German drugmaker settles for US$650 mil. over blood thinner's safety
By Jim Suhr , AP
May 30, 2014, 12:09 am TWN
EAST ST.LOUIS, Illinois--German drugmaker Boehringer Ingelheim said Wednesday it has agreed to pay US$650 million to settle thousands of U.S. claims questioning the marketing and safety of its popular blood thinner Pradaxa.
The company said the settlement, filed in federal court in East St. Louis, resolves roughly 4,000 claims, paying out an average of $162,500 per case.
The drug, known chemically as dabigatran, was approved in October 2010 by the U.S. Food and Drug Administration as a treatment to reduce the stroke risk in patients with irregular heartbeats, or atrial fibrillation. Pradaxa works by stopping the enzyme involved in blood clotting.
But the plaintiffs had argued the company didn't adequately warn Pradaxa users of the risks, including severe or in many cases fatal bleeding blamed on the anticoagulant. Unlike other blood-thinning medications, those behind the lawsuits said, there is no known reversal agent or antidote for Pradaxa, an alternative to decades-old warfarin.
Boehringer Ingelheim, based in Ingelheim, Germany, stands "resolutely" behind Pradaxa "and believed from the outset that the plaintiffs' claims lacked any merit," the company's global general counsel said in a statement.
"Time and again the benefits and safety of Pradaxa have been confirmed in many clinical trials and in real-world data analyses," Andreas Neumann added. "This settlement does not change the facts about Pradaxa or its importance to patients."
But Neumann said the deal eliminates the distraction and uncertainty of possibly years of litigation in the U.S. court system.
"Furthermore, we have to consider that juries composed of lay people have to decide about very difficult scientific matters," Neumann said. "All this does not allow reliable predictions for the outcome of a huge number of individual trials, and that is why we came to the tough decision to settle."
Roger Denton, one of the plaintiffs' attorneys, said the settlement was "an outstanding result and is in the best interests of our clients who have suffered serious injuries after using Pradaxa."
Last October, Boehringer Ingelheim filed for additional marketing approvals for Pradaxa as a possible treatment for deep vein thrombosis and pulmonary embolism. A deep vein thrombosis is blood clot in a deep vein, usually in the leg or pelvis, that partly or completely blocks blood flow. A pulmonary embolism occurs when one of those blood clots travels to the lungs. That can create a life-threatening blockage.