Pradaxa Litigation Centralized in MDL in Southern District of Illinois

A panel of federal judges has ordered that all Pradaxa lawsuits filed in federal district courts throughout the United States will be consolidated before one judge for coordinated pre-trial proceedings as part of an MDL, or multidistrict litigation. 

Earlier today, the U.S. Judicial Panel on Multidistrict Litigation issued an order (PDF) centralizing the Pradaxa litigation before U.S. District Judge David R. Herndon in the Southern District of Illinois.

There are 21 currently pending lawsuits pending in 11 different district courts that will be transferred to the Pradaxa MDL. However, the Panel noted that there are at least another 19 lawsuits that will be transferred to the MDL shortly. In addition, as Pradaxa lawyers throughout the country file new cases in federal district courts, they will also be transferred to the Southern District of Illinois for pretrial proceedings.

Lawsuits Over Pradaxa Bleeding Problems

All of the complaints involved in the Pradaxa litigation involve similar claims filed on behalf of individuals who suffered uncontrollable bleeding after taking the drug. Plaintiffs allege that Boehringer Ingelheim, the manufacturer, failed to provide adequate warning about the risk of Pradaxa side effects and the lack of an effective reversal agent to stop bleeding problems that may develop.

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.

Pradaxa Litigation Already Moving Forward Before Judge Herndon

At least 17 of the currently pending lawsuits over bleeding problems with Pradaxa were already pending before Judge Herndon in the Southern District of Illinois, representing about half of the cases filed nationwide. While the U.S. JPML considered the consolidation of the litigation, Judge Herndon denied a request filed by Boehringer Ingelheim to stay the proceedings in his court, therefore those cases have continued to move forward in recent months.

In response to several early lawsuits filed, Boehringer Ingelheim filed a Motion to Dismiss pursuant to Federal Rule 12(b)(6), arguing that the lawsuits should be dismissed because of Pradaxa warnings that indicated the medication may pose a risk of fatal bleeding events.

On July 25, Judge Herndon denied this request in several cases, pointing out that the Pradaxa litigation also involves claims that the drug maker failed to adequately inform users or the medical community about the lack of a reversal agent and that there is an alleged increased risk of excessive or uncontrollable bleeding with Pradaxa.

Boehringer Ingelheim had opposed the centralization of the Pradaxa litigation before Judge Herndon in the Southern District of Illinois, citing the large MDL over Yaz and Yasmin birth control that is currently pending in his court.

However, the U.S. JPML was persuaded by several plaintiffs that the Southern District of Illinois was the most appropriate transferee district for the litigation, pointing out that centralization in this district will also facilitated coordination with pending state court litigation, including at least one Pradaxa lawsuit filed in Illinois state court by over 70 plaintiffs. The MDL Panel also pointed to Judge Herndon’s experience and handling of the Yasmin and Yaz litigation as further support for centralizing this litigation in his court.

Judge Herndon will preside over all pretrial proceedings 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.