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In the federal litigation over claims that Boehringer Ingelheim failed to adequately warn about the bleeding risks with Pradaxa, the parties are continuing to prepare a small number of claims for early trial dates, which are expected to begin in August 2014.
More than 1,500 Pradaxa lawsuits filed in U.S. District Courts throughout the country are currently consolidated for pretrial proceedings as part of an MDL, or Multi-District Litigation, The cases are centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.
As part of the coordinated litigation, a small group of cases are being prepared for early trial dates, known as “bellwether” cases. These early trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout a large number of other cases.
According to the minutes (PDF) of a status conference held before Judge Herndon on October 8, the parties recently updated the Court on the progress of the preparations for the bellwether cases, including the status of discovery depositions involving plaintiffs, doctors and sales representatives.
Shortly after the Pradaxa litigation was centralized in August 2012, Judge Herndon indicated that he intended to move the cases toward an “expeditious resolution” for the factual allegations, which is designed to benefit both plaintiffs and the maker of the drug.
In October 2012, a case management order was issued establishing an aggressive bellwether trial schedule that will result in the selection of four Pradaxa suits for early trial dates. The first case is scheduled to begin on August 11, 2014, and the subsequent cases are expected to begin approximately six weeks apart.
Judge Herndon is expected to select the four specific cases that will serve as the first bellwether trial cases next month.
Pradaxa Bleeding Problems
All of the cases centralized in the Pradaxa MDL involve similar allegations that plaintiffs suffered serious or fatal injuries when doctors were unable to reverse the blood thinning effects of the anticoagulant. Plaintiffs argue that Boehringer Ingelheim failed to adequately warn about the hemorrhage risk or disclose that there is no reversal agent for Pradaxa to allow doctors to stop bleeding events that may develop.
Pradaxa (dabigatran) was introduced by Boehringer Ingelheim in October 2010, as the first member of a new class of anticoagulants promoted as a superior alternative to warfarin for stroke prevention, as it is easier to take and requires less medical monitoring.
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.
Pradaxa Bleeding Litigation
The U.S. Judicial Panel on Multidistrict Litigation centralized all Pradaxa cases before Judge Herndon in August 2012, to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
At the time the MDL was established, there were only 21 cases pending in 11 different U.S. District Courts. However, as Pradaxa lawyers have continued to review additional lawsuits for individuals who suffered severe injuries from uncontrollable bleeding events, the number of complaints has continued to increase. More than 200 cases have been added to the MDL over the past three months.
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.
If agreements are not reached before the first trial dates, the outcomes of the bellwether trials may help the parties better gauge the relative strengths and weaknesses of their cases and may facilitate a Pradaxa settlement agreement involving a large number of cases.
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.