Xarelto Lawsuit Filed Over Life-Threatening Bleeding Problems from Anticoagulant

According to allegations raised in a recent product liability lawsuit filed against Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, side effects of Xarelto caused life-threatening bleeding problems for a woman who received the controversial new-generation anticoagulant.

The case joins a growing number of Xarelto lawsuits filed on behalf of individuals who have experienced similar problems with uncontrollable bleeding, with more than 5,250 cases currently pending as part of a federal multidistrict litigation (MDL), which 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.

While all blood thinners carry a risk of bleeding, the cases raise similar allegations that Bayer and Janssen failed to warn consumers and doctors about the potential Xarelto bleeding problems, and the fact that the anticoagulant had no reversal agent to allow doctors to quickly stop bleeding that may develop while using the drug.

A complaint (PDF) filed this week by Texas resident Ruth Ramsoondar is one of the latest to join the litigation, indicating that she suffered a life-threatening bleeding event in June 2014, after she began using Xarelto in April 2014. She survived the bleed, but indicates that she has been left with permanent injuries, pain, suffering and severe emotional distress.

Like other lawsuits pending nationwide, Ramsoondar alleges that the drug makers failed to conduct adequate testing for bleeding problems, or else they would have known Xarelto bleeds were difficult, and sometimes impossible, to stop.

“Prior to applying for and obtaining approval for Xarelto, Defendants knew or should have known that consumption of Xarelto was associated with and/or would cause the induction of life-threatening bleeding, and Defendants possessed at least one clinical scientific study, which evidence Defendants knew or should have known was a signal that life-threatening bleeding risk needed further testing and studies prior to its introduction to the market,” the lawsuit states.

Ramsoondar is pursuing claims of negligence, strict product liability, breach of warranty, fraudulent misepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, and loss of consortium on behalf of her husband, Ramjit Ramsoondar. The lawsuit seeks both compensatory and punitive damages.

Xarelto Bleeding Problems

Xarelto (rivaroxoaban) was introduced in 2011 as a new-generation anticoagulant, designed to replace for Coumadin (warfarin), which has been the go-to anticoagulant treatment for decades.

The drug is part of a new class of medications designed to avoid blood clots among individuals at risk for deep vein thrombosis or pulmonary embolism, which have been promoted as easier to use than warfarin. However, since the drugs have hit the market, there have been a large number of reports involving severe and sometimes fatal bleeding problems with Xarelto and other members of this new class, including Pradaxa and Eliquis.

Each of the lawsuits involved in the Xarelto MDL raise nearly identical allegations, indicating that the drug carries a high risk of severe bleeds, and that information was withheld from the medical community about the lack of a safe and effective reversal agent for Xarleto to allow doctors to quickly stop the blood thinning effects of the drug.

While the side effects of warfarin can be quickly reversed with a widely known antidote if bleeding occurs, 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.

Similar claims were raised in the litigation over Pradaxa, which is a different medication that is part of the same new class of novel oral anticoagulants.

More than 4,000 Pradaxa lawsuits were ultimately filed by users of that drug who suffered bleeding injuries over that medication, which was introduced about one year before Xarelto. Following several years of litigation, the manufacturer of that medication ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.

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, and will far exceed those involved in the Pradaxa litigation.

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.