Weeks after a federal judicial panel centralized nearly two dozen product liability lawsuits against Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals over the popular blood thinner Xarelto, the first hearing has been scheduled.

On Jan. 29, U.S. District Judge Eldon E. Fallon in the U.S. District Court in the Eastern District of Louisiana will hold a status conference to address scheduling and other issues.

Anticipating thousands of yet-to-be-filed Xarelto lawsuits, the U.S. Judicial Panel on Multidistrict Litigation placed some 21 Xarelto cases that allege the drug caused plaintiffs to suffer dangerous internal bleeding and other serious complications before one judge.

The federal panel decided it made sense to centralize the Xarelto lawsuits with common issues, “including the adequacy of Xarelto’s warning label as to the risk of severe bleeding, the results of certain clinical studies, and the alleged need for blood monitoring.”

Creating a multidistrict litigation — assigning all the cases before a single judge — helps to reduce duplicative discovery, makes the litigation more convenient for the various witnesses and parties involved on both sides and helps avoid inconsistent court rulings.

The defendants opposed the creation of the Xarelto MDL, arguing that it would “generate the filing of voluminous claims without due diligence by plaintiffs’ counsel.”

The Xarelto lawsuits allege severe internal bleeding and/or wrongful death caused by the relatively new blood thinner, which received FDA approval in 2011. In the wrongful death cases, family members say Xarelto (rivaroxaban) resulted in fatal bleeds.

Xarelto is in the same class of drugs as Pradaxa, an anticoagulant (blood thinner) that is the defendant in more than 4,000 lawsuits where plaintiffs allege bleeding complications. Pradaxa manufacturers have settled with plaintiffs for $650 million.

Similar to the Pradaxa lawsuits, the Xarelto lawsuits accuse the manufacturers of failing to provide adequate warnings about the risk of severe bleeding and the lack of an approved reversal agent.

Xarelto is manufactured and marketed by Janssen Pharmaceutical and Bayer that has been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (arrhythmia of the heart), deep vein thrombosis (blood clots deep within the body), pulmonary embolism (blood clots in the lungs), stroke, and patients who have recently undergone a knee or hip replacement surgery.

Many doctors prescribe it instead of Warfarin (Coumadin), a blood thinner that has been used in the United States for 50 years. Severe internal bleeding and death are Xarelto’s most commonly reported side effects, but others include thrombosis (blood clots), decreased hemoglobin (a substance that carries oxygen in red blood cells), cerebrovascular accidents (an event that leads to a cerebral hemorrhage), hematoma (a semisolid mass in the blood), peripheral edema (swelling of the lower limbs), and dyspnea (difficulty breathing).

Johnson & Johnson and Bayer have marketed Xarelto as a superior blood thinner alternative to Coumadin for anticoagulant therapy.

There is no known cure to reverse internal bleeding caused by Xarelto.

In July 1, 2011, the FDA approved rivaroxaban (the generic term for Xarelto) for prophylaxis of deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. Four months later, the agency approved its use for stroke prophylaxis in patients with non-valvular atrial fibrillation.