Just a year and a half after Pradaxa was released as a safe and effective anticoagulant for those dealing with atrial fibrillation, the drug faces FDA safety warnings, hundreds of reports of fatal internal bleeding, and now the first Pradaxa lawsuits by families dealing with loss.
Bloomberg reported recently that the first lawsuits over Pradaxa internal bleeding were filed last month in Louisiana, Tennessee and Kentucky.
The first was filed on March 4 in Tennessee by Bertha Bivens, who claimed that her mother Nancy Brummett died from uncontrollable internal bleeding within months of taking Pradaxa.
Brummett was first given Pradaxa in January of 2011 to prevent blood clots possible with her atrial fibrillation. Within two months, she was in the hospital with massive internal bleeding of the intestines.
According to the lawsuit complaint, doctors were unable to reverse the bleeding caused by the blood thinner. Brummett was discharged to the care of hospice where she died shortly after. She died within three months of the time she first started taking Pradaxa.
In December, the FDA issued a statement that was launching an investigation into the safety of Pradaxa after it received a large amount of adverse reports of injury or death in patients.
German drug maker Boehringer Ingelheim has now admitted that they received at least 260 confirmed reports of death from internal bleeding among Pradaxa users since launching the drug in 2008.
Court records show that Pradaxa lawsuits were also filed last month in Kentucky and Louisiana. Experts expect thousands of people may eventually seek legal help for serious injury or death associated with the drug.