Two Xarelto lawsuits have been filed in New York state court against Bayer HealthCare Pharmaceuticals and Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson. The lawsuits filed by two couples allege that the companies downplayed the risks of serious side effects associated with their anticoagulant drug Xarelto.

Plaintiff Joseph R. And Thomas W., along with their wives, both state in their lawsuits that they suffered life-threatening bleeding from Xarelto along with other severe and personal injuries. The lawsuits also allege that the manufacturers purposely concealed their knowledge of these “serious and dangerous side effects” which allegedly resulted from improperly carried out clinical trials.

“Upon information and belief, defendants concealed and failed to completely disclose its knowledge that Xarelto was associated with work cause life-threatening bleeding as well as its knowledge that they had failed to fully test or study said risk,” the pair of lawsuits states.

Xarelto is an anticoagulant drug designed to thin the blood of individuals who are prone to clotting. This can help avoid issues that can be caused by blood clots, including heart attack, stroke and pulmonary embolism.

However, the drug interferes with the normal clotting mechanisms of the body that are needed to stop bleeds. So some patients who have taken the drug, like Joseph and Thomas, have experienced life-threatening bleeding from Xarelto that is not easily controlled, and which has led to death in a number of situations.

In 2013, the manufacturers of Xarelto launched a massive advertising campaign totaling $11 million. This campaign  included direct-to-consumer advertising. According to the Xarelto lawsuits, this advertising to consumers overstated the actual effectiveness of the drug at preventing stroke, blood clots and pulmonary embolism, and the marketing failed to disclose that an antidote for excessive bleeding is not available.

The FDA has received thousands of reports of serious adverse events surrounding Xarelto, with several dozen reporting hemorrhage-related deaths due to life-threatening bleeding from Xarelto, the plaintiffs claimed. They state that the companies responsible for the manufacture of Xarelto did not respond appropriately by alerting the public of the risks, nor did they conduct additional safety testing of the drug.

While the Xarelto label has been updated to include information about increased risks to patients taking other medications concurrently with Xarelto, the lawsuits claim that the manufacturers still “failed to provide adequate disclosures or warnings” surrounding the drug’s lack of a reversal agent and safety risks associated with the drug.

“Prior to applying for and obtaining approval of 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 pair of lawsuits claims.

The couples in their respective lawsuits have raised claims of strict products liability, negligence, fraudulent misrepresentation, breach of warranties, fraudulent concealment, negligent misrepresentation and fraud and deceit. They are seeking compensatory damages as a result of the injuries they suffered from Xarelto.

In addition to these lawsuits filed in state court, the makers of Xarelto are involved in a multidistrict litigation over allegations of life-threatening bleeding from Xarelto. The manufacturers have won the first two bellwether trials in the multidistrict litigation, and a third bellwether trial is on the books for August.

The Life-Threatening Bleeding from Xarelto Lawsuits are Case Nos. 15612/2017 and 156166/2017, both in the Supreme Court of the State of New York, County of New York.