Boehringer Ingelheim Pharmaceuticals has lost a bid to have Pradaxa lawsuits filed in Illinois federal court dismissed. Currently 17 Pradaxa lawsuits alleging the blood thinner caused uncontrollable bleeding are pending in U.S. District Court, Southern District of Illinois. Additional claims are pending in other federal districts, bringing the total to 27.
Alleged Pradaxa bleeding victims from around the U.S. began filing lawsuits shortly after the U.S. Food & Drug Administration (FDA) warned in December of reports of bleeding-related side effects. Pradaxa was introduced in October 2010, and has become popular due to perceptions that it is easier to use than decades-old blood thinner warfarin.
Pradaxa does not require frequent laboratory tests to adjust the dose—as is the case with warfarin—and it has fewer drug interactions. However, while warfarin bleeding can be stopped with the administration of vitamin K, there is no readily available antidote for Pradaxa bleeding.
Boehringer had filed a motion to dismiss claims in the Southern District of Illinois, arguing among other things that plaintiffs failed to connect their allegation of uncontrollable bleeding to their injuries “because the plaintiff is not still bleeding.”
Boehringer also sought to have plaintiff’s claims that it failed to warn about the drug’s risks
In denying that assertion, Judge Herndon wrote that the company’s “overly literal interpretation of the term ‘uncontrollable’ is not well taken.” Boehringer also sought to have plaintiff’s claims that it failed to warn about the drug’s risks dismissed, arguing Pradaxa has always included a warning about the risk of “serious and sometimes fatal bleeding.”
But Judge Herndon wrote that the company was presuming the plaintiff’s claims are “premised on failure to warn about the risk of serious or fatal bleeding and nothing more.” Instead, the plaintiffs have argued that Boehringer “failed to warn that, if a serious bleeding event occurs, there is no effective means for reversing the anticoagulation effects of Pradaxa,” he pointed out.
On July 26, the Judicial Panel on Multidistrict Litigation heard oral arguments on a motion to consolidate the Pradaxa lawsuits and transfer them to a single federal jurisdiction. A decision from the Panel is expected any day.