Xarelto is a popular anticoagulant drug produced by healthcare behemoth, Johnson & Johnson’s Bayer division. The drug is prescribed to combat pulmonary embolus and deep vein thrombosis, which are types of blood clots. 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.
It was first approved in 2011. Soon, however, life-threatening side effects began showing up in patients who had used the drugs. The primary and most dangerous side effect that patients began to experience was uncontrollable internal bleeding. Sadly, this condition has led to death for many of these patients. Everything from brain bleeds to bleeding from the eyes has been reported.
The FDA was first alerted to these issues mere months after the drug went to market. Soon allegations and claims started rolling in against Johnson & Johnson. According to plaintiffs, the company failed to adequately warn patients of the increased risk of the deadly internal bleeding risks associated with the drug. Not only patients were not made aware of these risks but also physicians were unaware of the increased risk. Claims have been reported that Johnson & Johnson didn’t just provide inadequate information about these side effects but they went as far as to mislead consumers and physicians.
Through an aggressive advertising campaign, the company claimed or at the very least implied that Xarelto was safer than its leading competitor, Warfarin, a long-standing drug used for the same health issues. Johnson & Johnson, through its marketing campaign, claimed that the drug was so safe that patients didn’t need to have blood monitoring or dosage adjustments. Warfarin requires both of these for safety purposes.
Another discrepancy that the drug makers failed to mention was the fact that there is no known antidote to control internal bleeds caused by Xarelto. This means that if a patient using Xarelto experiences this bleeding that likely it will lead to death and it has in many, many cases. It is alleged that Johnson & Johnson knew these risks but chose to hide them ahead of the drug’s release in 2011. This has opened the door for a massive number of lawsuits from victims and their families who may have avoided these tragic consequences if the company had done its due diligence.
Throughout the years since the release of the drug, in the face of skyrocketing reports, the FDA has issued warnings to the public about the risk of uncontrollable bleeding. In addition, the FDA “flagged” Xarelto, which is akin to a slap on the wrist, for the fraudulent ad campaign that claimed the drug to be safer than alternatives.
It is now estimated that around 17,000 lawsuits against Johnson & Johnson’s Xarelto are awaiting trial. The first of these, which is a bellwether trial, will begin in New Orleans, Louisiana on March 13. The trial will be of national interest and other victims with pending Xarelto class action lawsuits will be watching to see how this initial trial will work out.