A six-woman, four-man jury in Atlantic City awarded compensatory damages to a Moody, Alabama, man, but did not assess punitive damages against the Nutley, New Jersey-based drugmaker.
Andrew McCarrell, 36, a manager at a software company, 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 has significant grounds for appeal and will pursue them.
“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. It is an umbrella term for several poorly understood diseases involving chronic inflammation of the intestinal tract; they cause symptoms including severe abdominal cramps, fever and recurring, sometimes bloody 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” with an illustration of a pregnant woman and a circle with a slash through it.
A brief, plain-type warning states Accutane has been associated with inflammatory bowel disease.
Lawyers for Roche 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 worldwide 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 expenses.
Barr said Superior Court Judge Carol Higbee excluded evidence about a change in the wording of the inflammatory bowel disorder warning after McCarrell stopped using the drug — evidence Barr said could help plaintiffs who used it later win punitive damages.
McCarrell took Accutane from June 1995 to October 1995 and suffered from achy knees and chapped lips while he was taking it. Months later, he began to have abdominal pain, was diagnosed with inflammatory bowel disorder and had his rectum and most of his colon removed, Barr said. After years using a colostomy bag, McCarrell had another surgery to connect the remains of the colon with the anus, resulting in permanent diarrhea because there is no colon to draw out excess water.
According to Roche, the only trial it has faced over Accutane in the last decade was in 2002, when it won a jury verdict over a plaintiff alleging the drug caused depression.
I took accutane twice when i was younger. I have just been recntly been
dianoised with IBS. I also have a small nogle in my lung and thicking in my
lungs that was not present there before. I have been medically retired since
1995 from a maufaturing company in Whithall, Michigan. I have many health
problems that are quite bothersomed. thank-you