Sunday, July 5, 2015 - The first bellwether trials for multidistrict litigation relating to the blood-thinning drug Xarelto have been set to begin in August of 2016. More than 400 lawsuits are currently included in the MDL against Xarelto manufacturers Bayer AG and Johnson & Johnson, and 50 plaintiffs from those cases have been selected to participate in the bellwether trials before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana federal court. The bellwether trials are expected to take place between August and October of 2016.
The claims against Bayer and Johnson & Johnson‘s medication Xarelto stem from a bevy of serious bleeding incidents that have taken place connected to their drug. The drug, intended to work as a blood thinner to help prevent heart complications and strokes, was discovered to lack a blocking agent that could help clot the blood in the event of a bleeding accident. This feature of the blood-thinner was crucial in Xarelto‘s predecessor drug Warfarin, which included Vitamin K as the ingredient that assisted in clotting a patient‘s blood. The plaintiffs claim that Xarelto‘s lack of a reverse agent has contributed directly to the dozens of bleeding injuries connected to the drug.
Xarelto became popular almost instantly after its initial FDA approval in 2011, selling over ten million units since its introduction to the market. The medication peaked in 2013, when its net sales reached $2 billion. However, reports began to surface of minor bleeding incidents involving Xarelto turning serious and sometimes fatal because of a patient‘s inability to staunch the affected area and stop bleeding. More than 50 deaths have allegedly been connected to bleeding injuries suffered in patients using Xarelto.
The lawsuits that originally filed for an MDL were transferred in December of 2014. Only 33 lawsuits were transferred at the time, though since then the total has grown to more than 400 with some lawyers estimating the final number could pass 1,000 lawsuits. This number takes into account more than 100 Xarleto lawsuits that are currently pending in state court in Pennsylvania. Plaintiffs are claiming that the manufacturers of Xarelto were aware of the severe bleeding risk the medications posed to patients and chose not to affix an adequate warning to the drugs because of the profits they were making off their sales.
New studies related to Xarleto have also highlighted concerns regarding the drug‘s connection to internal bleeding. Doctors and the British Medical Journal have both published reports linking Xarleto to a rise in the risk of both eye hemorrhaging and stomach bleeding when compared to the drug‘s predecessor Warfarin.
The Xarelto MDL recently had what Judge Fallon referred to as a "Science Day," where both sides were able to present information on many of the complex topics relate to the claims filed against the defendants in an informal hearing. Many of the topics involved information relating to the bleeding issues at the heart of the plaintiffs‘ claims, including presentations on anticoagulants and atrial fibrillation. Judge Fallon will hear the next status conference in the Xarelto MDL this week on July 9.