§300aa–23 Trial

Summary

Lawsuits against vaccine makers for injuries or deaths from vaccines given after October 1, 1988, and not barred by section 300aa–11(a)(2), must be tried in three stages. The first stage decides if the manufacturer is legally responsible under section 300aa–22. The second stage decides how much non-punitive money the manufacturer must pay. The third stage, only if the plaintiff asks, decides whether punitive damages apply and how much. If the manufacturer shows it complied in all important respects with the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and this chapter for that vaccine, it cannot be hit with punitive damages unless it committed fraud or intentionally withheld information from the Secretary during approval under section 262, intentionally withheld safety or effectiveness information after approval, or did other criminal or illegal acts tied to the injury. The Vaccine Injury Table, any findings or rulings by a special master or the U.S. Court of Federal Claims on a petition under section 300aa–11, and that court’s final judgment and appeals on such a petition cannot be used as evidence at any stage.