Product liability cases brought against pharmaceutical and medical device manufacturers typically focus on failure-to-warn claims. But who decides whether the challenged warning is adequate? Judge or jury? In its decision in Banner v. Hoffmann-La Roche Inc., 383 N.J. Super. 364 (App. Div. 2006), New Jersey’s Appellate Division challenged the conventional wisdom that juries alone should decide whether a manufacturer’s warning is adequate by taking one such determination into its own hands.

The plaintiffs in Banner were a married couple whose child had been born with profound birth defects due to the mother’s prenatal use of the drug Accutane. The couple sued Accutane’s manufacturer, Roche, for damages. Accutane, a Food and Drug Administration-approved medication for the treatment of severe acne, is a known teratogen, or chemical known to cause birth defects. Roche, aware of this danger, established a comprehensive pregnancy prevention program to be completed by each potential woman patient of childbearing age, which included a pregnancy test and consent and survey enrollment form.