Pradaxa Lawsuit Trials Scheduled To Begin in August 2014

Trial dates have been scheduled to begin less than three years after the first Pradaxa lawsuit was filed in the federal court system, with a recent scheduling order indicating that “bellwether” trials in the federal Pradaxa MDL will begin in August 2014.

At least 120 product liability lawsuits have been filed against Boehringer Ingelheim in U.S. District Courts throughout the United States since the first reported Pradaxa complaint was brought in March 2012.

The cases were just recently consolidated for pretrial proceedings before U.S. District Judge David R. Herndon in August 2012, as part of an MDL or multi-district litigation.

The Pradaxa litigation has been centralized in the Southern District of Illinois to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the Court.

Shortly after the MDL was formed, Judge Herndon issued a Case Management Order indicating that he intended to move the Pradaxa litigation toward an “expeditious resolution to the factual allegations made”, which would benefit both plaintiffs and the drug maker.

Based on a Unified Case Management Plan (PDF) issued on October 3, it appears that Judge Herndon is following through with his promise, establishing a “bellwether” trial program involving four Pradaxa suits scheduled to begin approximately six weeks apart starting on August 11, 2014.

Common Allegations Raised in Pradaxa Suits

Pradaxa (dabigitran) is an anticoagulant that was introduced by Boehringer Ingelheim in October 2010 for prevention of strokes in patients with atrial fibrillation.

The medication has been promoted as a superior alternative to warfarin (Coumadin), because it is easier to take and requires less monitoring.  However, if bleeding problems develop on warfarin, patients can be given vitamin K to quickly stop the bleeding, but no such antidote is available to stop Pradaxa bleeding.

All of the complaints included in the federal MDL involve similar allegations that Boehringer Ingelheim failed to adequately warn consumers or the medical community about the risk of bleeding from Pradaxa side effects or provide information about the lack of an effective reversal agent to quickly stop the blood thinning effects.

According to a report issued earlier this year by the Institute for Safe Medication Practices (ISMP), which analyzed all adverse event reports submitted to the FDA during 2011, there were 2,367 reports of bleeding problems with Pradaxa, as well as 542 reports of death among Pradaxa users.  By comparison, warfarin was linked to 1,106 adverse event reports, including 72 patient deaths.

Early Trial Dates May Lead Towards Pradaxa Settlement

Judge Herndon has established a plan that will result in the preparation of a small group of cases for early trial dates, with the fist trial scheduled to begin on August 11, 2014. A state court case in Connecticut is currently scheduled to begin on September 22, 2014. Those first two trials will be followed by three more federal cases in the MDL, with additional trial dates set to begin on November 3, 2014, January 5, 2015 and February 16, 2015.

The parties have been directed to submit a proposed Order to Judge Herndon by March 2013, identifying the process and parameters for selecting plaintiffs that will be prepared for these early trial dates.

According to the order, Plaintiffs and Defendants will each identify 12 bellwether candidates by May 15, 2013. Those lawsuits will then undergo case-specific discovery and the court will select four cases for the first federal trial dates by November 15, 2013.

Known as “bellwether” cases, such early trial dates are often used to allow the parties to gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation. During the preparations for the cases, or following the first verdicts, the parties may reach an agreement to settle Pradaxa other cases in the litigation.

Following the Pradaxa bellwether trials, if a settlement or other resolution for the lawsuits is not reached, Judge Herndon may begin remanding cases back to the U.S. District Courts where they were originally filed for individual trial dates.