Roche Wins Reversal Of $7M Accutane Verdict

By Christine Caulfield

Law360, New York (October 27, 2009) -- Hoffmann-La Roche Inc. has won the reversal of a $7 million jury verdict in favor of a man who claimed he developed inflammatory bowel disease after taking the drugmaker's acne medication Accutane.

A Florida appeals court issued a per curiam order overturning the award on Tuesday, saying plaintiff Adam Mason had presented no evidence at his trial to support the claim that Accutane's deficient warning label was the proximate cause of his disease.

The Nutley, N.J.-based unit of Swiss pharmaceutical giant Roche Holding AG appealed the verdict to the Florida District Court of Appeal, First District, after a state trial court refused its motion for a directed verdict during the October 2007 trial.

The trial was the first of six cases over Accutane to have gone before a jury. All six have resulted in verdicts against Hoffmann-La Roche, which still faces more than 600 state court cases and multidistrict litigation in federal court.

Mason was awarded $7,028,294 in compensatory damages by a jury in Florida's Escambia County Court, which found that Hoffmann-La Roche had put Accutane on the market without adequately warning consumers or physicians of the risk of IBD and that the failure to warn had substantially contributed to Mason's developing the disease.

In finding that the trial court erred in denying a directed verdict, the appeals court said this week that Mason had proved neither that Accutane's warning label was inadequate nor that the inadequacy of the warning proximately caused his injury, and should not have prevailed at trial.

“Because [Mason] presented no evidence from either treating physician that a differently worded warning would have resulted in either physician not prescribing Accutane for his extreme acne, [Mason] failed to establish that the allegedly deficient warning was the proximate cause of his injury,” the appeals court said.

The appeals court noted that Mason's treating physician had testified that the label was sufficient to warn him of the link between Accutane and IBD and that he had made an informed decision to prescribe the drug despite the risk.

“Any inadequacies in Accutane's warning label could not have been the proximate cause of [Mason's] injury,” the appeals court said.

Mason's lawyer Michael Hook, of Hook & Bolton PA, said Tuesday the decision was disappointing but that he and his client would “continue to pursue all of our appellate rights.” Mason can seek a rehearing before the same appeals court panel.

Hoffmann-La Roche said in a statement Tuesday the company was pleased with the verdict.

"The court of appeal ruled that Roche could not be held liable because the plaintiff's prescribing physician understood Roche's warning labeling and would have prescribed Accutane to the plaintiff, given his medical needs, even with a different warning," the company said.

Accutane's labeling has included a warning about IBD for more than 20 years, but there is no reliable scientific evidence that the acne drug causes the condition, the company said.

In May 2007, a New Jersey jury awarded an Alabama man $2.5 million, and an additional $119,000 in damages for past medical expenses, after finding against Hoffmann-La Roche in the second Accutane trial.

In April 2008, the company lost its third trial when another New Jersey jury awarded $10.5 million to an Accutane user — the largest award so far.

Mason is represented by Levin Papantonio Thomas Mitchell Echsner & Proctor PA, Hook & Bolton PA and Beggs & Lane RLLP.

Hoffmann-La Roche is represented by Covington & Burling LLP, Greenberg Traurig LLP, Moore Hill & Westmoreland PA and Shook Hardy & Bacon LLP.

The case is Hoffmann-La Roche Inc. et al. v. Adam W. Mason, case number 1D08-2032, in the District Court of Appeal, First District, State of Florida.