Pradaxa Internal Bleeding Lawsuit - Consumer Drug Report
Pradaxa® lawsuit filed for wrongful death

A wrongful death lawsuit has been filed against Boehringer Ingelheim, the manufacturer of Pradaxa. According to the lawsuit brought by Bertha Bivens, daughter to Nancy Brummett, Pradaxa caused her mother to die after suffering a gastrointestinal bleed. The lawsuit was filed in the U.S. District Court for the Eastern Court of Tennessee.

Bivens claims that her mother was prescribed Pradaxa in January of 2011 for the treatment of atrial fibrillation and in two months she suffered from gastrointestinal bleeding, one of the side effects of Pradaxa. Nancy Brummet died three months after first taking Pradaxa.

Pradaxa (dabigatran) was introduced to the United States and approved by the Food and Drug Administration in October 2010 for the treatment of atrial fibrillation; two years after the European Commission approved it. It is included in a class of drugs referred to as direct thrombin inhibitors that work by preventing the enzyme which causes blood cells to clot from functioning.

Shortly after the FDA approved Pradaxa use, numerous reports were filed with the agency claiming that Pradaxa causes adverse side effects. Internal bleeding, gastrointestinal bleeding, heart attack, brain hemorrhaging, and death have all been reported thus far.

Atrial fibrillation is a condition that occurs when part of the heart does not beat the way it should, causing blood clots to form. A blood clot can be very dangerous and may pose the risk for stroke if it travels to the brain or even a pulmonary embolism if it travels to the lungs. Pradaxa is a blood thinning medication which breaks up blood clot formulation.

No recall has been issued on Pradaxa, however as of November 2011, a startling 260 deaths, primarily caused by internal bleeding, have been reported as a result of Pradaxa use. The FDA is currently investigating the large number of reported internal bleeding deaths. Some argue that newer blood thinning medications such as Pradaxa fail to contain a reversing agent to stop internal bleeding incidents from escalating. Internal bleeding caused by older blood thinners like warfarin could be reversed by simply taking Vitamin K.

The Pradaxa lawsuit filed by Bertha Bivens may be the first lawsuit filed in the U.S., however, the number of lawsuits filed may grow as attorneys continue to investigate claims brought forth by injured victims.

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