Hoffmann-LaRoche, Inc., the makers of Accutane, will appeal a multimillion dollar jury verdict awarded to a man who said his irritable bowel disease was caused by the medication. Aside for the financial considerations, physicians are concerned that the case will make it more difficult for suitable patients to use a very valuable medication.
An Atlantic City, N.J., jury awarded Andrew McCarrell, 36, $119,000 for past medical expenses and $2.5 million in compensatory damages to cover future medical costs and pain and suffering. The jury did not assess punitive damages.
The McCarrell verdict is the first in a case linking Accutane (isotretinoin) to inflammatory bowel disorder (IBD) rather than to more highly publicized side effects such as suicidal behavior and birth defects, says David R. Buchanan, one of Mr. McCarrell's attorneys. Three more trials are scheduled this year, in Florida and Illinois, involving Accutane and IBD. Some 400 U.S. lawsuits have been filed involving the drug, which has been on the market since 1982.
"Our issue in this trial is ensuring that people get the appropriate warnings about Accutane and all of its potential side effects," Mr. Buchanan tells Dermatology Times. "I'm sure (Roche) will appeal the verdict, and I think the verdict is highly likely to be upheld."
"Roche is disappointed in the outcome of the McCarrell case, but the company believes it has significant grounds for appeal and will pursue them," says Shelley Rosenstock, executive director of public affairs for Roche.
"Notwithstanding the verdict, the cause of inflammatory bowel disease remains unknown, and there is no reliable scientific evidence that Accutane causes inflammatory bowel disease. While we cannot comment on any overall impact on the company (as a result of the verdict), we believe we will be successful on an appeal."
Ms. Rosenstock says that Roche "is pleased that the jury also found no liability for Roche" under the New Jersey Consumer Fraud Act.
"We are also pleased that, after hearing all the evidence, the court concluded that there was insufficient evidence to allow the jury to consider any punitive damage award," she says.
Ms. Rosenstock adds that Accutane labeling has contained a warning about IBD for more than 20 years.
"Accutane has been prescribed worldwide for more than 13 million patients," she says. "After 25 years, Accutane is still the only medicine that is effective for severe cystic acne that has not responded to other treatments."
Many dermatologists would agree. Joel Schlessinger, M.D., president of the American Society of Cosmetic Dermatology & Aesthetic Surgery (ASCDAS) and director of Skin Specialists P.C., Omaha, Neb., says he was "amazed" at the verdict in the New Jersey trial.
"It shocks and saddens me to see that this drug that has helped so many people with severe acne is being implicated in this (IBD) condition that can happen at any time to any individual," he says. "Accutane is used over a relatively long period of time -five months, typically - and people can suffer coincidental conditions such as depression or bowel disorders, and, as we see here, it becomes fair game for trial lawyers."
Dr. Schlessinger says the Accutane situation reminds him of the ban and eventual reinstatement of silicone breast implants.