New Jersey Jury Awards $12.9 Million to Three Patients Whose Use of Roche Acne Medication Accutane Found to Cause Severe Bowel Illness

November 20, 2008       In another major courtroom verdict linking powerful acne medication Accutane with long-term inflammatory bowel disease (IBD), an eight-person jury in Atlantic City has found that pharmaceutical maker Hoffman-La Roche failed to provide adequate warning of the possible condition to three patients who began taking the drug as teenagers and shortly thereafter developed severe forms of IBD. The jury awarded compensatory damages of $12.89 million to be apportioned among the three individuals, now aged in their mid-to-late 20s. The verdict capped a five-week trial in New Jersey State Superior Court and follows a series of recent plaintiffs' wins here and in other state courts against Nutley, NJ-based Roche over allegations that Accutane was a cause of severe bowel maladies, in some cases even after the plaintiffs discontinued use of the drug.      The three plaintiffs are all Florida residents -- Kelly Mace, 25, of Pensacola, along with Jordan Speisman, 27, of Gainesville, and Lance Sager, 28, of Ft. Lauderdale. All were first prescribed Accutane nearly a decade ago while still in their teens to relieve adolescent acne. All three succumbed to various forms of IBD, including ulcerative colitis and Crohn's disease, while taking Accutane or shortly thereafter. Mr. Speisman is expected to shortly undergo surgical removal of his colon; Ms. Mace and Mr. Sager will rely on medications in an effort to manage their disease in the future. As a result of their disease, all suffer from a dramatic increased risk of colon cancer.      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 for 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 performed in animal models specifically to test the gastrointestinal safety of the drug, tested exposures that were lower than those seen in patients taking Accutane. Also in Roche's files but not shared with the medical community, were hundreds of patient reports of IBD in connection with Accutane use. Notably, in numerous of the reports, the symptoms of IBD appeared with Accutane use, subsided when Accutane use was terminated, but then recurred following re-introduction of the drug. Roche repeatedly determined internally that Accutane was the best and only explanation for these IBD reports.      The jury awarded Mr. Speisman approximately $8.64 million; Mr. Sager $2.62 million and Ms. Mace approximately $1.63 million. Punitive damages were not sought in the case.