Xarelto Lawsuit

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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. In March 2019, Johnson & Johnson and Bayer announced a $775 million settlement resolving 25,000 outstanding Xarelto lawsuits against the two companies.

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 U.S. Food & Drug Administration (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 is prescribed widely to millions of people each year. Until May 2018, however, there was no FDA-approved antidote for Xarelto, and some patients who took the blood thinner before an antidote became available suffered from severe bleeding that could not be stopped. As a result, tens of thousands of people have filed Xarelto lawsuits against Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer for marketing their blood thinner without properly warning consumers about its potentially dangerous side effects.

Serious Xarelto Side Effects

Most Xarelto lawsuits focus on the dangerous side effects of the blood thinner before an antidote became widely available. While Xarelto certainly had some advantages over warfarin, the most commonly prescribed blood thinner, the lack of an antidote may have endangered some patients. Patients who took Xarelto before May 2018 were at risk of prolonged bleeding from even small injuries that normally would clot quickly. Some patients also suffered from severe internal hemorrhaging or brain bleeding, which was harder to control without an antidote.

Anticoagulants can cause many serious side effects. According to the FDA's adverse drug event data for 2016, four common anticoagulants were together associated with over 29,000 serious reaction cases, including over 4,700 deaths. 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.

Failure to Inform and Misleading Information

Many Xarelto lawsuits also claim that Janssen failed to inform patients of potentially life-threatening 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, though the FDA ultimately determined that the faulty device did not significantly change the outcome of the trial.

Summary of Xarelto Warning Label Updates
  • 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
  • June 2018: Update about the new reversal agent

Learn how to read a prescription drug label >

How a Xarelto Antidote Affects Legal Claims

Andexanet alfa, known by the brand name Andexxa, was approved by the FDA in May 2018 and quickly became available to help counteract the effects of factor Xa inhibitors like Xarelto (rivaroxaban) and Eliquis (apixaban). As a result, these blood thinners have become much safer, since doctors have a reliable way to reverse them in the event of severe bleeding or other complications.

Because most Xarelto lawsuits have focused on the irreversible effects of the drug, it is unlikely that complications experienced after Andexxa became available will be considered eligible for personal injury claims. However, new claims may still be filed for complications experienced by patients before Andexxa became widely available.

Damages Sought in Xarelto Lawsuits

Pharmaceutical companies have seen great financial benefits from Xarelto and other new blood thinners like Pradaxa and Eliquis. In September 2018, financial reports showed that Xarelto earned Johnson & Johnson $1.86 billion in the preceding nine months.

While the drug manufacturer saw high profits, many patients have faced high medical bills as a result of Xarelto side effects. Treatment costs for a bleeding injury can quickly accumulate and may not be fully covered by insurance, especially when factoring hospitalizations and follow-up visits. Many patients also lost income while recovering, making it even more difficult to keep up with medical bills. Xarelto lawsuits seek damages to recover these medical costs and lost wages for patients who suffered from severe side effects of the blood thinner.

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. Punitive damages are meant to punish companies for actions that lead to unnecessary suffering and encourage them to prevent such problems from happening in the future.

Xarelto Litigation

Nearly 32,000 Xarelto lawsuits have been handled in a special federal court process known as multidistrict litigation (MDL). Another 2,000 other Xarelto lawsuits have been filed under a mass tort program in the Philadelphia Complex Litigation Center (CLC).

Due to a series of wins by in 2017 and 2018 the defendants, Johnson & Johnson and Bayer, the number of Xarelto lawsuits being filed are starting to slow down. In March 2019, a settlement resolved most outstanding Xarelto litigation.

MDL 2592 In re: Xarelto Products Liability Litigation

In December 2014, the Judicial Panel on Multidistrict Litigation (JPML)  established MDL 2592 in the Eastern District of Louisiana to handle Xarelto claims against Janssen Pharmaceuticals and its parent company, Johnson & Johnson. Defendants argued against the formation of an MDL, claiming each lawsuit was unique, but the JPML denied their claims and moved ahead with the transfer order.

Judge Eldon E. Fallon scheduled three bellwether trials for 2017. Juries ruled in favor of the defendants - Johnson & Johnson and Bayer (who markets Xarelto outside the U.S.) - for all three of these trials.

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 of 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 the Philadelphia Complex Litigation Center

The second large group of consolidated Xarelto claims was established in December 2014 and is overseen by Judge Arnold New. As of February 2019, there were approximately 1,979 Xarelto cases filed in the Philadelphia CLC, a Pennsylvania State court that handles major litigation. 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. The first bellwether trial in this court was held in November 2017.

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, Hartman suffered bleeding complications and was hospitalized, taken off Xarelto, and eventually recovered from her injuries. The jury awarded Hartman and her husband $27.8 million, 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 were adequately listed on the Xarelto warning label.

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 again 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 Settlement

In March 2019, Johnson & Johnson and Bayer announced a joint $775 million settlement that would resolve approximately 25,000 outstanding Xarelto lawsuits against the two pharmaceutical companies. According to the settlement terms, each company would pay $387.5 million, though at least some of those funds will be paid by insurance providers. Neither company admits liability for claims related to severe Xarelto side effects, which is common for these types of settlements, and the settlement amount is far less than the companies made from the drug in 2018 alone.

The average amount works out to about $31,000 per plaintiff. However, the actual amount each person will receive is likely to go up or down based on the severity of the side effects and other factors.

It is notable that the Xarelto settlement comes after both companies did relatively well in the first six trials they faced. According to the press release by Johnson & Johnson, the company chose to settle the cases because the lawsuit process "demands an enormous amount of time and resources." Of course, J&J still faces a variety of other lawsuits, as does Bayer, some of which are going poorly for the drugmakers. By settling, the companies could focus on other litigation efforts that might require more time, attention and money.

Xarelto Lawsuit FAQs

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 Xarelto lawsuit if you meet the following criteria:

  • You took Xarelto as prescribed and suffered a bleeding event, stroke or another severe injury before the reversal agent was widely available.
  • 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.

If you believe you or a loved one meet these criteria, or you are unsure about whether your case is viable, you should schedule a free case evaluation.

What Compensation Can I Receive for a Xarelto Lawsuit?

Compensation may be awarded to cover the burden of medical expenses, loss of income as a result of injuries, funeral expenses for a deceased loved one, as well as pain and suffering. In some cases, punitive damages may also be awarded to punish Janssen Pharmaceuticals and Johnson & Johnson for promoting a dangerous drug.

How Can I Pay for a Xarelto Lawyer?

If you are worried about the financial costs of filing a lawsuit, consider a contingency agreement. This agreement allows you to forgo paying any legal costs until you receive compensation for your case either through a verdict or settlement.