The companies defending a lawsuit filed against them for safety concerns over blood-thinning drug Xarelto say their first win in a string of bellwether court cases bolsters their claims the drug is safe and contains proper patient warnings.
“The jury’s verdict affirms 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,” Chris Loder, head of Bayer U.S.’s external communications, told the Louisiana Record.
Drug manufacturers Bayer and Janssen Pharmaceuticals and parent company Johnson & Johnson won the first bellwether case May 3, which was argued before Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana.
That suit was filed on behalf of 75-year-old Joseph Boudreaux, who claimed the drug led to gastrointestinal bleeding and additional treatments after he was prescribed Xarelto to help treat a heart condition in 2014.
While the Bayer side won the Boudreaux case, Loder said the defense team was gearing up to face several more cases filed in state court and being heard through the multi-district litigation process used to expedite mass suit filings.
“Bayer’s most recent disclosure reports approximately 18,000 cases in total,” Loder said, “which includes the MDL and cases pending in state courts.”
Under the MDL structure, suits also are being scheduled for several jurisdictions through the country, including in Mississippi, Texas and Pennsylvania.
“In the MDL before Judge Fallon, there are four bellwether cases that are set for trial,” Loder said. “Boudreaux has concluded with a defense verdict. The (Joseph) Orr trial is scheduled for May 30 in New Orleans. Then there is a case scheduled before Judge Fallon in the Southern District of Mississippi scheduled for August 7. The fourth case will be in the Northern District of Texas in January 2018, and Judge Fallon will preside over this one as well.”
Loder would not comment on what the Boudreaux win means in the larger context of the remaining lawsuits but said the case further illustrates the companies’ contentions that Xarelto is safe to prescribe and use.
“Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it,” he said.