Robert L. Tucci, Carmen P. Curio and James A. Devos said the drug makers misrepresented the risks of their Eliquis anticoagulant by hiding their knowledge of the treatment’s shortcomings. To that end, the plaintiffs allege the US Food and Drug Administration (FDA) approved Eliquis in 2012 based on the results of the ARISTOTLE clinical trial that was conducted by “incompetent and untrustworthy” parties in China where certain Eliquis side effects were hidden from the regulator.
The plaintiffs allege there was also a death involved in the clinical trial, together with the loss of trial participants available for follow-up, poor quality control, dispensing errors and falsified records.
Eliquis is one of a handful of new-age anticoagulants brought to market in recent years as a response to long-held demands for a blood thinner easier to use than Coumadin (warfarin), an effective anticoagulant for some fifty years that is nonetheless a challenge to manage based on the need for regular and stringent blood monitoring. Eliquis was brought to market amidst claims that apixaban was easier to use, without the requirement for the kind of stringent monitoring necessary for warfarin.
However, Eliquis was also brought to market without an effective reversing agent, a feature of Coumadin. The blood thinning properties of warfarin can be effectively reversed with an infusion of vitamin K. Eliquis, and others in its class, were brought to market without an available reversing agent in place.
“Upon information and belief, defendants concealed and failed to completely disclose their knowledge that Eliquis was associated with or could cause life-threatening bleeding in specific patient populations, and failed to fully identify and convey the risks of use of Eliquis at the same time as other blood-thinning agents, such as aspirin,” the complaint said.
The plaintiffs allege manufacturers Bristol-Myers Squibb Co. and Pfizer Inc. failed to disclose the lack of a reversing agent on the product label when Eliquis was brought to market and promoted with an aggressive marketing campaign.
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“In the course of these direct-to-consumer advertisements, defendants overstated the efficacy of Eliquis with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent or means to reverse the anticoagulation effects of Eliquis, and that such irreversibility would have life-threatening and fatal consequences,” the filing claimed.
The Eliquis injury lawsuits are Robert L. Tucci v. Bristol-Myers Squibb Co. and Pfizer Inc., Carmen P. Curio v. Bristol-Myers Squibb Co. and Pfizer Inc., and James A. Devos v. Bristol-Myers Squibb Co. and Pfizer Inc., Case Nos. 154745/2017, 154740/2017 and 154694/2017, respectively, in the Supreme Court of the State of New York, County of New York.