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Despite Growing Pradaxa Litigation, No Sign of a Pradaxa Recall

Pradaxa litigation continues to grow as more patients who have suffered bleeding from the anticoagulant file lawsuits against Boehringer Ingelheim Pharmaceuticals, the drug’s manufacturer. But despite the lawsuits, there has been no announcement of a recall.

Bleeding risk from Pradaxa

Pradaxa was approved by the FDA in October 2010. The drug is a blood-thinner used to prevent strokes in patients with atrial fibrillation. At the time, it was marketed as a convenient alternative to Coumadin (warfarin), another anticoagulant, because patients on Pradaxa do not need to follow a restricted diet or frequently monitor their blood levels, as patients on warfarin do.

However, both drugs carry a risk of bleeding, and bleeding from Pradaxa has no known antidote, whereas bleeding from warfarin can be stopped by administering Vitamin K. Bleeding from Pradaxa can occur in the brain, intestines, or internal organs.

Reports filed with the FDA reveal that from October 2010 through March 2011, there were 272,119 patients who were prescribed Pradaxa. Out of that number, there were 932 adverse event reports, which included 500 cases of life-threatening bleeding and 117 deaths.

Pradaxa MDL

On August 8, 2012, the Judicial Panel on Multidistrict Litigation established a Pradaxa MDL in the U.S. District Court, Southern District of Illinois (East S. Louis) to consolidate lawsuits claiming injuries from the anticoagulant. By the end of August, there were nearly 80 lawsuits in the MDL. The MDL is being overseen by Chief Judge David R. Herndon.

One lawsuit recently added to the MDL was filed by plaintiff Roselyn Hay. Her lawsuit was transferred to the MDL on September 4, 2012. According to her complaint, Hay was hospitalized for four days because of complications of bleeding from Pradaxa. She alleges that Boehringer Ingelheim failed to warn patients about the drug’s risks.

The purpose of an MDL is to consolidate lawsuits that cite similar evidence and make similar claims. In an MDL, cases share pretrial proceedings and the discovery process, but each lawsuit remains separate and individual: each plaintiff’s is able to argue his or her own individual case and receive his or her own individual verdist. This differs from a class action lawsuit, in which the claims of all plaintiffs in a class are combined into one single lawsuit, and the verdict of that single lawsuit applies to all the plaintiffs. In a class action lawsuit, any damages awarded are divided among the plaintiffs according to predetermined criteria.

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