On September 29, 2011, in Bailey v. Wyeth, et al., a New Jersey appellate court affirmed summary judgment in favor of two Pfizer subsidiaries and Wyeth, Inc., dismissing claims for violations of New Jersey's Product Liability Act (PLA). The claims arose from breast cancer injuries allegedly sustained from certain hormone replacement therapy (HRT) pharmaceuticals. The plaintiffs contended that the manufacturers failed to provide adequate warnings of the risks allegedly associated between breast cancer and the HRT medications.

At issue was whether plaintiffs were able to circumvent New Jersey's statutory presumption of adequacy defense, which bars failure-to-warn claims relating to an FDA-approved drug label. As the PLA has been interpreted, New Jersey courts presume that FDA-approved labels are adequate as a matter of law, unless plaintiffs can offer proof of: (1) deliberate concealment from and nondisclosure to the FDA of after-acquired knowledge of adverse health effects relating to the drug at issue; or (2) manipulation of the post-market regulatory process by the defendant drug manufacturer in diluting risk information through its marketing practices.

The trial court held that the plaintiffs failed to present compelling or substantial evidence of the type necessary to rebut the presumption of adequacy. The trial court relied heavily on the testimony of the plaintiffs' expert, who stated that she saw no evidence that the defendants had withheld from the FDA information about the risks of breast cancer associated with the HRT medication. The trial court further found that because the FDA had the regulatory authority to require a specific breast cancer warning in the labeling of the drugs, had the knowledge to determine whether such a warning was necessary, and received an immediate and positive response from the companies when it requested they revise the drugs' labeling, there was insufficient evidence for the plaintiffs to overcome the statutory presumption of adequacy. A three-judge panel of the Superior Court of New Jersey, Appellate Division, unanimously affirmed the trial court's decision, and held the lower court's ruling was well-supported by the evidence and was "legally unassailable."

What This Means for Drug Companies

Most immediately, this decision is likely to have a direct impact on the more than 150 HRT cases pending in New Jersey, as well as other current and future pharmaceutical products liability actions that include a failure-to-warn claim.

Though New Jersey historically is viewed as a safe haven for the products liability plaintiff's bar because of its liberal venue rules, this decision appears to be a significant setback for plaintiffs who want to bring failure-to-warn claims against drug companies in New Jersey. It is likely to provide powerful ammunition to drug companies defending against these claims. The ruling underscores the viability of New Jersey's presumption of adequacy defense, and joins a long line of New Jersey cases that preclude failure-to-warn claims against drug manufacturers absent specific evidence of intentional concealment or misconduct.

Though New Jersey historically is viewed as a safe haven for the products liability plaintiff's bar because of its liberal venue rules, Bailey v. Wyeth appears to be a significant setback for plaintiffs who want to bring failure-to-warn claims against drug companies in New Jersey.