Bayer and J&J Win Second Xarelto Trial
A federal court in New Orleans, Louisiana, has cleared manufacturer Bayer and its US marketing partner Johnson & Johnson of liability in the second trial of what is expected to be more than 18,000 lawsuits involving the blood thinner Xarelto.
Bayer and J&J also won the first lawsuit, also heard in New Orleans, last month. In a statement, the German group said the two verdicts "affirm both the safety and efficacy of Xarelto” and that its FDA-approved label contains “accurate, science-based information on the benefits and risks of this life-saving medicine." J&J's Janssen Pharmaceuticals subsidiary said it “will continue to defend against the allegations.”
Attorneys for the plaintiffs, however, said they "will continue to press forward with the legal claims of the thousands of innocent victims of this drug." They contend that the companies should have warned patients that they could be tested to assess their bleed-out risk before taking the blood thinner.
Approved by the US Food and Drug Administration (FDA) in 2011 to prevent deep vein thrombosis and pulmonary embolisms in patients undergoing knee and hip surgeries, Xarelto’s indication was later extended to patients who suffer from atrial fibrillation (irregular heartbeat) and are at high risk of stroke as.
The drug is Bayer’s top-selling medication, with annual sales of around €3 billion ($3.24 billion) in 2016, and is J&J’s third largest in terms of revenue, accounting for $2.29 billion last year.
The case just heard was brought by the family of a 67-year-old academic advisor at Louisiana’s Tulane University. Reports said the woman began taking Xarelto in February 2014 for treatment of atrial fibrillation. She died in May 2015, ten days after suffering a massive brain hemorrhage.
The drugmakers contended that Xarelto was not the cause of the patient’s death, but instead serious disorders that she suffered from, including poorly managed diabetes and chronic kidney disease.
A federal court in Jackson, Mississippi, is due to hear the next Xarelto lawsuit, on Aug. 7.
