Pradaxa is a direct thrombin inhibitor, which is used to reduce the risk of stroke and embolism in patients with non-valvular atrial fibrillation. It was approved by the FDA in October 2010, and was the first anticoagulation drug to be introduced in the United States in more than 50 years.
There have been numerous cases filed in many jurisdictions that allege that Pradaxa causes uncontrolled and excessive bleeding inpatients taking the drug. These lawsuits also allege that the manufacturer of the drug (Boehringer Ingelheim) failed to warn physicians of the lack of an effective means of reversing Pradaxa’s anticoagulative effect.
On May 30, 2012, a motion was filed before the Judicial Panel on Multidistrict Litigation to create a coordinated MDL docket for all federal personal injury and wrongful death cases involving the drug Pradaxa. The motion seeks the transfer of nearly a dozen pending cases as well as all future claims to a centralized docket and suggests that the Southern District of Illinois in East St. Louis may be the best venue for establishment of an MDL, since Judge Herndon has more Pradaxa cases pending before him than any other federal judge in the country and has significant experience in handling multi-district litigation.
The law firm of Searcy Denney represents one of the Pradaxa victims from Southern Illinois whose case is pending before Judge Herndon. Brenda Fulmer attended a status conference before Judge Herndon on July 16, 2012, that included attorneys on behalf of all of the plaintiffs with pending lawsuits as well as counsel for Boehringer. This first Pradaxa hearing covered a number of critical first-steps in the national Pradaxa litigation efforts, including confidentiality and protective orders, the placement of a “litigation hold” by the defense, potential foreign defendants, briefing on a number of issues relating to jurisdiction, and the protocol for the production of paper and electronic discovery (which should begin by late August or early September).
Nearly 275,000 prescriptions were written for Pradaxa between the date of its FDA approval and March 2011. During this time period, the FDA received 932 reports of serious adverse events associated with use of the drug. Among the reported events were 120 deaths and 500 reports of severe, life-threatening bleeding. As of December 31, 2011, the FDA received more than 500 reports of U.S. deaths linked to Pradaxa. Adverse event reports have continued to climb in early 2012. The lawyers of Searcy Denney have been active in the Pradaxa litigation on behalf of clients nationwide and continue to accept new clients who have suffered catastrophic injuries or died due to Pradaxa-induced GI bleeds, intracranial hemorrhages, and other serious bleeding incidents.