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A Connecticut jury has determined that Boehringer Ingelheim should pay more than half a million dollars in compensatory damages to a New York man who suffered a severe bleeding injury from Pradaxa, and that additional punitive damages should be awarded to punish the drug maker for failing to adequately warn consumers and the medical community about the risks associated with the controversial anticoagulant.
The verdict was handed down on Friday, in a Pradaxa lawsuit filed by Eugene Roberto, including $42,645 for past medical expenses and $500,000 for non-economic damages, such as pain and suffering. The court will now determine the amount of punitive damages during an upcoming hearing, which may be up to two times the amount of the compensatory damages award.
After using Pradaxa, Roberto indicated that he suffered a life-threatening upper gastrointestinal bleeding event on January 30, 2014. As a result of the bleeding injury, he was hospitalized for 10 days and underwent months of recovery.
Roberto had a 40-year history of gastroesophageal reflux disease (GERD), which his lawsuit indicated put him at a higher risk of bleeding events when taking Pradaxa. However, the lawsuit claimed the manufacturer failed to warn users and the medical community that GERD placed patients at an increased risk of bleeding problems.
The trial lasted from April 30 to May 17 in Harford Superior Court in Connecticut, where about 3,000 similar Pradaxa lawsuits are currently pending and awaiting trial.
Pradaxa was the first member of a new generation of anticoagulants released in recent years, which did not have a safe and effective reversal agent when first introduced, leaving many doctors helpless to control or stop bleeding problems that develop among users.
Boehringer Ingelheim has promoted Pradaxa as a superior alternatives to warfarin, which has been the go-to treatment for blood clots for decades among individuals with atrial fibrillation. However, the blood thinning effects of warfarin can be quickly reversed with a dose of vitamin K and fresh frozen plasma.
Although the drug maker previously reached an Pradaxa settlement agreement in 2014, which resolved thousands of claims pending at that time, Boehringer Ingelheim has failed to settle the claims currently pending in Connecticut and taken a series of claims to trial.
This verdict is the second loss for the drug maker, after a prior jury awarded $1.25 million in a wrongful death lawsuit last year that went to trial in West Virginia.
CORRECTION: An earlier version of this article indicated that the jury was still determining whether to award punitive damages. However, the jury already determined that punitive damages are warranted, and the court will award those damages in an amount up to two times the compensatory damages following an upcoming hearing.