Pradaxa Stroke Hemorrhage Lawsuits on Track

The U.S. JPML heard oral arguments on the formation of the Pradaxa MDL on July 26, at a hearing at the Carl B. Stokes U.S. Courthouse in Cleveland, Ohio.

What is an MDL?

Consolidation or grouping of injury 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. The cases in an MDL would be handled in a coordinated manner and each lawsuit remains an individual case.

In the event that a Pradaxa settlement 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.

MDL Approval and Transfer Process

Multidistrict litigation occurs when enough lawsuits are filed against the same defendant for similar injuries. When this happens, a request is made to the Judicial Panel on Multidistrict Litigation (JPML) for the cases to be grouped into an MDL proceeding, and court location. Once an MDL is approved, federal courts with cases will transfer their cases automatically to the MDL court before one judge who will manage all cases as one case.

This coordinated mechanism 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.

What is Pradaxa?

Pradaxa (dabigitran) was introduced by Boehringer Ingelheim in October 2010, as a superior alternative to Coumadin (warfarin) for prevention of stroke among patients with non valvular atrial fibrillation. Warfarin bleeding problems can be reversed with vitamin K. Pradaxa has no antidote for users of Pradaxa who start to bleed.

Pradaxa Bleeding Problems

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.

From October 2010 through August 2011 about 1.1 million prescriptions were dispensed in the U.S. and about 371,000 patients received the prescriptions from U.S. outpatient retail pharmacies.

Pradaxa MDL Consolidation

48 Pradaxa side effects lawsuits had been filed in federal courts across the United States. 18 cases are in the United States District Court for the Southern District of Illinois, East Saint Louis Division.

In addition to the Southern District of Illinois, other parties argued for the Northern District of Ohio, the Southern District of Florida, and the Eastern District of New York. The defendants do not opposed the consolidation of Pradaxa cases.

Read related articles here

Pradaxa Bleeding Death Lawsuits Update posted June 8, 2012

Pradaxa Cerebral Hemorrhage Lawsuit posted May 2, 2012

Pradaxa Overdose and Hemorrhage posted April 6, 2012

The Problem with Pradaxa posted April 1, 2012