A Tennessee couple has filed a lawsuit against the manufacturers of the blood thinning drug Xarelto (rivaroxaban), alleging that Bayer and Janssen Pharmaceuticals (a subsidiary of Johnson and Johnson) produced and marketed a dangerous and defective drug.

In the Xarelto lawsuit, plaintiffs Charles and Margaret G. accuse the manufacturers of purposely concealing important safety information from the medical community, the FDA, and the public. They also allege that the manufacturers did not test the drug enough before it was put on the market.

Charles was prescribed Xarelto in December 2013 to treat a medical condition known as atrial fibrillation. He took the drug as directed, but suffered serious and dangerous side effects including life-threatening gastrointestinal bleeding in June 2014. Charles had to be hospitalized and undergo blood transfusions.

Charles claims the drug should not be sold and that Bayer and Johnson & Johnson continued to sell it even though they knew the risks. Charles’ Xarelto lawsuit is seeking compensatory, economic, and punitive damages. Charles’ wife is joining the Xarelto lawsuit, seeking damages for emotional distress, medical expenses and loss of consortium.

FDA Warns of Xarelto Bleeding Risks

Rivaroxaban, marketed under the brand name Xarelto, is a prescription blood thinner designed to stop blood coagulation. Manufactured by Bayer and approved by the U.S. Food and Drug Administration in July 2011, Xarelto is often given to patients who undergo joint replacement surgery or have non-valvular atrial fibrillation.

Despite its wide use, Xarelto has been linked to an increased risk of serious bleeding, stroke, blood clots, and other serious side effects. In August 2013, the FDA required Bayer to change the warning label on packages of Xarelto.

Xarelto Injury

Injuries associated with Xarelto side effects are potentially life-threatening and include serious bleeding events, pulmonary bleeding, and deep vein thrombosis.

Serious Bleeding Events: Uncontrollable Xarelto bleeding can be very dangerous, often requiring extended hospitalization. In severe cases, it can result in death. Major Xarelto bleeding events can include gastrointestinal bleeding, intracranial bleeding, brain aneurism, hemorrhagic stroke, and more.

Pulmonary Bleeding: Pulmonary bleeding or pulmonary embolism occurs when a blood clot formed in the legs or pelvis travels to the lungs. Pulmonary bleeding can cause difficulty breathing, rapid heart rate, low blood pressure, and sudden death.

Deep Vein Thrombosis (DVT): DVT occurs when a blood clot forms in a deep vein—most often in the legs. Complications of DVT include swelling of the legs, leg pain, and pulmonary embolism if the clot travels to the lungs.

Unlike other blood thinners, such as warfarin (Coumadin), there are no counteracting drugs for Xarelto and no way to reverse its effects. This can increase the risk of severe injury or death in the event of major bleeding.

If you or someone you love took Xarelto and developed any of these complications, you may be eligible for compensation.

The Xarelto Lawsuit is Case No. 2:15-cv-01571-MBN, in the U.S. District Court for the Eastern District of Louisiana.