Committee of Lawyers Appointed to Negotiate Pradaxa Settlement
The U.S. District Judge presiding over all federal Pradaxa lawsuits has issued a stay in the litigation and created a committee of attorneys to negotiate the terms of a master settlement agreement that may resolve several thousand failure to warn complaints against Boehringer Ingelheim.
In the federal court system, more than 2,350 product liability lawsuits over Pradaxa have been consolidated as part of an MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.
All of the complaints involve similar allegations that Boehringer Ingelheim failed to provide adequate warnings for consumers or the medical community about the risk of serious bleeding events on Pradaxa, as well as the lack of an effective reversal agent to allow doctors to control hemorrhaging that develops among users.
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As part of the coordinated pretrial proceedings in the MDL, a small group of cases are being prepared for early Pradaxa trial dates that were expected to begin in September 2014.
On May 20, Judge Herndon issued a case management order (PDF) that stayed all aspects of the Pradaxa litigation, including a scheduled deposition of Boehringer Ingelheim’s CEO. The order required the court appointed mediator and a group of plaintiffs’ attorneys to appear in Judge Herndon’s chambers last week to provide a “full and detailed report of the status of settlement negotiations and why the case has not yet settled.”
This week, Judge Herndon issued another case management order (PDF) on May 27, appointing a group of eight attorneys to serve on a Pradaxa Claimants’ Negotiating Committee (PCNC), whose job it is to negotiate the terms of a settlement agreement with Boehringer Ingelheim.
If the parties are able to reach a global Pradaxa settlement agreement, it may avoid the need for hundreds of individual trials to be scheduled throughout the country.
Pradaxa Bleeding Concerns
Pradadxa (dabigatran) was first approved by the FDA in October 2010, for prevention of strokes among patients with atrial fibrillation.
It was the first member of a new class of medications that have been promoted as superior alternatives to warfarin, also known by the brand name Coumadin, since they require less monitoring during treatment. However, shortly after its introduction, Pradaxa began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events.
There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced by Boehringer Ingelheim. Many doctors have expressed concerns about the lack of an effective reversal agent for Pradaxa. While doctors are able to reverse the blood thinning effects of warfarin with a dose of vitamin K, there is no such antidote available for Pradaxa users.
The first order came just days after the FDA revealed that Pradaxa increased the risks of gastrointestinal bleeding when compared to its older competitor warfarin. Even though Pradaxa decreased the risk of stroke and brain bleeds, the FDA said evidence indicated it increased the risk of gastrointestinal bleeding.
Gastrointestinal bleeding complaints form the core of Pradaxa injury claims. Just before the order was released, Boehringer Ingelheim revealed that its own investigation found that a number of bleeding incidents were left out of clinical trials that led to Pradaxa’s approval, even though the company stood by the safety of the blood thinner.
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