A victim of the famous anticoagulant drug Xarelto has just been rewarded with over $28 million in damages in a Philadelphia court. While the legal proceedings of the centralized multidistrict litigation (MDL) MDL keep moving on, this verdict was reached in a state court as a part of the ongoing class action (case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation). This suit is the first bellwether trial outside the federal MDL, and the first one won by plaintiffs so far..

Plaintiff Lynn Hartman, 75, was prescribed rivaroxaban from March 2013 to June 2014, until she suffered a serious gastrointestinal bleeding that threatened her very life. According to her claim, manufacturers Bayer and Johnson & Johnson failed to warn her and her doctor about this risk, and distributed to the US market a defective product. The court adjudicated $2 million in compensatory damages and $26 million in punitive damages to the plaintiff.

Xarelto (rivaroxaban) is one of the most widely sold blood thinners in the United States. Shortly after it received approval in 2011, however, thousands of patients found that it was much more dangerous than originally advertised. The anticoagulant power of this drug was, in fact, impossible to titrate because of its popularly advertised “once daily” formula and lack of blood monitoring. What was initially marketed as a more convenient format, quickly proved to be a substantial danger form many subjects who did not tolerate well the universal dosage used on all patients, regardless of their age, weight or sex.

However, the most significant risk associated with Xarelto treatment, was the inability for doctors to reverse its effects with an antidote. Once a bleeding accident of any kind occurs, the patient’s hemorrhage cannot be stopped anymore, leading to serious complications including death. As a consequence, tens of thousands of victims filed a litigation seeking compensation, generating one of the largest waves of lawsuits in the last decades. Eventually, the U.S. Judicial Panel on Multidistrict Litigation consolidated these suits into the MDL No.2592 in the District Court for the Eastern District of Louisiana. However, since the number of cases was so high, another mass tort class action was also centralized in Philadelphia, Pennsylvania.

Article by Dr. Claudio Butticè, Pharm.D.