(1 of 506) Case: 16-15360, 06/07/2016, ID: 10005906, DktEntry: 86-1, Page 1 of 45 Case No. 16-15360 IN THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT NATIONAL ABORTION FEDERATION, Plaintiff-Appellee, CENTER FOR MEDICAL PROGRESS, BIOMAX PROCUREMENT SERVICES, LLC,DAVID DALEIDEN, aka ROBERT DAOUD SARKIS, and TROY NEWMAN, Defendants-Appellants. On Appeal from the United States District Court for the Northern District of California Case No. 3:15-cv-03522-WHO Hon. William H. Orrick, United States District Court Judge Brief of Amici Curiae Fetal Tissue Researchers, Scientists, Physicians, Medical and Legal Ethicists and Academics in Support of Plaintiff-Appellee JANET I. LEVINE (jlevine@crowelLcom) JASON C. MURRAY ([email protected]) LAURA SCHWARTZ ([email protected]) CROWELL & MORING LLP 515 South Flower St., 40th Floor Los Angeles, CA 90071 Telephone: 213.622.4750 Attorneys for Amici Curiae [signature block continued on next page] (2 of 506) Case: 16-15360, 06/07/2016, ID: 10005906, DktEntry: 86-1, Page 2 of 45 Erez Aloni David H. Ledbetter Hazel Beh Christopher Mason Ann Bonham Joseph M. McCune R. Alta Charo Marcus Muench Wendy K. Chung David Mutch F. Sessions Cole Kim Mutcherson Ron Clyman Vivek R. Nerurkar Mitchell Creinin Mark Nichols Judith Daar Siripanth Nippita Gillian Dean Robert Nussbaum Jeffrey Dicke Paul Offit Eleanor Drey David Orentlicher Jeffrey Ecker Harry Ostrer Maxine Eichner Maureen Paul David Eisenberg Sarah Prager Mark I. Evans Maura Quinlan Eric Feldman Radhika Rao Susan J. Fisher Hope Riccioti Renee C. Fox John A. Robertson Arupa Ganguly M. Elizabeth Ross Steven Goldman Jennifer Salcedo Rudolf Jaenisch Robert Schwartz Bliss Kaneshiro Nathaniel Snyder Jennifer Kerns Reni Soon Antonella Lavelanet Phillip Stubblefield Sylvia Law Jennifer Tang (3 of 506) Case: 16-15360, 06/07/2016, ID: 10005906, DktEntry: 86-1, Page 3 of 45 TABLE OF CONTENTS Page STATEMENT OF IDENTITY,INTEREST, AND AUTHORITY TO FILE .........1 SUMMARY OF ARGUMENT ................................................................................3 ARGUMENT............................................................................................................7 I. WHAT IS FETAL TISSUE RESEARCH? ....................................................7 A. Why Fetal Tissue and Not Adult, Animal or Computer- Generated Material? .............................................................................8 1. What Makes These Cells Unique?............... ..............................8 2. Why Is There No Substitute for Fetal Tissue Research on Human Development and Treating Infants and Newborns?................................................... .............................10 IL WHAT LAWS AND REGULATIONS APPLY TO USING FETAL TISSUE FOR RESEARCH? ........................................................................13 A. What is the History of Fetal Tissue Research Laws?.........................13 B. What Is the Current Law on Fetal Tissue Research? .........................15 III. WHAT ROLE HAS FETAL TISSUE RESEARCH PLAYED IN MODERN HEALTH`? ..................................................................................17 A. What Role Has Fetal Tissue Research Played in Vaccine Development?........................................................ .............................17 B. What Role Does Fetal Tissue Research Play in the Treatment of Devastating Diseases? ........................................................................20 C. Where Is the Future Opportunity For Fetal Tissue Research?...........21 CONCLUSION.......................................................................................................26 CERTIFICATE OF COMPLIANCE ......................................................................27 CERTIFICATE OF SERVICE ...............................................................................28 APPENDIXA .................................................................................................. A-001 e (4 of 506) Case: 16-15360, 06/07/2016, ID: 10005906, DktEntry: 86-1, Page 4 of 45 TABLE OF AUTHORITIES Pages) CASES Roe v. Wade, 410 U.S. 113( 1973)............................................................... .............................14 STATUTES 42 U.S.C. § 289g-1 ...................................................................................................16 42 U.S.C. § 289g-2(c)(1) .........................................................................................16 NIHRevitalization Act ............................................................................................15 Uniform Anatomical Gift Act ..................................................................................16 RULES Fed. R. App. P. 29(d).................................................................. .............................27 Fed. R. App. P. 32(a)(5).............................................................. .............................27 Fed. R. App. P. 32(a)(6).............................................................. .............................27 Fed. R. App. P. 32~a)~~)~B) .....................................................................................27 Fed. R. App. P. 32~a)~~)~B)~iii) ...............................................................................27 OTHER AUTHORITIES AAAS Annual Report: Innovation, Information and Imaging at C2 (2015)..................................................................................... .............................18 AAMC Statement in Support of Fetal Tissue Research (Mar. 18, 2016).................................................................................. .............................4, 20 Alison Abbott, Fetal-Cell Revivalfor Parkinson's, 510 Nature Int'1 J. of Science 195 (June 12, 2014).............................................. .............................24 (5 of 506) Case: 16-15360, 06/07/2016, ID: 10005906, DktEntry: 86-1, Page 5 of 45 TABLE OF AUTHORITIES Page The American Society for Cell Biology, Facts About Fetal Tissue Research (Mar. 2000).................................................. .............................7, 11, 12 Amir Attaran, Offthe Podium: Why Public Health Concernsfor Global Spread ofZika ViNUS Means That Rio de Janeiro's 2016 Olympic Games Must Not Proceed, Harvard Pub. Health Rev. Special Commentary- Zika Virus and Public Health Concerns (May 2016)............................................................................. .............................21 Amy Maxmen, Fetal Tissue Probe Unsettles Scientific Community, 34 Nature Biotechnology 447(May 2, 2016)......................... .............................7, 13 Ariana E. Cha &Lena H. Sun, What Is Zika? And What Are The Risks As It Spreads?, The Washington Post(Feb. 4, 2016)............ .............................21 California Department of Public Health, Public Health Repots First Confirmed Zika Virus Case Acquired Though Sexual Transmission in Califoi^nia (Mar. 25, 2016).......................... .............................21 Cassandra Willyard, The Boom in Mini Stomachs, Brains, Breasts, Kidneys and More, 523 Nature Int'1 Weekly J. of Science 520 (July 30, 2015)....................................................................... .............................11 CDC,APolio -Free U.S. Thanks to Vaccine Efforts (last updated July 27, 2015)........................................................................... ............................18, 19 CDC,About Zika Virus Disease (last updated May 5, 2016)............................21, 22 CDC,Pregnancy and Rubella (last updated Mar. 31, 2016)...... .............................19 CDC,Rubella (last updated Jan. 19, 2016)................................. .............................19 CDC, The Time to Eradicate Polio Is Now (last updated Mar. 3, 2014)...................4 CDC, Why Aye Childhood Vaccines So Important? (last updated May 19, 2014)................................................................................ .............................17 (6 of 506) Case: 16-15360, 06/07/2016, ID: 10005906, DktEntry: 86-1, Page 6 of 45 TABLE OF AUTHORITIES Page Congressional Research Service, Fetal Tissue Research: Frequently Asked Questions (July 31, 2015)............................................. ..............................8 Danielle Paquette, We Lose Money Doing This: Tiny Company Caught in Abortion Debate Takes on Congress, The Washington Post(May 27, 2016)................................................................ ..............................3 David Quammen, Why Zika Virus Is This Year's Scary ViNUS, National Geographic (Jan. 28, 2016).................................................... .............................21 Donald G. McNeil Jr., et al., Shot Answers to Hard Questions about Zika Virus, The New York Times (Mar. 18, 2016)............... .............................21 E. Norrby & S.B. Prusiner, Polio and Nobel Prizes: Looking Back 50 Yeas, 61 Ann. Neurol. 385 (May 2007)............................... .............................18 Final Vote Results for Roll Call 147(May 28, 1992) .............................................15 Harry Johns, Testimony before the Fiscal Year 2014 Appropriations for Alzheimer's-related Activities at the United States Department of Health and Human Services, Subcommittee on Labor, Health and Human Services, Education and Related Agencies Committee on Appropriations, United States House of Representatives (Mar. 13, 2013)................................................................................ .............................23