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42 U.S.C. § 300aa–23Trial

submitted 82 years ago by Pub. L. 99-660 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 381 words · no verdicts yet

in plain englishAI-generated · not legal advice

A civil lawsuit against a vaccine maker happens in three stages. First, the court decides if the maker is liable. Second, it sets regular damages. Third, if asked, it sets punitive damages — but only in limited cases. The vaccine court's own findings can't be used as evidence.

(a) General rule: A civil lawsuit against a vaccine manufacturer for a vaccine given after October 1, 1988 — one not barred by section 300aa–11(a)(2) — must be tried in three separate stages. (b) Liability: The first stage decides whether the manufacturer is liable under section 300aa–22. (c) General damages: The second stage decides how much the manufacturer must pay in damages, not counting punitive damages, if it was found liable in stage one. (d) Punitive damages: (1) If the person suing asks for it, the third stage decides how much the manufacturer must pay in punitive damages. (2) If the manufacturer shows it mostly followed the Federal Food, Drug, and Cosmetic Act and this chapter for that vaccine, it cannot be forced to pay punitive damages — unless the manufacturer committed: (A) fraud or intentionally and wrongly hid information from the Secretary while the vaccine was being approved under section 262; (B) intentionally and wrongly hid information about the vaccine's safety or effectiveness after it was approved; or (C) other criminal or illegal activity related to vaccine safety and effectiveness, connected to the injury or death the lawsuit is about. (e) Evidence: At any stage of the trial, the Vaccine Injury Table, any fact or legal conclusion from the U.S. Court of Federal Claims or a special master in a related vaccine-court case, and the final judgment (and any appeal) from that vaccine-court case cannot be used as evidence.
the actual law source: uscode.house.gov ↗public domain
(a) General rule

A civil action against a vaccine manufacturer for damages for a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, which is not barred by section 300aa–11(a)(2) of this title shall be tried in three stages.

(b) Liability

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

(c) General damages

The 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 section 300aa–22 of this title shall be required to pay.

(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

In 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 section 300aa–11 of this title and the final judgment of the United States Court of Federal Claims and subsequent appellate review on such a petition shall not be admissible.

Source credit: (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.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 99-660 · 100 Stat. 3774
  • 1987Amended · Pub. L. 100-203 · 101 Stat. 1330
  • 1989Amended · Pub. L. 101-239 · 103 Stat. 2292
  • 1992Amended · Pub. L. 102-572 · 106 Stat. 4516

A history note hasn’t been published yet. The record shows enactment by Pub. L. 99-660 on 1944-07-01.

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