Amicus Curiae Brief — Food and Drug Administration, et al., Petitioners v. Alliance for Hippocratic Medicine, et al.

Nos. 23-235, 23-236

In the Supreme Court of the United States

FOOD AND DRUG ADMINISTRATION, ET AL.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

DANCO LABORATORIES, L.L.C.,

Petitioner,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

ON WRITS OF CERTIORARI TO THE UNITED STATES

COURT OF APPEALS FOR THE FIFTH CIRCUIT

BRIEF OF AMICI CURIAE LOCAL GOVERNMENTS

AND LOCAL GOVERNMENT LEADERS IN

SUPPORT OF PETITIONERS

JONATHAN B. MILLER

Counsel of Record

AADIKA SINGH

JORDAN L. PHILLIPS

Public Rights Project

490 43rd Street, #115

Oakland, CA 94609

(510) 738-6788

jon@publicrightsproject.org

Counsel for Amici Curiae

i

TABLE OF CONTENTS

TABLE OF AUTHORITIES ...................................... iii

STATEMENT OF INTEREST ....................................1

SUMMARY OF ARGUMENT .....................................3

ARGUMENT ................................................................4

I.

RESPONDENTS HAVE NOT SUFFERED

AN INJURY-IN-FACT......................................4

A. Respondents’ Diversion of Resources

Theory of Standing Suffers from

Multiple Fatal Flaws ...................................5

1. Seeing Patients Is What Doctors Do .....6

2. Probabilistic Standing Is Not

Cognizable ..............................................8

3. Respondents’

Theory

Turns

Physicians and Other Actors Into

Super-Plaintiffs ....................................12

B. Respondents’ Supposed Conscience

Violations Are Not Supported by the

Record ........................................................14

C. Respondents’ Frustration of Mission

Claim Does Not Create an Injury-inFact ............................................................18

D. None of the Other Purported Harms

Gives Respondents Standing ....................20

II.

RESPONDENTS’ ALLEGED INJURIES

ARE NOT FAIRLY TRACEABLE TO THE

FDA’S 2016 AND 2021 ACTIONS .................22

ii

III.

RESPONDENTS’ CLAIMS ARE NOT

REDRESSABLE IN THIS LITIGATION ......23

IV.

THE FIFTH CIRCUIT IMPROPERLY

SUBSTITUTED ITS JUDGMENT FOR

THE SCIENTIFIC EVALUATIONS OF AN

EXPERT AGENCY .........................................26

V.

THE INJUNCTION CONTRAVENES THE

PUBLIC INTEREST .......................................27

CONCLUSION ..........................................................30

APPENDIX A – List of Amici Curiae .......................1a

iii

TABLE OF AUTHORITIES

CASES

California v. Texas,

141 S. Ct. 2104 (2021) ........................................... 22

City of Los Angeles v. Lyons,

461 U.S. 95 (1983) ................................................... 8

Clapper v. Amnesty Int’l USA,

568 U.S. 398 (2013) ................................. 8, 9, 10, 19

Cytori Therapeutics, Inc. v. FDA,

715 F.3d 922 (D.C. Cir. 2013) ......................... 25, 26

Dep’t of Educ. v. Brown,

600 U.S. 551 (2023) ............................................... 11

Diamond v. Charles,

476 U.S. 54 (1986) ................................................. 21

FCC v. Prometheus Radio Project,

592 U.S. 414 (2021) ............................................... 26

FDA v. Am. Coll. of Obstetricians and Gynecologists,

141 S. Ct. 10 (2020) ............................................... 26

FDA v. Am. Coll. of Obstetricians & Gynecologists,

141 S. Ct. 578 (2021) ............................................. 25

Fort Lauderdale Food Not Bombs v. City of Fort

Lauderdale, 11 F.4th 1266 (11th Cir. 2021)......... 19

Havens Realty Corp. v. Coleman,

455 U.S. 363 (1982) ............................................... 18

Lujan v. Defenders of Wildlife,

504 U.S. 555 (1992) ..................................... 4, 14, 15

OCA-Greater Houston v. Texas,

867 F.3d 604 (5th Cir. 2017) ........................... 18, 19

iv

Otsuka Pharm. Co. v. Burwell,

302 F. Supp. 3d 375 (D.D.C. 2016) ....................... 25

Otsuka Pharm. Co. v. Price,

869 F.3d 987 (D.C. Cir. 2017) ............................... 25

Spokeo, Inc. v. Robins,

578 U.S. 330 (2016) ............................................. 4, 6

Steel Co. v. Citizens for a Better Env’t,

523 U.S. 83 (1998) ................................................. 20

Summers v. Earth Island Institute,

555 U.S. 488 (2009) ............................................. 8, 9

TransUnion LLC v. Ramirez,

594 U.S. 413 (2021) ..................................... 3, 15, 20

CONSTITUTION AND STATUTES

U.S. Const. Art. III ............ 3, 5, 6, 8, 12, 14, 19, 21, 22

42 U.S.C. § 238n ........................................................ 17

42 U.S.C. § 300a-7(b) ................................................. 17

42 U.S.C. § 300a-7(c) ................................................. 17

42 U.S.C. § 300a-7(d) ................................................. 17

42 U.S.C. § 1395dd ...................................................... 7

42 U.S.C. § 1395dd(b)(1)............................................ 17

OTHER AUTHORITIES

Clark Alves, et al., Early pregnancy loss

(spontaneous abortion), NATIONAL LIBRARY OF

MEDICINE (2023),

https://www.ncbi.nlm.nih.gov/books/NBK56052

1/...............................................................................6

v

American Medical Association, Principles of

Medical Ethics, 1.1.2 PROSPECTIVE PATIENTS,

https://www.ama-assn.org/system/files/code-ofmedical-ethics-chapter-1.pdf...................................7

Yanxia Cao et al., Efficacy of Misoprostol

Combined with Mifepristone on Postpartum

Hemorrhage and its Effects on Coagulation

Function, 13 INT. J. CLIN. EXP. MED. 2234 (Apr.

30, 2020) ................................................................27

Mara Gordon & Sarah McCammon, A Drug that

Eases Miscarriages is Difficult for Women to

Get,

NPR

(Jan.

10,

2019),

https://www.npr.org/sections/health-shots/

2019/01/10/666957368/a-drug-that-easesmiscarriages-is-difficult-for-women-to-get ...........27

Stephanie Rae Hagan et al. Alcohol-Related

Presentations to Emergency Departments on

Days with Holidays, Social, and Sporting

Events: An Integrative Literature Review, 38

PREHOSPITAL AND DISASTER MEDICINE (2023),

https://www.ncbi.nlm.nih.gov/pmc/articles/PM

C10694469/ ............................................................13

Anupam B. Jena, Delays in Emergency Care and

Mortality during Major U.S. Marathons, 376

NEW ENGLAND JOURNAL OF MEDICINE (2017),

https://www.nejm.org/doi/full/10.1056/nejmsa1

614073..............................................................13, 14

vi

Marike Lemmers et al., Medical Treatment for

Early Fetal Death (Less Than 24 Weeks),

COCHRANE DATABASE SYSTEMATIC REVIEWS

(June 17, 2019) ......................................................28

William M. McLaughlin, An Epidemiological

Study of Cell Phone-Related Injuries of the

Hand and Wrist Reported in United States

Emergency Departments From 2011 to 2020, 5

JOURNAL OF HAND SURGERY (2023),

https://www.sciencedirect.com/science/article/p

ii/S2589514122001785 ..........................................14

Honor Macnaughton et al., Mifepristone and

Misoprostol for Early Pregnancy Loss and

Medication Abortion, 103 AM. FAM. PHYSICIAN

473 (2021) ..............................................................28

Jennifer L. Peel et al., Ambient Air Pollution and

Respiratory Emergency Department Visits, 16

EPIDEMIOLOGY (2005) ............................................13

Elizabeth G. Raymond, Efficacy of Misoprostol

Alone for First-Trimester Medical Abortion: A

Systematic Review, Obstet Gynecol. 2019 Jan;

133(1): 137–147,

https://www.ncbi.nlm.nih.gov/pmc/articles/PM

C6309472/ ..............................................................24

vii

Elizabeth Raymond et al., The comparative safety

of legal induced abortion and childbirth in the

United States, Obstet. Gynecol., Feb. 2012;

119(2): 215–19,

http://unmfamilyplanning.pbworks.com/w/file/f

etch/119312553/Raymond%2520et%2520alComparative%2520Safety.pdf ..............................24

Joe V. Selby, Bruce H. Fireman, and Bix E. Swain,

Effect of a Copayment on Use of the Emergency

Department in a Health Maintenance

Organization, 334 NEW ENGLAND JOURNAL OF

MEDICINE (1996) ....................................................12

The Accreditation Council for Graduate Medical

Education,

Program

Requirements

for

Graduate Medical Education in Emergency

Medicine

(effective

July

1,

2023),

https://www.acgme.org/globalassets/pfassets/pr

ogramrequirements/110_emergencymedicine_2

023.pdf .............................................................16, 17

Ushma D. Upadhyay, Leah R. Koenig & Karen R.

Meckstroth, Safety And Efficacy Of Telehealth

Medication Abortions In The US During The

Covid-19 Pandemic, JAMA NETWORK (2021),

https://jamanetwork.com/journals/jamanetwor

kopen/fullarticle/2783451 .....................................11

Christopher M. Worsham et al., Carbon Monoxide

Poisoning during Major U.S. Power Outages,

386 NEW ENGLAND JOURNAL OF MEDICINE

(2022) .....................................................................13

viii

Ruihong Zhou and Yingfeng Li, Traffic Crash

Changes Following Transitions between

Daylight Saving Time and Standard Time in

the United States: New Evidence for Public

Policy Making, 83 JOURNAL OF SAFETY

RESEARCH (2022) ...................................................13

1

STATEMENT OF INTEREST

Over the last two decades, the Food and Drug

Administration (“FDA”) has reviewed robust scientific

evidence and repeatedly determined that mifepristone

is safe and effective under the approved conditions of

use. Since its initial approval, mifepristone has

provided meaningful therapeutic benefits over other

treatments for reproductive health conditions. It has

been used widely for miscarriage management and the

treatment of other reproductive health conditions, and

approximately six million pregnant people in the

United States have used mifepristone and a

companion medication, misoprostol, to safely

terminate early pregnancies. The decision below, if

allowed to stand, would significantly impair access to

mifepristone, run counter to decades of clear scientific

evidence, and contradict established precedent of this

Court. Any reversal of FDA authorization would

immediately disrupt essential healthcare across the

United States, including in amici’s jurisdictions,

without basis in law or fact.

Amici are cities, counties, local government

leaders, and public entities from across the country. 1

We file this brief in furtherance of our shared interest

in and responsibility for protecting the health and

safety of our diverse populations, including preserving

access to essential healthcare such as reproductive

healthcare. Some amici are large cities administering

public health systems that depend on the availability

1 No counsel for a party authored this brief in whole or in part.

No person other than amici or amici’s counsel made a monetary

contribution to the preparation or submission of this brief. A list

of all amici is available at Appendix A.

2

of a range of devices and medicines, including access

to mifepristone, that are subject to FDA approval.

Other amici are smaller cities, counties, and their

elected leaders, including some in remote and difficult

to access parts of our country. All amici represent

populations that are low-income and medically

underserved.

The 2016 and 2021 REMS have advanced crucial

interests in healthcare access. Eliminating in-person

visits that do not improve outcomes has preserved

precious resources for public health systems.

Telemedicine has an especially important role to play

in ensuring people who live in more rural areas have

access to safe, effective care. On the other hand,

imposing unnecessary restrictions on this medication

will overburden health systems. Pregnant people who

are unable to access mifepristone because of such

restrictions may face worse health outcomes. Without

access to mifepristone, those who seek to terminate a

pregnancy may delay care, face additional barriers,

terminate their pregnancies using alternative means

that present additional risks, or may be forced to carry

to term unwanted or unviable pregnancies or those

that threaten their health. Pregnant people who

would rely on mifepristone for treating miscarriages

could instead be forced to endure more pain and health

risks at an already challenging time. If the decision

below is affirmed, there will be significant economic,

health, and social consequences for amici.

3

SUMMARY OF ARGUMENT

Under well-established precedent, Respondents

lack Article III standing to challenge the FDA’s 2016

and 2021 actions relating to mifepristone, because

those actions do not require Respondents to do

anything or refrain from doing anything. Respondents’

alleged injuries—which rely on an indirect theory of

harm—are simply too attenuated and speculative to

constitute an injury-in-fact. Closer examination of

their claims make clear that Respondents’ theories for

standing are not supported by the record in this case

and are foreclosed by established precedent about the

probability of future harm. Additionally, Respondents’

claims are not traceable to the FDA’s decisions and

cannot be redressed by this case either. In fact,

making mifepristone less available could produce

more health complications of the type that

Respondents fear will land in their emergency rooms

and hospitals. Because the Fifth Circuit committed

clear errors of law by ignoring or misconstruing

precedent, and by incorrectly applying Article III’s

standing requirements when it comes to injury-in-fact,

traceability, and redressability, this Court should

reverse the decision below on jurisdictional grounds

and enter judgment for Petitioners. See TransUnion

LLC v. Ramirez, 594 U.S. 413, 423 (2021).

Should this Court move to the merits of the case,

amici underscore two reasons for reversal. To start,

the Fifth Circuit improperly substituted its own

judgment for the FDA’s expert agency analysis. The

decision to override the 2016 and 2021 REMS is

contrary to the clear weight of the evidence that was

before FDA at the time of decision-making. In

4

addition, the injunction should be reversed for

running counter to the public interest, given the farranging and disruptive impacts of the Fifth Circuit’s

ruling.

ARGUMENT

I.

RESPONDENTS HAVE NOT SUFFERED

AN INJURY-IN-FACT

A showing of injury-in-fact requires “an invasion of

a legally protected interest” that is both “concrete and

particularized” and “actual or imminent, not

conjectural or hypothetical.” Spokeo, Inc. v. Robins,

578 U.S. 330, 339 (2016) (citation omitted).

Respondents lack standing because they are not

directly regulated by the agency action at issue. They

do not administer or prescribe mifepristone, and the

FDA’s approval of the drug does not require them to

do or refrain from doing anything. They are not “the

object of the government action or inaction [they]

challenge[].” Lujan v. Defenders of Wildlife, 504 U.S.

555, 562 (1992).

To establish their standing, Respondents offer

several indirect theories for their injuries. They all

fail. These theories are not legally cognizable, illogical,

too speculative, and not substantiated either by the

record before the Court or by a general understanding

of how medical professionals operate. Amici local

governments focus principally on the issue of standing

herein, because (i) the analysis is dispositive to the

case; and (ii) the Fifth Circuit’s analysis, if affirmed,

would enable actors with no direct connection to a law

or regulation to sue if they come into contact with

third parties affected in some way by said regulation,

5

thus burdening local governments with the costs of

defending such a flood of lawsuits. 2

A.

Respondents’ Diversion of Resources

Theory of Standing Suffers from

Multiple Fatal Flaws

Respondents’ main contention for standing is that

FDA authorization of mifepristone requires member

physicians who practice in emergency rooms to divert

their time and attention away from other patients.

Implied in this argument is that these “other patients”

are preferred, because they have not chosen to

terminate a pregnancy through medication.

Respondents’ diversion of resources theory fails for at

least three reasons: (1) seeing patients in an

emergency room is not an injury; (2) probabilistic

theories of standing have been rejected by this Court;

and (3) there is no limiting principle for their

contention, which would convert physicians into

super-plaintiffs given all of the policies and decisions

that influence the number of patients presenting for

care at hospitals.

2 Amici agree with the Fifth Circuit in so far as it concluded that

Respondents’ assertion of stress and emotional distress “does not

provide a separate basis for Article III standing.” Pet. App. 35a.

Accordingly, it is not addressed directly herein. See also FDA Br.

26 (“Endorsing [Respondents’] novel theory would open the

courthouse doors to an endless parade of suits. Doctors could sue

to challenge virtually any policy that allegedly increased the risk

that they would be presented with patients whose cases they find

distressing.”).

6

1.

Seeing Patients Is What Doctors Do

Respondents’ assertion that the availability of

mifepristone forces a diversion of their resources is not

cognizable harm. Caring for patients is what doctors

do. It is the principal purpose of the profession. At the

very least, the argument that treating Patient A

versus Patient B constitutes harm is too abstract to

meet the concreteness requirements of Article III.

Spokeo, 578 U.S. at 340 (“When we have used the

adjective ‘concrete,’ we have meant to convey the usual

meaning of the term—’real,’ and not ‘abstract.’”). The

record does not indicate that Respondents’ members

are required to provide different types or scopes of care

for patients experiencing complications from

mifepristone compared to patients who are

experiencing a spontaneous miscarriage. In fact, the

treatment is generally the same. In both

circumstances, doctors will treat bleeding and fluid

loss. In both circumstances, doctors will monitor for

and, if needed, treat infection and remove products of

conception from the uterus. And, in both

circumstances, doctors will support patients

experiencing emotional distress. 3

Digging deeper into Respondents’ theory of harm,

their contention is really about worthiness of care.

Respondents’ theory is effectively an expression of a

preference to care for certain types of patients. See,

3 Clark Alves, et al., Early pregnancy loss (spontaneous abortion),

LIBRARY

OF

MEDICINE

(2023),

NATIONAL

https://www.ncbi.nlm.nih.gov/books/NBK560521/;

Julia

S.

Marcus, et al., Complications of elective medical abortions,

Emergency

Medicine

Residents’

Association

(2022),

https://www.emra.org/emresident/article/abortion-complications.

7

e.g., J.A. 198 (Decl. Dr. Shaun Jester) (describing

harm as “los[ing] the opportunity to provide these

obstetrical and medical services to care for the woman

and child through pregnancy”). That theory cannot be

credited. This is particularly true for physicians like

Respondents’ members who have chosen to treat all

incoming patients in a hospital or emergency setting.

Such doctors do not get to choose which patients they

treat and which complications they like or dislike.

They may not approve of the choices their patients

make, but their obligation to provide care exists

nonetheless. 4 It is common for patients to smoke, not

exercise, not take their medications appropriately,

abuse alcohol or other substances, or make choices

about their lives and exhibit behaviors that a doctor

might not agree with. But when a patient arrives

seeking care in an emergency room setting, care must

be provided. See, e.g., 42 U.S.C. § 1395dd (requiring

the provision of appropriate screening and stabilizing

treatment when any patient arrives at an emergency

department and requests treatment) (emphasis

added). Otherwise, Respondents’ theory of standing is

effectively a license to sanction discrimination against

particular patients.

4 American Medical Association, Principles of Medical Ethics,

1.1.2 PROSPECTIVE PATIENTS, https://www.ama-assn.org/system/

files/code-of-medical-ethics-chapter-1.pdf. (“Physicians must also

uphold ethical responsibilities not to discriminate against a

prospective patient on the basis of… other personal or social

characteristics that are not clinically relevant to the individual’s

care.”).

8

Moreover, there is no limiting principle to

Respondents’ assertion here. All patients require

resources that could otherwise be directed to other

patients, and all patients make choices that might

impact a physicians’ perception of their worthiness for

care. Any particular patient may engage in behavior,

take medication, or make choices that impact their

care. None of that should give rise to a theory for

Article III standing. See also FDA Br. 26.

2.

Probabilistic

Cognizable

Standing

Is

Not

This Court’s precedent demands that standing be

denied where the alleged anticipated injury results

from “a highly attenuated chain of possibilities.”

Clapper v. Amnesty Int’l USA, 568 U.S. 398, 410

(2013). The Fifth Circuit incorrectly relied on

probabilistic speculation that Respondents would be

impacted given that “millions of women take

mifepristone” and a “number of them experience

complications” and “a large number of association

members [ ] are emergency room doctors.” Pet. App.

17a. Among other errors, this reasoning clearly runs

afoul of the standing analysis in Summers v. Earth

Island Institute, 555 U.S. 488 (2009).

Here, Respondents say that they have treated

people with mifepristone complications on some

occasions in the past and say that they or members of

their association will need to do so again in the future.

That assertion of statistical likelihood is not enough

for injunctive relief. Cf. City of Los Angeles v. Lyons,

461 U.S. 95, 101–02 (1983). Standing for prospective

relief cannot be based on past injury. An “imminent

future injury” must be shown. Summers, 555 U.S. at

9

495. And it cannot be based on “a statistical

probability that some of those members are

threatened with concrete injury. . . . This novel

approach to the law of organizational standing would

make a mockery” of Supreme Court precedent. Id. at

497–98.

The Fifth Circuit found that “evidence of prior

injury is especially probative,” and “where the causes

that produced the first injury remain in place, pastinjury evidence bears strongly on whether there is a

real and immediate threat of repeated injury.” Pet.

App. 16a (internal quotation omitted). That is the

exact type of probabilistic approach soundly rejected

by this Court. See Clapper, 568 U.S. at 410

(“[O]bjectively reasonable likelihood standard is

inconsistent with our requirement that threatened

injury must be certainly impending to constitute

injury in fact.”) (internal quotations omitted). Seeking

to distinguish Summers, the Fifth Circuit posited that

this Court’s “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.” Pet. App. 29a (emphasis in

original). That is the precise problem here. No

individual can claim that they will be injured in the

future with any certainty. Instead, Respondents rely

on the assertion that “it is highly likely that one or

more” of the organizations’ members “will be required

to provide emergency care to a mifepristone patient in

the near future.” Pet. App. 23a–24a.

Respondents’ theory also “rest[s] on speculation

about the decisions of independent actors,” Clapper,

568 U.S. at 414, which this Court has been “reluctan[t]

10

to endorse.” Id. Among the attenuated circumstances

involved are the following chain of events:

● a pregnant person chooses to use

mifepristone to terminate a pregnancy;

● the usage falls outside of initial

authorization, and is connected to the

2016 and 2021 REMS—mifepristone was

prescribed based on a telemedicine

interaction, mailed to the patient, or

prescribed by an APC;

● the person experiences

complications;

significant

● the person does not or cannot seek care

from the prescribing physician;

● the person goes to a hospital emergency

room, among all others available, where

a

physician

within

Respondents’

membership works;

● the person needs medical attention from

a doctor at that hospital;

● a

physician

within

Respondents’

membership is working at the hospital or

on-call at that time;

● that particular physician is an

appropriate medical specialty to see and

care for the person; 5 and

5 Danco’s argument about the range of medical specialties and

practices within Respondents’ membership groups further

undercuts Respondents’ standing contention along these same

lines. See Danco Br. 26.

11

● none of the other doctors at the hospital

see this person.

See also FDA Br. 21 (listing “contingencies [that]

would have to occur” for Respondents to suffer alleged

injury); Brief Amici Curiae of Profs. Cohen &

Rebouché at 10 (“[C]ausal chain via which the Alliance

seeks to link its injury to the FDA’s actions is lengthy

and attenuated at best, filled with ‘pure

speculation.’”). Given this chain of events required for

Respondents’ theory to come to fruition, it is clear that

their standing is “all too dependent on conjecture.”

Dep’t of Educ. v. Brown, 600 U.S. 551, 567 (2023)

(internal quotation omitted).

One more point here warrants analysis.

Respondents appear to claim that the 2016 and 2021

REMS make their future injury more probable

because they perceive that they are seeing more

patients with complications from mifepristone in

recent years. See, e.g., J.A. 153 (Decl. of Dr. Christina

Francis). Respondents offer no clinical data to support

these anecdotes, and there is no reason to credit these

cursory observations. Recent data has shown that

telehealth-only visits where mifepristone is prescribed

produce similarly strong results for patient safety. 6

These recent findings are in addition to the studies

before the FDA at the time of its decision-making. The

weight of this scientific research undermines the

6 See, e.g., Ushma D. Upadhyay, Leah R. Koenig & Karen R.

Meckstroth, Safety And Efficacy Of Telehealth Medication

Abortions In The US During The Covid-19 Pandemic, JAMA

NETWORK

(2021),

https://jamanetwork.com/journals/

jamanetworkopen/fullarticle/2783451.

12

credibility of Respondents’ highly speculative

assertions and offers further basis to defeat standing.

3.

Respondents’

Theory

Turns

Physicians and Other Actors Into

Super-Plaintiffs

Under the standing theory Respondents advance,

many parties would enjoy Article III standing so long

as they could conjure up some downstream effect

(however speculative) that might affect them at some

point. Physicians, in particular, would enjoy a special

status under Article III to bring lawsuits.

A cursory review of medical literature and other

scholarship reveals the wide array of issues that could

be opened to federal litigation by individual physicians

or their membership groups. Numerous studies have

shown correlation between policy changes, public

events, or natural occurrences and emergency room

visits.

Under Respondents’ theory of standing, any one of

these changes or decisions could be challenged by

doctors required to shoulder an increased or more

challenging patient load.

● A change in a health plan’s copayment by as few

as $10 has been shown to impact the frequency

of emergency room visits. 7

● Temporary changes in emissions and localized

pollution can result in more emergency room

7 Joe V. Selby, Bruce H. Fireman, and Bix E. Swain, Effect of a

Copayment on Use of the Emergency Department in a Health

Maintenance Organization, 334 NEW ENGLAND JOURNAL OF

MEDICINE 635-642 (1996).

13

visits due to pneumonia and respiratory

disease. 8

● Daylight savings time changes are associated

with more vehicle accidents and trips to the

hospital. 9

● Power outages increase carbon monoxide

poisoning, also resulting in more trips to the

hospital. 10

● Alcohol consumption during sporting events, at

concerts, and even on holidays results in more

patient trips to the emergency department. 11

● Road closures due to major-city marathons

delay and divert care, which can result in

patients arriving at the hospital in worse

condition. 12

8 Jennifer L. Peel, et al., Ambient Air Pollution and Respiratory

Emergency Department Visits, 16 EPIDEMIOLOGY, 164-174 (2005).

Ruihong Zhou and Yingfeng Li, Traffic Crash Changes

Following Transitions between Daylight Saving Time and

Standard Time in the United States: New Evidence for Public

Policy Making, 83 JOURNAL OF SAFETY RESEARCH, 119-127

(2022).

9

10 Christopher M. Worsham, et al., Carbon Monoxide Poisoning

during Major U.S. Power Outages, 386 NEW ENGLAND JOURNAL

OF MEDICINE 191-192 (2022).

11 Stephanie Rae Hagan, et al. Alcohol-Related Presentations to

Emergency Departments on Days with Holidays, Social, and

Sporting Events: An Integrative Literature Review, 38

PREHOSPITAL AND DISASTER MEDICINE 764–773 (2023).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10694469/.

12 Anupam B. Jena, Delays in Emergency Care and Mortality

during Major U.S. Marathons, 376 NEW ENGLAND JOURNAL OF

14

● Increased availability of cell phones and other

portable devices increases serious patient

injuries from falls and accidents arriving at

hospitals. 13

The examples of studies are extensive and the

possibility for litigation are almost limitless. Many

decisions, activities, and policies impact patient visits

to hospitals. In fact, many of the scenarios set forth

above are more specific and localized than the facts at

issue in this case, making the standing arguments

stronger for those physician-plaintiffs. To agree with

Respondents’ view of standing would be to transform

emergency room physicians and other hospital-based

doctors into super-plaintiffs under Article III.

B.

Respondents’ Supposed Conscience

Violations Are Not Supported by the

Record

Respondents also assert that “treatment violates

their conscience rights, putting them in a position

where they must perform or complete an abortion even

though doing so is contrary to their moral beliefs.” Pet.

App. 24a. This argument is not supported by the

testimony in the record. As the parties required to

meet the burden of proof and persuasion to satisfy

standing, a lack of sufficient evidence at this stage

eliminates Article III jurisdiction. Lujan, 504 U.S. at

MEDICINE 1441-1450 (2017),

10.1056/nejmsa1614073.

https://www.nejm.org/doi/full/

13 William M. McLaughlin, An Epidemiological Study of Cell

Phone-Related Injuries of the Hand and Wrist Reported in United

States Emergency Departments From 2011 to 2020, 5 JOURNAL OF

HAND SURGERY 184-188 (2023), https://www.sciencedirect.com/

science/article/pii/S2589514122001785.

15

561. Mere allegations are not enough; “the specific

facts set forth by the plaintiff to support standing

must be supported adequately by the evidence.”

TransUnion, 594 U.S. at 431 (internal quotation and

citation omitted). A closer examination of the record

shows that claims of a conscience violation are

unsubstantiated.

Dr. Christina Francis, for example, recounts an

episode when a patient experienced complications and

“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.” J.A. 154 (emphasis

added). The partner is not identified, and Dr. Francis

did not allege a conscience violation of her own. In a

second episode involving a patient who received

medication from India and experienced complications,

Dr. Francis does not identify the drug as mifepristone

and clearly it was not. J.A. 153. Moreover, Dr. Francis

does not allege any kind of conscience violation—she

merely says she saw the patient in the emergency

room.

Testimony from Dr. Ingrid Skop does not fare

better on close evaluation. Dr. Skop’s declaration

states that she has “cared for at least a dozen women

who have required surgery to remove retained

pregnancy tissue after a chemical abortion” J.A. 163,

but no assertion that she herself had to perform the

surgery against her conscience. In a specific example,

Dr. Skop described in-office treatment she provided

for a woman: “I performed a sonogram, identified a

significant amount of pregnancy tissue remaining in

her uterus, and performed a suction aspiration

procedure to resolve her complication.” J.A. 164. This

16

example cannot be treated as a conscience violation:

Dr. Skop saw the patient in her office after two followup appointments at Planned Parenthood and Dr. Skop

could have referred this patient to someone else, if she

had an objection, which she fails to assert in the

declaration. Dr. Skop concludes her declaration with a

speculative assertion that FDA approval of

mifepristone “could force” her to “surgically finish an

incomplete elective chemical abortion,” J.A. 167, but

offers no explanation of why or how that could happen.

Dr. Nancy Goodwin-Wozniak describes an episode

involving a patient who had been advised against a

medication abortion, had one, and suffered

complications. J.A. 173. Even in this example, Dr.

Goodwin-Wozniak asserts no action that violates her

conscience: she advised the patient not to take

misoprostol, instructed an internist, and describes the

actions taken by other medical providers. J.A. 174.

No other declarant offers examples or specifics

regarding the conscience claim. Notably, the only

declarant who is an emergency room physician, Dr.

Tyler Johnson, made no mention of a possible

conscience violation. J.A. 177–181. That is consistent

with the scope of emergency medicine. If a patient

needed a procedure, such as a dilation and curettage

(D&C), following the use of mifepristone, an

emergency physician would refer the case to an OBGYN. 14 There would be no obligation to “complete” an

14 Training for emergency room physicians requires that they

perform certain key procedures a minimum number of times

before they graduate from their residency programs. This

includes delivering a baby. Procedures such as D&C and manual

vacuum aspiration (MVA) are not on that mandate. See The

17

abortion. In sum, none of the declarations relied upon

by the Fifth Circuit states that the physicians

conscientiously objected to providing care in the

particular instance, explain why the doctor chose to

proceed without invoking conscience protections, or

state that they could not otherwise pass the care to

another doctor.

Additionally, federal law currently offers

significant conscience protections, yet none of the

declarants explain why these provisions are

inadequate. See, e.g., 42 U.S.C. §§ 238n, 300a-7(c) &

(d) (federal conscience protections). These statutes

prohibit health care facilities from discriminating

against physicians who refuse to provide an abortion

or to force such physicians to provide an abortion

against their will. Id. §§ 238n, 300a-7(b), (c), & (d).

Currently enjoined federal guidance about emergency

treatment does not change this conclusion, either. See

U.S. Br. 23. Among other things, EMTALA creates

obligations for hospitals, not individual providers, 42

U.S.C. § 1395dd(b)(1), and the federal government has

taken the position that EMTALA would not compel

individuals to perform an abortion against their

sincerely held beliefs. Gov’t C.A. Reply Br. at 25, Texas

v. Becerra, No. 23-10246 (5th Cir. Aug. 4, 2023).

Accreditation Council for Graduate Medical Education, Program

Requirements for Graduate Medical Education in Emergency

Medicine (effective July 1, 2023), at 27–28, https://www.acgme.

org/globalassets/pfassets/programrequirements/110_emergency

medicine_2023.pdf.

18

C.

Respondents’ Frustration of Mission

Claim Does Not Create an Injury-inFact

Respondents also seek to establish standing by

asserting that the FDA’s decisions on mifepristone

have frustrated their organizational missions. Agency

decisions that do not align with the viewpoints of an

organization are not enough to establish standing. For

Respondents to have standing, the challenged conduct

must impact the organizations’ activities specifically,

not merely frustrate the achievement of their mission

in a general sense. See Havens Realty Corp. v.

Coleman, 455 U.S. 363, 379 (1982). Additionally, the

organization cannot undertake these activities solely

with an eye toward litigation.

Respondents have failed to substantiate how any

action by the FDA has directly impeded their ability

to do work to achieve their mission. At the certiorari

stage, for example, Respondents argued based on

outreach efforts to membership, public education, and

new studies and analysis. AFHM Opp. Br. 37-38. But

Respondents’ declarations are critically devoid of any

assertions how the FDA’s actions on mifepristone

specifically impacted their ability to operate. Instead,

Respondents simply state that the FDA’s 2021

decisions “perceptibly impaired” their missions.

AFHM Opp. Br. 38.

Even a cursory review of the cases relied upon by

Respondents show this is not nearly enough. For

example, in OCA-Greater Houston v. Texas, 867 F.3d

604 (5th Cir. 2017), a community-based organization

challenged a state law claiming it was preempted by

the federal Voting Rights Act. “The membership

19

consists of people with limited English proficiency,” id.

at 610, and the state law restricted the use of

interpreters at the polls. Of course, the plaintiff

organization disagreed with the state law. But its

standing was based on actual operational impact.

More specifically, the Fifth Circuit relied on testimony

about the fact that “in-depth conversations take more

time than merely explaining the requirements of the

VRA, and therefore OCA must spend more time on

each call (and reach fewer people in the same amount

of time) because of Texas’s law.” Id. The 2016 and 2021

REMS do not interact with Respondents’ operations in

a similar manner. See also Fort Lauderdale Food Not

Bombs v. City of Fort Lauderdale, 11 F.4th 1266, 1287

(11th Cir. 2021) (city ordinance blocked organization

from traditional meeting following demonstration in

public park).

Respondents similarly failed to identify any Article

III injury that their alleged diversion of resources is

necessary to avoid. Respondents assert that FDA’s

2016 actions caused them to “expend[] ‘considerable

time, energy and resources’ on their 26-page citizen

petition challenging” those actions. AFHM Opp. Br. 38

(citation omitted). In Clapper, this Court rejected

arguments regarding costly and burdensome

measures allegedly incurred to protect their

communications with foreign contacts. 568 U.S. at

415. The Court’s reasoning that “Plaintiffs cannot

manufacture standing merely by inflicting harm on

themselves,” id. applies with equal force to this case.

20

D.

None of the Other Purported Harms

Gives Respondents Standing

Respondents hint at several other types of harms

in their declarations. None of them has received much

attention at prior stages of this litigation. That is for

good reason. Further inspection of these assertions

demonstrate that they are unsubstantiated or not

cognizable.

First, some of the testifying physicians claim

greater exposure to liability and increased insurance

premiums because of expanded access to mifepristone.

Pet. App. 31a. But they failed to make a requisite

showing to establish standing. See TransUnion, 594

U.S. at 431. All Respondents do is vaguely suggest

that physicians will see higher insurance costs

because of the perceived increased liability exposure.

See, e.g., J.A. 142 (Decl. of Dr. Jeffrey Barrows). No

one testified that their insurance premiums increased

or that they paid more money out of pocket directly as

a result of the FDA rules on mifepristone. In addition,

past injury is not enough for prospective relief, and

Respondents offer no facts showing such an increase

is imminently coming. See Steel Co. v. Citizens for a

Better Env’t, 523 U.S. 83, 108 (1998) (because

injunctive relief “cannot conceivably remedy any past

wrong,” past harm is not enough for standing).

Beyond their vague and bald assertions, the

testimony on its face strains credulity. For example,

Dr. Tyler Johnson’s testimony asserts that because

some people present at the emergency department and

are reluctant to share that they have taken

mifepristone, “[t]he FDA’s actions have created a

culture of chaos for emergency room physicians.” J.A.

21

180. As a result, “[t]his culture puts us in increasingly

higher risk situations, which increases our exposure

to claims of malpractice and liability.” J.A. 180.

Emergency room physicians, in particular, regularly

work in high-pressure situations. Patients are not

always forthcoming about a host of information, some

of which may be highly relevant to the course of care.

Some patients may not be able to communicate

information about their condition. Even taking Dr.

Johnson’s testimony at face value, he has not

described anything distinct from the type of care these

physicians typically provide, whether for pregnancy

loss or other medical interventions.

Second, some of the declarants assert injury

because of loss of income derived from patients who

would otherwise carry their pregnancies to term. See,

e.g., J.A. 198 (Decl. of Shaun Jester). This theory is

clearly foreclosed by Supreme Court precedent. In

Diamond v. Charles, 476 U.S. 54 (1986), this Court

rejected a physician’s attempt to defend a state law

restricting abortions. The physician asserted that

fewer abortions would lead to more paying patients,

but this Court rejected the argument as “unadorned

speculation” and insufficient to meet the requirements

of Article III. Id. at 66. Even without Diamond on

point, first principles of standing dictate a quick

dismissal of this theory. At the very least, it requires

the Court to accept the speculation that the patients

who would otherwise take mifepristone would choose

Respondents’ members as their treating physicians as

opposed to terminating the pregnancy through a

surgical abortion, a misoprostol-only medication

abortion, or by other means.

22

II.

RESPONDENTS’ ALLEGED INJURIES

ARE NOT FAIRLY TRACEABLE TO THE

FDA’S 2016 AND 2021 ACTIONS

The FDA initially approved mifepristone in 2000,

but that approval cannot be challenged at this late

date, as the Fifth Circuit correctly concluded. As a

result, Respondents are left to explain how the more

recent changes connect directly to the harms they

allege. See, e.g., California v. Texas, 141 S. Ct. 2104,

2119 (2021) (injury must be “fairly traceable to

enforcement of the allegedly unlawful provision of

which the plaintiffs complain”) (internal quotations

omitted). They cannot do so, which thwarts any

possible standing assertions under Article III’s

traceability requirements.

In 2016, the FDA allowed advanced practice

clinicians, such as nurse practitioners and physician

assistants, to become certified prescribers under the

mifepristone REMS, where permitted under state law.

FDA Br. 5. Also in 2016, the FDA modified adverse

event reporting requirements to align with what is

required for the vast majority of other drugs. FDA Br.

5-6. In 2019, the FDA approved an application from

GenBioPro to market a generic version of

mifepristone. FDA Br. 6. In 2021, the FDA determined

that the in-person dispensing requirement was not

necessary to ensure mifepristone’s safe use. FDA Br.

7.

Focusing almost exclusively on alleged injuries

caused by the availability of mifepristone in general,

Respondents did not specify the impacts to them from

the 2016 and 2021 actions. Respondents offered no

evidence that the 2016 and 2021 FDA actions

23

increased the number of people who will suffer

complications of sufficient severity to require

emergency room care by Respondents or their

members. Nor did the Fifth Circuit point to any such

substantiated evidence. The record shows that serious

adverse events remain extremely infrequent with the

relevant actions in place. See, e.g., C.A. Add. 658–59

(reporting adverse events received by FDA through

June 30, 2021).

III.

RESPONDENTS’ CLAIMS ARE NOT

REDRESSABLE IN THIS LITIGATION.

The Fifth Circuit failed to analyze how

Respondents’ claims are redressable or explain how

enjoining the FDA’s 2016 and 2021 actions in

particular would cause fewer injuries to Respondents.

Here, there are at least three core flaws in any

conclusion that Respondents’ claims are redressable.

First, eliminating or impairing access to

mifepristone will not end medication abortions. A twomedicine regimen comprising of mifepristone and

misoprostol is safe, effective, and the most common

means of providing a medication abortion in the

United States. But patients can also terminate

pregnancies by taking misoprostol alone. The

availability of a misoprostol-only abortion protocol

undercuts Respondents’ assertion that their “injury”

can be redressed by limiting patients’ access to

mifepristone. Put simply: if Respondents prevail in

this lawsuit, it likely will result in many more

misoprostol-only medication abortions. And, while

still very infrequent, side effects from misoprostol-only

abortions could lead patients to seek medical care of

the same kind that plaintiffs speculate they will seek

24

under the two-drug regimen. 15 A “win” for

Respondents in this lawsuit therefore will not redress

their asserted “injury” of caring for patients

experiencing the effects of medication-abortion.

Second,

Respondents’

diversion-of-resources

theory is undercut by the fact that carrying a

pregnancy to term is far riskier than any method of

abortion. 16 Mifepristone is eminently safe and used by

millions of people across the country. Respondents

may prefer to help patients who are experiencing

complications from childbirth (or other medical

issues). But that is not about diversion of resources.

The restricted use of mifepristone will not change

Respondents’ need to treat patients, nor will it reduce

the number of patients experiencing pregnancyrelated complications.

Third, as Danco contends, the FDA’s 2016 and

2021 actions made mifepristone more effective and

reduced adverse events. Danco Br. 33. By requiring

Danco to return to pre-2016 labeling, Respondents

would make it more likely that people using the drug

need additional, medical intervention. J.A. 450 (92%

need no intervention under original labeling); J.A. 449

(96.1% and 97.4% of women need no intervention

15 See, e.g., Elizabeth G. Raymond, et al., Efficacy of Misoprostol

Alone for First-Trimester Medical Abortion: A Systematic Review,

Obstet Gynecol. 2019 Jan; 133(1): 137–147, https://www.ncbi.

nlm.nih.gov/pmc/articles/PMC6309472/.

16 See, e.g., Elizabeth Raymond, et al., The comparative safety of

legal induced abortion and childbirth in the United States,

Obstet. Gynecol., Feb. 2012; 119(2): 215–19, http://unmfamily

planning.pbworks.com/w/file/fetch/119312553/Raymond%2520et

%2520al-Comparative%2520Safety.pdf.

25

under 2016 changes). See also Brief of Cohen &

Rebouché at 22–24.

IV.

THE FIFTH CIRCUIT IMPROPERLY

SUBSTITUTED ITS JUDGMENT FOR THE

SCIENTIFIC EVALUATIONS OF AN

EXPERT AGENCY

The Fifth Circuit improperly substituted its own

judgment for both the scientific evaluation of an

expert agency and an established track record. This is

not just disfavored but constitutes reversible error.

See, e.g., FDA v. Am. Coll. of Obstetricians &

Gynecologists, 141 S. Ct. 578, 579 (2021) (“[C]ourts

owe significant deference to the politically accountable

entities with the ‘background, competence, and

expertise to assess public health.’”) (Roberts, C.J.,

concurring); Cytori Therapeutics, Inc. v. FDA, 715 F.3d

922, 927 (D.C. Cir. 2013) (“A court is ill-equipped to

second-guess that kind of agency scientific judgment

under the guise of the APA’s arbitrary and capricious

standard.”) (Kavanaugh, J.); Otsuka Pharm. Co. v.

Burwell, 302 F. Supp. 3d 375, 403 (D.D.C. 2016) (“To

begin with, the FDA is an expert agency charged with

making precisely these sorts of highly technical

determinations, and its interpretation of romanette iv

is premised on ‘the agency’s evaluations of scientific

data within its area of expertise.’”) (Jackson, J.), aff’d

sub nom. Otsuka Pharm. Co. v. Price, 869 F.3d 987

(D.C. Cir. 2017).

The Fifth Circuit substituted its judgment in the

place of thorough agency review because of a

purported failure to cite to a study that evaluated the

effects of those changes “as a whole.” Pet. App. 53a. To

the contrary, it was not arbitrary or capricious for the

26

FDA to “rel[y] on the data it had (and the absence of

any countervailing evidence) to predict” that the

individual changes also would be safe as a whole. FCC

v. Prometheus Radio Project, 592 U.S. 414, 425 (2021).

The Fifth Circuit’s judgment of how evidence-based

scientific review should proceed is not enough to

override years-long, deliberative and expert decisionmaking. See Cytori Therapeutics, 715 F.3d at 923.

Moreover, the Fifth Circuit was wrong that the FDA

only studied the changes individually and not

cumulatively. The FDA made clear it relied on data

from several studies “to support multiple changes.”

FDA Br. 38–39 (citing J.A. 299).

This Court criticized such a lack of judicial

restraint before. See, e.g., FDA v. Am. Coll. of

Obstetricians and Gynecologists, 141 S. Ct. 10, 12

(2020) (“Nevertheless, a District Court Judge in

Maryland took it upon himself to overrule the FDA on

a question of drug safety.”) (Alito, J., dissenting from

holding of request for stay in abeyance). Here, the

Fifth Circuit, demonstrating little regard for science

or evidence, in fact substituted its own policy

judgment for that of an expert agency, imperiling the

lives and health of our residents by limiting the

availability of mifepristone and potentially many

other drugs in medicine cabinets.

V.

THE INJUNCTION CONTRAVENES THE

PUBLIC INTEREST

Returning to the pre-2016 restrictive conditions

will eliminate or impair access to mifepristone for

abortion, miscarriage management, and the

treatment of other reproductive health conditions.

None of this serves patients, and it imposes higher

27

burdens on our local healthcare systems. The Fifth

Circuit in fact conceded that eliminating access to

mifepristone, even temporarily as the result of its

order, “may pose health risks to women, including

those who use the drug to manage miscarriage,” and

will burden state and local health care systems. Pet.

App. 69a-70a. Disruption and restrictions in accessing

mifepristone

will

certainly

be

devastating,

particularly for those of amici’s residents living in

rural areas or otherwise underserved by medical

facilities and doctors.

Some of amici’s communities that already lack

access to adequate medical care are also home to

populations with maternal mortality rates twice those

of other communities. Access to timely, high-quality,

effective therapeutic care like mifepristone is essential

in these communities to treat miscarriage, to reduce

bleeding and life-threatening hemorrhaging, and to

treat other serious pregnancy and reproductive health

complications. 17 One community is so remote and has

such high rates of life-threatening hemorrhage from

miscarriages that it requires, on average, one medevac

a week. Mifepristone is frequently administered in

that community for miscarriage management and

17 See Yanxia Cao et al., Efficacy of Misoprostol Combined with

Mifepristone on Postpartum Hemorrhage and its Effects on

Coagulation Function, 13 INT. J. CLIN. EXP. MED. 2234 (Apr. 30,

2020); Mara Gordon & Sarah McCammon, A Drug that Eases

Miscarriages is Difficult for Women to Get, NPR (Jan. 10, 2019),

https://www.npr.org/sections/health-shots/2019/01/10/666957368

/a-drug-that-eases-miscarriages-is-difficult-for-women-to-get.

28

remains an essential tool for keeping emergency

incident numbers down. 18

Barriers to accessing mifepristone will also cause

some of the millions who wish to end unwanted or

unviable pregnancies with safe and effective

mifepristone to turn to alternatives outside the

medical system, some of which may be dangerous.

Some will be pushed toward more invasive and latergestational age procedural abortions, which can carry

higher risks. Others will delay care, leading to more

complications, worse health outcomes, and greater

strain on local governments and medical providers.

The impediments to accessing mifepristone for

miscarriage management and various other

reproductive health conditions will strain provider

availability, exacting enormous costs on amici’s

understaffed and underfunded medical facilities.

The FDA’s most recent evidence-based decisions to

allow non-physician health care providers to be

certified prescribers of mifepristone and to permit

remote prescription and by-mail delivery of the drug

have the potential to reduce great disparities in

healthcare delivery. These recent changes are

particularly meaningful to the rural, medically

underserved, and lower-income people in amici’s

jurisdictions. The Fifth Circuit’s decision would take

us back in time and further entrench us in a two-tiered

medical system, where necessary medical care is

18 Honor Macnaughton et al., Mifepristone and Misoprostol for

Early Pregnancy Loss and Medication Abortion, 103 AM. FAM.

PHYSICIAN 473 (2021); Marike Lemmers et al., Medical

Treatment for Early Fetal Death (Less Than 24 Weeks),

COCHRANE DATABASE SYSTEMATIC REVIEWS 25 (June 17, 2019).

29

accessible only to those with the geography or means

to access healthcare despite higher burdens. All of

those harms to pregnant people and communities

should be enough to command this Court’s attention.

But the harms threatened by the Fifth Circuit’s order

extend further—to industry.

The pharmaceutical industry has warned that the

lower courts’ approach would “result in a seismic shift

in the clinical development and drug approval

processes, erecting unnecessary and unscientific

barriers to the approval of lifesaving medicines,

chilling

drug

development

and

investment,

threatening patient access, and destabilizing the

rigorous, well-established, and long-standing drug

approval process.” Pharmaceutical Companies Amicus

Br. at 18, FDA v. Alliance for Hippocratic Medicine,

No. 22A902 (Apr. 14, 2023). The industry will be

significantly disrupted “[i]f every FDA drug approval

decision is subject to an appreciable risk of being

upended by a court based on flawed assessments of

studies, reliance on anecdotes, and judicially added

requirements.” Id. at 26. The Fifth Circuit’s ruling

undermines “the durability of FDA drug approvals”

and

“diminish[es]

the

incentives

for

biopharmaceutical companies to invest in new

medications.” Id. at 20-21.

More specifically, Danco explains that the Fifth

Circuit’s decision will have the effect of removing its

brand-name drug Mifeprex from the market for an

extended period of time (first while Danco prepares,

and the FDA approves, an application to revert to the

2011 labeling and REMS, and then longer while Danco

relabels Mifeprex, implements the modified REMS,

30

recertifies prescribers, and updates its distribution

model). Danco Pet. 35; Danco Br. 53. This type of

disruption in the availability of safe care does not

promote the public interest.

CONCLUSION

For the foregoing reasons and for the reasons

provided by the Petitioners and their other amici, the

judgment of the Fifth Circuit should be reversed.

Respectfully submitted,

JONATHAN B. MILLER

Counsel of Record

AADIKA SINGH

JORDAN L. PHILLIPS

PUBLIC RIGHTS PROJECT

490 43rd Street, #115

Oakland, CA 94609

(510) 738-6788

jon@publicrightsproject.org

Counsel for Amici Curiae

Dated: January 30, 2024

31

ADDITIONAL COUNSEL

YIBIN SHEN

City Attorney

City of Alameda

2263 Santa Clara Avenue, Room #280

Alameda, CA 94501

Attorney for the City of Alameda, California

CHERAN IVERY

City Attorney

301 King Street Suite 1300

Alexandria, VA 22314

Attorney for the City of Alexandria, Virginia

ANNE L. MORGAN

City Attorney

P.O. Box 1546

Austin, TX 78701

Attorney for the City of Austin, Texas

EBONY M. THOMPSON

City Solicitor

100 N. Holliday Street

Baltimore, MD 21202

Attorney for the City of Baltimore, Maryland

LIBBY BAKALAR

City Attorney

300 State Highway

P.O. Box 1388

Bethel, AK 99559

Attorney for the City of Bethel, Alaska

32

ADAM CEDERBAUM

Corporation Counsel

City Hall, Room 615

Boston, MA 02201

Attorney for the City of Boston, Massachusetts

AMY FITZPATRICK

County Solicitor

55 East Court St.

Doylestown, PA 18901

Attorney for the County of Bucks, Pennsylvania

MARY B. RICHARDSON-LOWRY

Corporation Counsel of the City of Chicago

MYRIAM ZRECZNY KASPER

Deputy Corporation Counsel

SUZANNE M. LOOSE

Chief Assistant Corporation Counsel

121 N. LaSalle Street, Room 600

Chicago, IL 60602

Attorneys for the City of Chicago, Illinois

EMILY SMART WOERNER

City Solicitor

801 Plum Street, Room 214

Cincinnati, OH 45202

Attorney for the City of Cincinnati, Ohio

MARK D. GRIFFIN

Chief Legal Officer

601 Lakeside Ave., Room 106

Cleveland, OH 44114

Attorney for the City of Cleveland, Ohio

33

ZACHARY M. KLEIN

Columbus City Attorney

77 North Front Street, 4th Floor

Columbus, OH 43215

Attorney for the City of Columbus, Ohio

KERRY TIPPER

City Attorney

1437 Bannock St., Room 353

Denver, CO 80202

Attorney for the City and County of Denver, Colorado

MATTHEW GIGLIOTTI

City Attorney

414 E. 12th Street, 2300

City Hall

Kansas City, MO 64106

Attorney for Mayor Quinton D. Lucas and the City of

Kansas City, Missouri

HYDEE FELDSTEIN SOTO

City Attorney

DENISE C. MILLS

Chief Deputy City Attorney

VALERIE L. FLORES

Chief Assistant City Attorney

SCOTT MARCUS

Chief Assistant City Attorney

SHAUN DABBY JACOBS

Supervising Assistant City Attorney

200 North Main Street, 8th Floor

Los Angeles, CA 90012

Attorneys for the City of Los Angeles, California

34

MICHAEL HAAS

City Attorney

210 Martin Luther King Jr. Blvd., Room 401

Madison, WI 53703

Attorney for the City of Madison, Wisconsin

BRIAN E. WASHINGTON

County Counsel

3501 Civic Center Dr., Suite 275

San Rafael, CA 94903

Attorney for the County of Marin, California

MARGARET C. DAUN

Corporation Counsel

901 North 9th St., Room 303

Milwaukee, WI 53233

Attorney for Milwaukee County, Wisconsin

KRISTYN ANDERSON

City Attorney

City Hall, Room 210 350

South Fifth Street

Minneapolis, MN 55415

Attorney for the City of Minneapolis, Minnesota

SUSAN BLITCH

Acting County Counsel

1428 Abbott Street

Salinas, CA 93901

Attorney for Monterey County, California

35

JOHN P. MARKOVS

County Attorney

101 Monroe Street, 3rd Floor

Rockville, MD 20850

Attorney for Montgomery County, Maryland

BARBARA J. PARKER

City Attorney

One Frank H. Ogawa Plaza, 6th Floor

Oakland, CA 94612

Attorney for the City of Oakland, California

KRYSIA KUBIAK

City Solicitor and Chief Legal Officer

414 Grant Street

Pittsburgh, PA 15219

Attorney for the City of Pittsburgh, Pennsylvania

ROBERT TAYLOR

City Attorney

1221 SW Fourth Avenue, Room 430

Portland, OR 97204

Attorney for the City of Portland, Oregon

LYNDSEY M. OLSON

City Attorney

400 City Hall & Court House

15 West Kellogg Blvd.

Saint Paul, MN 55102

Attorney for the City of St. Paul, Minnesota

36

MARA W. ELLIOTT

San Diego City Attorney

1200 Third Ave., Suite 1100

San Diego, CA 92101

Counsel for the City of San Diego, California

DELIA GARZA

Travis County Attorney

P.O. Box 1748

Austin, TX 78701

Attorney for Travis County, Texas

MIKE RANKIN

City Attorney

P.O. Box 27210

Tucson, AZ 85726-7210

Attorney for the City of Tucson, Arizona

ELI SAVIT

VICTORIA M. BURTON-HARRIS

P.O. Box 8645

Ann Arbor, MI 48107

Attorneys for Washtenaw County Prosecuting

Attorney’s Office, Michigan

APPENDIX

1a

Appendix A – List of Amici Curiae

Local Governments

City of Alameda, California

City of Alexandria, Virginia

City of Austin, Texas

City of Baltimore, Maryland

City of Bethel, Alaska

City of Boston, Massachusetts

Bucks County, Pennsylvania

City of Chicago, Illinois

City of Cincinnati, Ohio

City of Cleveland, Ohio

City of Columbus, Ohio

City and County of Denver, Colorado

City of Kansas City, Missouri

City of Los Angeles, California

City of Madison, Wisconsin

Marin County, California

Milwaukee County, Wisconsin

City of Minneapolis, Minnesota

Monterey County, California

Montgomery County, Maryland

City of Oakland, California

City of Pittsburgh, Pennsylvania

City of Portland, Oregon

City of St. Paul, Minnesota

City of San Diego, California

Travis County, Texas

City of Tucson, Arizona

2a

Washtenaw County Prosecuting Att’ys Off., Michigan

Local Government Leaders

Jenne Alderks

Councilmember, City of Bothell, Washington

Soli Alpert

Vice Chair, Rent Stabilization Bd., Berkeley, Calif.

Dorcey Applyrs

Chief City Auditor, City of Albany, New York

Rebeca Armendariz

Councilmember, City of Gilroy, California

Valarie Bachelor

Unified School Board Director, Oakland, California

Mary-Ann Baldwin

Mayor, City of Raleigh, North Carolina

Rachel Barnhart

Legislator, Monroe County, New York

Natalie Beyer

Board Member, Durham Public Schools, N. Carolina

Justin M. Bibb

Mayor, City of Cleveland, Ohio

Xouhoa Bowen

Councilmember, City of San Leandro, California

3a

Kendra Brooks

Councilmember At-Large and Minority Leader, City

of Philadelphia, Pennsylvania

Jesse Brown

Councilor, County of Indianapolis, Indiana

Chris Canales

Councilmember, City of El Paso, Texas

Michael Chameides

Supervisor, Columbia County, New York

John Clark

Mayor, Town of Ridgway, Colorado

Tyrona Clark-Murray

Councilmember, City of Jacksonville, Florida

Laura Conover

County Attorney, County of Pima, Arizona

Christine Corrado

Councilmember, Town of Brighton, New York

Mitchel Craig

Mayor, City of Portage, Wisconsin

Crystal Dávila

Trustee of Independent School Dist., Pasadena, Texas

Alix Deslume

Mayor, City of North Miami, Florida

4a

Olgy Diaz

Councilmember, City of Tacoma, Washington

Marilyn Ezzy Ashcrashaft

Mayor, City of Alameda, California

Sommer Foster

Trustee, Canton Township, Michigan

Vanessa Fuentes

Councilwoman, City of Austin, Texas

Megan Green

President of the Bd. of Aldermen, St. Louis, Missouri

Deborah Gonzalez

District Attorney, Western Judicial Circuit, Georgia

Iris Guzman

Deputy Mayor, City of SeaTac, Washington

Beau Harbin

Legislator, Cortland County, New York

Ashley Hartmeier-Prigg

City Councilor, City of Beaverton, Oregon

Jani Hitchen

Councilmember. Pierce County, Washington

Susan Hughes-Smith

Legislator, District 14, Monroe County, New York

5a

Tishaura Jones

Mayor, City of St. Louis, Missouri

Lisa Kaplan

Councilwoman, City of Sacramento, California

Phillip Kramer

Mayor, Franklin Township, New Jersey

Nicole LaChapelle

Mayor, City of Easthampton, Massachusetts

Drew Lawrence

Councilman, New Cumberland Borough,

Pennsylvania

Noah Leigh

School Board Member, City of New Berlin, Wisconsin

Jerald Lentini

Member on Manchester Board of Directors, Town of

Manchester, Connecticut

Sarah Leonardi

School Board Member, Broward County, Florida

Stephanie Loredo

Governing Board Member of Unified School District,

Culver City, California

Quinton D. Lucas

Mayor, City of Kansas City, Missouri

6a

Caity Maple

Vice Mayor, City of Sacramento, California

Alexander Marion

Auditor, City of Syracuse, New York

Dexter McCoy

Commissioner, Fort Bend County, Texas

Ryan Mello

Council Chair, Pierce County, Washington

Christian Menefee

County Attorney, Harris County, Texas

Wayne Messam

Mayor, City of Miramar, Florida

Nancy Metayer Bowen

Commissioner, City of Coral Springs, Florida

William Moehle

Supervisor, Town of Brighton, New York

Sarah Moore

Councilmember, Fayetteville, Arkansas

David O’Keefe

County Commissioner, County of Leon, Florida

Isabel Piedmont-Smith

Councilmember, City of Bloomington, Indiana

7a

Veronica Pillar

Legislator, Tompkins County, New York

Jacqueline “Jack” Porter

Commissioner, City of Tallahassee, Florida

Michael Rodriguez

22nd Ward Alderperson, City of Chicago, Illinois

Kim Roney

Councilmember, City of Asheville, North Carolina

Katie Rosenberg

Mayor, City of Wausau, Wisconsin

Eli Savit

Prosecuting Attorney, Washtenaw County, Michigan

Mike Schmidt

District Attorney, Multnomah County, Oregon

Seema Singh

Councilmember, City of Knoxville, Tennessee

Karen Stegman

Council Member, City of Chapel Hill, North Carolin

April Thanos

Councilmember, City of Gulfport, Florida

Mason Thompson

Mayor, City of Bothell, Washington

8a

Caroline Torosis

Councilmember, City of Santa Monica, California

Katie Valenzuela

Councilmember, City of Sacramento, California

Ginny Welsch

Councilmember, City of Nashville, Tennessee

Christopher Werner

Town Board Member, Town of Brighton, New York

Jared Williams

District Attorney, City of Augusta, Georgia

VanCedric Williams

Unified School Dist. 3 Director, Oakland, California

Kimberly Wilburn

Councilmember, City of Minnetonka, Minnesota

Robin Wilt

Councilmember, Town of Brighton, New York

Cynthia Wirth

School Board Member, Norristown, Pennsylvania

Gregory Young

Supervisor, Fulton County, New York