Whether an individual can bring a private right of action under 42 U.S.C. § 1983 for violation of informed consent rights related to Emergency Use Authorization experimental drugs

When Congress amended the Food, Drug, and Cosmetic Act (“FDCA”) in 2004 to permit emergency use authorization of certain experimental drugs in a declared emergency, they did not forget to include the right of informed consent. However, since 1938, the FDCA has required that all actions under the FDCA shall be in the name of the United States. The Ninth Circuit in this case, and all other courts to have considered the issue, reject private enforceme nt of an individual right to informed consent for EUA authorized experimental drugs. QUESTION : May an individual bring a lawsuit via 42 U.S.C. § 1983 for violation of his right to informed consent to the administration of an EUA experimental drug or device? – ii –