Limitations Period for Accutane Lawsuits Not Necessarily Started by Warning

In a decision that could have widespread ramifications on the drug industry, the New Jersey Supreme Court has ruled that the statute of limitations on filing a product liability lawsuit does not always begin when the FDA places a warning on a drug’s label. 

The decision came in a case filed in December 2005 by Kamie Kendall, who was diagnosed with ulcerative colitis after taking Accutane, an acne medication manufactured by Roche.

Following trial, Kendall was awarded $10.5 million in damages. However, Roche attempted to argue that she filed the claim too late, because warnings about the risk of bowel problems from Accutane were added to the label in August 2003.

Every action has a statute of limitations, which gives the plaintiff a certain amount of time to file their claim. In New Jersey, claims must be filed within two years from the date of the injury or when the plaintiff reasonably should have known that a drug caused the injury.

Roche attempted to have Kendall’s lawsuit dismissed, arguing that she reasonably should have known about the connection between Accutane and ulcerative colitis when the warning label was updated, meaning that she missed the two year deadline.

Earlier this week, the New Jersey Supreme Court ruled that the label warning is not necessarily the point at which one can assume the plaintiff knew about the problems with Accutane. Based on the specific facts of the case, the Court found that a reasonable person in Kendall’s position would not necessary know about the relationship between her condition and side effects of Accutane by December 2003.

The decision could have ramifications in other Accutane lawsuits filed against Roche, as well as cases filed against other drug makers in New Jersey state court.

Accutane (isotretinoin) has been used by more than 16 million people worldwide since it was first introduced by Roche in the early 1980s as a treatment for severe acne. The drug maker discontinued Accutane in June 2009, due to the increasing costs associated with the litigation over Accutane, but a number of generic versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

Several Accutane trials have already occurred in New Jersey state court, with a number of multi-million dollar verdicts being returned for damages caused by Accutane.

More than 7,000 lawsuits over Accutane and generic equivalents are currently consolidated in New Jersey state court before Judge Carol Higbee, in Atlantic County. Although the first cases were filed in 2003, the number of complaints has more than doubled over the last year.

All of the suits involve similar allegations that the popular acne drug carried inadequate warnings that side effects of Accutane may increase risk of debilitating inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, which could develop years after the medication is used.