§ 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)).