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)).
Notes of Decisions
Kobar Ex Rel Kobar v. Novartis Corp., 378 F. Supp. 2d 1166 (D. Ariz. 2005).
· cites it 21× “A.R.S. § 12-701 Defendant argues that it is immune from liability for punitive damages in light of A.”
Watts v. Medicis Pharm. Corp., 342 P.3d 847 (Ariz. Ct. App. 2015).
· cites it 2× “Under A.R.S. § 12-701(A), the maker of a drug is not liable for punitive damages if the drug was manufactured and labeled in accordance with FDA standards.”
Zimmerman v. Novartis Pharm. Corp., 889 F. Supp. 2d 757 (D. Maryland 2012).
“927(l)(a) (2005); Utah Code Ann. § 78-18-2 (1). One state, Michigan, adopted a complete, blanket immunity based upon compliance with FDA regulations.”
Sievers-Greene v. Davis (D. Ariz. 2023).
· cites it 2× “) On April 1, 2020, Plaintiff’s attorney filed a Notice of Filing Foreign Judgment in 12 Maricopa County Superior Court pursuant to A.R.S. § 12-701 et seq. (AR. 35.) Ten days 13 later, on April 11, 2020, MSgt Greene died.”
— Ariz. Rev. Stat. § 12-701(A) — 1 case
Watts v. Medicis Pharm. Corp., 342 P.3d 847 (Ariz. Ct. App. 2015).
“Under A.R.S. § 12-701(A), the maker of a drug is not liable for punitive damages if the drug was manufactured and labeled in accordance with FDA standards.”
— Ariz. Rev. Stat. § 12-701(a)(l) — 1 case
Zimmerman v. Novartis Pharm. Corp., 889 F. Supp. 2d 757 (D. Maryland 2012).
“927(l)(a) (2005); Utah Code Ann. § 78-18-2 (1). One state, Michigan, adopted a complete, blanket immunity based upon compliance with FDA regulations.”
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