Jeri Pearson, et al. v. Shriners Hospitals for Children, Incorporated, et al.

Since Congress enacted the 1974 National Research Act, it has been the federal government’s policy that no individual can be subjected to a penalty or lose a benefit to which they are otherwise entitled when refusing federally funded, unapproved medical treatments or related research activities. To ensure the congressional mandate was faithfully executed, the Executive Branch established the Federalwide Assurance program in 2001, requiring contracting parties to provide written assurance that they will not place a human under coercion, undue influence, or unjustifiable pressures to participate in such treatments or related activities. Consent to an unapproved medical treatment (i.e., investigational new drugs) in the absence of such coercion, influence, or pressure is known as legally effective informed consent. QUESTIONS:

1. Is the right to refuse an unapproved medical treatment a fundamental right subject to the Due Process Clause of the Fourteenth Amendment?

2. If a federal program requires a State to obtain legally effective informed consent and the State delegates that duty to a private party, does the private party’s deprivation of that consent constitute State action?