Xarelto Injury Categories for Bellwether Cases Outlined by Court

The federal judge presiding over all Xarelto injury lawsuits has outlined the various categories that cases must fit into to be selected as part of a small group of claims that will be prepared for a series of “bellwether” test trials, which are expected to begin in 2017.

There are currently at least 2,400 complaints filed throughout the federal court system involving allegations that side effects of Xarelto caused individuals to suffer severe bleeding injuries. The cases are all consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana as part of an MDL, or multidistrict litigation.

As part of the coordinated proceedings before Judge Fallon, the parties are engaging in generic discovery into issues that apply to all claims, but are also working to identify a small group of bellwether cases that will go through case-specific discovery and be eligible for early test trials, to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

The Xarelto bellwether trials are designed to be representative of other claims in the litigation, and a series of trials are expected to go before federal juries between February 2017 and May 2017 if Xarelto injury settlements are not reached before then to resolve large numbers of cases.

In a case management order (PDF) issued on December 17, Judge Fallon outlined the eligibility requirements and substantive categories for cases that will be included in this discovery pool.

A total of six Xarelto categories were identified, including three different injuries and two different reasons the medication was prescribed. Injury categories include individuals who suffered a gastrointestinal bleeding injury, rectal bleeding injury or brain bleed/hemorrhagic stroke. Each of those Xarelto injury categoies were broken down into individuals who were prescribed Xarelto for to reduce the risk of stroke, or to treat either deep vein thrombosis or pulmonary embolism.

By January 11, each side will select ten cases for the bellwether pool, including five from the Eastern District of Louisiana, one from Mississippi, one from Texas and three cases from other states selected by the party. While the parties have been directed to “endeavor” to pick at least one case from each category, they are not required to do so.

By January 15, the Court will then randomly select twenty additional cases, including ten from Louisiana, two from Mississippi and one each from eight other states selected by the parties.

Xarelto Bleeding Problems

Xarelto (rivaroxoaban) 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 blood thinners, which have been promoted as easier to use than warfarin, which has been the go-to anticoagulation treatment for decades. However, a large number of Xarelto bleeding problems have been reported since the drug hit the market.

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 potential bleeding risks, as well as the lack of a safe and effective reversal agent to allow doctors to quickly stop the blood thinning effects of the drug if problems develop.

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.