US Code

Public Law 119-102 (07/12/2026)

42 U.S.C. § 300aa–23

Trial

Section text and notes

(a)

General rule

section 300aa–11(a)(2) of this titleA civil action against a vaccine manufacturer for damages for a vaccine-related injury or death associated with the administration of a vaccine after , which is not barred by shall be tried in three stages.

(b)

Liability

section 300aa–22 of this titleThe first stage of such a civil action shall be held to determine if a vaccine manufacturer is liable under .

(c)

General damages

section 300aa–22 of this titleThe second stage of such a civil action shall be held to determine the amount of damages (other than punitive damages) a vaccine manufacturer found to be liable under shall be required to pay.

(d)

Punitive damages

(1)
section 300aa–22 of this title 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 shall be required to pay.
(2)
21 U.S.C. 301 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 [ 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)
section 262 of this title fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under ,
(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

section 300aa–11 of this titleIn any stage of a civil action, the Vaccine Injury Table, any finding of fact or conclusion of law of the United States Court of Federal Claims or a special master in a proceeding on a petition filed under and the final judgment of the United States Court of Federal Claims and subsequent appellate review on such a petition shall not be admissible.

July 1, 1944, ch. 373 Pub. L. 99–660, title III, § 311(a)100 Stat. 3774 Pub. L. 100–203, title IV101 Stat. 1330–221 Pub. L. 101–239, title VI, § 6601o103 Stat. 2292 Pub. L. 102–572, title IX, § 902(b)(1)106 Stat. 4516 (, title XXI, § 2123, as added , , ; amended , §§ 4302(b)(1), 4307(9), , , 1330–225; (), , ; , , .)

Editorial Notes

References in Text

act June 25, 1938, ch. 675 52 Stat. 1040 The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (d)(2), is , , which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables.

Codification

section 323 of Pub. L. 99–660section 300aa–1 of this titleIn subsec. (a), “” substituted for “the effective date of this subpart” on authority of , as amended, set out as an Effective Date note under .

Amendments

Pub. L. 102–5721992—Subsec. (e). substituted “United States Court of Federal Claims” for “United States Claims Court” in two places.

Pub. L. 101–239Pub. L. 100–203, § 4307(a)1989—Subsec. (e). substituted “finding of fact or conclusion of law” for “finding”, “special master” for “master appointed by such court”, and directed substitution of “the United States Claims Court and subsequent appellate review” for “a district court of the United States” which was executed by inserting “and subsequent appellate review” after “the United States Claims Court” the second place it appeared to reflect the probable intent of Congress and the amendment by , see 1987 Amendment note below.

Pub. L. 100–203, § 4302(b)(1)1987—Subsec. (a). , substituted “effective date of this subpart” for “effective date of this part”.

Pub. L. 100–203, § 4307(9)Subsec. (e). , substituted “the United States Claims Court” for “a district court of the United States” in two places.

Statutory Notes and Related Subsidiaries

Effective Date of 1992 Amendment

Pub. L. 102–572section 911 of Pub. L. 102–572section 171 of Title 28Amendment by effective , see , set out as a note under , Judiciary and Judicial Procedure.

Effective Date of 1989 Amendment

Pub. L. 101–239section 6601(s)(1) of Pub. L. 101–239section 300aa–10 of this titleFor applicability of amendments by to petitions filed after , petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see , set out as a note under .