NO. 15-274
IN THE

Supreme Court of the United States
WHOLE WOMAN’S HEALTH, ET AL.,
Petitioners,
v.
JOHN HELLERSTEDT, M.D., COMMISSIONER OF THE
TEXAS DEPARTMENT OF STATE HEALTH SERVICES,
ET AL.,
Respondents.
On Writ of Certiorari to the United States Court of
Appeals for the Fifth Circuit
BRIEF OF AMICI CURIAE AMERICAN
ASSOCIATION OF PRO-LIFE OBSTETRICIANS
AND GYNECOLOGISTS, AMERICAN COLLEGE OF
PEDIATRICIANS, CHRISTIAN MEDICAL &
DENTAL ASSOCIATION, CATHOLIC MEDICAL
ASSOCIATION AND PHYSICIANS FOR LIFE IN
SUPPORT OF RESPONDENTS
DAVID A. CORTMAN
STEVEN H. ADEN
KEVIN H. THERIOT
Counsel of Record
ALLIANCE DEFENDING
ALLIANCE DEFENDING
FREEDOM
FREEDOM
1000 Hurricane Shoals
440 1st St., N.W., Suite 600
Road, NE
Washington, DC 20001
Suite D-1100
(202) 393-8690
Atlanta, GA 30043
saden@ADFlegal.org
Counsel for Amici Curiae

 i
TABLE OF CONTENTS
TABLE OF AUTHORITIES ..................................... iii
INTEREST OF AMICI CURIAE ............................... 1
SUMMARY OF ARGUMENT.................................... 3
ARGUMENT
I.

HB2 APPROPRIATELY EXPRESSES TEXAS'S
CONSTITUTIONAL
INTEREST
IN
SAFEGUARDING WOMEN'S HEALTH AND
MAINTAINING MEDICAL STANDARDS ..................... 4
A. Abortion, Like Many Outpatient
Procedures, Carries Inherent Serious
Risks .............................................................. 6
B. Drug-Induced
Abortion
Carries
Greater Risks than Surgical Abortion.......... 9
C. Recognizing these Risks, Texas has
Taken Appropriate Steps to Safeguard
Women’s Health and Safety by
Regulating Abortion in a Manner
Consistent With Other Outpatient
Procedures. .................................................. 17
1. Texas's
Prior
Regulation
of
Abortion Facilities ................................ 17
2. Texas Reasonably Addressed a
Record of Substandard Outpatient
Abortion Practice. ................................. 19

 ii
3. HB2 Was Intended to Strengthen
Protections for the Health and
Safety
of
Women
Seeking
Abortions. .............................................. 20
II. THE FIFTH CIRCUIT CORRECTLY APPLIED
THE CASEY STANDARD TO UPHOLD HB2'S
OUTPATIENT SURGERY AND ADMITTING
PRIVILEGES REQUIREMENTS. .............................. 22
A. The Ambulatory Surgical Center
Requirements Rationally Relate to
Texas's
Legitimate
Interest
in
Upholding Consistent Standards for
Outpatient Abortion Providers ................... 27
B. The Admitting Privileges Requirement
Rationally
Relates
to
Texas's
Legitimate Interest in Regulating
Outpatient Abortion …………………. ......... 30
CONCLUSION ......................................................... 35

 iii
TABLE OF AUTHORITIES
Cases:
City of Akron v. Akron Center for Reproductive
Health,
462 U.S. 416 (1983)............................................ 25
City of Cleburne v. Cleburne Living Center,
473 U.S. 432 (1985)............................................ 24
Gonzales v. Carhart
550 U.S. 128 (2007)......................... 3, 5, 23, 24,25
Greenville Women’s Clinic v. Bryant,
222 F.3d 157 (4th Cir. 2000) ............................. 25
Harris v. McRae,
448 U.S. 297 (1980)............................................ 27
Karlin v. Foust,
188 F.3d 446 (7th Cir. 1999) ............................. 26
Mazurek v. Armstrong,
520 U.S. 968 (1997).......................... 23, 24, 26, 27
McCleskey v. Kemp,
481 U.S. 279 (1987)............................................ 26
Personnel Administrator of Massachusetts v.
Feeney,
442 U.S. 256 (1979)............................................ 27
Planned Parenthood Association of Kansas City,
Missouri., Inc. v. Ashcroft,

 iv
462 U.S. 476, 504 (1983) .................................. 25
Planned Parenthood Minnesota, North Dakota,
South Dakota v. Rounds,
686 F.3d 889 (8th Cir. 2012) ............................. 26
Planned Parenthood of Greater Texas Surgical
Health Services v. Abbott,
748 F.3d 583 (5th Cir. 2014) ......... 8, 9, 10, 30, 31
Planned Parenthood of Southern Pennsylvania v.
Casey,
505 U.S. 833 (1992)............................. 5, 22-25, 29
Planned Parenthood v. Humble,
753 F.3d 905 (9th Cir. 2014) ............................. 26
Planned Parenthood v. Schimel,
806 F.3d 908 (7th Cir. 2015) ....................... 25, 26
Roe v. Wade,
410 U.S. 113 (1973)............................ 5, 17, 23, 25
Simopoulos v. Virginia,
462 U.S. 506 (2004)................................ 25, 28, 29
Smith v. Doe,
538 U.S. 84 (2003).............................................. 26
Tucson Woman’s Clinic v. Eden,
379 F.3d 531 (9th Cir. 2004) ............................. 26
Washington v. Glucksberg,
521 U.S. 702 (1997).............................................. 5

 v
Whalen v. Roe,
429 U.S. 589, 597 (1977) .................................... 24
Whole Woman’s Health v. Cole,
790 F.3d 563 (5th Cir. 2015) ................................ 9, 29
Whole Woman’s Health v. Lakey,
46 F. Supp. 3d 673 (W.D. Tex. 2014) ........ passim
Williamson v. Lee Optical,
348 U.S. 483 (1955)............................................ 25
Women’s Health Center of West County, Inc. v.
Webster,
871 F.2d 1377 (8th Cir. 1989) ........................... 26
Women’s Medical Professional Corporation v.
Baird,
438 F.3d 595 (6th Cir. 2006) ............................. 26
Legislative Materials:
21 C.F.R. § 314.520 .................................................. 11
42 C.F.R. § 416.41(b) ................................................ 32
25 Tex. Admin. Code § 135.5 ................................... 29
25 Tex. Admin. Code § 139.1 ............................. 18, 19
25 T ex. Admin. Code § 139.40 .......................... 21, 30
47 Fed. Reg. 34082, 34086 ....................................... 32

 vi
Senate Committee on Health & Human Services,
Bill Analysis, Texas H.B. 2, 83d Legislature, 2d C.S.
(2013) ................................................................ passim
Texas Health & Safety Code § 171.004 ................... 18
Texas Health & Safety Code § 171.063 ................... 10
Texas Health & Safety Code § 245.010 ............. 19, 21
Texas Health & Safety Code § 245.004 ................... 19
Texas Health & Safety Code § 243.010 ................... 21
Other Authorities:
A. Filippini, et al., Acute Hemolytic Anemia with
Acanthocytosis Associated with High-dose
Misoprostol for Medical Abortion, 50 Ann.
Emerg. Med. 289 (2006) ........................................... 17
Accreditation Council of Graduate Medical
Education (ACGME), Program Requirements for
Graduate Medical Education in Emergency
Medicine,
eff.
Jul.
1,
2013
http://www.abim.org/certification/policies/combin
edim/comccm.aspx .................................................... 33
ACOG Practice Bulletin 67: Med. Management of
Abortion (Oct. 2005, reaffirmed 2011) ..................... 15
American Association for Accreditation of
Ambulatory Surgery Facilities, Inc. (AAASF)
Surgical Standards 13.0, available at http://
www.aaaasfsurveyors.org/asf_web/PDF%20FILE

 vii
S/ASC%20Standards%20and%20Checklist%20V
ersion%2013.pdf ....................................................... 31
C. Pallardy and S. Becker, 50 Things to Know
About the Ambulatory Surgery Center Industry,
Becker’s ASC Review (Jul. 20, 2013), t
http://www.beckerasc.com/lists/50-things-toknow-about-the-ambulatory-surgery-centerindustry.html ........................................................... 28
Center for Studying Health System Change,
Hospital Emergency On-Call Coverage: Is There
A Doctor in the House? (November 2007),
http://www.hschange.com/CONTENT/956/............. 33
Centers for Disease Control, National Health
Statistics Reports: Ambulatory Surgery in the
United States, No. 11 (Jan. 28, 2009, revised
Sept. 4, 2009). ............................................................. 8
Danco Laboratories, LLC, Risk Evaluation and
Mitigation Strategy (REMS), available at
http://www.accessdata.fda.gov/drugsatfda_docs/r
ems/Mifeprex_2011-0608_REMS%20DOCUMEN
T. pdf ......................................................................... 14
E. Hakim-Elahi, et al., Complications of First
Trimester Abortion: A Report of 170,000 Cases,
76 Obstet. Gynecol. 129 (1990) .................................. 6
F. Cittadini, et al., A Case of Toxic Shock Due to
Clandestine Abortion by Misoprostol Selfadministration, 10 J. Forensic Sci. 59 1662
(2014) ........................................................................ 17

 viii
FDA, Approved Risk Evaluation and Mitigation
Strategies (REMS), available at http://www.
accessdata.fda.gov/scripts/cder/rems/index.cfm ...... 14
FDA, CDER Drug and Biologic Accelerated and
Restricted Distribution Approvals, June 30, 2015,
available
at
http://www.fda.gov/downloads
/Drugs/Development/ApprovalProcess/HowDrugs
areDevelopedandApproved/DrugsandBiologicAp
provalReports/NDAandBLAApprovalReports/UC
M404466.pdf ............................................................. 11
FDA, Mifeprex Approval Letter to Population
Council dated Sep. 28, 2000, http://www.access
data.fda.gov/drugsatfda_docs/appletter/2000/206
87appltr.pdf ........................................................ 12, 15
FDA, Mifeprex (mifepristone) Information, May
17, 2015, available at http://www.fda.gov/
Drugs/DrugSafety/PostmarktDrugSafetyInforma
tionforPatientsandProviders/ucm111323.htm ........ 14
FDA, Mifeprex Medication Guide, available at
http://www.accessdata.fda.gov/drugsatfda_
docs/label/2011/020687s014lbl.pdf .......................... 12
FDA, Mifeprex Questions and Answers, Feb. 24,
2010,
available
at
http://www.fda.gov/
Drugs/DrugSafety/PostmarketDrugSafetyInform
ationforPatientsandProviders/ucm111328.htm ...... 13
FDA, Mifepristone U.S. Postmarketing Adverse
Events Summary Through 04/30/2011 (July
2011) ....................................................................15-16

 ix
Henshaw, S.K. and Finer, L.B., The Accessibility
of Abortion Services in the U.S., 2001, 35
Perspectives on Sexual and Reproductive Health
16 (2003) ................................................................... 16
Incidence of Emergency Department Visits and
Complications After Abortion, 125 Obstet.
Gynecol. (2015) ........................................................... 9
M. Chen and M. Creinin, Mifepristone with
Buccal Misoprostol for Medical Abortion, 126
Obst. & Gyn. 12 (2015)............................................. 10
M. Fischer et al., Fatal Toxic Shock Syndrome
Associated with Clostridium Sordelli after
Medical Abortion, 353 New Eng. J. Med. 2352
(2005) ........................................................................ 17
M.F. Greene, Fatal Infections Associated with
Mifepristone Induced Abortion, 353 New Eng. J.
Med. 353 2317 (2005) .............................................. 17
M. Niinimäki, et al., Immediate Complications
after Med. Compared with Surgical Termination
of Pregnancy, 114 Obstet. Gynecol. 795 (Oct.
2009) ......................................................................... 16
Merck
Manuals,
available
at
http://www.merckmanuals.com/home/womens_he
alth_issues/complications_of_pregnancy/miscarri
age.html ...................................................................... 6
Mifeprix
FPL
at
11,
available
at
http://www.accessdata.fda.gov/drugsatfda_docs/l
abel/2009/020687s015lbl.pdf ................................... 12

 x
R. Jones and J. Jerman, Abortion Incidence
and Service Availability in the United States,
2011 (Alan Guttmacher Institute 2013),
www.guttmacher.org%2Fpubs%2Fjournals%2
Fpsrh.46e0414.pdf&usg=AFQjCNHA0QeuMc
SHPbtDE_5y8a1QmYOow&sig2=i7a96rPvN
79UYCJvLKevfQ ................................................. 27-28
S. Kaali, et al., The Frequency and Management
of Uterine Performations During First-Trimester
Abortions, 6 Am. J. Obstet. Gynecol. 406 (1989) ...... 7
S.K. Henshaw & L.B. Finer, The Accessibility of
Abortion Servs. in the U.S., 2001, 35
Perspectives on Sexual and Reproductive Health
16 (2003) ..................................................................... 8
S. Su, et al., Delayed Presentation of Uterine
Perforation with Ovary Migration After
Dilatation and Curretage, 8 In. J. Exp. Med.
6311 (2015). ............................................................ 7, 8
Te Linde’s Operative Gynecology 9th ed. 499-504
(Philadelphia: Lippincot Williams & Wilkins
2003) ............................................................... 7, 27, 31
Dale W. Stovall et al., Dilation & Curettage:
Complications, UpToDate, Jan. 14, 2014,
available at http://www.uptodate.com/contents/
dilation-and-curettage ............................................. 31
Tex. Dep’t of Health & Human Servs.,
Statements of Deficiencies and Plans of
Correction with Various Dates from 2011-2013,
available at http://www.texasallianceforlife.org

 xi
/wpcontent/uploads/imported/issues/hb2/DSHS_i
nspection_WWH_Beaumont_11_17_2011.pdf. ....... 19
Tex. Dep’t of Health & Human Servs.,
Statement of Deficiencies and Plan of Correction,
October 3, 2013, available at http://www.
texasallianceforlife.org/issues/hb2/DSHS_inspect
ion_WWH_Beaumont_11_17_2011.pdf. .................. 20
United States Government Accountability Office,
GAO-08-751, Food and Drug Administration:
Approval and Oversight of the Drug Mifeprex 2
(2008) ........................................................................ 12
U. Upadhyay, et al., Incidence of Emergency
Department Visits and Complications After
Abortion, 125 Obstetrics & Gynecology 175
(2015) .......................................................................... 9

 1
INTEREST OF AMICI CURIAE1
Amici curiae are national medical organizations
and their combined membership of thousands of
physicians,
nurses,
physician
assistants,
pharmacists and other healthcare professionals who
share a profound interest in protecting maternal
health and the sanctity of human life. Amici’s
members include obstetrician/gynecologists whose
patients see abortion providers and then return to
their care, emergency physicians and other staff who
treat emergent complications caused by abortion,
and clinical staff who counsel women regarding
abortion and treat its damaging physical and
psychological consequences.
American
Association
of
Pro-Life
Obstetricians & Gynecologists (“AAPLOG”) is a
non-profit professional medical organization that
consists of 3,000 obstetrician-gynecologist members
and associates. AAPLOG held the title of “special
interest
group”
within
the
American
College/Congress of Obstetricians and Gynecologists
(ACOG) from 1973 to 2013 until this designation was
discontinued by ACOG. AAPLOG is concerned about
the quality of care provided to pregnant women and
the potential long-term adverse consequences of
abortion on women’s future health, and explores
data from around the world regarding abortionThe parties to this case have consented to the filing of this
brief and letters indicating their consent are on file with the
Clerk. Amici state that no counsel for a party authored this
brief in whole or in part, and no person other than Amici and
their counsel made any monetary contribution intended to fund
the preparation or submission of this brief.
1

 2
associated complications (such as depression,
substance abuse, suicide, other pregnancy-associated
mortality, subsequent preterm birth, and placenta
previa) in order to provide the general public and
others
with
a
realistic
appreciation
and
understanding of abortion-related health risks.
American College of Pediatricians is a
national not-for-profit organization of pediatricians
and other healthcare professionals formed in 2002
dedicated to the health and well-being of children.
The mission of the College is to enable all children to
reach their optimal physical and emotional health
and well-being. To this end, the College has written
a number of position statements on matters unique
to children, and continues to produce sound policy
based upon the best available research to assist
parents and society in the care of children.
Membership is open to qualifying healthcare
professionals who share the College’s Mission, Vision
and Values. The College currently has members in
forty-seven states and several countries outside of
the United States.
Christian Medical and Dental Association
(“CMDA”), founded in 1931, is a non-profit national
membership organization primarily for physicians
and dentists. With more than 16,000 members,
CMDA provides a public voice on bioethics and
healthcare policy.
CMDA provides missionary
doctors and medical education to the developing
world, provides continuing medical and dental
education, and sponsors student chapters at most
U.S. medical and dental schools.

 3
Catholic Medical Association
(“CMA”)
consists of over 1,000 physician members and
hundreds of allied health members nationwide.
CMA members seek to uphold the principles of the
Catholic faith in the science and practice of medicine
– including the belief that human life begins at
conception.
Physicians for Life is a national membership
organization whose purpose is to inform and educate
the public about stem cell research, cloning, fetal
development, abortion, infanticide, euthanasia, “safe
sex”, sexually transmitted diseases, and risk
elimination through sexual abstinence.
SUMMARY OF ARGUMENT
Amici respectfully wish to address Petitioners’
Question I from their perspective as medical
professionals, and particularly whether Texas House
Bill 2 (“HB2”)’s provisions are medically reasonable.
Amici urge that far from expressing views based on
“medical uncertainty,” Gonzales v. Carhart, 550 U.S.
128, 163 (2007), the surgical center and admitting
privileges requirements imposed by the Act reflect
the professional standard of practice for outpatient
gynecological and similar surgery.
The Fifth Circuit recognized that Texas has a
legitimate interest in regulating abortion because it
is a surgical or drug-induced procedure that carries
significant health risks. Thus, Texas has a proper
interest in protecting the health and safety of women
who seek abortions. In enacting HB2, Texas sought

 4
to protect women’s health by requiring that abortion
facilities meet the same health and safety standards
as Texas requires of outpatient surgical centers.
Texas also sought to protect women’s health by
ensuring that physicians who terminate pregnancies
are able to attend to the patient’s health, both
during and after an abortion, by having admitting
privileges at a hospital within thirty miles of the
location of the abortion. Amici urge the Court to
affirm that the quality of medical care provided to
women seeking abortion should not be any lower
than the quality of care provided to women
undergoing similar invasive procedures. The health
and safety of all women should not be compromised.
ARGUMENT
I. HB2 APPROPRIATELY EXPRESSES TEXAS’S
CONSTITUTIONAL INTEREST IN SAFEGUARDING
WOMEN’S HEALTH AND MAINTAINING MEDICAL
STANDARDS.
Texas women obtained 68,298 reported abortions
in 2012. See Tex. Dep’t of State Health Servs., 2012
Induced Terminations of Pregnancy (2014), available
at
http://www.dshs.state.tx.us/chs/vstat/vs12/t38.s
htm (last visited February 1, 2016). The vast
majority of these abortions – 78.6 percent – were
performed in outpatient abortion facilities or
locations other than hospitals or licensed ambulatory
surgical centers (“ASC”s). Id. Because abortion
involves risks to patient health and safety, Texas
has a legitimate interest in regulating abortions,
abortion providers, and abortion facilities.

 5
In passing HB2, Texas relied upon long-standing
Supreme Court precedent that recognizes the states’
constitutional authority to regulate abortion and
their strong interests in doing so. In Roe v. Wade,
410 U.S. 113, 162-64 (1973), this Court recognized
an “important interest” in protecting a pregnant
woman’s health, and a “legitimate interest in seeing
to it that abortion, like any other procedure, is
performed under circumstances that ensure
maximum safety for the patient.” Id. at 150. In
replacing Roe’s trimester framework with a
bifurcated pre-viability/post-viability framework and
applying a new “undue burden” standard to gauge
the constitutionality of pre-viability abortion
restrictions, this Court in Casey acknowledged that
“the State has legitimate interests from the outset of
the pregnancy in protecting the health of the
woman.” Planned Parenthood of Se. Pa. v. Casey, 505
U.S. 833, 846 (1992) (plurality op.). The Casey
plurality held that an abortion regulation could be
declared unconstitutional if “in a large fraction of
cases in which [the challenged requirement] is
relevant, it will operate as a substantial obstacle to a
woman’s choice to undergo an abortion.” Id. at 895
(emphasis added). More recently, in Gonzales v.
Carhart, this Court acknowledged that government
“undoubtedly ‘has an interest in protecting the
integrity and ethics of the medical profession.’” 550
U.S. at 128 (quoting Washington v. Glucksberg, 521
U.S. 702, 731 (1997)). Gonzalez affirmed the wellaccepted rule that states have “wide discretion” in
passing health and safety legislation, even if
“medical and scientific uncertainty” exists – a
threshold of authority that outpatient and admitting

 6
privileges standards easily surmount. Id. at 163.
The safeguards HB2 inaugurated are an appropriate
expression of the states’ duty and authority to
maximize patient safety.
A. Abortion,
Like
Many
Outpatient
Procedures, Carries Inherent Serious
Risks.
The performance of abortion, whether by means
of surgery or medication, is associated with risks,
including risks of major complications and even
death. See, e.g., E. Hakim-Elahi, et al.,
Complications of First Trimester Abortion: A Report
of 170,000 Cases, 76 Obstet. Gynecol. 129 (1990).
Surgical abortion is directly comparable to dilatation
and curettage (“D&C”) a procedure done usually in
an ambulatory surgical facility.
There are no
substantive technical differences between a D&C
procedure performed for the purpose of abortion and
one to manage a natural miscarriage.2 Even the
most experienced physician performing a D&C
procedure (whether for induced abortion or natural
miscarriage) faces known complications, including
perforation of the uterus (meaning that the tip of an
instrument can pass through the wall of the uterus),
damage to the cervix, retention of fetal parts,
Treatment for a suspected miscarriage involves an
examination of the cervix and the use of ultrasonography to
confirm fetal death. If any remnants of the pregnancy remain
in the uterus after a miscarriage, D&C is often used to remove
the remaining uterine contents. Merck Manuals, available at
http://www.merckmanuals.com/home/womens_health_issues/co
mplications_of_pregnancy/miscarriage.html(miscarriage/sponta
neous abortion) (last visited Feb. 1, 2016).
2

 7
infection and hemorrhage. Am. Coll. of Obstetricians
and Gynecologists (“ACOG”), Dilation and Curettage
(May 2012), available at https://www.acog.org//media/Forpatients/faq062.pdf?dmc=I&ts=20141102
Tl6275925 44 (last visited Feb. 1, 2016); Mayo Clinic
Staff, Dilation and Curettage (D&C): Risks (2014),
available
at
http://www.mayoclinic.org/
tests
procedures/dilation-andcurettagelbasics/risks/prc200
13836 (last visited Feb. 1, 2016).3
The frequency of perforating the uterus at the
time of first trimester surgical abortion has been
estimated to vary between .08% to 3% of first
trimester abortions. S. Kaali, et al., The Frequency
and Management of Uterine Performations During
First-Trimester Abortions, 6 Am. J. Obstet. Gynecol.
406 (1989).
These complications usually go
undetected until after the abortion procedure has
been completed and the patient has left the clinic,4
Besides these immediate complications, a more
comprehensive list of potential complications includes: Rh
sensitization (endangering future children), missed diagnosis of
ectopic pregnancy, missed diagnosis of twin pregnancy with
surviving or retained twin demise, inability to complete the
procedure, embolization of gestational trophoblastic disease
(GTD) tissue, convulsive seizure due to administration of local
anesthetic, bowel injury following uterine perforation, bladder
injury following uterine perforation, large vessel injury
following uterine perforation, nerve injury following uterine
perforation, and uterine synechia formation (Asherman's
syndrome), sepsis (bacterial infection of the blood), and
maternal death. Te Linde’s Operative Gynecology 9th ed. 499504 (Philadelphia: Lippincot Williams & Wilkins 2003).
4
See, e.g., S. Su, et al., Delayed Presentation of Uterine
Perforation with Ovary Migration After Dilatation and
Curretage, 8 In. J. Exp. Med. 6311 (2015).
3

 8
and can require the patient to be hospitalized and
undergo surgical correction. Such complications can
be life threatening and likely occur in hundreds of
cases in Texas per year. See Planned Parenthood of
Greater Tex. Surgical Health Services v. Abbott, 748
F.3d 583, 595 (5th Cir. 2014) (“Abbott II”) (citing
figure of 210 hospitalizations annually).
Texas
counsels women about these risks and complications
in a booklet entitled “A Woman’s Right to Know,”
which must be provided to all women seeking
abortions. See Tex. Dep’t of Health, A Woman’s
Right to Know, available at http://www.dshs.
state.tx.us/wrtk/ (2003) (last visited Feb. 1, 2016).
The overall hospitalization rate following
elective abortion (one in three hundred patients) is
similar to rates for other invasive outpatient
procedures such as liposuction, gastrointestinal
endoscopy such as colonoscopy and upper endoscopy.
Ctrs. for Disease Control, National Health Statistics
Reports: Ambulatory Surgery in the United States,
No. 11 (Jan. 28, 2009, revised Sept. 4, 2009). S.K.
Henshaw& L.B. Finer, The Accessibility of Abortion
Services in the United States, 2001, 35 Perspectives
on Sexual and Reproductive Health 16 (2003)
(stating hospitalization rate for abortion is 0.3%).
Thus, for a year such as 2012 in which Texas
reported 68,298 abortions, the state should expect to
see approximately 204 abortion patients hospitalized
for complications, a figure that is consistent with the
number of 210 annual hospitalizations acknowledged

 9
by one of the plaintiffs in Abbott II.
595.5

748 F.3d at

B. Drug-Induced Abortion Carries Greater
Risks than Surgical Abortion.6
While the term “abortion” is most often
associated with surgical abortion, the practice of
drug-induced abortion has become prevalent in
Texas and other states. Drug-induced abortion is
accomplished by administering drugs such as
mifepristone (“RU-486”) and misoprostol to
terminate a pregnancy. HB2 requires that druginduced abortion providers adhere to the only dosage
and treatment protocol for the practice that has been
approved by the federal Food and Drug

This figure may be conservative. Compare U. Upadhyay, et
al., Incidence of Emergency Department Visits and
Complications After Abortion, 125 Obst. & Gyn . 175 (2015)
(stating that one in 115 abortions resulted in an abortion
related complication treated in an emergency room; for 2012,
this would equate to 593 hospitalizations in the state of Texas).
6
The Fifth Circuit held that Petitioners failed to defend
their claim that the ASC requirement was unconstitutional as
applied to medication abortion. Whole Woman’s Health v. Cole,
790 F.3d 563, 590-91 (5th Cir. 2015). Petitioners mention the
legal practice of medication abortion only twice in their brief,
and then in passing. Pet. Br. at 18, 20. Their brief makes no
argument that HB2, as applied to their practice of medication
abortion in Texas, violates the Casey standard, nor do they cite
any authority in support of such an argument. Petitioners
have therefore waived this argument. Hill v. Colorado, 530
U.S. 703, 720 (2000).
5

 10
Administration (FDA). Texas Health & Safety Code
§ 171.063(a).7
The district court concluded that “[t]he
imposition of [ASC] requirements [on abortion
facilities] is even weaker in the context of medication
abortions, where no surgery is involved.” Whole
Woman’s Health v. Lakey, 46 F. Supp. 3d 673, 684-85
(W.D. Tex. 2014). But approximately 1 out of 20
women require post-abortion surgery to complete a
failed drug-induced abortion, and that number
increases for gestational ages over 49 days. M. Chen
& M. Creinin, Mifepristone with Buccal Misoprostol
for Medical Abortion, 126 Obst. & Gyn. 12 (2015).
Drug-induced abortion involves substantial risks to
patient health and safety and Texas has a legitimate
interest in regulating such abortions and the
facilities in which they occur, just as it has in
regulating surgical abortions.
The health risks associated with drug-induced
abortion were acknowledged by both the United
States FDA and the manufacturer of Mifeprex, the
principal drug used for the procedure. When the
FDA approved the new drug application for Mifeprex
(mifepristone), the approval was made subject to
“Subpart H” restrictions. Subpart H is the only FDA
approval process that allows for post-marketing
restrictions, i.e., restricting the way in which a drug
is used after it has been approved and released into

The Fifth Circuit upheld this provision in Planned
Parenthood v. Abbott, supra, 748 F.3d at 604-605, and it is not
at issue here.
7

 11
the market.8 To put this restricted distribution
Subpart H approval in perspective, out of almost
1,800 New Drug Applications (NDAs) approved
between 1992 and 2015, only eight were approved
under the restricted distribution section Subpart H.9
Subpart H restrictions apply only when the drug
product presents safety concerns. 21 C.F.R. §
314.520(b) (2007).
The “FDA concluded that
Mifeprex could only be used safely if distribution
was limited to physicians who could assess the
duration of a pregnancy, diagnose an ectopic
pregnancy, and provide patients with access to
surgical intervention if necessary.” U.S. Gov’t
See 21 C.F.R. 314.520, Approval with restrictions to assure
safe use.
8

(a) If FDA concludes that a drug product shown to be
effective can be safely used only if distribution or use
is restricted, FDA will require such postmarketing
restrictions as are needed to assure safe use of the
drug product, such as:
(1) Distribution restricted to certain facilities or
physicians with special training or experience; or
(2) Distribution conditioned on the performance of
specified medical procedures.
(b) The limitations imposed will be commensurate with
the specific safety concerns presented by the drug
product.
9
These include one drug for prostate cancer (Plenaxis), two
drugs for severe pulmonary hypertension (Letairis, Tracleer),
one drug for severe anemia (Revlimid), one drug for
narcolepsy(Xyrem), one drug for leprosy (thalidomide), one
drug for severe cancer pain in patients that cannot take
narcotics (Actiq) and one drug for abortion (Mifeprex). See
http://www.fda.gov/downloads/Drugs/Development/ApprovalPro
cess/HowDrugsareDevelopedandApproved/DrugsandBiologicAp
provalReports/NDAandBLAApprovalReports/UCM404466.pdf
(last visited 01/23/16).

 12
Accountability Office, GAO-08-751, Food and Drug
Administration: Approval and Oversight of the Drug
Mifeprex 2 (2008) (emphasis added).
Because of these unusual risks, the FDA
conditioned its approval on the manufacturer’s
compliance with Subpart H restrictions, which
mandated that physicians prescribing Mifeprex
“fully explain the procedure to each patient,” provide
her with a copy of a “Medication Guide” and “Patient
Agreement” and obtain her signature on the
agreement. Both the Medication Guide and the
Patient Agreement specify the exact regimen which
the FDA approved. FDA, Mifeprex Approval Letter
to Population Council dated Sep. 28, 2000 at 3,
available at http://www.accessdata.fda.gov/drugsa
tfda_docs/appletter/2000/20687appltr.htm
(last
visited Feb. 1, 2016). FDA, Mifeprex Medication
Guide at 3, available at http://www.accessdata
.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.p
df (last visited Feb. 1, 2016). Likewise, the FDAapproved Mifeprex final printed labeling (FPL)
warns that “[n]early all [90%] of the women who
receive Mifeprex and misoprostol will report adverse
reactions, and many can be expected to report more
than one such reaction.” FDA, Mifeprix FPL at 11
(2009), available at http://www.accessdata.fda.gov/
drugsatfda_docs/ label/2009/020687s015lbl.pdf (last
visited Feb. 1, 2016). These risks include, but are not
limited to, abdominal pain, cramping, vomiting,
headache, fatigue, uterine hemorrhage, viral
infections, anemia, and pelvic inflammatory disease.
Id. at 12 (Table 3). In part because of these risks,
the Subpart H restrictions included the mandate
that physicians prescribing Mifeprex have “[the]

 13
[a]bility to provide surgical intervention in cases of
incomplete abortion or severe bleeding, or have made
plans to provide such care through other qualified
physicians, and are able to assure patient accesss to
medical facilities equipped to provide blood
transfusions and resuscitation, if necessary.”
Mifeprex Approval Letter, supra.
While FDA would be fully empowered to lift its
restrictions, the FDA has never concluded that any
other regimen is safe for use. The FDA continues to
identify the FPL regimen as the only regimen
approved for use:
While some of the modified regimens have
been well described in the literature, the
safety and effectiveness of Mifeprex dosing
regimens, other than the one approved by
FDA, including use of oral misoprostol
intravaginally, has not been established by
the FDA.10
That the FDA has not changed its opinion about the
need to adhere to the FDA-approved label is also
evidenced by the 2011 enrollment of Mifeprex on the
list of medications which require a Risk Evaluation
and Management Strategy (REMS).
The FDA
enrolls drugs into a REMS when the drug is
identified as being at high risk of post-marketing
complications:
See FDA, Mifeprex Questions and Answers, Feb. 24, 2010,
available at http://www.fda.gov/Drugs/DrugSafety/Postmarket
DrugSafetyInformationforPatientsandProviders/ucm111328.ht
m (last visited Feb. 1, 2016).
10

 14
The
Food
and
Drug
Administration
Amendments Act of 2007 gave FDA the
authority to require a Risk Evaluation and
Mitigation
Strategy
(REMS)
from
manufacturers to ensure that the benefits of a
drug or biological product outweigh its risks.11
The Mifeprex REMS includes a clear directive that
providers and patients must adhere to the
postmarketing restrictions as reflected in the Patient
Agreement and Provider Agreement discussed
above.12 The FDA also continues to identify the FPL
regimen as the only approved regimen in the context
of the FDA Drug Safety information.13
According to ACOG, the risks of drug-induced
abortion are similar to surgical abortion, and include
infection, heavy bleeding/hemorrhage, and failed
medical abortion/retained products of conception, in
addition to other risks. ACOG warns of these risks
in Practice bulletins published in 2005 (and
reaffirmed in 2011). See ACOG Practice Bulletin 67:
Med. Management of Abortion 4-6 (Oct. 2005,
reaffirmed 2011). Approximately two to three
See FDA, Approved Risk Evaluation and Mitigation
Strategies (REMS), available at http://www.accessdata.fda.gov
/scripts/cder/rems/index.cfm (last visited Feb. 1, 2016)
12
See Danco Laboratories, LLC, Risk Evaluation and
Mitigation Strategy (REMS), available at http://www.access
data.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_REM
S%20DOCUMENT.pdf (last visited Feb. 1, 2016).
13 See FDA, Mifeprex (mifepristone) Information May, 17, 2015,
available at http://www.fda.gov/Drugs/DrugSafety/Postmarket
DrugSafetyInformationforPatientsandProviders/ucm111323.ht
m (last visited Feb. 1, 2016).
11

 15
percent of drug-induced abortion patients will
require a D&C procedure to aspirate retained
products of conception, and the rate is higher for
later gestational ages. See Chen and Creinin, supra.
The complication logs from petitioner Whole
Woman’s Health reflect dozens of patients who
required surgical follow-up after an incomplete druginduced abortion. J.A. 865.
Since treatment of drug-induced abortion
complications can require surgical intervention, the
same rationale for admitting privileges applies to the
provision of drug-induced abortion as to surgical
abortion. According to ACOG’s current guidance,
“Clinicians who wish to provide medical abortion
services either should be trained in surgical abortion
or should work in conjunction with a clinician who is
trained in surgical abortions.”
ACOG Practice
Bulletin
143, Medical Management of FirstTrimester Abortion (2014), available at http://www.
acog.org/Resources-And-Publications/PracticeBulleti
ns/Committee-on-Practice-BulletinsGynecology/Medi
cal-Management-of-First-Trimester-Abortion
(last
visited Jan. 29, 2016).
Another Subpart H condition of Mifeprex
approval mandated that physicians prescribing
Mifeprex report adverse events to the FDA, Mifeprex
Approval Letter, supra at 2. In July 2011, the FDA
reported 2,207 cases of adverse events after
mifepristone abortions. FDA, Mifepristone U.S.
Postmarketing Adverse Events Summary Through
04/30/2011 (July 2011). Among these were 14
deaths, 612 hospitalizations, 339 blood transfusions,

 16
and 256 infections (including 48 “severe infections”).
Id.
The largest and most accurate study of druginduced abortion was published in 2009 and consists
of a review of medical records of 22,368 women who
underwent drug-induced abortions, compared with
20,251 women who underwent surgical abortions.
According to this study, the “overall incidence of
adverse events was fourfold higher in” drug-induced
abortions than in surgical abortions. See M.
Niinimäki, et al., Immediate Complications after
Medical Compared with Surgical Termination of
Pregnancy, 114 Obstet. Gynecol. 795 (Oct. 2009).
Likewise, a 2015 review of women receiving buccal
administration of misoprostol for the abortion
regimen at 50-56 days gestation reported that 3.3%
of women required surgery to complete the abortion.
M. Chen and M. Creinin, supra. However the
number of women requiring surgery to complete the
abortion increased to 6.9% as the gestational age of
the pregnancy increased. Id.
Drug-induced abortion presents a much greater
risk of life-threatening infections than does surgical
abortion. For example, drug-induced abortion is
associated with a greater risks of death from
dangerous Clostridium sordelli bacterial sepsis than
surgical abortion. Mark Fischer of the Centers for
Disease Control and Prevention (CDC) reports the
risk of death from C. sordelli infection during a
mifepristone abortion is at least ten times the risk of
death from all types of infection after surgical
abortion. See M. Fischer et al., Fatal Toxic Shock

 17
Syndrome Associated with Clostridium Sordelli after
Medical Abortion, 353 New Eng. J. Med. 2352
(2005); see also M.F. Greene, Fatal Infections
Associated with Mifepristone Induced Abortion, 353
New Eng. J. Med. 353 2317 (2005). Other serious
complications from using misoprostol for druginduced abortion have been reported anecdotally,
including acute hemolytic anemia, see A. Filippini, et
al., Acute Hemolytic Anemia with Acanthocytosis
Associated with High-dose Misoprostol for Medical
Abortion, 50 Ann. Emerg. Med. 289 (2006), and fatal
septic shock. See F. Cittadini et al., A Case of Toxic
Shock Due to Clandestine Abortion by Misoprostol
Self-administration, 59 J. Forensic Sci. 1662 (2014).
C. Recognizing these Risks, Texas has Taken
Appropriate Steps to Safeguard Women’s
Health and Safety by Regulating Abortion
in a Manner Consistent With Other
Outpatient Procedures.
Texas, like many other states, recognized the
risks associated with both surgical and drug-induced
abortion and took steps to regulate abortion
procedures to minimize these risks and protect
women’s health and safety. The steps Texas has
taken, from its prior regulation of abortion to HB2,
are consistent with the standard of care for
outpatient medical practice.
1. Texas’s Prior Regulation of Abortion
Facilities.
Due to the significant health and safety risks to
women, well before HB2, Texas regulated abortions

 18
and abortion facilities consistent with Roe and its
progeny. It did so in a regime that was, until HB2,
separate from the regulation of ASCs. See 25 Tex.
Admin. Code § 139.1 et seq. Texas defined abortion
facilities as facilities that perform abortions,
excluding licensed hospitals, ASCs, and physician
offices that perform 50 or fewer abortions per year.
Notably, since 2009, well before the Legislature
enacted HB2, Texas required licensed abortion
facilities either to have a physician with admitting
privileges at a local hospital or to have a working
arrangement with an outside physician who had
those privileges so as to ensure that abortion
facilities could provide appropriate follow-up patient
care when necessary. See id. at § 139.56. Texas also
required abortion facilities to maintain a quality
assurance program, see id. at § 139.8, and to submit
to a full on-site inspection at least once per year. See
id. at § 139.31. And several years earlier, in 2003,
the Texas Legislature required that abortions after
fifteen weeks’ gestation generally must be performed
in an ambulatory surgical center or hospital. See
Tex. Health & Safety Code § 171.004.
These provisions were insufficient to ensure
patient safety in outpatient abortion practice, see
generally I.C.2 infra, and so Texas took further steps
to protect its citizens. Among other provisions, HB2
required (1) that licensed abortion facilities
operating after September 1, 2014 meet ASC
standards; and (2) that abortion practitioners must
possess admitting privileges at a hospital within
thirty miles of where an abortion is performed. See
Tex. Health & Safety Code §§ 245.010(a),
171.0031(a). The rules for licensing general ASCs

 19
pre-date
HB2
and
include
“Operating
Requirements,” “Fire Prevention and Safety
Requirements,”
and
“Physical
Plant
and
Construction Requirements.” See 25 Tex. Admin.
Code §§ 135.1-56. HB2 left in place existing laws
allowing abortions to be performed at hospitals and
general ASCs, even where the latter are not licensed
as abortion facilities. Tex. Health & Safety Code
§ 245.004; 25 Tex. Admin. Code § 139.1(b); see also
Tex. Health & Safety Code chs. 241, 243.
2. Texas Addressed Reasonable Concerns
Over Substandard Outpatient Abortion
Practice.
Documented experiences in Texas illustrate the
legitimacy of Texas’s concern over the adequacy of
abortion facilities’ care for women. Inspections of
Texas abortion facilities over the past few years have
documented
many
deficiencies
that
reflect
substandard patient care, including lack of staff
training; lack of sterilization; lack of medical
personnel; lack of emergency medication and
procedures; expired credentials, equipment, and
medication; failure to follow emergency procedures;
and performing abortions beyond the legal
gestational limit. See Tex. Dep’t of Health & Human
Servs., Statements of Deficiencies and Plans of
Correction with Various Dates from 2011-2013,
available at http://www.texasallianceforlife.org/wpcontent/uploads/imported/issues/hb2/DSHS_inspecti
on_WWH_Beaumont_11_17_2011.pdf (last visited
Feb. 1, 2016). When questioned, one employee said it
was too expensive to maintain a sanitary

 20
environment: “The functional check is more
expensive and the facilities do not want to pay for
the functional check.” Id. In short, the facilities
“failed to provide a safe environment for patients
and staff.” Id. At another facility, there was no one
in charge of medical decisions, and employees were
observed handling tissue and body fluids and
drawing up medications and sterilizing instruments
at the same time, without washing hands or wearing
gloves. See Tex. Dep’t of Health & Human Servs.,
Statement of Deficiencies and Plan of Correction
(5/23/2013),available at http://prolifeaction.org/docs
/2013/2013-05-23AlamoWomens.pdf (last visited Feb.
1, 2016).
At Whole Woman’s Health Beaumont (a facility
run by one of the Petitioners), state health
inspectors reported in October 2013 that “[b]ased on
observation and interview, the facility failed to
provide a safe environment for patients and staff.”
Inspectors documented numerous deficiencies at the
abortion facility. See Tex. Dep’t of Health & Human
Servs.,
Statement of Deficiencies and Plan of
Correction, October 3, 2013, available at http://www.
texasallianceforlife.org/issues/hb2/DSHS_inspection_
WWH_Beaumont_11_17_2011.pdf (last visited Feb. 1
2016). Given this unfortunate track record for
unhealthy and dangerous conditions at multiple
abortion facilities in the state, Texas’s concerns over
substandard outpatient abortion practice were more
than reasonable.
3. HB2 Was Intended to Strengthen
Protections for the Health and Safety of
Women Seeking Abortions.

 21
Because of this poor safety record in Texas and
reports of abominable dangerous practices at
abortion facilities elsewhere in the country, the
legislature passed HB2 with the overarching
purpose of “increase[ing] the health and safety” of
abortion patients and providing them with “the
highest standard of health care.” See Senate Comm.
on Health & Human Servs., Bill Analysis, Tex. H.B.
2, 83d Leg., 2d C.S. (2013). HB2 required that “the
minimum standards for an abortion facility must be
equivalent to minimum standards adopted under
[Texas Health & Safety Code] Section 243.010 for
ambulatory surgical centers.” See Tex. Health &
Safety Code § 245.010(a); 25 Tex. Admin. Code §
139.40 (incorporating existing ASC standards). HB2
also added Tex. Health & Safety Code § 171.0031,
which requires that an abortionist must, on the date
the abortion is performed or induced, “have active
admitting privileges at a hospital that: (A) is located
not further than 30 miles from the location at which
the abortion is performed or induced; and (B)
provides obstetrical or gynecological health care
services.” HB2 further required that the abortionist
provide the pregnant woman with 24-hour contact
information for the physician or another medical
employee of the facility with access to the woman’s
relevant medical records, as well as the name and
telephone number of the hospital nearest to the
woman’s home at which an emergency would be
treated. Id. These provisions of HB2 were clearly
designed to protect women’s health and safety by
ensuring that every abortion patient in Texas has
access to a doctor familiar with her particular case at

 22
every step of the procedure and recovery and that all
abortions are performed in facilities that meet the
same minimum health and safety standards as other
ASCs.
The District Court dismissed, inter alia,
petitioners’ equal protection and “arbitrary and
unreasonable state action” claims, and recognized
HB2’s rational relation to patient health and safety.
Lakey, supra, 46 F. Supp. 3d at 680 (citing Order on
Motion to Dismiss dated Aug. 1, 2014). Petitioners
did not dispute on appeal, nor before this Court, that
HB2’s admitting privileges and ASC requirements
are rationally related to a legitimate state interest.
Petitioners instead focus their attack on whether
HB2 has the purpose or effect of erecting a
“substantial obstacle” to abortion access in Texas.
See Pet. Br. at 35-53. For the reasons set forth
below, Amici maintain that even if the Court
determines to re-weigh the reasonableness of HB2
twice under separate prongs of Casey (an analysis
that would be both unnecessarily redundant and
contrary to Casey’s intent), the sound medical
purposes for HB2’s protections more than meet the
Casey standard.
It is eminently reasonable to
require providers of outpatient procedures such as
abortion to comply with basic outpatient clinic safety
and health regulations and to have the capacity to
admit patients to a nearby hospital and treat them
should emergent complications arise.
II. THE FIFTH CIRCUIT CORRECTLY APPLIED THE
CASEY
STANDARD
TO
UPHOLD
HB2’S

 23
OUTPATIENT
SURGERY
AND
14
PRIVILEGES REQUIREMENTS.

ADMITTING

When the Court first held that the Constitution
includes the right to obtain a previability abortion, it
also recognized that states could regulate doctors
and medical facilities to “insure maximum safety for
the patient.” Roe, 410 U.S. at 150. More recently, it
rejected the notion that federal courts should serve
as “the country’s ex officio medical board with
powers to approve or disapprove medical and
operative practices and standards throughout the
United States.” Gonzales, 550 U.S. at 162-64
(internal quotation marks and citation omitted).
Under the Casey standard, the Court has declined to
perform the legislative role that would be the
essence of such judicial oversight – balancing the
medical justifications of regulations against their
putative burdens. Casey itself upheld a requirement
that a physician provide the patient with informed
consent information, “even if an objective
assessment might suggest that those same tasks
could be performed by others.” 505 U.S. at 885; see
also Mazurek v. Armstrong, 520 U.S. 968, 973 (1997)
(upholding a requirement that abortions be
performed by physicians, even though “the only
extant study comparing the complication rates for
first-trimester abortions performed by [physician
assistants] with those for first-trimester abortions
performed by physicians found no significant
The Fifth Circuit’s application of the undue burden standard
to require that the McAllen, Texas clinic stay open is not
challenged by Texas in this Court, and Amici likewise do not
take up this point.
14

 24
difference”) (internal quotation marks and citation
omitted); Gonzales, 550 U.S. at 158 (upholding a
ban on partial-birth abortion without conducting a
balancing analysis, requiring only that the state
have “a rational basis to act” and that it not “impose
an undue burden”).
Rational basis is satisfied if the law at issue is
rationally related to a legitimate state interest. 748
F.3d at 594-596; City of Cleburne v. Cleburne Living
Ctr., 473 U.S. 432, 440 (1985). The district court
concluded that the admitting privileges requirement
“surmount[s] the low bar of rational-basis review.”
Lakey, 46 F. Supp. 3d at 680. Casey’s holding that a
state interest in health and safety exists throughout
pregnancy necessarily rejects application of a strict
standard to reasonable first trimester or previability procedures.15
Petitioners contend that the undue burden test
requires that the reasonableness of abortion
Petitioners also note Casey’s statement that “[u]nnecessary
health regulations that have the purpose or effect of presenting
a substantial obstacle” are unconstitutional. Pet. Br. at I
(Questions Presented). But this Court has not used the term
“unnecessary” literally to mean “not required,” but simply as a
proxy for “unreasonable.” Indeed, this Court has never used
the phrase “unnecessary health regulations” in another
abortion case and there is no reason to believe that it adds an
additional layer of scrutiny beyond the established undueburden test articulated in Casey, as well as Gonzales, 550 U.S.
at 158, and Mazurek, 520 U.S. at 971. To the contrary, “State
legislation which has some effect on individual liberty or
privacy may not be held unconstitutional simply because a
court finds it unnecessary, in whole or in part.” Whalen v. Roe,
429 U.S. 589, 597 (1977).
15

 25
regulations essentially be assessed by the court
twice, first under Casey’s rational basis prong and
then again under the “purpose” prong. But this
approach is not warranted by Casey’s text and is
inconsistent with the manner in which medical
regulations have been assessed by this Court.16 One
need look no further than Justice O’Connor’s
concurrence in Simopoulos and her dissent in its
companion cases, in which she stated that the
rational basis of the ASC mandates in those cases,
coupled with the fact that they would not unduly
restrict access in the relevant jurisdictions, was
enough to uphold them. Simopoulos v. Virginia, 462
U.S. 506 at 520 (1983) (O’Connor, J., concurring in
part and in the judgment); City of Akron v. Akron
Ctr. for Repro. Health, 462 U.S. 416, 467 (1983)
(O’Connor, J., dissenting) (citing Williamson v. Lee
Optical, 348 U.S. 483 (1955)); Planned Parenthood
Ass’n of Kansas City, Mo., Inc. v. Ashcroft, 462 U.S.
476, 504
(1983) (O’Connor, J., dissenting)
(“Assuming arguendo that the [second trimester
hospitalization requirement] was an undue burden,
it would nevertheless ‘reasonably relate to the
preservation and protection of maternal health.’”)
(quoting Roe, 410 U.S. at 163). In hewing to this
rational basis/undue burden interpretation of Casey,
the Fifth Circuit also reflected the prevailing view
among the courts of appeals. Greenville Women’s
In essence, Gonzales “simplified Casey’s description of an
undue burden by collapsing the purpose inquiry into the effects
test.” Planned Parenthood v. Wisc., Inc. v. Schimel, 806 F.3d
908, 930 (7th Cir. 2015) (Manion, J., dissenting); accord
Jackson Women’s Health Org. v. Currier, 760 F.3d 448, 460 n.4
(Garza, J., dissenting).
16

 26
Clinic v. Bryant, 222 F.3d 157, 170-72 (4th Cir.
2000); Women’s Med. Prof’l Corp. v. Baird, 438 F.3d
595, 604-09 (6th Cir. 2006); Women’s Health Ctr. of
W. Cnty., Inc. v. Webster, 871 F.2d 1377, 1380-81
(8th Cir. 1989)); Planned Parenthood Minn., N.D..,
S.D. v. Rounds, 686 F.3d 889, 904 (8th Cir. 2012) (en
banc).17
As in Mazurek, “[o]ne searches the Court of
Appeals’ opinion in vain for any mention of any
evidence suggesting an unlawful motive on the part
of the [Texas] Legislature.” 520 U.S. at 972. Where
a legislature has “legitimate reasons” for acting,
courts will not infer an impermissible purpose.
McCleskey v. Kemp, 481 U.S. 279, 298-99 (1987); see
Smith v. Doe, 538 U.S. 84, 92 (2003) (“only the
clearest proof’ will suffice to override” the
“legislature’s stated intent”) (internal citation
omitted). Lacking direct evidence of a purpose to
To the extent that cases in the Seventh and Ninth Circuits
have interpreted Casey differently, those cases are outliers that
do not reflect consistent holdings within their own circuits and
can be corrected on further review.
Compare Planned
Parenthood v. Schimel, 806 F.3d 908 (adopting balancing test),
with Karlin v. Foust, 188 F.3d 446, 481 (7th Cir. 1999) (“[A]
court’s proper focus [in the undue burden analysis] must be on
the practical impact of the challenged regulation and whether
it will have the likely effect of preventing a significant number
of women for whom the regulation is relevant from obtaining
abortions”); and compare Planned Parenthood v. Humble, 753
F.3d 905 (9th Cir. 2014) (adopting balancing test), with Tucson
Woman’s Clinic v. Eden, 379 F.3d 531, 541 (9th Cir. 2004)
(holding ASC regulations to be rational; “the undue burden
standard is not triggered at all if a purported health regulation
fails to rationally promote an interest in maternal health on its
face”).
17

 27
unduly burden abortion access, Petitioners urge that
the improper purpose for HB2 is manifest in its realworld effects, but as Mazurek also held, effects alone
cannot prove unconstitutional motive. 520 U.S. at
972 (“We do not assume unconstitutional legislative
intent even when statutes produce harmful results.”)
Even a legislator’s awareness of possible
consequences is insufficient to demonstrate an
unconstitutional intent. Pers. Adm’r of Mass. v.
Feeney, 442 U.S. 256, 278-79 (1979). Nor can
differential treatment of abortion providers
demonstrate an unconstitutional motive. If HB2
regulates outpatient abortion differently from other
outpatient procedures (an assertion neither
Respondents nor Amici admit), the Court has
recognized that abortion may be regulated
differently than other medical procedures. See, e.g.,
Harris v. McRae, 448 U.S. 297, 325 (1980).
A. The
Ambulatory
Surgical
Center
Requirements Rationally Relate to Texas’s
Legitimate
Interest
in
Upholding
Consistent Standards for Outpatient
Abortion Providers.
The practice of surgical abortion overwhelmingly
occurs in outpatient clinical facilities. Te Linde’s
Operative Gynecology 448 (reporting that 93% of
abortions occur in free-standing clinics and 2% in
physicians’ offices); R. Jones & J. Jerman, Abortion
Incidence and Service Availability in the United
States, 2011 (Alan Guttmacher Institute 2013),
available
at
http://www.guttmacher.org/pubs/journals/psrh.46e04

 28
14.pdf (last visited Jan. 29, 2016). Abortion practice
is similar to procedures that are typically performed
in ASCs such as cataract surgery, upper
gastrointestinal endoscopy, colonoscopy and spinal
injection. See C. Pallardy & S. Becker, 50 Things to
Know About the Ambulatory Surgery Center
Industry, Becker’s ASC Rev. (Jul. 20, 2013),
available at
http://www.beckersasc.com/lists/50things-to-know-about-the-ambulatory-surgerycenterindustry.html (last visited Feb. 1. 2016). In passing
the ASC requirements, the Texas legislature relied
upon testimony that surgical abortion should be
performed in a sterile environment because it
involves entry into the sterile uterus (J.A. 846-50);
that procedures requiring entry into the uterus, such
as dilation and curettage, are traditionally
performed in ASC or hospital settings (J.A. 48-50);
that performing such procedures in an ASC
environment ensures enhanced pain management
options for patients (J.A. 807-08);18 and that ASCs
provide accountability and monitoring mechanisms
that ensure patient safety (J.A. 852).
The ambulatory surgical centers requirement is
rationally related to a legitimate state interest. The
District Court below concluded that the ASC
requirement “surmount[s] the low bar of rationalbasis review.” Lakey, 46 F. Supp. 3d at 673. And
this Court, in Simopoulos, upheld Virginia’s similar
ASC requirement for second-trimester abortions
The president of petitioner Whole Woman’s Health
acknowledged that its ASC offers “more robust pain
management options” for abortions than those performed at
non-ASC facilities. See J.A. 807-08.
18

 29
even under this Court’s pre-Casey strict-scrutiny
framework. Simopoulos, 462 U.S. at 519.19
Petitioners claim they will close if forced to
comply with the ASC provisions, but many of the
regulations impose no real burden and are consistent
with procedures that outpatient clinics should
already voluntarily have in place. For example, the
regulations establish patient rights, including the
right to be “treated with respect, consideration, and
dignity,” to be “provided with appropriate privacy,”
to be provided with “appropriate information
concerning
their
diagnosis, treatment,
and
prognosis,” and a host of other commonsense
provisions. 25 Tex. Admin. Code § 135.5. Another
regulation requires that “[a]dministrative policies,
procedures and controls shall be established and
implemented to assure the orderly and efficient
management of the ambulatory surgical center.” Id.
§ 135.6. Healthcare practitioners are required to
have “the necessary and appropriate training and
skills to deliver the services provided.” Id. § 135.7.
While the financial concerns of the district court
seemed to be focused on the construction
requirements contained in 25 TEX. ADMIN. CODE §
139.40, that is but one small portion of the
regulations, and conflicts with the district court’s
Although Petitioners did not identify which ASC
regulations would require them to close, the Fifth Circuit
granted as-applied relief to the McAllen facility from two
components of the ASC regulations - the physical-plant and
fire-prevention requirements. Cole, supra, 790 F.3d at 596.
But the Court of Appeals agreed with the trial court that the
ASC requirement had a rational basis and could be applied to
facilities opening after September 2014. Id. at 567.
19

 30
broad injunction finding that the entire “ambulatorysurgical-center requirement is unconstitutional.”
Lakey, 46 F.Supp.3d at 687.
B. The Admitting Privileges Requirement
Rationally Relates to Texas’s Legitimate
Interest
in
Regulating
Outpatient
Abortion.
Based upon convincing testimony, the Texas
legislature concluded that the admitting privileges
requirement was “reasonable and medically
necessary”
to
“improve
the
post-operative
management of serious post-abortion complications.”
J.A. 865; see also Cole, 790 F.3d at 579 n.19
(admitting-privileges requirement “assures peerreview” and “protect[ s] patients”). HB2’s admitting
privileges requirement is consistent with the
ordinary standard of care for D&C and similar
outpatient procedures, and as such is a reasonable
and medically necessary measure to promote patient
health and safety.20
Because of the threat of complications, the
success and safety of performing a D&C depend in
part on the willingness of the practitioner to admit a
See Declaration of Mikeal Love, M.D. filed Oct. 15, 2013 in
Abbott, Civ. No. 1:13-cv-862-LY (W. Dist. Tex.), Doc. No. 60-1 at
3 (“Requiring hospital admitting privileges for physicians who
perform abortions is the general standard of care.”); id. at 3
(“This is the standard of care, and it is consistent with the way
medicine has been practiced for over 100 years.”); Stenberg v.
Carhart, 530 U.S. 914, 958 (2000) (Kennedy, J., dissenting)
(observing that the respondent was an “abortionist” who
“lack[ed] admitting privileges at any hospital”).
20

 31
patient for observation should complications occur.
Te Linde’s Operative Gynecology 473 (“Outpatient
Curettage”); Dale W. Stovall et al., Dilation &
Curettage: Complications, UpToDate, Jan. 14, 2014,
available at http://www.uptodate.com/contents/dilat
ion-and-curettage (last visited Feb. 1. 2016). While
some complications of abortion may be treated on an
outpatient basis such as by a return visit to the
abortion facility if the physician is still available, it
is the expectation any physician who operates on a
woman as an outpatient have in place a concrete
plan for taking care of known and expected
complications which often require inpatient
hospitalization and further surgery to correct the
complication. For this reason, the National Abortion
Federation recommended that women choose a
doctor who can admit them to a nearby hospital.
Abbott II, 748 F.3d at 595.21 Moreover, the 30-mile
Cf. American Association for Accreditation of Ambulatory
Surgery Facilities, Inc. (AAASF) Surgical Standards 13.0,
available
at
http://www.aaaasfsurveyors.org/asf_web/
PDF%20FILES/ASC%20Standards%20and%20Checklist%20Ve
rsion%2013.pdf at 13 (last visited Jan. 28, 2016) (“Every
physician, podiatrist, and oral and maxillofacial surgeon
operating in an AAAASF accredited facility, must hold, or must
demonstrate that they have held, unrestricted hospital
privileges in their specialty at an accredited and/or licensed
acute care hospital within thirty (30) minutes of the accredited
facility for all operations that they perform within the facility.
Only surgical procedures included in those hospital privileges
may be performed within the AAAASF accredited facility.”).
AAASF is one of the largest not-for-profit accrediting
organizations in the United States, accrediting more than 2000
outpatient facilities.
See About AAAASF, available at
http://www.aaaasf.org/aboutus.html (last visited Jan. 28, 2016).
Similarly, federal law has long required ASCs participating in
Medicare to have written transfer agreements with local
21

 32
proximity to a hospital required by HB2 is a
reasonable provision for the most serious
complications such as major hemorrhage or uterine
perforation which may occur during or shortly after
the abortion procedure, in which case the emergency
services best provided by the physician who
performed the surgery would need to be nearby.
The ability to admit a patient to a local hospital
and follow up to complete her care is essential in
emergency circumstances in order to provide
outpatients with an acceptable level of care. If an
abortion doctor is not involved in the admission of a
patient experiencing post-abortion complications, a
failure to timely convey information about the
woman’s medical history and the details of her
abortion procedure can result in significant time
delays that could compromise her physical and
emotional health. Most cases of incomplete abortion
with retained tissue are first discovered in the
emergency room because they occur outside of
normal clinic operating hours.22
If abortion
providers were accessible at this time, the woman
would have been able to return to the abortion
facility, or the ER staff could call the physician who
performed the procedure.
Instead, women are
hospitals or “[e]nsure that all physicians performing surgery in
the [center] have admitting privileges” at the hospital. 42
C.F.R. § 416.41(b). This mandate “ensure[s] that patients have
immediate access to needed emergency or medical treatment in
a hospital.” 47 Fed. Reg. 34082, 34086 (Aug. 5, 1982).
22
It is frequently the case with abortion practice that a clinic
will have doctors on site only a few days a week. Patients
cannot be safely treated for emergent complications at an
abortion clinic when a physician is not present on site.

 33
usually forced to rely on the much less efficient
process of ER triage and subsequent consultation
with a different physician — one who presumably
has admitting privileges, but may not have access to
the patients records or have accurate information
about her abortion.
Unfortunately, an emergency physician is not
necessarily trained to treat complications of abortion
requiring surgical intervention such as uterine
perforation, retained products of conception or
uterine hemorrhage. The accreditation requirements
for board certification in emergency medicine include
no requirement for this type of surgical training.
Accreditation Council
of Graduate Medical
Education (ACGME), Program Requirements for
Graduate Medical Education in Emergency
Medicine, eff. Jul. 1, 2013, available at
http://www.abim.org/certification/policies/combinedi
m/comccm.aspx (last viewed Feb. 1, 2016). In such
cases, the ER department has to contact an on-call
specialist to handle the complications. Regrettably,
however, many hospitals have inadequate on-call
specialist coverage. See, e.g., A.S. O’Malley et al.,
Hospital Emergency On-Call Coverage: Is There A
Doctor in the House? 115 Issue Brief Ctr. for
Studying Health Sys. Change 1 (2007); Love Dec.,
supra n.20 at 4 (“Not all hospitals have OB/GYNs on
emergency department call.”). When one is available,
there is usually some delay between the call to a
specialist and his or her arrival.
Ambulatory surgery facilities require admitting
privileges for physicians who do procedures
comparable to surgical and medical abortion. This

 34
requirement ensures that someone knowledgeable
about the patient’s case, and familiar with the
management of complications of abortion be
available to help the patient in time of an emergency
complication, or at the very least have access to the
pertinent details of the patient’s history and be able
to communicate that professional information with
the treating physician at the hospital. This
information about abortion history becomes
particularly important when evaluating the patient
for infection after abortion. As mentioned above,
medical abortion patients are at higher risk of fatal
infection from C. sordelli, and if the patient arrives
in the ER without the treating physician being
aware of the details of the abortion history, the
diagnosis of C. sordelli sepsis can be delayed, and
delay in diagnosis can be fatal.
Likewise, the standard of practice for more
serious complications, such as perforated uterus,
hemorrhage and serious infection, is to hospitalize
the patient. Perforations are particularly dangerous
because the perforation could result in bowel
contents being introduced into the uterus. In these
cases, laparoscopic surgery is the first step in
diagnosis, and more serious surgery may be
indicated. Where the patient is seriously
hemorrhaging, the situation warrants immediate
attention in a facility that offers blood transfusion.
The blood transfusion process is not available in an
abortion clinic setting because blood has to be stored
and refrigerated in a blood bank, which requires a
level of resources and equipment which physicians
do not have access to in non-hospital clinics. Thus it

 35
is imperative for patient safety that close
communication between the facility which is
performing the surgery and the hospital be assured
to maximize patient safety in the predictable cases of
surgical emergencies.
In light of the irreducible risks that inhere in
practicing surgical and drug-induced abortion, the
fulfillment of the medical principles of timely care
and continuity of care can best be accomplished only
when the physician who performed the procedure
that resulted in the complication can assure rapid
treatment of the patient in the facility equipped to
care for these types of surgical emergencies. That is
exactly why ambulatory surgical facilities require
admitting privileges for physicians performing
surgery comparable to elective abortion, and exactly
why Texas needs this law to ensure the health and
safety of women undergoing both medical and
surgical abortion.
CONCLUSION
For the foregoing reasons, Amici urge the Court
to affirm the judgment of the court of appeals.
Respectfully submitted,
ALLIANCE DEFENDING
FREEDOM:
STEVEN H. ADEN
Counsel of Record
440 1st St., N.W., Suite 600
Washington, DC 20001

 36
(202) 393-8690
saden@adflegal.org
DAVID A. CORTMAN
KEVIN H. THERIOT
1000 Hurricane
Shoals Road, NE
Suite D-1100
Atlanta, GA 30043
February 3, 2016