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 [email protected] 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 ......................................................... 36 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 iv Planned Parenthood Association of Kansas City, Missouri., Inc. v. Ashcroft, 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 v Washington v. Glucksberg, 521 U.S. 702 (1997) .............................................. 5 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 vi 47 Fed. Reg. 34082, 34086 ....................................... 32 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:// vii www.aaaasfsurveyors.org/asf_web/PDF%20FILE 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-to- know-about-the-ambulatory-surgery-center- industry.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 Self- administration, 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.