The first verdict to go against Bayer and Johnson & Johnson over Xarelto's bleeding risks didn't stand up to court scrutiny. A U.S. judge overturned the $28 million award on grounds it was an unreasonable result.
In the case of Lynn Hartman, Judge Michael Erdos in Philadelphia this week entered a judgment notwithstanding the verdict, which is a finding that a no reasonable jury could have reached the same conclusion.
Hartman brought the case in Pennsylvania, arguing her Xarelto use—prescribed to prevent strokes associated with atrial fibrillation—caused severe gastrointestinal bleeding, according to Reuters. The case was the first to go to trial in state courts over Xarelto bleeding risks, a J&J spokesperson previously said.
Representatives for both Bayer and J&J said the companies are "pleased" with the decision and that they will continue defending their product in court.
Michael Weinkowitz an attorney for Hartman, said the "dismissal was based on a very narrow issue related to Mrs. Hartman’s prescribing physician." He said the court determined the jury's punitive damages award was "appropriate and that sufficient evidence existed for the jury to find that the defendants acted with reckless disregard for human life."
"This ruling regarding the defendants' wrongful conduct—which resulted in the jury awarding $26 million in punitive damages—has far broader implications for the Xarelto litigation as a whole. We look forward to trying the next series of cases in Philadelphia. "
The original verdict in December was the first case to go against Bayer and J&J in their defense of the blockbuster blood thinner, which has come under legal attacks claiming it can cause serious bleeding and that the drugmakers didn't appropriately warn patients and physicians. For their part, both companies contend the med's label discloses its risks.
"Xarelto’s FDA-approved labeling has always warned of bleeding events—a known risk associated with anticoagulation—and appropriately informs physicians of the information that they need to make treatment decisions with their patients," a J&J spokesperson said via email late Tuesday.
J&J faces about 21,400 Xarelto liability cases, as of its most recent quarterly filing. About 1,400 are in Philadelphia, Reuters reports. First approved by the FDA in 2011, Xarelto was Bayer’s top-selling drug last year, with $3.24 billion in revenues. It ranked third for J&J at $2.5 billion in sales.