Wrongful Death Lawsuit Filed Over Xarelto Internal Bleeding

Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary continue to face a growing number of lawsuits that allege side effects of Xarelto caused severe and uncontrollable internal bleeding, with one of the latest being brought by the son of a Tennessee man who bled to death following use of the controversial anticoagulant.

The complaint (PDF) was filed by Danny Julien in the U.S. District Court for the Eastern District of Louisiana on March 20, following the death of his father, Tommy Julien in early 2013.

According to allegations raised in the wrongful death lawsuit, Tommy Julien was first prescribed Xarelto to prevent strokes linked to atrial fibrillation in November 2012. Only a few months later, Julien began suffering internal bleeding on Xarelto, which his son indicates resulted in significant injuries and eventually led to his death.

The case joins over 300 similar Xarelto internal bleeding lawsuits currently pending in the Eastern District of Louisiana, where complaints filed throughout the federal court system have been consolidated for pretrial proceedings as part of a multidistrict litigation, or MDL.

U.S. District Judge Eldon E. Fallon is presiding over coordinated pretrial proceedings in the cases, since each of the lawsuits raises similar allegations that Bayer and Janssen withheld important warnings and safety information about the risk of internal bleeding on Xarelto, as well as the lack of an approved reversal agent that doctors could have used to control bleeding problems that may develop.

Internal Bleeding Problems on Xarelto

Xarelto (rivaroxoaban) is a new-generation anticoagulant introduced in 2011 as a superior replacement for Coumadin (warfarin), which has been the “go-to” medication for prevention of blood clots and strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a risk of bleeding injury, Xarelto has been linked to a surprising number of problems as more and more patients are switched to the novel anticoagulant.

Xarelto has been promoted as superior to warfarin, with the drug makers indicating that it is easier to use, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims, with researchers suggesting that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.

In addition to failing to warn about the risk of bleeding and importance of blood monitoring, plaintiffs claim that drug makers withheld information about the lack of a Xarelto antidote to stop hemorrhaging or internal bleeding.

While warfarin’s blooding thinning effects can be quickly reversed in an emergency, there is no antidote for Xarelto currently available. This has left many doctors unable to control bleeds, increasing the risk of severe injury or death.

Xarelto Litigation

With a growing number of Xarelto injury and wrongful death lawsuits being filed in U.S. District Courts throughout the country, the U.S. Judicial Panel on Multidistrict Litigation established coordinated proceedings for the federal courts in December 2014, transferring cases filed nationwide to Judge Fallon to reduce the risk of duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts.

As part of the MDL process, it is expected that a small group of cases will be scheduled for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the U.S. litigation.

While the outcomes of these “bellwether” trials will not be binding on the claim brought by Julien and other claimants, they may influence eventual Xarelto settlements that would avoid the need for hundreds of cases to go before juries nationwide.

Julien claims his father would have never used Xarelto had he known it carried a risk of potentially deadly bleeding events with no antidote to stop the drug’s blood thinning effects.

The lawsuit accuses the manufacturers of failure to warn, designing a defective drug, negligence, negligent design, negligent misrepresentation, breach of warranty, fraud, and violation of consumer protection laws, seeking both compensatory and punitive damages.