Process Outlined for Selecting First Pradaxa Trials in Federal Litigation

As discovery continues in hundreds of Pradaxa internal bleeding lawsuits, the federal judge presiding over the litigation is expected to select a group of four cases early next year to be prepared for early trial dates beginning in August 2014.

Boehringer Ingelheim faces more than 1,500 product liability complaints filed in U.S. District Courts throughout the United States, which all involve similar allegations that the drug maker failed to adequately warn about the potential Pradaxa bleeding risk or the lack of a reversal agent to stop the blood thinning effects of the medication if a hemorrhage does develop.

In the federal court system, the Pradaxa litigation has 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.

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As part of the coordinated pre-trial proceedings, Judge Herndon has established an aggressive discovery schedule, which calls for the first Pradaxa trials to begin in the second half of next year, with four cases scheduled to go before juries on August 11, 2014, November 3, 2014, January 5, 2015 and February 16, 2014.

These early Pradaxa trials, known as “bellwether” cases, are designed to help the parties gauge how juries may respond to certain facts and testimony that may be offered throughout a large number of similar cases. The outcomes are designed to further Pradaxa settlement negotiations and potentially facilitate a resolution for the litigation.

According to a case management order (PDF) issued on November 4, plaintiffs and defendants have each been directed to each select up to three cases for these early trial dates, which will be submitted simultaneously on December 16, 2013 at 5:00 p.m. CST.

Each side will submit with each selection a two-page report outlining “any and all facts demonstrating why the designating party believes that case is representative.” The opposing side will then have an opportunity to respond to each selection by December 23, outlining whether they believe the picks are representative of other cases in the litigation or not.

Judge Herndon has indicated that the Court will identify the four cases that will be set for the first trial dates before January 23, 2014.

Pradaxa Bleeding Complications

Pradadxa (dabigatran) is a Boehringer Ingelheim blood thinner approved by the FDA in October 2010. It was the first member of a new class of anticoagulants promoted as superior alternatives to warfarin, also known by the brand name Coumadin, for stroke prevention. However, shortly after its introduction Pradaxa racked up a record number of adverse event reports after patients experienced uncontrolled bleeding events.

Warfarin, sold under the brand name Coumadin, has been the go-to anticoagulant for decades. While Pradaxa does require less monitoring, concerns have emerged about the lack of an effective reversal agent to stop the blood thinning effects of the medication.

Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.

During the first full year the drug was on the market in the United States, 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.

As the parties continue to prepare for the early bellwether trials, settlement negotiations continue between plaintiffs and the drug maker. In July, Judge Herndon appointed a mediator and ordered the parties to meet at least once a month to discuss possibly settling Pradaxa lawsuits to avoid individual trials.

Following the bellwether trial process, if Boehringer Ingelheim fails to settle or otherwise resolve the Pradaxa litigation, Judge Herndon could begin remanding hundreds of cases back to U.S. District Courts throughout the country where they were originally filed for individual trial dates.


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