Vaccine liability in the era of bioterrorism.

THIS PAPER ANALYZES Section 304 of the Homeland Security Act of 2002,1 as amended in April 2003,2 which sets forth liability protection for participants in the current national smallpox vaccination program.3 It explains to nonlawyers the state of liability protection as it stands in mid-2003. Section 304 (or “the Homeland Security Act” or “the Act”) has been controversial since its enactment—in part because liability protection could have been structured in a variety of ways. Some controversy was inevitable, though, as the issue of vaccine liability in the era of bioterrorism is new territory. Until now, national defense has never been a factor in a decision to vaccinate civilians. Theoretically, vaccination could reduce the anticipated rewards of a biological attack, possibly deterring the proliferation and use of a particular agent.4 But as will be discussed, the smallpox vaccination program has not progressed as initially anticipated, partially because of concerns about liability. The recent experience with the smallpox vaccine is therefore instructive for future vaccination programs. A brief description of the main approaches to vaccine liability is presented first, followed by an analysis of the liability protection provided under Section 304. The paper then concludes with a discussion of several key principles related to liability that policymakers should consider when vaccines are used to defend against bioterrorism. APPROACHES TO VACCINE LIABILITY