Pretrial Schedule Established for First Pradaxa Lawsuit in MDL

The U.S. District Judge presiding over all federal Pradaxa lawsuits has established the pretrial schedule for the first bellwether trial, which is scheduled to begin, outlining the dates by which parties must exchange witness lists, exhibit lists and file various pretrial motions.

Trial is scheduled to begin on September 8, 2014 in a wrongful death lawsuit filed by Suzanne Mackiewicz, the daughter of Malachy Higgins, which has been selected as the first out of several thousand cases involving bleeding problems from Pradaxa to go before a jury.

In the federal court system, all product liability lawsuits filed against Boehringer Ingelheim over Pradaxa have been consolidated as part of an MDL, or Multidistrict Litigation, which are centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois to reduce duplicative discovery into common issues, avoid conflicting rulings from different judges and to serve the convenience of witnesses, parties and the courts.

There are currently more than 2,000 Pradaxa cases pending before Judge Herndon, which all involve similar allegations that Boehringer Ingelheim failed to adequately warn consumers and the medical community about the bleeding risk with Pradaxa, or the lack of an effective reversal agent to allow doctors to stop hemorrhages that develop among users.

Judge Herndon previously established a bellwether program, where a small group of cases were prepared for early Pradaxa trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of other cases. The Higgins lawsuit was selected for the first of four test trials, with additional cases expected to begin in December 2014, February 2015 and March 2015.

In a Case Management Order (PDF) issued on April 9, Judge Herndon outlined the pretrial schedule related to the Higgins trial. Plaintiffs have been directed to serve their witness list by July 2, with defendants submitting their witness list by July 9. Depositions for any witnesses not previously deposed must be completed by July 31, with any motions in limine seeking to exclude the mention of certain evidence or issues at trial filed by August 8.

Jury selections in the case are set to begin on September 8, with opening statements expected to begin on September 15. Given the complexity of the case, trial is expected to last several weeks.

Although the outcome of the bellwether trials are not binding on other cases in the litigation, the process is likely to influence any potential Pradaxa settlements that may be reached to avoid hundreds of additional trials that may be scheduled throughout the country.

Pradaxa Bleeding Risks

Pradadxa (dabigatran) is a relatively new anticoagulant therapy that was approved by the FDA in October 2010. It was the first member of a new class of medications that are promoted as superior alternatives to warfarin, also known by the brand name Coumadin, for stroke prevention. However, shortly after its introduction, Pradaxa began to rack 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 was promoted as easier to use, because it requires less monitoring by the doctor during treatment, 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.

There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced in October 2010. 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.