A Philadelphia jury on Tuesday hit Johnson & Johnson and Bayer with a $27.8 Million verdict for injuries linked to its blood-thinning drug, Xarelto.
This verdict marks the drugmaker’s first loss in Xarelto litigation after federal juries sided against plaintiffs in 3 cases earlier this year. In Philadelphia state court, jurors found the companies responsible for the Indiana plaintiff’s injuries. She had taken the drug for more than a year, with no warning of internal bleeding risks, before experiencing a serious hemorrhage that required multiple blood transfusions.
She and her spouse, who sued the companies in 2015, were awarded $1.8 Million in actual damages and $26 Million in punitive damages. Their victory leads more than 20,000 pending complaints about similar side effects.
Best-Selling Drug Risks Thousands of Lives
Xarelto, approved by the Food and Drug Administration (FDA) in 2011, is part of a class of new blood thinners called anticoagulants. These are prescribed to prevent and treat blood clots, or in the Indiana woman’s case, to prevent an irregular heartbeat from leading to stroke.
The drug is a best-seller for Bayer, which raked in $3.4 Billion in revenue last year, while Johnson & Johnson made $2.2 Billion. However, for thousands of U.S. consumers, the drug has been associated with serious, uncontrollable bleeding – and for many, this side effect was fatal.
During Xarelto’s clinical trials, evidence found, Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals had discovered a higher rate of bleeding in U.S. patients than overseas, amounting to 8.1 percent annually versus 3.6 percent. The companies also found significant disparities between U.S. patients and higher risks from Xarelto when taken alongside aspirin. None of these findings was included on the drug’s warning label.
Based on testimony from Food and Drug Administration (FDA) chief David Kessler, the jury concluded that the drugmakers should have warned doctors and patients about the severity of risks in the U.S. The plaintiff argued she may then have chosen an alternative medication. However, in the companies’ defense, the plaintiff’s physician testified that she would have prescribed the drug even if given additional warning.
Experts Hope to Keep Settlement Alive
Both Bayer and Janssen announced plans to appeal. The drugmakers insist their labeling “has always warned of bleeding events” and stand behind the safety and efficacy of its blood thinner.
“Xarelto’s safety and efficacy is supported by both real-world experience with 31 million patients and expert health regulators in 130 countries, and its FDA-approved label provides accurate and science-based information on the medicine’s benefits and risks,” said Bayer spokesperson Christopher Loder.
Sarah Freeman, Janssen spokesperson, conceded: “At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines. This verdict contradicts years of scientific data and the [FDA’s] repeated confirmation of Xarelto's safety and efficacy.”
Despite this supposed scientific evidence, the FDA has received reports of more than 68,000 serious cases and at least 370 deaths associated with the drug. And according to Johnson & Johnson, Xarelto suits have grown by 27 percent this year.
Further growth remains to be seen, but legal experts hope this win will spark more settlements in Philadelphia, a state known for its plaintiff-friendly juries. The next case goes to trial in January.