Bayer, Johnson & Johnson notch win number 3 in Xarelto bleeding-risk litigation

Bayer and Johnson & Johnson have won three bellwether lawsuits in the last 5 months over the bleeding risks of blockbuster blood thinner Xarelto.

With a win in a federal court in Mississippi, Bayer and Johnson & Johnson are now three for three in fending off lawsuits over the bleeding risks of blockbuster blood thinner Xarelto.

A jury found in the drugmakers’ favor on Friday in a case brought by a woman who claimed she developed acute gastrointestinal bleeding after taking Xarelto following an operation in 2015, Reuters reported.

Bayer and J&J both said they will continue to defend the drug against legal attacks.

“This is the third Xarelto trial and the third verdict in favor of the company,” Sarah Freeman, a spokesperson for J&J’s Janssen Pharmaceuticals, said in an emailed statement. “We will continue to defend against the allegations made in this litigation.”

And there is lots of litigation. The drugmakers still face more than 18,600 lawsuits in both state and federal courts.

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

So far, the companies have fared well in the courts, having won two previous so-called bellwether cases in New Orleans that also accused them of downplaying the bleeding risks of the drug. Lawyers for the company have argued that patient monitoring and a “simple blood test” can help identify patients most likely to suffer severe bleeding. 

Bellwether cases are used by lawyers on both sides of an issue to gauge how likely their side is to win or lose cases and thus how soon to consider settling and for how much.

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.

Xarelto leads the market for next-generation anticoagulants, but Boehringer’s Pradaxa enjoys one advantage over others: A reversal agent approved for it can be taken in case of uncontrolled bleeding.

RELATED: Pfizer, BMS loan Portola $50M to help deal with CRL for antibleeding agent AndexXa

J&J and Bayer had expected to be able to offer bleeding antidote AndexXa for Xarelto, but that effort was stymied last year when the company developing it, Portola, got an FDA complete response letter, delaying its entry into the market.