Amicus Curiae Brief — Food and Drug Administration, et al., Petitioners v. Alliance for Hippocratic Medicine, et al.
Supreme Court briefFeb 28, 2024
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No. 23-235 & 23-236 VIDED
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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
Court Of Appeals For The Fifth Circuit
---------------------------------♦--------------------------------BRIEF OF WOMEN AND FAMILIES
HARMED BY MIFEPRISTONE AND FORMER
ABORTION PROVIDERS AS AMICI CURIAE
IN SUPPORT OF RESPONDENTS
---------------------------------♦--------------------------------LINDA BOSTON SCHLUETER
Counsel of Record
TRINITY LEGAL CENTER
1150 N. Loop 1604 W., Suite 108-208
San Antonio, Texas 78248
210-274-5274
TLC4Linda@aol.com
Counsel for Amici Curiae
================================================================================================================
COCKLE LEGAL BRIEFS (800) 225-6964
WWW.COCKLELEGALBRIEFS.COM
i
TABLE OF CONTENTS
Page
STATEMENT OF INTEREST OF THE AMICI
CURIAE ............................................................
1
SUMMARY OF THE ARGUMENT .....................
2
ARGUMENT ........................................................
3
I.
THE FDA FAILED IN ITS RESPONSIBILITY TO ENSURE MIFREPRISTONE
WAS SAFE, AND THEREFORE, ITS ACTION WAS ARBITRARY AND CAPRICIOUS........................................................
3
A. The FDA Had Willful Blindness in
Failing to Appropriately Review and
Evaluate the Data and Studies on Mifepristone ..............................................
4
B. Although the FDA Acted in Willful
Blindness and Failed Its Responsibilities, Congress and the States Knew of
the Dangers and Risks of Mifepristone
and Attempted to Provide Warnings .....
7
C. The FDA’s Failures Had a Profound
and Devastating Impact on Women as
They Were Not Given Accurate and
Truthful Information to Make an Informed Decision That Is Required By
This Court ............................................ 14
ii
TABLE OF CONTENTS – Continued
Page
II. CHEMICAL ABORTIONS EXPOSE WOMEN
TO INCREASED RISKS OF PHYSICAL
AND PSYCHOLOGICAL HARM, AND
THEREFORE, THE FDA SHOULD HAVE
PROVIDED ADEQUATE WARNINGS
AND SAFETY MEASURES TO PROTECT WOMEN .......................................... 19
A. Scientific
and
Medical
Studies
Demonstrate That Chemical Abortions Present Increased Risks of Physical and Psychological Problems Thereby
Requiring Adequate Warnings ............... 19
B. Women Attest to the Trauma They Experienced as a Result of the RU-486
Regimen and Wish They Had Been
Given Accurate Information ................ 25
CONCLUSION..................................................... 31
APPENDICES
Appendix A: Affidavit of Leslie Wolbert .............. App. 1
Appendix B: Affidavit of Tammi Morris .............. App. 9
Appendix C: Affidavit of Carol Everett ............. App. 16
Appendix D: Affidavit of Monty Patterson,
father of Holly Patterson ............................... App. 24
iii
TABLE OF AUTHORITIES
Page
CASES
Alliance for Hippocratic Medicine v. FDA, ___
F.3d ___, 2023 U.S. App. LEXIS 8898 (5th Cir.
2023) ................................................................ 4, 5, 15
Gonzales v. Carhart, 550 U.S. 124 (2007) ...................25
Planned Parenthood v. Casey, 505 U.S. 833
(1992), overruled on other grounds, Dobbs v.
Jackson Women’s Health Organization, ___
U.S. ___, 142 S. Ct. 2228 (2022) .................. 14, 15, 25
Planned Parenthood of Indiana, Inc. v. Commissioner, 794 F. Supp. 2d 892 (S.D. Ind. 2011)..... 16, 17
Planned Parenthood v. Rounds, 686 F.3d 889
(8th Cir. 2012)..........................................................17
Women’s Medical Center v. Bell, 248 F.3d 411
(5th Cir. 2001)..........................................................24
STATUTES
5 U.S.C. § 706(2)(A) .......................................................4
21 U.S.C. § 393(b)(1) .....................................................3
21 U.S.C. § 393(b)(2)(B) ................................................3
iv
TABLE OF AUTHORITIES – Continued
Page
OTHER
Aamlid, I. B., Dahl, B., & Sommerseth, E.,
Women’s Experiences with Information Before
Medication Abortion at Home, Support During
the Process and Follow-up Procedures – A
Qualitative Study, 27 J. SWEDISH ASSOC. OF
MIDWIVES 100582 (2021) ...........................................5
Affidavit of Dr. Priscilla Coleman on file with
Trinity Legal Center (2013) ..................... 5, 14, 21-23
American Medical Association Code of Ethics,
Informed Consent, Opinion 2.1.1, available at
https://code-medical-ethics.ama-assn.org/ethicsopinions/informed-consent ......................................16
Coleman, A Tidal Wave of Published Data
(2010), available at https://www.afterabortion.
org/a-tidal-wave-of-published-data/ .........................5
Congressional Staff Report, The FDA and RU486: Lowering the Standard for Women’s
Health, prepared for the Chairman of the
House Subcommittee on Criminal Justice,
Drug Policy and Human Resources, at page 30
(Oct. 2006), available at http://old.usccb.org/
prolife/issues/ru486/SouderStaffReportonRU486.pdf ................................................................. 7-10
CRS Report for Congress, Abortion: Termination
of Early Pregnancy with RU-486 (Mifepristone) at 14 (Feb. 23, 2001) ................................. 26, 27
v
TABLE OF AUTHORITIES – Continued
Page
Dr. Theresa Burke, Psychotherapist and founder
of Rachel’s Vineyard, Address at the American
Association of Pro-Life OB-GYNS (AAPLOG)
meeting entitled “Medical Abortion: New
Emotional and Psychological Landscape”
(Jan. 28, 2011) ............................................. 22, 24, 26
Food and Drug Administration, Mifepristone
U.S. Postmarketing Adverse Events Summary
Through 04/30/2011 (July 2011), available
at http://www.fda.gov/downloads/Drugs/Drug
Safety/PostmarketDrugSafetyInformationfor
PatientsandProviders/UCM263353.pdf ........... 10, 11
Guttmacher Institute, Fact Sheet: Facts on Induced Abortions in the United States (Sept.
2019), available at http://www.guttmacher.org/
sites/default/files/factsheet/fb_induced_abortion.
pdf ...................................................................... 15, 16
Guttmacher Institute, Guttmacher Institute Releases 2020 Abortion Provider Census with
Important Data on US Abortion Landscape
Before the Fall of Roe (Dec. 1, 2022), available
at https://www.guttmacher.org/news-release/2022/
guttmacher-institute-releases-2020-abortionprovider-census-important-data-us ........................31
Guttmacher Institute, Number of Abortions in
the United States Likely to Be Higher in 2023
than in 2020 (Jan. 17, 2024), available at
https://www.guttmacher.org/news-release/2024/
number-abortions-united-states-likely-be-higher2023-2020 ................................................................31
vi
TABLE OF AUTHORITIES – Continued
Page
Kelly, T., et al., Comparing Medical Versus Surgical Termination of Pregnancy at 13–20
Weeks of Gestation: A Randomized Controlled
Trial, 117 BJOG 1512–1520 (2010) ..........................6
Lowenstein L., et al., Psychological Distress
Symptoms in Women Undergoing Medical vs.
Surgical Termination of Pregnancy, 28(1)
General Hospital Psychiatry 43–47 (2006) ..............5
MIFEPREX™ Label, available at http://www.
accessdata.fda.gov/drugsatfda_docs/label/2000/
20687lbl.htm .............................................................8
National Abortion Federation, Facts About Mifepristone (RU-486), available at http://www.
prochoice.org/about_abortion/facts/facts_
mifepristone.html ............................................. 26, 27
National Right to Life, “A Woman’s Right to
Know: Casey-style Informed Consent Laws,”
(2018), available at https://www.nrlc.org/uploads/stateleg/WRTKFactSheet.pdf........................11
Rafferty, K. A., & Longbons, T., #AbortionChangesYou: A Case Study to Understand the Communicative Tensions in Women’s Medication
Abortion Narratives [published online ahead
of print, Jun. 1, 2020], Health Commun. 1‐10
(2020) .........................................................................5
Report of the South Dakota Task Force to Study
Abortion 41-48 (Dec. 2005), available at
http://www.dakotavoice.com/Docs/South%20
Dakota%20Abortion%20Task%20Force%20
Report.pdf .......................................................... 13, 14
vii
TABLE OF AUTHORITIES – Continued
Page
Shuping, Harrison, & Gacek, Medical Abortion
with Mifepristone (RU-486) Compared to Surgical Abortion, available at http://rachelnetwork.
org/images/Medical_Abortion_with_Mifepristone.
pdf ...................................................................... 13, 20
Slade, P., et al., A Comparison of Medical and
Surgical Methods of Termination of Pregnancy: Choice, Psychological Consequences,
and Satisfaction with Care, 105 BRITISH J. OBSTETRICS AND GYNECOLOGY 1288-1295 (1998) ....... 5, 6
Texas Department of State Health Services
(DSHS), A Woman’s Right to Know Booklet
(2016), available at https://www.hhs.texas.gov/
sites/default/files/documents/services/health/
women-children/womans-right-to-know.pdf...........12
The Silent Scream, Former Abortionist Bernard
Nathanson, M.D. Warns of RU-486 Dangers,
available at http://www.silentscream.org/ru486drnat.htm .......................................................... 20, 21
1
The Amici respectfully submit this amicus curiae
brief in support of Respondents. This brief supporting
Respondent was prepared by counsel for Amici.1
---------------------------------♦---------------------------------
STATEMENT OF INTEREST
OF THE AMICI CURIAE
The women Amici who have taken RU-486,2 their
families, and former abortion providers have personal
knowledge as to how RU-486 negatively affects women
both physically and psychologically. The women Amici
attest that they were not given accurate and truthful
information about the risks of RU-486. Their interest
is that other women are not misled as they were and
to spare other women and families the grief and pain
associated with RU-486. The Amici are Carol Everett
(Texas) who had an abortion and was also an abortion
provider; Tammi Morris (Pennsylvania) who took RU486; Monty Patterson, whose daughter Holly Patterson
(California) died after taking RU-486; and, Leslie
1
No counsel for a party authored this brief in whole or in
part, and no counsel or party made a monetary contribution intended to fund the preparation or submission of this brief. Trinity
Legal Center is a nonprofit corporation and is supported through
private contributions of donors who have made the preparation
and submission of this brief possible. No person other than Amici,
their counsel, or donors to Trinity Legal Center made a monetary
contribution to its preparation or submission.
2
Throughout this brief, three terms have been used depending on the sources. Mifepristone is the one abortion drug; RU-486
is the two-drug abortion regimen; and, chemical abortion is used
in contrast to surgical abortion.
2
Wolbert (New York) who took RU-486. They urge this
Court to affirm the Court of Appeals for the Fifth Circuit decision.
---------------------------------♦---------------------------------
SUMMARY OF THE ARGUMENT
I.
The FDA must prove that it did not act arbitrarily
or capriciously. The FDA, however, had willful blindness in failing to appropriately review and evaluate
the data and studies on Mifepristone, and therefore,
acted in an arbitrary and capricious manner. A decade
before the FDA reduced its standards and warnings of
Mifepristone, the Congressional Staff Report on RU486 warned of its dangers and risks. Contrary to this
Court’s requirements, women were not given accurate
and truthful information to make an informed decision. Therefore, Amici urge this Court to protect
women and affirm the Court of Appeals’ decision.
II.
The RU-486 regimen used in chemical abortions
expose women to an increased risk of both physical and
psychological harm. This is supported by scientific and
medical studies that demonstrate this increased risk.
In addition, the women Amici attest to the physical
and psychological trauma they experienced as a result
of taking RU-486. Therefore, the lower court’s decision
should be upheld.
---------------------------------♦---------------------------------
3
ARGUMENT
I.
THE FDA FAILED IN ITS RESPONSIBILITY TO ENSURE MIFREPRISTONE WAS
SAFE, AND THEREFORE, ITS ACTION
WAS ARBITRARY AND CAPRICIOUS.
The stated responsibilities of the Food and Drug
Administration (FDA) are to (1) “promote the public
health by promptly and efficiently reviewing clinical
research and taking appropriate action on the marketing of regulated products in a timely manner”;3 and,
(2) “protect the public health by ensuring that . . . human and veterinary drugs are safe and effective.”4
These responsibilities are provided to the public
through the FDA’s website.5
The FDA failed its responsibilities by reducing the
safety standards for Mifepristone and not reviewing
the studies that demonstrate it is a dangerous drug
that can cause serious physical and psychological
harm including death. Had the FDA given “accurate,
science-based health information to the public” as it
was required to do, it would not have reduced the
standards and would have provided better warnings.
3
21 U.S.C. § 393(b)(1).
Id. § 393(b)(2)(B) (emphasis in original) (stating a court
could “hold unlawful and set aside agency action, findings, and
conclusions” that are “arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law”).
5
Food and Drug Administration, available at https://www.
usa.gov/agencies/food-and-drug-administration (2024).
4
4
A. The FDA Had Willful Blindness in Failing
to Appropriately Review and Evaluate
the Data and Studies on Mifepristone.
The FDA’s actions are held to an arbitrary and capricious standard.6 The Court of Appeals for the Fifth
Circuit determined that the FDA failed to carry its
burden that the FDA’s actions were not arbitrary and
capricious.7 The court stated that it had two principal
concerns.8 First, the FDA failed to review the relevant
data.9 Specifically, “it relied on zero studies that evaluated the safety-and-effectiveness consequences of the
2016 Major REMS Changes as a whole,”10 and thereby,
it failed to consider “an important aspect of the problem” when it made its 2016 changes.11
Second, the 2016 changes eliminated the requirement that non-fatal adverse events (complications)
must be reported to the FDA.12 Then in 2021 the FDA
declared that there were no non-fatal adverse reports,
and therefore, concluded that Mifepristone was safe.13
The court of appeals correctly concluded that this “ostrich’s-head-in-the-sand approach is deeply troubling”
6
5 U.S.C. § 706(2)(A).
Alliance for Hippocratic Medicine v. FDA, ___ F.3d ___,
2023 U.S. App. LEXIS 8898 at *46 (5th Cir. 2023).
8
Id.
9
Id.
10
Id. at *47.
11
Id.
12
Id.
13
Id.
7
5
particularly considering FDA’s own documents.14 This
makes the FDA’s actions arbitrary and capricious.
Over the years, there have been many studies
showing the dangers and psychological risks of Mifepristone and chemical abortions.15 But women did not
feel that they had been given adequate information.16
14
Id.
See, e.g., Rafferty, K. A., & Longbons, T., #AbortionChanges
You: A Case Study to Understand the Communicative Tensions in
Women’s Medication Abortion Narratives [published online ahead
of print, Jun. 1, 2020], Health Commun. 1‐10 (2020) (reporting
negative and difficult emotions following chemical abortions were
common, with 38% explicitly stating problems with anxiety, depression, drug abuse, and suicidal thoughts); Lowenstein L., et al.,
Psychological Distress Symptoms in Women Undergoing Medical
vs. Surgical Termination of Pregnancy, 28(1) General Hospital
Psychiatry 43-47 (2006) (finding greater psychological consequences of medical abortion); Slade, P., et al., A Comparison of
Medical and Surgical Methods of Termination of Pregnancy:
Choice, Psychological Consequences, and Satisfaction with Care,
105 BRITISH J. OBSTETRICS AND GYNECOLOGY 1288-1295 (1998) (finding difference between the two methods is the consciousness and
participation of the patient in the medical procedure in a process
that involves blood, pain, and death). See generally Coleman, A
Tidal Wave of Published Data (2010), available at https://www.
afterabortion.org/a-tidal-wave-of-published-data/ (citing hundreds
of studies published in major medicine and psychology journals
throughout the world).
16
See, e.g., Affidavit of Dr. Priscilla Coleman on file with
Trinity Legal Center (2013) (stating “If a woman obtains subsequent information, contradicting that provided by the abortion facility and used as the basis of her earlier abortion decision,
devastating psychological consequences become more probable”);
Aamlid, I. B., Dahl, B., & Sommerseth, E., Women’s Experiences
with Information Before Medication Abortion at Home, Support
During the Process and Follow-up Procedures – A Qualitative
Study, 27 J. SWEDISH ASSOC. OF MIDWIVES 100582 (2021)
15
6
Furthermore, there was a high rate of dissatisfaction
with chemical abortions and the surveyed women
would not choose it again.17
It was egregious enough when the FDA failed to
do its due diligence by not wanting the data, appropriately reviewing it, and considering the studies demonstrating the dangers of Mifepristone. The information
through both data and studies was known from the
FDA’s own information as well as from independent
researchers. Women considering chemical abortion deserve better from government agencies in whom the
public puts its trust to ensure drugs are safe.
However, it was equally egregious because of the
subsequent effect that its failures had. This had a
trickle-down negative effect because doctors did not
provide women with important information concerning the risks of Mifepristone. Thereby, women did not
have the necessary information to make an informed
decision. This Court has correctly required informed
(concluding that women felt information provided for chemical
abortion was inadequate, especially as related to bleeding and
pain).
17
Kelly, T., et al., Comparing Medical Versus Surgical Termination of Pregnancy at 13–20 Weeks of Gestation: A Randomized Controlled Trial, 117 BJOG 1512–1520 (2010) (finding 47%
of women who underwent chemical abortions indicated they
would not choose the method again and 53% felt the procedure
was worse than expected); Slade, P., et al., A Comparison of Medical and Surgical Methods of Termination of Pregnancy: Choice,
Psychological Consequences, and Satisfaction with Care, 105
BRITISH J. OBSTETRICS AND GYNECOLOGY 1288-1295 (1998) (stating
47% of women who had a chemical abortion would not choose the
same procedure again).
7
consent before an abortion. The Amici have indicated
that they did not have this information and they wish
it had been provided to them.18
B. Although the FDA Acted in Willful
Blindness and Failed Its Responsibilities, Congress and the States Knew of
the Dangers and Risks of Mifepristone
and Attempted to Provide Warnings.
Congress Recognized the Dangers of RU-486.
As early as 2006 the FDA knew there were serious
complications with Mifepristone. The Congressional
Staff Report for the House Subcommittee on Criminal
Justice, Drug Policy and Human Resources19 reviewed
what the FDA knew about the dangers and risks of
Mifepristone and its “dismal” outcomes. The Report
concluded that there were “startling adverse effects”20
and a “dismal result.”21
The FDA knew the RU-486 regimen posed a substantial risk to the physical health of women including
18
Affidavits of the women Amici.
Congressional Staff Report, The FDA and RU-486: Lowering the Standard for Women’s Health, prepared for the Chairman
of the House Subcommittee on Criminal Justice, Drug Policy and
Human Resources (Oct. 2006), available at https://aaplog.
wildapricot.org/resources/Souder%20Comm.%20Rprt_RU-486_
October%202006_converted%5B1%5D%20%281%29.pdf.
20
Id. at 30.
21
Id. at 31.
19
8
the risk of death. Both the FDA22 and Danco, the drug
manufacturer,23 acknowledged that RU-486 poses
health risks for women. The Mifeprex drug label
acknowledges that “[n]early all of the women who receive Mifeprex and misoprostol [the RU-486 regimen]
will report adverse reactions, and many can be expected to report more than one such reaction.”24 The
MIFEPREX™ Label listed adverse reactions including
abdominal pain, uterine cramping, nausea, vomiting,
diarrhea, pelvic pain, fainting, headache, dizziness,
and asthenia.25
The Congressional Staff Report cited FDA findings
concerning the physical risks to women taking the RU486 regimen.26 This longer list included: “abdominal
pain; uterine cramping; nausea; headache; vomiting;
22
Id. at 30 (citing FDA findings and reporting adverse reac-
tions).
23
See MIFEPREX™ Label, available at http://www.accessdata.
fda.gov/drugsatfda_docs/label/2000/20687lbl.htm.
24
See MIFEPREX™ Label, available at http://www.accessdata.
fda.gov/drugsatfda_docs/label/2000/20687lbl.htm; Congressional
Staff Report, The FDA and RU-486: Lowering the Standard for
Women’s Health, prepared for the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources, at page 30 (Oct. 2006), available at http://old.usccb.org/
prolife/issues/ru486/SouderStaffReportonRU-486.pdf.
25
MIFEPREX™ Label, available at http://www.accessdata.
fda.gov/drugsatfda_docs/label/2000/20687lbl.htm.
26
Congressional Staff Report, The FDA and RU-486: Lowering the Standard for Women’s Health, prepared for the Chairman
of the House Subcommittee on Criminal Justice, Drug Policy
and Human Resources, at page 30 (Oct. 2006), available at
https://aaplog.wildapricot.org/resources/Souder%20Comm.%20Rprt_
RU-486_October%202006_converted%5B1%5D%20%281%29.pdf.
9
diarrhea; dizziness; fatigue; back pain; uterine hemorrhage; fever; viral infections; vaginitis; rigors
(chills/shaking); dyspepsia; insomnia; asthenia; leg
pain; anxiety; anemia; leucorrhea; sinusitis; syncope;
endrometritis/salpingitis/pelvic inflammatory disease;
decrease in hemoglobin greater than 2 g/dL; pelvic
pain; and fainting.”27
The FDA’s Medical Officer’s review indicated that,
“[m]ore than one adverse event was reported for most
patients. . . . Approximately 23% of the adverse events
in each gestational age group were judged to be severe.”28 The Congressional Staff Report calls these
“startling adverse effects,” which the FDA knew during the RU-486 NDA review process.29
The Report also was concerned about “the incredibly high failure rate of the drug.”30 The FDA knew the
failure rate was averaging 14.6% in the U.S. trial testing the drug through 63 days gestation. The findings
were that 27% had ongoing pregnancies, 43% had incomplete abortions, 10% requested and had surgical
terminations, and the remaining 20% of patients had
surgical terminations performed because of medical
indications directly related to the chemical abortion
procedure.31
27
Id.
Id.
29
Id.
30
Id.
31
Id.
28
10
The Congressional Staff Report stated the “best”
outcome was in the patient group where the pregnancies were less than or equal to 49 days of gestation.32
In this group, the Report stated that 7.9% of patients
required surgical intervention after taking RU-486.33
The Report also stated that as “the gestational age increases, the failure rate of RU-486 increases rapidly, to
17% in the 50-56 days gestation group, and 23% in the
57- 63 days gestation group.”34 The Report concluded
that “By any objective standard, a failure rate approaching eight percent and requiring subsequent surgical intervention as the ‘best’ outcome is a dismal
result.”35
In 2011, the FDA had more data concerning the
adverse consequences of RU-486 and risk of death. The
FDA issued a report on the post-marketing events of
RU-486.36 The FDA reported that there were 2,207 adverse events (complications) in the United States related to the use of RU-486, including hemorrhaging,
blood loss requiring transfusions, serious infections,
and death.37 Among the 2,207 adverse events were 14
32
Id. at 31.
Id.
34
Id.
35
Id.
36
Food and Drug Administration, Mifepristone U.S. Postmarketing Adverse Events Summary Through 04/30/2011 (July
2011), available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
UCM263353.pdf.
37
Id.
33
11
deaths, 612 hospitalizations, 339 blood transfusions,
and 256 infections (including 48 “severe infections”).38
Even without data and studies by independent researchers, the FDA knew of the serious complications
of Mifepristone. Yet in 2016 and 2021, the FDA did not
require the reporting of complications and lowered the
standards. This was willful blindness and a failure of
its responsibilities to protect the public from dangerous drugs.
The States Knew of the Dangers of RU-486
Although the FDA failed its responsibilities, the
states attempted to explain the risks. The Woman’s
Right to Know laws were enacted to protect “a woman’s
right to know the medical risks associated with abortion, its alternatives, and nonjudgmental, scientifically
accurate medical facts about the development of her
unborn child before making this permanent and lifeaffecting decision.”39 Twenty-eight states have enacted
such laws.40
The states’ Departments of Health were responsible for “A Woman’s Right to Know” booklet which was
based on the medical board’s scientific medical
38
Id.
National Right to Life, “A Woman’s Right to Know:
Casey-style Informed Consent Laws,” (2018), available at
https://www.nrlc.org/uploads/stateleg/WRTKFactSheet.pdf (explaining the right to know laws).
40
Id. (providing a chart of state laws).
39
12
evidence concerning RU-486.41 The booklets provided
pictures of the baby at two-week internals and discussed the physical and psychological risks of surgical
and chemical abortion as compared to child birth.42
For example, the Texas Department of State
Health Services (DSHS) produced “A Woman’s Right to
Know” booklet which discusses the risks associated
with chemical abortions.43 Some of these risks include:
nausea, weakness, fever/chills, vomiting, headache, diarrhea or dizziness.44 There can be excessive bleeding
and hemorrhaging requiring blood transfusions or surgery.45 Severe infection is also a known risk following a
chemical abortion and can cause death.46 Three percent of chemical abortions fail and require surgery.47
About five of every 100 procedures results in a woman
going to the emergency room for care and treatment.48
41
For example, the Texas medical board held hearings and
obtained evidence on the risks of abortion.
42
Texas Department of State Health Services (DSHS),
A Woman’s Right to Know Booklet (2016), available at
https://www.hhs.texas.gov/sites/default/files/documents/services/
health/women-children/womans-right-to-know.pdf.
43
Id.
44
Id. at 16.
45
Id.
46
Id.
47
Id.
48
Id.
13
The risks associated with Mifepristone is greater than
that of surgical abortions.49
In the largest government study since Roe, the
South Dakota Task Force held extensive hearings and
heard from medical and scientific experts and postabortive women.50 The Task Force articulated a long
list of physical risks.51 These risks were both shortterm and long-term.52
The Task Force also heard extensive evidence from
distinguished experts and post-abortive women of the
psychological consequences of abortion.53 The Task
Force found that “there is a substantial discrepancy
between current medical and psychological information and the medical and psychological information
conveyed by abortion facilities (including Planned
49
See Shuping, Harrison, & Gacek, Medical Abortion with
Mifepristone (RU-486): Compared to Surgical Abortion (2007), available at https://www.lifeissues.net/writers/shu/shu_06mifepristone_
ru486.html.
50
Report of the South Dakota Task Force to Study Abortion
(Dec. 2005), available at http://www.dakotavoice.com/Docs/South
%20Dakota%20Abortion%20Task%20Force%20Report.pdf.
51
Id. at 48.
52
Id. (finding long-term risks include placenta previa, higher
rates of complications, and pre-term birth in subsequent pregnancies).
53
Report of the South Dakota Task Force to Study Abortion
41-48 (Dec. 2005), available at http://www.dakotavoice.com/Docs/
South%20Dakota%20Abortion%20Task%20Force%20Report.pdf.
14
Parenthood of South Dakota) to their abortion patients.”54
Citing the results of the four largest record-based
studies in the world, the Task Force stated that these
studies “have consistently revealed that women with a
known history of abortion experience higher rates of
mental health problems of various forms when compared to women without a known abortion history.”
The mental health consequences of abortion have included guilt, post-abortion anger and resentment,
anxiety, posttraumatic stress disorder (PTSD), psychological numbing, depression, suicidal ideation, substance abuse, relationship problems, and parenting
problems.55 Although the Task Force was focused on
abortion in general, it is known that the psychological
problems are magnified with chemical abortion.56
C. The FDA’s Failures Had a Profound and
Devastating Impact on Women as They
Were Not Given Accurate and Truthful
Information to Make an Informed Decision That Is Required By This Court.
In Planned Parenthood v. Casey,57 this Court emphasized the need for full, accurate, and truthful
54
Id. at 41.
Id. at 43-46 (citing studies).
56
Affidavit of Dr. Priscilla Coleman on file with Trinity Legal
Center (2013).
57
Planned Parenthood v. Casey, 505 U.S. 833 (1992), overruled on other grounds, Dobbs v. Jackson Women’s Health Organization, ___ U.S. ___, 142 S. Ct. 2228 (2022).
55
15
information so that a woman can make an informed
decision.58 This Court correctly stated that it is important for a woman to have this information because
of the “devastating psychological consequences” of
later realizing that she did not have accurate information or know the truth.59 The FDA’s failures thus
have a profound and devastating impact on women.
When the FDA argues that “Mifepristone is comparable to ‘ibuprofen,’ ”60 it is false and misleading. The
Court of Appeals for the Fifth Circuit correctly determined that “Mifepristone bears no resemblance to
ibuprofen.”61 In coming to this conclusion, the Court of
Appeals reviewed FDA’s own documents and the
“Black Box” warnings which is used when the drug
“may lead to death or serious injury.”62
Abortion statistics also emphasize the need for
accurate and truthful information because of the increased use of Mifepristone and more women are at
risk. Eighteen percent of pregnancies in 2017 ended in
abortion which was approximately 862,320 abortions.63
Chemical abortions accounted for 39% of all abortions
58
Id. at 882.
Id.
60
Alliance for Hippocratic Medicine v. FDA, ___ F.3d ___,
2023 U.S. App. LEXIS 8898 at *27 (5th Cir. 2023).
61
Id.
62
Id.
63
Guttmacher Institute, Fact Sheet: Facts on Induced Abortions in the United States (Sept. 2019), available at http://www.
guttmacher.org/sites/default/files/factsheet/fb_induced_abortion.
pdf.
59
16
in 2017 which was an increase from 29% in 2014.64
Thus, even though the number of abortions decreased,
chemical abortions increased from 5% of all abortions
in 2001 to 39% in 2017.65 With the steady increase in
chemical abortions, it becomes even more important
that women have the facts about the drugs that they
are taking and what side effects and risks may occur.
To do any less would not be informed consent.
From a medical perspective, abortion should mandate informed consent like any other medical procedure. The American Medical Association states that
“Informed consent to medical treatment is fundamental in both ethics and law.”66 Furthermore, it states
that “Patients have the right to receive information
and ask questions about recommended treatments so
that they can make well-considered decisions about
care.”67 Because informed consent is “fundamental,” a
woman needs accurate information at this critical time
in her life.
Similarly from a legal perspective, one court
opined that women should be given factual information about the physical and psychological risks of
the RU-486 regimen.68 The court stated that the
64
Id.
Id.
66
American Medical Association Code of Ethics, Informed
Consent, Opinion 2.1.1, available at https://code-medical-ethics.
ama-assn.org/ethics-opinions/informed-consent.
67
Id.
68
Planned Parenthood of Indiana, Inc. v. Commissioner, 794
F. Supp. 2d 892, 918 (S.D. Ind. 2011).
65
17
purpose of informed consent provisions is to “serve not
only to communicate information that would not necessarily be known to the patient, but also help the
woman to make a fully informed decision.”69 Therefore,
women should know they are exposed to increased
risks of physical and psychological complications by
taking the RU-486 regimen.70
Although this is “fundamental,” Amici contend
and have experienced the fact that women are not
given accurate information.71 Amici Leslie Wolbert
states in her affidavit that no one told her “how scary
it would be to experience this alone at home,” or that
she would feel “a deep loss.”72 She attests that:
These things just weren’t discussed, yet they
had great effects on me then and still do today.
Women need to be counseled about all of their
choices when it comes to an unplanned pregnancy, and not ushered into choosing one that
is most convenient at the time. The truth needs
to be told; it is far too great of a matter for it
to continue to be handled the way it has been.73
69
Id.
Planned Parenthood v. Rounds, 686 F.3d 889, 898 (8th Cir.
2012) (holding disclosure that an increased risk of suicide ideation and suicide is non-misleading and relevant to the patient’s
decision to have an abortion and other psychological distress was
not challenged).
71
See Affidavit of Leslie Wolbert, Appendix A; Affidavit of
Tammi Morris, Appendix B; and Affidavit of Monty Patterson,
Appendix D.
72
Affidavit of Leslie Wolbert, Appendix A, ¶ 22.
73
Id.
70
18
Amici Tammi Morris also lacked information. She
states the clinic said that “my chemical abortion would
be simple, safe, and mostly painless. It would be a little
more than a menstrual cycle. They did not prepare me
for what was to come.”74 She states: “This was unexpected because the clinic only told me the benefits and
not the risks.”75 She said that seeing her dead baby
that she had expelled was devastating.76
Amici Carol Everett was both a consumer and a
provider.77 At one time, she was involved in the operation of four clinics with a fifth scheduled to open and
oversaw 35,000 abortions.78 She was Dallas’ largest
abortion chain owner.79 She attests that abortion facilities lie to women about the physical and psychological
risks and what will actually occur when they take the
drug.80 In addition, the abortion facilities do not speak
accurately that it is a baby but say it is only a “product
of conception,” a “blood clot,” or, a “piece of tissue.”81
This is what causes such psychological trauma because
she sees it is a baby that she has expelled in the toilet
or shower.82
74
Affidavit of Tammi Morris, Appendix B, ¶ 3.
Id. at ¶ 4.
76
Id. at ¶¶ 17, 21.
77
Affidavit of Carol Everett, Appendix C, ¶ 2.
78
Id.
79
Id.
80
Id. at ¶ 22.
81
Id. at ¶ 20.
82
Id. at ¶ 21.
75
19
In the case of Holly Patterson, her father describes
the “pain experience” for their family after Holly took
RU-486.83 He states that “Women need to have accurate and factual information regarding the potential
risks of severe and life threatening side-effects.”84
Holly was not given that information.85 He concludes:
“No woman should risk her life or her health because
she lacks factual and accurate medical abortion information to make a well-informed decision when terminating an early pregnancy with mifepristone (RU-486)
and misoprostol.”86
II.
CHEMICAL ABORTIONS EXPOSE WOMEN
TO INCREASED RISKS OF PHYSICAL AND
PSYCHOLOGICAL HARM, AND THEREFORE, THE FDA SHOULD HAVE PROVIDED
ADEQUATE WARNINGS AND SAFETY
MEASURES TO PROTECT WOMEN.
A. Scientific and Medical Studies Demonstrate That Chemical Abortions Present
Increased Risks of Physical and Psychological Problems Thereby Requiring Adequate Warnings.
Physical Risks of RU-486
In reviewing and assessing the scientific literature, researchers have concluded that there are
83
Affidavit of Monty Patterson, Appendix D, ¶ 3.
Id.
85
Id.
86
Id. ¶ 74.
84
20
increased risks of physical problems with the RU-486
regimen.87 These include: more pain, more nausea or
vomiting, higher failure rate, greater risks of acute
bleeding requiring surgery, post-procedure bleeding
continues for a longer period of time, more women require surgery for persistent bleeding, more total blood
loss, and greater risk of massive, life-threatening hemorrhage.88 They also report that “Mifepristone abortion
has 10 times more risk of death from infection than
surgical abortion and 50 times more risk of death from
infection compared to childbirth.”89
The risks of RU-486 are not only with the current
pregnancy but may be transgenerational. Dr. Bernard
Nathanson, co-founder of the National Association for
the Repeal of Abortion Laws (NARAL) and who presided over 60,000 abortions, warned that if a woman
starts taking the regimen but then changes her mind
and wants to carry the baby to term, the newborn may
have serious deformities.90
In addition, Dr. Nathanson warned there may be
the possibility that disorders could be passed down to
surviving offspring of women who have taken the
87
Shuping, Harrison, & Gacek, Medical Abortion with Mifepristone (RU-486) Compared to Surgical Abortion, available at
http://rachelnetwork.org/images/Medical_Abortion_with_Mifepristone.
pdf.
88
Id.
89
Id. (citations omitted).
90
The Silent Scream, Former Abortionist Bernard Nathanson, M.D. Warns of RU-486 Dangers, available at
http://www.silentscream.org/ru486-drnat.htm.
21
drug.91 “RU-486 is the drug which acts on the female
reproductive system, and anything that does that we
have to be keenly aware of what are called transgenerational effects.”92
Psychological Risks of RU-486
The RU-486 regimen also has increased risks for
psychological problems. In scientific studies, women
rated chemical abortions more stressful and experienced more disruptions in their lives.93 They also experienced a significant decline in self-esteem and higher
PTSD intrusion scores.94
There are at least five major reasons why women
are at greater risk of more severe psychological trauma
with the RU-486 regimen than with a surgical abortion.95 First, the woman has a participatory role with a
chemical abortion which may cause greater psychological trauma.96 This is because the woman is directly responsible for the abortion which may exacerbate guilt
and other negative feelings.97
91
Id.
Id.
93
Affidavit of Dr. Priscilla Coleman on file with Trinity Legal
Center (2013) (citing scientific studies).
94
Id.
95
Id.
96
Id.
97
Id.
92
22
The RU-486 regimen is a very difficult process and
simply adds to emotional consequences. Unlike surgical abortion, the woman acts as the abortionist.98 The
drug is self-administered by her own hand and there is
no one else to blame or project anger on such as the
abortionist or others.99 Because the woman plays an
active role in the procedure and is conscious of each
step, it is more likely that there will be psychological
consequences.100 Here is one of the profound differences between surgical and chemical abortion. In a
surgical abortion, the woman is usually given drugs to
be relaxed or to wake up after the procedure is complete. With RU-486, however, “she will have a memory
of each step and its effects on her body and the body of
her child. She cannot close her eyes to the process and
tell herself that someone else is doing this to her . . .
Simply looking in the mirror can become a triggering
event.”101
Second, chemical abortion requires the woman to
be more alert and involved during the process.102
98
Dr. Theresa Burke, Psychotherapist and founder of Rachel’s Vineyard, Address at the American Association of Pro-Life
OB-GYNS (AAPLOG) meeting entitled “Medical Abortion: New
Emotional and Psychological Landscape” (Jan. 28, 2011).
99
Id.
100
Id.
101
Id.
102
Affidavit of Dr. Priscilla Coleman on file with Trinity Legal Center (2013).
23
Therefore, it is impossible for her to distance herself
psychologically from the abortion.103
Third, there is a greater potential for the woman
to see her expelled unborn child.104 There is no doubt
in her mind that she has taken the life of her unborn
child.
Fourth, although women usually say that they
choose a chemical abortion because it is in the privacy
of her home, it is that privacy that can also lead to
greater trauma.105 This is because the woman is more
likely to be at home and alone. Thus, it is likely that
she is without emotional support at the time of the
abortion.106
Fifth, the woman’s home becomes a trigger point
for negative emotions instead of being a place of refuge.107 This is because she is at home and more specifically in the bathroom. Therefore, her home and the
bathroom are associated with the abortion that she
participated in, in a major and very visual way.
The trauma continues because the woman’s home
becomes a daily trigger. Instead of being a sanctuary
or refuge, the home is a trigger for the abortion
103
Id.
Id.
105
Id.
106
Id.
107
Id.
104
24
experience108 because she is in her home and specifically the bathroom or bedroom. Women who take the
RU-486 regimen do “not have the luxury of using the
normal coping mechanisms, like avoidance of their
abortion clinic and doctors. . . .”109 These coping mechanisms allow her to distance herself from “the painful
reality of what she has done.”110 Therefore, this “traumatic scene will be accessible each time a woman uses
her bathroom, lays on her bed, or any other associations they make while waiting for the pill to do its job.
Her very home becomes a daily trigger to traumatic
feelings and sensations.”111
The courts also have recognized the negative psychological impact that abortion has on women. For example, the Court of Appeals for the Fifth Circuit cited
testimony that abortion as practiced is “almost always
a negative experience for the patient. . . .”112 This
Court has recognized that abortion:
. . . is an act fraught with consequences for
others; for the woman who must live with the
implications of her decision; for the persons
who perform and assist in the procedure; for
108
Dr. Theresa Burke, Psychotherapist and founder of Rachel’s Vineyard, Address at the American Association of Pro-Life
OB-GYNS (AAPLOG) meeting entitled “Medical Abortion: New
Emotional and Psychological Landscape” (Jan. 28, 2011).
109
Id.
110
Id.
111
Id.
112
Women’s Medical Center v. Bell, 248 F.3d 411, 418 (5th
Cir. 2001).
25
the spouse, family, and society which must
confront the knowledge that these procedures
exist, procedures some deem nothing short of
an act of violence against innocent human life;
and depending on one’s beliefs, for the life or
potential life that is aborted.113
More recently, this Court recognized, “whether to
have an abortion requires a difficult and painful moral
decision” and is “fraught with emotional consequences.”114 In addition, women can suffer from depression, regret, guilt, and a loss of self-esteem following
an abortion.115 As Justice Ginsburg wrote, “The Court
is surely correct that, for most women, abortion is a
painfully difficult decision.”116
B. Women Attest to the Trauma They Experienced as a Result of the RU-486
Regimen and Wish They Had Been
Given Accurate Information.
The courts and the scientific research support
the conclusion that there are negative physical and
psychological consequences of abortion on women and
particularly the RU-486 regimen. But it is the real life
113
Planned Parenthood v. Casey, 505 U.S. 833, 852 (1991),
overruled on other grounds, Dobbs v. Jackson Women’s Health
Organization, ___ U.S. ___, 142 S. Ct. 2228 (2022).
114
Gonzales v. Carhart, 550 U.S. 124, 159 (2007).
115
Id.
116
Id. at 184 n.7 (Ginsburg, J., dissenting).
26
experiences of women that bring to light the true impact of this dangerous drug regimen.117
The RU-486 regimen exacerbates the impact because it takes longer than surgical abortion. The RU486 regimen process is generally over a two week period, and therefore, much longer than a surgical abortion which is completed on the same day in
approximately fifteen minutes.118 On Day 1, the patient
reads the Medication Guide, reads and signs the patient agreement, and then swallows three tablets of
Mifeprex in the presence of a health professional.119 On
Day 3, she is supposed to return to the abortion facility
and be examined to determine if she is still pregnant.120 If she is pregnant, she is given two tablets of
117
See, e.g., Affidavit of Leslie Wolbert, attached as App. A;
Affidavit of Tammi Morris, attached as App. B.
118
Dr. Theresa Burke, Psychotherapist and founder of Rachel’s Vineyard, Address at the American Association of Pro-Life
OB-GYNS (AAPLOG) meeting entitled “Medical Abortion: New
Emotional and Psychological Landscape” (Jan. 28, 2011).
119
CRS Report for Congress, Abortion: Termination of Early
Pregnancy with RU-486 (Mifepristone) at 14 (Feb. 23, 2001),
available at http://www.law.umaryland.edu/marshall/crsreports/
crsdocuments/RL30866.pdf (discussing the process and history
of RU-486), see also National Abortion Federation, Facts About
Mifepristone (RU-486), available at http://www.prochoice.org/
about_abortion/facts/facts_mifepristone.html (describing the process).
120
CRS Report for Congress, Abortion: Termination of Early
Pregnancy with RU-486 (Mifepristone) at 14 (Feb. 23, 2001) (discussing the process and history of RU-486), available at
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/
RL30866.pdf.
27
misoprostol.121 However, this is not the experience of
these post-abortive women as they are given a “brown
bag of pills” to be taken at home.122 On Day 14, she is
supposed to return to the abortion facility for a followup visit to confirm the pregnancy has been terminated
and assess the level of bleeding.123 This also may not be
the case if she has had to go to the emergency room due
to hemorrhaging or infection. Just by the mere method
of the RU-486 regimen, the woman’s ordeal is prolonged over at least a two-week period in contrast to
the surgical abortion procedure which is usually over
in 15 minutes.
Although the abortion facility may generally tell a
woman what the regimen will be, the women are not
prepared for what is truly involved. For example, Amici
Leslie Wolbert attests that “Nothing could have prepared me for what I would experience, or the emotional
pain that I would carry for years.”124 She “trusted the
121
Id.
Affidavit of Tammi Morris, attached as App. B. The National Abortion Federation admits that there may not be a second
visit to the clinic but that the drugs may be taken at home. National Abortion Federation, Facts About Mifepristone (RU-486),
available at http://www.prochoice.org/about_abortion/facts/facts_
mifepristone.html.
123
CRS Report for Congress, Abortion: Termination of Early
Pregnancy with RU-486 (Mifepristone) at 14 (Feb. 23, 2001) (discussing the process and history of RU-486), available at
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/
RL30866.pdf.
124
Affidavit of Leslie Wolbert, attached as App. A, ¶ 2.
122
28
clinic.”125 They referred to the baby as “just a blob of
tissue.”126 When the clinic workers counseled her, they
told her about the abortion pill and “how ‘simple’ it was
and that you didn’t have to go through surgery, but
that you would have a heavy period instead.”127
But Leslie quickly learned that what she had been
told was not accurate or truthful information. “It was
the second day that I experienced the worst pain I’ve
ever felt in my life. The experience wasn’t just a heavy
period. I was bleeding like I never knew possible.”128
She goes on to say that “ . . . the cramps were not just
severe --- I thought I was dying because they were so
intense. I was crying hysterically and begging to die
because the pain was more than I could handle. I was
sweating like crazy and on the toilet while throwing up
too.”129 She “was alone, and afraid” and too ashamed to
share with anyone what was truly causing her physical
and emotional pain.130
Leslie also experienced severe hemorrhaging. She
states: “I bled so much that it clogged the drain . . . It
was my baby that was clogging the drain of the shower.
I had to turn off the water, get out, and clean it up
125
Id. at ¶ 4.
Id. at 11.
127
Id. at ¶ 4.
128
Id. at ¶ 8.
129
Id.
130
Id. at ¶ 9.
126
29
myself and then I flushed it down the toilet. It was even
more horrifying than it sounds.”131
In addition, Leslie experienced the trigger problems associated with the RU-486 regimen. She attests:
“This was all done in my own home, in the family bathroom, the family shower, the home where I had to live
after this experience. The emotional pain this caused
made it almost unbearable to be at home after that. I
hated showering and I hated sleeping in my bed, I
hated being around my family, I didn’t want to be there
anymore and tried my best to avoid being home.”132
Leslie’s experience is not unusual.133 Amici Tammi
Morris had a similar experience.134 She was not given
truthful and accurate information about chemical
abortion, and specifically, about what she would experience.135 Although the clinic said that she would expel
“tissue,” she was devastated to see it was a baby, her
baby.136 Seeing her baby sent her “over the emotional
edge. Everything got worse for me. Drinking heavily,
hiding, anger, depression, and suicidal thoughts. I
eventually filed for divorce from my husband. It also
affected my relationship with my son and daughter.”137
131
Id. at ¶¶ 11-12.
Id. at ¶¶ 13-14.
133
For example, see Affidavit of Tammi Morris, attached as
App. B; Affidavit of Carol Everett, attached as App. C.
134
Affidavit of Tammi Morris, attached as App. B.
135
Id. at ¶3.
136
Id. at ¶¶ 3, 17.
137
Id. at ¶ 20.
132
30
Amici Carol Everett says that since 2000 she has
counselled women who have taken RU-486.138 She attests that they have more physical and psychological
problems than women who have surgical abortions.139
They have more severe physical issues including “severe hemorrhaging and pain from RU-486.”140 “In addition, some of the most severe post-abortion syndrome
occurs because the women actually see the baby is being expelled.”141
One woman who was certainly hurt by RU-486
was Holly Patterson who was the first woman in the
United States to die of the drug regimen. Planned
Parenthood had given Holly the unapproved, off-label
RU-486 chemical abortion regimen.142 Holly tragically
died from an infection known as Clostridium sordellii
toxic shock syndrome that was associated with a chemical abortion.143 Holly had not been given accurate and
truthful information concerning the RU-486 regimen
so that she could make an informed decision.144 Mr.
Patterson, Holly’s father, attests that “This has been
such a painful experience for our family. I do not want
to see any other family go through what we have.”145
He states “This was the worst day of my life” as he
138
Affidavit of Carol Everett, Appendix C, ¶ 19.
Id.
140
Id.
141
Id. at ¶ 21.
142
Affidavit of Monty Patterson, attached as App. D, ¶ 2.
143
Id.
144
Id. at ¶ 35.
145
Id. at ¶ 3.
139
31
watched his daughter die.146 Chemical abortion not
only hurts women, it hurts families.
The women Amici attest to the harm of chemical
abortion. But the harm is magnified by the fact that
chemical abortions are rising by large numbers. The
Guttmacher Institute reports that the number of abortions is on the rise, and specifically, in 2020 “Medication abortion accounted for 53% of all abortions,
compared with 39% in 2017.”147 This number is even
greater in 2023.148 Therefore, the FDA’s failing its responsibilities and having willful blindness to the scientific studies demonstrating the physical and
psychological harm of mifepristone is creating undue
harm to women and their families.
---------------------------------♦---------------------------------
CONCLUSION
The data, scientific studies, and personal testimony of women all attest that chemical abortion has
146
Id. at ¶ 13.
Guttmacher Institute, Guttmacher Institute Releases
2020 Abortion Provider Census with Important Data on US Abortion Landscape Before the Fall of Roe (Dec. 1, 2022), available
at https://www.guttmacher.org/news-release/2022/guttmacherinstitute-releases-2020-abortion-provider-census-important-dataus.
148
Guttmacher Institute, Number of Abortions in the United
States Likely to Be Higher in 2023 than in 2020 (Jan. 17, 2024),
available at https://www.guttmacher.org/news-release/2024/
number-abortions-united-states-likely-be-higher-2023-2020.
147
32
serious negative physical and psychological consequences. Therefore, the FDA’s willful blindness in not
reviewing and evaluating the data and studies which
it knew from its own information caused it to fail its
responsibilities and act in an arbitrary and capricious
manner. Women deserve truthful and accurate information to make an informed decision.
Mifepristone and the RU-486 regimen creates
greater risks of both physical and psychological harm
to women than surgical abortion. Thus, the FDA
should have protected women by fulfilling its responsibilities concerning this dangerous drug which has severe risks including death. The FDA’s willful blindness
has caused women sorrow, grief, and regret because
they did not have the needed information. It has also
caused families great pain and sorrow. Thus, Amici
urge this Court to affirm the court of appeal’s decision.
Respectfully submitted,
LINDA BOSTON SCHLUETER
Counsel of Record
TRINITY LEGAL CENTER
1150 N. Loop 1604 W., Suite 108-208
San Antonio, Texas 78248
210-274-5274
TLC4Linda@aol.com
Counsel for Amici Curiae
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.