A federal judge in New York dismissed one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.
Granting a motion to dismiss, Judge Denise Cote threw out Utts et al v. Bristol-Myers Squibb Company et al, case number 1:16-cv-05668, in the U.S. District Court for the Southern District of New York, In Re: Eliquis (Apixaban) Products Liability Litigation, MDL No. 2754.
The court said that all the plaintiff’s claims — for failure to warn, design defect claims, warranty violations, fraud, and consumer protection claims — were preempted, adding that the Eliquis label is adequate as a matter of law.
Not ‘newly acquired information’
Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says. “Accordingly, the plaintiffs’ claims are preempted because federal law would not have permitted the defendants to make any change to the Eliquis label.”
“The risk of excessive bleeding from this blood thinner and the lack of an antidote were clearly disclosed to the Food & Drug Administration (“FDA”) when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug,” the judge says.
Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.
Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.
Eliquis was approved by the FDA in 2012. The judge said the Eliquis label warns about the risk of serious bleeding five times, and warns that there is no specific antidote two times.