Drugmaker Roche says that it will continue to contest the thousands of lawsuits filed against the company over the acne medication Accutane. Accutane was recalled in 2009 after it was linked to an increased risk of digestive disorders, birth defects, and psychological problems.
Since the first Accutane lawsuits were filed in 2003, Roche has lost seven cases that were tried in Atlantic County Superior Court in New Jersey, including a verdict of $25.16 million for a man who had his colon removed after developing inflammatory bowel disorder from taking Accutane. Despite these rulings, the company maintains that Accutane users were adequately warned about the side effects risk of the drug.
Studies have linked Accutane to a number of serious side effects. In 2009, researchers with the University of North Carolina at Chapel Hill found that Accutane users were at an increased risk of a number of digestive disorders, including irritable bowel disease and ulcerative colitis. Researchers found that Accutane users were four times more likely to develop ulcerative colitis. Patients who had filled at least four Accutane prescriptions were 2.67 times more likely to develop IBD.
After a 2007 study published by the British Journal of Clinical Pharmacology highlighted the link between Accutane and birth defects, the Food and Drug Administration required the creation of a national registry to track how the drug was prescribed to women. Accutane users who could become pregnant were required to use two forms of contraception and show proof of a negative pregnancy test in order to fill a prescription for the drug.
A 2001 study published by the New England Journal of Medicine has also linked Accutane to an increased risk of depression and suicide.
Roche announced that it would recall Accutane in 2009 due to the high cost of lawsuits filed by users of the acne drug who suffered from stomach disorders, psychological problems, or given birth to a child with birth defects. The company is facing almost 1000 Accutane lawsuits filed by former patients.