Eliquis is a type of anticoagulant prescribed for the prevention of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and blood clots. Despite claims of superior safety and effectiveness compared to the older anticoagulant warfarin, there is thin supporting evidence that Eliquis is safer or more effective than warfarin.
Patients have filed lawsuits against drugmakers Bristol-Myers Squibb and Pfizer for alleged Eliquis-related injuries and deaths.
Unlike warfarin, Eliquis does not have an antidote that allows doctors to stop bleeding complications, nor does it require regular blood monitoring that can help prevent dangerous bleeding events. The Eliquis approval process has also come under scrutiny for reported irregularities at a clinical trial site.
Lawsuits are being filed against drugmakers Bristol-Myers Squibb and Pfizer for alleged Eliquis-related injuries and deaths.
Serious Eliquis Side Effects
Eliquis may cause internal bleeding that is serious, irreversible, and potentially fatal. Eliquis bleeding risks include:
- Gastrointestinal bleeding
- Kidney bleeding
- Rectal bleeding
- Eye bleeding
- Spinal bleeding
- Cerebral hemorrhage
Because they reduce blood clotting, all blood thinners can cause bleeding. But Eliquis is arguably more dangerous than warfarin, a drug that was for decades the industry-standard blood thinner.
The new generation of blood thinners are marketed as alternatives to warfarin that offer benefits over the older treatment, including no routine blood testing and no major dietary restrictions. However, while regular anticoagulation blood tests may be seen as burdensome to patients, research suggests that measuring coagulation function can help assess bleeding risk.
And while Eliquis is also marketed as producing less major bleeding than warfarin, this benefit comes with a catch: With warfarin, major bleeding can be reversed with Vitamin K. Eliquis does not have an antidote to stop bleeding. In other words, once an Eliquis patient develops serious bleeding, a doctor may not be able to stop it.
Eliquis Clinical Trial Irregularities
Aristotle is a prime example of the cozy ties between the drug industry and researchers.
Lawsuits claim that clinical trials used to support Eliquis approval were fraudulent, and that this fraud led to patients using a harmful drug that should not have been on the market in the first place.
The FDA delayed approval of Eliquis for nine months over misconduct, errors, and an alleged cover-up at a clinical trial site in China. The FDA said that the mistakes demonstrated a “pattern of inadequate trial conduct and oversight.”
The trial in question is known as ARISTOTLE (Apixaban for Reduction in Stroke and Other Thrombotic Events in Atrial Fibrillation). According to FDA documents, issues with the clinical trial included:
- Failure to report adverse medical events (including deaths)
- Late reports of adverse events
- The exclusion of medical outcomes
- A high percentage of patients who were given the wrong drug or the wrong drug dose.
The Aristotle study was eventually published in the New England Journal of Medicine, but its publication was criticized by many, including former NEJM editor-in-chief Arnold Relman, who pointed out flaws in the study and said that financial interests influenced its publication.
According to Relman, the study failed to show that Eliquis was more effective than warfarin, while safety data may have been skewed in favor of Eliquis. He cited Aristotle as a prime example of the cozy ties between the drug industry and researchers and how this can result in biased data. At least three of the study authors were Bristol Myers Squibb employees.
As for why Bristol-Myers/Pfizer were so eager to introduce a new medication that is marginally (if at all) better than warfarin, it helps to follow the money. The annual cost of Eliquis is more than 10 times higher than the annual cost of warfarin.
Eliquis Lawsuit Allegations
More than 130 lawsuits have been filed against Bristol-Myers Squibb and Pfizer over alleged injuries and deaths caused by Eliquis. Plaintiffs in Eliquis lawsuits make a number of accusations against the drugmakers, including the following:
- Not providing adequate warnings about Eliquis’ lack of a bleeding reversal agent
- Overstating the safety of Eliquis while downplaying its risks
- Failing to conduct complete and proper testing of Eliquis
- Bringing to market a drug with unreasonable, dangerous side effects
- Breaching a drug maker’s duty to bring to market reasonably safe products
- Negligently advertising and recommending Eliquis without sufficient knowledge of its dangers
- Concealing product safety information from the public
- Prioritizing profits over patient safety
- Committing fraud during Eliquis testing
- Causing patient injuries and deaths as a result of these acts and omissions
All three new generation blood thinners—Eliquis, Xarelto, and Pradaxa—have been the targets of bleeding side effect lawsuits. More than 4,000 Pradaxa lawsuits settled in 2014 for $650 million.
These drugs are similar in that they’re marketed as being safer, more effective, and easier to use than warfarin. The lawsuits filed over these drugs are also similar: They accuse manufacturers of concealing medication side effects and causing patient harm through their negligence.
Since Eliquis is the last of these drugs to be approved and has been on the market for the shortest amount of time, Eliquis lawsuits are only now being filed in significant numbers. As more patients become aware of the link between the drug and life-threatening bleeding, more cases are expected to be filed.
Approximately 18,400 Xarelto lawsuits have been consolidated as part of a multidistrict litigation (MDL). Eliquis lawsuits could also reach MDL status if a sufficient number of lawsuits are filed.
How a Lawsuit Can Help
If you suffered complications or severe side effects from your medication, a lawsuit may be able to recover damages for medical bills, as well as for lost wages or reduced earning power. Lawsuit compensation may also cover things like physical pain, mental anguish, and reduced quality of life.
Contact us for a free legal consultation. We’ll explain your rights, answer your questions, and tell you whether you might have a case against the manufacturer.
It costs nothing to have your claim reviewed, and you pay nothing unless our attorneys win your case. To date, we have secured $4 billion for our clients.