First Loss for Bayer and J&J in Xarelto Suits
In the fourth of three lawsuits heard by US courts over the risks of the blockbuster blood thinner Xarelto to date, a jury in Philadelphia, Pennsylvania, last week ordered Bayer and Johnson & Johnson to pay $1.8 million in compensatory and $26 million in punitive damages to an Indiana couple.
It was the first loss for the two drugmakers in the Xarelto litigation after three previous wins.
The plaintiffs, Lyn Hartman and her husband, claimed that when taking the drug prescribed to prevent strokes associated with atrial fibrillation, she suffered severe gastrointestinal bleeding.
The Hartmans contended that Xarelto package information does not disclose its risks, while Bayer & J&J said it does. Both drugmakers said they plan to appeal the decision.
A spokeswoman for J&J subsidiary Janssen told the news agency Reuters that the jury’s verdict “contradicts years of scientific data” and that the US Food and Drug Administration had “repeatedly confirmed” Xarelto’s safety and efficacy.
Bayer said the drug’s label "has always warned of bleeding events, a risk associated with anticoagulants, and “appropriately” informed physicians.
This case was the first concerning Xarelto bleeding risks to be heard by a US state court. Bayer and J&J previously won three bellwether suits in federal courts in Jackson, Mississippi, and New Orleans, Louisiana.
According to a filing by J&J quoted by news agencies, more than 21,000 liability cases are still pending, including some 1,400 in Philadelphia.
First approved by the FDA in 2011, Xarelto, developed by Bayer, was the German life sciences group’s top-selling drug with sales of €2.9 billion in 2016. J&J took in $2.2 billion in revenues from the drug in the same year.
