Over the past several months, plaintiffs have been filing product liability lawsuits against Eliquis manufacturers Bristol-Myers Squibb and Pfizer, Inc. As of December 2016, there were about 34 Eliquis lawsuits pending in different courts around the country. In each, plaintiffs claim that the manufacturers failed to provide adequate warnings of the risks associated with the drug.
Eliquis is one of several newer-generation anticoagulant medications, including Pradaxa and Xarelto. Thousands of lawsuits have already been filed against makers of these other two drugs, and it’s expected that Eliquis cases will continue to increase as well.
Questions Surround Eliquis Clinical Trial
The FDA granted approval for Eliquis in 2012. The drug was approved to help prevent blood clots in patients with nonvalvular atrial fibrillation. It was later approved to treat deep vein thrombosis, and to prevent blood clots in patients going through hip or knee replacements.
The manufacturers then marketed it as a better alternative to warfarin, which was the leading anticoagulant at the time. They stated that unlike warfarin, Eliquis did not require blood monitoring or dietary restrictions, and came in convenient once-a-day doses.
The drug, however, faced increased scrutiny even from the beginning. Approval was based largely on the ARISTOTLE study, which was published in September 2011 in the New England Journal of Medicine. It concluded that Eliquis (apixaban) was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding and resulted in lower mortality.
It was later discovered, however, that the study was plagued with flaws. For one, the defendants’ agents concealed side effects associated with Eliquis, including a death that occurred during the study. As another example, there were dispensing errors, including subjects that were said to be receiving Eliquis when they weren’t. Subsequent reports found that the results from the study were heavily manipulated.
In 2012, prior to the FDA approval of Eliquis, a physician in the FDA objected to missing data from the ARISTOTLE study and recommended that the labeling for the drug include quality control problems in the study. The manufacturers did not follow that recommendation.
The drug was ultimately approved, and the manufacturers went on to market it to doctors and patients.
Eliquis Has No Antidote
Eliquis, Pradaxa and Xarelto are all direct thrombin inhibitors, meaning they inhibit the Factor Xa enzyme to reduce blood clotting. The problem with all of these drugs, compared with warfarin, is that they have no readily available antidote. When patients suffer from excessive bleeding, there is no way to stop it. Patients taking warfarin, on the other hand, can be treated for excessive bleeding with injections of vitamin K.
Eliquis was designed to compete with Pradaxa and Xarelto, and enjoyed sales of $774 million in 2014. According to ProPublica, the manufacturers paid $8 million to doctors in 2013 to encourage them to prescribe the drug.
Arguments regarding the potential consolidation of all federally filed Eliquis lawsuits into one court were heard on January 26, 2017.