A motion has been filed to consolidate Xarelto lawsuits into a federal multidistrict litigation (MDL). MDLs are common when litigation becomes large and more complex; centralizing cases to one court before one judge helps make the process more efficient. The plaintiffs in the Xarelto litigation asked the U.S. Joint Panel of Multidistrict Litigation (JPML) to centralize cases in the Southern District Illinois court, arguing that the court is ideal because it has has experience with the recent MDL over Pradaxa, another new bloodthinner. In a hearing that will take place either late this year or early next year, the JPML will hear arguments on the motion.
There have been significant safety concerns regarding Xarelto in the short time it has been on the market. A number of lawsuits have been filed alleging that Bayer hid the risks of the drug, including an increased risk of bleeding. The drug was approved in 2011 to reduce the risk of blood clots in patients who have undergone knee or hip replacement surgery. It is also approved for patients who suffer from atrial fibrillation.
Xarelto belongs to a class of drugs referred to as New Oral Anticoagulants, which also includes the drugs Pradaxa and Eliquis. These drugs are touted as the next-generation medications to replace warfarin, an older anticoagulant that requires monitoring and dietary restrictions. Xarelto and other new anticoagulants do not require this. However, there is no reversal agent to stop bleeding in Xarelto patients once it starts. Warrfarin also carries a bleeding risk, but there is an antidote to reverse it.
The Institute of Safe Medication Practices (ISMP), a nonprofit patient safety watchdog, reported that there were 680 serious adverse event reports linked to Xarelto in the first quarter of 2013. Comparatively, there were 528 incidents reported for Pradaxa. Reuters interviewed a number of doctors who indicated that they were hesitant to prescribe Xarelto, due to the risk of irreversible bleeding. This is especially a concern in patients with poor kidney function.