Just two weeks after convincing a judge in New York to toss a liability case over Eliquis bleeding risks, Pfizer and Bristol-Myers Squibb face three new suits in the same state over claims their big-selling anticoagulant ended up hurting patients.
Filed this week in New York State court, the suits say Pfizer and BMS “negligently and fraudulently” represented their blockbuster med as “safe and effective for its indicated uses.” The companies “concealed their knowledge of Eliquis' defects” from prescribing physicians and the larger public, the lawsuits claim.
After several months on Eliquis, the plaintiffs developed a variety of bleeding problems—bilateral subdural hemorrhages in one case, a subdural hematoma in another and postoperative bleeding, acute blood loss anemia and a hematoma in the third, according to the lawsuits. All of them required lengthy hospital stays.
Pfizer and BMS “believe that the claims in these cases lack merit,” according to a Pfizer spokesperson.
“The FDA-approved label for Eliquis (apixaban) is based on a strong body of scientific evidence and accurately describes the medicine’s benefits and risks,” she said. “The companies stand behind Eliquis and will vigorously defend the medicine in this litigation.”
The plaintiffs filed suit just two weeks after BMS and Pfizer prevailed in a separate case in a New York federal court. The judge in that case threw out claims that Eliquis led to a patient’s severe gastrointestinal bleeding and that the drug’s label didn’t adequately warn of the risks.
Eliquis’ risks, plus the known lack of an antidote, “were clearly disclosed to the Food and Drug Administration when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug,” the judge said in a ruling.
Eliquis reeled in $3.34 billion in sales last year, Bristol-Myers reported in its annual financials. As of Bristol’s last quarterly filing with the Securities and Exchange Commission, it and Pfizer faced more than 130 cases over the blockbuster med’s bleeding risks in the U.S. and two in Canada.
That figure pales in comparison to the lawsuits filed over bleeding risks for Eliquis’ market rival, Xarelto from Johnson & Johnson and Bayer. Those companies have been named in about about 18,400 suits. Risks associated with Boehringer Ingelheim's Pradaxa, another of the next-gen anticoagulants in the class of warfarin alternatives, have also been argued in thousands of lawsuits. In 2014, Boehringer paid $650 million to settle 4,000 of them.
But J&J and Bayer scored an important victory earlier this month when they won a bellwether case for their big-selling anticoagulant in New Orleans. That victory could affect future settlement negotiations.
For all of the meds, the lawsuits follow years of debate over their safety and utility. The next-gen anticoagulants, launched as alternatives to the standard therapy warfarin, have been billed as easier and safer than the older med, which requires dietary restrictions and regular monitoring.
Warfarin does, however, have an antidote. Neither Xarelto nor Eliquis does—yet—and without one, some patients and doctors have been wary of their bleeding risks, which are listed on their official FDA labels.
BI's Pradaxa now has an approved antidote in Praxbind. Portola Pharmaceuticals is developing an antidote to Xarelto and Eliquis but its approval application was rejected by the FDA last August.