All federal product liability lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa have been consolidated as part of an MDL, or Multidistrict Litigation. The MDL is centralized for pre-trial discovery before U.S. District Judge Herndon in the Southern District of Illinois.
Nationwide Pradaxa Claims Over 2,000
There are more than 2,000 Pradaxa personal injury cases before Judge Herndon. The plaintiffs, allege that Boehringer Ingelheim failed to adequately warn consumers and the doctors about the bleeding risk with Pradaxa, or the lack of an effective reversal agent to allow doctors to stop hemorrhages that develop among users.
The court has established a bellwether trial litigation program, where a small group of cases were prepared for early Pradaxa trial dates to help the parties determine similar evidence and testimony. The Higgins lawsuit is the first of four test trials, with additional cases expected to begin in December 2014, February 2015 and March 2015.
Jury selections in the Higgins case are set to begin on September 8, with opening statements expected to begin on September 15. Because the Pradaxa litigation is extremely complex, trial is expected to last several weeks.
If the Higgins plaintiffs are successful, then a potential global Pradaxa settlement may be announced.
What is the problem with Pradaxa?
Pradadxa (dabigatran) is a new anticoagulant therapy that was approved by the FDA in October 2010. Pradaxa is promoted as a superior alternative to warfarin, also known by the brand name Coumadin, for stroke prevention in non valular atrial fibrillation. Atrial fibrillation is a very common heart rthythm abnormality that causes strokes. Unfortunately, Pradaxa is exposed to a record number of adverse event reports after patients experienced uncontrolled bleeding events.
Pradaxa was promoted as a no muss no fuss anticoagulant, because it requires less monitoring. Experts have expressed concerns and grave doubts about the lack of an effective reversal agent to stop the blood thinning effects of Pradaxa.
Warfarin, bleeding side effects can be quickly reversed with a dose of vitamin K and plasma, but there is no available reversal agent for Pradaxa.
There have been thousands of reports of bleeding side effect injuries and hundreds of deaths associated with Pradaxa use since introduction. The Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.