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Arizona Revised Statutes Title 12. Courts and Civil Proceedings § 12-701. Drugs; exemplary or punitive damages; definition

Current as of January 01, 2025 | Updated by Findlaw Staff

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 § 301, et seq.)  1 or the public health service act (42 United States Code § 201, et seq.)  2 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 § 201(g)(1) of the federal food, drug and cosmetic act (21 United States Code § 321(g)(1)). 3

1 21 U.S.C.A. § 301 et seq.
2 42 U.S.C.A. § 201 et seq.
3 21 U.S.C.A. § 321(g)(1).
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Cite this article: FindLaw.com - Arizona Revised Statutes Title 12. Courts and Civil Proceedings § 12-701. Drugs; exemplary or punitive damages; definition - last updated January 01, 2025 | https://codes.findlaw.com/az/title-12-courts-and-civil-proceedings/az-rev-st-sect-12-701/

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