§300aa–22 Standards of Responsibility

Summary

State law usually governs lawsuits for vaccine-related injury or death, except for the limits below. For vaccines given after October 1, 1988, a manufacturer normally cannot be sued for harm that came from side effects that were unavoidable if the vaccine was properly made and had proper directions and warnings. A manufacturer is assumed to have given proper directions and warnings if it followed the Federal Food, Drug, and Cosmetic Act and section 262 (and related rules), unless the injured person shows the maker did certain misconduct described in section 300aa–23(d)(2) or proves by clear and convincing evidence that the maker failed to exercise due care despite following those rules. A manufacturer also cannot be sued just because it did not give direct warnings to the injured person or their representative about vaccine dangers for vaccines after October 1, 1988. If a prior lawsuit against a manufacturer was denied or dismissed with prejudice, the person cannot bring a new suit on the same injury. States may not pass laws that stop someone from suing a vaccine maker when this federal part allows the suit.