A wave of revolutionary blood thinning drugs has swept the US market, promising patients significant benefits over older options like warfarin. But unlike traditional anticoagulants, which have been used for more than 60 years, the recent approval of Xarelto, Pradaxa and Eliquis was not accompanied by an antidote.
While a potential reversal agent for these products is now in phase 3 clinical trials, no available drug can stop their potentially life-threatening effects.
This litigation is now closed. You can learn more about a similar case and Uloric settlements from our team of attorneys.
Patients who experienced severe, irreversible “bleeds” after being prescribed Eliquis are now considering legal action, amid allegations that the drug’s manufacturers concealed safety data from the US Food & Drug Administration.
Yes. At least three Eliquis claims have already been filed against Bristol-Myers Squibb and Pfizer, the companies producing Eliquis, in New York and Alabama federal courts. Two were filed on the same day.
On July 24, 2015, Deborah Herschell filed the first Eliquis lawsuit against Bristol-Myers Squibb and Pfizer.
According to her complaint, Herschell’s late husband Donald suffered from atrial fibrillation, an abnormal heartbeat that increases the risk of blood clots. She says that her husband was prescribed Eliquis in August of 2014, and began taking the drug as prescribed.
Soon, Donald Herschell was hospitalized for subarachnoid hemorrhage, a severe form of bleeding in the brain. But her husband’s death would come as a result of a separate bleeding event, plaintiff claims.
Less than four months after being prescribed Eliquis, Herschell suffered a gastrointestinal hemorrhage. The bleed was “life-threating,” writes his widow, and could not be reversed. He died on October 21, 2014, according to court documents.
Herschell accuses Pfizer and Bristol-Myers Squibb of marketing a product that, without an adequate antidote to reverse its blood thinning effects, was unreasonably dangerous and defective in design.
She claims that Eliquis’ manufacturers fraudulently promoted the drug as at least as safe and effective as older anticoagulants while concealing unfavorable study results from the FDA, public, and health community.
In a separate complaint filed the same day, the widow of Arthur D. Yelder claims Bristol-Myers Squibb and Pfizer failed to adequately test Eliquis’ risks, despite early clinical trial results finding an abnormal increase in severe bleeding events.
One month after Yelder and Herschell filed their claims, another patient stepped forward.
On July 28, 2015, Lester Baldwin Jr. brought a lawsuit against Bristol-Myers Squibb and Pfizer, claiming the company’s blood thinner had caused him to suffer an intracranial hemorrhage.
One of Baldwin’s allegations is particularly troubling. In his complaint, filed in the US District Court for the Southern District of Alabama, the man claims that a major study, the purported results of which served to justify Eliquis’ FDA approval, was marred by poor quality control, numerous errors and outright fraudulent data reporting.
His allegation isn’t an opinion. It’s backed by the FDA’s own records.
Eliquis’ safety for patients was demonstrated in two clinical trials: the ARISTOTLE and AVERROES studies. But one of those studies, which “found” Eliquis more effective and safer than warfarin, was flawed.
A recent investigative report has concluded that research contributing to ARISTOTLE’s results was heavily manipulated, potentially inflating the appearance of Eliquis’ benefits and minimizing its risks.
Many pharmaceutical companies now contract their research out to third-party firms. With low costs and numerous potential subjects, China has become a favorite location for drug companies out-sourcing even their most important studies: clinical trials, which form the basis for the FDA’s approval process.
Clinical trials serve to answer two essential questions:
But for these questions to be adequately answered, clinical trials have to be tightly-controlled, conducted according to the medical community’s best practices. If a study is botched, and thus untrustworthy, it goes without saying that we can’t truly know whether or not a drug is safe and effective.
According to a report published by Pharmaceutical Approvals Monthly, Bristol-Myers Squibb & Pfizer relied on one such outsourced clinical trial to support their approval application for Eliquis.
The study, nicknamed ARISTOTLE, included 18,201 patients, all of whom lived at an increased risk of stroke and systemic embolism. Half were prescribed Eliquis, and half warfarin then followed over almost 3 and a half years.
The study’s results, published by the New England Journal of Medicine in 2011, were unequivocal:
“In patients with atrial fibrillation, [Eliquis’ active ingredient] was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.”
Bristol-Myers Squibb and Pfizer soon submitted their New Drug Application for Eliquis, including the ARISTOTLE study’s overwhelmingly favorable results.
It would take nine more months for the FDA to approve Eliquis. Now we know why.
A trove of FDA documents obtained by Pharmaceutical Approvals Monthly (PAM), and since made public, reveal that FDA researchers discovered numerous errors, including blatant data tampering, which call the ARISTOTLE study’s results into question:
The FDA concluded that records had been falsified “in order to cover-up GCP [Good Clinical Practice] violations.”
And while the majority of inaccuracies were found at one research site, a hospital in Shanghai, the agency was forced to consider whether misrepresentations didn’t extend to other sites, and possibly, the entire study. In a 2012 meeting with executives from Bristol-Myers and Pfizer, the FDA observed that the ARISTOTLE study’s numerous mistakes demonstrated a systemic “pattern of inadequate oversight.”
Visiting the Shanghai hospital, FDA analysts were startled to find that a number of patient records had “disappeared” right before their arrival. In the documents obtained by PAM, the FDA blamed this instance of “fraud” on an employee of Bristol-Myers Squibb, not one of the Chinese contractors hired to perform the research.
The ARISTOTLE study’s fraudulent misrepresentation of data stands at the center of the three filed Eliquis lawsuits.
Plaintiffs claim that Bristol-Myers and Pfizer failed to inform patients and physicians about an alleged lack of medically-acceptable evidence supporting the drug’s safety and efficacy. In their claims, patients and widows say evidence demonstrating Eliquis’ true risk of irreversible bleeds was actively concealed from regulatory authorities.
Relative to warfarin, a drug whose effects can be reversed, Eliquis does not provide a safer or more effective alternative, they say, making the companies’ marketing efforts fraudulent, too.
While only several Eliquis claims have been filed so far, the legal community expects numerous patients to raise their own voices against potential corporate misconduct in the coming months.
But Eliquis is only one of several “new generation” blood thinners. Turns out the manufacturers of Pradaxa and Xarelto have already been hit by thousands of lawsuits.
In 2014 Boehringer Ingelheim, the German manufacturer of blood thinning agent Pradaxa, settled more than 4,000 lawsuits for a total of $650 million. Like Eliquis, Pradaxa was approved without an accompanying antidote, a fact that spurred thousands of injured patients to file suit against the drug’s manufacturer.
In the course of litigation, numerous troubling allegations surfaced, including claims that Boehringer Ingelheim had concealed unfavorable study results from the FDA. As in the case of Eliquis’ ARISTOTLE study, at least some of those allegations were proven true.
Unsealed court documents obtained by media sources including Bloomberg Business revealed evidence that Boehringer hid a study demonstrating Pradaxa’s extremely high risk for major bleeding events from federal regulators. Rather than submit results which found that 19.5 out of every 10,000 Pradaxa patients would suffer uncontrollable bleeding, the company chose to submit a different study: one that found a risk of only 6.1 out of 10,000.
As subsequent studies found a significant increase in the risk of bleeding among Pradaxa patients, researchers sought to compare the drug’s effects to warfarin, a traditional blood thinner whose effects can be quickly reversed. In contrast to Boehringer’s marketing claims, a study in the Journal of the American Medical Association found that Pradaxa increased bleeding risks by up to 60% over warfarin.
With Pradaxa lawsuits now settled for tens of millions of dollars, many patients have begun to wonder whether Eliquis claims will meet with similar success.
More than 1,400 plaintiffs have filed Xarelto lawsuits against Bayer and Johnson & Johnson, accusing the manufacturers of minimizing the drug’s significant risks and attempting to conceal its lack of an antidote.
Xarelto’s active ingredient is slightly different from Eliquis, but the two drugs perform an identical function in the body: blocking the production of factor Xa, a key component of the coagulation process.
While plaintiffs may be allowed to file class actions on behalf of others, Banville Law does not believe that a potential Eliquis lawsuit will be litigated as a class action.
Our attorneys intend to file individual personal injury lawsuits. But there is a possibility of consolidation, through a different mechanism known as Multidistrict Litigation (MDL).
Many litigations in which numerous plaintiffs are expected to file claims against a common defendant eventually end up as MDLs.
This is certainly true for claims involving the “new generation” blood thinners. Most Pradaxa lawsuits were consolidated in an MDL in the US District Court for the Southern District of Illinois. Similarly, Xarelto claims have been transferred to the US District Court for the Eastern District of Louisiana and consolidated in an MDL.
In an MDL, numerous similar lawsuits are transferred to a single federal court and presided over by one federal judge. For the purposes of pretrial proceedings, like Discovery (in which plaintiffs and defendant obtain evidence from one another), this “consolidation” allows for improved efficiency, along with lower court and legal fees.
Since each of the lawsuits share similar questions of law and fact, the single judge can make rulings that apply universally, and only has to do so once.
After pretrial proceedings are over, the individual lawsuits can be “remanded,” sent back to their original courts. From here, each plaintiff can decide for themselves to proceed to trial or accept a settlement offer, if one is available. This power, to control the course of your own lawsuit, is what distinguishes MDL from a class action. In a class action, major decisions are made by a small group of “representative” plaintiffs, but those decisions apply to every member of the class equally.
Any patient who was prescribed Eliquis and then suffered a serious bleeding event may be eligible to file a claim. Lawsuits are likely to involve:
but any type of excessive, irreversible bleed may qualify former Eliquis patients to bring a suit against the drug’s manufacturers.
The attorneys at Banville Law are here to help. Our personal injury lawyers have years of experience taking on large corporate defendants, with successful results. Now we’re assisting Eliquis patients pursue justice.
Continue Reading: Eliquis Side Effects: Severe Irreversible Bleeding