Process Established for Selection of Pradaxa Cases for Early Trials in MDL

The U.S. District Judge presiding over all federal Pradaxa cases has established guidelines for selecting a series of “bellwether” trials, involving lawsuits that allege the manufacturers of the anticoagulant failed to adequately warn about the side effects of Pradaxa.  

Pradaxa (dabigatran) is a relatively new anticoagulant, which was introduced by Boehringer Ingelheim in October 2010, as a superior alternative to warfarin, which has been the go-to-drug for prevention of strokes for decades.

Nearly 300 Pradaxa lawsuits have been filed on behalf of individuals who suffered uncontrollable bleeding or other problems with Pradaxa, alleging that the drug maker failed to adequately warn about the risks associated with the medication or about the lack of a reversal agent to stop hemorrhaging that may develop while using the drug.

In the federal court system, all Pradaxa cases filed throughout the country have been consolidated before U.S. District Judge David R. Herndon in the Southern District of Illinois. The cases have been centralized as part of an MDL, or Multi-District Litigation, for coordinated pretrial proceedings and a series of “bellwether” trials that are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be offered throughout the Pradaxa litigation.

Pradaxa Bellwether Cases

In a Case Management Order (PDF) issued on April 9, Judge Herndon outlined the process for selecting 16 cases that will be prepared for a series of four Pradaxa bellwether trials, which are scheduled to begin between August 2014 and February 2015.

The Pradaxa cases that are eligible to be considered for early trial selection are limited to those filed on or before April 5, with each side selecting 8 of the “bellwether” lawsuits. Claims alleging a heart attack from Pradaxa are not eligible for the trial pool, and no more than three cases involving the same primary plaintiff’s law firm shall be selected by each side.

At least five of the cases selected by each side must involve allegations of gastrointestinal bleeding from Pradaxa, but nore more than two from each side may allege that a traumatic injury was exacerbated by use of Pradaxa and no more than one case each can allege that a plaintiff suffered a TIA (transient ischemic attack) or stroke before using Prada. In addition, Judge Herndon indicated that no more than six Pradaxa wrongful death lawsuits will be included in the pool of cases eligible for early trial dates, with only three chosen by each side.

The parties will exchange their list of eight case each on May 15, and the court has established the process for dealing with duplicate selections and replacing Pradaxa lawsuits that settle or are otherwise dismissed before July 2013.

After conducting case-specific discovery on the 16 Pradaxa “bellwether” cases, the parties will each propose three lawsuits to serve as early trial plaintiffs in mid-November 2013. Judge Herndon has indicated that he will then select four cases by November 22, scheduling specific lawsuits for trials that will begin on August 11, 2014, November 3, 2014, January 5, 2015 and February 16, 2015.

Pradaxa Settlement Discussions To Begin August 2013

After the Pradaxa MDL was established in August 2012, Judge Herndon said that he intended to move the cases forward “expeditiously,” indicating that both consumers and the medical community will benefit from a quick resolution to the factual allegations made in this case.

Since it was introduced in October 2010, Pradaxa has become a widely used medication for prevention of strokes among individuals with atrial fibrillation. Boehringer Ingelheim has promoted the medication as superior to warfarin, as it requires less monitoring during treatment. However, Pradaxa quickly became one of the medications most commonly associated with adverse event reports submitted to the FDA after it hit the market.

According to allegations raised in many of the complaints, Boehringer Ingelheim failed to adequately warn about the risk of bleeding problems with Pradaxa and about the difficulty stopping hemorrhages that may occur. Unlike warfarin, which has a “reversal agent” that can be used to stop the blood thinning effects of the mediation, no such antidote is available with Pradaxa, leaving many doctors unable to stop bleeding that develops with Pradaxa, resulting in severe injuries and death.

The bellwether test cases in the federal MDL are designed to help the parties weigh the relative strengths and weaknesses of their arguments. The outcomes may be beneficial in promoting a Pradaxa settlement agreement or other resolution for the litigation.

According to a prior Case Management Plan issued in October 2012, Judge Herndon has ordered the parties to meet at least once per month to discuss settling Pradaxa cases, beginning in August 2013.