Bayer, J&J win first trial over Xarelto bleeding risks

[May 04, 2017] By Nate Raymond

(Reuters) - A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the first trial to flow out of thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drugmakers said on Wednesday.

The verdict by a federal jury in New Orleans came in a lawsuit filed by Joseph Boudreaux of Louisiana. It was the first in a series of test trials aimed at helping the plaintiffs and companies assess similar claims about bleeding risks.

"The jury's verdict affirms 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," Bayer said in a statement.

William Foster, a spokesman for J&J's Janssen Pharmaceuticals Inc unit, said the verdict reflected the case's facts and the appropriateness of Xarelto's prescribing information.

In a joint statement, Andy Birchfield and Brian Barr, lawyers for Boudreaux, said they were disappointed but would press on in similar cases.

"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," they said.

The lawsuit is one of an estimated 18,000 lawsuits in federal and state courts related to Xarelto. The verdict came in the first of four test trials, or bellwethers, scheduled in the federal litigation. The next trial is May 30.

The U.S. Food and Drug Administration approved Xarelto in 2011. The drug is prescribed for people with a common heart rhythm disorder known as a trial fibrillation and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.

But plaintiffs contend Xarelto was unreasonably dangerous and that J&J and Bayer, which jointly developed it, failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies.

In Boudreaux's case, the 75-year-old said he was prescribed Xarelto in 2014 to treat a heart condition and suffered gastrointestinal bleeding, leading to his hospitalization and numerous blood transfusions.

Xarelto is among a new class of blood thinners aimed at replacing the Bristol-Myers Squibb Co's Coumadin, or warfarin, which has long been on the market.

Others include Boehringer Ingelheim's Pradaxa, which also became the subject of thousands of lawsuits claiming it caused bleeding in patients. Boehringer in 2014 reached a $650 million settlement to resolve those cases.

The case is In Re Xarelto Products Liability Litigation, U.S. District Court, Eastern District of Louisiana, No. 14-md-2592.

(Reporting by Nate Raymond in Boston; Editing by Jonathan Oatis and Lisa Shumaker)

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