(a) 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 Federal Food, Drug and Cosmetic Act or the Public Health Service Act; or

(b) 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.

(2) Subsection (1) of this section does not apply if the plaintiff proves, in accordance with the standard of proof set forth in ORS 30.925 (1), 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 agency or prescribing physician information known to be material and relevant to the harm which the plaintiff allegedly suffered.

(3) Nothing contained in this section bars an award of punitive damages where a manufacturer of a drug intentionally fails to conduct a recall required by a valid order of a federal or state agency authorized by statute to require such a recall.

(4) For the purposes of this section, the term "drug" has the meaning given to the term in section 1201 (g)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 (g)(1). [1987 c.774 §5]

Note: Sections 1 and 2, chapter 536, Oregon Laws 2007, provide:

Sec. 1. (1) As used in this section, "COX-2 inhibitor" means a medication that is intended to inhibit the enzyme known as cyclooxygenase-2.

(2) A civil action for injury, including any product liability action under ORS 30.900 to 30.920 and any action based on negligence, resulting from the use of a COX-2 inhibitor must be commenced not later than four years after the date on which the plaintiff first discovered, or in the exercise of reasonable care should have discovered, the injury and the causal relationship between the injury and the product, or the causal relationship between the injury and the conduct of the defendant.

(3) A civil action for death, including any product liability action under ORS 30.900 to 30.920 and any action based on negligence, resulting from the use of a COX-2 inhibitor must be commenced not later than six years after the date on which the plaintiff first discovered, or in the exercise of reasonable care should have discovered, the causal relationship between the death and the product, or the causal relationship between the death and the conduct of the defendant. [2007 c.536 §1]

Sec. 2. (1) Except as provided in subsection (2) of this section, section 1 of this 2007 Act applies only to causes of action arising on or before January 1, 2007.

(2) Section 1 of this 2007 Act does not apply to any causes of action for which a judgment was entered in the register of a court before the effective date of this 2007 Act [January 1, 2008]. [2007 c.536 §2]