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Roche Holding’s decision to withdraw its acne drug Accutane from the U.S. market may help fuel settlement of the costly mass tort litigation proceeding against the company.

Roche, which is based in Switzerland, faces about 700 personal injury suits from plaintiffs who claim they developed inflammatory bowel disease because of Accutane.

Most of the suits have been consolidated in state court in New Jersey, where Accutane is manufactured by Hoffman-LaRoche, a U.S. subsidiary of Roche.

Withdrawing the drug from the market “enables Roche to gain finality from any ultimate settlement after the statute of limitations has run,” said Elizabeth Chamblee Burch, an assistant professor at Florida State University College of Law and a contributor to the Mass Tort Litigation Blog.

Plus, it “ultimately makes the cases easier to settle,” she said.

The company announced in late June that it has notified the Food and Drug Administration of its intent to immediately discontinue the manufacture and distribution of Accutane, which is used to treat severe acne.

Roche has lost all six Accutane personal injury trials, with damages totaling more than $33 million.

In the most recent trial last November, a New Jersey jury awarded a total of $12.9 to three Florida plaintiffs.

“We’ve been winning without them pulling the drug. But pulling the drug is not going to hurt us any,” commented Michael D. Hook, a partner at Hook, Bolton, Mitchell, Kirkland & McGhee in Pensacola, N.J., who has led plaintiffs’ trial efforts.

The suits accuse Roche of failing to warn doctors and patients – many of them teenagers – about the risks of developing chronic bowel diseases, such as ulcerative colitis and Chron’s disease. Accutane has also been linked to birth defects and depression.

Roche has already removed Accutane from markets in 11 other countries.

“Every jury in every Accutane trial has reached the same conclusion – that Roche failed to warn about the increased risk of inflammatory bowel disease,” said Peter Kaufman, a plaintiffs’ attorney in the Accutane litigation and shareholder in Levin, Papintonio, Thomas, Mitchell, Echsner & Proctor in Pensacola, Fla.

But Roche so far has shown little willingness to settle.

“I’m certainly willing to talk to them, but I haven’t been able to predict their behavior at any point in this litigation,” Hook said.

‘Horrible injuries’

About 13 million people have taken Accutane since it was introduced in 1982. Since its patent expired in 2002, a generic version has pushed its U.S. market share below 5 percent, the manufacturer said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” the statement said.

Burch said the discontinuation of the drug is unlikely to affect Roche’s trial strategy.

“I don’t think it will make the cases harder to defend,” she said. “Plaintiffs still have to prove everything they would have had to prove otherwise, and Roche can chalk up the withdrawal [of the drug] to an overabundance of caution.”

The next trial is scheduled for August in Illinois state court.

Mark Herrmann, a partner in the Chicago office of Jones Day and co-author of the Drug and Device Law blog, noted that action in the Accutane federal multi-district litigation stalled in 2007, when a U.S. District Court judge in Florida granted Roche’s Daubert motion to exclude the plaintiffs’ general causation expert.

“The federal judge says it’s junk science, and the juries in state court award millions of dollars. It’s kind of a head-scratcher,” Herrmann said.

Plaintiffs’ lawyers claim Roche knew of the connection between Accutane and inflammatory bowel disease as far back as 1994, but failed to report the link to the FDA or to change the labeling.

Hook said his clients have suffered “horrible injuries,” many of which require surgeries ranging from partial removal of the intestines to complete removal of the colon.

The company says that it provided adequate warnings, and that the removal of the drug from the market was not for safety reasons.

Questions or comments can be directed to the writer at: nora.tooher@lawyersusaonline.com

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