Pradaxa Lawsuits Centralized in Federal MDL

August 8, 2012 — The U.S. Judicial Panel on Multidistrict Litigation (JPML) has assigned Pradaxa litigation into one federal court, before Judge David Herndon, in the Southern District of Illinois. The order will centralize 21 Pradaxa lawsuits pending in 11 district courts throughout the U.S. These lawsuits and any Pradaxa lawsuits filed in the future will be transferred to Judge Herndon’s Illinois court.

The order was filed on August 8, 2012.

The parties all supported the formation of a Pradaxa MDL, but they disagreed about where the MDL should be located. The only party that did not support the Illinois venue as their first or second choice was defendant Boehringer Ingelheim, which preferred Connecticut because that is where the U.S. division of the German company is headquartered.

The JPMDL decided on the Illinois venue for several reasons. One was that Southern Illinois is central in the U.S., and the Pradaxa litigation is spread throughout the nation. Another reason is that there is already a Pradaxa lawsuit pending in state court involving at least 70 plaintiffs, and the choice of Illinois will facilitate the transfer of this matter to federal court.

Another major reason is that Judge Herndon has experience handing another large pharmaceutical products liability litigation — he is currently presiding over the Yaz and Yasmin litigation involving at least 12,000 lawsuits. Those lawsuits are settling at a rapid pace.

Multidistrict Litigations (MDLs) are usually formed to litigate major nationwide product liability lawsuits for drugs or medical devices. Centralizing the litigation increases efficiency, reduces costs, conserves court resources, reduces the risk of duplicative discovery and conflicting rulings in lower courts.

Pradaxa (dabigatran etexilate) is a medication created by Boehringer Ingelheim. It was approved in 2010 to reduce the risk of stroke in people with atrial fibrillation, which is a type of irregular heart rhythm that can cause blood clots to form inside the heart. Pradaxa is a blood-thinner, and the first major competitor to Coumadin (warfarin), a blood-thinner that has been used for decades. When Pradaxa was first sold, it was advertised as superior to warfarin because Pradaxa is easier to use — Pradaxa is a once-daily pill, whereas warfarin require blood tests to adjust dosage. Unfortunately, the blood-thinning effects of Pradaxa cannot be easily reversed (warfarin can be reversed with a dose of Vitamin K). A patient who starts bleeding may require 2-3 hours of dialysis to remove Pradaxa. By the time dialysis takes effect, serious bleeding injury may occur.

In 2011, Pradaxa was associated with 542 deaths and 2,367 adverse event reports. Warfarin, in comparison, was associated with 72 deaths and 1,106 adverse event reports.

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