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:

Terms Used In Arizona Laws 12-701

  • Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
  • Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
  • 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.
  • including: means not limited to and is not a term of exclusion. See Arizona Laws 1-215
  • Plaintiff: The person who files the complaint in a civil lawsuit.
  • United States: includes the District of Columbia and the territories. See Arizona Laws 1-215

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.) or the public health service act (42 United States Code § 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 § 321(g)(1)).