MDL Panel to Consider Centralizing Lawsuits over Pradaxa on July 26

A panel of federal judges will hear oral arguments next month to consider whether all lawsuits over Pradaxa, which are filed in U.S. District Courts throughout the country, should be consolidated and centralized before one judge for pretrial proceedings.

According to a scheduling order (PDF) issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML), a motion to consolidate the Pradaxa litigation will be considered on July 26, during a hearing to be held at the Carl B. Stokes U.S. Courthouse in Cleveland, Ohio.

There are currently at least 21 complaints involving Pradaxa, which are filed in 11 different federal district courts against Boehringer Ingelheim, the manufacturer of the relatively new anticoagulant. However, it is expected that hundreds, if not thousands, of cases will ultimately be filed in the coming months.

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All of the lawsuits involve similar allegations, that the drug maker failed to adequately research risk of uncontrollable bleeding from Pradaxa or warn consumers and the medical community about the lack of a reversal agent for the anticoagulant.

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 bleeding problems with Pradaxa 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.

The request to centralize the lawsuits over Pradaxa was filed on May 30, by plaintiff Vera Lee Sellers, who indicated that the litigation should be transferred to U.S. District Judge David R. Herndon in the Southern District of Illinois for coordinated pretrial proceedings. At least eight of the cases filed so far have been brought in that district.

According to a briefing schedule issued last month, responses from Boehringer Ingelheim or any other interested parties are not due until June 21. Therefore, it is not clear whether the drug maker will support the consolidation of the cases, or what judge it will propose to preside over the litigation.

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. Coordinated handling during pretrial proceedings is designed to reduce duplicative discovery, avoid inconsistent pretrial rulings from different judges and to serve the convenience of the parties, the witnesses and the courts.

Following the July hearing, the U.S. JPML will decide whether an MDL is appropriate for the Pradaxa cases and determine the most convenient location for the litigation to be centralized. If a Pradaxa MDL is formed, all currently filed cases and all future cases will be transferred to the selected U.S. District Court.

Although the cases in an MDL are 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.


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