A judge in New York tossed liability claims against Pfizer and Bristol-Myers Squibb over bleeding risks for their blockbuster anticoagulant on Monday, ruling that the drugmakers and U.S. drug regulators clearly presented Eliquis’ risks to patients and doctors.
Plaintiffs Charlie and Ciara Utts brought the case against the companies last year, claiming that the big-selling Eliquis caused Charlie to experience severe gastrointestinal bleeding. Further, the plaintiffs said the drug’s label didn’t adequately warn of the risks.
But that’s not true, U.S. District Judge Denise Cote wrote in an opinion filed Monday.
Eliquis’ risks, plus the known lack of an antidote, “were clearly disclosed to the Food & Drug Administration when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug,” Cote wrote in her 85-page opinion.
In their suit, the plaintiffs also contend the label is flawed because dosage recommendations aren’t individually tailored for patients and because it doesn't recommend constant monitoring, according to the judge. Cote said those claims “fare no better” under scrutiny.
The decision is important as the partners face another 80 or so similar cases in state and federal courts in the U.S. and two in Canada.
Pfizer and BMS’ victory comes just after partners Johnson & Johnson and Bayer scored a big legal win with their competitor to Eliquis. In a New Orleans courtroom last week, a federal jury said the drugmakers did not fail to adequately warn a prescriber about Xarelto’s bleeding risks.
As a bellwether trial, that decision marked a critical victory for J&J and Bayer as the drugmakers face an estimated 18,000 lawsuits claiming Xarelto caused harm. The jury’s verdict could impact settlement negotiations going forward.