A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects may be irreversible.
The Plaintiff, a resident of Greenville County, Tennessee, is being represented by the national law firm of Parker Waichman LLP. According to his lawsuit, the Plaintiff was prescribed Pradaxa on or about February 22, 2011 and continued using the drug until approximately April 23, 2011. On or about April 23, 2011, he suffered a cerebral hemorrhage, as well as other severe personal injuries which, according to the lawsuit, are permanent and lasting in nature. As a result of Pradaxa, the Plaintiff alleges he has suffered physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications, and fear of developing additional health consequences.
As we’ve reported previously, Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in October 2010 and is one of a number of new blood thinners that have been positioned as a superior alternative to warfarin, an anti-coagulant that has been marketed for decades. Both warfarin and Pradaxa pose a risk of serious bleeding, a side effect associated with most blood thinners. However, warfarin bleeding can be stopped with the administration of vitamin K or a drug called recombinant factor VIIa. There is currently no practical antidote for Pradaxa bleeding.
According to a press release issued by Parker Waichman LLP, Pradaxa levels in the blood are difficult or impossible to assess and bleeds cannot be stopped since there is no known reversal antidote for this dangerous drug. The lawsuit alleges that the Defendants concealed their knowledge that Pradaxa can cause life threatening, irreversible bleeds from the Plaintiff, other consumers, the general public, and the medical community. Among other things, Defendants did not warn of the irreversible nature of Pradaxa in the “Warnings and Precautions” section of the products initial warning label, according to the lawsuit.
Last year, Boehringer Ingelheim, acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. Just last month, the Institute for Safe Medicine Practices (ISMP) reported that Pradaxa was associated with a total 856 reports of serious, disabling or fatal injury, including 117 bleeding deaths, in the second quarter of 2011. In its previous QuarterWatch report, the ISMP had found that more than 500 cases of serious Pradaxa bleeding had been reported to the FDA in the first quarter of 2011.
The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects, while regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.