More than 18,000 Xarelto lawsuits have been filed against Bayer and Johnson & Johnson for allegedly hiding the severe bleeding risks of the blood thinner, and failing to make an antidote. It’s also been discovered that studies proving the superiority of the drug were tainted by faulty equipment and missing data.
Common Xarelto Lawsuit Claims
Xarelto (rivaroxaban) is an anticoagulant – a type of drug commonly known as a blood-thinner. It works by inhibiting an enzyme known as “factor X” to prevent blood from clotting. People often take Xarelto after surgery or if they have a high risk of developing blood clots—such as those diagnosed with atrial fibrillation.
Serious Xarelto side effects
One advantage Xarelto has over similar blood thinners like Pradaxa, is that it works very quickly to stop blood clotting. However, the drug also has a major drawback: there is no antidote to reverse the effects. This can cause life-threatening bleeding from normally insignificant injuries, as well as posing a risk of severe internal bleeding that can result in hospitalization or even death. Other Xarelto side effects include a higher risk of developing blood clots for patients who have had spinal taps or epidurals.
According to the FDA’s adverse drug event data, nearly 22,000 severe injuries, including over 3,000 deaths, resulted from anticoagulants in 2016. In the same year, the CDC released a report stating that blood thinners accounted for more emergency department visits than any other class of therapeutic drug—including opioids and antibiotics.
Failure to Inform of risks
Xarelto was approved by the FDA in 2011, and has since had five warning label updates between 2013 and 2016. These additions include: increased risk of spinal bleeds, lack of an antidote, not to be used by patients with prosthetic heart valves, and an increased bleeding risk with SSRI and SNRI antidepressants. Drug manufacturers have a responsibility to adequately inform doctors and patients about all the risks of using their products.
Xarelto injury liability
Bayer and Johnson & Johnson’s Janssen Pharmaceuticals, Inc. are both being sued by those who suffered injuries from Xarelto. Plaintiffs argue that the drug’s manufacturers acted in negligence by carelessly making and marketing a drug that endangers consumers’ health without enough benefit to outweigh the risks.
Further allegations include a failure to warn consumers about the severity of side effects, and producing a defective drug with no antidote. Unlike Xarelto, the side effects of Pradaxa and other anticoagulants can be controlled with an antidote to reverse their bleeding effects.
Why file a Xarelto lawsuit?
There are several types of compensation injured Xarelto users might receive by filing claims in the form of an award (verdict) or settlement.
- Recover medical expenses: The cost of treatment, hospitalization and follow-up visits after a bleeding injury can rack up quickly and may not always be covered by insurance.
- Lost income: Frequent medical visits and inability to work during recovery time can result in lost wages when income is needed most.
- Pain and suffering: Damages may be awarded to help compensate a victim for their pain and suffering after being subjected to the adverse effects of Xarelto.
- Punitive action: Xarelto has brought in billions of dollars in revenue while putting those who took the drug at risk. Punishing Bayer and J&J financially lets them know that they need to take better care to ensure their drugs are safe and effective for the people taking them.
- Funeral expenses: In the tragic cases where Xarelto has contributed to someone’s death, their surviving family members may be able to recoup costs related to their untimely death and burial.
How much does it cost to file a suit?
There is zero cost to work with our legal partner unless you receive compensation through a verdict or settlement. The attorneys we work with have all agreed to take a percentage of the award to cover legal fees and trial costs, rather than taking payment upfront.
Why contact a lawyer?
While you have the right to file suit without a lawyer, drug companies have deep pockets to fund an army of attorneys. Hiring a legal team that understands these cases will give you the best chance of being awarded a settlement. We did the research for you, and partnered with a law group that puts consumers first.
If you or a loved one has experienced bleeding complications after taking Xarelto, contact us, and someone will reach out to you within 24 hours to discuss your claim.
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Xarelto Multidistrict Litigation (MDL)
Most Xarelto lawsuits are being handled by a special federal court process known as multidistrict litigation (MDL). An MDL allows many people who have the same (or very similar) complaints to follow an established process for filing their claims, which are reviewed by justices familiar with the intricacies of the case.
Xarelto is handled under MDL No. 2592 in the Eastern District of Louisiana. It was established on December 12, 2014, when the Judicial Panel on Multidistrict Litigation issued a transfer order for 21 cases from 8 different states into the MDL.
The transfer order lists several common complaints among those who filed Xarelto claims:
- The inadequacy of labels on Xarelto packaging about the potential for severe bleeding (as well as other harmful effects);
- The omission of results from some clinical trials on the warning label;
- The need for monitoring a patient’s blood while taking the drug.
Janssen and Bayer tried to prevent these cases from being centralized under a single MDL by arguing that each individual case was different, among other things. However, the judicial panel overseeing MDLs ultimately denied the big pharmaceutical companies’ claims and went ahead with the transfer order.
Johnson & Johnson Xarelto Lawsuits
Given that there are thousands of Xarelto lawsuits waiting to be tried, judges overseeing MDL cases generally hold bellwether trials that can highlight the primary arguments, motions, and other issues that are likely to arise in later cases. While these trials might take a little longer to complete, it can help all the trial participants – including plaintiffs, defendants, lawyers, and judges – smooth out the procedures for later lawsuits, ultimately making the entire process more efficient. It can also help each side determine whether it makes sense to settle rather than bring the case to trial at all.
Given the complexity of the issues at hand, Judge Eldon E. Fallon scheduled three bellwether trials for the Xarelto MDL in 2017.
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2017 Xarelto Verdicts
Judge Eldon E. Fallon scheduled three Xarelto bellwether trials in 2017 to highlight the primary arguments that are likely to arise in later cases. These trials can help make the entire process more efficient—especially given the massive number of suits that have been filed. Bellwether trials can also help each side determine whether it makes sense to settle rather than bring the case before a jury. For example, In May 2014, Boehringer Ingelheim announced that it would settle over 4,400 Pradaxa lawsuits filed against the company in the United States rather than fighting them in court.
Joseph Boudreaux — April 2017 — The first bellwether trial for Xarelto was the case of Joseph Boudreaux, a Louisiana security guard who required a week-long stay in the hospital after being prescribed Xarelto by his cardiologist. Mr. Boudreaux’s case relied on witness testimony that Johnson & Johnson and Bayer failed to disclose the fact that a certain blood test could help predict who might experience adverse reactions to rivaroxaban. Ultimately, the jury sided with the drug companies, determining that they had provided enough information to doctors to make appropriate determinations about Xarelto’s risks when prescribing the medication.
Sharyn Orr — June 2017 — The second Xarelto bellwether trial was brought by Joseph Orr on behalf of his deceased wife Sharyn, who died of a stroke in May 2015 after being prescribed Xarelto. Like the Boudreaux case, Orr’s attorneys argued that doctors in the U.S. were not given the same instructions as those in other countries about a relatively simple blood test that could have predicted whether Sharyn might react poorly to the medication. However, after only a few hours of deliberation, the jury came back with a verdict for the defendants.
Dora Mingo — August 2017 — The third verdict in the bellwether trials came from U.S. District Court in Jackson, Mississippi. Plaintiff Dora Mingo claimed she suffered severe GI bleeding after taking Xarelto for one month in 2015 to prevent blood clotting following an operation. However, the jury ruled in favor of the defendants after just four hours of deliberation. This is the third consecutive win for the drug manufacturers in 5 months.
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Similar Blood Thinner Lawsuits
Xarelto isn’t the first blood thinner to find itself in legal trouble. Thousands of people filed Pradaxa lawsuits as well because the anticoagulant was sold without an approved antidote for nearly five years. In May 2014, Boehringer Ingelheim announced that it would settle then filed against the company in the United States. As part of the agreement, a Qualified Settlement Fund of $650 million was created to cover the costs of medical expenses, pain and suffering, and related costs.
Bayer and J&J Hid Xarelto Research Data
One of the claims being made by plaintiff’s lawyers is that a letter from Duke University academics to The New England Journal of Medicine left out important data from laboratory experiments. The legal theory is that the drug companies were responsible for this deception by failing to speak up and correct the data themselves, even though the university researchers insist they were working independently.
Nonetheless, omitted research data has been a huge problem in the pharmaceutical industry for many years. Without complete data, it is impossible for other medical professionals to verify the results of clinical trials, and it can put people’s lives in danger.
Xarelto tests tainted by recalled equipment
Another point of contention in Xarelto lawsuit filings is the fact that a number of medical devices that were used to test the drug’s blood clotting capabilities were found to have manufacturer defects. Specifically, investigators from the European Medicines Agency discovered that results may have been compromised in the control group using warfarin, another blood thinner that has been in use longer and which has an antidote (unlike Xarelto).
Researchers from both Bayer and Duke University claim that the faulty devices did not have an effect on the ultimate conclusions of the clinical trial. However, a review by the BMJ showed that the pharmaceutical companies were aware of the faulty devices while the trial was being conducted and knowingly withheld that information in their report to the U.S. Food & Drug Administration. Ultimately, however, a separate review by the FDA concluded that the faulty monitoring devices did not meaningfully affect trial results.