Trenton, NJ: When Andy McCarrell started using Accutane for acne control, he got more than he bargained for: Accutane inflammatory bowel disease, also known as Accutane IBD. And while the disease cost him his colon, his bank account is to benefit by $25.16 million.
According to the 3/7/10 issue of Pharma Investments, Ventures & Law Weekly, McCarrell was prescribed Accutane in the mid-1990s. McCarrell, now 38, developed chronic ulcerative colitis a little over a year after completing his Accutane treatment. He has since suffered from chronic bowel difficulty and severe complications from IBD, which ultimately led to the removal of his colon. He has also had to undergo several other surgeries as a result.
McCarrell's is not an isolated case. Other users of Accutane for acne have experienced similar health issues.
The manufacturer of Accutane, Hoffman-La Roche (Roche), first alerted the medical community to a possible association between the acne medication and inflammatory bowel disease in 1984. However, Roche allegedly failed to strengthen warnings about Accutane, even in the face of mounting evidence that Accutane induced IBD in patients.
McCarrell sued the manufacturer. During the ensuing five-week trial in New Jersey Superior Court, the jury saw evidence of Roche studies, never before published to the scientific and medical community, confirming that Accutane damages the gastrointestinal tract and leads to degeneration and erosion of the intestinal lining—a trigger for IBD. Studies of the gastrointestinal safety of Accutane were found to have exposed animal models to lower doses than those given to humans.
It was also discovered that Roche possessed patient reports demonstrating that use of Accutane triggered the symptoms of IBD. Physicians found that those symptoms tended to disappear when Accutane was stopped, only to reappear when Accutane use started again. Many of those patients were subsequently diagnosed with IBD.
At trial it was reported that the manufacturer argued against the causal association of Accutane with IBD, but internally had concluded that Accutane was "causally associated" with the emergence of IBD in Accutane patients.
The jury eventually found that Hoffman-La Roche Inc. failed to adequately warn the plaintiff's physician of the potential for IBD, which in turn led to McCarrell's development of IBD. The plaintiff was awarded $25.16 million in compensatory damages.
The manufacturer withdrew Accutane from the market in June 2009.