Johnson & Johnson and Bayer AG are responsible for a woman’s injuries tied to the blood-thinning drug Xarelto and must pay almost $28 million in damages, jurors concluded in the companies’ first loss at a trial over the medicine.
Lynn Hartman said she took Xarelto, sold by J&J’s Janssen Pharmaceuticals unit, for more than a year before being hospitalized in 2014 with gastrointestinal bleeding she blamed on the drug. A Philadelphia jury on Tuesday ordered J&J and Bayer, which jointly developed the product, to pay $1.8 million in actual damages and $26 million in punitive damages, one of Hartman’s lawyers said after the verdict.
Johnson & Johnson and Bayer won the first three cases to come to trial in federal courts in Louisiana and Mississippi, after juries found the drug was safe and the companies properly warned about Xarelto’s bleeding risks. Plaintiffs had pinned their
hopes on winning in state court in Philadelphia, which is known for having plaintiff-friendly juries.
“Xarelto is the worst in class of the new blood thinners,” Michael Weinkowitz, a Philadelphia attorney who represents Hartman, said in an emailed statement. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”
J&J and Bayer officials said Tuesday that they’d appeal the jury’s finding that Xarelto posed a health risk. Xarelto’s labeling “has always warned of bleeding events” and provided information doctors need to make proper “treatment decisions,” Sarah
Freeman, a Janssen spokeswoman, said by email.
“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,” Chris Loder, a Bayer spokesman, said in an emailed statement.
The companies still face more than 21,000 patent suits over Xarelto, which has been linked to at least 370 deaths, according to U.S. Food and Drug Administration reports. Patients have said that Xarelto can cause uncontrollable bleeding and that
Bayer and J&J failed to provide an antidote. Some also claim the companies failed to properly warn about the drug’s risks.
Bayer and J&J officials counter that Xarelto is safe and that its bleeding risks are fully outlined in the drug’s warning label and are well-known by doctors. They also note that FDA officials found the drug to be safe and effective.
The drug is Bayer’s top-selling product, generating $3.24 billion in sales (3 billion euros) last year and $2.5 billion (2.3 billion euros) in 2015 for the Leverkusen, Germany-based pharmaceutical company. Xarelto is J&J’s third-largest seller,
bringing in $2.29 billion in 2016 as the New Brunswick, New Jersey, company seeks to replace revenue from its Remicade arthritis treatment, which lost patent protection a year ago.
Xarelto belongs to a new class of drugs aimed at replacing Bristol-Myers Squibb Co.’s Coumadin, which has thinned patients’ blood since the 1960s. Other new thinners include Pradaxa made by Boehringer Ingelheim GmbH, a German company that paid $650 million in 2014 to settle thousands of suits claiming it hid the medicine’s bleeding risks.