The Arizona Revised Statutes have been updated to include the revised sections from the 56th Legislature, 1st Regular Session. Please note that the next update of this compilation will not take place until after the conclusion of the 56th Legislature, 2nd Regular Session, which convenes in January 2024.
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This online version of the Arizona Revised Statutes is primarily maintained for legislative drafting purposes and reflects the version of law that is effective on January 1st of the year following the most recent legislative session. The official version of the Arizona Revised Statutes is published by Thomson Reuters.
12-701 - Drugs; exemplary or punitive damages; definition
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)).