Eliquis Lawsuit Reveals Manufacturers Face Restrictions on Label Changes

New York, NYAn Eliquis lawsuit that is one of several consolidated in multidistrict litigation (In Re: Eliquis (apixaban) Products Liability Litigation, MDL No. 2754, before the US Judicial Panel on Multidistrict Litigation) alleging that the blood thinner is a dangerous drug with no available antidote, translated to a loss for the plaintiffs on the heels of an 85-page opinion that suggest federal laws prevented the defendants from updating the Eliquis label.

The blood thinner known as Eliquis (apixaban) is one in a series of latest-generation anticoagulants designed to afford patient and caregiver alike an easier regimen than Coumadin (warfarin), the previous gold standard for prevention of blood clots and stroke that has proven effective for fifty years, but requires stringent monitoring.

Eliquis and others in its class promised less-stringent monitoring, while lacking an antidote capable of quickly reversing a severe bleeding event. Coumadin has such an antidote.

Plaintiffs Charlie and Clara Utt brought their Eliquis blood thinner lawsuit following Charlie Utt’s hospitalization for severe gastrointestinal bleeding. The Eliquis anticoagulant is alleged to have triggered a series of events that resulted in Utt requiring blood transfusions and dialysis. The couple launched their lawsuit in July, 2016, claiming amongst other allegations that the manufacturers of Eliquis should have done more to warn consumers about Eliquis side effects, and the lack of an effective antidote.

The ruling, which favored defendants Bristol-Myers Squibb Co. (Squibb) and Pfizer Inc. appeared to hinge on what that product label did, or didn’t say. The opinion penned by US District Judge Denise Cote noted that the defendants had, indeed informed the US Food and Drug Administration (FDA) of the risks associated with Eliquis, together with the absence of an effective antidote when seeking approval of apixaban. The ruling noted that such facts were, and are already disclosed on the drug’s label.

The Utts responded that the drug label for Eliquis needs to be more detailed on those counts, and / or that the label should have been revised to reference the need for tailoring of dosages in order to minimize the risks of grievous Eliquis side effects.

As with other blood thinner lawsuits filed against other manufacturers, the Utts held that patients on Eliquis should be monitored more intensely on an ongoing basis – not less, as many latter-day blood thinners maintain.

However, that claim was shut down by the judge, who in sum reminded the plaintiffs that Squibb and Pfizer had duly informed the FDA of the issues when Eliquis was up for approval. What’s more, claims made by the plaintiffs were not sufficiently proven as new information – and federal law prevents the manufacturer from updating product labels in the absence of new information.

“The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s [changes being effected] regulation,” the opinion states. “Accordingly, the plaintiffs’ claims are preempted because federal law would not have permitted the defendants to make any change to the Eliquis label.

“These two complaints concern features of the design of the drug that were well known to the FDA when it approved the drug,” the opinion states.

It is not known if the Utts plan to appeal. Their Eliquis lawsuit is Utts et al v. Bristol-Myers Squibb Company et al, Case No. 1:16-cv-05668, in the US District Court for the Southern District of New York.