A jury in the United States has ordered drug manufacturer Roche to pay $12.9 million to three Accutane users who say they developed chronic bowel disorders from using the popular acne drug. The jury determined that the Swiss drug maker failed to properly warn of the side effects that can result from using Accutane.
The patients began using Accutane more than 10 years ago when they were teenagers to treat their acne. As a result of using the acne drug, two of the patients say they now require long-term drug rehabilitation and the third patient has to have his colon removed.
This is not the first drug litigation lawsuit filed against Roche that links Accutane to inflammatory bowel disease. This is the fourth IBD civil trial the Swiss Drug maker has lost.
Inflammatory Bowel Disease
There are two kinds of chronic diseases that can cause inflammation to the intestines and result in ulcers:
• Crohn’s Disease
• Ulcerative Colitis
While the drug’s warning label says Accutane is “associated with” chronic bowel problems, the drug maker maintains that there is no direct connection between chronic bowel ailments and Accutane. The drug litigation attorneys for the plaintiffs, however, say Roche has conducted internal studies that indicate Accutane can damage the intestinal tract and result in inflammatory bowel disease.
Hoffman-La Roche, Roche’s US subsidiary, plans to appeal the dangerous drug verdict. The company continues to maintain that there is no scientific evidence that proves using Accutane can cause IBD.
Over 13 million people have used Accutane since 1982. Until the drug’s patent expired six years ago, the acne medication was one of Roche’s top selling drugs. It is also a controversial drug.
Accutane was linked to birth defects in the 1980’s and 266 suicide cases in the US. It has also been associated with problems affecting the musculoskeletal, cardiovascular, and autoimmune systems, as well as the pancreas, liver, central nervous system, and kidneys. Some 500 lawsuits have been filed over the acne drug.
Roche Loses Fourth Accutane Trial, Ordered to Pay 3 IBD Victims, $12.9 Million, News Inferno, November 21, 2008
Pharma Roundup: Lawsuit for Roche, Teva Troubles for AstraZeneca, and More, BNET, November 19, 2008
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