On December 5, 2017, a Philadelphia jury ordered Bayer AG and Johnson & Johnson to pay over $27 million in damages to a patient injured by the companies’ most lucrative medication, Xarelto®.
In a verdict that marks the first patient victory in the ongoing Xarelto® litigation, a Philadelphia jury ordered Bayer AG and Johnson & Johnson to pay $27.8 million in damages for the companies’ failure to warn of the health risks associated with the drug Xarelto®. The jury decision requires the companies to pay $1.8 million in compensatory damages and $26 million in punitive damages.
In this case, and many others that have been filed, the plaintiff was prescribed Xarelto® —a prescription anticoagulant (blood thinner)—to help prevent strokes caused by atrial fibrillation. However, a short period of time after beginning the medicine, the plaintiff suffered gastrointestinal bleeding and needed to be hospitalized for the condition. Many legal claims filed by former Xarelto® patients allege that they, or a family member, experienced similar severe injuries after taking the medication, and several cases claim that these injuries led to death.
What is Xarelto®
Xarelto® was approved by the FDA in 2011 for use in treating and reducing the risk of pulmonary embolism, deep vein thrombosis and stroke. According to Reuters, the medication is Bayer’s most lucrative pharmaceutical product, yielding $3.41 billion in revenue in 2016.
Xarelto® has been promoted as the only once a day blood thinner with no dietary restrictions and no blood monitoring on the market. Yet, despite these potential benefits, there is also no antidote for the medication, and any internal bleeding in patients that occurs while taking Xarelto® is difficult to control. Bayer and Janssen were cited by the FDA in June of 2013 for “misleadingly minimiz[ing] the risks associated with Xarelto®.”
In May of 2013, the Institute for Safe Medication Practices released a report suggesting that, due to the number of adverse events associated with the medication, Xarelto® had become the most dangerous drug in the Anticoagulant market. Hundreds of the adverse events reported have involved bleeding in the form of brain hemorrhaging, rectal bleeding, intestinal bleeding, and death caused by the former. Further, in 2012, FDA reports showed that in comparison with those of Warfarin, adverse effects of Xarelto® resulted in three times as many deaths.
This trial was the first of more than one thousand cases against the pharmaceutical companies pending in the Philadelphia state court system. However, there are nearly 19,000 lawsuits that have been consolidated in a multidistrict litigation at the U.S. District Court for the Eastern District of Louisiana. Despite the overwhelming number of similar claims against the companies, both Bayer AG and Johnson & Johnson have indicated that they plan to appeal the verdict, siting that the decision contradicted scientific research and reporting of Xarelto® ’s safety by organizations including the FDA itself. The December jury decision serves as a significant victory for plaintiffs and victims of Xarelto® .