring of abortion . . . shall be
carried in the mail.”).
Congress later extended the mailing prohibition to cover common
carriers as well. See Act of Feb. 8, 1897, ch. 172, 29 Stat. 512, 512 (“[I]t shall
be unlawful for any person to deposit with any express company or other
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18 U.S.C. § 1462.
In 1996, Congress added “interactive computer service” to the
Comstock Act. See Telecommunications Act of 1996, Pub. L. No. 104-104,
§ 507(a), 110 Stat. 56, 137. So it’s also illegal to use the internet to ship or
receive abortifacients. See 18 U.S.C. § 230(f)(2) (defining “interactive
computer service”); id. § 230(f)(3) (“interactive computer service”
includes “the Internet”); Doe v. MySpace, Inc., 528 F.3d 413, 415 (5th Cir.
2008) (“interactive computer service” includes “a Web site”).
The FDA’s 2021 Mail-Order Decision violates the Comstock Act.
That decision authorizes the dispensing of mifepristone “through the
mail . . . or through a mail-order pharmacy.” FDA Letter to American
College of Obstetricians and Gynecologists at 2 (Apr. 12, 2021). But “us[ing]
the mails for the mailing” of a “drug . . . for producing abortion” is precisely
what the Comstock Act prohibits. 18 U.S.C. § 1461. See Alliance, 2023 WL
2913725, at *20 (“[A] user of those shipping channels violates the plain text
merely by knowingly making use of the mail for a prohibited abortion item.”).
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Next, the FDA claims that the Comstock Act prohibits sending
abortifacients only when they are used in violation of state law. To support
this theory, it relies on a handful of early twentieth century cases outside our
circuit. See Application of the Comstock Act to the Mailing of Prescription Drugs
That Can Be Used for Abortions, 46 Op. O.L.C. _, _ (Dec. 23, 2022)
(collecting cases).
But the earliest case it cites, Bours v. United States, 229 F. 960 (7th
Cir. 1915), rejects the FDA’s position. Bours says that “it is immaterial what
the local statutory definition of abortion is, what acts of abortion are included,
or what excluded.” Id. at 964. Rather, “the word ‘abortion’ in the national
statute must be taken in its general medical sense.” Id. And “[i]ts inclusion
in the statute governing the use of the mails indicates a national policy of
discountenancing abortion as inimical to the national life.” Id. Under Bours,
the Act’s definition of “abortion” excludes “operation[s]” that are
necessary to “save [the mother’s] life.” Id. But anyone who uses the mails
to “destroy[] life” violates the statute. Id.
So the FDA can’t invoke the prior-construction canon. Under that
canon, legislative reenactment of a statute can, under certain conditions,
effectively ratify preexisting, authoritative judicial interpretation of that
statute. But the canon requires robust judicial consensus, such as “uniform
holdings of lower courts.” Scalia & Garner, supra, at 324. See, e.g.,
Armstrong v. Exceptional Child Ctr., Inc., 575 U.S. 320, 330 (2015) (quoting
Bragdon v. Abbott, 524 U.S. 624, 645 (1998)) (canon applies when “judicial
interpretations have settled the meaning of an existing statutory provision”)
(emphasis added); Tex. Dep’t of Housing & Community Affairs v. Inclusive
Communities Project, Inc., 576 U.S. 519, 536 (2015) (“Congress accepted and
ratified the unanimous holdings of the Courts of Appeals.”) (emphasis
added). The FDA can claim no such consensus here. To the contrary, the
circuits were at best split. Bours rejects the FDA’s reading of the statute.
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And the amicus brief from the Ethics and Public Policy Center puts forth a
strong argument that no circuit court adopted the FDA’s reading.
What’s more, Congress certainly knew how to prohibit only those
abortifacients used to violate state law. The Tariff Act of 1930, for example,
prohibits all persons “from importing . . . any drug or medicine or any article
whatever for causing unlawful abortion.” 19 U.S.C. § 1305 (emphasis
added). See also Act of June 17, 1930, ch. 497, tit. III, § 305, 46 Stat. 590, 688
(same). In response, the FDA suggests that it would be irrational for
Congress to target all abortions in the Comstock Act, but only unlawful
abortions in the Tariff Act. But different Congresses can reach different
judgments about how to regulate abortion in different contexts. There’s
nothing irrational about the Congress that enacted the Comstock Act in 1873
making a different judgment from the Congress that enacted the Tariff Act
decades later.
Moreover, Congress has actually considered amending the Comstock
Act to apply only to “illegal abortions”—and chosen not to. In 1978,
Congress rejected a proposed Comstock Act amendment to prohibit the
shipment of “any drug, medicine, article, or thing, with the intent that such
drug, medicine, article, or thing be used to produce an illegal abortion.” H.R.
13959, 95th Cong. § 6702(1)(C)(i) (1978) (emphasis added). See also id.
§ 6701(a)(2) (same). A contemporaneous Congressional report explained:
[R]evised title 18 changes current law by requiring proof that the
relevant material or object to be used to produce an illegal
abortion and that the offender specifically intended the
material object to be so used. . . . [A]n abortion is “illegal” if it
is contrary to the law of the state in which the abortion is
performed.
Report of the Subcommittee on Criminal Justice on Recodification of Federal
Criminal Law, H.R. Rep. No. 95-29, pt. 3, at 42 (1978) (emphasis added).
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Congress could have exempted the FDA generally—or its approval of drugs
specifically—from APA review. See 5 U.S.C. § 701(a)(1) (no APA review
where “statutes preclude judicial review”). But it didn’t—and for
understandable reasons.
Scientists have contributed an enormous amount to improving our
lives. But scientists are human beings just like the rest of us. They’re not
perfect. See, e.g., Whole Woman’s Health v. Paxton, 10 F.4th 430, 464–70 (5th
Cir. 2021) (en banc) (Ho, J., concurring). None of us are. We all make
mistakes.
And the FDA has made plenty. Several of the FDA’s past mistakes
are detailed in the amicus briefs from the United States Medical Association
and the Association of American Physicians and Surgeons Educational
Foundation. I’ll highlight just a few examples here.
Earlier this year, the FDA was forced to pull the drug Makena from
the market. See FDA News Release: FDA Commissioner and Chief Scientist
Announce Decision to Withdraw Approval of Makena (Apr. 6, 2023). The FDA
had approved this drug in 2011 to treat premature birth, using Subpart H. See
Frank J. Sasinowski & Alexander J. Varond, FDA’s Flexibility in Subpart H
Approvals: Assessing Quantum of Effectiveness Evidence, 71 Food & Drug
L.J. 135, 167 (2016). Yet the drug turned out to have “no benefit for mothers
or babies.” Christina Jewett, Preterm Birth Drug Withdrawn After 12 Years,
N.Y. Times (Mar. 7, 2023). As one headline put it, “F.D.A. Rushed a
Drug for Preterm Births. Did it Put Speed Over Science?” Christina Jewett,
N.Y. Times (Mar. 25, 2022). “Makena is another example . . . of a
medication fast-tracked by the [FDA] onto the market even though
considerable doubt remained about whether it worked.” Id. (Makena
involved the other Subpart H approval pathway—approval with a surrogate
endpoint, not approval with restrictions. But an agency that relies on bad
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science for approval under one Subpart H pathway can surely do so under the
other as well.)
The FDA hasn’t just approved ineffective drugs—it’s also approved
harmful drugs. In 1941, for example, it approved DES for use by pregnant
women to treat certain postpartum conditions. Several years later, the FDA
approved it to prevent miscarriages as well. The FDA’s approval has since
been called a “tragedy.” Jessica Dye, FDA Outlines Initiatives Inspired by
DES ‘Tragedy’, Law360 (Feb. 24, 2011). “Even before the [FDA]
approved the drug in 1941, researchers knew that DES caused cancer and
problems with sexual development in laboratory animals.” Nancy Langston,
The Retreat from Precaution: Regulating Diethylstilbestrol (DES), Endocrine
Disruptors, and Environmental Health, 13 Environmental History 41,
42 (2008). “These concerns initially led [the] FDA Commissioner . . . to
reject the drug.” Id. But “by 1947, the FDA had abandoned its position of
precaution.” Id.
Only in 2000 did FDA finally and formally “withdraw[] approval” of
DES—nearly six decades after it approved the drug. 65 Fed. Reg. 55264
(“Withdrawal of Approval of 28 New Drug Applications”). DES turned out
to be a carcinogen. See Diethylstilbestrol (DES) Exposure and Cancer, Nat’l
Cancer Inst. (Dec. 20, 2021). It also significantly increases the odds of
infertility, miscarriage, stillbirth, and neonatal death. See id.
The FDA has been blamed for contributing to the opioid crisis.
Opioid overdose was “once rare” in the United States. Andrew Kolodny,
How FDA Failures Contributed to the Opioid Crisis, 22 AMA J. Ethics 743,
743 (2020). But now “the vast oversupply of opioid drugs in the United
States has caused a plague.” In re Nat’l Prescription Opiate Litigation, 927
F.3d 919, 924 (6th Cir. 2019) (approvingly quoting the district court). As one
noted scholar observed in the AMA Journal of Ethics, “[t]he FDA did not
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properly enforce the Food, Drug, and Cosmetic Act when it approved
Purdue Pharma’s new drug application for extended-release (ER) oxycodone
in 1995.” Kolodny, supra, at 744. And “despite mounting evidence that a
surge in opioid consumption was resulting in adverse public health
consequences, the FDA continued to approve new opioid formulations for
chronic pain based on efficacy trials utilizing a controversial methodology.”
Id. at 745. It wasn’t just that the studies were bad—the FDA suffered from
regulatory capture by the pharmaceutical industry, which pursued its own
interest rather than the interest of the American people. See id. at 745–46.
Finally, consider this statistic from the Journal of the American Medical
Association: Of all the novel therapeutics approved by the FDA in the decade
following its approval of mifepristone, nearly one-third experienced safety
issues. See Nicholas S. Downing et al., Postmarket Safety Events Among Novel
Therapeutics Approved by the US Food and Drug Administration Between 2001
and 2010, 317 J. Am. Med. Ass’n 1854, 1854 (2017).
Problems at the FDA have not escaped Congress’s attention. Just last
year, the chair of the Senate Committee on Health, Education, Labor, and
Pensions criticized the FDA for its “unacceptable, longstanding” food safety
failures. Letter of Senator Patty Murray, Chair, Senate Committee on
Health, Education, Labor, and Pensions to FDA Commissioner (Apr. 11,
2022). As she put it, “[t]he FDA’s failure over decades to regulate and
enforce food safety standards . . . has put the health of Americans at risk.”
Id.
So it’s not surprising that our court is far from the first to identify
problems with FDA action sufficient to necessitate judicial intervention.
Courts have held a number of FDA actions unlawful under the APA—
including drug approval. See, e.g., Am. Bioscience, Inc. v. Thompson, 269 F.3d
1077, 1078 (D.C. Cir. 2001) (“Appellant argues that the [FDA’] decision to
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***
By the applicant’s own admission, the FDA used an unlawful
procedure when it approved mifepristone. And the agency’s later regulations
are likewise invalid—both under the APA as the majority outlines, and under
the Comstock Act as well. In sum, the regulations are “not in accordance
with law” and therefore must be set aside. 5 U.S.C. § 706(2)(A).
Accordingly, we should affirm. I concur in part and dissent in part.
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