Xarelto Failure to Warn Claims to Proceed, After Summary Judgment Motion Denied

The U.S. District Judge presiding over all federal Xarelto lawsuits has denied two motions for partial summary judgment filed by the makers of the controversial new-generation oral anticoagulant, rejecting attempts to dismiss claims over failure to warn about the risk of severe and uncontrollable bleeding problems.

More than 16,000 complaints are currently pending throughout the federal court system over the bleeding side effects of Xarelto, which are centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of an MDL or multidistrict litigation.

Each of the cases raise similar allegations, indicating that the manufacturers withheld important information and warnings from consumers and the medical community about the lack of an effective antidote, which would 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.

On April 17, Judge Fallon issued an order (PDF) denying partial summary judgment in two of the pending bellwether cases, rejecting requests by the drug maker to dismiss claims filed by Joseph Boudreaux, Jr. and Joseph Orr, Jr.

Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary attempted to argue that the failure to warn claims should not be permitted to proceed, indicating that the plaintiffs could not prove that their doctors would have prescribed a different drug if the warning label for Xarelto had been stronger. However, Judge Fallon said it was not necessary to prove that the doctors would have prescribed a different drug if a stronger warning had been provided, under Louisiana law applicable to the cases.

“This Court finds that Plaintiffs do not contend that prescribing physicians never should have prescribed Xarelto. Instead, they argue their claim survives merely by showing the doctor would have acted differently had they been adequately instructed, and that Plaintiffs’ injuries could have then been avoided,” Judge Fallon said in his ruling. “Louisiana law contains a presumption that if adequate warning is provided, that warning would have been followed, or ‘heeded.’”

The case filed by Boudreaux is set for trial to begin on April 30, followed by the Orr case on May 30, each in the Eastern District of Louisiana. Those lawsuits will be followed by additional bellwether trials over the summer in Mississippi and Texas.

While the outcome of these cases will not binding on other lawsuits pending in the MDL, they will likely influence potential Xarelto settlement agreements that may avoid the need for thousands of individual trials to set 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.