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
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.