A Pennsylvania state court recently ordered Bayer AG and Johnson & Johnson to pay $27.8 million in damages for failing to warn users that Xarelto, a blood thinner made by the companies, could cause internal bleeding.
The plaintiff in the Philadelphia case had been hospitalized in 2014 with severe gastrointestinal bleeding, which she claimed resulted from her Xarelto use. She had been taking Xarelto for at least a year at the time of her hospitalization, according to court records. In 2015, she and her husband filed suit against Xarelto’s joint manufacturers, Bayer and J&J.
According to a report from Reuters, the verdict included $1.8 million in compensatory damages and $26 million in punitive damages. Approximately 1,400 Xarelto-related cases are still pending in Pennsylvania state courts, while another 18,500 have been consolidated into multidistrict litigation in federal court.
Next Steps in Xarelto-Related Cases
The Pennsylvania case was not the first Xarelto lawsuit that Bayer and J&J have defended. The verdict does, however, represent Bayer and J&J’s first Xarelto-related loss at trial. During three previous federal trials, the companies prevailed on their argument that they were not liable for failure to warn.
Both Bayer and Johnson & Johnson have stated that they plan to appeal the Pennsylvania verdict. In published statements, both companies have stood by their assertions that Xarelto’s labeling has always warned about the risks of internal bleeding and that the companies provided adequate information to allow doctors to make informed treatment decisions.
Xarelto remains Bayer’s best-selling drug, adding $3.41 billion in revenue to the company’s bottom line. Johnson & Johnson has reported earning $2.2 billion in revenue from Xarelto. With so much on the line, it is unsurprising that the company will continue to fight Xarelto cases – and that it will likely turn to the best expert witnesses it can find to help build its case.
Xarelto and The Experts: What Happens Now?
Xarelto, approved by the U.S. Food and Drug Administration (FDA) in 2011, is prescribed to reduce the risk of blood clots in patients with atrial fibrillation and certain other conditions. These blood clots, in turn, may cause serious or life-threatening conditions like deep vein thrombosis and pulmonary embolism.
Many of the Xarelto claims, including the one that led to the $27.8 million Pennsylvania verdict, are based on the argument that the company failed to warn consumers of the risks of internal bleeding. As a result, experts in drug safety, drug usage, and warning labels for medications have and will continue to play a key role in the Xarelto litigation. Additional experts likely to appear include physicians who treated plaintiffs, as well as medical experts on the conditions for which plaintiffs received Xarelto and the conditions which plaintiffs claim resulted from their Xarelto use.
Certain events related to Xarelto’s approval by the FDA may also raise questions in upcoming cases. In 2016, the FDA reviewed the data used in its 2011 approval of the drug after a monitoring device used in the clinical trials was recalled. The agency found that the effects of the recalled monitoring device’s use on the study outcomes were “minimal.”
Although the FDA “conclude[d] that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation” after the review, the question may complicate future Xarelto cases, further diversifying the expertise called upon to build both plaintiffs’ and defendants’ cases. For example, questions about how clinical trials are run and the effects of monitoring devices may require parties in upcoming cases to expand their list of experts to include researchers with knowledge in these fields, as well as experts who can break down the FDA’s approval process and demands for jurors.