Bid to Dismiss Pradaxa Bleeding Lawsuits Rejected

A federal judge in Illinois has denied Boehringer Ingelheim Pharmaceuticals motion to dismiss Pradaxa bleeding lawsuits.  The decision by Judge David Herndon in U.S. District Court, Southern District of Illinois, comes as Pradaxa plaintiffs throughout the country wait to hear if such lawsuits will be consolidated in one federal jurisdiction.

According to a report from The Madison Record, Judge Herndon is overseeing 17 Pradaxa lawsuits that allege the blood thinner caused uncontrollable internal bleeding.  Boehringer had filed a motion to dismiss claims on various grounds, including an assertion that some of the plaintiffs failed to connect their allegations to their alleged injuries.  The drug maker’s motion argued that the “alleged injury of ‘uncontrollable’ bleeding cannot support any claim for relief because the plaintiff is not still bleeding.”  In denying that assertion, Judge Herndon wrote that the company’s “overly literal interpretation of the term ‘uncontrollable’ is not well taken,” according to The Madison Record.

Boehringer also sought to have plaintiffs 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 in rejecting that argument, Herndon wrote that Boehringer was presuming “that the inadequacies or deficiencies being alleged by the plaintiff 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.”

According to the Madison Record, a total of 27 Pradaxa bleeding lawsuits are pending in various federal jurisdictions, inclusive of the claims before Judge Herndon.  As we reported previously, the U.S. Judicial Panel on Multidistrict Litigation heard oral arguments regarding a potential Pradaxa consolidation on July 26.  A decision is expected any day now.

Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation.  It was meant to replace decades-old warfarin, which requires regular blood monitoring or frequent doctor follow-up.  However, serious internal bleeding is still a known side effect of the drug, and there is no known antidote for Pradaxa bleeding.  Warfarin bleeding, on the other hand, can be stopped via the administration of vitamin K.

In December, the FDA launched a review of Pradaxa over reports of bleeding-related side effects, while regulators in Europe and Japan have directed Boehringer Ingelheim to strengthen warnings for the drug. Most recently, European regulators asked Boehringer Ingelheim to update the Pradaxa label with additional information regarding its bleeding side effects.

According to the latest QuarterWatch report from the Institute for Safe Medicine Practices, adverse event reports for Pradaxa surpassed those for all other drugs monitored by the FDA in 2011.  That year, Pradaxa was cited in 3,781 adverse event reports, including 541 deaths, 2,367 reports of hemorrhage, 291 reports of kidney failure and 644 reports of stroke.  Pradaxa was also a suspect in more than 15 cases of liver failure reported to the FDA.

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