Bristol-Myers Squibb and Pfizer are facing a new lawsuit alleging that its anticoagulant drug Eliquis caused fatal bleeding in a Louisiana woman. The two companies merged efforts in 2007 to market Eliquis, pointing to Bristol-Myers Squibb’s “long-standing strengths in cardiovascular drug development and commercialization” with Pfizer’s “global scale and expertise in this field.” Lawsuits such as this one allege that the manufacturers promoted the drug without warning about its irreversible bleeding risks.
Eliquis was approved in 2012 to treat patients with atrial fibrillation. The drug is one of several new anticoagulants that aim to replace warfarin, an older drug that requires blood monitoring and dietary restrictions. Patients taking Eliquis and other new generation anticoagulants do not need to undergo regular blood monitoring, but they have a different drawback; there is no antidote to reverse bleeding if it occurs. Patients that suffer hemorrhaging due to warfarin can be treated with an antidote.
The lawsuit alleges that the drug makers were aware of the risks associated with Eliquis, but failed to disclose this information to the medical community or the public. The manufacturers are also accused of failing to share data on the number of adverse reactions linked to Eliquis.
The drug’s approval was based on clinical trials known as Aristotle. Plaintiffs in the lawsuit allege that Bristol-Myers Squibb and Pfizer hired personnel in China who defrauded the results and omitted data. Allegedly, the testing agents failed to report a death, did not follow-up with subjects, made dispensing errors that resulted in some subjects not receiving the drug, poor overall quality control and falsifying records.
According to the lawsuit, company executives allegedly ordered records to be omitted right before a visit by the U.S. Food and Drug Administration (FDA). The suit was filed in the U.S. District Court for the Eastern District of Louisiana.