The upcoming Xarelto Multidistrict Litigation has grown to truly epic proportions. To date, a total of 5,853 lawsuits has been centralized in the MDL number 2592 in the Louisiana Eastern District Court. The massive mass tort presided over by Judge Eldon Fallon includes just a portion of the total disputes filed by plaintiffs all across the United States, as another class-action in Philadelphia, Pennsylvania, counts almost 600 more claims. Patients who used Bayer’s new blood thinner are waiting for the bellwether trials to be heard, as the most famous attorneys and doctors are going to provide their expertise and set the tone for future complaints.

Xarelto (rivaroxaban) is new generation anticoagulant drug used to treat Atrial Fibrillation (Afib), Pulmonary Embolism (PE), as well as several other conditions caused by blood clots such as Deep vein thrombosis (DVT). Initially advertised as a safer and more effective alternative to warfarin, Xarelto sales rapidly surpassed all its competitors in just a few years since its approval in 2011. While treatment with warfarin required the patient to endure several dietary restrictions and continuous blood monitoring, the newer medication manufactured by Bayer and Janssen Pharmaceuticals left them free to do whatever they want. A simple one-size-fits-all dosage was used for every patient, regardless of weight, sex, or age. However, the pharmaceutical companies never warned the public about the anticoagulant’s main risk: uncontrolled bleeding. Since no antidote is available, doctors could do nothing to save the many patients who suffered from an internal haemorrhage after taking the medicine. Even worse, lately the same clinical trial that the Big Pharma used to prove rivaroxaban’s safety and effectiveness, the ROCKET-AF trial, was put under the microscope. According to several investigations, in fact, a device used to monitor the patients’ blood coagulability was defective and skewed the results in favor of Janssen’s new drug.

Since the number of litigations kept growing after so many patients got seriously injured or even died, the Judicial Panel on Multidistrict Litigation (JPML) decided to centralize them in an MDL. Most of these lawsuits allege that subject who used the infamous medication suffered uncontrolled bleeding events, so the Judges decided to consolidate all those suits that shared similar questions of fact. Plaintiffs claim that the pharmaceutical companies never adequately warned them about the risks associated with the use of the blood thinner and that their negligence led to permanent injuries such as strokes and gastrointestinal bleedings. In one of the latest litigations, the Rowell suit (case number 2:16-cv-07281), Rebecca and David Rowell alleged that Bayer and Janssen negligently misrepresented their medication, and failed to properly manufacture, research and design it. David took Xarelto for just 10 days in June 2015, yet he suffered from a potentially lethal internal haemorrhage that almost killed him.

 
Article written by: Dr. Claudio Butticè, Pharm.D.
 
Published: 2016/08/08