July 2, 2012 – Last month, pharmaceutical giant Roche Holding AG was ordered to pay a total of $18 million to settle a pair of lawsuits claiming the company’s blockbuster acne drug Accutane caused the plaintiffs’ inflammatory bowel disease (IBD). The ruling came about a week after European health regulators determined that Roche had systematically failed to evaluate reports of safety issues involving its wide variety of medications. The company has now lost nine of 13 lawsuits brought by former Accutane users that have gone to trial since April 2007.
What’s the problem?
A New Jersey jury deliberated for about six hours before finding that Roche was negligent in failing to adequately warn Kathleen Rossitto and Riley Wilkinson that Accutane has the potential to cause IBD. Both plaintiffs were awarded $9 million in compensatory damages. The case is Kathleen Rossitto v. Hoffmann-La Roche Inc., ATL-l-7481-10-MT, New Jersey Superior Court, Atlantic County (Atlantic City).
Accutane is the brand name for the drug isotretinoin, which was originally developed by Roche for treating severe cystic (nodular) acne. The medication is also marketed under the names Roaccutane, Amnesteem, Claravis and Sotret. Since it was first approved by the U.S. Food & Drug Administration (FDA) in 1982, approximately 16 million people were prescribed Accutane before it was recalled in 2009 after juries awarded millions in damages over bowel-disease claims.
In addition to being linked to inflammatory bowel disease, Accutane has also been associated with the following serious side effects: