Lights! Camera! Accutane! Roche Versus Hollywood

The usual interplay between Hollywood and drugmakers occurs when a celebrity endorses a drug. Now, though, Roche is about to encounter a Hollywood experience of an entirely different sort - James Marshall, who played a US Marine in the 1992 hit film ‘A Few Good Men,’ claims his acting career was derailed after he used the Accutane acne pill and developed inflammatory bowel disease. His colon was subsequently removed and he is suing the drugmaker for $30 million

His trial, and two others, start next week in a New Jersey courtroom and the spectacle is likely to cause a side effect of its own - attention on product liability litigation in ways that previous lawsuits have not generated. For all of the thousands of such lawsuits filed against drugmakers in recent years, the featured plaintiffs were almost always ordinary people whose ordinary lives were allegedly disrupted by the use of a medication. Their trials were rarely covered in the media. And even when this happened in a big way - such as the first few Vioxx lawsuits - these folks faded from the screen.

Marshall, however, was a star. And the New Jersey-bred pretty boy will rely on testimony from even biggers names - Martin Sheen, Brian Dennehy and Rob Reiner. His Hollywood pals are expected to testify that Marshall, 42, was headed for stardom before his ailments upended his career. "Rick Nicita, who was (a managing partner) at Creative Artists Agency, the biggest agency for all sorts of stars, is going to testify that James was going to be a mega-star," Marshall's lawyers, Mike Hook, tells us. "He was already in three major motion pictures. But then he took Accutane and, suddenly, his career was gone. Once in awhile, he's taken a small part, but his acting career is pretty much over."

At issue is whether Roche properly warned its drug, which has also been linked to psychiatric side effects and birth defects, could cause IBD (see this). "Roche knew their drug caused IBD and failed to disclose that to the medical community and to people prescribng the drug," Hook says. About 2,500 lawsuits have been filed in New Jersey against the drugmaker, which maintains proper warnings were issued and that there is no science to confirm that a link exists between the med and IBD.

The drug, which lost patent protection in 2002, was once a huge seller and Roche continued to market the med until 2009, after losing several IBD cases. However, Roche has won dismissals in federal court and challenged state court verdicts by asking judges to throw them out or filing appeals (one example). A Roche spokesman writes: "Roche takes any and all information about our products seriously, and our sympathies remain with James Marshall, Kelly Andrews and Gillian Gaghan (whose trials will occur simultaneously) over their disease." The drugmaker also notes that last July, the FDA posted a notice that the Accutane was not withdrawn due to safety or efficacy concerns.

The legal battle, however, has largely occurred off the collective radar screen. Now, though, the prospect of one Hollywood headliner after another taking the stand in Atlantic City, New Jersey, may just attract television cameras, celebrity bloggers and countless Tweeters - further underscoring the contentious debate over side effects and proper disclosure just as several other large drugmakers are scampering to settle thousands of lawsuits as quickly as possible.