Until 2015, there was no way to reverse uncontrollable bleeding caused by Pradaxa. This resulted in thousands of adverse events and hundreds of fatalities.
Pradaxa (dabigatran) is an anticoagulant (blood thinner) manufactured by the German pharmaceutical company Boehringer Ingelheim. It was approved for use in Europe and Canada before receiving U.S. FDA approval 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 test 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, usually from uncontrollable bleeding.
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).
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.
How Anticoagulants Work
Anticoagulants are designed to prevent blood clots, which can block blood flow to vital organs, sometimes fatally.
Blood clotting is normally a process that aids in healing, but blood clots can also form abnormally within blood vessels, break away, and travel through the bloodstream. They can then become lodged in a blood vessel and block the flow of blood to the lungs and heart, or brain: an event known as a thromboembolism.
Some patients—including those recovering from injury or surgery, and those with certain health conditions—are at an increased risk of blood clot formation and may be prescribed a medication such as Pradaxa to reduce the risk of thromboembolism.
Blood-thinning medications don’t actually thin the blood, nor do they dissolve existing clots. Rather, they prevent clots from forming in the first place. They can also keep clots from getting larger.
Approved Uses for Pradaxa
In the U.S., Pradaxa was first approved as a blood thinner for a-fib patients who are at a greater risk of stroke. Late last year, the FDA also approved Pradaxa to reduce the risk of venous thromboembolism (VTE) in patients who have had knee or hip replacement surgery.
Atrial fibrillation is the most common type of cardiac arrhythmia. It occurs when erratic electrical signals cause the atria (the heart’s upper chambers) to contract quickly and irregularly. Blood doesn’t pump into the lower chambers as it should, so it pools in the atria. A-fib can increase the risk of stroke, which is why patients take blood thinners like Pradaxa.
VTE is a blood clot in a deep vein (often in the leg). It is more common after surgery and in older people, and is responsible for hundreds of thousands of deaths a year.
The danger with any blood thinner, of course, is that it can cause uncontrollable hemorrhaging. Unfortunately for Pradaxa patients, until 2015, there was no antidote to stop these bleeding events.
Bleeding Risks and Adverse Events
In 2011, Pradaxa outnumbered every other drug for adverse events caused by hemorrhage, stroke, and acute renal failure.
Pradaxa is one of the most lethal prescribed drugs in recent memory. In 2011, the year after the FDA approved it, Pradaxa was linked to 542 deaths. According to the Institute for Safe Medication Practices:
The most frequently identified suspect drugs in direct reports to the FDA were the anticoagulants dabigatran (PRADAXA) and warfarin (COUMADIN), showing that inhibiting clotting ranks among the highest risk of all drug treatments.
Pradaxa was the #1 most suspect drug that year, with 817 direct reports to the FDA. It accounted for 3,781 serious adverse events in 2011 and was the leading drug in three different categories: hemorrhage (2,367 cases), stroke (644), and acute renal failure (291). The Institute’s QuarterWatch report concludes:
The 2011 annual results emphasize that anticoagulant drugs used in a vulnerable older population are resulting in thousands of serious injuries and deaths, and these must rank among the highest risk of all outpatient drug therapies. Additional steps to achieve safer use of these drugs—especially dabigatran—should be an important priority.
The following year, two separate studies—one in the Journal of American College of Cardiology, one by the Cleveland Clinic—found that Pradaxa carries an increased risk of heart attack versus warfarin.
While the FDA and Boehringer Ingelheim often countered that Pradaxa was associated with an equal or lower risk of bleeding events as warfarin, neither could deny the key difference that there is an antidote (vitamin K) for hemorrhaging brought on by warfarin. Until 2015, there was no such antidote for Pradaxa. This is what made the drug so disastrous for so many patients, especially the elderly (who are more prone to hemorrhaging).
Dr. Richard H. Schmidt, a surgeon at the University of Utah who witnessed a Pradaxa-related fatality firsthand (an 83-year-old patient), told The New York Times, “The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin [warfarin].”
Pradaxa produced so many catastrophes, in fact, that thousands of patients took legal action against the manufacturer.
Boehringer Ingelheim Settles for $650 Million
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.
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 a major bleeding event.
That means that for nearly a year and a half (from May 2014 to October 2015), Pradaxa patients did not recover any damages from Boehringer Ingelheim but still had no antidote for hemorrhages.
If you were not a part of the 2014 Pradaxa settlement, and you were taking 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.
If you or a loved one have suffered a major bleeding event or death after taking Pradaxa, contact us for a free, no-obligation case review. Don’t wait; these cases are time-sensitive, and you could be entitled to compensation.