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

________________________

FOOD AND DRUG ADMINISTRATION, et al.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

_____________________

DANCO LABORATORIES, L.L.C.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

_____________________

On Writs to the United States

Court of Appeals for the Fifth Circuit

_____________________

BRIEF OF UNITED STATES MEDICAL

ASSOCIATION AS AMICUS CURIAE

IN SUPPORT OF RESPONDENTS

_____________________

NATHAN W. KELLUM

Counsel of Record

CENTER FOR

RELIGIOUS EXPRESSION

699 Oakleaf Office Lane,

Suite107

Memphis, TN 38117

(901) 684-5485

nkellum@crelaw.org

Counsel for Amicus Curiae

Julio Gonzalez, M.D.

241 Nokomis Ave. S.

Venice, FL 34285

(941) 441-0310

usemdicalassn@gmail.com

i

TABLE OF CONTENTS

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

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

INTEREST OF AMICUS CURIAE ......................... 1

INTRODUCTION AND SUMMARY OF

ARGUMENT ............................................................. 2

ARGUMENT ............................................................. 5

I. Excludes Physicians from the Process of

Administering Mifepristone When They Should

be Involved ........................................................... 5

A. Mifepristone use poses serious health

risks .……………………...…………………..5

B. Discounting doctor care causes harm........8

II. Constrains Physicians to Participate in

Chemical Abortions When They Would Rather

Not Be Involved ................................................. 13

A. Sets physicians up for failure and

deleterious repercussions ………..………..13

B. Without any means for avoiding the

unconscionable dilemmas cause by

the FDA ……………..………………………17

CONCLUSION ...………..…………………...……….20

ii

TABLE OF AUTHORITIES

Brittany Bernstein, Researcher Decries ‘Increasingly

Politicized Environment’ after Journal Retracts

Pro-Life Studies, (Feb 8, 2024)

https://www.nationalreview.com/news/researcherdecries-increasingly-politicized-environment-afterjournal-retracts-pro-life-studies/ .......................... 19

Isabelle Carlsson, Karin Breding, and P.G. Larson,

Complications Related to Induced Abortion: A

Combined Retrospective and Longitudinal FollowUp Sturdy, 18 BMC WOMEN’S HEALTH (2018),

............................................................................... 10

“We Celebrate Each of These Children”—APRN

Marks 5K Lives Saved, PREGNANCY HELP NEWS,

https://pregnancyhelpnews.com/we-celebrate-eachof-these-children-aprn-marks-5k-lives-saved .... 5, 6

A Guide to Surviving in a Post-Roe World; How to

Have a Medication Abortion ................................. 12

Alliance for Hippocratic Medicine, et al. v. U.S. Food

and Drug Administration, et al., 2:22-CV-223-Z,

(N.D. Tex., Apr. 7, 2023)......................................... 3

Andrea Sonenberg and Diana J. Mason, Maternity

Care Deserts in the US, (January 12, 2023)

https://jamanetwork.com/journals/jama-healthforum/fullarticle/2800629 ..................................... 16

iii

CDCs Abortion Surveillance System FAQs, CDC,

https://www.cdc.gov/reproductivehealth/data_stats

/abortion.htm .......................................................... 9

Complications from Abortions in England:

Comparison of Abortion Notification System Data

and Hospital Episode Statistics 2017 to 2021,

OFFICE OF HEALTH IMPROVEMENT AND

DISPARITIES (Nov. 23, 2023)

https://www.gov.uk/government/statistics/complica

tions-from-abortions-in-england-2017-to2021/complications-from-abortions-in-englandcomparison-of-abortion-notification-system-dataand-hospital-episode-statistics-2017-to2021#:~:text=Table%201%3A%20complication%20

type%20using%20the%20ANS%2C%20England%2

C%202021 ............................................................. 11

Declaration of Dr. Ingrid Skop, Alliance for

Hippocratic Medicine, et al. v. U.S. Food and Drug

Administration, et al.,

(N.D. Tex., Nov. 11, 2022) ..................................... 12

Elizabeth G. Raymond, et. al., TelAbortion;

Evaluation of Direct to Patient Telemedicine

Abortion Service in the United States, 100

CONTRACEPTION (May 24, 2009) .................... 10

iv

FDA Medical Officer’s Review of Amendments 024

and 033, Final Reports for the U.S. Clinical Trials

Inducing Abortion up to 63 Days Gestational Age

and Complete Responses Regarding Distribution

System and Phase 4 Commitments, 8 (Nov. 22,

1999) at

http://www.fda.gov/cder/foi/nda/2000/20687_Mifepr

istone_medr_P1.pdf ................................................ 6

H.R. Subcom. Crim. J., Drug. Pol., and Hum.

Resources Rpt., The FDA and RU-486: Lowering

the Standard for Women’s Health; Prepared for the

Hon. Mark Souder Chairman, Subcommittee on

Criminal Justice, Drug Policy and Human

Resources, 25 (Oct. 2006) ........................................ 7

Information about Mifepristone for Medical

Termination of Pregnancy Through Ten Weeks

Gestation, FOOD AND DRUG ADMINISTRATION,

https://www.fda.gov/drugs/postmarket-drugsafety-information-patients-andproviders/information-about-mifepristone-medicaltermination-pregnancy-through-ten-weeksgestation............................................................ 9, 10

Jestin N. Carlson, et. al, Provider and Practice

Factors Associated with Emergency Physicians

Being Named in a Malpractice Claim, 71 ANN.

EMERG. MED., (Feb 2018)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC57

85561/ .................................................................... 13

v

Joel Silverstein, American College of OB-GYNs Bans

Pro-Life Doctors From Conference; ‘Vague

Explanation’, FOX NEWS, (Mar 1, 2023)

https://www.foxnews.com/media/american-collegeob-gyns-bans-pro-life-doctors-conference-vagueexplanation ........................................................... 18

Luu Doan Ireland, Mary Gatter, & Angela Y. Chen,

Medical Compare with Surgical Abortion for

Effective Pregnancy Termination in the First

Trimester, 126 OBSTET & GYNECOL. (2015) ....... 7, 8

Maarit Niinimaki, et al., Immediate Complications

After Medical Compared With Surgical

Termination of Pregnancy, 114 OBST & GYNEC, 795

(2009) ...................................................................... 7

March of Dimes, Maternity Cares Desert Report. No

where to go: Maternity Care Deserts Across the US.

(2022 Report)

https://www.marchofdimes.org/maternity-caredeserts-report........................................................ 15

Medication Abortion Now Accounts for More Than

Half of All US Abortions, GUTTMACHER

INSTITUTE,

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

ation-abortion-now-accounts-more-half-all-usabortions ........................................................... 8, 11

vi

Michael J, New, A Journal Retracts Three Studies

Showing Health Risks of Chemical Abortions, (Feb

8, 2024) https://www.nationalreview.com/corner/ajournal-retracts-three-studies-showing-healthrisks-of-chemical-abortions/ ................................. 19

Rachel Kingery in Jordan Boyd, American College of

OB-GYNs Bans Pro-Life Doctors From Conference

After they Show Up, THE FEDERALIST, (Feb 28,

2023)

https://thefederalist.com/2023/02/28/americancollege-of-ob-gyns-bans-pro-life-doctors-fromconference-after-they-show-up/ ............................ 18

Rebecca Grant & Elizabeth Isadora Gold, How to

Have a Medication Abortion Where to Find the Pill

and What to Expect., NEW YORK, (updated Jun

28,2022) https://www.thecut.com/article/findabortion-pill-what-toexpect.html?utm_source=Sailthru&utm_medium=

email&utm_campaign=Cover%20Drop%205/23&ut

m_term=NYMag%20-%20Paywall. ...................... 14

Risk Evaluation and Mitigation Strategy (REMS)

Single Shared System for Mifepristone 200MG,

FOOD AND DRUG ADMINISTRATION (Most Recent

Modification May 2021)

https://www.fda.gov/media/164651/download?attac

hment ...................................................................... 9

vii

Sage Retraction Notice, SAGE JOURNALS, (February

5, 2024)

https://journals.sagepub.com/doi/10.1177/23333928

231216699 ............................................................. 19

The Changing Face of Abortion Today; Abortion

Trends Following the Overturn of Roe,

HEARTBEAT INTERNATIONAL, Figure at 11

https://www.heartbeatinternational.org/images/He

artbeatServices/WhitePapers/WhitePaperTheChan

gingFaceofAbortionToday.pdf .............................. 10

1

INTEREST OF AMICUS CURIAE

The United States Medical Association

(“USMA” or “amicus curiae”) is a medical society

representing physicians in the United States of

America, giving them a voice and to their concerns. 1

The amicus curiae extolls the values of compassion,

self-sacrifice, dedication, and excellence in the

practice of medicine ingrained in America’s doctors

throughout their training, and throughout the long

illustrious history of this noble profession. Its core

principles are:

x

x

x

x

To strive for the continuous delivery of the

most compassionate and advanced care for

Americans.

Support the equal standing of all members of

society before the law without favor to any

particular group, whether those individuals

engage our industry as deliverers of care, or its

recipients.

Work to create a legal and administrative

environment that supports America’s practices

and enables physicians to craft the best

possible care for their patients independent of

external influences.

To ensure that, above all, the doctor-patient

relationship reigns supreme, and that no policy

1 In compliance with Supreme Court Rule 37.6, amicus curiae

counsel represents they authored this brief in its entirety and

neither the parties, nor their counsel, nor anyone other than the

amicus and amicus counsel, made a monetary contribution to

fund the preparation or submission of this brief.

2

or rule, or law acts to interfere with the

sanctity of that relationship.

USMA believes the art and science of medicine

perform best when physicians are free to oversee their

own practices and patients are able to independently

design their care with their doctors. The amicus

curiae strives to minimize external influences

imposed on the practice of medicine and the doctorpatient relationship. Above all, USMA serves as

fiduciary to the House of Medicine.

For these reasons the amicus curiae is keenly

interested in this matter before the Court. Of

particular interest to the amicus curiae is the

question of whether Respondents, a group of medical

associations and doctors, have Article III standing to

challenge the wrongful actions of the Federal Drug

Administration (FDA) in removing safeguards on the

use of mifepristone. Some of USMA’s members are

obstetricians and gynecologists, others are emergency

room physicians. All have apprehensions about the

FDA unnecessarily and unduly interfering with

patient care. The amicus curiae contends the FDA

caused Respondents to suffer harm that can be

redressed through legal remedy. USMA has

encountered like harm from the FDA’s actions.

INTRODUCTION AND SUMMARY OF

ARGUMENT

Mifepristone is a synthetic steroid designed to

induce the abortion of an unborn human when used

in conjunction with misoprostol, a prostaglandin

3

medication that causes uterine contractions. 2 The

drug’s potential for harm would seemingly

contemplate caution and restraint on its use. Yet, in

characterizing a pregnancy as a “life threatening

illness,” the FDA fast tracked approval of

mifepristone for new drug authorization (“NDA”).

Alliance for Hippocratic Medicine, at 2-3. 3

At the very least, FDA approval of mifepristone

came with some common-sense safety standards

ensuring medical oversight. But alas, this sense was

fleeting. Over the course of just a few years, the FDA

diminished the role of physicians, eventually

eliminating them from the process altogether, as

though medically trained physicians have nothing to

offer in the administration of this patently dangerous

drug. The FDA only wants physicians to stand by and

ready to clean up the mess created by their exclusion.

On March 29, 2016, the FDA expanded the

approval for mifepristone use by 1) increasing the

maximum estimated gestational age by which

mifepristone could be administered in inducing an

2 The term “unborn human” describes a developing human who

has not yet exited the mother’s womb, a term employed in

deference to the district court’s depiction in this case. See

Alliance for Hippocratic Medicine, et al. v. U.S. Food and Drug

Administration, et al., 2:22-CV-223-Z, 2. n. 1 (N.D. Tex., Apr. 7,

2023).

3 The FDA accomplished this feat under subpart H. a provision

in federal law that allows for accelerated approval of a

medication designed for the treatment of a “life threatening

illness.” 21 C.F.R. § 314.500. Subpart H was subsequently

codified as Risk Evaluation and Mitigation Strategy (“REMS”).

21 U.S.C. § 355-1(a)(1)– (2).

4

abortion from seven weeks to ten weeks gestational

age; 2) reducing the number of required in-person

office visits from three to one; 3) allowing nonphysicians to prescribe and administer the

medication; and 4) eliminating the reporting

requirements for non-fatal adverse events. Id. at 4.

On April 12, 2021, the FDA paved the way for mail

order dispensation of mifepristone during the COVID

pandemic. Id. at 3. Then, later that year, on

December 16, 2021, the FDA declared that it would

permanently allow for mail dispensing of the drug.

Id.

Following the FDA machinations, mifepristone

is now a widely accessible drug with no meaningful

oversight. No one needs an appointment with a doctor

to obtain mifepristone. No one needs to bother with

an ultrasound to order it. Consequently, recipients of

mifepristone are often kept in the dark about the

harms the drug may pose for them, maintaining an

ignorance that could lead to various, avoidable

medical complications that are urgent in nature,

implicating emergency room visits with physicians

who may not have the capacity or the expertise to

properly handle the medical emergency, putting the

physician as well as the patient in great peril.

FDA’s politically driven and arbitrary actions

cannot stand. The measures are injurious and

challengeable, placing unlawful obstacles on

physicians who earnestly wish to care for their

patients.

5

ARGUMENT

The FDA excludes physicians from the

mifepristone process when they should be involved

and constrains them to participate when physicians

would rather not be involved, causing substantial

harm in both respects.

I. Excludes Physicians from the Process of

Administering Mifepristone When They

Should be Involved

A. Mifepristone use poses serious health

risks

As known from the outset of FDA approval of

the medicine, the use of mifepristone, either alone or

coupled with other medications, is rife with physical

risks and potential complications. It is common for

women to experience significant hemorrhaging when

taking mifepristone. “We Celebrate Each of These

Children”—APRN

Marks

5K

Lives

Saved,

PREGNANCY HELP NEWS, (accessed Feb 18, 2024)

https://pregnancyhelpnews.com/we-celebrate-each-ofthese-children-aprn-marks-5k-lives-saved.

Those

using the drug can also present with incomplete

abortions and uterine ruptures. Id. What’s more,

without medical supervision, ectopic pregnancies can

be confused with intrauterine ones and induced for

abortion with the medicine, which can threaten life

6

and necessitate timely intervention of a physician.

Id. 4

While the FDA claims complications with

mifepristone are “rare,” U.S. Food and Drug

Administration, et al. v. Alliance for Hippocratic

Medicine, et al., No. 23-235, pp. 18 & 24 (SCOTUS

Petition, Sep. 8, 2023 [Petition]), even “exceedingly

rare;” id. at 2, 5, & 12, and “extremely rare,” id. at 14

& 24, these events are not unusual. Indeed, a Medical

Officer’s Review Report produced by the FDA found

chemical terminations of pregnancies “had more

adverse events, particularly bleeding, than did

surgical abortion.” FDA Medical Officer’s Review of

Amendments 024 and 033, Final Reports for the U.S.

Clinical Trials Inducing Abortion up to 63 Days

Gestational Age and Complete Responses Regarding

Distribution System and Phase 4 Commitments, 8

(Nov. 22, 1999) (accessed May 5, 2023), at

http://www.fda.gov/cder/foi/nda/2000/20687_Mifepris

tone_medr_P1.pdf.

This report is consistent with other findings on

the topic.

A U.S. Congressional hearing on

mifepristone revealed the prevalence of health

complications, noting “the deaths of six women,

associated with the drug, nine life-threatening

incidents,

232

hospitalizations,

116

blood

transfusions, and 88 case infections. . . added up to a

4 Another increasingly common complication occurs when the

mother changes her mind and does not wish to proceed with the

termination after taking mifepristone, generating the need to

urgently reverse the effects of the medication. Id. The Abortion

Pill Reversal Network (“APRN”) reports having received over

8,300 requests of this nature. Id.

7

total of 1070 adverse reports (AERs) as of April 2006.”

H.R. Subcom. Crim. J., Drug. Pol., and Hum.

Resources Rpt., The FDA and RU-486: Lowering the

Standard for Women’s Health; Prepared for the Hon.

Mark Souder Chairman, Subcommittee on Criminal

Justice, Drug Policy and Human Resources, 25 (Oct.

2006). A 2009 study out of Finland calculated the

incidence of adverse events as “fourfold higher”

amongst medical abortions (22,385 or 20% including

4 deaths) relative to surgical abortions (20,251 or

5.6% including 2 deaths). Maarit Niinimaki, et al.,

Immediate Complications After Medical Compared

With Surgical Termination of Pregnancy, 114 OBST &

GYNEC, 795, Table 2 (2009). 5 Even a study by Planned

Parenthood of Los Angeles drew a similar deduction,

upon evaluating the experience of 30,146 women

seeking terminations with estimated gestational ages

of 9 weeks or less. Luu Doan Ireland, Mary Gatter, &

Angela Y. Chen, Medical Compare with Surgical

Abortion for Effective Pregnancy Termination in the

First Trimester, 126 OBSTET & GYNECOL. 22, 22

(2015). Though 15.9% of the women receiving a

medical abortion were lost to follow up, with

researchers dubiously determining that all women

had uncomplicated and complete abortions, id. at 24,

the study still estimated a 0.7% serious complication

rate amongst medical abortions and an overall

complication rate of 21.6%, the latter being three

5 The authors of the study dismiss the deaths, two of which were

attributed to a subarachnoid hemorrhage and a traffic accident

as not being related to pregnancy, but four others-three suicides

and one homicide-suggest mental health issues that may have

been related to the abortion. Id. at 796.

8

times higher than the overall surgical complications

rate. Id., Table 3.

B. Discounting doctor care causes harm

In the face of all the obvious health risks

surrounding mifepristone usage, the FDA did not see

fit to pursue more extensive regulations or physician

guidance. Rather, to allow for greater, easier access

to the drug, the FDA purged physicians from the

process altogether. But while the FDA achieved its

goal – removing the barrier to mifepristone access it

perceives physicians to be – the agency sacrificed

much, namely, the health and welfare of women

taking the drug.

The

FDA’s

elimination

of

physician

participation in mifepristone usage was systematic

and relatively swift work.

In 2016, the FDA

authorized non-physicians to prescribe the medicine.

It also reduced the number of requisite in-person

visits. Then, in 2021, the FDA executed a coup de

grâce on physician care, permitting mail order of

mifepristone, initially, on a temporary basis, and later

making the change permanent, to keep physicians out

of the loop.

These

changes

were

(unsurprisingly)

impactful.

By 2020, medicine induced abortion

became the most common form of aborting an unborn

human. Medication Abortion Now Accounts for More

Than Half of All US Abortions, GUTTMACHER

INSTITUTE,

(accessed

Feb

17,

2024)

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

on-abortion-now-accounts-more-half-all-us-abortions.

9

According to the Center for Disease Control and

Prevention (“CDC”), “early medication abortion[s]”

accounted for 53% of those reported abortions in 2021,

representing an increase of 137% since 2012. CDCs

Abortion Surveillance System FAQs, CDC, (accessed

Feb

17,

2024)

https://www.cdc.gov/reproductivehealth/data_stats/a

bortion.htm. And the increased usage of mifepristone

correspondingly increased the associated health

risks. Compounding the risks even more, the FDA

allows women to obtain the medicine without an inperson doctor office visit or a screening—or staging—

pre-use ultrasound. Risk Evaluation and Mitigation

Strategy (REMS) Single Shared System for

Mifepristone

200MG,

FOOD

AND

DRUG

ADMINISTRATION (Most Recent Modification May

2021)

(accessed

Feb

18,

2024)

https://www.fda.gov/media/164651/download?attach

ment.

Without physician consult or ultrasound,

women

lack

adequate

information

about

mifepristone, unaware of latent dangers with the

ingestion.

Moreover, the dropping of physician

safeguards works to extend the gestational age of

pregnancies in women taking the drug, to their

detriment. The indication for a mail order is a desire

to undergo a medical termination of an intrauterine

pregnancy through ten weeks (70 days) gestational

age as measured from the first day of the patient’s last

menstrual period. Information about Mifepristone for

Medical Termination of Pregnancy Through Ten

Weeks Gestation, FOOD AND DRUG ADMINISTRATION,

(accessed

Feb

17,

2024)

10

https://www.fda.gov/drugs/postmarket-drug-safetyinformation-patients-and-providers/informationabout-mifepristone-medical-termination-pregnancythrough-ten-weeks-gestation. While an ultrasound is

now deemed superfluous and no longer required for

this assessment, id., studies on safe mifepristone use

anticipate ultrasound staging of the patient’s

pregnancy to ensure proper gestational age. Isabelle

Carlsson, Karin Breding, and P.G. Larson,

Complications Related to Induced Abortion: A

Combined Retrospective and Longitudinal Follow-Up

Sturdy, 18 BMC WOMEN’S HEALTH (2018), at 3;

Elizabeth G. Raymond, et. al., TelAbortion;

Evaluation of Direct to Patient Telemedicine Abortion

Service in the United States, 100 CONTRACEPTION

(May 24, 2009), at 174: According to a white paper by

the APRN, the percentage of women seeking their

services who reported having an ultrasound prior to

taking the abortifacient has steadily diminished from

100% in 2017 to 62% in 2023. The Changing Face of

Abortion Today; Abortion Trends Following the

Overturn of Roe, HEARTBEAT INTERNATIONAL,

Figure

at

11

(accessed

Feb

17,

2024)

https://www.heartbeatinternational.org/images/Hear

tbeatServices/WhitePapers/WhitePaperTheChanging

FaceofAbortionToday.pdf. As a consequence, between

2019 and 2023, the APRN noted a 35% increase in

clients who were beyond ten weeks of gestation when

taking mifepristone. Id., Figure at 7. 6 And as a

recent study out of England confirms, there is a direct

6 APRN routinely deals with patients who present requests for

reversal of their chemical abortion with gestational ages far

beyond those recommended by the FDA at the time they given

mifepristone.

11

correlation between increasing gestational age and

complication rates (~1 per thousand for those under 9

weeks estimated gestational age and ~48 per

thousand in those with estimated gestational ages of

twenty weeks or greater).

Complications from

Abortions in England: Comparison of Abortion

Notification System Data and Hospital Episode

Statistics 2017 to 2021, OFFICE OF HEALTH

IMPROVEMENT AND DISPARITIES, Fig. 3 (Nov.

23,

2023)

(accessed

Feb

17,

2024)

https://www.gov.uk/government/statistics/complicati

ons-from-abortions-in-england-2017-to2021/complications-from-abortions-in-englandcomparison-of-abortion-notification-system-dataand-hospital-episode-statistics-2017-to2021#:~:text=Table%201%3A%20complication%20ty

pe%20using%20the%20ANS%2C%20England%2C%2

02021.

Following the FDA’s efforts to excise

physicians from mifepristone usage, Petitioners boast

that “millions of women have taken mifepristone;”

Petition, at 15. But if true, and the complication rate

lies somewhere between 2% and 20% of cases, as

studies confirm, even with a minimum volume of two

million women their needs – the smallest number

that would earn “millions” a plural designation –

between 40,000 and 400,000 cases of mifepristone

complications have taken place. Alternatively, using

CDC’s estimate of 368,868 early chemical abortions in

2021, Medication Abortion Now Accounts for More

Than Half of All US Abortions, the estimated number

of complications range from 7,377 cases to 73,773

cases in one year. Anecdotally, according to one

12

obstetrician, he has personally cared for over twenty

patients suffering from serious mifepristone

complications necessitating hospitalizations over a

two-year period, as one of seven doctors rotating

coverage in the emergency room in his hospital.

Conversation with Dr. Brent Boles (Feb. 16, 2024).

Additionally, Dr. Ingrid Skop testified that she has

“often treat[ed] patients who [were] admitted through

the hospital’s emergency room with complications

from chemical abortions.” Declaration of Dr. Ingrid

Skop, Alliance for Hippocratic Medicine, et al. v. U.S.

Food and Drug Administration, et al., at 4 (N.D. Tex.,

Nov. 11, 2022).

Abortion advocates are also encouraging

women to stock up on mifepristone, not only so they

may have it for later use, but also to give the drug to

others. A Guide to Surviving in a Post-Roe World;

How to Have a Medication Abortion. The opportunity

for stocking up is available only because of the FDA’s

mail order decision. As one advocate put it “[f]or now,

abortion pills via telemedicine are accessible and

legal;” A Guide to Surviving in a Post Roe World.

In

effect,

the

FDA’s

procedurally

unsubstantiated decisions have wrought a perilous,

wild-west type of system conducive to unsupervised

chemical abortions and other abuses. An alarming

number of women have received mifepristone without

a pre-dispensing ultrasound to ascertain the baby’s

gestational age and to determine whether the

patient’s pregnancy is ectopic or intrauterine. In the

face of this health crisis, it bears remembering:

Physicians play a key role in the health and wellbeing of individuals taking dangerous drugs like

13

mifepristone. They should not be removed from the

process.

II.

Constrains Physicians to Participate in

Chemical Abortions When They Would

Rather Not Be Involved

Neither should physicians be forced to manage

a health crisis created by the FDA’s marginalization

of them.

A. Sets physicians up for failure and

deleterious repercussions

The emergency room setting can be arduous for

physicians – even under the best of circumstances –

due to the urgency of the care, the undifferentiated

patient population, the absence of an established

relationship with most patients, the unstable

conditions that patients present, and the limited time

and resources available to manage the acutely ill and

injured. Jestin N. Carlson, et. al, Provider and

Practice Factors Associated with Emergency

Physicians Being Named in a Malpractice Claim, 71

ANN. EMERG. MED., 71, 158 (Feb 2018)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785

561/. The FDA’s dictates on mifepristone have made

this challenging context considerably more difficult

for physicians, constraining them to work under

intolerable conditions.

The FDA’s reckless actions in 2016 and 2021

sanctioned

virtually

uninhibited

access

to

mifepristone, leading to increasing frequency and

numbers of chemical abortions conducted in the

14

United States, elevating the drug to the abortion

method of choice for most women. This newfound

popularity, in turn, has led to a far greater need for

physicians trained in obstetrics and gynecology to

emergently respond to complications that come with

mifepristone. The increased need is not only due to

the greater number of chemical abortions, but also to

the cavalier way by which this method is carried out.

In the absence of a directive to do otherwise, women

are prone to take mifepristone without consulting a

physician or having an ultrasound.

Moreover,

chemical abortion proponents are encouraging women

to undergo “self-managed abortions” without the

support or supervision of a physician. Rebecca Grant

& Elizabeth Isadora Gold, How to Have a Medication

Abortion Where to Find the Pill and What to Expect.,

NEW YORK, (updated Jun 28,2022) (accessed Feb 18,

2022) https://www.thecut.com/article/find-abortionpill-what-toexpect.html?utm_source=Sailthru&utm_medium=e

mail&utm_campaign=Cover%20Drop%205/23&utm_

term=NYMag%20-%20Paywall. 7

The “self-managed abortion” approach is a

recipe for a health disaster. Without doctor care,

more and more women are taking mifepristone at a

later gestational stage or when its consumption would

7 The full extent of the harm caused by this unsavory advice

cannot be ascertained because patients are often not forthcoming

about their mifepristone use and there are no billing codes

differentiating between medication induced abortions and

miscarriage related conditions. (Conversation with Dr. William

Lile, Feb. 16, 2024). Dr. Lile is a board-certified obstetrician and

gynecologist practicing in Florida and a member of the Abortion

Pill Rescue Network.

15

otherwise be harmful, prompting mifepristone

complications that tend to overwhelm the capacity of

emergency rooms and their physicians.

The

predicament is further exacerbated by the predatorial

market for mifepristone, with advocates of the drug

telling women to keep their use of mifepristone under

wraps. There are numerous reports of women falsely

denying use of mifepristone when presenting in the

emergency room. (Conversations with Dr. DM, 8 Dr.

HB, 9 and Dr. Brent Boles. 10) In an environment

where the medication is taken in a manner

inconsistent with medical recommendations (as well

as FDA’s own procedural policies), and this misuse is

concealed by the patient, the physician is put at a

great disadvantage to provide appropriate care.

This situation is even more dire for numerous

emergency rooms across the country that have no

access to trained obstetricians and gynecologists,

“healthcare deserts” that must rely on physicians who

practice outside of the OB/GYN specialty to treat

patients with emergent mifepristone complications.

March of Dimes, Maternity Cares Desert Report. No

Dr. DM is a board-certified, obstetrician and gynecologist

practicing in Florida. The doctor requested to remain anonymous

because of concerns regarding negative professional standing

repercussion as a result of the views expressed in this document.

9 Dr. HB is a board-certified, obstetrician and gynecologist

practicing in Florida. The doctor requested to remain anonymous

because of concerns regarding negative professional standing

repercussion as a result of the views expressed in this document.

Dr. HB is also a member in good standing of the USMA.

10 Dr. Brent Boles is a board-certified obstetrician and

gynecologist practicing in Florida. He is the Medical Director of

Heartbeat International.

8

16

where to go: Maternity Care Deserts Across the US.

(2022 Report) (accessed February 27, 2024)

https://www.marchofdimes.org/maternity-caredeserts-report. Andrea Sonenberg and Diana J.

Mason, Maternity Care Deserts in the US, (January

12,

2023)

(accessed

February

27,

2024)

https://jamanetwork.com/journals/jama-healthforum/fullarticle/2800629. These emergency rooms

are not equipped to handle the medical traumas

caused by the drug. But, for that matter, no

emergency room is truly equipped to deal with the

dilemma perpetuated by the FDA’s abandonment of

much-needed regulations on mifepristone usage.

Emergency room physicians treating patients who

have taken the drug, covertly or otherwise, are thrust

into an uncontrollable, unpredictable environment

fraught with peril.

And this peril goes beyond the patient. Though

the impact of FDA’s actions on pregnant women

taking mifepristone is profound, it is not isolated. The

FDA’s actions adversely affect emergency room

physicians as well (who are represented by

Respondents and amicus curiae).

Petitioners suggest the emergency room

conditions triggered by the FDA do not negatively

impact physicians because they are not required to

receive or prescribe mifepristone. Petition, at 13. This

view is myopic. FDA actions produce a highly

stressful emergency room environment that places

undue burdens on the doctors working in these

facilities. Physicians aim to successfully treat their

patients and the complications caused by

mifepristone intake without medical oversight sets

17

them up for failure, in situations where they may not

be able to bring their patients back to full health.

Aside from the harm to the patients, these bad results

harm the physicians too, subjecting them to

malpractice claims and costly litigation.

Also, as explained in Respondents’ Brief, the

FDA’s de-regulation of mifepristone can cause some

physicians to go through internal dilemmas, pitting

their profession against their morality in urgent

situations, obliging these doctors to violate their

conscience. See Resp. Brief, pp. 18-21.

These resultant harms to physicians are real, a

by-product of the FDA’s arbitrary and capricious 2016

and 2021 actions.

B. Without any means for avoiding the

unconscionable dilemmas caused by

the FDA

Despite emergency room physicians being

placed in unbearable conditions – not of their own or

any other physician’s making – they are not afforded

an opportunity to opt out. They are forced to proceed

with medical treatment, regardless of their capacity,

competence, and conscience.

Petitioners claim the FDA’s actions do not

harm physicians because they do not require

physicians to treat patients. Petition, at 18. But

physicians are nevertheless required to do their job.

Petitioners ignore state regulations and hospital rules

obliging physicians to treat anyone in need. An

emergency room physician has a duty to care for a

18

patient whose life is in danger regardless of how he or

she got there or the physician’s beliefs about the

appropriateness of the patients’ actions.

Additionally, emergency room physicians are

not well positioned to better their situation in the

current political climate.

Physicians who call

attention to the concerns surrounding FDA’s policies

on mifepristone are subject to harassment,

particularly

within

their

own

professional

communities. Illustrative of this concern, last year in

2023, American College of Obstetrics and

Gynecologist (herein “ACOG”) kept the nation’s

premiere pro-life obstetrics and gynecology

organization, the American Association of Pro-Life

Obstetricians

and

Gynecologists

(herein

“AAPLOG”)—a respondent in this case— from having

a booth at a meeting, despite their having a booth for

fifteen years. In explaining the sudden departure

from practice, ACOG denigrated the organization for

its views, claiming AAPLOG no longer “align[s] with

ACOG’s and APGO’s 11 commitment to the

advancement

of

evidence-based,

scientific

information.” Rachel Kingery in Jordan Boyd,

American College of OB-GYNs Bans Pro-Life Doctors

From Conference After they Show Up, THE

FEDERALIST, (Feb 28, 2023) (accessed Feb 18, 2023)

https://thefederalist.com/2023/02/28/americancollege-of-ob-gyns-bans-pro-life-doctors-fromconference-after-they-show-up/; Joel Silverstein,

American College of OB-GYNs Bans Pro-Life Doctors

From Conference; ‘Vague Explanation’, FOX NEWS,

APGO is the Association of Professors of Obstetrics and

Gynecology.

11

19

(Mar 1,

2023) (accessed Feb

18,

2023)

https://www.foxnews.com/media/american-college-obgyns-bans-pro-life-doctors-conference-vagueexplanation.

Another professional espousing an antimifepristone position was censored for espousing

these views, resulting in retractions of scientific

articles demonstrating higher hospitalization and

complication rates with medical abortions as

compared to surgical abortions. Brittany Bernstein,

Researcher

Decries

‘Increasingly

Politicized

Environment’ after Journal Retracts Pro-Life Studies,

(Feb

8,

2024)

(accessed

Feb

18,

2024)

https://www.nationalreview.com/news/researcherdecries-increasingly-politicized-environment-afterjournal-retracts-pro-life-studies/.

The publisher

alleged that the reason for the retraction was the

absence of a declaration of conflict of interests, but the

conflicts were clearly mentioned on the first page of

each study. Michael J, New, A Journal Retracts Three

Studies Showing Health Risks of Chemical Abortions,

(Feb

8,

2024)

(accessed

Feb

18,

2024)

https://www.nationalreview.com/corner/a-journalretracts-three-studies-showing-health-risks-ofchemical-abortions/.

Short of any allegation of

researcher misconduct, the retractions appear more

politically motivated than scientifically based.

Researcher

Decries

‘Increasingly

Politicized

Environment’. Also peculiar is the delayed timing of

the retractions, as they were announced on February

5, 2024, in the midst of the present appellate process,

for studies published in 2019, 2021, and 2022. Sage

Retraction Notice, SAGE JOURNALS, (February 5,

20

2024)

(accessed

February

19,

2024)

https://journals.sagepub.com/doi/10.1177/233339282

31216699.

In line with this professional bullying, most of

the doctors with whom we spoke about the

mifepristone issue for the purpose of this brief did not

wish to have their names published in the record for

fear of negative repercussions to their career. Only

those physicians who were already openly involved in

advocacy efforts agreed to be named in this amicus

brief.

CONCLUSION

The FDA’s 2016 and 2021 actions egregiously

interfere with the doctor-patient relationship,

divorcing the two, depriving the patient of a doctor,

doing serious harm to both.

Consisting of organizations and physicians

directly and adversely affected by the FDA’s actions,

Respondents demonstrate requisite harm for

standing to challenge them. Similarly affected,

sharing the same concerns, and having a vested

interest in the outcome of this case, amicus curiae

joins Respondents in asking this Court to affirm the

Fifth Circuit’s Order.

21

Respectfully Submitted,

NATHAN W. KELLUM

Counsel of Record

CENTER FOR RELIGIOUS

EXPRESSION

699 Oakleaf Office Lane

Suite 107

Memphis, TN 38117

(901) 684-5485

nkellum@crelaw.org

Counsel for Amicus Curiae

Julio Gonzalez, M.D.

241 Nokomis Ave. S.

Venice, FL 34285

(941) 441-0310

usemdicalassn@gmail.com