Jury Hands J&J, Bayer Win In 3rd Xarelto Bellwether

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The trial was the third win for Janssen and Bayer in a bellwether trial in Louisiana multidistrict litigation over claims they didn’t warn about the possibility of dangerous internal bleeding associated with the blood thinner.

The trial was the third win for Janssen and Bayer in a bellwether trial in Louisiana multidistrict litigation over claims they didn’t warn about the possibility of dangerous internal bleeding associated with the blood thinner. The trial was presided over by a Louisiana federal judge but took place in Jackson, Mississippi. A fourth bellwether trial is pending.

“The defense verdicts in the first three 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,” a Bayer spokesperson said in a release. “Plaintiffs’ attorneys in these cases have presented multiple theories to juries regarding the alleged inadequacy of the Xarelto label, and all three juries have rejected their claims and found in favor of the companies.”

Dora Mingo developed deep vein thrombosis after having her hip replaced in 2015, according to her complaint. She was given Xarelto to treat the thrombosis, but as she was taking it, she started having gastrointestinal bleeding, for which she had to be hospitalized, the complaint said. She argued that the drugmakers knew of the problem and failed to warn patients and doctors about it.

At the trial, which kicked off on Aug. 7, Mingo testified that when Xarelto was introduced to the market, the companies knew or should have known about the danger of a patient taking the drug if a doctor doesn’t perform a standard laboratory test to evaluate his or her risk of bleeding on Xarelto.

The companies’ argument that Mingo wouldn’t have taken the drug if she had read a medication guide was also flawed, she said.

In the previous trial, widower Joseph Orr said that the companies failed to warn doctors of Xarelto’s dangers, and therefore were responsible for the stroke that killed his wife Sharyn Orr in May 2015. A New Orleans federal jury last month found in favor of Janssen and Bayer.

In Mingo’s case, Janssen and Bayer argued that they didn’t have the authority to change the drug’s label and that her state law claims were preempted by federal law.

“The makers of Xarelto need to be candid about the risks posed by this blood thinner,” Mingo’s attorney, Andy Birchfield, said in a statement to Law360 following the verdict. “Johnson & Johnson, Janssen Pharmaceuticals and Bayer Healthcare engaged in aggressive direct-to-consumer, physician marketing and advertising campaigns, but gave little weight to the dangers of Xarelto because they were more focused on their business plan than patient safety. Health complications suffered by Ms. Mingo and thousands of others could have been avoided if physicians were told they could run a simple blood test to help identify patients at an increased risk of excessive bleeding.”

The case was presided over by U.S. District Judge Eldon E. Fallon.