Xarelto Lawsuit Filed After Woman Suffers Hemorrhagic Pericardial Effusion

A recent lawsuit filed by a woman who alleges that side effects of Xarelto caused her to suffer a hemorrhagic pericardial effusion, where the sac around her heart filled with blood, is one of the latest in a growing number of product liability cases filed against Bayer and Johnson & Johnson over bleeding complications linked to their controversial anticoagulant.

The complaint (PDF) was filed by Margaret Garvy in the U.S. District Court of the Eastern District of Louisiana on February 18, where it will join an estimated 4,000 similar complaints filed throughout the federal court system.

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.

Garvy indicates that she took the new-generation anticoagulant Xarelto for less than two weeks in May 2014, before she was diagnosed with hemorrhagic pericardial effusion, pericardial tamponade and plural effusion. The lawsuit indicates the conditions, which involve bleeding around the heart and lungs, were the result of her Xarelto use and the lack of an effective reversal agent to stop the drug’s blood thinning effects.

Like other claims pending in the federal court system, Garvy alleges that Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary 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.

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, which has been the go-to anticoagulation treatment for decades. However, a large number of adverse event reports began to surface after the drug hit the market, often involving hemorrhaging that doctors were unable to stop.

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.

“Importantly, Xarelto’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects,” the lawsuit filed by Garvy states. “Therefore, in the event of hemorrhagic complications, there is no available reversal agent.”

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 parties involved in the Xarelto MDL are scheduled to meet with Judge Fallon today for a scheduled status conference, at which time the Court is expected to discuss the status of discovery in those bellwether claims, according to a joint report (PDF) filed last week.

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 lawsuits over Pradaxa, which is 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.