In another major courtroom verdict linking powerful acne medication Accutane with long-term inflammatory bowel disease (IBD), a nine-person New Jersey jury has found that pharmaceutical maker Hoffman-La Roche Inc. failed to provide an adequate warning of the possible condition to Andrew McCarrell's prescribing physician, which then led to his development of chronic IBD. Mr. McCarrell, who was 23 at the time he took Accutane, developed a severe case of IBD and thereafter had his colon removed. The jury awarded compensatory damages of $25.16 million to Andy, now in his thirties.
The verdict capped a five-week trial in New Jersey Superior Court and follows a series of recent plaintiffs' wins here and elsewhere against Roche over allegations that Accutane was a cause of severe bowel maladies, chronic bowel disease, and in some cases removal of all or some of plaintiffs' colons and intestines. The symptoms of disease in many cases have arisen even after patients have discontinued their use of Accutane.
Andy McCarrell, now 38, was first prescribed Accutane in the mid-1990s while in his early 20s to treat his acne. Shortly after discontinuing his use of Accutane, Mr. McCarrell developed chronic ulcerative colitis, which led to the subsequent removal of his colon -- little over a year after completing his course of Accutane. Since having his colon removed, Mr. McCarrell has suffered from chronic bowel problems and severe complications of IBD, including several additional surgeries.
Roche first advised physicians about a possible association between Accutane and inflammatory bowel disease in 1984. In the ensuing years, the evidence accumulated by Roche and outside scientists demonstrated that, far from a coincidence, Accutane was in fact inducing inflammatory bowel disease in Accutane patients. Nonetheless, Roche failed to strengthen its warnings either to patients or prescribing physicians.
The jury saw evidence of Roche studies, never published to the scientific and medical community, that Accutane's by-products damage the gastrointestinal tract and lead to degeneration and erosion of the intestinal lining -- a trigger for IBD. Significantly, those studies, which were done in animal models specifically to test the gastrointestinal safety of the drug, used exposures of the drug that were lower than those given to humans. Likewise, in the company's files but not shared with the medical community, were numerous patient reports from physicians where Accutane use triggered the symptoms of IBD, which subsided when Accutane use was terminated but then reoccurred following subsequent Accutane usage; those patients were ultimately diagnosed with IBD. Roche repeatedly determined internally that Accutane was the best or only explanation for the patient's condition. While Roche internally concluded that Accutane use was "causally associated" with the development of inflammatory bowel disease, in this trial as in others, Roche argued otherwise to the jury.
In reaching their verdict, jurors addressed the following questions:
1. Did Roche fail to provide an adequate warning to Plaintiff Andy McCarrell's prescribing physician about the risks of inflammatory bowel disease from Accutane that Roche either knew or should have known about prior to June 1995?
2. Was Roche's failure to warn a proximate cause of Plaintiff's inflammatory bowel disease?
Having answered "Yes" to these questions, the jury then turned to the issue of what amount of money would "fairly and reasonably" compensate Mr. McCarrell for his damages? The jury answered that question with a $25,159,530 compensatory damage award. Punitive damages were not sought in the case.