Sec. 2122. STANDARDS OF RESPONSIBILITY

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## Sec. 2122 STANDARDS OF RESPONSIBILITY **[**300aa–22**]** ###

(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 the effective date of this part23 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. 23Effective October 1, 1988. ####

(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 and section 351 of the Public Health Service Act (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 2123(d)(2), 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 the effective date of this part24 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. 24Effective October 1, 1988. ###

(d)Construction The standards of responsibility prescribed by this section are not to be construed as authorizing a person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in which damages were denied or which was dismissed with prejudice to bring a new civil action against such manufacturer for such injury or death. ###

(e)Preemption No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this subtitle.