Whether the Food, Drug, and Cosmetic Act's enforcement provision preempts state-law claims that mirror federal drug approval requirements

No question identified. : TO: THE HONORABLE ELENA KAGAN, ASSOCIATE JUSTICE OF THE UNITED STATES AND CIRCUIT JUSTICE FOR THE NINTH CIRCUIT Pursuant to Supreme Court Rule 13.5, Petitioner Hope Medical Enterprises, Inc. respectfully requests a 14-day extension of the time to file a petition for a writ of certiorari up to and including January 16, 2024. The United States Court of Appeals for the Ninth Circuit issued its decision on July 26, 2023, see Attachment A, and denied rehearing en banc on October 2, 2023, see Attachment B. Absent an extension, a petition for certiorari would be due on January 2, 2024. This application is timely because it has been filed more than ten days before the date on which the petition is otherwise due. S. Ct. R. 13.5. This Court has jurisdiction under 28 U.S.C. § 1254(1). 1. This case implicates States’ historical power to regulate the in-state sale of drugs that have not been reviewed for safety or approved by any government body. At the founding, that power belonged exclusively to the States. Wyeth v. Levine, 555 U.S. 555, 566 (2009). Not until 1938 did Congress enact a “provision for premarket approval of new drugs” as part of the Food, Drug, and Cosmetic Act. Id. The FDCA “supplemented” but did not override the “protection for consumers already provided by state regulation and common-law liability.” Jd. While expanding FDA’s authority, Congress still “took care to preserve state law.” Id. at 567. Thus, while the FDCA contains a standing provision stating that all “proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States,” 21 U.S.C. § 337(a), that standing provision has long been understood not to prohibit States from enacting laws that borrow or “parallel” the FDCA’s requirements as a matter of state law. See Allergan, Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350, 1354— 56 (Fed. Cir. 2013), cert. denied, 576 U.S. 1054 (2015); Farm Raised Salmon Cases, 175 P.3d 1170, 1181-84 (Cal. 2008), cert. denied sub nom. Albertson’s, Inc. v. Kanter, 555 U.S. 1097 (2009). 2. The Ninth Circuit held otherwise in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022). In Nexus the Ninth Circuit held that FDCA § 337(a) preempts state statutes that prohibit the in-state sale of drugs that have not received premarket approval from the U.S. Food and Drug Administration or appropriate state agencies, even if those state statutes impose the exact same requirements as the FDCA. Id. at 1046-50. Because the conduct that violates state drug-approval statutes also involves “noncompliance with FDA requirements,” the court held that private enforcement of those state statutes is in fact private enforcement of the FDCA prohibited by § 337(a). Id.; see id. at 1049— 50 (holding enforcement of state drug-approval statutes “would amount to litigation of the alleged underlying FDCA violation” because the statutes “say[] in substance ‘comply with the FDCA”). The Ninth Circuit also held that state drug-approval statutes conflict with “FDA’s exclusive enforcement authority.” Jd. at 1048. Even when conduct violates both state and federal law, the court extended preemptive force to FDA’s “enforcement discretion.” Jd. It held that states may not “facilitate enforcement” under state law “beyond what the FDA has deemed appropriate” under federal law. Id. 3. In the decision below, the Ninth Circuit applied Nexus to hold that the FDCA preempted Petitioner’s state-law claims against Respondents. Hope Med. Enters., Inc. v. Fagron Compounding Servs., LLC, 2023 WL 4758454 (9th Cir. July 26, 2023). Petitioner manufactures and sells “Sodium Thiosulfate Injection,” an FDAapproved drug. Hope Med. Enters. Inc. v. Fagron Compounding Servs., LLC, 2021 WL 4963516, at *1, *12 (C.D. Cal. Oct. 26, 2021). Respondents sell a competing sodium thiosulfate drug that has not received premarket approval from FDA or any state agency. Id. Petitione