Xarelto Side Effects Blamed For Bleeding Death In New Lawsuit

Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary continue to face a growing number of Xarelto lawsuits over bleeding problems linked to their controversial anticoagulant, including a recent wrongful death claim filed by the family of a woman who suffered a fatal gastrointestinal bleed only months after she began taking Xarelto.

In a complaint (PDF) filed in the U.S. District Court for the Eastern District of Louisiana on July 12, Robert Smith indicates that the drug makers’ failure to adequately warn about the potential side effects of Xarelto caused the bleeding death of his wife, Sylvia Ann Smith.

The case joins more than 5,000 other similar claims pending in the federal court system, including many Xarelto wrongful death lawsuits brought by families who indicate their loved ones died due to uncontrollable bleeding after using the anticoagulant, alleging that the manufacturer failed to warn about the risk or the lack of an effective antidote that could reverse the blood thinning effects of the drug if bleeding occurs.

According to the complaint filed by Robert Smith, his wife began taking Xarelto in April 2014 and suffered a gastrointestinal bleeding event in July 2014. Smith indicates that his wife died of complications from the bleeding on February 20, 2015.

Xarelto (rivaroxoaban) is a new-generation anticoagulant, which was introduced in 2011 as a replacement for Coumadin (warfarin), which has been the go-to treatment for prevention of clots for decades. However, while there is a known and effective reversal agent for warfarin, many doctors have been left in a position where they are unable to prevent or stop bleeds that occurred among users of Xarelto.

The drug makers promoted Xarelto as easier to use, claiming that it required no blood monitoring to maintain the appropriate dose. However, Smith and other plaintiffs allege that evidence shows regular monitoring on Xarelto may have prevented many bleeding events and saved lives.

“The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” the lawsuit filed by Smith states. “Physicians using Xarelto have been able to balance the dose so that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event. The Defendants were aware of this risk and the need for blood monitoring but have failed to disclose this vital health information to patients, doctors and the FDA.”

Xarelto Problems

The lawsuit came just days after a report by the Institute for Safe Medication Practices (ISMP) found that Xarelto was linked to more serious adverse events reported to the FDA than any other drug in 2015, including more than 1,100 patient deaths.

According to the findings, severe complications with Xarelto exceed those linked to all other drugs, mainly involving injuries associated with uncontrolled bleeding and failure to prevent a stroke or pulmonary embolism, which is what the drug is designed to do.

Xarelto is part of a controversial new class of anticoagulants introduced in recent years to help prevent blood clots among individuals at risk for deep vein thrombosis or pulmonary embolism. However, the large number of Xarelto bleeding problems that have been reported since the drug hit the market have raised questions about the research and warnings provided by the drug makers.

Smith’s lawsuit will be coordinated during pretrial proceedings with more than 5,250 product liability lawsuits pending in the federal court system over severe, and often fatal, bleeding injuries on Xarelto.

Given the similar questions of fact and law raised in the cases, the lawsuits have been consolidated as part of a federal multidistrict litigation (MDL), which is is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the courts.

Judge Fallon has scheduled a series of early Xarleto bellwether trials in the MDL, which are expected to begin in February 2017. While the outcomes of these early trial dates will not be binding on other claims, they may help the parties negotiate Xarelto settlements that could avoid the need for thousands of individual cases to go before juries nationwide.

On July 2, both plaintiffs and defendants involved in ongoing Xarelto litigation filed a joint status report (PDF) on the cases, indicating that discovery in 40 cases selected for potential bellwether trials is moving forward. The status report was filed ahead of a conference on Xarelto lawsuits planned for today.

As Xarelto injury lawyers continue to review potential cases for individuals and families nationwide, it is expected that the number of lawsuits involved in the MDL will continue to grow over the coming months.