42 USC 300aa-23

U.S Code last checked for updates: Jan 19, 2025

§ 300aa–23.

Trial

(a)

General rule

(b)

Liability

(c)

General damages

(d)

Punitive damages

(1)

If sought by the plaintiff, the third stage of such an action shall be held to determine the amount of punitive damages a vaccine manufacturer found to be liable under section 300aa–22 of this title shall be required to pay.

(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 [21 U.S.C. 301 et seq.] and this chapter 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—

(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 262 of this title,

(B)

intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or

(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

(July 1, 1944, ch. 373, title XXI, § 2123, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3774; amended Pub. L. 100–203, title IV, §§ 4302(b)(1), 4307(9), Dec. 22, 1987, 101 Stat. 1330–221, 1330–225; Pub. L. 101–239, title VI, § 6601(o), Dec. 19, 1989, 103 Stat. 2292; Pub. L. 102–572, title IX, § 902(b)(1), Oct. 29, 1992, 106 Stat. 4516.)

cite as: 42 USC 300aa-23