Page:United States Statutes at Large Volume 100 Part 5.djvu/300

 100 STAT. 3774

PUBLIC LAW 99-660—NOV. 14, 1986 TRIAL

42 USC

300aa-23.

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2123. (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 the effective date of this subtitle which is not barred by section 2111(a)(2) shall be tried in three stages. "O?) LIABILITY.—The first stage of such a civil action shall be held to determine if a vaccine manufacturer is liable under section 2122. "(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 2122 shall be required to pay. "SEC.

"(d) PUNITIVE DAMAGES.—

Fraud.

21 USC 301 note. 42 USC 201 note.

42 USC 262. Safety.

Safety.

"(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 2122 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 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— "(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, "(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 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. "PART C—ASSURING A SAFER CJHILDHOOD VACCINATION PROGRAM IN THE UNITED STATES

RECORDING AND REPORTING OF INFORMATION

42 USC 300aa-25.

2125. (a) GENERAL RULE.—Each health care provider who administers a vaccine set forth in the Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person's permanent medical record (or in a permanent office log or file to which a legal representative shall have access upon request) with respect to each such vaccine— "(1) the date of administration of the vaccine, "(2) the vaccine manufacturer and lot number of the vaccine, "(3) the name and address and, if appropriate, the title of the health care provider administering the vaccine, and "SEC,

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