| (1) |
Punitive damages may not be awarded if a drug causing the claimant’s harm:
Terms Used In Utah Code 78B-8-203- Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
| (a) |
received premarket approval or licensure by the Federal Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. or the Public Health Service Act, 42 U.S.C. § 201 et seq.; |
| (b) |
is generally recognized as safe and effective under conditions established by the Federal Food and Drug Administration and applicable regulations, including packaging and labeling regulations. |
|
| (2) |
This limitation on liability for punitive damages does not apply if it is shown by clear and convincing evidence that the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the Federal Food and Drug Administration under its regulations, which information was material and relevant to the claimant’s harm. |
Renumbered and Amended by Chapter 3, 2008 General Session
