Initial Conference Scheduled in Federal Pradaxa MDL

Lawyers involved in the federal Pradaxa lawsuits are scheduled to meet for the first time with the judge recently appointed to preside over the litigation, with an initial status conference set for early next month in the MDL (multidistrict litigation).

On August 8, the U.S. Judicial Panel on Multidistrict Litigation established a Pradaxa MDL for product liability lawsuits filed in U.S. District Courts throughout the country on behalf of individuals who allege they suffered severe and uncontrollable bleeding from Pradaxa side effects.

All of the complaints involve similar allegations that the manufacturer of Pradaxa, Boehringer Ingelheim, failed to adequately warn consumers or the medical community about the risk of bleeding with the medication and the lack of an effective reversal agent to quickly stop the blood thinning effects.

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The Pradaxa cases have been centralized before Judge David R. Herndon in the Southern District of Illinois, for coordinated pretrial proceedings. While there were 21 lawsuits pending in 11 different federal district courts at the time the MDL was established, there are now nearly 80 cases that have been transferred to the Southern District of Illinois and new complaints continue to be filed by Pradaxa lawyers who are reviewing potential cases for individuals throughout the country.

Pradaxa Trial Dates May Begin in 18 to 24 Months

According to the first Case Management Order (PDF), which was issued by Judge Herndon on August 17, an initial conference has been scheduled for October 3, 2012 at 1:30 p.m.

It is expected that the various attorneys involved in the litigation will discuss the organization and structure of the Pradaxa MDL with the Court, including a timetable for moving the cases forward, preserving discoverable information and other issues that may arise during the pre-trial process.

Judge Herndon has indicated that he wants the conference to result in a unified case management plan agreed upon by all counsel, and that he intends to move the litigation forward expeditiously.

“It is clear that whether the number of plaintiffs remain static or increase, the allegations that have been made are quite serious,” wrote Judge Herndon in the August 17 Order. “The plaintiffs and potential plaintiffs will benefit from an expeditious resolution to the factual allegations made in this case, whether the plaintiffs’ allegations are proven or disproven.”

If the cases survive dispositive pre-trial motions, Judge Herndon has indicated that it is the goal of the Court to hold the first Pradaxa trial in approximately 18 to 24 months after the date of the first conference.

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 was 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.

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.

Judge Herndon will preside over all pretrial proceedings in the federal litigation, as well as any bellwether trials that may be scheduled in the MDL.  However, if a Pradaxa settlement agreement or other resolution for the litigation is not reached in all cases, individual lawsuits may be remanded back to the federal districts where they were originally filed for trial dates if necessary.


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