A man from Oklahoma is bringing a multi-million dollar claim against the manufacturers of his blood thinner medication, claiming they were responsible for his severe bleeding injury.

Plaintiff George B. says he suffered life-threatening bleeding and related consequences as a result of the defendants’ mishandling of their knowledge of Xarelto’s dangerous side effects.

George says he had been taking Xarelto for just a few months, from March to May 2014, when he suffered a hemorrhage in his right renal capsule. He attributes that Xarelto bleeding injury to the medication he had been taking.

George is bringing this Xarelto lawsuit against Janssen Pharmaceuticals, Bayer Healthcare Pharmaceuticals and their related companies, all of whom he alleges had a hand in designing, manufacturing or selling Xarelto.

Xarelto is a new-generation blood thinner approved by the FDA to help prevent blood clot-related injuries like stroke in persons with non-valvular atrial fibrillation. It’s also approved as a treatment for deep vein thrombosis and pulmonary embolism, and as a means to prevent those conditions from recurring.

Studies Show Risks of Blood Thinner Treatment

George cites a few clinical studies that he believes should have put the manufacturers on notice about the risk of Xarelto bleeding. One group of studies known as the RECORD studies compared Xarelto, referred to in the studies by its generic name rivaroxaban, to another blood thinner named enoxaparin. The studies found Xarelto bleeding led more often to decreased hemoglobin levels and need for blood transfusion, George says.

Another study called the ROCKET AF study compared Xarelto to the anticoagulant warfarin. George says that findings in that study showed that Xarelto was associated with more frequent bleeding from gastrointestinal sites, in addition to bleeding requiring transfusion or causing a drop in hemoglobin.

Yet another study, the EINSTEIN-PE study, demonstrated an increased risk of adverse events associated with Xarelto, including events that required prolonged hospitalization or permanent discontinuation of Xarelto.

George is making claims against Janssen and Bayer based on theories of negligence, products liability, breach of warranty, misrepresentation, concealment of vital information, and fraud. He alleges that due to the defendant’s actions he has been harmed to the tune of $10 million.

The Xarelto MDL

George’s Xarelto lawsuit is one of 2,800 similar claims that have been brought together in a single court as a multidistrict litigation, or MDL. The Xarelto MDL is going on in federal court in New Orleans, under the supervision of U.S. District Judge Eldon Fallon.

Generally, the plaintiffs in these cases make allegations similar to George’s. They typically say that Janssen and Bayer failed to properly warn Xarelto users about the risks of blood thinner side effects, and that if they had been  properly informed they may have elected not to take Xarelto.

The first few cases in the MDL to go to trial, known as “bellwether” trials, are scheduled to begin in early 2017. These four cases will be selected from a pool of forty consisting of ten cases selected by each side plus twenty cases randomly selected by the court.

More Xarelto lawsuits may join the MDL by the time the bellwether trials begin.

The Xarelto lawsuit is George B. v Janssen, part of the pending Xarelto MDL, MDL No. 2592 in the U.S. District Court for the Eastern District of Louisiana.