Eliquis Wrongful Death Lawsuit Filed Over Internal Bleeding Side Effects

The makers of the blood thinner Eliquis face a wrongful death lawsuit brought by a woman who alleges that her father suffered fatal bleeding problems while using the medication, which is part of the same class of drugs as Xarelto and Pradaxa, which have each been the subject of thousands of similar lawsuits over bleeding risks associated with the drugs. 

The complaint (PDF) was filed against Bristol-Myers Squibb and Pfizer last week in the U.S. District Court for the Southern District of Illinois by Kathleen Odum, the daughter of Oliver Becker, who died in June 2014 due to complications from internal bleeding while using Eliquis.

Odum alleges that the drug makers failed to adequately warn users and the medical community about the bleeding side effects of Eliquis, or the lack of an approved reversal agent that may be used by doctors to stop the blood thinning effects of the drug in the event internal bleeding develops.

Becker was prescribed Eliquis to prevent strokes and other health problems associated with atrial fibrilliation, and began taking the drug in January 2014, the lawsuit indicates. He died from internal bleeding on June 12, 2014.

The Eliquis wrongful death complaint accuses the manufacturers of hiding vital information about adverse events and bleeding problems that occurred during the clinical trial used to gain FDA approval for Eliquis, known as ARISTOTLE.

“Defendants’ agents committed fraud in their conduct of the ARISTOTLE study, by concealing side effects which occurred in test users of Eliquis,” the lawsuit states, indicating that the companies hid “a death which went unreported; 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 [Bristol-Myers Squibb].”

While only a handful of similar cases have been filed against Pfizer and Bristol-Myers Squibb over Eliquis bleeding problems, thousands of Xarelto lawsuits and Pradaxa lawsuits have been filed by individuals nationwide who suffered severe, and often fatal, bleeds following use of these other drugs that are part of the same class of anticoagulants.

Eliquis, Xarelto and Pradaxa Blood Thinner Concerns

Known as a factor xa medications, Xarelto, Pradaxa and Eliquis have been introduced in recent years as replacements for warfarin, which has been the go-to anticoagulation treatment for decades among individuals at risk of blood clots due to atrial fibrillation, or following hip or knee replacement surgery. Amid aggressive marketing by the drug makers, the new-generation treatments have rapidly become widely used, but concerns about the safety of the drugs has also emerged.

Since the medications have hit the market, thousands of adverse event reports have been filed with federal regulators involving severe and uncontrollable bleeding problems with Xarelto, Pradaxa and Eliquis.

While all anticoagulants carry a risk of bleeds, the blood thinning effects of warfarin can be quickly reversed in the event of a hemorrhage or bleed, allowing doctors to stop and control the problems. However, there were no reversal agents available for Pradaxa, Xarelto or Eliquis until recently.

Last year, a reversal agent for Pradaxa, Praxbind, was approved by the FDA, which will make the medication substantially safer. In addition, another reversal agent for Xarelto and Eliquis is under consideration for approval.

Since 2012, more than 4,000 lawsuits have been filed against Boehinger Ingelheim over bleeding problems with Pradaxa. Following several years of litigation, the manufacturer of that medication ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.

Johnson & Johnson and Bayer, the makers of Xarelto, now face more than 4,500 lawsuits over Xarelto filed in federal courts nationwide. Since December 2014, the cases have been centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated pretrial proceedings, given the similar questions of fact and law. As Xarelto bleeding lawyers continue to review potential cases for individuals prescribed the anticoagulant throughout the United States, the number of complaints has surpassed the number of claims involved in the Pradaxa litigation, as the drug has become more widely used in recent years.