February 13, 2017 — Dozens of Eliquis lawsuits over uncontrollable bleeding have been centralized in a Multi-District Litigation (MDL) under one judge in New York.
There were at least 53 Eliquis lawsuits pending in 17 districts nationwide. All of the lawsuits have been transferred into the Southern District of New York under U.S. District Judge Denise L. Cote.
The Eliquis MDL was established by an order (PDF) of the Judicial Panel on Multidistrict Litigation on February 7 — In re: Eliquis (Apixaban) Products Liability Litigation — MDL No. 2754.
All of the lawsuits involve serious injuries or deaths from bleeding after taking Eliquis (apixaban), a blood-thinning drug that was approved in December 2012.
Pfizer Inc. and Bristol-Myers Squibb are accused of failing to test Eliquis for safety or warn patients about potential risks — including the risk of uncontrollable bleeding due to Eliquis’s lack of a reversal agent.
Judges chose the Southern District of New York because Pfizer and Bristol-Myers Squibb have corporate headquarters in the state, so it will be convenient for witnesses, relevant documents, and evidence. Judge Cote already oversees at least 16 Eliquis lawsuits in New York.
Judges rejected some plaintiffs’ arguments against centralization, mostly because there are already 10 law firms involved and everyone expects more lawsuits will be filed:
“It is clear that the number of involved counsel, the large number of actions and districts, and the complexity of the factual issues pose significant obstacles to informal coordination.”
Eliquis is a blood-thinning drug that prevents strokes. It works by blocking an enzyme called Factor Xa, which makes it harder for blood platelets to stick together and create blood clots. Eliquis is very similar to Xarelto, another Factor Xa inhibitor. There are more than 15,000 Xarelto lawsuits involving uncontrollable bleeding in MDL No. 2592.
These new blood-thinners were marketed as superior to Coumadin (warfarin), which has been on the market since the 1950s and is easily reversed with a dose of Vitamin K in an emergency. Unlike warfarin, Xarelto and Eliquis currently lack an antidote, which makes it harder for a doctor to stop bleeding or perform surgery in an emergency.
An antidote for Xarelto and Eliquis was developed by Portola Pharmaceuticals and has shown effectiveness in clinical trials, but the FDA delayed approval in August 2016 over manufacturing concerns.
The only new blood-thinner on the market with a reversal agent is Pradaxa (dabigatran), which was sold without an antidote for 5 years before drug-makers developed and got approval for Praxbind in October 2015. Around 4,000 Pradaxa lawsuits involving uncontrollable bleeding ended with a $650 million settlement in May 2014, or an average per-case payout of $162,500.