Challenging the PREP Act’s Liability Shield

The federal Public Readiness and Emergency Preparedness Act (PREP Act) was enacted in December 2005. Once the Secretary of Health and Human Services (HHS) determines that a public health emergency exists or may arise in the future, the PREP Act states that “a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure . . .” See 42 U.S.C. Sec. 247d6d(a)(1). In the PREP Act, “covered countermeasure,” “covered person,” and “loss” are defined terms. There is no immunity from liability under the PREP Act for pandemic and epidemic products that do not qualify as covered countermeasures. The PREP Act became law without the benefit of hearings specific to the Act, House or Senate Committee deliberation, or public debate. Instead, it was tacked on to a conference report for a Department of Defense appropriations bill at the last minute. At a Senate appropriations hearing on December 21, 2005, several Senators spoke against the PREP Act.