By: Austin Kirk | Published: January 4th, 2013
Lawyers involved in the federal Pradaxa litigation are expected to begin meeting to discuss possible settlement agreements later this year, as the first lawsuits are being prepared for trials that will begin in 2014.
A growing number of individuals throughout the United States have filed a Pradaxa lawsuit against Boehringer Ingelheim, alleging that the drug maker failed to adequately inform users about the risk of serious and potentially life-threatening bleeding side effects of Pradaxa. The complaints also allege that inadequate warnings were provided about the lack of an effective reversal agent to stop hemorrhages that may develop among users of the newer anticoagulant.
In the federal court system, all lawsuits over Pradaxa filed in U.S. District Courts throughout the country have been consolidated for pretrial proceedings before U.S. District Judge David R. Herndon in the Southern District of Illinois.
As part of the pre-trial proceedings, Judge Herndon has established a case management plan where a handful of cases are being prepared for early trial dates, which are expected to go to trial in August 2014.
According to a Unified Case Management Plan (PDF) issued on October 3, Judge Herndon has ordered each side to designate settlement counsel by July 1, 2013. Beginning in August 2013, the parties have been ordered to meet at least one time per month to discuss potential Pradaxa settlement agreements with the assistance of a designated mediator. That would give both sides a year to negotiate before the first Pradaxa bellwether trials begin.
If negotiations to settle Pradaxa lawsuits are unsuccessful, the Judge Herndon has scheduled a series of four “bellwether” trials that will be held between August 2014 and February 2015. These early trial dates are designed to allow the parties to gauge how juries are likely to respond to certain evidence and testimony that will be offered throughout the litigation. The outcome of these test cases may also help move the parties closer to a settlement agreement.
Status of Pradaxa Litigation
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.
At least 120 claims have been filed against Boehringer Ingelheim in the federal court system, with the complaints centralized before Judge Herndon as part of an MDL, or multidistrict litigation.
Such organization is common in complex pharmaceutical litigation involving a large number of claims over injuries associated with the same prescription medication. The cases are being coordinated during pretrial proceedings to reduce duplicative discovery, avoid conflicting pretrial orders from different judges and to serve the convenience of the witnesses, the parties and the courts.
During a status conference held on December 13, the parties reported that discovery and document production is already underway.
The next conference in the Pradaxa MDL is scheduled to be held on January 14, 2013 at 3:00 p.m.