The “breakthrough” blood clot drug Eliquis has been linked to severe and uncontrollable bleeding incidents. Patients have begun filing lawsuits, saying the drug’s approval was based on fraudulent trial results.

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With no available antidote to reverse its effects, the new blood thinner Eliquis has been linked to excessive bleeding episodes that may lead to death in the event of an emergency.

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Eliquis Lawsuits: Patients Consider Bleeding Claims

In crisis situations, physicians regularly administer “antidotes” to patients taking blood thinners, allowing the body’s natural clotting ability to return and preventing uncontrollable “bleeds.” The anticoagulant effects of older, low-cost drugs like warfarin can be effectively reversed through a dose of Vitamin K, or donor plasma if immediate reversal is necessary.

Prior to surgical procedures or after a traumatic accident, these anticoagulant reversal agents save lives every day.

But as with two other “new-generation” blood thinners, Pradaxa and Xarelto, there is currently no reversal agent that can stop Eliquis’ anticoagulant effects. An antidote, developed by Portola Pharmaceuticals in collaboration with Pfizer and Bristol-Myers Squibb, the manufacturers of Eliquis, has recently received FDA approval.

Have Any Lawsuits Been Filed?

Eliquis patients who suffered severe bleeding events after trauma, along with those who experienced internal bleeding, are now considering legal action against the manufacturers of this life-threatening, irreversible drug.

At least three Eliquis claims have already been filed.

Patients Say Anticoagulant Caused Death, Serious Injury

Bringing their claims against both Bristol-Myers Squibb and Pfizer, two widows filed suit in New York on June 18. Alleging the companies failed to warn patients and members of the health community that Eliquis has no available antidote, these women say the blood thinner caused their late husbands’ deaths. One man experienced an “irreversible” brain hemorrhage, according to his surviving wife’s complaint.

One month later, an Alabama man filed his own claim against the manufacturers, accusing them of concealing unfavorable study results in their initial approval application with the FDA. The ARISTOTLE study, upon which Eliquis’ approval was largely based, was shoddily performed by incompetent researchers and failed, among other things, to report subject deaths, he writes.

To learn more about these damning allegations, and the shocking Pharmaceutical Approvals Monthly investigation that uncovered evidence of fraud and data concealment that could call Eliquis’ safety into question, visit our Eliquis Lawsuits page.

In light of the drug’s quickly-growing popularity, and with a release date for Eliquis’ antidote unannounced, many members of the legal community expect numerous lawsuits to follow the three already filed.

What Is Eliquis?

Eliquis is an anticoagulant, or blood thinner, manufactured by Pfizer and Bristol-Myers Squibb, the world’s 4th and 15th largest pharmaceutical companies respectively.

Approved in 2012, Eliquis is designed to decrease the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis’ approval was extended on March 14, 2014, for the prevention of deep vein thrombosis (DVT), a condition in which blood clots form in leg veins, in patients who have had knee or hip replacement surgeries. Ultimately, Eliquis’ approval would also come to encompass patients being treated for DVT and pulmonary embolism (PE), as well as those at risk of recurrent DVT and PE.

The drug’s active ingredient, apixaban, belongs to a class of drugs called “Direct factor Xa inhibitors.” Xarelto, another Direct factor Xa inhibitor, has also been linked to a severe risk of uncontrollable bleeding.

For Pfizer and Bristol-Myers Squibb, Eliquis’ market performance has proven extremely lucrative. In 2014 alone, the drug drew in more than $774 million in sales for both companies, on the back of exponential growth. 36% of Eliquis sales came in the last quarter of 2014, suggesting that the drug’s popularity has only begun to take off.

How Do Xa Inhibitors Work?

Direct factor Xa inhibitors like Eliquis knock out an enzyme, factor X, essential to the blood clotting process.

Once a blood vessel is injured, fragmentary blood cells called platelets crowd around the site of injury and literally plug the hole.

After filling the vessel’s ruptured lining, platelets need a way to bind together, so they can’t be carried off by the flow of passing blood. In a process known as secondary hemostasis, platelets release several “coagulation factors,” one of which is factor X.

Factor X is first “activated” to become factor Xa. Thus activated, the new factor Xa is able to split a protein called prothrombin into smaller enzymes known simply as “thrombin.” Thrombin, in turn, transforms proteins that are normally soluble into “fibrin,” a fibrous non-soluble protein that can act like a mesh lining or fabric, linking individual platelets together and covering the rupture in the blood vessel.

Together, this process of discrete transformations is called the “coagulation cascade.”

But Eliquis’ active ingredient inhibits factor X’s ability to become factor Xa, thus stopping the coagulation cascade before it can start. Xarelto works in much the same way. A different anticoagulant, Pradaxa, steps in at a different point in the coagulation cascade, inhibiting thrombin rather than factor X.

Blood Clots, Stroke & Systemic Embolism

With the ability to inhibit coagulation, Xarelto, Pradaxa and Eliquis have been approved to treat patients at a high risk of developing life-threatening blood clots.

This approval was initially limited to patients with atrial fibrillation, an irregular heartbeat that often prevents the organ from pumping blood properly. Unsynchronized electrical signals force the heart’s upper chambers, or atria, to quiver chaotically. Rather than being pumped efficiently down to the ventricles, blood can pool at the base of either atrium and eventually clot.

But when the heart’s rhythm returns to normal, these newly-formed clots can be pumped out toward vital organs. According to Dr. Stuart J Connolly, a cardiovascular researcher in Ontario, as many as 95% of blood clots that reach the heart’s left atrium are pumped to the brain, potentially causing strokes.

Less common, but no less dangerous, is systemic embolism, in which the clot is pumped out toward another part of the circulatory system.

Soon after its initial approval, Eliquis was also approved to reduce the risk of blood clots in patients predisposed to deep vein thrombosis or pulmonary embolism, as well as help dissolve blood clots already present in patients with those conditions.

But Eliquis’ effects don’t simply stop at these life-threatening blood clots. The drug has a systemic, currently irreversible effect on coagulation, meaning trauma or internal hemorrhage are more likely to lead to potentially-fatal blood loss in patients on Eliquis.

Latest Eliquis Updates

Laurence P. Banville - Zofran Product Lawyer
Eliquis has been known to cause severe bleeding in patients who are using the drug. Below you will find updates about various Eliquis side effects and lawsuits in the news.

April 14, 2017 – Eliquis Federal Litigation Leadership Roles Appointed

In February the U.S. Judicial Panel on Multidistrict Litigation consolidated the federal Eliquis lawsuits which will go before U.S. District Judge Denise L. Cote in the Southern District of New York. On April 10, Judge Cote issued an order appointing 2 lawyers to serve as the Plaintiffs’ co-lead counsel, 2 lawyers to serve as Plaintiffs’ co-liaison counsel, 2 lawyers to serve on a Plaintiffs’ Executive Committee, and 10 lawyers to serve on a Plaintiffs’ Steering Committee. All of the Eliquis lawsuits that are consolidated raise similar allegations of side effects caused by the drug that often caused users to suffer life-threatening bleeding complications.

March 9, 2017 – Drug Makers’ Abstracts Including Eliquis Study Accepted For Presentation

Makers of the blood thinner Eliquis, Bristol-Myers Squibb and Pfizer Inc., announced that 8 of their abstracts have been accepted to present at the American College of Cardiology ‘s 66th Annual Scientific Session. Analyses from Phase 3 Aristotle trial will be included, in addition to real-world research from part of the global ACROPOLIS program which is intended to add to the understanding and knowledge regarding anticoagulation.

February 17, 2017 – New Eliquis Lawsuit Filed In Delaware Superior Court

Earlier this month a woman filed a product liability lawsuit against the makers of anticoagulant, Eliquis. The suit alleges that the manufacturers failed to give information to the medical community and consumers which led to the plaintiff suffering severe bleeding as a side effect of the drug. According to her suit, the plaintiff was prescribed Eliquis to prevent a stroke because she suffers from atrial fibrillation. Unfortunately, in February 2015 the plaintiff suffered an ischemic stroke and severe gastrointestinal bleeding. This case will join many other Eliquis lawsuits with similar allegations.

January 31, 2017 – Eliquis Could Bring In Large Profits For Bristol-Myers In 2017

Eliquis is a new-generation oral anticoagulant manufactured by Bristol-Myers Squibb as a replacement for the traditional blood thinner warfarin. Several other new anticoagulants have been developed in the same class, such as Pradaxa and Xarelto, but Eliquis has become the most preferred anticoagulant in the institutional setting and has become increasingly prescribed by primary care physicians. Bristol-Myers plans to target patients using warfarin in order to expand Eliquis’ market. The drug has been outperforming branded competitors and has been witnessing demand in major markets like Japan and Germany.

December 30, 2016 – Doctors Voice Concerns Over Proposed Eliquis Antidote

In letters to the editor in a recent edition of the New England Journal of Medicine, several doctors urged caution in enthusiasm for the proposed reversal agent for the anticoagulants Eliquis and Xarelto. Some doctors have indicated that they feel recent positive study results may have overplayed their findings and are calling for placebo-controlled trials to better assess the drug’s efficacy. The reversal agent has been named andexanet alfa and was submitted to the FDA for approval already, but did not receive it. The FDA stated that they needed additional information on the manufacturing of the drug. Drug makers are obviously very invested in obtaining an antidote for the anticoagulants, especially since Eliquis and Xarelto are at the center of many lawsuits that allege the drugs’ side effects caused serious injury and/or death.

November 7, 2016 – Wrongful Death Suit Filed Over Eliquis Side Effects

A wrongful death lawsuit was filed in the U.S. District Court for the Southern District of New York on October 22 over the death of a Pennsylvania woman. The complaint alleges that the deceased passed away after suffering an irreversible bleeding event which they attribute to the blood thinner, Eliquis, which the woman was taking at the time of her death. According to the suit, the woman had begun taking Eliquis as a treatment for atrial fibrillation just 2 months prior to her development of the fatal gastrointestinal bleed. She died on October 23, 2014.

October 25, 2016 – Eliquis Moves Closer In Sales To Top-Selling NOAC, Xarelto

The new generation anticoagulants, NOACs, are continuing to experience market growth and to be competition for the more traditional blood thinners, like warfarin, which still dominates the market. Despite challenges of concerns over the effectiveness of the once daily dosage and the integrity of the ROCKET-AF study Xarelto is the top-selling NOAC. These challenges, though, may have given an opening to Eliquis to threaten the top-seller, as recent data has shown tremendous market growth for the drug, and a decline for Xarelto. There is currently no approved antidote for either Eliquis or Xarelto.

September 14, 2016 – Portola Releases Interim Results For AndexXa Study

Portola Pharmaceuticals recently suffered a major setback when the FDA denied approval of AndexXa, it’s Factor Xa inhibitor antidote developed for Eliquis and other similar new generation anticoagulants. Earlier this month Portola released promising interim results from the ongoing Phase 3b/4 ANNEXA™-4 study of AndexXa at the European Society of Cardiology’s annual meeting. The results indicated positive effects for the majority of patients who used it, with 79% experiencing a stoppage of bleeding. While these results seem promising, Portola CEO William Lis stated that understanding the FDA’s questions about the antidote, many of which center around the manufacturing, “will require a meeting.”

August 22, 2016 – Portola Receives Rejection From FDA

Portola Pharmaceuticals received a Complete Response Letter from the FDA in regard to their antidote, AndexXa, in development to reverse the effects of new factor Xa inhibitors such as Eliquis. The pharmaceutical company’s CEO expressed his disappointment in the rejection of the antidote which the FDA had agreed to an accelerated review of due to the great unmet need for the drug. The FDA’s response stated concerns regarding  AndexXa’s use in drugs other than Eliquis and Xarelto and stated that the agency needed more time to go over the recently submitted documents.

April 19, 2016- Widow Files Eliquis Lawsuit For Her Husband’s Death While Using The Drug

A widow filed a lawsuit against Bristol-Myers Squibb stating that the makers of the drug Eliquis misrepresented the drug as being one that has been proven in tests to be safe and effective for use. Her husband had been prescribed the drug to treat his atrial fibrillation. Her husband subsequently developed a gastrointestinal bleed after being on the drug a short time. Even though he was admitted to hospital, doctors could not stop the bleeding which eventually led to his death.

March 18, 2016- Federal Lawsuit Alleges Eliquis Manufacturers Didn’t Disclose Risk

A lawsuit filed in the U.S. District Court for the Eastern District of Kentucky, states that the plaintiff is accusing Bristol-Meyers Squibb and Pfizer for not disclosing the risks involved with taking the drug. The woman was taking the drug and was not aware of the risk of hemorrhagic complications.

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