In re Accutane Litigation

Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively, Roche) (defendants) developed and sold Accutane, a drug to treat severe acne. The Food and Drug Administration (FDA) approved marketing of Accutane in 1982. At that time, the product’s warning label did not mention inflammatory bowel disease (IBD) because IBD had not been reported in the clinical trial. However, in the product’s first year, Roche received reports that six to eight users had developed IBD. Roche amended the physician warning label to state that Accutane had been temporarily associated with IBD. In 1999, Roche’s data showed that of the approximately 300 instances in which Accutane had been associated with IBD, two-thirds of users experienced reversal of their IBD upon stopping Accutane. At the FDA’s urging, Roche amended the physician warning label in 2002 to remove the word temporarily and add a statement that IBD symptoms sometimes continued after Accutane use ended. By 2018, 532 Accutane users (the users) (plaintiffs) had filed suits against Roche across 45 jurisdictions, alleging that the 2002 warning label failed to adequately warn of Accutane’s IBD risk. They argued that the label did not sufficiently indicate causation, merely stating that Accutane was associated with IBD, rather than caused IBD. The cases were consolidated for trial in New Jersey, the state where Roche had its principal place of business. The trial court concluded that New Jersey law governed all claims and, under New Jersey’s Products Liability Act, the claims were not viable because the users failed to rebut the presumption of adequacy afforded to FDA-approved warning labels. The court granted summary judgment to Roche on all claims. The appellate division reversed, holding that the claims were subject to the laws of the states in which each user used Accutane. It concluded that summary judgment was appropriate under some states’ laws but not others. The New Jersey Supreme Court granted review.