Eliquis Lawsuits Filed Over Bleeding Side Effects, Lack of Reversal Agent

After thousands of product liability lawsuits have been filed against the makers of Pradaxa and Xarelto, a growing number of Eliquis lawsuits are now being pursued on behalf of individuals who suffered irreversible bleeding after using this third member of the same controversial class of oral anticoagulants.

Eliquis (apixaban) is part of a new class of anticoagulants introduced in recent years for prevention of strokes among individuals with atrial fibrillation. Pradaxa (dabigatran) was the first member of this class to hit the market in late 2010, followed by Xarelto (rivaroxoaban) in 2011 and Eliquis in 2012.

The medications are promoted as superior alternatives to Coumadin (warfarin), indicating that they are easier to use since patients do not require the same level of blood monitoring. However, concerns have emerged about the potential bleeding side effects associated with the medications, as none were introduced with an effective antidote that doctors can use to reverse the blood thinning effects of the medication if bleeding occurs.

Allegations raised in recent cases filed against Bristol-Myers Squibb and Pfizer are similar to those pursued in Pradaxa lawsuits and Xarelto lawsuits filed in recent years, claiming that the drug maker failed to adequately warn about the bleeding risk and the lack of an effective reversal agent.

According to one complaint (PDF) filed last month in the U.S. District Court for the Southern District of Alabama, Lester Baldwin, Jr. indicates that he was admitted to the hospital for numbness and loss of control in his right hand only two days after he began using Eliquis in July 2014. An examination revealed that Baldwin was suffering an intracranial hemorrhage, which his doctors attributed to the side effects of Eliquis.

Although Baldwin was taken off of the drug immediately, the bleeding from Eliquis continued for some time, as indicated by later testing that showed the hemorrhage increased in size before it stopped.

“At all times relevant hereto, Defendants… failed adequately to warn emergency room doctors, surgeons, and other critical care medical professionals that unlike generally-known measures taken to treat and stabilize bleeding in users of warfarin, there is no effective agent to reverse the anticoagulation effects of Eliquis, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Eliquis,” claims Baldwin in the complaint.

Nearly identical allegations were raised in an Eliquis wrongful death lawsuit filed in June, in which the family of Donald Herschell claim that the anticogulant caused fatal gastrointestinal bleeding for the Virginia man.

Eliquis has gained market share over the past year, generating $774 million in 2014, of which $281 million was from the fourth quarter alone. As more individuals learn about the link between Eliquis and bleeding problems suffered in recent years, it is expected that the number of claims will continue to grow.

There are currently more than 1,200 lawsuits pending throughout the federal court system over side effects of Xarelto, which are currently centralized for pretrial proceedings as part of an MDL, or multidistrict litigation. Unless Xarelto settlements are reached to resolve the litigation, the first trials are expected to begin by August 2016.

In the Pradaxa litigation, Boehringer Ingelheim agreed to pay about $650 million to settle about 4,000 cases in May 2014, with an average of about $150,000 awarded to former users who experienced bleeding side effects. However, additional cases continue to be filed by individuals who have suffered injuries since the date of the settlement.