Roche Wins Reversal in Accutane Lawsuit

Newark, NJRoche Holding AG won a reversal of a substantial verdict awarded against the drugmaker in an Accutane lawsuit. An appeals court ruled that the judge in the lawsuit improperly prevented Roche from providing evidence about Accutane medication's use. Due to the reversal, the lawsuit, which alleges the plaintiff suffered severe Accutane side effects, will go back to trial.

According to Forbes (08/10/10), Kamie Kendall began taking Accutane in 1997, when she was 13. Two years after she started taking the medication, she began experiencing bloody diarrhea. Eventually, Kendall developed symptoms that required removal of her entire colon and rectum.

Initially, a jury awarded Kendall $10.5 million in her lawsuit against Roche. The jury found that Roche didn't provide adequate warnings about the risks associated with Accutane, including the risk of bowel problems.

An appeals court, however, found that Roche was prevented from providing statistics about the total number of Accutane users during the Kendall trial. Those statistics were only allowed during the final stage of the trial. The appeals court ruled that those statistics could have resulted in a different verdict in the case.

The overturned appeal does not mean Kendall's lawsuit is over. The lawsuit will go back to court for a retrial.

Since 2007, Roche has lost all seven Accutane lawsuits that have been heard by juries, although at least two awards have been overturned. One lawsuit resulted in a jury award of $25.1 million; that award was the result of a retrial of an overturned verdict.

According to Bloomberg (08/05/10), the overturned appeal has already affected at least one other lawsuit. The lawsuit filed by James Marshall, alleging side effects from Accutane had a serious negative impact on his acting career, has been delayed. Martin Sheen, Esai Morales, Rob Reiner and Brian Dennehy are all expected to testify at the trial.

Accutane was recalled in 2009 due to market pressure, according to Roche. Although there was some speculation that the drug was recalled due to safety concerns, the US Food and Drug Administration issued an announcement in the Federal Register (07/07/10) that the Accutane recall was not due to safety or effectiveness of the drug but was in fact simply due to market pressure.