After the post-9/11 anthrax attacks and the Severe Acute Respiratory Syndrome (SARS) outbreak, the Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. §§247d-6d, 247d-6e, was enacted to bolster federal and state cooperation, and to garner necessary private resources, for a whole-of-nation response to public health crises. The Act placed significant authority in the U.S. Department of Health and Human Services (HHS) to lead the response effort.

The PREP Act is a particularly well-constructed piece of legislation, setting up extensive federal protections for the private participants marshalled by the federal government. Those protections include: immunity from civil action for death or serious injury arising from the use of a countermeasure or the management and operation of a countermeasure program or facility; preemption of all claims except those lodged under an “exclusive federal cause of action”; an “exclusive federal jurisdiction” in the U.S. District Court for the District of Columbia (DDC); an enhanced pleading standard (“willful misconduct”) and burden of proof (“clear and convincing evidence”); and a required pre-litigation non-adversarial no-fault non-binding claims process with a Benefits Table setting injury valuations.