On Wednesday, Boehringer Ingelheim announced that it would pay $650 million to settle claims that the company failed to provide adequate warnings for its blood-thinner Pradaxa, which could allegedly cause patients to suffer life-threatening complications in the case of a bleeding emergency.
In a press release, Boehringer Ingelheim said that it hopes the settlement will resolve approximately 4,000 federal and state lawsuits involving Pradaxa.
Pradaxa was approved for use in 2010 and was marketed as a superior alternative to the anticoagulant warfarin because it did not require patients to undergo frequent blood tests or restrict their diets. While warfarin’s blood-thinning effects can be reversed using vitamin K, Pradaxa’s are irreversible because Boehringer Ingelheim has not yet produced an antidote for its medication.
In 2011, the FDA announced that it would investigate the safety of Pradaxa after receiving numerous post-market reports of serious bleeding events in Pradaxa users, and, in 2012, researchers found that patients using Pradaxa were at a 33 percent increased chance of suffering a heart attack compared to those using warfarin. Soon after the publication of that study, patients began filing lawsuits against Boehringer Ingelheim.
In these lawsuits, the plaintiffs alleged that patients were unaware of the serious risk of irreversible bleeding with Pradaxa and that doctors did not have adequate means to stop the bleeding during an emergency. As a result, the plaintiffs claim that they suffered internal bleeding in the brain, gastrointestinal tract, kidneys and other organs. Some allege that they lost a loved one who used Pradaxa after a bleeding complication could not be controlled.