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Boehringer Agrees $650M Settlement in Pradaxa MDL

This is a settlement for the Pradaxa (bleeding deaths) lawsuit.

Newark, NJ: A $650 million settlement deal has been struck by Boehringer Ingelheim International GmbH potentially ending claims in multidistrict litigation that its blood thinner Praxada (dabigatran) caused serious injuries including severe bleeding.

If approved, the settlement will resolve both state and federal personal injury lawsuits. Boehringer said in its statement that it expects the settlement will resolve roughly 4,000 claims over the drug, and noted that the US Food and Drug Administration has reaffirmed the drug's positive benefit-risk profile.

During the past several years the number of Pradaxa lawsuits has increased, with users alleging they experienced bleeding events and other injuries associated with Pradaxa use. Lawsuits began to be filed in March 2012, according to court records, following the publication of a study in the Archives of Internal Medicine which linked Pradaxa with an increased risk of heart attack compared with other anticoagulants.

Boehringer received FDA approval in October 2010 for Pradaxa, to reduce clotting risks in patients with atrial fibrillation, an irregular heartbeat that causes problems with blood flow, that is not caused by a heart valve problem.

The case is In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, case number 3:12-md-02385, in the U.S. District Court for the Southern District of Illinois.

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Published on May-28-14


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