Beth Boyd, et al. v. Shriners Hospitals for Children, et al.

The Federal Food, Drug, and Cosmetic Act (“FDCA”), the National Research Act (“NRA”), the Public Readiness and Emergency Preparedness Act (“PREP Act”), and the Project BioShield Act of 2004 together form a comprehensive federal framework governing investigational drugs. Together with their implementing regulations and Executive Branch agreements, those Acts require that the administration of such drugs be the product of voluntary, informed consent, a requirement not imposed on drugs approved for their marketing application under 21 U.S.C. § 355 et seq. The questions presented are:

1. Whether the Fourteenth Amendment prohibits a State, or its delegated agent, from mandating that an individual accept the administration of a drug that is exempt from 21 U.S.C. § 355(a), under threat of penalty, where federal law conditions that exemption on consent obtained free of coercion, undue influence, and unjustifiable pressure.

2. Whether the Fourteenth Amendment prohibits a State or its delegated agent from mandating that an individual accept the administration of a covered countermeasure, where the PREP Act’s immunity provision, 42 U.S.C. § 247d-6d(a)(1), extinguishes the recipient’s right to access the courts for a resulting injury.