Xarelto Cases Selected for Bellwether Discovery Pool in MDL

The U.S. District Judge presiding over pretrial proceedings in all federal Xarelto bleeding lawsuits is scheduled to meet with parties involved in the litigation today, at which time the Court is expected to review the 40 cases recently selected to be part of a bellwether trial discovery pool. 

Since December 2014, all product liability lawsuits filed in U.S. District Courts nationwide over the side effects of Xarelto have been centralized in the Eastern District of Louisiana as part of a federal MDL, or multidistrict litigation.

The Xarelto cases are centralized before U.S. District Judge Eldon Fallon for coordinated pretrial proceedings to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different courts and to serve the convenience of the parties, witnesses and the courts.

As part of the management of the litigation, Judge Fallon has previously established a bellwether program where a small group of representative cases will be prepared for early trial dates to help determine how juries may respond to certain testimony, evidence and arguments that may be repeated throughout the Xarelto claims.

A series of bellwether trials in the MDL are expected to begin between February and May 2017, which may influence eventual Xarelto settlement negotiations that would avoid the need for hundreds of individual cases to go before juries nationwide.

Earlier this month, Judge Fallon issued an order (PDF) identifying 40 Xarelto cases selected for a bellwether discovery pool, which will go through case-specific depositions and discovery. The first trial cases will later be selected from this discovery pool.

According to a joint report (PDF) submitted in advance of a case management conference that will be held today with Judge Fallon, the parties indicate that they will be prepared to discuss the bellwether discovery pool selections, as well as other issues that have arisen during the pretrial proceedings, such as preservation orders, interactions with plaintiffs’ prescribing and treating physicians and other discovery issues.

Xarelto Bleeding Problems

Xarelto (rivaroxoaban) is a new-generation anticoagulant that was introduced in 2011 as a replacement for Coumadin (warfarin), which has been the go-to anticoagulant treatment for decades.

The drug is part of a new-generation of treatments designed to avoid blood clots among individuals at risk for deep vein thrombosis or pulmonary embolism, which has been promoted as easier to use than warfarin. However, since it has hit the market, there have been a large number of reports involving severe and sometimes fatal bleeding problems with Xarelto.

Each of the lawsuits involved in the Xarelto MDL raise nearly identical allegations, indicating that users and the medical community were provided inadequate warnings about the problems with uncontrollable bleeding on Xarelto, and the fact that the anticoagulant lacked a safe and effective reversal agent to allow doctors to quickly stop the blood thinning effects of the drug.

While all blood thinners carry a risk of bleeding injury, the side effects of warfarin can be quickly reversed with a widely known antidote of bleeding occurs. However, there was no Xarelto reversal agent when the drug was introduced. Plaintiffs allege that the drug makers failed to adequately warn doctors about the lack of an antidote.

Similar claims were raised in the litigation over Pradaxa, which is another new-generation anticoagulant introduced in October 2010, one year before Xarelto hit the market.

More than 4,000 Pradaxa lawsuits were ultimately filed by users of that drug who suffered bleeding injuries. Following several years of litigation, the manufacturer of that medication ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.

As Xarelto bleeding lawyers continue to review potential cases for individuals prescribed the anticoagulant throughout the United States, it is expected that this litigation will involve many more cases than the Pradaxa litigation, as the drug has become more widely used in recent years.