A jury in Philadelphia delivered a verdict of $29 million in damages against a pair of Johnson and Johnson and Bayer AG units, the first of its kind, after finding the companies had not provided the adequate warnings about the risks of bleeding associated with the blood thinner Xarelto.
After juries in federal multidistrict litigation sided with the drugmakers earlier this year, this verdict was a result of claims from Indiana woman native Lynn Hartman, who said she suffered from a gastrointestinal bleed while using the product in question.
Hartman’s trial is one case in a mass tort program in the Philadelphia County Court of Common Pleas to consolidate Xarelto-related product liability claims comprised by over 1,500 cases.
Hartman’s case centered around claim
s that Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. failed to include the necessary information in Xarelto’s warning label indicating that the rate of bleeding events observed in
a clinical trial, which showed that the rate among participants in the United States was 8.1 percent annually versus 3.6 percent annually among participants globally.
Furthermore, Hartman’s attorneys also accused the companies of failing to properly warn Xarelto users of the higher risk of bleeds when using the medication alongside aspirin, and of failing to inform doctors that some patients end up with significantly higher levels of the medication in their blood than others.
“Xarelto is the worst in class of the new blood thinners,” said Michael Weinkowitz, an attorney with Levin Sedran & Berman representing Hartman. “The serious health complications suffered by thousands of patients could have been avoided if physicia
ns were properly instructed about the risks, and if patients were given the choice to switch to Eliquis and Pradaxa which are safer and far more effective.”
Hartman’s case was strengthened by testimony from former Food & Drug Administration chief David Kessler, who believed the Xarelto warning label was lacking in key information about the dangers of bleeding associated with the drug.
The defendant’s’ trial team was led by Beth Wilkinson of Wilkinson Walsh & Eskovitz, who focused their defense on the language in the Xarelto label, which warns that the medication “can cause serious and fatal bleeding.”
“There isn’t a more serious warning you could give,” Wilkinson told jurors during closing arguments on Friday, emphasizing that the label could not have been more clear in its warning.
The defense also pointed to testimony from Hartman’s physician that she would not have changed her decision to prescribe the drug even with the additional information she said should have been included on the label.
“Bayer stands behind the safety and efficacy of Xarelto, believes there is no basis in fact or law for the verdict, including the punitive award, and plans to appeal,” said Bayer spokesman Christopher Loder. “Xarelto’s safety and efficacy is supported by both real-world experience with 31 million patients and expert health regulators in 130 countries, a
nd its FDA-approved label provides accurate and science-based information on the medicine’s benefits and risks.”
Sarah Freeman, a spokeswoman for Janssen, said the company would appeal the verdict.
“At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines,” she said. “This verdict contradicts years of scientific data and the [FDA] repeated confirmation of Xarelto’s safety and efficacy. We will appeal this verdict and will continue to defend against the allegations made in this litigation.”
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