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

No. 23-235, 23-236

In the

Supreme Court of the United States

________________________________________________

U.S. FOOD AND DRUG ADMINISTRATION, ET AL.,

v.

Petitioners,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

_____________________________________________________

DANCO LABORATORIES, L.L.C.,

v.

Petitioner,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

__________________________________________________________________________

On Writs of Certiorari to the

United States Court of Appeals for the Fifth Circuit

________________________________________________

BRIEF OF AMICUS CURIAE

LIFE LEGAL DEFENSE FOUNDATION

IN SUPPORT OF RESPONDENTS

________________________________________________

CATHERINE SHORT

Counsel of Record

SHEILA A. GREEN

LIFE LEGAL DEFENSE FOUNDATION

PO Box 2105

Napa, CA 94558

(707) 224-6675

kshort@lldf.org

Counsel for Amicus Curiae

i

TABLE OF CONTENTS

TABLE OF CONTENTS ............................................... i

TABLE OF AUTHORITIES ........................................ii

INTERESTS OF AMICUS CURIAE ........................... 1

SUMMARY OF ARGUMENT ..................................... 1

ARGUMENT ................................................................ 3

I.

The FDA’s Removal of Safety Standards

for the Use of Abortion Drugs Causes an

Injury in Fact to the Conscience Rights of

Respondents. ..................................................... 3

A.
Respondents Have Identified Several

Members Who Have Already Been

Harmed and Who Face Imminent Injury

to their Consciences........................................ 3

B.
Federal Conscience Protections Are

Inadequate to Protect the Consciences

of Doctors in the Emergency Context. ........... 8

C.
The Ongoing Adverse Effect of the

FDA’s Decision to Remove Safeguards

Means the Harm to Respondents is Not

Speculative.................................................... 11

II.
Granting Standing to Respondents Will

Not Result in an “Endless Parade of

Suits”................................................................ 17

III.
Aesthetic Harm Is an Additional Basis for

Granting Standing to Respondents. ............... 19

IV.
Respondents Have Established

Associational Standing. .................................. 23

CONCLUSION ........................................................... 23

ii

TABLE OF AUTHORITIES

Cases

A.S.P.C.A. v. Ringling Bros. & Barnum &

Bailey Circus,

317 F.3d 334 (D.C. Cir. 2003) ................................ 19

Am. Bottom Conservancy v. U.S. Army Corps of

Eng’rs,

650 F.3d 652 (7th Cir. 2011) .................................. 20

Animal Legal Def. Fund v. Glickman,

154 F.3d 426 (D.C. Cir. 1998) ................................ 19

Bryant v. Stein, No. 1:23-cv-00077 (M.D. N.C.

filed Jan. 25, 2023) ................................................. 16

Burwell v. Hobby Lobby Stores, Inc.,

573 U.S. 682 (2014) ............................................ 6, 10

Cedar Park Assembly of God of Kirkland v.

Kreidler,

860 Fed. Appx. 542 (9th Cir. 2021) ......................... 6

City of L.A. v. Lyons,

461 U.S. 95 (1983) ............................................ 11, 12

Clapper v. Amnesty Int’l USA,

568 U.S. 398 (2013) ...................................... 2, 16, 17

Clean Wis. v. Env’t. Prot. Agency,

964 F.3d 1145 (D.C. Cir. 2020) .............................. 21

Clemens v. ExecuPharm Inc.,

48 F.4th 146 (3d Cir. 2022) .................................... 18

Ctr. for Biological Diversity v. Env’t. Prot.

Agency,

861 F.3d 174 (D.C. Cir. 2017) ................................ 20

iii

Denney v. Deutsche Bank AG,

443 F.3d 253 (2d Cir. 2006) ................................... 18

Friends of the Earth, Inc. v. Laidlaw Env’t.

Servs. (TOC), Inc,

528 U.S. 167 (2000) ................................................ 20

Fulton v. City of Phila.,

141 S. Ct. 1868 (2021) .............................................. 7

GenBioPro, Inc. v. Raynes, et al.,

No. 3:23-cv-0058, 2023 U.S. Dist. LEXIS

149195 (S.D. W. Va. Aug. 24, 2023) ...................... 16

Hedges v. Obama,

724 F.3d 170 (2d Cir. 2013) ................................... 18

Humane Soc’y. of U.S. v. Hodel,

840 F.2d 45 (D.C. Cir. 1988) .................................. 20

Hunt v. Wash. State Apple Adver. Comm’n.,

432 U.S. 333 (1977) ............................................ 2, 23

Little Sisters of the Poor Saints Peter & Paul

Home v. Pennsylvania,

140 S. Ct. 2367 (2020) .............................................. 6

Lujan v. Defenders of Wildlife,

504 U.S. 555 (1992) ........................................ 2, 3, 11

Maddox v. Bank of N.Y. Mellon Tr. Co.,

19 F.4th 58 (2d Cir. 2021) ...................................... 18

O’Shea v. Littleton,

414 U.S. 488 (1974) .......................................... 11, 12

Ohio Valley Env’t. Coal., Inc. v. Hobet Mining,

LLC,

702 F. Supp. 2d 644 (S.D. W. Va. 2010) ................ 20

iv

Port Arthur Cmty. Action Network v. Tex.

Comm’n. On Env’t. Quality,

86 F.4th 653 (5th Cir. 2023) .................................. 21

Religious Sisters of Mercy v. Azar,

513 F. Supp 3d 1113 (D. N.D. 2021) ........................ 6

Sierra Club v. U.S. Env’t. Prot. Agency,

964 F.3d 882 (10th Cir. 2020) ................................ 21

Summers v. Earth Island Inst.,

555 U.S. 488 (2009) .................................................. 5

Thomas v. Review Bd. of Ind. Emp’t Sec. Div.,

450 U.S. 707 (1981) .................................................. 7

United Food & Commer. Workers Union Local

751 v. Brown Grp.,

517 U.S. 544 (1996) ............................................ 2, 23

Statutes

42 U.S.C. § 238n ....................................................... 8, 9

42 U.S.C. § 300a-7 ........................................................ 8

Weldon Amendment to the Consolidated

Appropriations Act, 2023, Pub. L. No. 117328, § 507(d)(1), 136 Stat. 4459, 4908 ..................... 8

Other Authorities

Aimee Picchi, Abortion Pill: Will Women in

States with Abortion Bans Still Have Access?,

CBS News (June 29, 2022, 6:21 PM),

https://www.cbsnews.com/news/abortion-pillmifepristone-access-in-states-with-abortionbans/ ........................................................................ 15

FACT SHEET: President Biden to Sign

Presidential Memorandum on Ensuring Safe

v

Access to Medication Abortion, The White

House (January 22, 2023),

https://www.whitehouse.gov/briefingroom/statements-releases/2023/01/22/factsheet-president-biden-to-sign-presidentialmemorandum-on-ensuring-safe-access-tomedication-abortion/ (emphasis added) ................ 16

Rachel K. Jones, Elizabeth Nash, Lauren Cross,

Jesse Philbin, Marielle Kirstein, Medication

Abortion Now Accounts for More than Half of

All US Abortion, Guttmacher Institute

(February 24, 2022),

https://www.guttmacher.org/article/2022/02/m

edication-abortion-now-accounts-more-halfall-us-abortions ....................................................... 13

Rachel K. Jones, Marielle Kirstein, Jesse

Philbin, Abortion Incidence and Service

Availability in the United States, 2020,

Guttmacher Institute (November 2022),

https://www.guttmacher.org/article/2022/11/a

bortion-incidence-and-service-availabilityunited-states-2020 .................................................. 13

1

INTERESTS OF AMICUS CURIAE1

Amicus Life Legal Defense Foundation (“Life

Legal”) is a California non-profit 501(c)(3) public

interest legal and educational organization that

works to assist and support those who advocate in

defense of life. Its mission is to give innocent and

helpless human beings of any age, particularly unborn

children, a trained and committed defense against the

threat of death, and to support their advocates in the

nation’s courtrooms. Life Legal believes life begins at

the moment of conception and should not end until

natural death. It litigates cases to protect human life,

from preborn babies targeted by a billion-dollar

abortion industry to the elderly, disabled, and

medically vulnerable denied life-sustaining care.

Amicus opposes all forms of abortion – chemical

as well as medical – as a violation of the right to life

of the unborn child, as well as a detriment to the

health of women and girls, particularly when not

accompanied by commonsense safeguards. Amicus

unequivocally supports doctors’ right of conscience to

refuse to participate in abortion whether directly by

performing them or indirectly by being complicit in

them.

SUMMARY OF ARGUMENT

Respondents,

as

individuals

and

as

organizations, have standing to challenge Petitioner

Food and Drug Administration’s (FDA) removal of

1 No counsel for any party authored this brief in whole or in part;

no party counsel or party made a monetary contribution intended

to fund its preparation or submission; and no person other than

amicus or its counsel funded it.

2

safeguards accompanying the use of abortion drugs

mifepristone and misoprostol. To support Article III

standing, a plaintiff must show, inter alia, that he has

sustained an injury in fact that is concrete and

particularized as well as actual or imminent, not

conjectural or hypothetical. Lujan v. Defenders of

Wildlife, 504 U.S. 555, 560 (1992). An association may

sue on behalf of its members when “(a) its members

would otherwise have standing to sue in their own

right; (b) the interests it seeks to protect are germane

to the organization’s purpose; and (c) neither the

claim asserted nor the relief requested requires the

participation of individual members in the lawsuit.”

Hunt v. Wash. State Apple Adver. Comm’n., 432 U.S.

333, 343 (1977).

Respondents have satisfied the first two prongs

of the Hunt test, and the third is not necessary when

an association is seeking prospective injunctive relief.

United Food & Commer. Workers Union Local 751 v.

Brown Grp., 517 U.S. 544, 545 (1996). Respondent

individual members have already sustained actual

injuries because of having to treat women who are

suffering from complications resulting from the

taking of the abortion drugs, in violation of the

doctors’ moral opposition to participating in elective

abortion. Also, given that it is virtually certain that

women will continue to take these abortion drugs

without proper safeguards and will therefore present

themselves to emergency rooms needing treatment

from complications, there is a “substantial risk” that

the injuries will occur to these pro-life doctors again.

Clapper v. Amnesty Int’l USA, 568 U.S. 398, 414 fn. 5

(2013). Therefore, we urge the Court to uphold the

Fifth Circuit’s decision to grant standing to

Respondents. Pet. App. at 34a-36a.

3

ARGUMENT

I.

The FDA’s Removal of Safety Standards

for the Use of Abortion Drugs Causes an

Injury in Fact to the Conscience Rights of

Respondents.

To establish Article III standing, a plaintiff

must show, inter alia, an injury in fact that is concrete

and particularized as well as actual or imminent, not

conjectural or hypothetical. Lujan, 504 U.S. at 560.

Respondents claim that the FDA’s approval of

mifepristone and misoprostol and subsequent removal

of safeguards in 2016 and 2021 has caused an injury

in fact to their rights of conscience to not participate

in or facilitate abortion and that this injury is

sufficient to support standing.

A.
Respondents Have Identified Several

Members Who Have Already Been

Harmed and Who Face Imminent Injury

to their Consciences.

Petitioners assert that Respondents have not

established injury in fact because they have not

identified any member who faces an imminent

conscience injury. They claim that Respondents have

not explained why federal conscience provisions are

not available to them, that their claim is based on

statistics and a series of contingencies, that it is not

an imminent future injury, and that no injuries have

actually occurred. Brief for the Federal Petitioners

(BFP) at 20-25; Brief for Danco Labs., LLC (BD) at 1929.

Petitioners

misrepresent

Respondents’

conscience claim as well as the scope of the conscience

4

right.2 While Respondents do claim that, at some

future unspecified time, they may have to participate

in the taking of an innocent human life by performing

an abortion, their overall claim in fact is much

broader: they assert that these medications force

them to become “complicit in the elective chemical

abortion” because they will be forced “to remove a

baby with a beating heart or pregnancy tissue as the

only means to save the life of the woman or girl.” Joint

Appendix (JA) at 87 ¶ 296 (emphasis added); Pet. App.

at 119a; JA at 142-43 ¶ 26 (“I am also concerned that

the FDA’s actions will force CMDA members to

complete an unfinished elective abortion in an

emergency situation, causing immediate emotional

and moral distress for our members who are opposed

to elective abortion and do not want to feel complicit

in an immoral, unnecessary procedure.”). They are

thus being forced to finish the abortion that the

medications started. Contrary to Petitioners’ claims

(BD at 22-23, 28), several of the Declarations attached

to the Complaint recount instances of Respondent

doctors having had to complete unfinished abortions.

JA at 163 ¶ 17 (“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”); id. at 164 ¶ 23 (“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.”); id. at 153 ¶ 12 (“one of my patients

. . . had obtained mifepristone and misoprostol from a

2 “Their primary theory is that their members could be forced to

violate their consciences by completing an abortion for a woman

with an ongoing pregnancy.” BFP at 17.

5

website. . . [and] required a dilation and curettage

(D&C) surgery to finish evacuating her uterus of the

remaining pregnancy tissue”)3; id. at 198 ¶ 17 (“I

provided her with intravenous antibiotics and

performed a dilation and curettage procedure” which

saved her life). As these Declarations state, these

doctors already have had to complete abortions,

against their own conscience, to save a woman’s life or

prevent her health from deteriorating further.

This case is thus unlike that of Summers v.

Earth Island Inst., 555 U.S. 488 (2009), relied on by

Petitioners. BFP at 19-20, 22-23; BD at 19-23. In

Summers, this Court rejected the environmental

organizations’ standing claim because they failed to

“make specific allegations establishing that at least

one identified member had suffered or would suffer

harm” (emphasis added) and instead relied upon

statistical probabilities. Here, Respondents have

made specific, personal allegations of harm that have

already occurred to their members, which

distinguishes them from the plaintiffs in Summers

because the latter had not suffered any identified

harms as a result of the government’s action.

Furthermore, the plaintiffs in Summers failed to

allege any “specific and concrete plan” to enjoy the

national forests in question so they failed to establish

likelihood of future harm. Id. at 495. In this case,

Respondent doctors have maintained that they will

continue to treat patients in an emergency context,

thereby subjecting them to the danger of repeated

conscience violations as a result of the FDA’s reckless

removal of safeguards. See Sec. I.C., infra.

Although the FDA has not specifically approved ordering of

abortion drugs from websites, the removal of the requirement of

an in-person visit in order to obtain a prescription has increased

the likelihood that women will go online to obtain them.

6

Petitioners’ objection that Respondents lack

standing because the government’s actions do not

require them to prescribe the abortion drugs or

perform abortions is also without merit. BFP at 16-17;

BD at 35. This Court has long recognized that injuries

to conscience encompass forced complicity, as well as

direct involvement, with the objectionable conduct.

For example, in Burwell v. Hobby Lobby Stores, Inc.,

573 U.S. 682, 719-26 (2014), this Court held that the

Health and Human Services mandate requiring

employers to cover abortifacients in their employee

insurance policy placed a substantial burden upon the

religious beliefs of closely held corporations. This was

so even though the employers did not themselves

perform abortions or directly provide the

abortifacients. It was enough that the government

action required them to be complicit. Id. at 691 (“If the

owners comply with the HHS mandate, they believe

they will be facilitating abortions.”). As this Court

later confirmed, Hobby Lobby held that “the

[contraceptive] mandate, standing alone, violated

RFRA as applied to religious entities with complicitybased objections.” Little Sisters of the Poor Saints

Peter & Paul Home v. Pennsylvania, 140 S. Ct. 2367,

2377 (2020) (emphasis added); see Cedar Park

Assembly of God of Kirkland v. Kreidler, 860 Fed.

Appx. 542, 543 (9th Cir. 2021) (plaintiffs established

injury in fact when, due to the enactment of a state

law, its health insurer stopped offering a plan with

abortion coverage restrictions and the church could

not procure comparable replacement coverage);

Religious Sisters of Mercy v. Azar, 513 F. Supp 3d

1113, 1134 (D. N.D. 2021) (plaintiffs had standing

when a Health and Human Services interpretation of

the Affordable Care Act forced them to choose between

providing insurance coverage for gender transitions or

7

risk loss of federal funding and other penalties; see

also Thomas v. Review Bd. of Ind. Emp’t Sec. Div., 450

U.S. 707, 713-18 (1981) (denial of unemployment

benefits to a worker who quit his job making weapons

violated his First Amendment right to free exercise;

“[w]hile the compulsion may be indirect, the

infringement upon free exercise is nonetheless

substantial”) (emphasis added); Fulton v. City of

Phila., 141 S. Ct. 1868 (2021) (holding that Catholic

Social Services had the right under the Free Exercise

Clause to decline to certify same-sex couples as foster

parents under the City of Philadelphia’s foster care

program).

Petitioners’ nit-picking of what they perceive as

deficiencies in the Respondents’ injury claims (BFP at

20-25; BD at 27-29) cannot undermine those claims.

This Court has stated “Courts should not undertake

to dissect religious beliefs because . . . [a party’s]

beliefs are not articulated with the clarity and

precision that a more sophisticated person might

employ.” Thomas, 450 U.S. at 716. Doctors are

medical professionals, not lawyers or clergy. It is of no

importance whatsoever that Petitioners do not believe

completing an abortion procedure could or should be

as morally troubling to the doctors as prescribing the

abortifacient pills themselves would be—the fact

remains that the doctors have asserted that it is

morally objectionable to them. And that is enough.

The Petitioners themselves refer in their briefs

to the very federal statutes that articulate and

vindicate the Respondents’ broad conscience claim.

BFP at 22-23, BD at 28. The 1973 Church

Amendments forbid requiring any recipient of Health

and Human Services Grants to perform or assist in

sterilization procedures or abortions, to make its

facilities available for such procedures, or to provide

8

personnel for the performance or assistance in such

procedures if that individual or entity is opposed to

the procedures for religious or moral reasons. 42

U.S.C. § 300a-7. The 1996 Coates-Snowe Amendment

to the Public Health Service Act prohibits any federal,

state or local government which receives federal

financial assistance from discriminating against any

health care entity, including individuals, if, among

other things, those individuals refuse to perform,

provide referrals for, or arrange for abortions. 42

U.S.C. § 238n. These conscience protections therefore

extend beyond the actual prescribing of abortion

drugs or performance of abortion on a living child.

The federal government has also prohibited any

federal agency or program, or state or local

government which receives money from the

Departments of Labor, Health and Human Services,

and Education from discriminating against any

individual or institutional health care entity for the

refusal, not merely to perform but to provide for, pay

for, provide coverage of, or refer for abortions.4

B.
Federal Conscience Protections Are

Inadequate to Protect the Consciences

of Doctors in the Emergency Context.

While these federal protections against

complicity in abortion exist on paper, the Fifth Circuit

rightfully questions their true availability in light of

the government’s contrary position in another case.5

4 Weldon Amendment to the Consolidated Appropriations Act,

2023, Pub. L. No. 117-328, § 507(d)(1), 136 Stat. 4459, 4908.

5 The FDA claims that doctors can refuse to provide abortion care

while ignoring the fact that hospitals are bound by the

(continues)

9

Additionally, regardless of whether doctors can in fact

legally refuse to provide abortion-related care, there

are practical realities of the emergency room, where

prompt decisions must be made and staffing can be

limited. Therefore, these federal protections are

inadequate to protect respondents from the moral

quandary that repeatedly ensues from the FDA’s

removal of safeguards.

If a woman with a life-threatening condition or

serious health complication presents herself to the

emergency room, a doctor can in theory

conscientiously refuse to assist her and instead

provide a referral. This option creates two problems.

First, providing a referral is still participating in the

government’s elective abortion regime, to which they

have stated their objection. JA at 87 ¶ 296; 42 U.S.C.

§ 238n. Second, and more relevant in the emergency

room context, there is a risk that the woman’s

condition will worsen, perhaps irreversibly so, while

awaiting a referral. JA at 87 ¶ 296; 173-74 ¶¶ 23-25;

198 ¶ 17. It obviously would violate the conscience of

a pro-life doctor to fail to take action to save the life of

his patient or to cause the patient’s health to decline

because of the delay caused by the referral. The only

other option available to the doctor is to treat the

patient, thereby participating in the elective abortion

regimen. Even if the procedure were necessary at that

point to save the woman’s life, the necessity did not

arise as a result of the pregnancy, which is the only

reason many pro-life doctors would perform, or

facilitate, a procedure which may, as an unwanted

Emergency Medical Treatment and Active Labor Act (EMTALA).

BFP at 23, fn. 3. As the Fifth Circuit noted, the government in

other litigation has taken an inconsistent position on the rights

of doctors to refuse participation. Pet. App. at 32a-34a

10

side effect, cause the untimely death of an unborn

baby. Rather, the emergency at hand resulted from

the woman taking the prescribed drugs without

appropriate safeguards. Thus, both options available

to a doctor when a woman experiences an emergency

after ingesting these medications force the doctor to

be complicit with elective abortion—a position which

they find to be morally reprehensible.

The only scenario for which providing care

would not violate these pro-life doctors’ consciences is

one in which the woman’s life could be saved, and the

baby was still alive. One doctor has averred that she

provided care in just such a situation and saved the

lives of both baby and mother. JA at 173-74 ¶¶ 24-25.

As a result of the FDA’s removal of proper

safeguards for the administering of the abortion drugs

in question, all the options (except the unusual

scenario directly above) presented to the doctors in the

emergency room require them to violate their

consciences. Therefore, the FDA’s actions have placed

a “substantial burden” on the Respondent doctors and

organizations.

In Hobby Lobby, the only alternatives available

to the corporations besides paying for insurance

coverage that would cover abortifacients was to incur

large penalties for not providing the coverage or forego

providing insurance to their employees at all. This

latter option would cause them to incur other

penalties and also would violate their religious beliefs.

This Court held that both options still represented a

substantial burden on the corporations. Hobby Lobby,

573 U.S. at at 720-23.

Like the plaintiffs in Hobby Lobby, the

Respondent doctors have been cornered by the FDA’s

actions. In all but the rarest situations, every

available option presents them with a moral dilemma

11

requiring them to compromise their consciences. The

FDA’s actions therefore have already caused actual,

concrete and particularized injury to the Respondents’

consciences. This satisfies the first prong of the

standing requirements. Lujan, 504 U.S. 560 (“‘injury

in fact’ . . . which is (a) concrete and particularized. . .

and (b) ‘actual or imminent, not conjectural or

hypothetical’”).

C.
The Ongoing Adverse Effect of the FDA’s

Decision to Remove Safeguards Means

the Harm to Respondents is Not

Speculative.

The circumstances that gave rise to the

injury—the FDA’s current reckless chemical abortion

policy and its stated reliance on emergency rooms to

make up for the lack of required follow-up care and in

person

pre-screening6—constitute

“continuing,

present adverse effects” that establish a present case

or controversy. O’Shea v. Littleton, 414 U.S. 488, 49596 (1974) (denying standing where “past exposure” to

constitutional violations was “unaccompanied by any

continuing, present adverse effects” and future injury

would rest on likelihood that respondents would again

be arrested). In City of Los Angeles v. Lyons, 461 U.S.

95 (1983), the petitioner claimed to have been

subjected to a choke hold by police officers although

he had offered no resistance. He was seeking

injunctive relief barring the use of choke holds except

6 See Brief for the Respondents (BFR) at 8-9, 24-26, 40; JA at 384;

Respondent’s Brief in Opposition (RBO) at 25. There is a “Black

Box” warning on the packaging to “[e]nsure that the patient

knows whom to call and what to do, including going to an

Emergency Room if none of the provided contacts are reachable.”

Pet. App. at 219a.

12

in situations where the proposed victim reasonably

appeared to be threatening the immediate use of

deadly force. This Court held that there was no case

or controversy because “[i]t was to be assumed that

‘[plaintiffs] will conduct their activities within the law

and so avoid prosecution and conviction as well as

exposure to the challenged course of conduct.’” Id. at

103 (quoting O’Shea, 414 U.S. 488). Here, the

assumptions implicit in the evidence run counter to

the Petitioners’ position that the claim of future harm

is speculative and counterintuitive.

Petitioners argue six separate, attenuated

steps must happen before Respondents will be

harmed.7 But their steps do not properly represent the

situations.

First, contrary to Federal Petitioner’s claim, it

is not “speculative” that “(i) a woman [will] choose[] to

take mifepristone after consultation with another

provider.” (BFP at 21) Rather, it is virtually certain

that this will occur to women all over the United

States—because abortion providers are prescribing

these medicines daily nationwide. There is no reason

to believe the use of chemical abortion drugs by

women seeking to destroy their unborn children will

stop; rather it will likely increase, as it has every year

7 “(i) a woman chooses to take mifepristone after consultation

with another provider; (ii) the woman suffers an exceedingly rare

serious adverse event requiring emergency care; (iii) rather than

returning to the prescribing provider, the woman seeks care from

one of respondents’ members or presents in an emergency room

where a member is working; (iv) when the woman does so, her

pregnancy is still ongoing; (v) it would violate the member’s

conscience to complete an abortion in such urgent circumstances;

and (vi) the member is unable to seek assistance from another

doctor or invoke federal conscience protections and is instead

forced to complete an abortion.” BFP at 21; see BD at 25-26.

13

since 2000.8 The Guttmacher Institute estimates that,

in 2020, over 492,200 pregnancies were ended via

chemical abortion.9 Petitioner Danco asserts that the

only group of women who are relevant to the question

of whether any doctor faces injury are the ones who

were prescribed the abortion drugs after 2016 or 2021

and who would not have otherwise been prescribed

the drug, noting that that this number is not in the

record. BD at 24-25. This assertion is not true. All

women who were prescribed the drugs after 2016 and

2021 did so under the FDA’s riskier protocols, so that

entire group of women is relevant to the question of

injury since all of them would be endangered by the

lack of proper safeguards.

Next, contrary to Petitioners’ claims, it is not

“speculative” that “(ii) the woman suffers an

exceedingly rare serious adverse event requiring

emergency care” or that “(iii) rather than returning to

the prescribing provider, the woman seeks care from

one of respondents’ members or presents in an

emergency room where a member is working.” (BFP

at 21). To the contrary, Danco itself admits—and the

FDA has acknowledged—that 2.9 to 4.6% of women

Medication abortions have continued to increase as a

percentage of all abortions since first approved for use in 2000.

They accounted for 53% of abortions in 2020, up from 39% of

abortions in 2017 and 6% of abortions in 2001. Rachel K. Jones,

Elizabeth Nash, Lauren Cross, Jesse Philbin, Marielle Kirstein,

Medication Abortion Now Accounts for More than Half of All US

Abortion, Guttmacher Institute (February 24, 2022),

https://www.guttmacher.org/article/2022/02/medicationabortion-now-accounts-more-half-all-us-abortions.



Rachel K. Jones, Marielle Kirstein, Jesse Philbin, Abortion

Incidence and Service Availability in the United States, 2020,

Guttmacher Institute (November 2022),

https://www.guttmacher.org/article/2022/11/abortion-incidenceand-service-availability-united-states-2020.

8

14

will require a visit to the emergency room after

ingesting mifepristone (Pet. App. at 18a). That is over

14,000 women per year in the emergency room due

solely to this drug.

These are not “unsupportable” assumptions as

Petitioner Danco claims (BD at 24) but are easily

verified facts, admitted by Petitioners. (Pet. App. at

18a).

It is highly likely that some of these thousands

of women will continue to encounter one of the

Respondent doctors—or one of the doctors in the

Alliance for Hippocratic Medicine. There is no reason

to believe these doctors will cease to be confronted

with women seeking emergency care from taking the

abortion drugs who have retained pregnancy tissue.

The doctors have, in fact, stated that they expect to or

already are experiencing an increasing number of

women who need emergency care since the FDA

removed the safeguards to the dispensing of these

abortion drugs. JA at 120 ¶¶ 11-12; 131-32 ¶¶ 26-31;

148 ¶ 16; 153-55 ¶¶ 10-14; 163 ¶¶ 20-22; 164-65 ¶¶

25-28; 166-67 ¶ 32; 171-72 ¶¶ 14-18; 175 ¶ 29; 181 ¶

18; 185 ¶ 12; 186 ¶ 18; 192 -93 ¶ 18; 197 ¶12; 198-99

¶ 20.

Federal Petitioners’ fourth assertion is that it

is speculative that a woman will present to the

emergency room with an “ongoing pregnancy.” (BFP

at 21). The Respondents’ conscience concerns are not

limited to the situation where the abortion drugs

failed to end to the life of the child. See Sec. I.A, supra.

Nevertheless, this contingency is not speculative

because it has already occurred to one Respondent.

Though her partner was the one who ultimately

completed the abortion on the live child, the patient

was hers also. JA at 154 ¶ 13.

15

The FDA’s final two “speculative” contingencies

(i.e., “(v) it would violate the member’s conscience to

complete an abortion in such urgent circumstances;

and (vi) the member is unable to seek assistance from

another doctor or invoke federal conscience

protections and is instead forced to complete an

abortion”) were addressed in Sections I.A and I.B,

supra. Given the urgency of patients receiving timely

medical care in the emergency context, the doctors are

forced into being complicit in the FDA’s abortion

regimen and exercising their federal conscience rights

could place their patients’ lives or health in jeopardy.

Unless the Petitioners can show an intervening

cause that would significantly decrease the current

numbers of chemical abortions, there is no reason to

believe that the threat to Respondents posed by the

FDA’s actions will not continue. Petitioner Danco’s

claim that state laws banning abortion or regulating

medication abortions will “shrink the already tiny

fraction” of women who will seek emergency room

treatment (BD at 23) fails to take into account the

availability of the telehealth and remote access

options specifically created by the FDA. Women can

also travel out of state to obtain their prescriptions.

As one article noted: “It’s likely that many women will

be able to continue to access medication abortion in

states with abortion bans, although they may face

risks, experts say.”10 Danco’s argument also ignores

that there are two ongoing court cases filed by proabortion advocates for the sole purpose of overriding

state laws regulating and restricting the use of

Aimee Picchi, Abortion Pill: Will Women in States with

Abortion Bans Still Have Access?, CBS News (June 29, 2022, 6:21

PM), https://www.cbsnews.com/news/abortion-pill-mifepristoneaccess-in-states-with-abortion-bans/.

10

16

mifepristone11 as well as the fact that President Biden

issued a Presidential Memorandum that directs the

Secretary of the Department of Health and Human

Services to consider new guidance to support patients,

providers, and pharmacies who wish to legally access,

prescribe, or provide mifepristone—“no matter where

they live.”12 Given these ongoing battles, there is no

reason to assume that the numbers of women seeking

medication abortion and who will need care in the

emergency room will decrease.

Predicting the continuation of the current trend

does not “require guesswork as to how independent

decisionmakers will exercise their judgment.”

Clapper, 568 U.S. at 413 (denying standing to

attorneys and human rights organizations who had no

actual knowledge of the Government’s surveillance

targeting practices and could not possibly know if the

Foreign Intelligence Surveillance Court would grant

authorization to surveil their foreign contacts). This is

because, as previously stated, Petitioners have made

clear that a percentage of women will of necessity seek

out emergency care after taking Mifeprex, and we

know with reasonable certainty how many women

have and will continue to seek out medical abortions.

See fns. 8-9, supra. Therefore, the prospect of

11 GenBioPro, Inc. v. Raynes, et al., No. 3:23-cv-0058, 2023 U.S.

Dist. LEXIS 149195 (S.D. W. Va. Aug. 24, 2023) (appeal

pending); Bryant v. Stein, No. 1:23-cv-00077 (M.D. N.C. filed Jan.

25, 2023).

12
FACT SHEET: President Biden to Sign Presidential

Memorandum on Ensuring Safe Access to Medication Abortion,

The

White

House

(January

22,

2023),

https://www.whitehouse.gov/briefing-room/statementsreleases/2023/01/22/fact-sheet-president-biden-to-signpresidential-memorandum-on-ensuring-safe-access-tomedication-abortion/ (emphasis added).

17

Respondents suffering future injury is not speculative

at all.

Petitioner’s long list of statistical facts that

they claim Respondents need to show in order to

establish standing (BD at 24-27) contradicts the

holding of Clapper, which clearly stated “Our cases do

not uniformly require plaintiffs to demonstrate that it

is literally certain that the harms they identify will

come about. In some instances, we have found

standing based on a ‘substantial risk’ that the harm

will occur.” Id. at 414, fn. 5 (emphasis added)

(citations omitted). Therefore, Respondents have

established injury in fact because the FDA’s actions

pose a “substantial risk” of future harm, injuries have

clearly already occurred, and future injury is not

based on a chain of speculative contingencies as

Petitioners claim.

II.

Granting Standing to Respondents Will

Not Result in an “Endless Parade of

Suits”.

The FDA argues that Respondents have put

forth a “novel theory” of injury based on “stress and

pressure” that would invite a “parade of suits” based

on presumptively spurious claims, at least in the mind

of the FDA. BFP at 26-27. However, as the Fifth

Circuit noted, the stress and pressure are “best

understood as additional to the Doctors’ conscience

injuries, not independent from them.” Pet. App. at

34a-35a. The FDA’s straw man argument depends on

ignoring the parts of the Respondents’ conscience

claim they disagree with. See Sec. I, supra. None of

the FDA’s hypotheticals featuring plaintiffs (i.e.

doctors, lawyers and other professionals) who

supposedly would be unleashed to challenge policies

18

for no reason other than that those policies cause

them stress includes sufficient details upon which to

determine standing. In particular, the examples do

not indicate that the offensive policy might have been

adopted illegitimately, as Respondents in this case are

alleging. JA at 4-8. Nor do the “parade” examples

indicate that the policymaker has specifically

provided that the victims of its bad decision can go to

any of the hypothetical plaintiffs to redress the effects

of the challenged policy, as is the case in this lawsuit.

See BFR at 8-9, 24-26, 40; JA at 384. And the FDA

also fails to address that some circuits have

acknowledged standing based on “emotional or

psychological harm.” Pet. App. at 34a-35a.13

Similarly, Danco argues that granting

Respondents standing would “bless any suit by an

association of healthcare providers challenging any

agency decision that might affect a potential patient.”

BD at 34. Danco argues that Respondents are merely

challenging the FDA because they “dislike” the drugs

which have side effects that require treatment, just

like any other drug. Id. But Respondents have not

alleged that they merely “dislike” chemical abortion

drugs or abortion. And they are not challenging the

13 Maddox v. Bank of N.Y. Mellon Tr. Co., 19 F.4th 58, 65 (2d Cir.

2021) (quoting TransUnion LLC v. Ramirez, 141 S. Ct. 2190,

2211 n.7 (2021)) (“great stress, mental anguish, anxiety, and

distress . . . . are of the sort that TransUnion contemplated might

form the basis for Article III standing”); Clemens v. ExecuPharm

Inc., 48 F.4th 146, 156 (3d Cir. 2022) (present experience of

”emotional distress” sufficient to allege a concrete injury in

identity theft case); see also Denney v. Deutsche Bank AG, 443

F.3d 253, 264 (2d Cir. 2006) (”An injury-in-fact may simply be

the fear or anxiety of future harm“ in a case involving improper

and fraudulent tax counseling); Hedges v. Obama, 724 F.3d 170,

195 (2d Cir. 2013) (fear of future harm that is imminent may

support standing).

19

removal of safeguards because of the dangers side

effects pose to the patients who take them but rather

because of the fact that they will be forced to provide

morally objectionable treatment due to the side effects

of the drugs. In other words, Danco ignores the legally

cognizable conscience claim that Respondents assert

regarding these drugs and elective abortion. And

while it is true that any drug has side effects,

Respondents are alleging that the FDA’s actions in

removing safeguards have increased the incidence of

women experiencing complications who then show up

in the emergency room rather than being treated by

the doctor’s office that initially prescribed the

mediation. Pet. App. at 10A. Like the FDA’s parade

list, Danco’s hypotheticals prove nothing because they

lack factual context, let alone any facts that are

analogous to Respondents’ allegations.

III.

Aesthetic Harm Is an Additional Basis for

Granting Standing to Respondents.

There are numerous cases in which

associational standing has been granted to

organizations whose members have experienced

aesthetic harm due to governmental or private action

affecting the environment or animals. Moreover,

several of these courts have recognized emotional

harm as indicative of aesthetic injury. Animal Legal

Def. Fund v. Glickman, 154 F.3d 426, 430 (D.C. Cir.

1998) (granting standing on the basis of aesthetic

injury when plaintiff experienced “extreme aesthetic

harm and emotional and physical distress” when

viewing primates subjected to inhumane treatment);

A.S.P.C.A. v. Ringling Bros. & Barnum & Bailey

Circus, 317 F.3d 334 (D.C. Cir. 2003) (plaintiff had

standing based on “aesthetic and emotional injury”

20

from viewing elephants who had suffered

mistreatment); Ohio Valley Env’t. Coal., Inc. v. Hobet

Mining, LLC, 702 F. Supp. 2d 644, 648 (S.D. W. Va.

2010) (standing granted on basis of aesthetic injury

when stream pollution deprived plaintiff of “emotional

and spiritual well-being” and “joy” from her outdoor

activities).

Aesthetic injury has been found to exist when

plaintiffs were forced to view dead animals; were

deprived of viewing animal, insect or plant species in

which they had an interest; or experienced reduced

enjoyment of the environment due to governmental

action. Humane Soc’y. of U.S. v. Hodel, 840 F.2d 45,

52 (D.C. Cir. 1988) (granting standing for aesthetic

injuries to organization because “the existence of

hunting on wildlife refuges forces Society members to

witness

animal

corpses

and

environmental

degradation, in addition to depleting the supply of

animals and birds that refuge visitors seek to view.”)

(emphasis added); Am. Bottom Conservancy v. U.S.

Army Corps of Eng’rs, 650 F.3d 652, 657-58 (7th Cir.

2011) (standing granted to birdwatchers to challenge

agency permit that would allow development and thus

“diminish the wildlife population visible to them” and

therefore reduce their pleasure); Ctr. for Biological

Diversity v. Env’t. Prot. Agency, 861 F.3d 174, 183

(D.C. Cir. 2017) (standing where agency authorization

to use pesticide created “demonstrable risk” to beetles

and butterflies that plaintiffs intended to view);

Friends of the Earth, Inc. v. Laidlaw Env’t. Servs.

(TOC), Inc, 528 U.S. 167, 182-83 (2000), remanded to

2000 U.S. App. LEXIS 3705 (environmental groups

had standing because emissions from a wastewater

treatment plant prevented them from fishing,

camping, swimming, canoeing, birdwatching, and

picnicking in affected areas); Sierra Club v. U.S.

21

Env’t. Prot. Agency, 964 F.3d 882, 888 (10th Cir. 2020)

(the Sierra Club had standing partly because its

members experienced diminished visibility of nearby

national parks and wilderness areas because of the

operations of a nearby industrial plant); Clean Wis. v.

Env’t. Prot. Agency, 964 F.3d 1145 (D.C. Cir. 2020)

(environmental group had standing because the

EPA’s challenged rule resulted in an increase in ozone

levels, thereby affecting their ability to engage in

healthy outdoor recreational activities); Port Arthur

Cmty. Action Network v. Tex. Comm’n. On Env’t.

Quality, 86 F.4th 653, 659 (5th Cir. 2023)

(environmental group had standing because of the

negative effect of air pollution on recreational

activities).

If a party’s desire to enjoy nature and to avoid

merely viewing dead or mistreated animals are

cognizable aesthetic interests for environmentalists,

how much more so is the pro-life Respondents’ desire

to avoid complicity in killing preborn children a

cognizable injury, especially if that involves directly

participating in the destruction of unborn life? JA at

154 ¶ 13. Respondent doctors believe in defending “the

sacredness and dignity of human life at all stages.” JA

at 119 ¶ 6; see id. at 134 ¶ 40. Consistent with “sacred

scripture,” they affirm “respect for the sanctity of

human life.” Id. at139 ¶ 6; see id. at 157 ¶ 21. They

are “committed to the care and well-being of their

patients including both pregnant women and their

unborn children . . . [and] are concerned about the

adverse impacts of chemical abortion on their practice

of medicine.” Id. at 126 ¶ 8; 127 ¶ 13. Their deep

spiritual and emotional regard for human life as

inherently valuable is no less important to them and

their medical practices than the environmentalist’s

love of nature. They experience deep spiritual and

22

emotional anguish when they are confronted with

women harmed by chemical abortion and

subsequently have to participate in completing those

abortions: “This causes CMA’s member physicians

much stress and grief, while impeding their ability to

perform their practice of medicine in the manner that

they desire.” Id. at 120-21 ¶ 14; 87 ¶ 296; 142-43

¶¶ 26-27; 167 ¶ 33 (“Unsupervised chemical abortion

is heartbreaking to me because it causes women to

suffer unnecessarily, and my patients deserve quality

medical care.”); id. at 191 ¶ 14 (“They are distressed,

sad, and feel terrible about what they have done.

While it is rewarding to offer these women a chance at

reversing chemical abortion, this is some of the most

emotionally taxing work I have done in my career.”);

id. at 198 ¶ 19 (“When my patients have chemical

abortions, I lose the opportunity to provide these

obstetrical and medical services to care for the woman

and child through pregnancy and bring about a

successful delivery of a new life.”); id. at 200 ¶ 27 (“[I]t

disturbed me that [my patient] was not informed that

it was not normal to bleed for multiple weeks and that

if she had a routine follow-up visit, as required by past

REMS, this situation could have been avoided before

requiring overnight hospitalization.”).

The loss of aesthetic enjoyment and

diminishment of pleasure in the environment due to

having to view dead or mistreated animals, being

unable to view birds and insects, or having to reduce

or eliminate recreational activities cannot be more

constitutionally significant than the emotional

distress

and

“heartbreak”

experienced

by

Respondents, who have had to view similar harms to

human women and babies and who do not wish to be

complicit in those harms any more.

IV.

23

Respondents

Have

Associational Standing.

Established

This Court has held that an association may

sue on behalf of its members when “(a) its members

would otherwise have standing to sue in their own

right; (b) the interests it seeks to protect are germane

to the organization’s purpose; and (c) neither the

claim asserted nor the relief requested requires the

participation of individual members in the lawsuit.”

Hunt, 432 U.S. at 343. This Court has also held that

the third prong is more a matter of “administrative

convenience and efficiency” rather than a necessary

element of “case or controversy within the meaning of

the Constitution.” United Food, 517 U.S. at 556. It

would not be required when, as in the present case, an

association seeks only prospective or injunctive relief.

Id. at 545.

Respondents have satisfied the first prong,

based on their conscience injury (Section I, supra) and

aesthetic injury (Section III, supra). Since, as

Petitioners note, Respondent pro-life organizations

oppose elective surgical or chemical abortion (JA at 912; BFP at 2; BD at 1), the second prong of

associational standing is satisfied as well. Therefore,

Respondent organizations have established that they

have standing to pursue their suit against the FDA.

CONCLUSION

Respondent doctors have established injury in fact

because they have been forced to be complicit in the

FDA’s regimen of elective abortion as a result of the

latter’s relaxation of safeguards in the administering

of the dangerous drugs mifepristone and misoprostol.

The pro-life organizations to which they belong, and

24

which share the doctors’ conscience concerns,

therefore also have standing. Additionally, the doctors

have sustained aesthetic injuries by having to

participate in the taking of human life, which is of

much greater weight than the aesthetic injuries

asserted by environmentalist groups, and on the basis

of which standing is routinely granted to those groups.

There is a substantial risk that these injuries will

recur because the under-regulated use of these drugs

to end human lives creates a continuous and present

threat that women will continue to arrive at

emergency rooms seeking assistance from pro-life

doctors in finishing the job. Federal conscience

protections are inadequate to address the moral

dilemma faced by emergency room doctors in timesensitive emergency situations. Therefore, this Court

should grant standing to the Respondents, and affirm

the Fifth Circuit opinion.

Respectfully Submitted,

CATHERINE SHORT

Counsel of Record

SHEILA A. GREEN

LIFE LEGAL DEFENSE FOUNDATION

PO Box 2105

Napa, CA 94558

(707) 224-6675

kshort@lldf.org

Counsel for Amicus Curiae