Last week, Johnson & Johnson (J&J) and Bayer AG had the first loss in the many Xarelto bleeding risk lawsuits. The Big Pharma duo has so far won the first three federal court cases. The Philadelphia state court jury handed down a $27.8M verdict for the plaintiffs, finding the companies didn’t adequately warn doctors and patients of the increased risk of internal bleeding with Xarelto use. The damages award is broken down into $1.8M in compensatory damages and $26M in punitive damages. The companies are already planning an appeal.Xarelto is a “next generation” blood thinner, what its makers hope will be long-used Warfarin’s replacement. So far, sales are very good, with Xarelto being Bayer’s biggest selling product at $3.2B just last year. It’s the third best seller for J&J, garnering the company $2.3B in sales in 2016.Approved by the FDA in 2011, Xarelto is used to treat those with atrial fibrillation (AFib, an irregular heartbeat) as well as to reduce the risk of developing pulmonary embolisms and deep vein thrombosis. While the drug comes with “benefits,” such as no dietary restrictions and no need for monthly bloodwork, it also comes with some serious drawbacks.The risk of serious, even fatal, bleeding events is high. More concerning is the fact that, unlike Warfarin, there is no reversal agent for Xarelto in the event of a bleed. If a patient taking Warfarin, also known as Coumadin, experiences a bleeding event, the correct dose of vitamin K will reverse the drug’s blood thinning effects. For Xarelto patients with bleeding events, the makers suggest blood transfusions. In healthy individuals ages 20 – 45, the drug remains in the system for 5 – 9 hours; the time increases to 11 – 13 hours for elderly patients.Currently, there are almost 20,000 pending federal cases dealing with Xarelto’s bleeding risks. They have been consolidated in a multi-district litigation (MDL) in the Eastern District of Louisiana.

Patient receiving blood transfusion; image courtesy of www.bloodcenter.stanford.edu.

The plaintiff in this case is 75-year-old Lynn Hartman. Mrs. Hartman’s doctor prescribed Xarelto as a stroke preventative given Mrs. Hartman’s AFib. Mrs. Hartman took the drug for about a year before being hospitalized due to severe gastrointestinal bleeding in June 2014. According to Mrs. Hartman, she had to undergo four blood transfusions to stop the drug’s effects. She has fully recovered and is currently using a different blood thinner with no ill effects.Mrs. Hartman’s attorney, Michael Weinkowitz, issued a statement saying, “Xarelto is the worst in class of the new blood thinners. The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”Of course, Bayer and Janssen (J&J’s subsidiary) both issued statements, too. Both companies are already planning to appeal the verdict.Sarah Freeman, spokesperson for Janssen, said that Xarelto’s label “has always warned of bleeding events” as well as giving doctors needed information to make good “treatment decisions.”Bayer’s spokesperson, Chris Loder, said, “Bayer stands behind the safety and efficacy of Xarelto and believes there is no basis in fact or law for the verdict, including the punitive award.”Janssen’s statement added that the verdict went against years of scientific data on Xarelto’s safety, as well as numerous confirmations of safety for use from the FDA.Interestingly, ex-FDA Chief David Kessler didn’t agree with Janssen during the trial. Mr. Kessler told the jury that Xarelto’s warning labels downplayed the bleeding risks and didn’t adequately warn doctors that certain patients’ risk for bleeding events would be higher.One finds it compelling that a former FDA Chief, no longer under pressure from the Agency and its corporate masters, made such a strong statement. Legal Reader will continue to cover this issue and report on the results of the appeal.A final word of advice for J&J and Bayer: that black eye you just got with this verdict is caused by internal bleeding. Let’s hope you’re using Warfarin.

Sources:

Jury Orders Bayer, J&J to Pay $28 Million in Xarelto Lawsuit

J&J, Bayer Ordered to Pay $28 Million in First Xarelto Loss