Multaq Lawsuit Filed Over Failure to Warn About Liver Injury Risks

Sanofi-Aventis faces a product liability lawsuit filed by multiple plaintiffs, which alleges that the drug maker withheld information about the risk of serious liver injury associated with side effects of Multaq. 

The complaint (PDF) was filed in the U.S. District Court for the Middle District of North Carolina on January 25, by Ruth Amanda Hardin and Michael Clay, both of North Carolina, Eric Biggs of Pennsylvania, Virginia Roberts of Oklahoma, and by Mary Jo Meyer of Indiana, who brought a claim on behalf of herself and the estate of James Meyer.

Hardin, Biggs, and James Meyer suffered serious drug-induced liver injuries due to the use of Multaq. Clay suffered liver damage, heart failure and other cardiovascular problems.

Multaq (dronedarone) is a prescription treatment for abnormal heart rhythms, which was introduced by Sanofi-Aventis in July 2009.

In January 2011, the FDA required new warnings about the potential risk of liver failure or liver injury from Multaq, indicating that at least two patients on Multaq suffered acute liver failure that required them to get a liver transplant.

In December 2011, the FDA issued another Multaq safety warning, advising that the drug should not be used in patients whose abnormal heart rhythms were permanent. It also required the manufacturer, Merck & Co., to add additional safety warnings and contraindications to the label.

“Plaintiffs allege that Defendants had an established duty to warn of the dangers of using Multaq. Defendants knew or should have known of the dangers generally known to the scientific community at the time they manufactured and distributed Multaq,” the lawsuit filed this week indicates. “Defendants failed to provide warning of the dangers of using Multaq, specifically failing to warn Plaintiffs and their physicians regarding known dangers including the danger of life-threatening liver and cardiovascular injuries.”

The complaint presents claims against the drug maker for failure to warn, designing a defective drug, negligence, and breach of warranty, seeking both compensatory and punitive damages.