Xarelto is a blood thinner that was initially approved by the Food and Drug Administration (FDA) in July 2011 to prevent strokes in patients who recently underwent hip and knee replacements. In November 2011, the manufacturers received an additional indication for use in patients with non-valvular atrial fibrillation, or an irregular heartbeat. In November 2012, Xarelto was approved to treat or reduce the recurrence of deep vein thrombosis and pulmonary embolism. Since Xarelto was first approved, there have been several reports of bleeding events for those taking Xarelto, including but not limited to, gastrointestinal bleeding, hemmorhagic strokes, and brain hemorrhages.
In December 2014, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally-filed lawsuits against Johnson & Johnson (J&J), Bayer, and other related entities in a multi-district litigation (MDL No. 2592) in the Eastern District of Louisiana. To date, over 300 lawsuits have been filed in the MDL. There have been approximately 202 cases filed in jurisdictions outside of the MDL.
In the lawsuits that have been filed, some of the allegations are that the manufacturers ignored patient safety and failed to warn about the significant risks with Xarelto, including that in the event of a serious bleeding incident there is no available reversal agent, or way to reverse the bleeding. Other claims are that the pharmaceutical companies heavily marketed Xarelto by overstating the benefits and understating the risks as a “one-size-fits-all” drug in their advertisements, failing to account for individual patient conditions. The lawsuits further assert that the manufacturers over-promoted Xarelto’s benefits compared with its anticoagulant predecessor, warfarin, since Xarelto does not require regular blood monitoring.
Despite the number of lawsuits filed and concerns about bleeding risks, Xarelto sales rose in the first quarter of 2015 and total J&J pharmaceutical division sales increased 3% in the first quarter to $7.7 billion. In addition, Bayer has raised its forecast for Xarelto’s 2015 sales growth to 30% from 20%.
Kelly A. Fitzpatrick is a senior associate in the Complex Litigation department at Ventura Ribeiro and Smith (“VRS”). VRS is a leading law firm that clients have entrusted with their complex legal issues for over 50 years. With five offices in Connecticut and New York, VRS handles cases nationally and has developed the experience and reputation as highly effective and dedicated legal counsel.