Xarelto (rivaroxaban) is a blood-thinning medication that has been linked to an increased risk of severe, sometimes fatal bleeding. When Xarelto was introduced in 2011, it had no antidote and some doctors struggled to stop bleeding in patients who had injuries or needed emergency surgery.
What You Can Do & How We Can Help
The Schmidt Firm, LLP is currently accepting Xarelto induced injury cases in all 50 states. If you or somebody you know has been diagnosed with severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: 75 Xarelto Lawsuits Centralized in Mass-Tort in Pennsylvania
January 22, 2015 — An administrative judge has ordered that 75 lawsuits involving the blood-thinning drug Xarelto will be centralized in a mass-tort in Philadelphia. Click here to read more.
January 16, 2015 — A study funded by Bayer HealthCare and Janssen, the manufacturers of Xarelto, have found that its rate of major bleeding is consistent with rates seen in clinical trials. Click here to read more.
January 12, 2015 — Portola Pharmaceuticals may have just discovered an antidote for Xarelto. A late-stage clinical trial of the intravenous medication, andexanet alfa, met its primary endpoint of “immediately and significantly” reversing Xarelto. Click here to read more.
January 7, 2015 — The number of lawsuits involving Xarelto has skyrocketed in the last three weeks, quadrupling to 80 cases centralized in a federal MDL. Click here to read more.
December 15, 2014 – Dozens of lawsuits involving Xarelto into a Multi-District Litigation (MDL No. 2592) in the U.S. District Court for the Eastern District of Louisiana, overseen by Judge Eldon E. Fallon. Click here to read more.
December 5, 2014 — With 50 Xarelto lawsuits pending in 15 district courts, Bayer AG and Johnson & Johnson told a panel of federal judges they oppose efforts to centralize the growing litigation. Click here to read more.
November 18, 2014 — Combining common painkillers with blood-thinning drugs could significantly increase the risk of bleeding and blood clots for people with atrial fibrillation. Click here to read more.
October 22, 2014 — The FDA has issued a Class II recall for about 13,500 bottles of Xarelto after receiving one customer complaint about microbial contamination in a sales sample. Click here to read more.
June 26, 2014 — A lawsuit (PDF) has been filed on behalf of a man who took Xarelto for atrial fibrillation and died six month later from uncontrollable bleeding in the brain (subdural hemorrhage). Click here to read more.
June 17, 2014 – The Frankfurter Allgemeine Zeitung, a newspaper in Germany, cited company sources as saying there were fewer than 10 lawsuits pending against Bayer. Bayer declined to comment except to say that Xarelto’s safety profile is consistent with clinical trials involving more than 75,000 patients. Click here to read more.
May 7, 2014 – A wrongful death lawsuit has been filed in Pennsylvania on behalf of a woman who died after taking Xarelto. Click here to read more.
November 25, 2013 – Study links Xarelto to a 3-fold increased risk of bleeding for acutely ill patients and a 4-fold increased risk of major bleeding in patients with Acute Coronary Syndrome (ACS). Click here to read more.
October 4, 2013 – Der Spiegel has reported that Xarelto has been linked to 968 adverse events (including 72 deaths) during the first 8 months of 2013. In 2012, Xarelto was associated with 750 adverse events, including 58 deaths.
September 28, 2012 – A new study has found that Pradaxa bleeding risks offset any health benefit compared to a placebo. The study found no improvement in survival rates. Click here to read more.
What’s the problem?
Xarelto (rivaroxaban) was approved by the FDA in 2011 for a small group of patients at risk of blood clots — patients who had hip or knee replacements. Soon after, Xarelto was approved for patients with atrial fibrillation, which is a type of abnormal heart rhythm that can cause strokes.
Xarelto is manufactured and marketed by Bayer HealthCare and Janssen Pharmaceuticals. The drug-makers claimed Xarelto was superior to warfarin because it did not require routine blood-tests. However, recent studies have found that patients at high risk of bleeding might actually benefit from blood-tests.
Another problem is that when Xarelto hit the market in 2011, it had no antidote. In an emergency, doctors must be able to quickly de-activate any blood-thinning medication so the patient can form blood clots and stop bleeding. This is especially important after a patient is severely injured or needs emergency surgery. In comparison, warfarin can be reversed with a dose of Vitamin K.
As the popularity of Xarelto increased, so have safety concerns and the number of lawsuits. In 2014, over 100 lawsuits were filed against Janssen and Bayer on behalf of people who were injured by severe bleeding. These lawsuits have been centralized in state and federal litigation.
Xarelto “ROCKET” Safety Study
The biggest clinical trial of Xarelto evaluated more than 14,000 patients, and compared Xarelto to warfarin. The study found that Xarelto was no more effective than warfarin, and the risks were comparable. The most common side effect was bleeding, with rates comparable to warfarin. It caused less bleeding in the brain and more bleeding in the stomach and intestines.
The safety and effectiveness of Xarelto has been questioned, after an editorial in the New England Journal of Medicine found that the use of multiple statistical analyses “muddied the waters” when it came to determining the drug’s safety.
One of the three FDA reviewers who examined the data found that the drug-makers failed to administer warfarin in an optimal way, which may have skewed the data.
Furthermore, FDA staff recommended against approving Xarelto for use in patients with atrial fibrillation, because the results of the ROCKET study do not clearly demonstrate the safety or effectiveness of the medication compared with warfarin. The reviewers recommended that an additional study is needed to clarify potential stroke and bleeding risks.
Percentage of Xarelto Patients Who Experience Bleeding
The safety of Xarelto compared to warfarin was established in the ROCKET AF clinical trial, which involved over 7,000 people. Researchers found the following rates of internal bleeding:
- Major bleeding: Xarelto (5.6%) – Warfarin (5.4%)
- Gastrointestinal (GI) bleeding: Xarelto (3.1%) – Warfarin (2%)
- Bleeding in a critical organ: Xarelto (1.3%) – Warfarin (1.9%)
- Fatal bleeding: Xarelto (0.4%) – Warfarin (0.8%)
- Bleeding resulting in transfusion: Xarelto (2.6%) – Warfarin (2.1%)
Xarelto was also linked to cases of cerebral hemorrhage (bleeding in the brain), but the risk was found to be significantly lower than patients on warfarin.
Higher Bleeding Risk Seen in Xarelto Patients with Acute Illnesses
In April 2011, a study of more than 8,000 people compared Xarelto to Lovenox in patients hospitalized for acute medical conditions, such as heart failure, infectious disease, and breathing difficulty.
Lovenox is typically given as an injection to prevent blood clots, usually for no more than two weeks. The study compared Xarelto to Lovenox used over 10 days, and found the two medications equally effective.
The study was then extended to 35 days to compare long-term effectiveness. Some patients were given Xarelto for 35 days. Some were given Lovenox for 10 days, and then a placebo for the remaining 25 days.
Patients taking Xarelto had significantly higher rates of bleeding — they were more than twice as likely to experience bleeding compared to Lovenox. 4.1% of patients taking Xarelto experienced bleeding, compared to 1.7% taking Lovenox.
Xarelto, Pradaxa, Eliquis, and Lixiana in a Race to Replace Warfarin and Dominate $20BN Market
The war over the multi-billion-dollar market for anti-stroke medications is heating up, as several major pharmaceutical companies push new drugs as alternatives to warfarin, a blood-thinning medication that has long dominated the stroke-prevention market. Warfarin is relatively inexpensive, but interacts with many foods and requires frequent blood testing to adjust the dosage.
The race for a safer, more user-friendly medication could potentially yield billions in profit. More than 2.2 million Americans and 4.5 million people in the European Union have atrial fibrillation, a type of irregular heartbeat that can cause blood clots that lead to stroke. The market for bloodthinners is estimated to be worth between $15-20 billion.
Pfizer and Bristol-Myers Squibb, which released data in September 2011 that showed its drug, Eliquis (apixaban) caused less bleeding and fewer deaths than warfarin. Boehringer Ingelheim has already launched its drug Pradaxa (dabigatran) with an aggressive marketing campaign. Lixiana (edoxaban) is an oral anticoagulant drug in development by Daiichi Sankyo in Japan.
Xarelto Class Action Lawsuit Information
A number of people have already filed lawsuits, but these are not part of a Xarelto class action — they are individual legal claims filed by plaintiffs who have hired personal legal representation.
In December 2014, federal judges established a Multi-District Litigation (MDL) to centralize 80 Xarelto lawsuits at the federal level. This litigation continues to grow rapidly. One month after the federal MDL was created, an administrative judge in Pennsylvania created a mass-tort to centralie 75 similar lawsuits.
Like a class action, centralization of Xarelto lawsuits at the state and federal level streamlines the litigation. Plaintiffs coordinate the pretrial discovery process. Later, individual lawsuits will be selected for “bellwether” trials to go before a jury.
Do I have a Xarelto Lawsuit?
The Schmidt Firm, LLP is currently accepting Xarelto induced injury cases in all 50 states. If you or somebody you know has experienced a side effect after taking Xarelto, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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