Boehringer Ingelheim’s $600 million settlement over bleeding risks with its blood thinner Pradaxa may offer a blueprint to the hundreds of people suing Johnson & Johnson’s Janssen Pharmaceuticals and Bayer over similar side effects with its anticoagulant Xarelto.
Pradaxa and Xarelto belong to the same class of blood thinners. Pradaxa was the first to hit the market in 2010, followed by Xarelto a year later. Both Pradaxa and Xarelto are used to prevent strokes in patients with the common heart irregularity atrial fibrillation, and to prevent or treat deep vein thrombosis and pulmonary embolism. Xarelto is also used to prevent blood clots in patients who have recently undergone hip or knee replacement surgery.
The new class of drugs offered the first alternative to the long-used warfarin. The newer meds were an attractive option because they carried fewer food or drug restrictions than warfarin. They also were as effective as warfarin but carried the same bleeding risks. Unlike warfarin, there were no antidotes to reverse the blood thinning effects of the drug in the event of a bleeding emergency.
Last fall, the FDA finally approved a reversal agent for Pradaxa. A similar agent for Xarelto is currently being reviewed. But before the antidote became available, thousands of patients were suffering from gastrointestinal bleeds, brain bleeds and bleeding deaths. As the first agent to hit the market, Pradaxa was the first to face lawsuits over bleeding risks. In May 2014, Boehringer Ingelheim agreed to pay $600,000 to settle hundreds of lawsuits.
Xarelto sales surged as Pradaxa sales suffered. It is now the top selling blood thinner in its class. But the drug is now the subject of similar bleeding side effects lawsuits. About 770 Xarelto lawsuits have been filed in Philadelphia’s Complex Litigation Center, and more are expected to be added to the mass tort program in the months and years to come. Legal experts say they don’t expect the first bellwether trial until at least summer of 2017.