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Jury's Verdict: Company Failed To Warn That Accutane May Cause IBD

June 4, 2007

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Following up on an earlier post, the verdict of the accutane trial is in.

Last week a jury found that Hoffman-LaRoche's drug accutane, an acne medication, caused inflammatory bowel disease in the case of an Alabama man.

The jury awarded the man $2.62 million because of LaRoche's inadequate warning labels. This is the first of 400 lawsuits regarding accutane causing inflammatory bowel disease.

After the verdict, one juror expressed her view:

"We'd like to send a message to Roche to clearly do further testing and evaluations," juror Cynthia Spivey, 50, said after the verdict. "We also want to make it clear that they need to address their warning label sufficiently because too many people are at risk of permanent injury."

source: Bloomberg news service

In closing arguments, the plantiff's attorney noted his client's bathroom habits over the past 10 years:

"[Andrew McCarrell] has gone to the bathroom 25,000 more times than the average person. I can't imagine that. He's doing the best he can with what he's got to live with, and what he's had to live with is hell for the last 10 years.''

source: Bloomberg news service

As described in the PharmaTimes:

The plaintiff's lawyers claimed that the warning on the drug's label was insufficient and the jury agreed, saying that Roche had not been specific about the real extent of the risk of inflammatory bowel disorder. Nevertheless, the jury did not find that the firm had violated New Jersey's Consumer Fraud Act, which bars misrepresentations about a product's safety, so it will not have to pay any punitive damages.

Roche issued a statement saying that it has significant grounds for appeal and will pursue them, claiming that "the cause of inflammatory bowel disease remains unknown and there is no reliable scientific evidence" that Accutane causes it. The firm believes the present label is adequate and noted that 13 million people have taken the drug since it was introduced in 1982.

Accutane's links to suicidal behaviour and birth defects are more widely recognised and the label includes a bold-typed warning about psychiatric disorders and has the words 'causes birth defects' and 'do not get pregnant' on the packaging, with an illustration of a pregnant woman and a circle with a slash through it. A plain-typed warning states that the drug has been "temporally associated" with inflammatory bowel disease.

The Washington Post, as well as several other news services, also carried the full story.