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A federal judge has rejected a motion for summary judgment filed by Boehringer Ingelheim, in what is expected to be the first case to go to trial over the side effects of Pradaxa, which allegedly caused the bleeding death of a Massachusetts doctor.
A wrongful death lawsuit filed by the family of Dr. Zhensheng Liu is set to be ready for trial to begin in the U.S. District Court for the District of Massachusetts by December 5, after Boehringer Ingelheim failed to resolve the case as part of a $650 million agreement reached in 2014, which settled thousands of similar Pradaxa lawsuits.
At one time, Boehringer Ingelheim faced more than 4,000 product liability lawsuits alleging that individuals suffered severe and fatal bleeding events while using their new-generation anticoagulant Pradaxa (dabigatran), which was introduced in October 2010 as a superior alternative to warfarin.
While the decades-old anticoagulant warfarin has a known and effective reversal agent, allowing doctors to control and stop bleeds that may occur during use, Pradaxa was introduced without an approved antidote, leaving many doctors helpless to treat bleeding patients who were prescribed the new anticoagulant.
The lawsuit filed by Dr. Liu’s family and other plaintiffs presented claims alleging that Boehinger Ingelheim failed to adequately warn consumers or the medical community about the bleeding risk and lack of a reversal agent, as well as claims for negligent design defect and negligent testing of Pradaxa.
Following several years of consolidated proceedings in a federal multidistrict litigation (MDL), Boehringer Ingelheim reached a Pradaxa settlement agreement that resolved most cases in 2014. However, the Pradaxa wrongful death lawsuit filed by Dr. Liu’s children was not settled, and the case was one of the first remanded back to the district court where it was originally filed for an individual trial date.
During a scheduling conference shortly after the case was transferred back to the District of Massachusetts, U.S. District Judge William Young ordered that the case be ready for trial to begin the first week of December 2016. However, Boehinger Ingelheim filed a motion for summary judgment, seeking to dismiss the claims before it reached a jury.
In an order (PDF) issued this week, Judge Young granted the motion to dismiss claims involving negligent design defects and negligent testing of Pradaxa, but rejected the request to dismiss the primary claims for negligent failure to warn. As a result, the case remains on track to be the first Pradaxa trial to go before a jury in the United States.
The case presents a factual pattern similar to what has been experienced by other users of the Pradaxa and similar new-generation anticoagulants, indicating that Dr. Liu died in 2012, after experiencing a fatal brain bleed allegedly caused by the atrial fibrillation anticoagulant.
While entering his car on Thanksgiving day, Dr. Liu suffered what his family describes as a “modest fall and head injury.” However, Dr. Liu experienced an uncontrollable brain bleed that ultimately resulted in his death days later, due to the lack of a safe and effective reversal agent.
Since the drug hit the market in October 2010, as the first member of a new class of anticoagulants known as factor XA inhibitors, a large number of Pradaxa bleeding problems began to emerge, where doctors indicated that they were unable to stop or reverse hemorrhaging or other bleeds.
Similar issues have also been seen with other members of this new generation of drugs, which also include the blockbuster medications Xarelto (rivaroxaban) and Eliquis (apixaban).