The prescription drug Pradaxa (dabigatran) has been prescribed to more than a million patients since the Food and Drug Administration (FDA) approved its entry into the market in 2010. It is a blood thinner designed to treat patients who suffer from a condition called atrial fibrillation, and it’s meant to prevent stroke by thinning the blood. The drug was the first entry into a new category of anticoagulants, or blood thinners, and it was marketed as a safer replacement for the market leader, warfarin, which had been around for more than 55 years at the time.
Within its first two years on the market, the manufacturer of Pradaxa, Boehringer Ingelheim (BI) saw more than $1 billion in revenue from Pradaxa, and more than 725,000 patients in the U.S. were prescribed the drug. Unfortunately, thousands of these patients have experienced negative health problems since then, including many who have experienced excessive and uncontrollable internal bleeding and hemorrhagic strokes, as well as a number of fatal incidents involving brain, rectal and gastrointestinal bleeding.
As early as 2011, the FDA felt it necessary to issue a safety warning after they fielded nearly 3,800 adverse event reports from people who had taken Pradaxa, and there were 542 fatalities associated with the use of the drug. At the time, the agency noted that Pradaxa use had resulted in the highest number of both adverse events and deaths of the nearly 800 drugs the agency monitors regularly.
Pradaxa Lawsuits: Then and Now
Since then, a large number of lawsuits were filed, culminating in a May 2014 settlement, in which Boehringer Ingelheim settled more than 4,000 claims against it for $650 million. Our lawyers handled over 100 of these cases. As part of the settlement, the drug maker admitted no fault, and even doubled down. The company has apparently decided that lawsuits are just a part of doing business, because they continue to market the drug the same way they did before.
According to Boehringer Ingelheim, Pradaxa’s benefits far outweigh its negative side effects and they continue to cite a report released by the FDA in 2012 in which the agency concluded that the bleeding risk for Pradaxa was no higher than that for warfarin. What the company fails to mention, however, is a key problem; while there are several antidotes available to stop excessive bleeding when it occurs while using warfarin, there is no such antidote available when excessive bleeding occurs using Pradaxa.
In other words, despite such a large settlement, Boehringer Ingelheim has not changed course and they continue to market the drug as they did before. They do contend that they are working on an antidote, but in the meantime, they continue to spend hundreds of millions of dollars on marketing, and to claim that Pradaxa is safer and more effective than warfarin.
Because of this, it’s time to work on claims for another lawsuit against Boehringer Ingelheim.
Contact the Praxada Injury Lawyers of Raizner Slania
If you have been prescribed and taken Pradaxa and have suffered any side effects, especially excessive bleeding, please contact the Pradaxa Lawsuit Lawyers at Raizner Slania, so we can work to get the drug company and the FDA to pay attention and do something about this.