The blood thinner drug Xarelto (rivaroxaban) has been linked to serious bleeding events and death, prompting legal action on behalf of injured users.
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 legal team at ClassAction.com is filing lawsuits on behalf of injures Xarelto users and their loved ones.
Serious Adverse Xarelto 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 does not have an antidote to stop internal bleeding side effects. 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 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.
U.S. patients may have been prescribed the following Xarelto oral dosages:
- 15 mg
- 20 mg
- 10 mg
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 constitutes 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.
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 warfarin. Also like Xarelto, Pradaxa does not have an antidote to stop dangerous bleeding events and is marketed as being easier to use than warfarin.
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.
Xarelto MDL and Mass Tort Lawsuit
ClassAction.com attorneys are filing Xarelto lawsuits on behalf of injured clients. The majority of lawsuits are part of a multidistrict litigation (MDL) in Louisiana federal court. Plaintiffs who file suit and join the MDL will maintain their own lawyer and their own trial. More than 7,000 separate claims are contained in the MDL. The first four bellwether trials will be held in 2017, with trials scheduled to begin on February 6, March 13, April 24, and May 30.
Nearly 1,000 additional lawsuits await trial in a mass tort program in Philadelphia. Bellwether trials are set to begin in August 2017.
It is not too late to file a Xarelto lawsuit, but the time to file a claim is limited.
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. Also potentially eligible are the family members of a patient who died while taking Xarelto.
Individual eligibility can be determined by speaking with our legal team.
How a Lawsuit Can Help
A Xarelto lawsuit settlement can provide money to injured users who suffered 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.
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 hire top-notch defense attorneys to minimize their liability for product-related injuries. In 2014, Xarelto brought in $1.5 billion in U.S. sales. Such profits make it possible for drug companies to thwart the efforts of everyday people seeking justice through the courts.
Working with an experienced injury attorney levels the playing field and gives plaintiffs the best chance at a favorable recovery.
What to Do if You Are 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.