Patients complain that Xarelto, a blood-thinning drug developed to help reduce strokes is causing internal bleeding that has required hospitalization in some cases. Xarelto was jointly developed by Bayer and Johnson and Johnson. It is Bayer’s top-selling product, amassing $3.24 billion in sales last year.
In the first product liability Xarelto case to go to trial, a federal jury cleared both corporations of liability. The jury found that neither company mislead the plaintiff, nor his doctors, about the risks of the drug. During the trial, the attorneys for the man claiming injury from using the drug cited that Xarelto has no antidote and can put patients at risk of bleeding out if injured. They contend that the pharmaceutical companies failed to warn patients of the serious risk of uncontrollable bleeding.
This was the first of four test trials on cases involving Xarelto. Thus far, approximately 18,000 cases have been filed in the United States that fault the medication for internal bleeding. Xarelto has been linked to 370 deaths.
A spokesperson for Johnson and Johnson told The Chicago Tribune before the case went to trial that the lawsuits against the company “contradict years of data on the medicine and the FDA’s determination of its safety and efficacy.” Bayer representatives responded that the risk of bleeding from using Xarelto is written on the drug’s warning label.
Xarelto was approved by the FDA in 2011 to prevent blood clots for patients undergoing hip and knee surgeries. It is also prescribed to individuals with a heart rhythm disorder known as trial fibrillation, and to treat pulmonary embolism and deep vein thrombosis.
The two pharmaceutical companies have been accused of falsely marketing Xarelto as more effective at preventing strokes and easier to use than competing blood-thinners.
The attorneys representing the plaintiff in the first Xarelto case told Reuters that they would continue to move forward with other cases of injuries while taking Xarelto.