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Johnson & Johnson, Bayer Win First Bellwether Xarelto Trial

In the first of over 18,000 Xarelto cases to come before a federal judge, a Louisiana jury has determined that drug makers Johnson & Johnson and Bayer bear no liability for the near-fatal gastro-intestinal hemorrhaging and resultant health complications of a 74-year-old Xarelto patient who has required several blood transfusions and hospitalization. The verdict favoring the defendants was handed down on Wednesday, May 3rd.

At the heart of the complaint are allegations that a test was available to gauge an individual’s risk of hemorrhage while taking Xarelto. According to the plaintiff, no information about this test was provided. According to the plaintiff’s co-counsel, Brian Barr of the Levin-Papantonio Law firm, this withholding of information was a deliberate attempt by J&J and Bayer to preserve their profits. In his closing argument before the jury, Barr said, “They only accept science they like, and decide to ignore science they don’t like…they know if they require blood tests, they’re terrified that doctors will just use another drug.”

That allegation would seem to be supported by the fact that Xarelto is Bayer’s top-selling prescription drug as well as one of J&J’s top three. Global sales of Xarelto grew by 77% between 2013 and 2014, and accounted for nearly $5 billion in revenue for the two companies in 2016 alone.

Xarelto is one of a trio of “new generation” anti-coagulant medications designed to replace warfarin, a type of rodenticide that has been used to treat patients at risk of blood clotting since the 1950s. Warfarin (sold by Bristol-Meyers Squibb under the brand name Coumadin) is a Vitamin K inhibitor with many potential interactions. Patients treated with warfarin require frequent blood tests and monitoring and are subject to many diet restrictions. However, bleed-outs due to warfarin are easily corrected by administering high doses of Vitamin K.

Xarelto inhibits the action of a blood clotting agent, known as Factor Xa (“ten-a”), and is much easier for doctors and patients, since there are fewer interactions. However, when a patient experiences serious hemorrhaging, the only realistic option is emergency dialysis – an unreliable solution, and one that depends on fast access to a hospital. The plaintiff’s lawyers pointed out that Xarelto has no antidote, putting patients at risk for fatal bleed-outs (an antidote has been in development at a small, San Francisco-based biotech firm, but has yet to gain FDA approval).

Despite evidence that Bayer and J&J were aware of the risks, the jury agreed with a Bayer spokesperson, who said that Xarelto’s “FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine.”

Plaintiff counsel says “we will learn from the experience of this trial, and continue to press forward with the legal claims of thousands of innocent victims whose lives have been shattered by Xarelto.” The next Xarelto case to come to trial will begin at the end of May.