Eliquis Cases Over Bleeding Risk in Jeopardy Following Court Order Granting Dismissal

The U.S. District Judge recently assigned to preside over all federal Eliquis injury lawsuits has granted a motion to dismiss filed by the drug makers, which may impact dozens of other claims brought on behalf of individuals nationwide who experienced uncontrollable bleeding problems.

In February, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for all federal Eliquis cases, which involve common allegations that Bristol-Myers Squibb and Pfizer failed to adequately warn consumers and the medical community about the bleeding risks associated with their novel oral anticoagulant.

About 80 cases filed in U.S. District Courts nationwide have been centralized before U.S. District Judge Denise L. Cote in the Southern District of New York as part of a federal MDL, or multidistrict litigation.

Each of the plaintiffs indicate that the side effects of Eliquis caused them to suffer severe or fatal bleeding problems, alleging that the drug makers withheld information about the lack of an antidote to reverse the blood thinning effects of the drug, and failed to provide proper recommendations regarding monitoring to maintain a safe dose.

In an order (PDF) issued in May 8, Judge Cote struck an early and severe blow to the litigation, granting a motion to dismiss filed by the drug makers in an Eliquis case brought by plaintiff Charlie Utts, who experienced severe gastrointestinal bleeding after using the controversial drug.

Judge Cote rejected arguments presented by Utts in an amended complaint, finding that the warnings provided on the Eliquis label were sufficient as a matter of law, resulting in the dismissal of the case. The court found that the lack of an antidote was disclosed to the FDA when the drug was approved, and disclosed in the drug labeling. In addition, Judge Cote found that Utt failed to allege sufficient evidence to establish that inadequate warnings were provided about the proper dosing recommendations, or that better warnings should have been provided about the importance of monitoring patients during treatment.

“The plaintiffs have not identified any research or other clinical work that recommends another dosage strategy than that currently described on the label, or explains what specialized monitoring of a patient would accomplish,” wrote Judge Cote in the 85 page opinion. “These two complaints concern features of the design of the drug that were well known to the FDA when it approved the drug.”

The decision will have a major impact on the dozens of other cases pending before Judge Cote, as well as hundreds of additional lawsuit currently under investigation by Eliquis injury lawyers.

In a separate order (PDF) issued on May 9, Judge Cote indicated that plaintiffs in all other actions pending in the Eliquis litigation have until May 23 to file an amended complaint and to show cause why their cases should not be dismissed based on the same analysis in the Utts opinion. Further, any individuals who bring a future Eliquis case in the federal MDL must file a memorandum within fourteen days explaining why the claim should not be dismissed for the same reasons.

Plaintiffs are expected to appeal the dismissal of the Eliquis cases, arguing that they should be permitted to conduct discovery in the litigation and proceed with the claims.

The allegations raised in the Eliquis lawsuits are similar to those presented in more than 18,000 Xarelto lawsuits filed against the makers of that competing novel oral anticoagulant, which was introduced about a year earlier. Plaintiffs in those cases also argue that the manufacturers failed to adequately warn about the bleeding risk, withheld information about the lack of an antidote and provided false and misleading information that led to improper monitoring during treatment.

After the judge presiding over the Xarelto cases rejected a similar motion to dismiss based on federal pre-emption, a series of early trial dates will be held this year in the federal court system, which are designed to help gauge how juries will respond to certain evidence and testimony that may be presented. Following the bellwether trials, if Xarelto settlements or another resolution for the litigation is not reached, thousands of individual cases may be set for trial dates nationwide.