12-701. Drugs; exemplary or punitive damages;
definition
A. The manufacturer or seller of a drug is not liable for exemplary or punitive
damages if the drug alleged to cause the harm either:
1. Was manufactured and labeled in relevant and material respects in accordance
with the terms of an approval or license issued by the federal food and drug
administration under the food, drug and cosmetic act (21 United States Code section 301,
et seq.) or the public health service act (42 United States Code section 201, et seq.) or
2. Is generally recognized as safe and effective pursuant to conditions established
by the federal food and drug administration and applicable regulations, including
packaging and labeling regulations.
B. Subsection A does not apply if the plaintiff proves, by clear and convincing
evidence, that the defendant, either before or after making the drug available for public
use, knowingly, in violation of applicable federal food and drug administration
regulations, withheld from or misrepresented to the administration information known to
be material and relevant to the harm which the plaintiff allegedly suffered.
C. In this section, "drug" means the same as provided in section 201 (g) (1) of the
federal food, drug and cosmetic act (21 United States Code section 321 (g) (1)).
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