All. for Hippocratic Med. v. U.S. Food & Drug Admin.

Docket Number23-10362
Decision Date16 August 2023
Citation78 F.4th 210
PartiesALLIANCE FOR HIPPOCRATIC MEDICINE; American Association of Pro-Life Obstetricians & Gynecologists; American College of Pediatricians; Christian Medical & Dental Associations; Shaun Jester, D.O.; Regina Frost-Clark, M.D.; Tyler Johnson, D.O.; George Delgado, M.D., Plaintiffs-Appellees, v. U.S. FOOD & DRUG ADMINISTRATION; Robert M. Califf, Commissioner of Food and Drugs; Janet Woodcock, M.D., in her official capacity as Principal Deputy Commissioner, U.S. Food and Drug Administration; Patrizia Cavazzoni, M.D., in her official capacity as Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; United States Department of Health and Human Services; Xavier Becerra, Secretary, U.S. Department of Health and Human Services, Defendants-Appellants, v. Danco Laboratories, L.L.C., Intervenor-Appellant.
CourtU.S. Court of Appeals — Fifth Circuit

Appeal from the United States District Court for the Northern District of Texas, USDC No. 2:22-CV-223, Matthew Joseph Kacsmaryk, U.S. District Judge

Erik Baptist, Matthew Scott Bowman, John J. Bursch, Erin Morrow Hawley, Alliance Defending Freedom, Washington, DC, Cody S. Barnett, Julie Marie Blake, Senior Counsel, Alliance Defending Freedom, Lansdowne, VA, Denise Harle, Alliance Defending Freedom, Lawrenceville, GA, Christian D. Stewart, Morgan Williamson, L.L.P., Amarillo, TX, for Plaintiffs-Appellees.

Sarah Elaine Harrington, U.S. Department of Justice, Civil Division, Washington, DC, Cynthia Barmore, Michael S. Raab, U.S. Department of Justice, Civil Division, Appellate Section, Washington, DC, Michael S. Raab, U.S. Department of Justice, Civil Division, Federal Programs Branch, Washington, DC, for Defendants-Appellants.

Jessica Lynn Ellsworth, Marian Golden, Philip Katz, Lynn Whipkey Mehler, Danielle Desaulniers Stempel, Catherine Emily Stetson, Esq., Hogan Lovells US, L.L.P., Hogan Lovells US, L.L.P., Eva Marie Schifini, Hogan Lovells US, L.L.P., Los Angeles, CA, Delia Scoville, Attorney, Boston, MA, for Intervenor-Appellant Danco Laboratories, L.L.C.

Ester Murdukhayeva, Office of the Attorney General, for the State of New York Appeals & Opinions, New York, NY, Grace Zhou, Office of the Attorney General for the State of New York, New York, NY, for Amici Curiae State of New York, State of Arizona, State of California, State of Colorado, State of Connecticut, State of Delaware, State of Hawaii, State of Illinois, State of Maine, State of Maryland, State of Massachusetts, State of Michigan, State of Minnesota, State of Nevada, State of New Jersey, State of New Mexico, State of North Carolina, State of Oregon, State of Pennsylvania, State of Rhode Island, State of Vermont, State of Washington, State of Wisconsin, District of Columbia.

Charles William Fillmore, Attorney, Fillmore Law Firm, L.L.P., Fort Worth, TX, for Amicus Curiae Ethics and Public Policy Center.

Stephanie L. Gutwein, Elizabeth A. Charles, Anthony Scott Chinn, Faegre Drinker Biddle & Reath, L.L.P., Indianapolis, IN, for Amicus Curiae Honeybee Health, Incorporated.

Emily Gerry, Akin Gump Strauss Hauer & Feld, L.L.P., Washington, DC, for Amici Curiae Leukemia and Lymphoma Society, Patient and Provider Advocacy Organizations.

Andrew Layton Schlafly, Far Hills, NJ, for Amicus Curiae Association of American Physicians and Surgeons Educational Foundation.

Heather Gebelin Hacker, Hacker Stephens, L.L.P., Austin, TX, for Amicus Curiae Coalition For Jewish Values.

David Ray Hogue, Attorney, Hogue Corbitt Ward, Conway, AR, for Amicus Curiae Allan Sawyer.

Joshua Rosenthal, Public Rights Project, Oakland, CA, for Amicus Curiae Local Governments.

Nicolas Sansone, Allison M. Zieve, Public Citizen Litigation Group, Washington, DC, for Amicus Curiae Public Citizen.

Michael Francis Smith, Attorney, Smith Appellate Law Firm, Washington, DC, for Amicus Curiae Family Research Council.

Warren Norred, Norred Law, P.L.L.C., Arlington, TX, for Amicus Curiae Students for Life of America.

Boris Bershteyn, Skadden, Arps, Slate, Meagher & Flom, L.L.P., New York, NY, for Amici Curiae 240 Members of Congress, 253 Members of Congress.

William B. Schultz, Margaret Dotzel, Alyssa Howard, Zuckerman Spaeder, L.L.P., Washington, DC, for Amicus Curiae Former Commissioners of the U.S. Food and Drug Administration.

Amanda Beane, Perkins Coie, L.L.P., Seattle, WA, for Amicus Curiae Advocates for Survivors of Intimate Partner Violence.

Justin Lee Matheny, Esq., Mississippi Attorney General's Office, Jackson, MS, for Amici Curiae State of North Dakota, State of Oklahoma, State of Alaska, State of Mississippi, State of Arkansas, State of Florida, State of Georgia, State of Indiana, State of Iowa, State of Kansas, State of Kentucky, State of Louisiana, State of Montana, State of Nebraska, State of Ohio, State of South Carolina, State of South Dakota, State of Tennessee, State of Texas, State of Utah, State of Wyoming.

Elissa Graves, Sachse, TX, for Amicus Curiae Human Coalition.

Jessica Ring Amunson, Jenner & Block, L.L.P., Washington, DC, for Amicus Curiae 200 Reproductive Health, Rights, and Justice Organizations.

Thomas S. Leatherbury, Esq., Thomas S. Leatherbury Law, P.L.L.C., Dallas, TX, Christopher Morten, Morningside Heights Legal Services, Incorporated (Columbia Law School), New York, NY, for Amici Curiae Doctors for America, Reproductive Health Coalition.

Simona Strauss, Simpson Thacher & Bartlett, L.L.P., Palo Alto, CA, for Amici Curiae National Association of Nurse Practitioners in Womens Health, American College of Nurse-Midwives.

Steven H. Aden, Americans United for Life, Washington, DC, for Amici Curiae 94 Members of the United States Congress, 69 Members of Congress.

Eva Temkin, Paul Alessio Mezzina, King & Spalding, L.L.P., Washington, DC, for Amicus Curiae Pharmaceutical Companies, Executives, and Investors.

Dean John Sauer, James Otis Law Group. L.L.C., Saint Louis, MO, for Amicus Curiae United States Medical Association.

Rachel Neil, Office of the County Counsel for the County of Santa Clara, San Jose, CA, Richard Dearing, Office of the Attorney General, for the State of New York, New York, NY, for Amicus Curiae City of New York, New York and NYC Health + Hospitals.

John Patrick Elwood, Robert J. Katerberg, Arnold & Porter Kaye Scholer, L.L.P., Washington, DC, for Amicus Curiae GenBioPro, Incorporated.

Roger K. Gannam, Hugh Carleton Phillips, Litigation Counsel, Liberty Counsel, Orlando, FL, for Amici Curiae Frederick Douglass Foundation, National Hispanic Christian Leadership Conference.

Rachel Neil, Office of the County Counsel for the County of Santa Clara, San Jose, CA, for Amicus Curiae County of Santa Clara, California.

Jayme Alyse Jonat, Charlotte Baigent, Rona Proper, Holwell Shuster & Goldberg, L.L.P., New York, NY, for Amicus Curiae Medical Students for Choice.

Jessica Lynn Ellsworth, Hogan Lovells US, L.L.P., Washington, DC, for Amicus Curiae Over 100 Reproductive Health, Rights, and Justice Organizations.

Shannon Rose Selden, Esq., Debevoise & Plimpton, L.L.P., New York, NY, for Amici Curiae American College of Obstetricians and Gynecologists, American Medical Association, Society for Maternal-Fetal Medicine, American Academy of Family Physicians, American Academy of Nursing, American Academy of Pediatrics, American Gynecological and Obstetrical Society, American Society for Reproductive Medicine, North American Society for Pediatrics and Adolescent Gynecology, Society for Academic Specialists in General Obstetrics and Gynecology, Society for Adolescent Health and Medicine, Society of Gynecologic Oncology, Society of OB/GYN Hospitalists.

Edward Lawrence White, American Center for Law & Justice, Ann Arbor, MI, for Amicus Curiae American Center for Law and Justice.

John Marc Wheat, General Counsel, Advancing American Freedom, Incorporated, Washington, DC, for Amicus Curiae Advancing American Freedom, Incorporated.

Samuel Spital, NAACP, Legal Defense & Educational Fund, Incorporated, New York, NY, for Amicus Curiae NAACP Legal Defense and Educational Fund, Incorporated.

John F. Walsh, III, Wilmer Cutler Pickering Hale & Dorr, L.L.P., Denver, CO, for Amicus Curiae Former U.S. Department of Justice Officials.

Gene C. Schaerr, Cristina Martinez Squiers, Schaerr Jaffe, L.L.P., Washington, DC, for Amicus Curiae Charlotte Lozier Institute.

Shannon Rose Selden, Esq., Adam B. Aukland-Peck, Debevoise & Plimpton, L.L.P., New York, NY, Megan McGuiggan, Debevoise & Plimpton, L.L.P., Washington, DC, for Amicus Curiae Medical and Public Health Societies.

Ben E. Clayton, Joshua Paul Clayton, Clayton Law Firm, L.L.C., Slidell, LA, Heather Gebelin Hacker, Hacker Stephens, L.L.P., Austin, TX, for Amici Curiae Susan B. Anthony Pro-Life America, Catholic Health Care Leadership Alliance, National Catholic Bioethics Center, Catholic Bar Association, Catholic Benefits Association, Christ Medicus Foundation.

Jordan Dentler Segall, Attorney, Munger, Tolles & Olson, L.L.P., Los Angeles, CA, for Amicus Curiae Former FDA Officials.

Janice Mac Avoy, Fried, Frank, Harris, Shriver & Jacobson, L.L.P., New York, NY, for Amicus Curiae Physicians for Reproductive Health.

Joshua M. Divine, Solicitor, Office of The Missouri Attorney General, Jefferson City, MO, for Amici Curiae State of Missouri, State of Alabama.

Peter Dominick Lepiscopo, Lepiscopo & Associates Law Firm, Newport Beach, CA, for Amicus Curiae State of West Virginia.

Allan Edward Parker, Jr., Justice Foundation, San Antonio, TX, for Amicus Curiae Women Injured By Abortion.

Robert Allen Long, Jr., Esq., Covington & Burling, L.L.P., Washington, DC, for Amicus Curiae Food and Drug Law Scholars.

Beth S. Brinkmann, Esq., Covington & Burling, L.L.P., Washington, DC, for Amici Curiae Pharmaceutical Research and Manufacturers of America, Advanced Medical Technology Association, Consumer Healthcare Products Association, National Association of Manufacturers.

Before Elrod, Ho, and Wilson, Circuit Judges.

Jennifer Walker...

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