Boehringer Ingelheim Supports Centralization of Pradaxa Lawsuits

In response to a request filed by plaintiffs to centralize all federal Pradaxa lawsuits, which involve claims brought by former users of the anticoagulant who suffered uncontrolled bleeding, Boehringer Ingelheim has filed a response indicating that the drug maker supports centralizing the cases before one judge for coordinated pretrial litigation.

Last month, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) calling for the centralization of all Pradaxa cases filed in federal courts throughout the United States.

At least 21 complaints involving bleeding problems with Pradaxa have been filed against Boehringer Ingelheim in U.S. District Courts across the country, all involving similar allegations that the drug maker failed to adequately research their medication, warn about the risk of severe bleeding events or provide sufficient information about the lack of a reversal agent to reverse the blood thinning effects of the drug.

Pradaxa (dabigitran) was introduced by Boehringer Ingelheim in October 2010, as a superior alternative to Coumadin (warfarin) for prevention of stroke among patients with atrial fibrillation.  However, unlike warfarin, where bleeding problems can be reversed with a dose of vitamin K, no such antidote is available for users of Pradaxa who start to bleed.

During the first full year that the medications was available in the United States, there were more reports of Pradaxa bleeding problems than were associated with any other medication, including the more widely used warfarin.

According to a report issued last month by the Institute for Safe Medication Practices (ISMP), the FDA received at least 2,367 reports of hemorrhage and 542 patient deaths involving Pradaxa during 2011.  By comparison, warfarin was linked to 1,106 adverse event reports and 72 patient deaths.

Dispute Over Where Pradaxa Lawsuit MDL Should Be Centralized

The original petition to consolidate the Pradaxa lawsuits was filed on May 30, by plaintiff Vera Lee Sellers, calling for the cases to be transferred to U.S. District Judge David R. Herndon in the Southern District of Illinois, who most recently presided over the federal Yaz and Yasmin birth control litigation.

In a response (PDF) filed by Boehringer Ingelheim on June 21, the drug maker indicated that it supports centralizing the cases before one judge for coordinated pretrial proceedings to reduce duplicative discovery, eliminate conflicting pretrial rulings from different judges and to serve the convenience of the parties, the witnesses and the courts. However, the manufacturer disagrees about where the cases should be sent.

Boehringer Ingelheim has recommended that the Pradaxa litigation be centralized in the District of Connecticut, which is where the drug maker’s corporate headquarters are based, and where most of the relevant documents, witnesses and parties common to all cases are located.

The U.S. JPML has scheduled oral arguments on the formation of the Pradaxa MDL for July 26, at a hearing to be held at the Carl B. Stokes U.S. Courthouse in Cleveland, Ohio.

Consolidation of cases as part of an MDL is common in complex pharmaceutical litigation, where a large number of cases are brought involving similar allegations of facts. Although the cases in an MDL would be handled in a coordinated manner, which many people equate with a class action, each lawsuit remains an individual case. 

In the event that a Pradaxa settlement or other resolution for the litigation is not reached during pretrial proceedings, the claims would be remanded back to the federal district court where they were originally filed for individual trial date.