Pradaxa is a prescription blood thinner manufactured by Boehringer Ingelheim and is designed to aid in the prevention of strokes and blood clots in patients with atrial fibrillation (AF). Pradaxa is also commonly used in patients with pulmonary embolism and blood clotting in the leg veins. Though there are other blood thinners on the market such as Warfarin, Pradaxa has been marketed as having fewer side effects and requiring less maintenance.
Pradaxa was approved by the FDA in 2010 for the prevention of strokes and blood clots in patients with AF. Unfortunately, after being on the market for a while, serious side effects of Pradaxa began to surface. After less than a year, the FDA had received reports of over 800 adverse events that were associated with the use of Pradaxa. The most serious side effect reported was uncontrollable bleeding, which actually caused the death of a number of patients.
In 2011 the FDA issued a safety announcement stating that they believed the dangerous side effects (serious bleeding) are outweighed by the benefits of Pradaxa. In 2012, the FDA issued a subsequent safety announcement noting that they also believed the bleeding rates of Pradaxa are no higher than bleeding rates associated with the use of Warfarin. The FDA noted that the high number of adverse event reports was a result of Pradaxa being new with relatively unknown side effects.
The difference between Pradaxa and Warfarin, however, is that Warfarin has an antidote to stop serious bleeding in the form of Vitamin K. Unlike Warfarin, there was no antidote for serious bleeding caused by Pradaxa until recently. In October 2015, Praxbind (a reversal agent manufactured by Boehringer) was approved through the FDA’s accelerated approval program and allows doctors to reverse the blood thinning effects of Pradaxa in cases of emergency.
As a result of being blamed for over 500 deaths as a result of uncontrollable bleeding, more than 4,000 lawsuits were filed against Boehringer. The lawsuits were alleging that Boehringer failed to warn doctors and patients of the potential for serious bleeding events. Many of the plaintiffs that filed suits suffered gastrointestinal bleeds caused by Pradaxa.
In May of 2014, just before the first Pradaxa trial was to be heard, Boehringer settled all the pending cases against it for a total of $650 million. This allowed every plaintiff an average of $162,000 for their injuries. In their settlement, Boehringer did not admit any wrongdoing and continued to stand behind Pradaxa.
Unfortunately for Boehringer, they might not be completely finished with Pradaxa litigation. The second wave of plaintiffs has now come forward, and they are choosing not to participate in the settlement. These new plaintiffs will be pursuing claims on a case by case basis, and there will probably be a much smaller total number of plaintiffs due to the 2014 settlement.
Pradaxa claims can still be filed against Boehringer, and it is unclear at this point whether or not they will also settle the new claims or choose to litigate.