Lawsuit Alleges Eliquis Caused Intracerebral Hemorrhage
Bristol-Myers Squibb and Pfizer Inc. are facing a new lawsuit alleging injuries from the anticoagulant drug Eliquis. The lawsuit was filed on behalf of a California man who was prescribed Eliquis to reduce the risk of blood clot and related complications, such as stroke and pulmonary embolism, associated with atrial fibrillation. He suffered intracerebral hemorrhaging, a type of brain bleed. He alleges that this life-threatening complication was associated with Eliquis, and that the drug makers failed to warn him or his physician about the risks.
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.
According to court documents, the lawsuit was filed Oct. 12 in California Superior Court. The plaintiff alleges that Eliquis led to uncontrollable internal bleeding, and that the drug makers knew about this risk but failed to warn patients or the medical community. The plaintiff alleges that he would have chosen a different treatment option if he knew Eliquis could lead to irreversible bleeding.
Eliquis is among new-generation anticoagulants, alongside Pradaxa and Xarelto. The U.S. Food and Drug Administration (FDA) approved the drug in 2012. The drug is used to reduce the risk of blood clot and stroke in patients with atrial fibrillation, an abnormal heart rhythm that increases the risk of a blood clot. Eliquis is also prescribed for deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is when a blood clot forms in one of the deep veins (usually the legs). PE is when the clot breaks free and becomes trapped in the lungs; it is a life-threatening condition.
Lawsuits filed over Eliquis (as well as Pradaxa and Xarelto) allege that the drug was marketed to replace warfarin (sold under the brand Coumadin). Warfarin is a decades-old anticoagulant that requires patients to undergo blood testing to ensure that the appropriate dose is present. Patients taking warfarin must also avoid certain foods, and some medications may interact with the anticoagulant. Although Eliquis and other new anticoagulants do not have these restrictions, plaintiffs point to another caveat that was allegedly not disclosed to them or their doctors. Eliquis lacks an antidote, or reversal agent, that counters the drug’s blood thinning effects if the patient suffers excessive bleeding.
Warfarin can be reversed with vitamin K, but no such antidote exists for Eliquis. The FDA approved a Pradaxa reversal agent last October. Plaintiffs allege that Eliquis makers knew about the lack of an antidote but failed to warn patients or the medical community.
Another lawsuit was recently filed on behalf of a Louisiana man who suffered internal eye bleeding and eventual partial blindness, allegedly due to Eliquis. He took the drug 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.
Eliquis Bleeding Lawsuits Consolidated into MDL
Eliquis uncontrollable bleeding lawsuits have been consolidated into a federal multidistrict litigation (MDL) in the U.S. District Court for the Southern District of New York. Plaintiffs similarly allege that BMS and Pfizer failed to disclose the lack of an antidote, which ultimately caused plaintiffs to suffer bleeding injuries such as gastrointestinal bleeding and brain bleeding.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidates lawsuits into a multidistrict litigation (MDL) to make complex litigation more efficient. An MDL transfers lawsuits with common questions of fact to one court, eliminating duplicate discovery and streamlining the legal process. In the Eliquis MDL, plaintiffs allege that the blood thinner caused bleeding and that the manufacturers failed to disclose the risk of irreversible bleeding associated with the lack of an antidote.
Plaintiffs suing over Eliquis also question clinical trial data used to obtain approval. Specifically, they cite data from the Aristotle study, which was conducted and controlled by the defendants in various countries, including China. Plaintiffs allege that the companies failed to report adverse events 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.
Lawsuits also allege that Eliquis makers failed to disclose the risk of bleeding injuries, including gastrointestinal bleeding and brain bleeding. Some plaintiffs allege the need for a blood transfusion due to excessive internal bleeding. 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.
Parker Waichman notes that similar lawsuits have been filed over Pradaxa and Xarelto. After Pradaxa was released in 2010, some 4,000 lawsuits were filed including 750 wrongful death cases. Boehringer Ingelheim agreed to settle Pradaxa lawsuits for $650 million on the eve of the first day of trial.
Xarelto lawsuits have been consolidated into an MDL 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).