Xarelto Bellwether Trial Underway Over Gastrointestinal Bleed

Jury selections began this week in the first bellwether trial for thousands of Xarelto lawsuits pending throughout the federal court system, involving allegations that the drug makers failed to adequately warn about the gastrointestinal bleeding risks associated with the controversial new-generation anticoagulant.

A case filed by Joseph Boudreaux, Jr. will be the first to go to trial out of more than 16,000 complaints pending in a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated discovery and management.

Each of the cases involve similar questions of fact and law, indicating that information was withheld from consumers and the medical community about the lack of an effective antidote, or reversal agent, which may have allowed doctors to reverse the blood thinning effects of the medication in emergency situations.

As part of the coordinated MDL proceedings, Judge Fallon has scheduled a series of early Xarelto trial dates over the next few months, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

According to the complaint (PDF) originally filed by Bourdreaux in December 2014, Xarelto was prescribed to reduce the risk of stroke due to atrial fibrillation. However, less than a month after he began taking the drug, Bourdreaux indicates that side effects of Xarelto caused him to develop a severe gastrointestinal bleed, which resulted in hospitalization and the need for several blood transfusions.

After the jury is seated in the New Orleans federal court, testimony in the case is expected to begin this week, and last about four weeks. A second bellwether trial is set to begin in the Eastern District of Louisiana on May 30, with additional cases set for trial in Texas and Mississippi over the summer.

While the outcomes of these bellwether trials will not have any binding effect on other cases in the litigation, they will be closely watched and may have a substantial influence on eventual negotiations to reach Xarelto settlements to avoid the uncertainty of thousands of individual cases being set for trial in U.S. District Courts nationwide.

Xarelto Bleeding Problems

Xarelto (rivaroxoaban) was introduced in 2011, as an alternative to Coumadin (warfarin), which has been the go-to anticoagulant treatment for decades.

The drug is part of a new class of medications, which have been promoted as easier to use than warfarin. However, since the drugs have hit the market, there have been a large number of reports involving severe and sometimes fatal bleeding problems with Xarelto and other members of this new class, including Pradaxa and Eliquis.

While all blood thinners may cause bleeding, the side effects of warfarin can be quickly reversed with a widely known antidote. 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, which led to severe and uncontrollable bleeds.

Similar claims were raised in the litigation over Pradaxa, which was the first member of this class introduced in October 2010, one year before Xarelto hit the market. About 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 just before the first bellwether trials were set to begin, 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, the number of complaints has surpassed the number of claims involved in the Pradaxa litigation, as the drug has become more widely used in recent years.

In recent months, there have also been an increasing number of Eliquis lawsuits filed over this newer member of the class, once again raising similar allegations that the drug maker failed to warn about the bleeding risk.