Johnson & Johnson and Bayer have settled 25,000 lawsuits relating to the company’s Xarelto blood thinners. The companies, which sell the product jointly, settled the lawsuits for $775 million. Patients that have used the drug claim that the companies did not properly warn consumers of the fatal bleeding episodes that can be experienced from taking the drug.
The companies will split the settlement amount evenly which resolves all state and federal cases involving Xarelto.
The companies do not admit liability. Instead, Johnson & Johnson claims that the settlement is an effort to avoid lengthy and resource-intensive lawsuits. Bayer also released their own statement, claiming that the company remains committed to their Xarelto product and the 45 million patients that use the drug worldwide.
Lawyers for patients that were prescribed Xarelto claim that the drug, which is designed to prevent blood clotting and strokes, can trigger massive bleeding in patients. Serious injury or death can result from these bleeding episodes.
The bleeding episodes did not have an antidote, and standard treatments to stop the bleeding often didn’t work.
The Food and Drug Administration, just last year, approved Andexxa, which is designed to stop bleeding in patients that take Xarelto. Johnson & Johnson and Bayer both stand behind their product, citing the many clinical trials which show that the blood thinner is safe.
The trial that led to the drug’s approval was flawed due to a blood-testing monitor being faulty. The FDA claims that the monitor’s faults did not skew the trial’s outcome.
Xarelto is a leading drug for Johnson & Johnson, bringing in $2.5 billion in revenue in 2018. The companies will still be allowed to sell Xarelto and stand behind the drug’s safe usage.
The companies were ordered to pay an Indiana couple $28 million in 2017 over not warning the couple of the potentially fatal bleeding episodes caused by Xarelto. The ruling has since been overturned.