Roche Owes $2.62 Million for Man's Illness, Jury Says

May 29 (Bloomberg) -- Roche Holding AG lost the first of 400 lawsuits claiming its Accutane acne drug causes inflammatory bowel disease when a jury awarded an Alabama man $2.62 million.

Accutane was a cause of the disease in Andrew McCarrell, 36, the jury in Atlantic City, New Jersey, found today. The computer manager testified he had severe diarrhea, surgeries and depression after taking Accutane in 1995 and becoming ill a year later. Roche failed to warn of the drug's risks, jurors said.

The verdict may complicate Roche's efforts to defend suits alleging the drug causes inflammatory bowel disease. Roche lawyers said the disease's cause is unknown and drug-label warnings were adequate. McCarrell's lawyer argued the label was misleading and Roche hid the risks to reap profit.

``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.''

About 13 million people have taken Accutane since it was introduced in 1982. Roche lost patent protection on the drug in 2002 and continues to sell it, with generic competition. Accutane also has been associated with birth defects and depression.

McCarrell, who lives in St. Clair, Alabama, said he was ``ecstatic'' with the verdict.

``It means that I can go and get a lot better medical treatment,'' he said. ``I won't have to worry about my financial future.''

Accutane is made by Roche unit Hoffmann-LaRoche Inc. of Nutley, New Jersey. Diane Lifton, an attorney for Basel, Switzerland-based Roche, said the company will appeal.

`Disappointed'

``We're very disappointed in the verdict,'' she said.

The panel of six women and four men awarded $2.5 million in damages to McCarrell and $119,000 for past medical expenses. The jurors, who deliberated three days, found Roche didn't violate New Jersey consumer fraud law in its marketing of Accutane. Superior Court Judge Carol Higbee had previously dismissed a punitive damages claim, ruling there was insufficient evidence.

McCarrell's attorney Michael Hook said in closing arguments that his client ``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.''

Restless Nights

McCarrell testified that he hadn't slept through the night since getting ill.

``On a bad day, I really can't get out of bed,'' he told jurors on May 3, the trial's first day. ``When I wake up, my body just doesn't work. I stay in bed or lay on the couch all day.''

Juror Sarah Thies said: ``We hope that we compensated him enough for his pain and suffering that he's still going to go through.''

``The first one out of the gate is always important,'' said Michael Kelly of McCarter & English, a lawyer who defends drug companies in product-liability cases. ``The fact that this was a sympathetic plaintiff may have been a big factor here. I'm sure that Roche is going to huddle and decide whether they're going to settle'' other Accutane cases.

Hook argued to jurors that Roche's label warning that Accutane was ``temporally associated'' with bowel disease was confusing and misleading, given internal company reports of patients' getting ill.

Roche attorney Andrew See had argued that scientists don't know what causes inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis. The drug passes from the body within four to seven days, the lawyer said, noting that McCarrell's disease began a year after he took it.

Closing Arguments

``The question is not, `Was this the best warning in the world, was it a perfect warning?''' See said in closing arguments. ``The question is `Did it adequately convey the risk as of 1995?' I submit to you that it does.''

Juror Mark Schoettler said jurors didn't believe Roche intended to harm anyone.

``We felt it was a case of benign neglect, rather than malice,'' said Schoettler, 48, a stock clerk and writer. ``For the vast majority of people, this drug has been a godsend. For a very few, there are very serious side effects, which need to be more seriously considered.''

A plaintiff's expert on gastroenterology, Dr. David Sachar, testified that Roche hasn't done any clinical studies to determine whether Accutane causes inflammatory bowel disease.

FDA Warning

The U.S. Food and Drug Administration warned in March that buying Accutane over the Internet raises the risk that patients will have babies with birth defects. Women are supposed to agree to use two forms of birth control and take a pregnancy test to get a prescription from a doctor.

The FDA imposed tougher restrictions on Accutane in March 2006 based on reports of deformities and low intelligence in children whose mothers took the drug during pregnancy. Internet pharmacies may bypass these rules and distribute products with counterfeit and potentially dangerous ingredients, the FDA said.

The case is McCarrell v. Hoffmann LaRoche Inc., L-1951-03, New Jersey Superior Court, Atlantic County (Atlantic City).