Hoffmann-La Roche ordered to pay Accutane user $2.6 million

Pharmaceutical company Hoffmann-La Roche Inc. was hit Tuesday with a $2.6-million jury verdict over its acne treatment Accutane, the first such verdict in a case that blamed the drug for inflammatory bowel disorder rather than other, more well-known side effects, lawyers say.

A six-woman, four-man jury in Atlantic City awarded compensatory damages to a Moody, Ala., man, but did not assess punitive damages against the Nutley, N.J.-based drug maker.

Andrew McCarrell, 36, was awarded $119,000 for past medical expenses and $2.5 million in compensatory damages to cover future medical costs, pain and suffering, said one of his lawyers, Brian Barr.

Barr said this was the first trial handled by five law firms jointly representing nearly 600 plaintiffs suing Roche over inflammatory bowel disorder claims; three more trials are scheduled this year in Florida and Illinois.

Swiss pharmaceutical company Roche Group, Hoffmann-La Roche’s parent, said in a statement it will appeal.

“The cause of inflammatory bowel disease remains unknown and there is no reliable scientific evidence that Accutane causes inflammatory bowel disease,” the statement adds.

Barr said the jury found the company failed to adequately warn the public about Accutane’s risk of causing inflammatory bowel disorder, an umbrella term for several poorly understood diseases involving chronic inflammation of the intestinal tract. They cause symptoms including severe abdominal cramps, fever and diarrhea.

Accutane’s links to suicidal behavior and birth defects are much better known. The detailed instructions in the package include a lengthy, bold-faced warning about psychiatric disorders and begin with the words “Causes birth defects” and “Do not get pregnant.”

A brief, plain-type warning states Accutane has been associated with inflammatory bowel disease.

Roche lawyers argued that the warning was adequate. It has been on the package insert for more than 20 years, and Accutane has been prescribed for more than 13 million people in the quarter-century it has been on sale, Roche said.

The jury apparently did not see the warning as adequate, Barr said, yet did not find that Roche violated New Jersey’s Consumer Fraud Act, which bars misrepresentations about a product’s safety. Because of that ruling, Roche was spared any punitive damages.