42 U.S.C. § 300aa–22 — Standards of responsibility

(a) General rule: Normally, state law decides vaccine-related lawsuits for damages. But subsections (b), (c), and (e) create exceptions. (b) Unavoidable adverse side effects; warnings: (1) A vaccine maker cannot be sued for a vaccine given after October 1, 1988, if the injury or death came from side effects that could not be avoided — as long as the vaccine was made correctly and came with the right instructions and warnings. (2) A vaccine is assumed to have the right instructions and warnings if the manufacturer shows it mostly followed the Federal Food, Drug, and Cosmetic Act and section 262 (and the rules made under them) for that vaccine. This assumption doesn't apply if the injured person shows either: (A) the manufacturer did the kind of wrongdoing described in section 300aa–23(d)(2)(A) or (B), or (B) with clear and convincing evidence, that the manufacturer failed to use reasonable care even though it followed those laws and rules. (c) Direct warnings: A vaccine maker cannot be sued for a vaccine given after October 1, 1988, only because it didn't warn the injured person (or their legal representative) directly about possible dangers. (d) Construction: This section does not let someone bring a new lawsuit against a manufacturer for the same injury or death if an earlier lawsuit against that manufacturer was denied or dismissed with prejudice. (e) Preemption: No state can pass or enforce a law that stops someone from suing a vaccine manufacturer for damages, as long as this part of the law doesn't already bar that lawsuit.