July 2, 2012 — A jury in New Jersey has ruled that the European pharmaceutical company Roche must pay $18 million to two women who claim that the acne drug Accutane caused their chronic bowel disease.
It took the jury just six hours to decide that Roche failed to adequately inform Kathleen Rossitto and Riley Wilkinson that Accutane could cause inflammatory bowel disease. Each of the women took Accutane in the 1990s and developed ulcerative colitis, a debilitating, permanent disease. The jury awarded them $9 million in compensation, but rejected claims from two other women.
This is the sixth jury trial Roche has faced in New Jersey. In the previous five trials, juries also found that Roche failed to adequately warn about the potential risk of inflammatory bowel disease. There are approximately 7,000 more cases pending in New Jersey and other states.
Since Accutane became available on the U.S. market in 1982, approximately 16 million people have used this drug to treat acne. After studies linked the drug to an increased risk of inflammatory bowel disease, Roche faced numerous Accutane lawsuits from people who claimed that Roche failed to warn them about the side effect. Juries awarded millions of dollars in damages in these cases. In 2009, Roche withdrew Accutane from the market.
A study published in the American Journal of Gastroenterology in September 2010 showed that isotretinoin, the active ingredient in Accutane, was associated with ulcerative colitis — a type of inflammatory bowel disease. The research also showed that higher exposures of isotretinoin were more strongly associated with the disease.
The company maintains that Accutane does not cause inflammatory bowel disease. According to a statement that Roche emailed to Bloomberg reporters, “The company believes that the evidence at trial demonstrated that Accutane did not cause this disease and that Roche acted appropriately in providing information to the medical, scientific, and regulatory communities.”
Last week, European regulators found that Roche had systematically ignored reports of safety issues with its drugs. An investigation found that Roche failed to inform health authorities about potential safety issues. Approximately 80,000 reports of safety issues with medicines that are marketed in the U.S. were never evaluated by the company.
Roche says they will appeal the judgements. Appeals courts have already thrown out some of the more substantial judgements, including one in which a jury awarded a man $7 million, and another in which a jury awarded a man $25.1 million. Of the 13 Accutane lawsuits brought against Roche, the company has lost 9 cases.