Amanda Antell  |  April 22, 2014

Category: Legal News

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Pradaxa risksA federal judge has officially announced the date for the first Pradaxa bellwether trial, as part of the Pradaxa multidistrict litigation. The judge has also determined an outline of dates the parties must meet for litigation deadlines, including exchanging witness lists and filing various pretrial motions.

The first Pradaxa bellwether trial is scheduled to begin on September 8. The lawsuit was filed by Suzanne Mackiewicz, who sued Boehringer Ingelheim for the wrongful death of her mother, after she took Pradaxa. This case is the first to be selected out of several thousand lawsuits involving Pradaxa internal bleeding complications, and other wrongful death allegations.

The multidistrict litigation (MDL) against the German pharmaceutical giant is centered in Southern Illinois, under U.S. District Judge David R. Herndon. These lawsuits were given MDL status to reduce the risk of repetitive discovery, conflicting rulings from different judges, and to simplify the process. There are more than 2,000 Pradaxa lawsuits pending in the United States, each involving similar allegations of negligence regarding Pradaxa.

Judge Herndon previously established the bellwether program, in which a small group of cases were prepared for early Pradaxa trial dates, to help determine how juries may respond to certain evidence and testimony. Now that the first trial has been selected, the cases are expected to begin in December, February and March. The Case Management Order was issued on April 9 by the judge.

Plaintiffs have been directed to serve their witness lists by July 2, with defendants submitting their witness lists by July 9. Depositions of any witnesses not previously deposed must be completed by July 31. Any additional evidence must be introduced by August 8, and jury selection begins Sept. 15.

Although the outcome of the bellwether trials will not bind other cases in the litigation process, they will most likely influence potential Pradaxa settlements that could be reached in order to avoid the need for hundreds of trials.

Overview of Pradaxa Complications

Pradadxa (dabigatran) is an anticoagulant drug approved by the FDA in October 2010. Like its predecessor, Warfarin, it is used to prevent stroke and blood-clotting in high-risk patients.  Despite being marketed as superior to Warfarin, Boehringer started to back-track its claims on the drug due to adverse reports, including uncontrollable internal bleeding. Pradaxa was originally said to be more efficient and easier to use, but in the case of internal bleeding, there is no reversal agent available to stop it. This contrasts with Warfarin, which uses vitamin K as its reversal agent.

Pradaxa is manufactured and marketed by Boehringer Ingelheim, and is one of the most popular drugs in the United States, earning $1 billion in sales in Boehringer’s 2011 fiscal year.  Boehringer has tried to argue that Pradaxa is no more dangerous than Warfarin, as some studies have indicated the likelihood of internal bleeding is about the same. However, recent scientific evidence has emerged to contradict this statement, by indicating that the Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.

Since its release in October 2010, the FDA received at least 3,781 reports involving Pradaxa injuries.  In 2011, it was reported that there were 2,367 reports of hemorrhage and 542 patient deaths allegedly related to Pradaxa.

File a Pradaxa Class Action Lawsuit Claim

If you believe that you or a loved one have been the victim of a Pradaxa internal bleeding injury, you have legal options. Enter your information below and an experienced attorney that works with Top Class Actions will review and determine whether you may join the Pradaxa investigation.

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