Attorneys Seek Leadership Roles in Pradaxa Litigation, As Stay Issued

The federal judge presiding over the recently consolidated Pradaxa litigation has issued a stay on all motions pending in individual cases, as attorneys representing plaintiffs seek leadership positions in the MDL (multidistrict litigation) and the structure of the proceedings are established.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered last month that all pending Pradaxa lawsuits filed throughout the federal court system will be consolidated for pretrial proceedings before U.S. District Judge David R. Herndon in the Southern District of Illinois.

Cases from throughout the country have been transferred to Judge Herndon’s court. While all of the lawsuits remain in the early stages of litigation, individual motions were already pending in many of the cases at the time they were transferred to the MDL.

According to a docket entry on September 12, Judge Herndon has issued a staying for all pending motions, including any deadlines for responsive pleadings, until further notice.

“Presently, a number of motions are pending that may raise questions common to these consolidated proceedings,” wrote Judge Herndon in a Minute Order. “In the interest of fair and efficient resolution of this litigation, the Court finds that it is necessary to issue a stay pending a determination by the Court regarding the relationship between pending motions and matters common to these consolidated proceedings.”

Pradaxa Attorneys Seeking Leadership Roles in MDL

The stay also allows the court to establish the leadership structure and organization for the Pradaxa MDL before considering any motions and responses that may affect multiple cases in the litigation.

In recent weeks, a number of attorneys have been applying for leadership roles in the MDL, including the positions of Lead Counsel, Liaison Counsel and membership on a Plaintiffs’ Steering Committee, which will perform certain tasks during the discovery and pretrial proceedings that benefit all individuals who have filed a lawsuit. This would include coordinating responses and arguments on any motions that have been filed.

According to the first Case Management Order (PDF) issued on August 17, Judge Herndon set a deadline of September 21 for applications to be submitted to the Court. To promote a candid and open discussion, Judge Herndon has indicated that the applications are being submitted in confidentiality and will not be made part of the public record.

An initial conference is scheduled for October 3, after which it is expected that Judge Herndon will issue an Order establishing the leadership structure of the MDL and a case management plan for moving the litigation forward.

Pradaxa Litigation Continues to Grow

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 involve similar allegations that Boehringer Ingelheim failed to adequately warn consumers or the medical community about the risk of bleeding from side effects of Pradaxa 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.

At the time the U.S. JPML decided to consolidate the Pradaxa lawsuits before Judge Herndon, there were only 21 lawsuits pending in 11 federal district courts. However, by the beginning of this month, the number of cases transferred to the Southern District of Illinois had already reached 80 and new complaints continue to be filed by Pradaxa lawyers, which will be transferred to Judge Herndon’s court for coordinated pretrial proceedings if they are brought in the federal court system.