Pradaxa Trial Dates in MDL Pushed Back to September 2014

The first of four Pradaxa lawsuits scheduled for early trial dates in the federal court system will now begin in September 2014, after the U.S. District judge presiding over the litigation delayed the start of the first case about one month.

U.S. Distict Judge David R. Herndon is currently presiding over more than 2,000 lawsuits pending against Boehringer Ingelheim in the federal court system, which all involve similar allegations that the drug maker failed to provide adequate warnings about the risk of Pradaxa bleeding injuries.

As part of the coordinated pretrial proceedings in the cases, Judge Herndon previously selected four cases for early trial dates, which were expected to begin between August 2014 and February 2015 in the U.S. District Court for the Southern District of Illinois.

In a case management order (PDF) issued March 5, Judge Herndon pushed back the trial dates about 30 days and established a new order for the cases to go before juries.

Jury selections in for lawsuit filed by Suzanne Mackiewicz will now begin on September 8, 2014, with opening statements expected to begin on September 15. Her case involves a wrongful death claim on behalf of her father, Malachy Higgins. The second bellwether trial will address a claim filed by Georgia Primus and is scheduled to begin on December 1, 2014. The third bellwether trial involves a wrongful death lawsuit by Adalaine Nancy Kohn, whose husband died after a Pradax bleeding event. Originally it was the scheduled to be the second case to go to trial, but it will now go before a jury on February 17, 2015. The fourth and final bellwether trial will involve a case brought by Helen Jean and John Edwards Hawkins, which is scheduled to begin on March 23, 2015.

All of the lawsuits contain similar allegations that the manufacturer failed to adequately warn consumers and the medical community about the potential bleeding side effects of Pradaxa, as well as the lack of an antidote that would allow doctors to stop the blood thinning effects of the medication. As a result, many doctors did not have a plan for counteracting the drug.

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.

These early Pradaxa trials are being closely watched by lawyers involved in the litigation, as they may help gauge how juries will respond to certain evidence and testimony that is likely to be similar to what is offered in other cases.

Following the bellwether trials, if the parties do not make progress towards reaching Pradaxa settlement agreements, it is possible that Judge Herndon will begin remanding hundreds of cases back to U.S. District Courts where they were originally filed for separate trial dates.