Washington v. U.S. Food & Drug Admin.

108 F.4th 1163

State of WASHINGTON; State of Oregon; State of Arizona;

State of Colorado; State of Connecticut; State of Delaware;

State of Illinois; Attorney General of Michigan; State of Nevada;

State of New Mexico; State of Rhode Island; State of Vermont;

District of Columbia; State of Hawaii; State of Maine;

State of Maryland; State of Minnesota; Commonwealth of Pennsylvania, Plaintiffs-Appellees, v. U.S. FOOD & DRUG ADMINISTRATION; Robert M. Califf,

in His Official Capacity as Commissioner of Food and Drugs;

United States Department of Health and Human Services;

Xavier Becerra, in his official capacity as Secretary of

the Department of Health and Human Service, Defendants-Appellees, v. State of Idaho; State of Iowa; State of Montana; State of Nebraska; State of South Carolina;

State of Texas; State of Utah, Proposed State Plaintiff-Intervenors, Movants-Appellants.

No. 23-35294

United States Court of Appeals, Ninth Circuit

Argued and Submission Deferred March 13, 2024

Submitted July 17, 2024 San Francisco, California

Filed July 24, 2024

Appeal from the United States District Court for the Eastern District of Washington Thomas O. Rice, District Judge, Presiding, D.C. No. 1:23-cv-03026-TOR

Emma Grunberg (argued) and Tera M. Heintz, Deputy Solicitors General; Noah G. Purcell, Solicitor General; Office of the Attorney General, Olympia, Washington; Andrew R.W. Hughes and Lauryn K. Fraas, Assistant Attorneys General; Kristin Beneski, First Assistant Attorney General; Colleen M. Melody, Civil Rights Division Chief; Robert W. Ferguson, Attorney General; Office of the Attorney General, Seattle, Washington;

Dustin Buehler, Deputy Attorney General; Ellen F. Rosenblum, Attorney General; Denise G. Fjordbeck, Assistant Attorney General; Sander Marcus Hull, Senior Assistant Attorney General; Youngwoo J. Osb, Assistant Attorney General; Oregon Department of Justice, Salem, Oregon; Carla Scott, Deputy Attorney General, Oregon Department of Justice; Portland, Oregon;

Luci D. Davis, Deputy Attorney General; Kris Mayes, Attorney General; Office of the Arizona Attorney General, Phoenix, Arizona; Daniel C. Barr, Perkins Coie LLP, Phoenix, Arizona;

Sabrena Clinton, Deputy Attorney General; Heidi P. Stern, Solicitor General; Aaron D. Ford, Attorney General; Office of the Nevada Attorney General, Las Vegas, Nevada;

Aletheia Allen, Solicitor General; Raul Torrey, Attorney General; Office of the New Mexico Attorney General, Albuquerque, New Mexico;

Peter F. Neronha, Attorney General; Julia C. Harvey, Special Assistant Attorney General; Office of the Rhode Island Attorney General, Providence, Rhode Island;

Douglas Keehn, Assistant Attorney General; Charity R. Clark, Attorney General; Eleanor L.P. Spottswood, Solicitor General; Office of the Vermont Attorney General, Montpelier, Vermont;

Brian L. Schwalb, Attorney General; Jennifer C. Jones, Deputy Attorney General Public Advocacy Division; William Stephens, Counsel to Deputy; Nicole S. Hill, Assistant Attorney General; Office of the District of Columbia Attorney General, Washington, D.C.;

Philip J. Weiser, Attorney General; Michael McMaster, Assistant Attorney General; Office of the Colorado Attorney General, Denver, Colorado; Eric Olson, Olson Grimsley Kawanabe Hinchcliff & Murray LLC, Denver, Colorado;

William Tong, Attorney General; Joshua Perry, Solicitor General; Office of the Connecticut Attorney General, Hartford, Connecticut;

Kathleen Jennings, Attorney General; Vanessa L. Kassab, Deputy Attorney General; Office of the Delaware Attorney General, Wilmington, Delaware;

Kwame Raoul, Attorney General; Lisa Roberson-Young, Public Interest Counsel; Office of the Illinois Attorney General, Chicago, Illinois;

Dana Nessel, Attorney General; Stephanie M. Service, Assistant Attorney Michigan Department of the Attorney General Health, Education and Family Services Division; Office of the Michigan Attorney General, Lansing Michigan;

Anne E. Lopez, Attorney General; Erin Lau, Deputy Attorney General, Office of the Hawaii Attorney General, Honolulu, Hawaii;

Aaron M. Frey, Attorney General; Halliday Moncure, Assistant Attorney General; Office of the Maine Attorney General, Augusta, Maine;

Joshua M. Segal, Assistant Attorney General; Anthony G. Brown, Attorney General, Office of the Maryland Attorney General, Baltimore, Maryland;

Keith Ellison, Attorney General; Liz Kramer, Solicitor General; Jennifer Olson, Assistant Attorney General; Office of the Minnesota Attorney General, St. Paul, Minnesota; Michael A. Henry, Attorney General; Jill M. Graziano, Chief Counsel to the Attorney General; Office of the Commonwealth of Pennsylvania Attorney General; Morrison, Pennsylvania; for Plaintiffs-Appellees.

Daniel L. Winik (argued), Dana Kaersvang and Michael S. Raab, Appellate Staff Attorneys; Vanessa R. Waldref, United States Attorney; Brian M. Boynton, Principal Deputy Assistant Attorney General; Civil Division, United States Department of Justice, Washington, D.C.; for Defendants-Appellees.

Joshua N. Turner (argued), Acting Solicitor General, Chief of Constitutional Litigation and Policy; Sean M. Corkery, Assistant Solicitor General; Theodore J. Wold, Solicitor General; Michael A. Zarian, Deputy Solicitor General; Raul R. Labrador, Idaho Attorney General; Office of the Attorney General, Boise, Idaho; Peter M. Torstensen Jr., Assistant Solicitor General, Office of the Montana Attorney General, Helena, Montana; Thomas T. Hydrick, Deputy Attorney General, Office of the South Carolina Attorney General, Columbia, South Carolina; Stanford Purser, Deputy Solicitor, Office of the Utah Attorney General, Salt Lake City, Utah; Lincoln D. Wilson, Alliance Defending Freedom, Washington, D.C.; for Movants-Appellants.

Before: Sidney R. Thomas, M. Margaret McKeown, and Morgan Christen, Circuit Judges.

OPINION

THOMAS, Circuit Judge:

In this appeal, we consider whether Idaho is entitled to intervene in Washington's lawsuit challenging the Food and Drug Administration's ("FDA") imposition of safe-use restrictions on the abortion drug mifepristone. We conclude that, because Idaho seeks different relief than Washington, it must independently satisfy the requirements of Article III standing. We further conclude that Idaho's complaint-in-intervention does not establish a cognizable injury-in-fact that is fairly traceable to FDA's revised safe-use restrictions. We are guided in our decision by the Supreme Court's recent decision on standing and the FDA's regulation of mifepristone in FDA v. Alliance for Hippocratic Medicine. 602 U.S. 367, 144 S.Ct. 1540, — L.Ed.2d — (2024). Because Idaho does not have standing to bring the claims in its complaint, we affirm the denial of its motion to intervene.

I

A

The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., tasks FDA with ensuring the safety and efficacy of all drugs that enter into interstate commerce. See Wyeth v. Levine, 555 U.S. 555, 566-67, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). Before a new drug is approved, the drug's sponsor must submit an application that includes patent and manufacturing information, the results of laboratory and clinical testing, and proposed labeling and instructions for use. 21 U.S.C. § 355(b). The statute instructs FDA to approve a new drug only when it determines that the drug is "safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling." Id. § 355(d).

The FDCA also authorizes FDA to restrict access to certain drugs by imposing a "risk evaluation and mitigation strategy" or "REMS" when it concludes that doing so is "necessary to ensure that the benefits of the drug outweigh the risks[.]" Id. § 355-1(a)(1).¹ A REMS may include restrictions on drug labeling and packaging, as well as more burdensome "safe use" restrictions, such as requirements that providers be specially certified or that patients be subjected to post-administration monitoring. Id. §§ 355-1(d)-355-1(f). Unlike package and labeling requirements, safe-use restrictions may only be imposed on drugs "with known serious risks" of a "serious adverse drug experience." Id. § 355-1(f); id. § 355-1(b)(4). The statute instructs FDA to design safe-use restrictions to ensure that they are "commensurate with the specific serious risk" and do not "unduly burden[ ]" patient access. Id. § 355-1(f)(2). Once safe-use restrictions have been imposed, FDA must periodically reevaluate them to ensure the restrictions are well calibrated to balance safety, access, and "the burden on the health care delivery system." Id. § 355-1(f)(5)(B).

B

Mifepristone is a medication that, when used in combination with another drug called misoprostol, can safely end an early pregnancy. FDA first authorized the marketing of mifepristone under the commercial name "Mifeprex" in 2000. As a condition of its approval, FDA stipulated that Mifeprex could only be dispensed in person, under the supervision of a physician with certain qualifications, after the patient had been advised of the drugs risks and had reviewed and signed a "patient agreement form." See All. for Hippocratic Med., 602 U.S. at 375-76, 144 S.Ct. 1540 (describing original restrictions on Mifeprex approval).

In 2011, FDA reauthorized Mifeprex under the revised statutory framework that codified and expanded the agency's authority to impose a REMS. FDA retained the original conditions on distribution, formulated as three discrete safe-use restrictions requiring (1) in-person dispensing, (2) prescriber certification, and (3) documentation of patient counseling and consent.

Between 2011 and 2019, FDA reviewed the Mifeprex REMS several times, authorizing a handful of changes to prescribing guidelines and, in 2019, approving a generic version of mifepristone. At the conclusion of each review FDA concluded it was necessary to retain the three safe-use restrictions with only minor adjustments. See All. for Hippocratic Medicine, 602 U.S. at 375-76, 144 S.Ct. 1540.

In 2020, FDA was forced to temporarily suspend the in-person dispensing requirement in...