Michael Brock, et al. v. City of Bellingham, Washington, et al.

Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), Congress established a single, unqualified rule: administration of any drug introduced into interstate commerce under an exemption from 21 U.S.C. § 355(a) must be the product of voluntary, informed consent. This Court has likewise held that a waiver of constitutional rights must never be the product of coercion or presumption. Berghuis v. Thompkins, 560 U.S. 370 (2010); Janus v. AFSCME, 585 U.S. 878 (2018). The Public Readiness and Emergency Preparedness Act (“PREP Act”) extinguishes access to all state courts. Access to the courts for a judicial remedy is a fundamental right protected by the Fourteenth Amendment. Christopher v. Harbury, 536 U.S. 403, 415 n.12 (2002). The questions presented are:

1. Whether the Fourteenth Amendment prohibits a local government from mandating that a public employee accept the administration of a drug exempt from approval under 21 U.S.C. § 355(a) — on pain of losing benefits — where the FDCA and the National Research Act, 42 U.S.C. § 289(a), together with their implementing regulations, expressly require such administration be the product of voluntary, informed consent.

2. Whether the Fourteenth Amendment prohibits a local government from mandating that a public employee accept the administration of a covered countermeasure — on pain of losing benefits — where the PREP Act’s immunity clause, 42 U.S.C. § 247d-6d(a)(1), extinguishes the employee’s right to seek judicial redress for any injury the countermeasure causes.