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Pradaxa Bleeding Lawsuits May be Heading for MDL

Jul 16, 2012 | Parker Waichman LLP

Word on whether Pradaxa bleeding lawsuits will be consolidated in a multidistrict litigation should come later this month or early.   According to a report from The Madison Record, the Judicial Panel on Multidistrict Litigation will hold a hearing July 26 on a motion to consolidate the Pradaxa lawsuits and transfer them to a single federal jurisdiction.

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.

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.  Regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

In June, Institute for Safe Medicine Practices (ISMP), that the FDA had received 3,781 adverse event reports associated with Pradaxa in 2011, more than were associated with any other drug the agency monitors. Pradaxa also led in reports of deaths (541), hemorrhage (2,367), kidney failure (291) and stroke (644), according to ISMP's most recent QuarterWatch report.  Pradaxa was also a suspect in 15 reports of liver injury made to the FDA. 

Just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts in Illinois, in Connecticut, Florida, Kentucky, Louisiana, Oklahoma and Tennessee.  All allege Pradaxa caused users to suffer severe, sometimes fatal internal bleeding, and accuse Boehringer Ingelheim Pharmaceuticals, Inc. of failing to properly warn users of the risks associated with Pradaxa.

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