Roche Holding AG, the world’s biggest maker of cancer drugs, has pulled its Accutane acne medicine from the U.S. market. The withdrawal comes 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 on June 26th, saying it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors.
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.
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. 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.
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%, according to the company.
So far every jury in every Accutane trial has reached the same conclusion and that is Roche failed to warn about the increased risk of inflammatory bowel disease. The next trial is scheduled for August in Illinois state court.
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. The company says that it provided adequate warnings, and that the removal of the drug from the market was not for safety reasons.
The drug also has been pulled off the market in 11 other countries including France, Denmark, Austria, Germany, Portugal, Norway and Spain. Roche claims Accutane’s safety wasn’t a factor in the decision to pull it off the U.S. market. Roche says it “stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA.” 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.
Sources: Bloomberg and Lawyers USA