Amicus Curiae Brief — Whole Woman's Health v. Cole, 136 S. Ct. 499 (2015) (No. 15-274)

No. 15-274 SE VEC

IN THE

Supreme Court of the United States

WHOLE WOMAN’S HEALTH, et al.,

Petitioners,

v.

KIRK COLE, M.D., et al.,

Respondents.

ON PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

BRIEF FOR AMICI CURIAE AMERICAN COLLEGE

OF OBSTETRICIANS AND GYNECOLOGISTS,

AMERICAN MEDICAL ASSOCIATION, AMERICAN

ACADEMY OF FAMILY PHYSICIANS, AND

AMERICAN OSTEOPATHIC ASSOCIATION

IN SUPPORT OF PETITIONERS

KIMBERLY A. PARKER

Counsel of Record

SKYE L. PERRYMAN

EMILY L. STARK

JESSICA E. NOTEBAERT

WILMER CUTLER PICKERING

HALE AND DORR LLP

1875 Pennsylvania Ave., NW

Washington, DC 20006

(202) 663-6000

kimberly.parker@wilmerhale.com

TABLE OF CONTENTS

Page

pe OP Gi Ply, 3 o,,)).)l eee iii

STATEMENT OF INTEREST OF AMICI

IIIS sccccienssussntinninsiciinseaiilaniaiieeeiddeisiimeatcecnieiin nen 1

INTRODUCTION AND SUMMARY OF AR-

IT Ty csicieensssicideitiiaiinnsicitaniiepaadaa sieeatmaeneei ee 4

EO vecctciinnintiininsssicitsiaiiaiaiditiaitiadimepseaettee ee 5

I. H.B.2’s ASC REQUIREMENT IMPOSES

MEDICALLY UNNECESSARY DEMANDS ON

ABORTION FACILITIES AND SERVES NO

| Ns ee ee 5

A. Abortion Is An Extremely Safe Medi-

cal Procedure And No Medical Evi-

dence Suggests That Abortion Would

Be Safer If Performed In An ASC Set-

CEU cancosocsnesnncsncnenansnsenmninicinisaiiinisiiiahiaiianiadienibaiadnial 6

B. H.B.2’s ASC Requirement Imposes

Medically Unnecessary Demands On

pene ee g

1. Abortion procedures do not re-

quire the full operating theater or

external sterility precautions that

are mandated by H.3B. 2 ............cccessesssseseees 10

2. Office-based surgery is common

and Texas law does not require

that facilities performing proce-

dures with higher mortality rates

than abortion meet the standards

NP FN cicccecsssnensinninieinicsigiemaniada

if

TABLE OF CONTENTS—Continued

Il. H.B.2’Ss PRIVILEGES REQUIREMENT DOES

Not SERVE THE HEALTH OF WOMEN IN

A. Clinicians Are Denied Medical Privi-

leges For Reasons Unrelated To Their

Ee 15

B. H.B.2’s Privileges Requirement Is In-

consistent With Accepted Medical

Practice And Provides No Benefit To

Patient Care Or Health Outcomes ................... 16

IIIT snncintscencscneseunisniisiensiensastindsesteenenesssenenssensssssess 21

TABLE OF AUTHORITIES

CASES

Page(s)

Planned Parenthood Southeast, Inc. v.

Strange, 33 F. Supp. 3d 1330 (M.D. Ala.

EE eee ae ee ee a 20

Planned Parenthood of Wisconsin, Inc. v. Van

Hollen, 738 F.3d 786 (7th Cir. 2013).................. 19, 20

Planned Parenthood of Wisconsin, Inc. v. Van

Hollen, No. 13-465, 2015 WL 1285829 (W.D.

ie SE cicreentsecitanieceaniochiaseaiibesiiainisiaiariemmaen 19, 20

STATUTORY PROVISIONS

22 Tex. Admin. Code §§ 192.1-192.6.................cccesceceeeeee 14

25 Tex. Admin. Code

Sra ciiniecesicenitieiisibensimnahes riba hiieanantiaicitliiie 11

i Tira iaiciaeicndisisiniekineiniieetineitiiaaminiatiniaiadintaindnecinblinanibaiine 18

Tex. Health & Safety Code Ann.

i Sern ceiretsstineieceseaieedeciieaeieiatnaneiiinihaiiaianaiiniaamaaseenmaeaaaials 19

GI cnminincctssanssinenmnnidemineienmamemminnatnaneil 6

Fe renrnctremnsnainepntecsinnnninnnnmenaninntiel 5

LEGISLATIVE MATERIALS

iv

TABLE OF AUTHORITIES—Continued

Page(s)

EXECUTIVE MATERIALS

Whether Abortion Facilities that are Exempt

from Licensing Under Section 245.004 of

the Health and Safety Code are Subject to

Regulation by the Texas Department of

Health Under Chapter 245, Op. No. GA-

0212 (Tex. Att’y Gen. July 7, 2004),

available at https://www.texasattorney

general.gov/opinions/opinions/HO0abbott/op/

2004/htim/ga0212.htm#N 4 on... eececcescecesceseceneeneneesenes 6

OTHER AUTHORITIES

ACOG, Committee on Health Care for

Underserved Women, Opinion Number

618, Increasing Access to Abortion (2014),

available at http://www.acog.org/-/media/

Committee-Opinions/Committee-on-Health

-Care-for-Underserved-Women/co613.pdf?

dme=1&ts=20150930T 1613286031 .................-0- 5, 10

ACOG, Committee on Patient Safety & Quality

Improvement, Opinion Number 459, The

Obstetric-Gynecologic Hospitalist (2010),

available at http//www.acog.org/-/media/

Committee-Opinions/Committee-on-Patient

-Safet y-and-Quality-Improvement/co459.pdf

?dmc=1&ts=20150930T 1631363865 ..............ccccceneeee 17

ACOG, Frequently Asked Questions, Dilation

and Curettage (2012), available at http://

www.acog.org/-/media/F or-Patients/faq062

pdf? dme=1&ts=20150930T 1632419491 oo... eee 8

v

TABLE OF AUTHORITIES—Continued

Page(s)

ACOG, Frequently Asked Questions, Induced

Abortion (2015), available at http:/

www.acog.org/-/media/F or-Patients/faq043

pdf?dme=1&ts=20150930T 1633507 149 ...........eccseeee 8

ACOG, Guidelines for Women’s Health Care: A

Resource Manual (4th ed. 2014)..................... 7, 10,17

ACOG, Patient Education Pamphlets:

TE cisisttsiasicisicicieurtiniiaseiiibiininetites 12

ACOG, Patient Education Pamphlets:

Endometrial Hyperplasia (2012).............-0ee-eeeees 12

ACOG, Patient Educetion Pamphlets: Loop

Electrosurgical Excision Procedure (2013)........... 12

ACOG, Practice Bulletin Number 1438, Medical

Management of First-Trimester Abortion

(2014), available at http//www.acog.org/-

/media/Practice-Bulletins/Committee-on-

Practice-Bulletins—Gynecology/Public/

pb143.pdf?dme=1&ts=20150930T1644381068.......... 10

ACOG, Statement of Policy, Legislative

Interference with Patient Care, Medical

Decisions, and the Patient-Physician

Relationship (2013), available at http://

www.acog.org/-/media/Statements-of-Policy

/Public/2013LegislativeInterference.pdf?dme

=1&ts=20150930T 1625461514 2.0... eeeecesceceseeseneesees 5

Allen, Rebecca H., et al. Pain Relief for

Obstetric and Gynecologic Ambulatory

Procedures, 40 Obstetrics & Gynecology

eo EEE FO ee 13

vi

TABLE OF AUTHORITIES—Continued

American Society for Gastrointestinal

Endoscopy, Complications of Colonoscopy,

74 J. Gastrointestinal Endoscopy 745 (2011).

Dennis, Amanda, et al., Barriers to and

Facilitators of Moving Miscarriage

Management Out of the Operating Room,

47 Persp. on Sexual & Reprod. Health 141

Godfrey, Emily M., et al., Early Pregnancy

Loss Needn’t Require a Trip to the

Hospital, 58 J. Fam. Prac. 585 (2009)..............

Grazer, Frederick M. & Rudolph H. de Jong,

Fatal Outcomes from Liposuction: Census

Survey of Cosmetic Surgeons, 105 Plastic &

Reconstructive Surgery 436 (2000) .............:..

Grimes, David A., et al., Abortion Facilities

and the Risk of Death, 13 Fam. Plan.

a N

Grimes, David A., et al., Comparative Risk nad

Death from Legally Induced Abortion in

Hospitals and Nonhospital Facilities, 51

Obstetrics & Gynecology 323 (1978)............-..

Grossman, Daniel, et al., The Public Health

Threat of Anti-Abortion Legislation, 89

Contraception 73 (2014).........sssssssseerssssesseeeess

Institute of Medicine, Crossing the Quality

Chasm: A New Health System for the 21st

SN GU ciictnninsnercininimencnmnetionnnmne

Page(s)

vii

TABLE OF AUTHORITIES—Continued

Joyce, Theodore, The Supply-Side Economics

of Abortion, 365 New Eng. J. Med. 1466

SEIU Tiitssascniasiiiesipnceaeceniniciminenaianeapiiaiiaaitintmmaaitia icine

Lohr, Patricia A. & Richard Lyus, Dilatation

and Evacuation, in Abortion Care 88 (Sam

a I anniccriscnsiietteinenniemeainiitinessinnes

National Abortion Federation, 2015 Clinical

Policy Guidelines (2015) .............ccecseceseeseeeenees

Nichols, Mark, et al., A Comparative Study of

Hysteroscopic Sterilization Performed In-

Office Versus a Hospital Operating Room,

13 J. Minimally Invasive Gynecology 447

Page(s)

GPU sesssenssesessssnssnsnsnsssssnscoenesnessssvanansenenssnssnscesnenesnsevsess 13

Paul, Maureen, Office Management of Early

Induced Abortion, 42 Clinical Obstetrics &

Gynecology 290 (1999) .............c-sccsecssessereseeeeees

Peacock, Lisa M., et al., Transition to Office-

Based Obstetric and Gynecologic

Procedures: Safety, Technical, and

Financial Considerations, 58 Clinical

Obstetrics & Gynecology 418 (2015)...............

Prine, Linda W. & Honor MacNaughton, Office

Management of Early Pregnancy Loss, 84

Am. Fam. Physician 75 (2011) ......sccsssssscsssssssessesennee 9

Raymond, Elizabeth G. & David A. Grimes,

The Comparative Safety of Legal Induced

Abortion and Childbirth in the United

States, 119 Obstetrics & Gynecology 215

GUID cosccescevessnerersconsesennsnesnnneensnsnesnsenennsuneneassssenesnnesaes 6, 7

TABLE OF AUTHORITIES—Continued

Page(s)

Rock, John A. & Howard W. Jones III, TE

Linde’s Operative Gynecology (10th ed.

SEPEIEE cncnstensecesustensessemiensesseerieseanenenninnmemmmenenemnen 8,11

Soffen, Kim, How Texas Could Set National

Template for Limiting Abortion Access,

N.Y. Times, Aug. 19, 2015, http//www

.nytimes.com/2015/08/20/upshot/how-texas-

could-set-national-template-for-limiting-abor

CISI-SSRBD TRTIET FD occccccecscesecccsessecscnsecsvesecssosssoseses 18

Texas Department of State Health Services,

2014 Healthy Texas Babies: Data Book

SETI cesinsisenicesmntttnincesieniatanamiannbiciabdinnibnieannineienmeninneeien 7

Texas Department of State Health Services,

Vital Statistics Annual Reports, http://

www.dshs.state.tx.us/chs/vstat/annrpts

shtm (last updated Sept. 14, 2015).................. 7, 8, 13

Upadhyay, Ushma D., et al., Incidence of

Emergency Department Visits and

Complications After Abortion, 125

Obstetrics & Gynecology 175 (2015)...............00. 7,18

Urman, Richard D. et al, Safety

Considerations for Office-Based Obstetric

& Gynecologic Procedures, 6 Revs.

Obstetrics & Gynecology e8 (2013)................es-se00+ 13

Weitz, Tracy A., et al., Safety of Aspiration

Abortion Performed by Nurse

Practitioners, Certified Nurse Midwives,

and Physician Assistants Under a

California Legal Waiver, 103 Am. J. Pub.

ee rcrnnenictennincnnccnnmisenmmnnnnnneces 8

STATEMENT OF INTEREST OF AMICI CURIAE

The American College of Obstetricians and Gyne-

cologists (the “College” or “ACOG”), the American

Medical Association (“AMA”), the American Academy

of Family Physicians (“AAFP”), and the American Os-

teopathic Association (“AOA”) submit this amici curiae

brief in support of Petitioners.

ACOG is a non-profit educational and professional

organization founded in 1951. The College’s objectives

are to foster improvements in all aspects of the health

care of women; to establish and maintain the highest

possible standards for education; to publish evidence-

based practice guidelines; to promote high ethical

standards; and to encourage contributions to medical

and scientific literature. The College’s companion or-

ganization, the American Congress of Obstetricians and

Gynecologists (the “Congress”), is a professional organ-

ization dedicated to the advancement of women’s health

and the professional interests of its members. Sharing

more than 57,000 members, including 2,532 obstetri-

cian-gynecologists in Texas, the College and the Con-

gress are the leading professional associations of physi-

cians who specialize in the health care of women.

The College and the Congress recognize that abor-

tion is an essential health care service and oppose laws

regulating medical care that are unsupported by scien-

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

and no party or counsel for a party made a monetary contribution

intended to fund the preparation or submission of the brief. No

person or entity other than amici or their counsel made a monetary

contribution to the preparation or submission of this brief. Emails

from the parties granting consent to the filing of this brief are on

file with the Clerk of the Court.

2

tific evidence and that are not necessary to achieve an

important public health objective.

The College has previously appeared as amicus cu-

riae in various courts throughout the country, including

this Court. In addition, the College’s work has been

cited by numerous courts seeking authoritative medical

data regarding childbirth and abortion.

AMA is the largest professional association of phy-

sicians, residents, and medical students in the United

States. Additionally, through state and specialty medi-

eal societies and other physician groups seated in the

AMA’s House of Delegates, substantially all U.S. phy-

sicians, residents, and medical students are represent-

ed in the AMA’s policymaking process. The objectives

of the AMA are to promote the science and art of medi-

cine and the betterment of public health, AMA mem-

bers practice in all fields of medical specialization and in

every state, including Texas. This Court and the feder-

al Courts of Appeal have cited the AMA’s publications

and amicus curiae briefs in cases implicating a variety

of medical questions.

AAFP is headquartered in Leawood, Kansas, and

is the national medical specialty society representing

family physicians. Founded in 1947 as a not-for-profit

corporation, its 120,900 members are physicians and

medical students from all 50 states, the District of Co-

lumbia, Guam, Puerto Rico, the Virgin Islands, and the

Uniformed Services of the United States. The AAFP

seeks to improve the health of patients, families, and

communities by advocating for the health of the public

and serving the needs of members with professionalism

and creativity.

3

AOA, established in 1897, is the national profes-

sional association for the more than 110,000 osteopathic

physicians (Doctors of Osteopathic Medicine or DOs)

and medica] students enrolled in accredited colleges of

osteopathic medicine in the United States. This in-

cludes more than 3,500 osteopathic physicians who

practice in the specialty of obstetrics and gynecology.

The AOA is recognized by the United States Depart-

ment of Education as the accrediting agency for colleg-

es of osteopathic medicine. Since 1943, the AOA’s

American Osteopathic Board of Obstetrics and Gyne-

cology has offered a program of specialty and subspe-

cialty board certification for osteopathic obstetricians

and gynecologists. The AOA is dedicated to promoting

public health, to encouraging scientific research, and to

maintaining and improving high standards of osteo-

pathic medical education.

4

INTRODUCTION AND SUMMARY OF ARGUMENT

Reproductive healthcare is essential to a woman’s

overall health, and access to abortion is an important

component of reproductive healthcare. When state leg-

islatures enact laws that restrict access to abortion

without any valid medical justification, they jeopardize

women’s health. Texas is one of a number of states that

has enacted such legislation.

Passed in 2013, Texas House Bill (“H.B.”)2 re-

quires that the majority of abortion providers in Texas

conform to the standards of ambulatory surgical cen-

ters (the “ASC requirement”), notwithstanding that

the legal abortions performed in Texas prior to the pas-

sage of H.B. 2 met or exceeded safety expectations for

outpatient medical procedures. H.B.2 also requires

that abortion providers obtain admitting privileges at

local hospitals (the “privileges requirement”) without

regard to the many reasons, unrelated to a clinician’s

technical competence, that can make it difficult or im-

possible to obtain such privileges.

H.B. 2’s ASC requirement and privileges require-

ment are contrary to accepted medical practice and are

not based on scientific evidence. They fail to enhance

the quality or safety of abortion-related medical care

and, in fact, impede women’s access to such care by im-

posing unjustified and medically unnecessary burdens

on abortion providers. Accordingly, without this

Court’s review, H.B. 2 would deprive women in Texas

of quality, evidence-based medical care and their rec-

ognized rights under the U.S. Constitution.

For these and the reasons discussed more fully be-

low, amici curiae, leading medical societies whose poli-

cies represent the considered judgments of the many

5

physicians in this country, urge the Court to grant Pe-

titioners’ request for a writ of certiorari so that the

Court may consider the compelling question of whether

H.B. 2 withstands constitutional muster.’

ARGUMENT

The Court’s review of the decision below is critical

to ensuring that women in Texas are not deprived of

access to abortion care. Patient safety is of paramount

importance to amici, but H.B.2’s ASC and privileges

requirements do nothing to protect the health and safe-

ty of women and are incongruous with modern medical

practice. Women’s access to high-quality, evidence-

based abortion care should not be limited by laws en-

acted under the guise of patient safety but that, in fact,

harm women’s health.’

I. H.B.2’s ASC REQUIREMENT IMPOSES MEDICALLY

UNNECESSARY DEMANDS ON ABORTION FACILITIES

AND SERVES NO MEDICAL PURPOSE

H.B. 2’s requirement that abortion facilities’ meet

the standards for ASCs is devoid of any medical or sci-

? The history of legal challenges to H.B.2 is set forth at

Pet. 4-15.

3 See ACOG, Comm. on Health Care for Underserved Wom-

en, Opinion Number 618, Increasing Access to Abortion 3 (2014)

(explaining that the College opposes medically unnecessary physi-

cal plant and admitting privileges requirements); ACOG, State-

ment of Policy, Legislative Interference with Patient Care, Medi-

cal Decisions, and the Patient-Physician Relationship (2013).

* Under Texas law, the term “abortion facility” applies to

providers of abortions, such as outpatient clinics, that are not hos-

pitals, ASCs, or physicians’ offices (unless the office performs more

than fifty abortions in any twelve-month period). Tex. Health &

6

entific purpose.’ Texas has argued that abortion pro-

cedures would be safer if performed in ASCs,° but

there is no scientific or medical evidence to support this

view. To the contrary, mandating that abortion facili-

ties meet ASC standards deprives women of access to

reproductive health care and is inconsistent with ap-

propriate and accepted medical practice.

A. Abortion Is An Extremely Safe Medical Pro-

cedure And No Medical Evidence Suggests

That Abortion Would Be Safer If Performed

In An ASC Setting

Abortion is one of the safest medical procedures

performed in the United States. Nationally, the risk of

death resulting from an abortion is exceptionally low—

0.6 per 100,000 (or 0.0006 percent).’ In Texas, publicly

Safety Code Ann. § 245.004; Whether Abortion Facilities that are

Exempt from Licensing Under Section 245.004 of the Health and

Safety Code are Subject to Regulation by the Texas Department of

Health Under Chapter 245, Op. No. GA-0212, at n.4 (Tex. Att’y

Gen. July 7, 2004). In this brief, amici use the terms “facilities” and

“clinics” interchangeably.

> Amici are aware that, in 2003, Texas enacted a law provid-

ing that abortions at sixteen weeks’ gestational age and later be

performed only in ASCs or hospitals. Tex. Health & Safety Code

Ann. § 171.004. Amici confine their statements here to abortions

occurring prior to sixteen weeks’ gestational age, which were per-

formed legally in clinics and physicians’ offices prior to the enact-

ment of H.B. 2.

® Pet. App. 25a (“The Texas Legislature’s stated purpose for

enacting these provisions was to raise the standard and quality of

care for women seeking abortions and to protect the health and

welfare of women seeking abortions.”); Resp. C.A. Br. 13, 35-36.

7 Raymond & Grimes, The Comparative Safety of Legal In-

duced Abortion and Childbirth in the United States, 119 Obstet-

7

available data suggests that the rate is even lower. Ac-

cording to Texas vital statistics data, 993,844 abortions

have been performed between 2001 and 2013 (the years

for which data is available online).* Only five deaths

were reported in this thirteen-year period, accounting

for a mortality rate of 0.5 per 100,000 (or 0.0005 per-

cent).? From 2009 through 2013, there were zero re-

ported deaths in 360,059 abortions performed in Tex-

as.'° The risk of major complications from the proce-

dure is similarly low. A recent study found an approx-

imately 0.2 percent risk of major abortion complications

that might require hospital care, surgery, or blood

transfusion.'' Another study found that the risk of ma-

rics & Gynecology 215, 216 (2012); see also ACOG, Guidelines for

Women’s Health Care: A Resource Manual 719 (4th ed. 2014).

* ‘The calculations in the text accompanying this note and sev-

eral subsequent notes are based on annual abortion statistics com-

piled by the Texas Department of State Health Services in its Vi-

tal Statistics Annual Reports, http://www.dshs.state.tx.us/chs/

vstat/annrpts.shtm (last updated Sept. 14, 2015).

9 Id.

1 Id. By contrast, the maternal mortality rate has been in-

creasing since at least 2007. See Tex. Dep’t of State Health Servs.,

2014 Healthy Texas Babies: Data Book 14 (2014). In 2011 (the lat-

est year graphed by DSHS), the average maternal mortality rate

was 24.4 per 100,000 live births (or 0.0244 percent); for black wom-

en, that rate was 67.3 per 100,000 (or 0.0673 percent). Jd. In com-

parison, there were no abortion-related deaths in Texas in 2011.

Similarly, one nationwide study found that the mortality risk asso-

ciated with childbirth is approximately fourteen times higher than

the risk associated with abortion. Raymond & Grimes, supra n.7,

at 216.

” Upadhyay et al., Incidence of Emergency Department Vis-

its and Complications After Abortion, 125 Obstetrics & Gynecolo-

gy 175, 176, 181 (2015) (using 2009-2010 data from California).

8

jor complications (uterine perforation, infection, and

hemorrhage) from first trimester abortions by the aspi-

ration method, the most common method for obtaining

an abortion in Texas, is even lower—0.05 percent.”

Outpatient clinics and phys ysicians’ offices are safe

places to obtain abortions.’ In the five years during

which Texas had no reported abortion-related deaths,

the overwhelming majority of abortions—83 percent—

were performed in these settings, not in ASCs or hospi-

tals.* From 2001 to 2013, when Texas statistics re-

flected an exceedingly low mortality rate of 0.5 per

100,000 abortions lene 0.0005 percent), 91 percent of

abortions were ormed in abortion facilities or phy-

sicians’ offices.'* Nationally, 95 percent of abortions are

performed in nonhospital settings.'* There is no medi-

cally sound reason to assume that abortions performed

in a hospital or ASC setting would be safer than those

? Weitz et al., Safety of Aspiration Abortion Performed by

Nurse Practitioners, Certified Nurse Midwives, and Physician

Assistants Under a California Legal Waiver, 103 Am. J. Pub.

Health 454, 458 (2013) (using 2007-2011 data from California);

DSHS Vital Statistics Annual Reports, supra n.8.

= See ACOG, Frequently Asked Questions, Induced Abortion

1 (2015); ACOG, Frequently Asked Questions, Dilation and Curet-

tage 1 (2012); see also Rock & Jones, TE Linde’s Operative Gyne-

cology 783 (10th ed. 2011).

- DSHS, Vital Statistics Annual Reports, supra n.8.

is

Id.

'® Rock & Jones, supra n.13, at 783; Peacock et al., Transition

to Office-Based Obstetric and Gynecologic Procedures: Safety,

Technical, and Financial Considerations, 58 Clinical Obstetrics &

Gynecology 418, 427 (2015); see also Joyce, The Supply-Side Eco-

nomics of Abortion, 365 New Eng. J. Med. 1466, 1466-1467 (2011)

(94 percent).

9

performed in an abortion clinic or office. Indeed, scien-

tific literature suggests that the safety of abortions

performed in an office setting is equivalent to the safe-

ty of those performed in a hospital setting.'’ There is,

thus, no medical basis to mandate that abortion clinics

meet the standards for ASCs.

B. H.B. 2’s ASC Requirement Imposes Medically

Unnecessary Demands On Abortion Facilities

Requiring that an abortion clinic meet the stand-

ards for ASCs is medically unnecessary because of the

nature and relative simplicity of abortion procedures

and because the complication rate associated with these

procedures is exceptionally low. ASCs are meant to

provide environments in which invasive surgeries his-

torically performed in hospitals can be performed out-

side a hospital-based setting. Abortion procedures,

however, do not require an incision into a woman’s

body and do not entail exposure of sterile tissue to the

external environment, and performance of such proce-

dures does not require a hospital-based or related out-

patient setting.

'! Paul, Office Management of Early Induced Abortion, 42

Clinical Obstetrics & Gynecology 290, 292 (1999); Peacock, supra

n.16, at 427 (“{F jirst-trimester aspiration abortions performed in

an office are as safe as those performed in hospitals.” (citing Prine

& MacNaughton, Office Management of Early Pregnancy Loss, 84

Am. Fam. Physician 75 (2011))); see also Grimes et al., Abortion

Facilities and the Risk of Death, 13 Fam. Plan. Persp. 30, 31

(1981); Grimes et al., Comparative Risk of Death from Legally In-

duced Abortion in Hospitals and Nonhospital Facilities, 51 Ob-

stetrics & Gynecology 323, 324 (1978).

10

1. Abortion procedures do not require the

full operating theater or external sterility

precautions that are mandated by H.B. 2

The physical plant requirements mandated by

H.B. 2 are not necessary for abortion procedures.'* For

example, an operating room—which is mandatory un-

der H.B. 2—is unnecessary for abortions. First, an in-

creasingly large percentage of abortion patients are

opting for medication abortion (7.e., taking prescription

pills that cause abortion), rather than surgical abor-

tions. No designated procedure space is required for

these abortions because they involve taking pills to in-

duce pregnancy termination, which then typically oc-

curs at home."

Second, even surgical abortions do not require an

operating room. To conduct first-trimester surgical

abortions, clinicians will have the patient recline on an

examination table fitted with stirrups, taking the same

position as for many gynecological exams. The number

of personnel involved is minimal; little is required by

way of equipment. These procedures are not commonly

'§ Current ACOG guidelines, which (in contrast to the Texas

regulations) provide evidence-based information to practitioners

based on well-accepted medical practice, already recommend phys-

ical plant standards for clinics and offices. See ACOG, Guidelines

for Women’s Health Care, supra n.7, at 142-143. They oppose,

however, facility requirements, including those that require facili-

ties to meet the physical plant standards of hospitals, that are en-

acted under the guise of patient safety but that impose medically

unnecessary requirements designed to reduce access to abortion.

ACOG, Opinion Number 613, supra n.3, at 3.

'? See ACOG, Practice Bulletin Number 143, Medical Man-

agement of First-Trimester Abortion 2-3 (2014) (providing current

evidence-based guidelines for medication abortion).

1]

performed using general anesthesia, so designated

space for equipment storage associated with general

anesthesia is not generally required.” Surgical abor-

tions simply do not require the size, layout, or equip-

ment of a full operating theater.

Moreover, many of the burdensome construction

requirements contained in the ASC regulations that are

designed to maintain a sterile environment, such as re-

stricted-access surgical suites, one-way traffic flow pat-

terns, scrub equipment, and special ventilation units,

are unnecessary in abortion clinics.”' This is because

clinicians performing abortions access the uterus

through the vagina, which is known as a “clean-

contaminated field” and is not naturally a sterile space.

Therefore, “[rjoutine sterile precautions (e.g., drapes,

caps, masks, and gowns) are nae under ac-

cepted medical practice for abortions. Indeed, accepted

medical practice requires only that the clinician use

sterile instruments and employ a “no-touch” technique,

20 Tn any event, as noted below, Texas law does not require

other procedures that require even general anesthesia to be per-

formed in a facility that meets ASC standards. See infra n.27 and

accompanying text.

?! One specific example of a structural element designed to

maintain a highly sterile environment in ASCs that is unnecessary

in the abortion context is the requirement that ASCs have operat-

ing rooms with ceilings that are “monolithic from wall to wall ... ,

smooth and without fissures, open joints, or crevices and with a

washable and moisture impervious finish.” 25 Tex. Admin. Code

§ 135.52(f(5XC). While such a requirement may be advisable for

procedures where sterile body tissue is exposed, abortions are not

such procedures and such stringent construction regulations are

unnecessary.

2 Rock & Jones, supra n.13, at 784.

12

“which ensures that the tips of instruments never con-

tact non-sterile surfaces before entering the uterus.””

The Respondents’ argument before the Fifth Cir-

cuit—that the external sterility requirements for ASCs

are necessary for abortion procedures because “surgi-

cal abortion involves invasive entry into the uter-

us,””*— ignores the fact that unlike some other obstet-

ric and gynecological procedures (such as cesarean de-

liveries and abdominal hysterectomies), surgical abor-

tions do not involve exposure of the uterus to the ex-

ternal environment. For this reason (among others),

ensuring the sterility of the portion of the surgical in-

struments that make contact with the uterus is suffi-

cient to achieve the sterility needed for the procedure.

In short, there has never been a substantial argument

in any accepted scientific or medical literature that fur-

ther sterility precautions would improve the already

exceptionally low complication rate associated with

abortions.

2. Office-based surgery is common and

Texas law does not require that facilities

performing procedures with higher mor-

tality rates than abortion meet the stand-

ards for ASCs

Office-based surgery is common and for many gy-

necological procedures it is the prevailing practice.”

3 Lohr & Lyus, Dilatation and Evacuation, in Abortion Care

88, 95 (Rowlands ed., 2014); see also Paul, supra n.17, at 293-294.

** See Pet. App. 31a; Resp. C.A. Br. 13.

- See, e.g., ACOG, Patient Education Pamphlets: Colposcopy

(2013); ACOG, Patient Education Pamphlets: Endometrial Hy-

perplasia (2012); ACOG, Patient Education Pamphlets: Loop

13

For example, incomplete miscarriages are commonly

treated in office settings via uterine aspiration, which is

the same procedure as that used for the majority of in-

duced abortion procedures covered by H.B. 2.”°

Texas permits physicians to perform surgical and

other procedures in an office setting, including surgical

procedures with complication and mortality rates simi-

Electrosurgical Excision Procedure (2013); Allen et al., Pain Re-

lief for Obstetric and Gynecologic Ambulatory Procedures, 40 Ob-

stetrics & Gynecology Clinics N. Am. 625, 631-640 (2013) (col-

poscopy, cervical biopsy, cervical dilation and uterine aspiration,

IUD insertion, endometrial biopsy, hysteroscopy); Nichols et al., A

Comparative Study of Hysteroscopic Sterilization Performed In-

Office Versus a Hospital Operating Room, 13 J. Minimally Inva-

sive Gynecology 447, 449 (2006); Peacock, supra n.16 (hysterosco-

py, [UD retrievals, sterilization, uterine evacuation (including di-

lation and aspiration), among other procedures); Urman et al.,

Safety Considerations for Office-Based Obstetric and

Procedures, 6 Revs. Obstetrics & Gynecology e8, el4 (2013)

(“There is no evidence to substantiate office-based gynecologic

procedures being inherently unsafe. On the contrary, gynecol-

ogists can perform procedures in the office setting in a safe, effec-

tive, efficient, patient-centered fashion.”).

7° Allen, supra n.25, at 632 (uterine aspiration is used for in-

duced abortion and treatment of miscarriages and can be done in

office setting); Dennis et al., Barriers to and Facilitators of Mov-

ing Miscarriage Management Out of the Operating Room, 47

Persp. on Sexual & Reprod. Health 141, 141, 143 (2015) (office-

based treatment for miscarriage “is equally safe or safer, quicker,

more cost-effective and more acceptable to some women” than

hospital-based care; technical aspects of miscarriage management

and induced abortion are the same); Peacock, supra n.16, at 427-

428 (vacuum curettage is used for abortion and miscarriage man-

agement and can be performed in office setting); DSHS, Vital Sta-

tistics Annual Reports, supra n.8; see also Godfrey et al., Early

Pregnancy Loss Needn't Require a Trip to the Hospital, 68 J. Fam.

Prac. 585, 588 (2009) (vacuum aspiration appropriate for office set-

ting).

14

lar to or higher than those posed by abortion. Texas

law authorizes physicians to perform procedures in

their offices—including procedures involving general

anesthesia, which are generally riskier than procedures

(such as the vast majority of abortions) that do not re-

quire general anesthesia—without meeting ASC stand-

ards.” For example, no law requires colonoscopies or

liposuction to be performed in an ASC or hospital set-

ting and the mortality rate for both procedures is high-

er than abortion. The mortality rate for colonoscopy is

0.007 percent.” The mortality rate for liposuction is

around 0.02 percent.”? There is no medical purpose or

principled reason for Texas legislation requiring abor-

tion facilities, but not other medical facilities that per-

form similar or even riskier outpatient procedures, to

meet heightened ASC standards.

Il. HB. 2’s PRIVILEGES REQUIREMENT DOES NoT SERVE

THE HEALTH OF WOMEN IN TEXAS

H.B. 2’s requirement that abortion providers main-

tain admitting privileges at a local hospital adds no

medical benefit to the treatment of Texas women and is

contrary to current medical practice. As with the ASC

requirement, the Texas legislature’s claimed purpose

for the privileges requirement is “to raise the standard

27 See 22 Tex. Admin. Code §§ 192.1-192.6.

*8 Am. Soc’y for Gastrointestinal Endoscopy, Complications

of Colonoscopy, 74 J. Gastrointestinal Endoscopy 745, 747 (2011).

For a discussion of the mortality rate associated with abortion, see

supra notes 7-10 and accompanying text.

29 Grazer & de Jong, Fatal Outcomes from Liposuction: Cen-

sus Survey of Cosmetic Surgeons, 105 Plastic & Reconstructive

Surgery 436, 441 (2000).

15

and quality of care for women seeking abortions and to

protect the health and welfare of women seeking abor-

tions.”** But abortion providers may be denied admit-

ting privileges for reasons unrelated to the quality of

care they provide, and the privileges requirement does

not improve the health and safety of women.

A. Clinicians Are Denied Medical Privileges For

Reasons Unrelated To Their Competency

Obtaining privileges can be difficult, if not impossi-

ble, for a clinician, irrespective of the clinician’s tech-

nical competence. For example, some academic hospi-

tals will only allow medical staff membership for clini-

cians who also qualify for and accept faculty appoint-

ments. Other hospitals require that clinicians admit a

certain number of patients, or perform a certain num-

ber of deliveries or major obstetric or gynecological

surgeries in order to be affiliated with the hospital.

Providers who specialize in performing abortions are

frequently unable to meet such requirements because

abortion is a very safe procedure only rarely resulting

in hospitalization. These factors result in a denial of

privileges that has nothing to do with a provider’s com-

petence.

The difficulty of obtaining privileges is not theoret-

ical; the Fifth Circuit credited evidence. that clinicians

at Petitioner’s clinic in McAllen have been denied privi-

leges for reasons unrelated to screening clinicians for

competency.”’ But the real-life impact of the privileges

© Pet. App. 25a; Resp. C.A. Br. 13.

*! Det. App. 70a-71a (“With respect to the admitting privileg-

es requirement, Whole Woman’s Health presented considerable

evidence that Plaintiff Dr. Lynn and three unidentified physicians

16

requirement is far more wide-ranging than the effect

on the McAllen clinic. In Texas, after the enactment of

H.B. 2, a significant percentage of abortion clinics were

forced to stop providing abortions because providers

did not have privileges. Requiring that clinicians ob-

tain hospital privileges—when such privileges may be

denied for any number of reasons having nothing to do

with a clinician’s competency or the quality of care that

he or she provides—does not promote the wellbeing of

Texas women.

B. H.B.2’s Privileges Requirement Is Incon-

sistent With Accepted Medical Practice And

Provides No Benefit To Patient Care Or

Health Outcomes

H.B. 2 is also inconsistent with prevailing medical

practices, which focus on ensuring prompt medical care

and continuity of care and do not require that each in-

dividual abortion provider has admitting privileges.’

Instead of requiring that clinicians who perform abor-

tions have admitting privileges at a local hospital, ac-

working at the McAllen facility were unable to obtain admitting

privileges at local hospitals for reasons other than their compe-

tence.”). There was also evidence in the record on appeal that a

clinician from Petitioner’s E] Paso clinic was denied privileges for

reasons unrelated to clinical competence, but the Fifth Circuit

found it unnecessary to consider this evidence in reaching its deci-

sion. Id. at 72a & n.44.

2 Grossman et al, The Public Health Threat of Anti-

Abortion Legislation, 89 Contraception 73, 74 (2014).

33 See Inst. of Med., Crossing the Quality Chasm: A New

Health System for the 21st Century 8-9 (2001) (recommending that

health care be available 24 hours a day and that “(cJlinicians and

institutions should actively collaborate and communicate to ensure

an appropriate exchange of information and coordination of care”).

17

cepted medical practice requires that an abortion pro-

vider’s facility have a plan to provide prompt emergen-

cy services and (if needed) to transfer a patient to a

nearby emergency facility if complications occur. This

practice ensures that, in the rare instance when a wom-

an experiences a complication during or immediately

after an abortion and seeks hospital-based care,’* con-

sistent with prevailing medical practice, she can be

treated appropriately by a trained emergency-room

clinician or the hospital’s on-call specialist. The care

provided by that emergency-room clinician or on-call

specialist is not contingent on the woman’s abortion

provider having admitting privileges.

In fact, the transfer of care from the abortion pro-

vider to an emergency-room clinician is consistent with

the increasing practice for inpatient and outpatient care

to be provided by different practitioners.” That is,

throughout modern medical practice, often the same

clinician does not provide both outpatient and hospital-

based care; rather, hospitals increasingly rely on “hos-

pitalists” who provide care only in a hospital setting.”’

Continuity of care is achieved through communication

** ACOG, Guidelines for Women’s Health Care, supra n.7, at

720 (“Clinicians who perform abortions ... should have a plan to

provide prompt emergency services if a complication occurs and

should establish a mechanism for transferring patients who re-

quire emergency treatment.”); Nat’] Abortion Fed’n, 2015 Clinical

Policy Guidelines 42 (2015).

5 See supra n.11 and accompanying text.

© See, e.g., ACOG, Comm. on Patient Safety & Quality Im-

provement, Opinion Number 459, The Obstetric-Gynecologic Hos-

pitalist (2010) (reaffirmed 2012).

18

and collaboration between specialized health care pro-

viders,”* which do not depend on those providers hav-

ing hospital privileges.

Prior to the enactment of H.B.2, Texas law ade-

quately required compliance with prevailing medical

practice by requiring that abortion facilities have pro-

tocols to ensure that patients could be transferred to a

hospital in the rare event of an emergency requiring

hospital treatment.*? There is no medical basis on

which to conclude that women’s health would be ad-

vanced by requiring that clinicians obtain privileges.

Doing so is inconsistent with prevailing medical prac-

tice and imposes unnecessary restrictions on the ability

of clinicians to provide abortion care.

Nor does H.B.2’s privileges requirement assist

Texas women in the rare event that they experience

complications after being discharged and returning

home. As with any emergency, it is likely that a woman

would seek treatment at a hospital near her home.”

Given the juxtaposition of H.B. 2’s requirement that an

abortion provider maintain privileges at a hospital

within thirty miles of her clinic with the fact that the

average Texas county is 111 miles from an abortion

clinic,” it is unlikely that the hospital at which a woman

8 See Inst. of Med., supra n.33, at 9, 62, 133-134.

*9 95 Tex. Admin. Code § 139.56(a) (requiring a “readily ac-

cessible written protocol for managing medical emergencies and

the transfer of patients requiring further emergency care to a hos-

pital”).

* Upadhyay, supra n.11, at 176.

- Soffen, How Tezas Could Set National Template for Limit-

ing Abortion Access, N.Y. Times, Aug. 19, 20165,

19

seeks emergency medical care will be the hospital at

which her provider maintains privileges. It would be

inappropriate to transport women an additional dis-

tance to the hospitals at which their abortion providers

maintain privileges.”

Noting the lack of scientific basis for the privileges

requirement, several federal courts—with the excep-

tion of the Fifth Circuit—have recently recognized that

requiring privileges provides no medical benefit to

women who undergo abortion procedures. For exam-

ple, the Seventh Circuit upheld a district court’s pre-

liminary injunction of a Wisconsin statute containing a

privileges requirement that is nearly identical to the

Texas requirement, and the United States District

Court for the Western District of Wisconsin recently

permanently enjoined enforcement of that require-

ment.”? The Seventh Circuit found, in the preliminary

injunction record, “no evidence that women who have

complications from an abortion recover more quickly or

more completely or with less pain or discomfort if their

http//www.nytimes.com/2015/08/20/upshot/how-texas-could-set-

national-template-for-limiting-abortion-access.html?_r=0.

*? Indeed, H.B. 2 acknowledges that the prevailing practice is

for a patient to receive emergency care at a facility near her home.

Tex. Health & Safety Code Ann. § 171.0031(aX2XB) (requiring

that a woman be given “the name and telephone number of the

nearest hospital to the home of the pregnant woman at which an

emergency arising from the abortion would be treated”).

*? See Planned Parenthood of Wis., Inc. v. Van Hollen (Van

Hollen I), T38 F.3d 786, 798 (7th Cir. 2013), cert. denied, 134 S. Ct.

2841 (2014); Planned Parenthood of Wis., Inc. v. Van Hollen (Van

Hollen II), No. 13-465, 2015 WL 1285829, at *42 (W.D. Wis.), ap-

peal docketed sub nom. Planned Parenthood of Wis., Inc. v.

Schimel, No. 15-1736 (7th Cir. Apr. 6, 2015).

20

physician has admitting privileges at the hospital to

which the patient is taken for treatment of the compli-

cations.“ The district court similarly concluded, after

a full trial on the merits of the plaintiffs’ challenge to

the admitting privileges requirement, that the state

failed to “demonstrat[e] through credible evidence a

link between the admitting privileges requirement and

a legitimate health interest.’”*°

In setting aside Alabama’s privileges requirement,

the United States District Court for the Middle District

of Alabama found that mandating that abortion provid-

ers have admitting privileges “falls outside the range of

standard medical practice for complication care” for

abortion procedures and “would, in reality, undermine

the State’s goal of continuity of care” because women in

Alabama would lose local access to the clinics forced to

close under the privileges requirement.“ As these

courts recognized, laws like H.B. 2 limit or delay access

to care while providing no benefit to patient care.

“ Van Hollen I, 738 F.3d at 798.

*° Van Hollen II, 2015 WL 1285829, at *1. Specifically, the

district court determined, largely on the basis of neutral expert

testimony, that complication rates from abortion are extremely

low and there was no evidence in the record that a clinician’s hav-

ing admitting privileges at a local hospital would improve abortion

outcomes, increase continuity of care, increase the quality of care

provided to women undergoing abortions, or increase accountabil-

ity for providers of abortion. See id. at *14-25.

*© Planned Parenthood Se., Inc. v. Strange, 33 F. Supp. 3d

1330, 1372 (M.D. Ala.), supplemented by 33 F. Supp. 3d 1381 (M.D.

Ala.), and amended by No. 2:13cv405-MHT, 2014 WL 5426891

(M.D. Ala. Oct. 24, 2014).

21

7 ~ *

H.B.2 does nothing to further the safety of abor-

tions or the competency of those performing them in

Texas. Indeed, legal abortions performed in Texas pri-

or to H.B.2 met or exceeded safety expectations for

outpatient medical procedures. H.B.2 is an unneces-

sary regulation that presents risks to women’s health

by restricting and delaying access to safe abortion. Ac-

cordinglv, amici urge the Court to grant the petition for

a writ ©. certiorari in order to review whether H.B. 2

can withstand constitutional scrutiny.

CONCLUSION

For the foregoing reasons, amici urge the court to

grant the petition for a writ of certiorari.

Respectfully submitted.

KIMBERLY A. PARKER

Counsel of Record

SKYE L. PERRYMAN

EMILY L. STARK

JESSICA E. NOTEBAERT

WILMER CUTLER PICKERING

HALE AND DORR LLP

1875 Pennsylvania Ave., NW

Washington, DC 20006

(202) 663-6000

kimberly.parker@wilmerhale.com

OCTOBER 5, 2015