SOL Clock on Drug Lawsuit Doesn’t Start with FDA Warnings, NJ Court Rules

The New Jersey Supreme Court has upheld a lower court’s ruling that Food and Drug Administration (FDA) warnings about the dangers of prescription drugs do not always “start the clock” on the statute of limitations for product liability claims.

According to a Law360.com report, the decision involved the case of Kamie Kendall, for whom a jury determined the acne medication Accutane caused her to suffer from ulcerative colitis starting in the late-1990s, awarding her $10.5 million in 2008. The makers of Accuntane, Roche, appealed the decision before the New Jersey’s Supreme Court in 2010, arguing its warnings about the risk of suffering severe gastrointestinal and bowel disorders expressed in FDA warnings should have been the beginning of when liability claims could be filed.

Roche has been ordered to pay tens of millions of dollars to people who claim its top-selling medication Accutane caused them to suffer similar complications, like Irritable Bowel Disease/Disorder (IBD), ulcerative colitis, and symptoms similar to Crohn’s disease. In the most extreme cases, those suffering from the side effects of Accutane have been forced to have portions of their colons removed, or in some cases, the entire organ.

Kendall had been taking Accutane “at various times” since 1997 and was diagnosed with ulcerative colitis in 1999. She said her gastroenterologist and dermatologist each approved her prescription for Accutane even after she began complaining of symptoms common with the bowel disorder.

She claims in her argument that she only became aware of the link between Accutane and her disorder in 2004 and filed her claim in 2005, well within New Jersey’s two-year statutory limit, according to its Product Liability Act, Law360.com reports.

The court nearly unanimously agreed with Kendall, believing that a “middle-of-the-road approach is justified” specific to her case. The justices ruled “that a reasonable person in her (Kendall’s) circumstances would not have known by December 2003 of the relationship between Accutane and her condition.” Having two specialist physicians “sign off” on prescriptions for Accutane despite her complaints would only further her belief that the drug was not responsible for the condition, the high court ruled.

Roche pulled Accutane from the market in 2009 but generic forms of the drug are still available in the U.S. The pharmaceutical company said its decision to discontinue the drug was because of business and not over the mounting legal pressure the company faced from people similar to Kendall who believe the drug caused their gastrointestinal injuries. Thousands of lawsuits have been filed against Roche claiming injuries from Accuntane. Those whose cases have reached a jury have most often been successful in getting large jury awards. In some cases, juries have ruled against the plaintiff.