July 2, 2012 — The pharmaceutical company Roche will pay $18 million to two women who developed ulcerative colitis, a type of inflammatory bowel disease, after using the acne drug Accutane. The disease causes lifelong pain and debilitation. The jury spent six hours deliberating, and decided to award Kathleen Rossitto and Riley Wilkinson $9 million each. The jury found that their injuries could have been avoided if Roche had adequately warned about the possible risk of ulcerative colitis.
This is the sixth jury trial that Roche has lost in New Jersey. Juries in the previous five trials also decided that Roche should pay millions of dollars in compensation to the victims of Accutane injuries. About 7,000 more cases are currently awaiting settlement or trial in courts in New Jersey and throughout the United States.
Accutane has been on the U.S. market since 1982, but it was withdrawn in 2009 amid safety concerns. Approximately 16 million people have used it to reduce acne, but several studies have linked the drug to serious side effects. One study published in the American Journal of Gastroenterology in September 2010 found a link between isotretinoin (the active drug in Accutane) and a higher risk of inflammatory bowel disease. The study also found that people who were exposed to higher amounts of isotretinoin had a higher risk of the bowel disease.
Roche decided to withdraw Accutane from the market after facing numerous Accutane lawsuits. Juries awarded injured people millions of dollars in damages in each of these cases.
Roche has consistently appealed each decision, and in some cases the appeals court has overturned the decision and ruled in Roche’s favor. Appeals courts have overturned a $25.1 million judgement and a $7 million judgement. Of the 13 Accutane lawsuits that have gone to trial, Roche has lost nine of the cases.
The company continues to assert that Accutane does not cause ulcerative colitis. In a statement that the company emailed to a Bloomberg reporter, Roche officials said that
“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, regulators in Europe found that Roche had failed to follow up on 80,000 reports of safety issues with its drugs, many of which are marketed in the United States. The European investigators found that Roche systematically ignored potential safety issues, failed to inform health authorities about potential safety issues, and never evaluated thousands of reports that could have been serious adverse events.