Xarelto Problems Caused Life-Threatening Subdural Hematoma, Lawsuit Alleges

A man who suffered a subdural hematoma has filed a lawsuit against Bayer and Johnson & Johnson’s Janssen subsidiary, alleging that his life-threatening bleeding injury was caused by problems with Xarelto, a controversial new-generation anticoagulant. 

The complaint (PDF) was filed by Thomas Coe in the U.S. District Court for the Eastern District of Louisiana on March 16, joining thousands of similar claims filed against the drug makers.

Coe indicates that he began using Xarelto in July 2013, and continued to receive the anticoagulant through April 2014, when he suffered life-threatening bleeding and a subdural hematoma. As a result of the injury, Coe claims that he suffered severe and permanent injuries.

Since December 2014, all Xarelto lawsuits filed in U.S. District Courts nationwide have been consolidated in the Eastern District of Louisiana as part of a federal MDL, or multidistrict litigation. Given the similar questions of fact and law raised in the claims, the litigation is centralized before U.S. District Judge Eldon Fallon for coordinated discovery and pretrial proceedings.

There are currently at least 4,500 claims pending in the Xarelto MDL, each alleging that Bayer and Janssen knew or should have known about the hemorrhage risks with Xarelto, yet withheld information from consumers and the medical community about the fact that users may experience uncontrollable bleeding. The lawsuits also accuse the manufacturers of failing to warn that the drug had no reversal agent to quickly halt its blood thinning effects in case of an emergency.

Xarelto Hemorrhage Risks

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. However, a large number of adverse event reports began to surface after the drug hit the market, often involving bleeds that doctors were unable to stop.

While all blood thinners carry a risk of hemorrhage, 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.

“Importantly, there is no antidote to Xarelto, unlike warfarin,” the lawsuit filed by Coe states. “Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section.”

Xarelto cases filed in U.S. District Courts nationwide have been centralized before Judge Fallon to reduce duplicative discovery into common issues, avoid contradictory pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.

Xarelto Bellwether Trials

As part of the coordinated management of the Xarelto litigation, Judge Fallon has established a “bellwether” program, where a small group of cases are being prepared for early trial dates, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout many cases.

The Xarelto bellwether trials are expected to go before federal juries between February 2017 and May 2017. If Xarelto injury settlements or another resolution for the litigation is not reached following the test trials, it is possible Judge Fallon will start remanding hundreds of individual cases back to U.S. District Courts nationwide for individual trial dates.

The litigation involves similar claims to those presented in thousands of Pradaxa lawsuits, which involve a similar medication that was the first member of this new generation of anticoagulants. Following several years of litigation, the manufacturer ultimately agreed to pay $650 million in Pradaxa settlements in 2014, 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 was much more widely used.