Pfizer and Bristol-Myers Squibb, two powerful and large international pharmaceutical companies, worked together to create a next generation blood thinner to replace older anticoagulants like warfarin. Warfarin and other older blood thinners have long been an important part of protecting people vulnerable to life-threatening blood clots, but they are dangerous, and require individual dosing and regular monitoring.
The two drug companies came up with Eliquis, a blood thinner that was supposed to be safer and easier to use than warfarin. It has only been on the market in the U.S. since 2012 and in the short time since then a number of problems have arisen, from dangerous bleeding to a cover up of clinical trial data. These issues have led to Eliquis lawsuits over the harm caused to certain patients who relied on it as what was supposed to be a safe alternative to warfarin.
What is Eliquis?
Eliquis is a type of drug called an anticoagulant, with the generic name apixaban. Anticoagulants are often called blood thinners. Although they don’t actually thin the blood, they do prevent blood clots from forming by inhibiting part of the clotting process. The U.S. Food and Drug Administration (FDA) approved Eliquis in 2012 to treat and prevent embolisms, or blood clots.
Blood clots can form anywhere in the body, but most often begin in the legs. The danger from blood clots comes when they migrate from there to the lungs, heart, or brain. In these parts of the body, a clot can cause a blockage that can easily become fatal if not recognized and treated quickly. People who are at risk for forming clots take blood thinners to prevent their formation in the first place. These patients include people undergoing surgery, and particularly for Eliquis, people with non-valvular atrial fibrillation.
Eliquis and other similar, newer blood thinners, like Pradaxa and Xarelto, are supposed to be easier to use than warfarin. They are more specific in how they prevent clots, which means they are supposed to be safer. Warfarin has a more general action, and as such has to be monitored very carefully in patients. Each individual must get a specific dose and be monitored by a doctor. Eliquis can be dosed more generally and isn’t supposed to require such careful monitoring.
The reason that patients on warfarin must be monitored regularly is that blood thinners come with a serious and possibly fatal risk of excessive bleeding. Because they interfere with clotting, a cut or other type of bleeding can quickly get out of control and even lead to death. Although warfarin requires careful monitoring, it does have an antidote, vitamin K, that can reverse the drug and get blood clotting again.
Eliquis does not have an antidote. According to Pfizer and Bristol-Myers Squibb the medication is safer than warfarin because the action of the drug wears off more quickly. The lack of antidote is troubling, though, and if a patient does start bleeding too much, it can easily get out of control and become fatal.
Trial Cover Ups
Eliquis may have been approved earlier than 2012 if it weren’t for questionable trial practices and possible cover ups of mistakes and errors. In a clinical trial of the drug called ARISTOTLE, the FDA found mistakes were made in dispensing medication to patients. The agency also found that the trial workers attempted to cover up those mistakes and evidence of adverse events in some patients, a clear case of trial fraud.
This discovery meant that the FDA had to conduct more investigations into 24 trial locations, which delayed the approval of Eliquis for use in the U.S. The trial data were ultimately reported in a medical journal, but critics believe it was not reviewed well enough and that some of the results were questionable.
Another issue with Eliquis that may give plaintiffs reason to win settlements in pending lawsuits is that the makes of this drug has made questionable claims about its effectiveness. Critics of the trial data published in The New England Journal of Medicine believe that claims that Eliquis is more effective than other blood thinners, and that it is better than warfarin, are dubious.
Pfizer and Bristol-Myers Squibb also have made the specific claim that Eliquis reduces death in patients with atrial fibrillation. The companies claim that patients in the clinical trials that took Eliquis were 11 percent less likely to end up dying than those taking warfarin. Some data were missing from the trial reports, though, including important information about the deaths of patients. According to an FDA reviewer, information was missing for more than 300 patients who were given Eliquis during the trial.
Lawsuits against Bristol-Myers Squibb and Pfizer over Eliquis are growing. What these plaintiffs argue is that the clinical trials were conducted by people not qualified to do it correctly, that information about side effects and safety was withheld, and that the companies promoted Eliquis as safer and more effective than warfarin in direct-to-consumer advertising.
In one particular Eliquis lawsuit case the plaintiff is the wife of a man who died two months after taking Eliquis. He died of a gastrointestinal hemorrhage, excessive bleeding that ended up being irreversible and fatal. In addition to the above claims, she also has criticized the drug companies for not making it clearer that there is no antidote for Eliquis to reverse excessive bleeding. This is just one of several suits filed against the makers of Eliquis, but as of yet there have been no settlements reached.
Why File a Lawsuit?
If you suffered because of taking Eliquis, or you lost a loved one to this blood thinner, you may want to consider filing a lawsuit. There is plenty of evidence that the drug makers messed up clinical trials, that fraud was committed, that they used unethical, perhaps even illegal, marketing practices, and that claims made about the safety and effectiveness of the drug are in serious doubt. While no lawsuits have won settlements yet, the evidence may continue to grow that Bristol-Myers Squibb and Pfizer were engaged in wrongdoing and that settlements are warranted.
What you can get in a potential settlement is a sense of justice as well as compensation. Knowing that the companies who behaved unethically will have to pay can help you recover some of the loss you have felt from the death of a loved one. Monetary compensation can also help by providing coverage for medical expenses, funeral expenses, and for pain and suffering. If you think you have a case against Eliquis, contact a lawyer to learn about your options.