A woman who developed inflammatory bowel disease (IBD) after taking Hoffman-LaRoche’s acne drug Accutane, has been awarded more than $1.5 million in compensatory damages and medical expenses. This was a retrial of the case; an earlier verdict was overturned on appeal.
On Tuesday, a New Jersey jury awarded Kamie Kendall Rees $1.5 million in compensatory damages and approximately $88,000 in past medical expenses, according to a Law360 report. During the monthlong trial, Kendall Rees’s attorneys presented evidence that Roche was aware Accutane (isotretionoin) can cause IBD but failed to adequately warn of the risks. Accutane now carries Food and Drug Administration (FDA) safety warnings about birth defects, mental health problems, vision and skin problems, and intestinal problems.
Kendall Rees began using Accutane at age 12 to treat severe recalcitrant nodular acne; at 15 she developed ulcerative colitis. The condition continued to grow worse until, at age 21 in 2006, her colon was removed. After the award was announced, Kendall Rees’ attorney told Law360 that the verdict will send a strong message to Roche that its failure to warn about Accutane’s risks has resulted in many young people suffering permanent loss of their quality of life. This verdict is Roche’s ninth loss in an Accutane liability suit.
Kendall Rees was awarded $10.5 million in the first trial but that verdict was overturned by the New Jersey appellate court, which ruled that the judge made an error in rejecting Roche’s evidence comparing the incidence of inflammatory bowel disease in the general population with the number of reported cases of the disease among Accutane users, Law360 reports.
At the second trial, Roche presented the results of six epidemiological studies released between 2009 and 2013. Roche argued these studies – which were not yet available at the time of the first trial – showed no association between Accutane use and IBD or showed inconclusive results, according to Law360. But Kendall Rees’s attorney argued that many of the studies were limited in their methodology and, arguably, were more helpful to Kendall Rees’s case than to Roche’s. Further, the attorney told the jury, Roche intentionally elided the results of human and animal studies conducted on Accutane. The attorney said internal Roche documents indicate the drug maker was aware of a potential link to IBD as early as 1978, but the company downplayed the reports to avoid removing the drug from the market.