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.

The PLA expressly states: "If the warning or instruction given in connection with a drug ... has been approved or prescribed by the federal Food and Drug Administration under the 'Federal Food, Drug, and Cosmetic Act,' ... a rebuttable presumption shall arise that the warning or instruction is adequate." N.J.S.A.2A:58C-4.

There was no dispute in Bailey that the PLA provides a rebuttable presumption of adequacy based on FDA approval of drug labeling. Rather, the issue in Bailey was the effect and operation of the rebuttable presumption under the PLA, as applied to the facts of the case.

The plaintiffs in Bailey appealed the trial court's finding that the presumption of adequacy applied such that the HRT drugs' warnings were adequate as a matter of law. They contended that the presumption could not apply prior to 1995 "because the combined use of estrogen and progesterone constituted an offlabel use of the drugs." Bailey v. Wyeth, Inc., et al., No. L-0999-06-MT (App. Div...