Presumption-of-Adequacy Defense Is Clarified and Reinforced


On Sept. 29, the Appellate Division took a significant step forward in clarifying and reinforcing the presumption-of-adequacy defense provided to manufacturers of prescription drugs under the New Jersey Product Liability Act (PLA). N.J.S.A.2A:58C-1 to -11. In Bailey v. Wyeth, et al., the court affirmed summary judgment in favor of the defendant drug manufacturers, dismissing the plaintiffs' claims for violations of the PLA. Those claims sought recovery for personal injuries based on allegations that the plaintiffs had sustained breast cancer from ingesting hormone replacement therapy (HRT) drugs. The plaintiffs asserted that the drug manufacturers failed to provide adequate warnings on the risks of breast cancer allegedly associated with HRT.

Under the PLA, a pharmaceutical company "that communicates adequate information on the dangers and safe use of the [prescription drug] product, ... taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician" will not be liable for failure to warn. N.J.S.A.2A:58C-4. Beyond this general statutory language, the PLA provides specific deference to the federal Food and Drug Administration's (FDA) determination of appropriate labeling for prescription drugs, by including a rebuttable presumption of adequacy in the statute. In other words, companies that comply with FDA labeling regulations are granted a rebuttable presumption that their labeling is adequate as a matter of law. N.J.S.A.2A:58C-4.

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Published In: Administrative Agency Updates, Civil Procedure Updates, Health Updates, Personal Injury Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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