A man who claimed that he developed severe bowel problems from Accutane, an acne medication, has reached a pre-trial settlement with Roche Laboratories, the drug’s manufacturer.
Roche has asked Madison County Circuit Judge David Hylla to approve the Accutane settlement, according to a report in The Madison Record. The case, which was brought by plaintiff Jason Peipert, also involves a medical malpractice claim against an Illinois doctor, who may also be in settlement talks with the plaintiff.
Peipert alleges that Dr. Daniel Goran prescribed him Accutane to treat his acne, and that the drug caused him to develop the debilitating condition, inflammatory bowel disease (IBD). The case was set to go to trial on April 19, but start of the trial was delayed due the potential settlement with Accutane manufacturers.
Roche faces nearly 1,000 Accutane lawsuits, which involve allegations that the drug maker failed to adequately warn users about potential side effects of Accutane. The company has lost all six Accutane bowel disease trials that have reached a jury so far, with verdicts totalling $56 million.
The largest judgment so far was awarded to Andrew McCarrell, of Alambama, who received $25.16 million in compensation by a New Jersey jury in an Accutane trial earlier this year.
Details of the Accutane lawsuit settlement with Peipert have not been disclosed. However, the terms of the agreement do not include an admission of guilt from Roche, and Peipert has reportedly agreed not to bring another case against Roche in the future.
Accutane (isotretinoin) has been used by more than 16 million people worldwide since it was first introduced in the early 1980s as a treatment for severe acne. Roche discontinued the drug in June 2009, citing cost of defending Accutane suits as a factor in their decision. However, the acne medication remains available as a generic sold under a variety of names, such as Claravis, Sotret, Amnesteem and generic isotretinoin.
Last month, a study published in the American Journal of Gastroenterology found that Accutane side effects quadruple the risk of ulcerative colitis. Researchers found that not only were those taking Accutane four times more likely to develop ulcerative colitis, but they also determined that the chance of developing the bowel disorder rose in relation to the size of the Accutane dose, strengthening the evidence of a causal relationship.
In February, Health Canada issued a warning that it has received numerous reports of severe skin reactions, including sometimes fatal reaction known as Stevens-Johnson Syndrome from Accutane. At least 66 reports of Accutane skin reactions were identified by Health Canada, including adults and children, with two of the cases resulting in death.
Stevens-Johnson syndrome (SJS) is a severe skin reaction that occurs as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.