Xarelto Lawsuits Over Bleeding Problems Not Expected to Slow Sales, According to Bayer

While a growing number of Xarelto lawsuits continue to be filed on behalf of individuals who have suffered severe and often fatal bleeding problems, Bayer reports that it anticipates sales for the controversial anticoagulant will continue to grow, with expected growth of 30% this year.

According to Bayer’s first quarter financial report (PDF), there are now more than 500 complaints pending throughout the U.S. involving allegations that the drug maker failed to adequately warn about the potential risk of uncontrollable bleeding with Xarelto. In addition, at least five Xarelto class action lawsuits have been filed in Canada.

Despite the mounting litigation, Bayer reports that Xarelto sales have exceeded half a billion dollars in the first quarter alone, setting it on an easy path to blockbuster status again this year, and dwarfing sales of competitors that are part of a new generation of novel oral anticoagulants, such as Pradaxa and Eliquis.

Bayer also reported that estimated sales growth for Xarelto is should be higher than expected in 2015, increasing from a previous prediction of 20% growth to 30%.

Internal Bleeding Problems on Xarelto

Xarelto (rivaroxoaban) was 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. It was the second member of of this new generation introduced, and quickly grew to become the most widely used.

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

Unlike warfarin, for which the blood thinning effects of the medication can be quickly reversed in the case of an emergency, there is no approved antidote for Xarelto, which has left many doctors helpless to stop hemorrhages or other bleeding experienced by users. While Bayer is currently working on obtaining an effective reversal agent, lawsuits have alleged that the drug never should have been introduced without an antidote or stronger warnings for doctors.

Sales of Xarelto have been fueled by claims that it is easier to use than warfarin, which requires frequent blood monitoring. While the drug makers have promoted a one-size fits all approach, recent studies have raised questions about whether many of the bleeding problems may actually have been avoided if Bayer had recommended blood monitoring with Xarelto to help doctors identify patients at the greatest risk bleeds.

Xarelto Bleeding Lawsuits

In December 2014, amid the growing number of injury and wrongful death lawsuits over Xarelto filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for the cases.

The Xarelto litigation is currently centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana. Given the nearly identical allegations raised in the cases, the lawsuits have been consolidated to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

One of the most recently filed lawsuits involves a complaint (PDF) brought this week by Frank Peck, which indicates that his wife, Ann, died after suffering uncontrollable internal bleeding and a hemorrhagic stroke. Ann Peck was prescribed Xarelto in late March 2013, and was dead by May 4, 2013.

“Defendants routinely marketed Xarelto as a ‘one size fits all’ drug,” the lawsuit states.”In their fervent marketing of Xarelto, Defendants’ misinformed patients and their healthcare providers as to the necessity to routinely monitor any patient requiring a blood thinning agent.”

Peck is pursuing claims against the drug makers for failure to warn, designing a defective drug, negligence, negligent design, negligent misrepresentation, breach of warranty, fraud, and violating consumer protection laws, seeking both compensatory and punitive damages.

It is ultimately expected that several thousand complaints will be centralized before Judge Fallon, as Xarelto bleeding lawyers continue to review and file lawsuits.

As part of the coordinated pretrial proceedings before Judge Fallon, it is expected that a small group of cases will be scheduled for early trial dates in the MDL. Known as “bellwether” cases, these trials will be designed 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 outcome of any early trial dates will not be binding in other cases, they may help the drug makers reach Xarelto settlements to avoid the need for hundreds of individual trials throughout the U.S.