Big Pharma Two, Patients Zero: Latest Xarelto Suits

Last week, Big Pharma giants Bayer and Johnson & Johnson scored a victory in the second bellwether trial involving the popular blood thinning drug, Xarelto. A federal jury in New Orleans handed down the verdict clearing the companies of all liability for Sharyn Orr’s 2015 death.

The suit, brought by Orr’s husband and children, alleged that Mrs. Orr’s stroke and subsequent death were a result of the medication’s bleeding risks. Such risks, the family claimed, could have been avoided if only Mrs. Orr’s doctor had been given adequate information on the bleeding risks involved with using Xarelto. She was taking the drug to treat her atrial fibrillation (a heart rhythm disorder).

The first bellwether case also went in favor of the Big Pharma duo. The previous trial was held in May. Bellwether trials are a means for parties and attorneys to test their arguments and are common in mass torts, such as with Xarelto. The cases are selected by each party as being representative of cases in the overall mass tort. Parties use the outcomes of bellwethers to determine if continued litigation or settlement is the best course of action.

There are an estimated 18,600 Xarelto lawsuits in state and federal courts.

Of course, the companies are thrilled with this latest verdict. Bayer issued a statement saying that the two verdicts “affirm both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine.”

The Janssen Pharmaceuticals, Inc. unit of J&J also issued a statement saying it will keep fighting the allegations in the remaining suits.

Xarelto was approved in 2011 by the U.S. FDA. It is used in patients with atrial fibrillation, as well as to treat and reduce the chances of pulmonary embolisms and deep vein thrombosis. The biggest problem with Xarelto is the fact that, unlike Warfarin, there is no antidote for uncontrolled bleeding. In fact, AndexXa, a drug in development by Portola Pharmaceuticals as a Xarelto antidote, was not approved by the FDA as of August 2016.

The effects of Warfarin, the traditional blood thinning agent, can be counteracted with an intravenous dose of vitamin K. With Xarelto, the only thing that can be done for uncontrolled bleeds or emergency surgery is to monitor the levels of the drug in the patient’s system until they’re low enough to safely proceed with treatment.

The Orr’s attorneys, Brian Barr and Andy Birchfield issued a statement saying they “will continue to press forward with the legal claims of the thousands of innocent victims of this drug.”

The Orr’s lawsuit claimed that, due to inadequate information provided to Mrs. Orr’s doctor by the companies, the doctor waited to operate for 12 hours, fearing that Mrs. Orr would bleed out. The surgery was finally performed, but Mrs. Orr died on May 4, 2015.

Bayer and J&J argued that Xarelto came with adequate warnings and that Mrs. Orr’s death had nothing to do with any perceived issues with those warnings.