Since its FDA approval in 2010, the blood thinner Pradaxa (dabigatran) has been linked to thousands of adverse events and over 1,000 fatalities. These injuries and fatalities spawned thousands of lawsuits. In August 2012, roughly 4,000 claims filed by Pradaxa patients were consolidated into a multidistrict litigation (MDL).
In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle all of its 4,000 lawsuits. (Eighteen months prior, in October 2012, the company had paid $95 million to the U.S. government to settle a whistleblower case over its off-label marketing of several drugs.)
But it wasn’t until October 2015 that the FDA approved an antibody called Praxbind (idarucizumab), which has been shown to reverse the anticoagulation effects of Pradaxa – which could save a patient’s life during the kind of irreversible bleeding that proved fatal to so many patients.
That means that for nearly a year and a half (May 2014-October 2015), Pradaxa patients did not recover any damages from the drug maker but still had no antidote for the drug’s hemorrhages.
If you were not a part of the 2014 settlement, and you took Pradaxa before Praxbind hit the market last fall, you could be entitled to compensation for damages.
Pradaxa (dabigatran) is an anticoagulant (blood thinner) manufactured by the German pharmaceutical company Boehringer Ingelheim. The FDA approved Pradaxa for the prevention of strokes in atrial fibrillation (a-fib) patients in October 2010.
Prior to Pradaxa’s approval (and later, Xarelto’s), warfarin had cornered the market on blood thinners for 60 years. But unlike warfarin, Pradaxa does not require rigid blood monitoring. By 2012, roughly 725,000 U.S. patients had taken Pradaxa.
Unfortunately, until 2015, there was no way to reverse a severe bleeding event brought about by Pradaxa. (Warfarin-related events could be stopped by vitamin K.) This resulted in thousands of adverse events and hundreds of fatalities from uncontrollable bleeding.
By February 2014, Pradaxa had been linked to more than 1,000 deaths. That May, Boehringer Ingelheim agreed to pay $650 million to settle all of its 4,000 lawsuits. (Eighteen months prior, in October 2012, the company had paid $95 million to the U.S. government to settle a whistleblower case over its off-label marketing of several drugs.)
In July 2014, the British Medical Journal (BMJ) published a report alleging that Boehringer Ingelheim withheld crucial data that showed monitoring Pradaxa patients’ plasma levels could improve the safety of the drug.
Finally, in October 2015, the FDA approved an antibody called Praxbind (idarucizumab) that has been shown to quickly reverse the anticoagulation effects of Pradaxa – which could save a patient’s life during a major bleeding event.
In November 2015, the FDA expanded Pradaxa’s approved uses to include the prevention of venous thromboembolism (VTE) in patients who have just had knee or hip replacement surgery.
Learn more about Pradaxa on our product page.
History of Pradaxa Litigation
As early as 2010, Pradaxa patients were already starting to file wrongful death and personal injury lawsuits against the manufacturer. In August 2012, roughly 4,000 claims filed by Pradaxa patients were consolidated into a multidistrict litigation (MDL).
By February 2014, Pradaxa had been linked to more than 1,000 deaths. That May, facing mounting pressure from plaintiffs, health experts, and the media, Boehringer Ingelheim agreed to pay $650 million to settle all of its 4,000 lawsuits.
There have not been any known settlements since that time, so it’s unclear how much compensation a plaintiff in 2016 might receive. But the biggest problem with Pradaxa was its lack of an antidote for bleeding events, and that didn’t change until Praxbind hit the market in Fall 2015.
For that reason, a patient who suffered serious hemorrhaging or other Pradaxa-related injury between May 2014 and October 2015 should have as valid a case as any member of that $650 million settlement (provided they were not part of that settlement, of course).
Recently, a similar lawsuit involving Xarelto patients was consolidated into a multidistrict litigation (MDL) in Louisiana federal court. More than 4,000 separate claims are contained in the Xarelto MDL. The first trials are scheduled to begin in early 2017, and could prove a bellwether for new Pradaxa cases.
Lawsuit Eligibility and Compensation
If you were not a part of the 2014 Pradaxa settlement, and you or a loved one were injured by the drug before Praxbind hit the market last fall, you could be entitled to compensation for damages. These monetary awards can cover the following:
- Pain and suffering
- Medical bills
- Lost wages and other financial losses
- Funeral expenses in the event of a loved one’s death
After more than a thousand Pradaxa-related casualties, it is shocking that neither Boehringer Ingelheim nor the FDA ever took Pradaxa off the market. Pradaxa’s antidote was several years overdue, and hundreds of people died as a result.
Morgan & Morgan Can Help
At Morgan & Morgan, our expert legal team helps people injured by pharmaceuticals hold drug companies accountable for their dangerous and defective medications. We have decades of experience handling these cases and know how to get victims the compensation they deserve.
We have helped more than 200,000 clients win $2 billion in settlements and awards—and we only collect a fee if we resolve your case successfully.
If you or a loved one suffered a major bleeding event after taking Pradaxa, you may be entitled to compensation for mental anguish, medical expenses, and other damages. To find out if you may be eligible for compensation, please contact us today.