Jury validates Accutane bowel risk.

In the first of hundreds of similar cases to go to trial, a New Jersey jury has determined that the maker of the acne drug Accutane failed to adequately warn users of the risk of developing bowel disease. The jury found that the failure to warn was a major contributing cause of Andrew McCarrell's ulcerative colitis, which resulted in the removal of his colon, and awarded compensatory damages. (McCarrell v. Hoffman-La Roche, Inc., No. ATL-L-1951-03 (N.J., Atlantic Co. Super. May 29, 2007).)

Accutane has been sold in the United States since 1982; last year, more than half a million prescriptions were written for it and generic equivalents. The drug is known to cause birth defects and has a "black box" warning that it must not be used by women who are or may become pregnant during treatment. Another warning states that it may cause psychiatric disorders, such as depression.

The label also says Accutane has been "associated with" other conditions including inflammatory bowel disease (IBD), but this implies a lower risk--one that doctors may regard as insignificant, according to plaintiff attorneys. IBD includes ulcerative colitis and Crohn's disease and causes abdominal pain, chronic diarrhea, weight loss, and gastrointestinal bleeding.

McCarrell, now 36, took Accutane in 1995. About a year after treatment, he began having IBD symptoms, including chronic diarrhea and incontinence. Drugs could not treat the condition, and he had several surgeries--including, finally, a colectomy.

The manufacturer, Hoffman-La Roche, Inc., "knew what it was doing and made billions in profits but did nothing to assess its drug, did not do tests even though scads and scads of people were reporting inflammatory bowel disease," said Michael Hook of Pensacola, Florida, who heads a consortium of law firms handling these cases. David Buchanan of New York City, whose firm is in the consortium, represented McCarrell.

In 2001, Hook, whose work was 80 percent defense at the time, took a case for a plaintiff who'd been prescribed Accutane, developed IBD, and eventually lost his colon. As the attorney investigated, he became convinced that there was something very wrong with the drug. Because small-firm lawyers can't do these cases alone, he said, "I formed a national consortium to take on the drug manufacturer and do this job the way it needed to be done."

As Hook started pursuing litigation, lawyers for Hoffman-La Roche "sent motion after motion after motion, trying to crush the opposition. By having the consortium in place, we were able to stay in the litigation," said Hook.

Now, more than 400 cases have been filed and many others are pending. Ninety-nine percent of the plaintiffs have IBD, said Hook, who is also co-lead counsel of a 24-case multidistrict litigation in Florida. (In re Accutane Prods. Liab. Litig., No. MDL-1626 (M.D. Fla., transferred Nov. 1, 2004).

"Some of my clients don't have intestines, don't have colons--it's horrible what they have to live with," said Hook. "It got to the point where I decided if I don't do this, who's going to? I knew it would require me to give up the rest of my practice and really work on it continuously. But how long has this been going on, and no one has gone after the company?"

Roche plans to appeal the McCarrell case. It argued that the causes of IBD are unknown, no significant scientific evidence proves Accutane causes it, and the label has carried a warning about bowel disease for more than 20 years.

Hook thinks plaintiffs are on solid ground with discovery evidence and experts. His lead expert, for example, is David Sachar, who until last month served as chair of the FDA advisory committee on gastrointestinal drugs.

"Early on, [Sachar] said, 'I believe Accutane is causing inflammatory bowel disease,'" said Hook. His experts have reviewed discovery materials and testified that the manufacturer withheld documents about IBD and other key plaintiff issues.

Meanwhile, Skip Campbell, a consortium attorney in Ft. Lauderdale, Florida, is representing Jason Piepart of Madison County, Illinois, who has ulcerative colitis. At press time, the trial had just been continued. Other attorneys in the consortium also have upcoming trial dates.

In the end, Hook said, "I think we're gong to win. Not every case--because I know that, I'm a trial lawyer--but most of them. And overwhelmingly."