Fraud.
“(2) If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
21 USC 301 note.
42 USC 201 note.
“(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 351,
42 USC 262. Safety.
“(B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or
Safety.
“(C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,
which activity related to the vaccine-related injury or death for which the civil action was brought.
“(e) EVIDENCE.—In any stage of a civil action, the Vaccine Injury Table, any finding of a district court of the United States or a master appointed by such court in a proceeding on a petition filed under section 2111 and the final judgment of a district court of the United States on such a petition shall not be admissible.
5 USC 5332.
“(e) STAFF.—The Secretary shall provide the Commission with such professional and clerical staff, such information, and the services of such consultants as may be necessary to assist the Commission in carrying out effectively its functions under this section.
“(f) FUNCTIONS.—The Commission shall—
“(1) advise the Secretary on the implementation of the Program,
“(2) on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine Injury Table,
“(3) advise the Secretary in implementing the Secretary’s responsibilities under section 2127 regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions,
“(4) survey Federal, State, and local programs and activities relating to the gathering of information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of section 2125(b), and advise the Secretary on means to obtain, compile, publish, and use credible data related to the frequency and severity of adverse reactions associated with childhood vaccines, and
1986 National Childhood Vaccine Injury Act - National Library of Medicine
https://www.ncbi.nlm.nih.gov/books/NBK220067/
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