In 2011, the FDA approved Johnson & Johnson’s, Bayer division to release their new anticoagulant to the market. Xarelto is used to prevent and treat types of blood clots called pulmonary embolus and deep vein thrombosis. These blood clots are common in patients suffering from atrial fibrillation, which is a rhythmic problem with the heartbeat. Blood can pool up from the hearts out of sync rhythm which in turn can lead to the blood clotting and then traveling to the heart and lungs. They also can be problematic in certain types of orthopedic surgeries such as knee or hip replacement. It serves to prevent the blood from clotting and traveling to the lungs and heart. It does this by removing a certain type of protein from the blood that contributes to blood clotting.
Soon after the drug hit the market devastating reports started coming in about some previously omitted or understated side effects. Hundreds then thousands of patients using the drug experienced uncontrollable hemorrhaging. Patients experienced brain bleeds, intestinal bleeds, rectum bleeds and numerous other areas of hemorrhaging. The bleeding in many of these patients proved to be completely uncontrollable and unfortunately led to death in many cases, causing Lawsuits.
Now, nearly six years into its place in the market, around 10,000 lawsuits are awaiting litigation across the country. Patients and their families are claiming that Johnson & Johnson were negligent in making them aware of the severity of the risks of uncontrollable bleeding that can be caused by taking this. The company is accused of inadequately warning patients and physicians of these risk. They are also alleging that the company intentionally misled them through an aggressive marketing campaign that claimed the drug was so safe that it wasn’t necessary to undergo blood monitoring or dosage adjustments. Both of these are requirements of Xarelto’s leading competitor and long-standing anticoagulant, Warfarin. In addition, it is alleged the company did not make patients and physicians aware of the fact that there is no antidote available to stop the uncontrollable bleeds that patients may experience.
In short, plaintiffs are alleging that Johnson & Johnson were aware of these life-threatening side effects before releasing the drug and throughout. Johnson & Johnson is being accused of being intentionally negligent in making consumers aware of these side effects and the fact there is no antidote. Patients who have suffered these uncontrollable bleeds, in many cases died from them.
Amid reports of these life-threatening side effects and deaths linked to the use of the blood-thinner, the FDA has issued several warnings about the risks associated with using the drug since its release. In addition, the FDA even flagged the drug maker for their aggressive ad campaign that claimed the drug was safer than others. Despite these warnings and slap on the wrist “flagging”, the company continued to aggressively market the drug to consumers and physicians.
On March 13, 2017, the first bellwether trial against Johnson & Johnson will begin in New Orleans, Louisiana. This is an important trial as it will set the tone for following lawsuits against Xarelto. Though the outcome of this initial trial will not be binding for others, it will, however, facilitate future settlements and possibly influence them away from going in front of a trial jury.