Eliquis Bleeding Injury Lawsuits Transferred to MDL
A multidistrict litigation (MDL) has been established for federal lawsuits alleging uncontrollable bleeding with the anticoagulant drug Eliquis. Federal lawsuits have been centralized to the U.S. District Court for the Southern District of New York. According to court records, Bristol-Myers Squibb and Pfizer are facing 34 Eliquis lawsuits filed in 13 different federal courts. The companies are accused of failing to warn about the risk of uncontrollable bleeding with the blood thinner. Attorneys say they expect the litigation to mount in the near future.
The personal injury attorneys at Parker Waichman LLP are closely monitoring events in the Eliquis litigation. The firm continues to offer free legal consultations to individuals with questions about filing an Eliquis lawsuit.
Eliquis is an anticoagulant, used to reduce the risk of blood clots and subsequent stroke in patients with atrial fibrillation and other conditions. Atrial fibrillation is an abnormal heart rhythm that can increase the likelihood of a blood clot. The U.S. Food and Drug Administration (FDA) approved Eliquis in 2012. It was among a new generation of anticoagulants, along with drugs such as Pradaxa and Xarelto.
Lawsuits allege that BMS and Pfizer failed to adequately warn about the risk of bleeding. Plaintiffs also allege that the companies did not disclose the lack of an antidote to reverse the drug’s blood-thinning effects.
According to plaintiffs, Eliquis and other new generation anticoagulants were marketed as being superior to warfarin, which has been on the market for decades. Unlike with warfarin, patients taking Eliquis do not need to undergo regular blood testing or other restrictions. The lawsuits allege that the companies failed to warn about the lack of an antidote, meaning that there is little physicians can do to reverse the drug’s effects if patients suffer uncontrollable bleeding. Warfarin, on the other hand, can be reversed with vitamin K. Plaintiffs allege that Eliquis makers failed to inform both patients and the medical community about this risk.
MDLs are established by the U.S. Judicial Panel on Multidistrict Litigation (JPML). They are created to streamline the legal process and make complex litigation more efficient. Cases transferred into an MDL all have the same basic allegations. In this case, plaintiffs allege Eliquis caused a bleeding injury and drug makers failed to disclose the risks. Consolidating the cases into one federal court eliminates duplicate discovery and conserves court resources. BMS and Pfizer requested that the MDL be held in New York because that is where headquarters are located. Additionally, half of the personal injury lawsuits have been filed in New York.
Plaintiffs Question Eliquis Clinical Trial Data
Among other things, plaintiffs in the Eliquis litigation take issue with clinical trial data used to gain approval. Specifically, they questioned the integrity of data from the Aristotle study, which was conducted and controlled by the defendants in various countries, including China. Plaintiffs allege that the companies hid side effects during the trial, including an unreported death.
“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,” the complaint states.
Plaintiffs also allege that Eliquis manufacturers failed to warn about the risk of certain complications, including gastrointestinal bleeding. The companies are accused of failing to warn about the risk of suffering a bleeding event, which may result in the need for a blood transfusion in patients taking Eliquis. Additionally, lawsuits allege that the companies failed to warn about the need to monitor kidney and liver function before and during the use of Eliquis.
One lawsuit was filed on behalf of a Louisiana man who took Eliquis from June 2013 to April 2016 to reduce the risk of blood clots associated with his atrial fibrillation. He alleges that neither he nor his doctor knew about the risk of irreversible bleeding with Eliquis. According to this lawsuit, the plaintiff suffered internal eye bleeding in August 2015. The bleeding persisted for several months and was eventually treated. However, he is now partially blind in his right eye, allegedly due to the use of Eliquis. The plaintiff alleges that he would have chosen a different treatment option if he was fully informed of the risks.
Lawsuits Filed over Pradaxa, Xarelto
Parker Waichman notes that the allegations in the Eliquis litigation are not unique. Similar lawsuits have been filed over other new generation anticoagulants, including Pradaxa and Xarelto. Until recently, no antidote existed for these anticoagulant medications. This changed last year, when the FDA approved a Pradaxa reversal agent.
Pradaxa, which was the first of these medications to be released, was the subject of over 4,000 personal injury lawsuits, including 750 wrongful death cases. Boehringer Ingelheim agreed to settle Pradaxa lawsuits for $650 million on the eve of the first day of trial.
An MDL has also been established for Xarelto lawsuits in the U.S. District Court for the Eastern District of Louisiana. The first bellwether trial is slated to begin on Mar. 13, 2017. The second trial is scheduled for Apr. 24, 2017. Bellwether cases are the first lawsuits in a mass tort selected for trial; the outcome of bellwether cases can impact the remaining litigation. For example, if juries continue to award large verdicts to the plaintiffs, drug companies may be more inclined to settle the lawsuits as opposed to seeing them through to trial.
Filing an Eliquis Lawsuit
If you or someone you know suffered uncontrollable bleeding related to the use of Eliquis, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).