Roche Pulls Accutane Off Market After Jury Verdicts

Bloomberg, June 26, 2009


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By Jef Feeley and Sophia Pearson

June 26 (Bloomberg) -- Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

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

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

In April, Basel, Switzerland-based Roche announced first- quarter sales rose 7 percent to 11.6 billion Swiss francs ($10.1 billion) from 10.9 billion francs a year earlier. Roche completed its $46.8 billion purchase of partner Genentech Inc. in March, gaining access to cancer drugs such as Avastin and Rituxan.

5,000 Cases

The company faces as many as 5,000 personal-injury claims over Accutane, said Michael Hook, a Pensacola, Florida-based attorney. He won a $10.5 million verdict against the drugmaker over the medicine in April 2008. He noted that Roche has lost six cases that have gone to trial over the drug.

“We’ve been winning the cases with the drug still on the market, but this move certainly isn’t going to hurt us going forward,” Hook said in an interview today.

Some Accutane users allege the drugmaker failed to properly warn them the medicine could cause inflammatory bowel disease. The drug also has been linked to birth defects and depression.

Lawyers for John Mullarkey, a 20-year-old Monroeville, Pennsylvania, man facing murder charges over the death of his 16-year-old cheerleader girlfriend, said he was suffering from an Accutane-fueled depression when the killing occurred, the Pittsburgh Tribune-Review newspaper reported today.

Shelley Rosenstock, a spokeswoman for Roche’s Nutley, New Jersey-based U.S. unit, said in an e-mailed statement that the company doesn’t break out Accutane sales.

Other Countries

The drug also has been pulled off the market in 11 other countries including France, Denmark, Austria, Germany, Portugal, Norway and Spain, Rosenstock said. She couldn’t provide dates for those withdrawals.

Rosenstock said Accutane’s safety wasn’t a factor in the decision to yank it off the U.S. market.

“Roche stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA,” she said in the statement.

In November, a state-court jury in New Jersey found company officials didn’t properly warn doctors about Accutane’s health risks and awarded three men a total of $12.9 million in damages.

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at; Sophia Pearson in Wilmington, Delaware, at

Last Updated: June 26, 2009 17:46 EDT