Johnson & Johnson, Bayer score a second key win in Xarelto bleeding litigation

A federal jury ruled in favor of J&J and Bayer over allegations they withheld info for Xarelto’s official FDA label.

Johnson & Johnson and Bayer are two-for-two in defending Xarelto against liability lawsuits. The drugmakers aren’t in the clear yet, though, with another bellwether trial set for August and thousands of additional suits claim the blockbuster blood thinner caused a patient’s injury or death.

In the case of Joseph Orr, Jr., et al. v. Janssen et al., a federal jury ruled Monday in favor of J&J and Bayer over allegations they withheld info for Xarelto’s official FDA label.

Plaintiffs in the case are the widower and children of Sharyn M. Orr, a grandmother who died in May 2015 at the age of 67 after suffering a brain hemorrhage. Their attorneys said Orr’s death was “completely avoidable,” alleging that the drugmakers concealed safety information that may have saved her life.

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On Monday, Sarah Freeman, a spokesperson for J&J, said the company offers its “deepest sympathy to the Orr family for their loss.” She added that the “decision reflects the facts of this case and the appropriateness” of Xarelto’s label.

Andy Birchfield and Brian Barr, co-lead counsel for the plaintiffs, see things differently. The attorneys said their team “will continue to press forward with the legal claims of the thousands of innocent victims of this drug.”

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Patient monitoring and a “simple blood test” can help identify patients most likely to suffer severe bleeding, according to the attorneys, who said J&J and Bayer concealed that info from U.S. doctors.

Monday's verdict marks the second bellwether win for J&J’s Janssen unit and Bayer out of about 18,400 cases over Xarelto bleeding injuries, according to a recent J&J filing. The companies came up victorious last month in a separate New Orleans bellwether trial. With thousands of cases pending, early trials can outline the strengths and weaknesses for both sides and potentially lead to a settlement.

First approved by the FDA in 2011, Xarelto was Bayer’s top-selling drug last year at $3.24 billion, and ranked third for J&J at $2.5 billion in sales.

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Responding to the jury’s decision on Monday, Bayer in a statement said the “defense verdicts in the first two trials 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 jury “heard several different theories regarding the alleged inadequacy of the Xarelto label, and did not find there was sufficient evidence to support any of them,” according to Bayer’s statement.

The next trial is scheduled for early August in the Southern District of Mississippi.