The Food and Drug Administration (FDA) first approved Xarelto (rivaroxaban) on July 1, 2011, to help reduce the risk of blood clots in patients undergoing knee and hip replacement surgery. Later that same year, they approved it to reduce the risk of stroke in patients with non-valvular atrial fibrillation, and in 2012, to help treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).
Marketed as a newer-generation blood thinner, or anti-coagulant, Xarelto was presented as being a more convenient alternative to warfarin (Coumadin), which was the leading blood thinner for decades. Manufacturers Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer AG advertised Xarelto as easier to take because of its once-daily dose, and simpler to manage because it didn’t require dietary changes or regular blood monitoring.
Within just a year, however, the manufacturers and the FDA received reports of patients suffering from serious side effects, including excessive bleeding leading to hospitalization and sometimes death. Some of those injured patients and their loved ones went on to file Xarelto lawsuits, in an attempt to hold Janssen and Bayer liable for failing to adequately warn about the risks.
Xarelto Bleeding More Serious than Patients Led to Believe
All blood thinners carry some risk of excessive bleeding. Xarelto, however, seems to be associated with a greater risk than the manufacturers indicated on their product labels or in their advertisements. Many patients feel they were duped into using a drug that they would have refused to use had they known about the real dangers.
There was no “boxed warning” on the product, for example, alerting patients to the potential for fatal bleeding, even though the original clinical trial (called the “Rocket AF” trial) used to establish approval for the drug showed that patients taking it suffered more gastrointestinal bleeding and required more transfusions than those taking warfarin.
FDA clinical reviewers also stated prior to Xarelto’s approval that rivaroxaban should not be approved unless the manufacturer conducted additional studies to ensure its efficacy and safety. Within just a little over a year of being on the market, the Institute of Safe Medicine Practices (ISMP) QuarterWatch report (October 3, 2012) stated adverse event reports for Xarelto were growing, with the largest number involving the development of severe blood clots in younger patients taking the drug after knee or hip replacement surgery. A total of 356 cases of serious, disabling problems, including pulmonary embolism, were associated with Xarelto by that time.
“The primary complaint seen,” the report read, “has been lack of efficacy—reports of the very venous and pulmonary thromboembolisms and other serious blood-clot related events that the drug is intended to prevent.”
Xarelto Lacks Antidote to Excessive Bleeding
Meanwhile, manufacturers continued to advertise all the benefits of the drug without adequately covering the risks. In 2013, the FDA sent the companies a warning letter, stating their print advertisement in WebMD magazine was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.”
Still, Xarelto enjoyed gradually increasing sales in the U.S. and in the United Kingdom. Doctors began to raise concerns, however, particularly because unlike warfarin, Xarelto had no readily available antidote to excessive bleeding. Patients taking warfarin who suffer from uncontrolled bleeding can be treated with injections of vitamin K, which encourage the blood to clot again. There is no such solution to Xarelto bleeding, however, making it much more dangerous and potentially deadly.
Plaintiffs who have filed Xarelto lawsuits note that the manufacturers never created a black-box warning alerting patients of Xarelto’s ability to cause irreversible bleeds. In their view, the companies sidestepped the issue, stating on the label only that Xarelto could cause excessive bleeding. They failed to mention the lack of an antidote in letters sent to doctors in 2013, as well.
Experts Question Wisdom of Once-Daily Dose
Though manufacturers leaned heavily on the convenience of Xarelto’s dosing regimen, and that fact that patients did not have to undergo blood monitoring, experts began to question the wisdom of such an approach. The ISMP notes in its 2012 QuarterWatch report that studies had shown “peaks and troughs that could be eliminated by twice-a-day dosing.”
Peaks and troughs refer to how long it takes blood to clot. Longer peak times indicate the blood is less likely to clot, which can increase risk of excessive bleeding. Splitting the dose into two a day could potentially even out the drug’s effect on blood clotting, reducing risks for patients.
A 2015 study published in the journal Cardiology showed that the absence of blood monitoring could prove dangerous for patients. In 29 out of 46 Japanese patients given rivaroxaban for the first time, peak times were significantly longer than expected, which could indicate increased risk of bleeding. Researchers concluded that blood monitoring in patients receiving the drug would be valuable.
A second 2015 study also warned that patients over the age of 75 with atrial fibrillation had a higher risk of gastrointestinal bleeding when taking Xarelto than when taking warfarin. Researchers warned that doctors should use caution when prescribing newer anticoagulants to older people.
Types of Injuries Associated with Xarelto
By the time ISMP’s QuarterWatch 2013, Quarter 1, came out, adverse event reports for Xarelto (680) had outnumbered those of Pradaxa, a previously approved newer generation anticoagulant. The manufacturers didn’t feel the rising numbers signaled a safety issue, however.
Types of injuries that may result from taking Xarelto include:
• Internal bleeding
• Gastrointestinal bleeding
• Brain hemorrhaging
• Blood clots
• Pulmonary embolism
• Deep vein thrombosis
• Heart attack
Manufacturers Face Increasing Number of Xarelto Lawsuits
Though manufacturers often advertised Xarelto as being superior to warfarin, a late 2014 study found that warfarin, Xarelto, and Pradaxa had nearly identical safety profiles when it came to bleeding risks and other side effects. These findings, paired with the fact that only warfarin has a readily available antidote, and that Xarelto’s once-daily dose doesn’t fit all, has led hundreds of patients to believe that Janssen and Bayer committed grave errors in their marketing of the drug.
As more and more people became aware of the inconsistencies, injured patients began taking their complaints to court. In December 2014, because of the growing litigation, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal cases into one court in the Eastern District of Louisiana. Judge Eldon D. Fallen was assigned to oversee the pre-trial proceedings.
The Xarelto MDL is expected to increase efficiency in handling these cases, reduce the risk of duplicative discovery, avoid conflicting rulings, and to preserve judicial resources. Currently, more than 300 cases are pending in Louisiana.
Shortly after the JPML consolidated all federal cases, Pennsylvania organized a Xarelto mass tort in Philadelphia. All state court cases were brought together in the Philadelphia Court of Common Pleas. Nearly 200 cases are pending there.
Plaintiffs claim that not only did the manufacturers fail to provide adequate warnings about Xarelto’s potential side effects or its lack of an antidote, they also failed to conduct proper studies on the drug to ensure its safety and efficacy before releasing it on the market. Had they taken these precautions, plaintiffs assert, many lives may have been saved.
A Xarelto Lawyer Can Help
If you or a loved one suffered a blood clot or bleeding injury caused by Xarelto, the attorneys at Chaffin Luhana LLP may be able to help. We understand that manufacturers like Janssen and Bayer are responsible for making sure their products are safe before releasing them on the market. They are also responsible for making sure doctors and patients are well aware of the risks before prescribing or taking their drugs.
At Chaffin Luhana, we are well educated in Xarelto’s history and in the studies illustrating its flaws. Call today for a free and confidential case evaluation at 1-888-316-2311.