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Eliquis Lawsuits Say Bleeding Risks “Unreasonable”

Patients who are at risk for dangerous blood clots deserve a strong line of protection. Thankfully, they’ve had one for over 60 years: Coumadin or warfarin. Warfarin is effective and relatively safe, but like all blood thinners, the drug does present a limited risk: excessive bleeding. That’s why the medical community reacted to the release of a “new-generation” anticoagulant with such excitement.

Eliquis promised to prevent blood clots from forming, and with less risk of bleeding than traditional methods. While it’s only been on the market for a year, patients have already come to believe that Eliquis may actually be a dangerous, unnecessary option.

No Antidote: Eliquis Could Lead To Wave Of Lawsuits

Warfarin’s great strength is that its anticoagulant effects can be easily reversed, with a shot of vitamin K or donor blood plasma. Eliquis on the other hand was released without an antidote, leaving patients helpless after a traumatic accident or internal bleed.

Portola Pharmaceuticals, a San Francisco-based company, is currently working on an antidote for Eliquis. According to the company’s website, the reversal agent has reached Phase 3 clinical trials and is now being administered to large groups of trial patients. An approval date for the antidote may be months, or even years, away.

Early reports suggest a link between Eliquis and multiple devastating side effects, including:

  • Eye bleeds
  • Brain bleeds
  • Gastrointestinal bleeds

but it’s unlikely that lawsuits will be limited to those risks. In fact, many Eliquis lawyers believe that any form of severe bleeding, internal or external, may justify legal action.

Blood Thinner Side Effects: Will History Repeat Itself?

Two other new blood thinners, Xarelto and Pradaxa, are already embroiled in a firestorm of controversy. Like Eliquis, both drugs were approved without antidotes and soon, patients seeking improvements in their health were suffering devastating complications.

By 2014, over 4,000 patients and surviving loved ones had filed lawsuits against Boehringer Ingelheim, the manufacturer of Pradaxa. The company was forced to settle for $650 million, after journalists discovered that the German drug maker had concealed damning study results from the FDA.

Xarelto, a drug even closer to Eliquis in its effects on the body, has also seen its share of litigation. In fact, more than 400 excessive bleeding lawsuits have been filed against the drug’s manufacturers, Bayer and Janssen Pharmaceuticals.

Early signals may suggest a similar fate for the manufacturers of Eliquis, Bristol-Myers Squibb and Pfizer.

Have Any Claims Been Filed Yet?

Yes, several lawsuits have already been filed, claiming Eliquis caused irreversible bleeding. Tragically, the majority of these lawsuits have been filed by widows and widowers, who seek justice and compensation on behalf of their deceased loved ones.

Find the story behind an Eliquis lawsuit in court documents obtained by Osborne & Associates below:

Herschell v. Bristol-Myers Squibb & Pfizer: The First Eliquis Lawsuit

In their complaints, Eliquis patients and survivors have stepped forward against a pharmaceutical industry they say is rife with corruption.

The 6 Allegations You Need To Know

To understand the outrage and grief these former patients and families have expressed, we need to look at their allegations. Plaintiffs accuseBristol-Myers Squibb and Pfizer of far-reaching wrongdoing, from failing to adequately study Eliquis’ risks to concealing test results from patients and their medical professionals.

Here are the 6 main claims they’ve made so far:

  1. Plaintiffs say that without an antidote, Eliquis presents an unreasonable
    risk of harm, making it defective in design.
  2. Since no reversal agent can stop Eliquis, patients believe that its benefits are far outweighed by its dangers. But they claim the drug’s warning label bore only a passing mention to the lack of an antidote, leading to an understatement of the risk.
  3. Patients and survivors aren’t blaming the doctors who prescribed Eliquis. They say physicians were just as deceived as the people looking for a safe and effective blood clot treatment.
  4.  Bristol-Myers Squibb and Pfizer overstated Eliquis’ superiority to warfarin, at least that’s what Plaintiffs have alleged.
  5. In fact, their most troubling allegation is already supported by good evidence. One of the primary studies used to support Eliquis’ approval was marred by fraud and data tampering. That’s not a bald-faced accusation; it’s the opinion of the FDA.
  6. Plaintiffs say that there’s no assurance Eliquis has any benefit over traditional anticoagulants, since its main safety study included fraudulent information.

Only time will tell whether these allegations are well-founded. But at least one of Plaintiffs’ claims, that Eliquis was inadequately studied, appears to have strong support – from the US Food & Drug Administration.

Flawed Study May Have Downplayed Eliquis Side Effects

In 2011, the New England Journal of Medicine published the results of Eliquis’ major safety study. Titled ARISTOTLE, the clinical trial was a resounding success for Bristol-Myers Squibb and Pfizer. Not only could Eliquis prevent blood cots better than warfarin, it was safer, too.

There was only one problem. The study, which had been out-sourced to a Chinese facility, was flawed. Seriously flawed, and those errors would delay Eliquis’ approval for nine months.

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Industry watchdog Pharmaceutical Approvals Monthly broke the story first. The Chinese researchers conducting ARISTOTLE had been caught:

  • listing patients who received warfarin as receiving Eliquis
  • deleting patient records entirely
  • underreporting bleeding events, including one fatal bleed, linked to Eliquis
  • labeling patient records with the wrong names

In at least one case, FDA researchers arrived in Shangai only to find that a trove of patient records had been mysteriously “misplaced” right before they got to the test facility.

The FDA’s exhaustive investigation found a “pattern of inadequate oversight,” and placed the blame on Bristol-Myers Squibb and Pfizer.

Are More Lawsuits On The Horizon?

The aftershock of these revelations is still being felt within the pharmaceutical industry. Beyond calls to limit drug companies from out-sourcing their critical safety trials, notable public safety advocates have even called Eliquis’ risk-benefit profile into question.

Amid this controversy one thing remains clear: more Eliquis lawsuits are coming. The only question is which patients, which families, will stand up to see their best interests protected?