Four Plaintiffs, Rebecca Reynolds, Riley Wilkinson, Jason Young and Kathleen Rossitto, brought separate suits against Hoffman La-Roche and Roche Laboratories, claiming that the manufacturer failed to adequately warn of the elevated risk that taking Accutane would lead to the development of permanent inflammatory bowel disease. All four plaintiffs ultimately developed ulcerative colitis after taking Accutane to treat their acne. Two of the four subsequently had to have their colons removed. An Atlantic County jury recently heard proof regarding all four claims, finding in favor of two of the four plaintiffs.
Although the drug was discontinued throughout the United States in 2009, anyone who previously took the drug for just over 60 days was five times more likely to develop ulcerative colitis than those who did not. The Accutane warning label indicated only that the drug had been “temporally associated with inflammatory bowel disease.” Plaintiffs argued that this warning suggested that such symptoms would not be permanent.
Plaintiffs presented an expert in U.S. Food and Drug Administration (FDA) regulatory affairs who opined that Defendants withheld critical information from the FDA regarding Accutane side effects, failing to inform them that inflammatory bowel disease was permanent and irreversible. The expert also pointed out that Roche never conducted a safety study of whether Accutane caused inflammatory bowel disease, despite having received complaints of such illness from Accutane users.
Defendant’s expert in FDA regulatory affairs asserted that Defendant acted as a reasonable pharmaceutical company would have throughout the FDA approval process. Defense counsel further argued that even if they had made the warnings stronger, it would not have deterred any of the plaintiffs from taking the drug.
The jury found in favor of Plaintiffs Rossitto and Wilkinson, who began taking the drug in 1997 and 1995, respectively, awarding them $9 million each. The jury determined that Defendant, Roche, knew or should have known about the risk of inflammatory bowel disease prior to May 1995 and that Defendant’s failure to provide an adequate warning was a substantial factor in each Plaintiff’s decision to take Accutane. With respect to Plaintiffs Reynolds, who began taking Accutane in 1992 and again in 1998, and Young, who started taking the drug in 1997, the jury found in favor of Roche. In those particular cases, the jury felt that an adequate warning would not have led to a different outcome.
MIXED VERDICT: $18,000,000
COURT: Atlantic County Superior Court, NJ
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