The German manufacturers of the popular anticoagulant Pradaxa have been fiend nearly $1 million and ordered to pay for overseas expenses of lawyers pursuing thousands of Pradaxa bleeding lawsuits.
Such sanctions are unusual but the U.S. District Court judge overseeing pre-trial evidence gathering on behalf of victims in these cases said he found that company officials and lawyers committed “egregious” wrongs.
The judge found defendants Boehringer Ingelheim International and Boehringer Ingelheim Pharmaceuticals, the manufacturer of Pradaxa, may have prejudiced the attempts by the victims in the cases to prove their cases in a multi-district litigation in the U.S. District Court for the District of Southern Illinois.
“The wrongs here are egregious in the eyes of the Court,” wrote Chief Judge David R. Herndon in his March 13, 2014 order.
“As herein before provided, there may be more orders yet to come; orders which take actions designed to determine what aspects of the plaintiffs’ case have been prejudiced or even so damaged as to interfere with their ability to prove what they legally have to prove and for the facts of this case to come out. Going forward, based on the findings heretofore, pursuant to the Court’s inherent powers, and to encourage defendants to respect this Court and comply with its orders, the Court fines both defendants, jointly and severally, $931,500.00 ($500.00 per case).”
The safety of Pradaxa, which millions of patients take as a blood-thinner, has been called into question by allegations in these and other lawsuits and from records of the U.S. Food and Drug Administration.
An independent, non-profit organization monitoring medical safety on Oct. 17, 2013 posted figures that showed that the FDA received more reports about side effects about Pradaxa than any other drug the FDA monitors.
The Institute for Safe Medical Practices in its QuarterWatch said that 3,292 reports warning of adverse events, including 582 deaths, were filed over Pradaxa (dabigatran) in 2012.
“For a second straight year, dabigatran and warfarin are the most frequently named suspect drugs in direct reports to the FDA.,” the authors of the report wrote.
“QuarterWatch has reported on the risks of anticoagulants previously and judged them to be one of the most dangerous of all outpatient drug treatments. The same property that allows anticoagulants to reduce the risk of strokes and blood clots elsewhere in the body leads to high risks for hemorrhage and other bleeding. The result is tens of thousands of emergency room visits or hospitalizations each year.”
In another Pradaxa warning, the recently published findings of a trial that was conducted to determine whether Pradaxa (dabigatran) is an effective alternative to warfarin in patients with atrial fibrillation was terminated because of a high number of bleeding incidents attributed to Pradaxa.
The results of the study were published in the Sept. 1, 2013 edition of the New England Journal of Medicine and involved hundreds of patients with mechanical heart valves who were tested in comparisons of the two popular anticoagulants.
The anticoagulant trial was terminated prematurely after the enrollment of 252 patients because of an excess of thromboembolic and bleeding events among patients in the dabigatran group, according to the published findings.