As the Pradaxa bleeding litigation movement continues, more and more evidence is being uncovered that supports the allegations of product liability against the drug’s manufacturer Boehringer Ingelheim Pharmaceuticals. These Pradaxa bleeding lawsuits allege that the manufacturing company knew about the risk of uncontrollable internal bleeding associated with their anticoagulant, but deliberately concealed it from Pradaxa patients.

To add to the mounting pile of evidence against Pradaxa, an April 2015 study conducted by the researchers of Johns Hopkins Bloomberg School of Public Health and George Washington University, published in the British Medical Journal, examined the risks of internal bleeding when using new generation blood thinners like Pradaxa. The study examined over 46,000 patients who were categorized by which anticoagulant they were prescribed: Pradaxa, Xarelto, and Warfarin. This research was conducted for several months in 2012.

The purpose of the study was meant to examine the risks of internal bleeding with new-generation anticoagulants, and compare the severity of the risk with Warfarin, one of the oldest anticoagulants on the market. Ultimately, the study found that Pradaxa and Xarelto carried a high risk of bleeding incidents when compared to Wafarin. The researchers are concluded that the risks of new anticoagulants like Pradaxa outweighed their potential benefits.

The results of this anticoagulant study are similar to other inquiries regarding new-generation anticoagulants and their likelihood to cause internal bleeding. At this point, Boehringer Ingelheim has not apologized for the bleeding incidents in its consumers, but acknowledges that a Pradaxa bleeding antidote is needed. At this point, Pradaxa’s manufacturing company is in the process of getting a reversal agent approved, which was recently granted priority review status by the FDA.

Overview of Pradaxa Bleeding Complications

Ever since Pradaxa was approved in 2010, the blood thinning medication has been at the center of major attention and controversy in the medical community. It was the first medication to be approved for blood-thinning purposes since Warfarin, and has since received both major success and public scrutiny. While it did very well and surpassed Warfarin in popularity, Pradaxa has caused its manufacturing company to face numerous Pradaxa lawsuits on account of uncontrollable internal bleeding incidents.

At the time of its release, Pradaxa was thought to be superior because it showed a greater aptitude in preventing strokes. Considering how new Pradaxa was to the market, it was quite a successful marketing feat for Boehringer Ingelheim. The drug remained at the top of the anticoagulant market until a little after the release of Xarelto.

By May 2014, however, Pradaxa’s manufacturer had settled more than 4,000 Pradaxa bleeding lawsuits for a staggering $650 million. Boehringer’s move to break into the anticoagulant market was bold and was meant to be a lucrative venture, so it was no surprise that the risk was just as tremendous as the payoff. According to medical experts, more than 500 deaths were reportedly caused from Pradaxa due to uncontrollable bleeding.

According to court records, medical experts explained that unlike Warfain, Pradaxa lacked a reversal agent in the case of uncontrollable internal bleeding. For Warfarin patients, all they need to do so apply vitamin K. Furthermore, Warfarin patients were also required to frequently see their doctors and undergo frequent dose adjustments. Pradaxa’s popularity soared because it lacked the dose adjustments and checkup requirements, and reportedly worked more efficiently than Warfarin.

Many experts agree that if Pradaxa patients had to adhere to the same requirements as those on Warfarin, then many Pradaxa internal bleeding events would have been avoided. The information of internal bleeding came too late for many Pradaxa patients who may have suffered these adverse effects.