(a)General rule
Except as provided in subsections (b), (c), and (e) State law shall apply to a civil action brought for damages for a
vaccine-related injury or death.
(b)Unavoidable adverse side effects; warnings
(1)
No vaccine manufacturer shall be liable in a civil action for damages arising from a
vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
(2)For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the
Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 301 et seq.] and
section 262 of this title (including
regulations issued under such provisions) applicable to the vaccine and related to
vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
(A)
that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of
section 300aa–23(d)(2) of this title, or
(B)
by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and
regulations issued under such provisions).
(c)Direct warnings
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
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