Bristol-Myers Squibb and Pfizer have filed a motion to create a new MDL 2754 consolidating mass tort litigation in US District Court for the Southern District of New York concerning bleeding-related injuries allegedly caused by Eliquis blood thinner.
The companies are facing 34 related actions filed in 13 different federal courts. Plaintiffs’ counsel have promised that they intend to file many more cases in the near future.
Starting in 2015, plaintiffs began filing lawsuits alleging the defendants failed to warn adequately about the risk of bleeding, and that the defendants should not have sold Eliquis without precautions for blood monitoring or an additional drug to reverse its anticoagulant effect.
Eliquis (also known by its molecular name apixaban) is an anticoagulant medication that thins the blood, prevents the formation of blood clots, and decreases the risk of stroke in patients with atrial fibrillation and certain other conditions. Atrial fibrillation is a common arrhythmia (abnormal heart beat) that causes blood clots to form in the heart, and that is known to be associated with a very high risk of stroke.
The companies claim that the drug is “no less safe than a daily aspirin.” It was approved by the FDA in 2012 and carries a warning that it increases the risk of bleeding that there is no antidote for Eliquis.
The companies requested the New York federal court because they have headquarters there and because half of the actions have been filed there. The court has previously handled 158 MDLs and now is handling 27 MDLs including product liability cases against prescription drugs Rezulin (MDL 1348) and Fosamax (MDL 1789).
Bogus Aristotle Study
Plaintiffs allege that approval of Eliquis was based in large part on clinical trials known as Aristotle, which was conducted under the supervision and control of the defendants, in various countries, including China.
“Defendants, as a means of cutting costs, chose incompetent and untrustworthy agents in China to conduct the Aristotle study Defendants’ agents committed fraud in their conduct of the Aristotle study, by concealing side effects which occurred in test users of Eliquis; a death which went unreported (whereas one purpose of the study was to study the rate of death in Eliquis users compared to others in Coumadin); loss of subjects to follow-up; major dispensing errors including indicating that certain subjects were getting Eliquis when they were not; poor overall quality control; and changing and falsifying records, including records disappearing just before the FDA made a site visit, reportedly on the order of an employee of BMS,” states the complaint in Charlie Utts and Ciara Utts v. Bristol-Myers Squibb Company and Pfizer Inc., Case 1:16-cv-05668-DLC (S.D.N.Y).
According to the complaint, the companies:
- Failed to provide adequate warnings about the increased risk of gastrointestinal bleeds in those taking Eliquis, especially, in those patients with a history of gastrointestinal issues and upset;
- Failed to provide adequate warnings about the increased risk of suffering a bleeding event, requiring blood transfusions in those taking Eliquis;
- Failed to provide adequate warnings about the need to assess renal functioning before starting a patient on Eliquis and to continue testing and monitoring of renal functioning periodically while the patient is on Eliquis.
- Failed to provide adequate warnings about the need to assess hepaticfunctioning prior to starting a patient on Eliquis and to continue testing and monitoring of hepatic functioning periodically while the patient is on Eliquis.