Eliquis is a dangerous blood thinner that has no antidote, and many of the victims who suffered from internal bleedings decided to seek justice by filing a lawsuit. The manufacturers Pfizer and Bristol-Myers are accused of misconduct during the clinical trial that allegedly proved the medication’s superiority over its counterparts. Lawyers argue that the pharmaceutical companies released to the market a drug they knew to be dangerous due to its blatant similarity to the other controversial NOACs that have been targeted by thousands of litigations
*Please seek the advice of a healthcare provider before discontinuing the use of this medication.
Bellwether Trial Date: April 2017
Injury: Bleeding Accidents, stroke, and death.
Manufacturer: Pfizer and Bristol-Myers
Settlement Amounts: EST – $100,000 over $1,000,000
What is Eliquis?
Eliquis (apixaban) is a Novel Oral Anticoagulant (NOAC) manufactured by Bristol-Myers Squibb (BMS) and Pfizer that was approved by the United States Food and Drug Administration (FDA) in 2012. The “younger brother” of Pradaxa and Xarelto, this blood-thinner is the third one in its category, and it’s indicated to treat and prevent the risk of stroke in patients affected by atrial fibrillation (AFib), pulmonary embolism (PE) and deep vein thrombosis (DVT).
An extremely powerful blood thinner, Eliquis has been widely overhyped as a safe, more convenient alternative to the oldest standard in this category: Warfarin. The older drug required, in fact, constant INR monitoring to assess its effectiveness and forced patients to observe several dietary restrictions. The newer NOACs, on the other hand, required a once- or twice-a-day regimen that avoided constant trips to blood clinics.
Why is Eliquis Dangerous
The major downside of treating a patient with Eliquis is the absence of a proper antidote to reverse its effects. In the event of an emergency bleeding in patients on Warfarin, doctors may administer intravenous infusions of Vitamin K to stop the hemorrhage. eliquis on the other hand, cannot be reversed in any way since no antidote has ever been approved. Andexanet alfa, the only reversing agent that has been submitted for approval, has been rejected by the FDA on August 17, 2016. Not even dialysis can remove this medication from a patient’s system, leaving no other option than waiting and hoping for the best (literally).
A simple accident like a bump, fall, or cut may cause an uncontrolled bleeding which may lead to death. Standard procedures like a dental surgery or gastrointestinal endoscopy may become dangerous because of the hemorrhage risk. If you or a loved one wants to stop taking Eliquis, it needs to be done under strict medical supervision since there’s a risk of blood clots, the same condition the drug should treat.
Injured? Compensation Is Available
Other NOACs Lawsuits
All the blood-thinners in the NOAC category proved to be dangerous medicines as soon as they hit the market. The death toll ranges in the thousands of victims so far since the side effects of these medications cannot be stopped or reversed. Both Xarelto (rivaroxaban) and Pradaxa (dabigatran) have been involved in some of the largest litigations in the history of pharmaceuticals shortly after receiving clearance from the FDA. Pradaxa’s manufacturer Boehringer Ingelheim eventually settled the over 4,000 lawsuits in 2014 by paying $650 millionThe Xarelto MDL is still ongoing, instead, with more than 13,000 cases pending in the Eastern District of Louisiana as per December 2016. In both instances, plaintiffs accused the Big Pharma of releasing a dangerously flawed medication to the market that caused grievous, and sometimes fatal, injuries to those unfortunate enough to take it.
The Heavily Flawed ARISTOTLE trial
According to the lawsuits filed against Bristol-Myers Squibb, the pharmaceutical company purposely hired untrustworthy and incompetent agents during the pivotal Eliquis trial in order to cut the costs. However, these were not the only irregularities found by the U.S. regulators when they scrutinized the Chinese testing site where the ARISTOTLE study took place. Serious adverse events were fraudulently unreported, and large percentages of patients received the wrong drug dosage or a different medicine altogether.
The FDA stalled the research for more than nine months when it found that many patient records were falsified or simply disappeared just before the agency’s investigators arrived at the site. Documents showed evidence of cover-ups attempting to conceal several errors and misconducts, as well as many instances of improper data manipulation. Medical outcomes from at least 300 patients among the 18,000 enrolled in the Shangai trial were omitted, including many cases of death that were missing. Eventually, regardless of whether fraud was perpetrated on purpose or not, all this mishandled data skewed the results in favor of Eliquis, inappropriately portraying the newer drug as safer and more effective than its older competitor Warfarin.
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Current Status Of the Eliquis MDL Lawsuits
The first federal Eliquis lawsuit was filed in June 2015, on behalf of, Donald Bruce Herschel, a 60-years-old man who took the drug to treat his atrial fibrillation. After a brief period of treatment, however, the man died because of an unstoppable gastrointestinal bleeding. On October 13, 2016, several attorneys filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize 34 claims in the Southern District of New York.
Consolidating all those disputes that share similar questions of law and fact in a single MDL will help speed up the proceedings. Plaintiffs claim that BMS misrepresented the blood thinner’s safety and effectiveness, inadequately conducted the trial that led to the drug’s approval, released a defective and hazardous product to the marked, and failed to warn the public about its risks.