In January 2015, Administrative Judge Kevin Dougherty established a mass tort docket for all Xarelto lawsuits filed in the state of Pennsylvania. At the time, 75 cases were transferred to the Philadelphia Court of Common Pleas for pre-trial proceedings. That number has now climbed to about 200 cases.
Plaintiffs seek to hold Xarelto manufacturers Janssen Pharmaceuticals (and parent company Johnson & Johnson) and Bayer AG liable for failing to provide adequate warnings about Xarelto side effects. The mass tort was established about a month after the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Xarelto lawsuits into one court in the Eastern District of Louisiana. Over 300 cases are pending there.
The Pittsburgh Xarelto attorneys at Chaffin Luhana stand ready to help those individuals who have taken Xarelto and suffered serious complications, such as excessive bleeding, heart attack, and stroke. If your life has been turned upside down by this medication, please contact us today for a free initial consultation.
Xarelto Advertised in Pittsburgh as Superior to Warfarin
Xarelto (rivaroxaban) belongs to a class of drugs known as “blood thinners” or “anticoagulants.” These drugs help reduce the “stickiness” of blood, making it less likely to clot. That’s good news if you’re at risk for clotting, but not such good news if you’re bleeding and want the bleeding to stop.
In July 2011, the FDA approved Xarelto for reducing the risk of blood clots in patients going through knee or hip replacement surgery. They later approved it for patients with non-valvular atrial fibrillation, to reduce the risk of blood clotting and stroke, and to treat or help prevent deep vein thrombosis and pulmonary embolism.
The manufacturers marketed Xarelto as being a “newer-generation” blood thinner, more convenient and easy to manage than warfarin, which has been the leading anticoagulant for decades. Patients taking warfarin have to modify their diets and go for regular blood tests to be sure the medication is working properly. Patients taking Xarelto, the manufacturers touted, didn’t have to do either of those things. Xarelto came in a more convenient once-daily dose and required no regular monitoring.
Within just a year, however, both the FDA and the manufacturers started receiving reports of serious and sometimes deadly Xarelto side effects.
Patients Suffer Serious Xarelto Side Effects
All anticoagulants come with an increased risk of bleeding. Reducing the ability of blood to clot means that even a small cut can bleed more than it normally would. Xarelto seemed to be causing more bleeding problems than the warning labels led consumers and doctors to believe, however.
Advertisements compared Xarelto to warfarin, and marketed it as the superior option, not only because it reduced risk of clotting at the same or higher efficacy, but because it had a greater safety profile. A later study, however, determined that warfarin, Xarelto, and Pradaxa had nearly identical safety profiles when it came to bleeding risks and other side effects.
Still, Janssen and Bayer continued to market Xarelto as the better option. In the first three months of 2012, doctors wrote 130,000 prescriptions for Xarelto. At the same time, however, patients were suffering serious complications.
On October 3, 2012, the Institute of Safe Medicine Practices (ISMP) issued its QuarterWatch report, detailing data gathered in the first quarter of 2012. It stated that adverse event reports for Xarelto were growing, and that the largest number involved the development of severe blood clots in younger patients taking the drug after knee or hip replacement surgery. A total of 356 serious, disabling, and fatal injuries, including pulmonary embolism and hemorrhage, were suspected as being linked to Xarelto at 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.”
The authors also noted concern that the one-size-fits-all dose was not wise, and could be “compromising both the safety and efficacy of this treatment.” They added, “Being easier to use than warfarin or enoxaprin has helped both rivaroxaban and dabigatran [Pradaxa] rapidly capture market share, but with consequences for patient safety that have not yet been adequately addressed.”
Even FDA Reviewers Question Safety of Xarelto Once-Daily Dosing
The ISMP report brought to light one more thing that Xarelto manufacturers had failed to reveal—that even before its initial approval by the FDA, Xarelto had caused some reviewers concern. Even before the drug hit the market, FDA reviewers questioned the once-daily dosing scheme, and stated that many patients could benefit from twice-daily dosing.
The issue here is how much of the drug is in the system and how much it affects the ability of the blood to clot. The goal is to strike a balance—to thin the blood enough to prevent dangerous blood clots, but not so much as to cause dangerous internal bleeding.
When doctors take blood tests, they can determine how much the drug is affecting the clotting ability. That’s why doctors ask patients taking warfarin to get regular blood tests, so they can keep an eye on how the drug is working. Higher doses work better in some patients, but lower doses are better for others. In addition, taking a low-dose pill in the morning and night can sometimes create a more consistent result in the blood than taking just one pill a day.
Still, FDA senior management disagreed, and Xarelto was approved.
Lack of a Readily Available Xarelto Antidote Puts Pittsburgh Patients at Risk
The clinical trial manufacturers used to gain the FDA’s approval for Xarelto—called the “Rocket AF” clinical trial—showed that in comparison to warfarin, Xarelto caused patients to suffer more gastrointestinal bleeds and to require more transfusions. Advertisements for the drug failed to mention this risk. Neither did the drug carry a black-box warning alerting doctors and patients to the findings.
In 2013, the FDA sent drug makers a warning letter stating their print advertisement in the WebMD magazine was false and misleading, because it minimized the risks associated with taking Xarelto, while overstating the benefits of the once-daily dosing. Two years later, a study published in the journal Cardiology showed that the absence of blood monitoring could prove dangerous for some patients. Researchers concluded that blood monitoring in patients receiving the drug would be valuable.
Doctors began questioning the use of the drug, as well, particularly because it lacked a readily available antidote. Patients taking warfarin who suffer life-threatening bleeds can be treated with vitamin K injections, which encourage the blood to clot again. There is no such treatment for patients taking Xarelto, however, making bleeding events much more dangerous and potentially deadly. This was another risk that the manufacturers failed to highlight in a black-box warning on the product label. Pittsburgh-area residents taking the drug would have had no idea such a risk existed.
In the ISMP’s 2012 Quarter 2 report, the authors noted that the number of adverse event reports associated with Xarelto had risen to 564. By the time the 2013 Quarter 1 report came out, reports of problems with Xarelto (680) had outnumbered those with Pradaxa—the other leading newer-generation blood thinner. At that time, the number of prescriptions for Xarelto had risen to near one million per quarter.
Types of Injuries Associated with Xarelto
Patients taking Xarelto may be at risk for the following injuries.
• Internal bleeding
• Gastrointestinal bleeding
• Brain hemorrhaging
• Blood clots
• Pulmonary embolism
• Deep vein thrombosis
• Heart attack
Those older than 75 years and those with kidney problems may be at a higher risk than other populations. A 2015 study, for example, 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.
Pittsburgh Area Residents May be Eligible to File Xarelto Lawsuits
Patients who have taken Xarelto and later suffered from serious injuries such as those listed above may be eligible to file a Xarelto lawsuit. So far, over 500 such lawsuits are pending in state and federal courts. Cases in Pennsylvania have been consolidated in Philadelphia, and federal cases in the Eastern District of Louisiana.
Plaintiffs seeking to hold Janssen, Johnson & Johnson, and Bayer liable for injuries typically claim that these companies failed to properly protect public safety. They failed to warn about serious risks, including gastrointestinal bleeding, hemorrhaging, pulmonary embolism, and more. They didn’t alert consumers and doctors to the very serious fact that Xarelto has no readily available antidote. They advertised Xarelto as being more convenient than warfarin because of the once-daily dosing scheme, but they failed to warn about the accompanying dangers of such dosing. They did not conduct enough studies to be sure the product was safe before releasing it onto the market.
Xarelto manufacturers maintain that their product is safe when used as directed. They are fervently defending themselves in court.
A Pittsburgh Xarelto Lawyer Can Help
If you or a loved one suffered a blood clot or bleeding injury caused by Xarelto, the Pittsburgh 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.
Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Western Pennsylvania, and Eastern Ohio, and will give you an initial consultation for free. Contact us today.