On December 21, 2005, plaintiff Kamie Kendall filed suit against Hoffman-LaRoche for injuries that allegedly resulted from her use of the acne drug Accutane, a drug produced and marketed by defendants. Defendants appealed a jury’s award to plaintiff, and the Appellate Division reversed the award. The plaintiff then appealed.

NJCJI joined with the Health Care Institute of New Jersey to argue to the Supreme Court that an FDA-written, FDA-approved warning should be presumed adequate, and that presumption of adequacy should be dispositive, absent evidence of fraud. The decline of New Jersey’s pharmaceutical industry coincides with a rise in pharmaceutical tort litigation and encouraging further litigation will further damage the weakened industry.

The court affirmed the Appellate Division’s ruling on a 5-1 vote, holding that the plaintiff has the burden of proving that that a reasonable person would not have been aware, within the prescribed statutory period, that defendant’s product caused injury, based on the FDA warning alone. The court found that the plaintiff in this case proved she was not aware that her injury could have been caused by defendant, despite having received the FDA’s warning.