Janssen Research & Development LLC, a Johnson & Johnson subsidiary, faces a gastrointestinal bleeding lawsuit filed by a woman on behalf of her husband who says he suffered severe side effects and subsequently died after having been prescribed the anticoagulant medication.

Plaintiff Joann M. a resident of Warrant County in the State of New York, filed the gastrointestinal bleeding lawsuit in Louisiana federal court joining a growing multidistrict litigation (MDL) against the company. The lawsuit was filed on May 29, 2018.

According to the gastrointestinal bleeding lawsuit, Joann’s husband Robert M. began taking Xarelto on Feb. 11, 2016 until approximately June 6, 2017. However, after ingesting Xarelto, he allegedly suffered “gastrointestinal bleeding with acute blood loss anemia requiring transfusions on June 6, 2016,” the gastrointestinal bleeding lawsuit states.

Robert died on Sept. 18, 2016, says the complaint.

The gastrointestinal bleeding lawsuit was filed on multiple counts including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud, violation of consumer protection laws/consumer fraud laws, loss of consortium, and NY state consumer protection laws.

Joann demands a trial by jury.

Gastrointestinal Bleeding Lawsuit Joins Many Others

Joann’s claims on behalf of her loved one were filed as part of a large multidistrict litigation (MDL) centered on allegations that Xarelto causes patients to suffer serious internal bleeding injuries, among other side effects. Other side effects include gastrointestinal bleeding, uncontrollable internal bleeding, hemorrhaging, deep vein thrombosis, pulmonary embolism, and ischemic stroke.

Like Joann’s husband there have been thousands of victims who say they or their loved ones have suffered from gastrointestinal bleeding side effects and have filed lawsuits against the drug’s manufacturers.

Although recently approved for a reversal agent, Andexxa (andexanet alfa), earlier this year, Xarelto’s prior lack of a reversal agent lead to a number of severe side effects, lawsuits contend.

According to tctMD, Andexxa is the first reversal agent for Factor Xa Inhibitors. This class of medication works when coagulation is initiated. This is done through the presence of small amounts of thrombin are generated when there is injury or when platelets become activated to help inhibit bleeding. However, Factor Xa “amplifies” coagulation thus generating more thrombin.

Xarelto (rivaroxaban), one of the more recent anticoagulant drugs became approved by the U.S. Food and Drug Administration (FDA) in 2011. Xarelto is prescribed to help lower a patients’ risks to stroke, development of deep vein thrombosis (DVT), and pulmonary embolism (PE).

However, according to FDA reports, among the most dangerous anticoagulant medication are warfarin (Coumadin), dabigatran (Pradaxa) and rivaroxaban (Xarelto). In fact, there were 1,734 adverse event reports filed with the FDA in 2012, and of these adverse event reports, 233 resulted in patient fatality and death. Adverse event reports included reports of uncontrollable internal bleeding in patients and patients hemorrhaging.

The Gastrointestinal Bleeding Lawsuit is Case No. 2:18-cv-05363-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana. The Xarelto Lawsuit is MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.