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An anti-coagulate, or blood thinner, Pradaxa was approved by the FDA in 2010 for patients with irregular heartbeats, or atrial fibrillation. The drug replaced Warfarin and, in marketing, claimed the patient needed to go to fewer checkups and not have as restrictive of a diet.
While advertisements characterized it as an improvement over previous medications, Pradaxa has been attributed to severe bleeding, including gastrointestinal and cerebral hemorrhaging. Hospitalization becomes required even for a seemingly-minor fall, and since its introduction, 542 deaths have occurred as a result of usage.
As lawsuits have been filed and increased through 2013, this case is expected to be one of the largest mass tort claims in the United States.
For patients taking Pradaxa, falls and minor trauma may lead to extreme bleeding, which has been known to occur simultaneously with the injury. Elderly patients have a greater risk, because of their blood vessels and minimal subcutaneous fat. However, even those who go off Pradaxa remain at risk.
Unlike for other blood thinners, an antidote does not exist for Pradaxa, and doctors handling a hemorrhage related to the medication have been unable to stop the blood. In some cases, medical professionals have claimed a patient could have been saved if it weren’t for this particular blood thinner.
One solution has been emergency dialysis, but the procedure is not practical for all patients and must be completed in a limited time frame.
Previously, doctors could have given a patient on an older blood thinner a dose of Vitamin K, fresh frozen plasma, or prothrombin complex concentrates to reverse the anti-clotting effects.
Before introducing the drug to the market, manufacturer Boehringer Ingelheim did not properly warn medical and emergency personnel about the lack of antidote. In turn, patients given this medication were not informed that an antidote in case of emergency does not exist, and that using Pradaxa may possibly lead to permanent disability, lifelong treatment, or even death.
As of December 2013, 1,936 lawsuits concerning Pradaxa’s harmful effects were filed at state and federal levels. Plaintiffs allege the manufacturer provided insufficient warning about bleeding risks and offered no guidance when severe bleeding develops. As a result of the long-term, life-altering conditions and significant number of deaths attributed to this blood thinner, plaintiffs have sought out compensation for decreased wages, medical bills, pain and suffering, and funeral expenses.