Bayer, Janssen Score Win In 1st Xarelto Trial

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(May 4, 2017) – A Louisiana federal jury on Wednesday sided with Janssen and Bayer in the first bellwether trial in multidistrict litigation over unstoppable bleeding allegedly caused by their blood thinner Xarelto.

The jury found in favor of Johnson & Johnson unit Janssen Pharmaceuticals Inc. and Bayer HealthCare Pharmaceuticals Inc. in the first of four bellwether trials in the MDL. Plaintiff Joseph Boudreaux’s trial started April 24; he, along with other patients or their representatives in the MDL, accused the drug companies of knowing about the unstoppable bleeding, but not warning doctors.

The jury found that the drugmakers did not fail to provide Boudreaux’s cardiologist, Dr. Kenneth Wong, adequate instructions for the safe use of Xarelto.

“The jury’s decision reflects the facts of this case and the appropriateness of the Xarelto prescribing information,” William Foster, a spokesman for Janssen, said in a statement. “Xarelto is an innovative medicine used to treat and reduce the risk of life-threatening blood clots.”

The jury rejected Boudreaux’s singular claim regarding a blood clotting test that neither the U.S. Food and Drug Administration nor any other health regulator in 130 countries has said should be used by doctors to determine if patients should use or continue with Xarelto therapy, a Bayer spokesman said in a statement.

“With more than five years on the U.S. market and 28 million patients prescribed worldwide in over 130 countries, real-world experience continues to confirm the favorable benefit-risk profile of Xarelto for patients who have a high risk of life-threatening blood clots that may cause strokes and other serious medical complications.,” Bayer spokesman Chris Loder said. “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

Boudreaux had claimed he started taking Xarelto to control his atrial fibrillation in January 2014 and less than a month later was hospitalized for dangerous gastrointestinal bleeding requiring blood transfusions. He says Janssen and Bayer misrepresented the safety of the drug to both the public and the FDA and that there are issues surrounding certain clinical trial results.

Xarelto, also known as rivaroxaban, is used to reduce the risk of stroke and life-threatening blood clots in patients with nonvalvular atrial fibrillation — a common heart rhythm disorder — and to treat blood clots lodged in an artery in the lungs, among other cardiovascular ailments.

Boudreaux claimed he began taking the drug to control his atrial fibrillation in January 2014 and was hospitalized less than a month later for dangerous gastrointestinal bleeding, which required multiple blood transfusions.

Days before his trial started, U.S. District Judge Eldon Fallon denied two motions for partial summary judgment, citing federal preemption as a defense to claims over the alleged Xarelto misdosing and a label with allegedly inadequate warnings.

Judge Fallon said the companies hadn’t made a convincing showing that FDA regulations prevented them from updating labels or creating more tailored dose-analysis guidelines.

Patients in the MDL claim that the companies told the medical community, the FDA and the public that Xarelto had been tested and was safe for its approved use, even though it wasn’t.

Specifically, the plaintiffs say there’s no antidote to the drug, so if a hemorrhage does occur, there’s nothing available to stop the bleeding.

The Xarelto cases were first consolidated in December 2014 and some suits have been filed in state court. Sales totaled $582 million for the drug during its first full year on the market, rising a few years later to $2 billion for the 2013 fiscal year.

But at the end of the 2012 fiscal year, more than 2,000 reports were filed with the FDA linking seriously harmful events to Xarelto, 151 of which resulted in death, the suits allege.

“While we are disappointed with the outcome, on behalf of our team and Mr. and Mrs. Boudreaux, we want to express our appreciation to the jury for their service and consideration during this long and complex trial,” Andy Birchfield of Beasley Allen Crow Methvin Portis & Miles PC said in a statement. “As always, 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 case is In re: Xarelto (Rivaroxaban) Products Liability Litigation, case number 2:14-md-02592, in the U.S. District Court for the Eastern District of Louisiana.

-Reporting by Emily Field and Cara Salvatore. Editing by Bruce Goldman.