(Updated Nov. 28, 2018)
Reviewed by: Michael Goetz
Approved by the U.S. Food and Drug Administration (FDA) in 2011, Xarelto is indicated to reduce the risk of strokes, deep vein thrombosis (DVT), pulmonary embolism (PE), and blood clots. Xarelto has been promoted as superior to older types of blood thinners but may in fact be more dangerous because, unlike older products, it can cause bleeding that cannot be stopped, even by a doctor.
The blood thinner drug Xarelto (rivaroxaban) has been linked to serious bleeding events and death, prompting legal action on behalf of injured users.
More than 20,000 patients who have suffered these extreme bleeding events have filed lawsuits against Bayer. The majority of Xarelto lawsuits are part of a multidistrict litigation (MDL) in the Eastern District of Louisiana, while more than 1,900 lawsuits await trial in Philadelphia.
Our lawyers are filing lawsuits on behalf of injured Xarelto users. If you or a loved one experienced a severe bleeding event after taking Xarelto, please contact us today for a free consultation.
What Are Xarelto’s Side Effects?
Like other anticoagulant drugs, Xarelto carries a risk of internal bleeding (hemorrhaging) side effects. But Xarelto—marketed as a superior alternative to traditional blood thinners such as warfarin—is different from earlier anticoagulants in important ways. First, it did not have an antidote to stop internal bleeding side effects until AndexXa was approved in May of 2018—seven years after Xarelto was first prescribed to patients. Second, it does not require regular blood monitoring tests that may help prevent uncontrolled bleeding.
Xarelto users have claimed that they suffered the following serious side effects while taking the drug as directed:
- Intracranial hemorrhages
- Abdominal hemorrhages
- Retinal hemorrhages
- Wound infection and complication
- Epidural hematoma
- Adrenal bleeding
- Excessive blood loss
Learn more about Xarelto side effects, scientific research, FDA warnings, and more on our Xarelto Product Information Page.
Has There Been a Xarelto Recall?
Xarelto has not been recalled. Doctors are still prescribing the drug to patients despite allegations of its potential to cause harm.
It’s worth noting that some FDA scientists had misgivings about approving Xarelto due to a perceived lack of care in clinical trial design. FDA reviewers concluded that patients could be put at greater risk of harm from stroke and/or bleeding when treated with Xarelto, compared to careful treatment with warfarin. In one Xarelto clinical trial, 30 days after the study ended Xarelto subjects had experienced 22 strokes while warfarin users had experienced six strokes.
What Do Xarelto Lawsuits Allege?
Lawsuits filed against Xarelto’s manufacturers allege that the companies were negligent in a number of ways.
Specific allegations include claims that the drug presents an unreasonable risk of injury and that its labeling does not adequately warn about its potential side effects.
Claimants also allege that Xarelto’s lack of an antidote constituted a design defect and that the drug does not provide greater patient benefits than drugs like warfarin, which were safely administered for decades.
Some believe that Janssen/Bayer intentionally concealed knowledge of Xarelto’s irreversible, life-threatening bleeding.
Have There Been Any Xarelto Verdicts, Settlements?
In December 2017, a jury in Philadelphia issued a $28 million verdict in favor of Lynn Hartman who claimed that she suffered serious gastrointestinal bleeding after taking Xarelto. The jury believed that Bayer and Janssen inadequately warned of the drug’s bleeding risk. The verdict has since been reversed, but is still being contested.
Xarelto lawsuits are similar to lawsuits over Pradaxa, another newer-generation anticoagulant. Thousands of Pradaxa lawsuits were filed and consolidated in federal court, and millions of dollars in compensation were awarded to victims.
Like Xarelto, Pradaxa (made by Boehringer Ingelheim) is marketed as superior to and easier to use than warfarin. Also like Xarelto, Pradaxa did not have an antidote to stop dangerous bleeding events when it was first approved.
Pradaxa, which gained FDA approval in 2010, led all drugs in FDA-reported adverse events in 2011 (3,781 events overall, including 542 patient deaths, 2,367 hemorrhage reports, and 644 stroke reports).
Widespread patient harm from Pradaxa led to about 4,000 lawsuits being filed as part of a multidistrict litigation (MDL). The MDL settled in 2014 for $650 million.
Xarelto and Pradaxa are different drugs, and there is no guarantee that Xarelto litigation will go the way of Pradaxa lawsuits. Still, given the similarity of the drugs and their side effects, the Pradaxa settlement should be encouraging to Xarelto victims who are currently seeking compensation.
Who Can File a Xarelto Lawsuit?
Patients who took Xarelto as indicated and suffered a major bleeding event, stroke, or death could be eligible for legal action against the drug’s manufacturers. Family members of a patient who died while taking Xarelto may also be eligible.
A Xarelto lawsuit settlement may be able to provide compensation for financial losses (such as medical bills and lost wages) as well as non-financial losses (pain and suffering) caused by a Xarelto injury. Compensation may also be available for the survivors of Xarelto patients who suffered fatal bleeding events or strokes.
It is not too late to file a Xarelto lawsuit, but the time to file a claim is limited.
Why Do I Need a Lawyer?
A lawyer is not necessary to file a lawsuit, but without experienced legal representation litigants risk not receiving a fair amount of compensation for their losses.
Drug manufacturers are among the most profitable companies in the world and many hire top-notch defense attorneys to try to minimize their liability for product-related injuries. In 2017, Xarelto brought in $3.84 billion in sales worldwide. Such profits often make it possible for drug companies to thwart the efforts of everyday people seeking justice through the courts. That’s why working with an experienced injury attorney, backed by a firm that has the resources to challenge large corporations, often gives plaintiffs the best chance at a favorable recovery.
Who Do I Contact If I’m Affected?
If you or a loved one took Xarelto and experienced bleeding complications, it’s in your best interest to speak with our legal team as soon as possible. Failure to take prompt action could mean that the statute of limitations expires, leaving you with no legal recourse.
There are never any costs unless we win a jury award or settlement. Contact us today for a free legal review.
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