What is the current state of the law on "warning defects" in prescription drugs?

California, United States of America


The following excerpt is from Carlin v. Superior Court, 13 Cal.4th 1104, 56 Cal.Rptr.2d 162, 920 P.2d 1347 (Cal. 1996):

This concern--not to impose an excessively broad standard of liability on prescription drug manufacturers--continues today. Thus, the current tentative draft of the Restatement Third of Torts contains a special section governing products liability for prescription drugs and medical devices. With regard to warning defects, section 8 provides: "(d) A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings when [p] (1) reasonable instructions or warnings regarding foreseeable risks of harm posed by the drug or medical device are not provided to prescribing and other health care providers...." (Rest.3d Torts: Products Liability (Tent. Draft No. 2, Mar. 13, 1995) 8, p. 210.) 1

This court has in recent years addressed liability for "warning defects" for products other than prescription drugs (Anderson v.

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