Xarelto Lawsuits Quick Facts
Janssen Pharmaceuticals (Johnson & Johnson), Bayer
To treat and reduce the risk of blood clots and their complications in adults with clotting risk factors
How Many Lawsuits
Major Side Effects
Federal: Eastern District of Louisiana
Patients who file a Xarelto lawsuit claim the manufacturer failed to warn them of severe, irreversible side effects like uncontrollable bleeding, brain hemorrhage and internal bleeding. More than 23,000 patients have filed Xarelto lawsuits in federal court, but none have reached settlements yet.
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Why Are People Filing Xarelto Lawsuits?
When Xarelto was first introduced, it was considered a groundbreaking new drug on the market. Unlike other anticoagulants, such as the long-used warfarin, Xarelto was praised by researchers for its effectiveness with only a single pill taken once daily. The FDA approved Xarelto for the prevention of blood clots (including traveling clots), reducing the risk of stroke, and preventing deep vein thrombosis.
With approvals for several conditions, Xarelto was prescribed widely to millions of people each year. There is no antidote, however, and with severe side effects that were unclear when first approved, patients and their loved ones have seen the dangerous, needless risks of taking Xarelto. Thousands are now taking legal action against the drug companies who produce and market Xarelto.
Serious Xarelto Side Effects
One of the most prominent claims against Xarelto focuses on the dangerous side effects of the drug and the inability to reverse those effects when problems arise.
While Xarelto was praised for its ability to act quickly against blood clots, the lack of an antidote has put patients in serious danger. Patients who take the prescription can experience life-threatening bleeding from even small injuries that normally would clot quickly. Some patients also suffered from severe internal hemorrhaging or brain bleeding. Xarelto does not require blood monitoring when used, which could have helped prevent some of these side effects, or at least helped detect them early.
Anticoagulants can cause many serious side effects. 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 were among the most dangerous drugs, and accounted for more emergency department visits than any other class of therapeutic drug — including opioids and antibiotics.
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Failure to Inform and Misleading Information
Related to the severe side effects, many Xarelto claims also point to the drug companies’ failure to inform patients of these risks and include sufficient warnings on the blood thinner’s label. Many patients were completely unaware that Xarelto didn’t have an antidote available, unlike warfarin, which can be reversed by taking vitamin K.
Though Xarelto was approved in 2011, an important clinical trial dubbed ROCKET AF that included over 14,000 patients was later found to have been tainted by the use of a faulty blood-testing device called INRatio. The clinical trial’s results were called into question when J&J revealed the device was recalled in 2014 because it understated the risk of bleeding. The revelation caused regulators to wonder if patients in the trial received incorrect warfarin dosages and thus harsher side effects, ultimately making Xarelto appear safer and more effective.
Since then, the FDA has also called for five updates to Xarelto’s warning label from 2013 to 2016, stating that consumers were not sufficiently warned of all the potential side effects.
- August 2013: Black-box warning added about the increased risk of spinal bleeds
- January 2014: Warnings about the lack of an antidote and that the drug should not be used by patients with prosthetic heart valves
- March 2014: Additional information added for healthcare professionals on limiting spinal bleeds
- December 2014: Addition of new adverse reactions, thrombocytopenia and hepatitis
- May 2016: Warning of an increased bleeding risk with SSRI and SNRI antidepressants
Holding Drug Companies Liable for Xarelto Injury
Despite the severe risks to patients and the misleading information presented, pharmaceutical companies have seen great financial benefits from Xarelto. The drug quickly became an important aspect of the drug companies’ revenue year after year, accounting for over $2 billion in sales in 2016. By September 2018, reports showed Xarelto earned its manufacturer $1.86 billion in the nine months, despite so many health risks and more emerging lawsuits.
While the two drug companies saw high profits, many patients faced high medical bills as a result of taking the drug. Treatment costs, including hospitalizations and follow-up visits, for a bleeding injury can quickly accumulate and may not be fully covered by insurance. Many patients also lost income while recovering, making it even more difficult to keep up with medical bills.
In addition to being compensated for these bills, as well as funeral expenses for some families, Xarelto lawsuits help hold the drug companies accountable for withholding important medical information and causing needless pain and suffering to so many.
Over 23,000 Xarelto lawsuits are being handled in a special federal court process known as multidistrict litigation (MDL). In December 2014, the Judicial Panel on Multidistrict Litigation established MDL No. 2592 in the Eastern District of Louisiana to handle claims against Xarelto. Although the defendants argued against the formation of an MDL, claiming each lawsuit was rather different and didn’t have similar enough complaints, the judicial panel denied their claims and moved ahead with the order. The court initially ordered the transfer of 21 cases from 8 states into the MDL, and since then the number of lawsuits has grown exponentially.
Another 1,500 plus Xarelto lawsuits have been filed under a mass tort program in the Philadelphia Complex Litigation Center (CLC). Mass torts are cases that involve multiple plaintiffs filing against the same corporation, in this case, Johnson & Johnson and Bayer. This second group of consolidated claims was also established in December 2014 and will be overseen by Judge Arnold New. The first bellwether trial in this state court was held in November 2017.
Federal Bellwether Trials in Favor of Drug Companies
Judge Eldon E. Fallon scheduled three bellwether trials for 2017. Juries ruled in favor of the defendants – Johnson & Johnson and Bayer – for all three of these trials. The first trial began on April 24, 2017 on a lawsuit brought forward by Joseph Boudreaux.
Joseph Boudreaux: Boudreaux took Xarelto as prescribed by his cardiologist, which resulted in a week-long stay in the hospital. His lawsuit relied on witness testimony that the drug companies 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.
Sharon Orr: The second bellwether trial for Xarelto was a wrongful death claim brought by Joseph Orr. His wife, Sharon, died of a stroke in May 2015 after being prescribed the blood thinner. Similarly to Boudreaux’s lawsuit, Orr’s attorney argued that doctors were not properly made aware about a simple blood test that could have shown Sharon would have a negative reaction to the medicine. After a few hours of deliberation, the jury sided once again with the drug companies.
Dora Mingo: In August 2017, the drug companies saw another victory in the third bellwether trial brought by Dora Mingo. In her claim, Mingo stated she suffered severe GI bleeding after taking Xarelto for one month in 2015 to prevent blood clotting following an operation. Within only four hours of deliberation, the jury decided in favor of the defendants.
Xarelto Trials in Philadelphia Complex Litigation Center
As of 2018, there were approximately 1,947 Xarelto cases filed in the Philadelphia Complex Litigation Center (CLC). According to one report, about 25% of those cases involved patients who had been prescribed Xarelto along with other anticoagulant drugs, including aspirin and Plavix. Here are a few notable cases.
Lynn Hartman: The first Philadelphia CLC bellwether trial involved Lynn Hartman, who sued Bayer and Johnson & Johnson in 2015 after she faced severe gastrointestinal bleeding from taking Xarelto. She began taking the blood thinner in 2013 to help treat atrial fibrillation. After about a year on the medication, she suffered these bleeding complications and was hospitalized. Fortunately, she recovered from her injuries once taken off of Xarelto.
In a first victory for the claimant, the jury awarded the Hartmans a $27.8 million verdict, with $26 million in punitive damages and $1.8 million in compensatory damages. In January, 2018, however, the judge overturned the jury award, claiming that the bleeding risks of the medication were adequately noted.
Daniel Russell: In the second bellwether trial for the Philadelphia CLC, which concluded in April 2018, the jury found in favor of the defendants, Bayer and Johnson & Johnson. As a result, no compensation was awarded to plaintiff Daniel Russell.
Kevin Cooney: A Pennsylvania jury found for Bayer and Jannsen in an August 2018 case. Cooney suffered internal bleeding as a result of taking Xarelto, and claimed the medication did not provide sufficient warnings for the bleeding risks. The jury ultimately reached the verdict after four weeks, and found that the warnings were adequately listed.
Xarelto Lawsuit FAQs
Find answers to a few of the most commonly asked questions about Xarelto.
Am I Eligible to File a Xarelto Lawsuit?
Thousands have already pursued legal action against Janssen Pharmaceuticals, a division of J&J, and Bayer because of the harmful risks of Xarelto, and many more may still be eligible to file a lawsuit against Xarelto. You may be eligible to file if you meet the following criteria:
- You took Xarelto as prescribed and suffered a bleeding event, stroke or another severe injury.
- In cases where the patient has passed away as a result of these injuries, surviving family members may be eligible to file a wrongful death claim.
- The statute of limitations is still current in your state.
What Compensation Can I Receive for a Xarelto Lawsuit?
Having a legal team on your side who understands the complexities of Xarelto litigation gives you the best chance at receiving compensation. Compensation may be awarded to cover the burden medical expenses, loss of income as a result of injuries, funeral expenses for a deceased loved one, as well as pain and suffering. Talk to a lawyer today to learn more about what compensation you may be eligible to receive.
How Can I Pay for a Xarelto Lawyer?
If you or a loved one have experienced any serious complications from taking this drug, it’s important to be aware of your legal rights and seek the help of an experienced Xarelto lawyer. Law firms will not ask you to pay up front, as they work on a contingency basis and will only request compensation if your case is successful.