Lawsuit Filed Over Pradaxa Gastrointestinal Bleeding Death

A wrongful death lawsuit has been filed by a Tennessee man, who alleges that his mother died from gastrointestinal bleeding caused by Pradaxa, adding to the growing number of cases filed by individuals throughout the United States over the relatively new anticoagulant that was introduced by Boehringer Ingelheim in 2010. 

The complaint (PDF) was filed in the U.S. District Court for the Western District of Tennessee on August 8, by James Lunsford, whose mother, Imojean Lunsford, died in April 2011.

According to the lawsuit, Imojean Lunsford was prescribed Pradaxa in December 2010, shortly after it was approved in the United States for prevention of strokes among individuals with atrial fibrillation.

Lunsford was hospitalized for gastrointestinal bleeding on March 29, 2011, which was allegedly caused by Pradaxa. Although the bleeding was diagnosed, doctors were unable to control it. She received dialysis treatment to remove Pradaxa from her blood, but doctors were unable to reverse the effects of Pradaxa, and she died on April 7, 2011.

Pradaxa Gastrointestinal Bleeding Was Fatal Due to Lack of Reversal Agent

Pradaxa (dabigitran) was introduced by Boehringer Ingelheim as a superior alternative to Coumadin, known generically as warfarin. However, unlike the older anticoagulant, Pradaxa has no reversal agent or antidote to reverse the effects of the drug when severe bleeding events occur.

The lawsuit alleges that Boehringer Ingelheim failed to provide sufficient warnings about the risk of bleeding and the lack of a reversal agent. Lunsford and her physicians were unaware and could not have reasonably learned that the use of Pradaxa would expose her to a risk of excessive and uncontrollable bleeding, according to the complaint.

James Lunsford indicates that had Boehringer Ingelheim provided adequate warnings that there is no agent to reverse the Pradaxa side effects, Imojean Lunsford never would have used the newer medication instead of warfarin/Coumadin.

Similar allegations have been raised in several dozen Pradaxa lawsuits filed by individuals throughout the United States who have suffered gastrointestinal bleeding or wrongful death from Pradaxa.

Pradaxa Litigation Consolidated in MDL

Lunsford’s case will soon be transferred to the recently established Pradaxa MDL, or multidistrict litigation, where it will be coordinated with all other lawsuits filed in the federal court system.

According to an order issued last week by the U.S. Judicial Panel on Multidistrict Litigation, all federal cases will be centralized in the U.S. District Court for the Southern District of Illinois, before Judge David R. Herndon.

While there are currently about 50 cases pending in the federal Pradaxa litigation, the number of lawsuit is expected to continue to grow in the coming weeks, as the organization and structure of the MDL is established.

Judge Herndon will preside over all pretrial proceedings, as well as any bellwether trials that may be scheduled to assist the parties in gauging how juries are likely to react to certain evidence and testimony that may be offered in multiple cases. However, if an agreement to settle the Pradaxa cases is not be reached during the MDL proceedings, the cases may be remanded back to the U.S. District Courts where they were originally filed for individual trials.