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More than 7,000 patients and surviving family members have filed Xarelto lawsuits, claiming the popular blood thinner causes severe harm. Approved without an antidote, Xarelto can lead to uncontrollable bleeding events - a complication that in many cases has proven fatal.
This litigation is moving quickly, but there may still be time for injured patients and family members to file Xarelto bleeding lawsuits of their own.
Approved by the US Food & Drug Administration in 2011, Xarelto is an anticoagulant medication intended to reduce the risk of complications in patients who live at an increased risk for life-threatening blood clots:
Xarelto is one of several "new generation" blood thinners to hit the US market in recent years. Like Eliquis and Pradaxa, the drug was designed to compete with warfarin (Coumadin), the industry standard anticoagulant. Multinational pharmaceutical giant Bayer serves as Xarelto's manufacturer, while marketing duties are carried out by Janssen Pharmaceuticals, a wholly-owned subsidiary of Johnson & Johnson.
Doctors have used warfarin for decades to treat patients who live at an increased risk of pulmonary embolism, a dangerous complication in people with atrial fibrillation. Blood thinners can help many patients, but these drugs are not without their risks.
Every anticoagulant is designed to inhibit the body's ability to clot blood; that's how they can prevent blood clots from forming in the first place. As an inevitable side effect, however, blood thinners create a risk of uncontrollable bleeding. This bleeding can be either internal or external; gastrointestinal bleeds appear to be most common. Severe complications can also occur after traumatic injuries or during surgery. Even minor injuries can result in significant blood loss, making emergency medical attention a necessity.
Warfarin has a simple answer to this problem: an antidote. Using an infusion of Vitamin K or donor blood plasma, physicians are able to reverse the blood-thinning effects of warfarin and stop excessive bleeding. Xarelto doesn't have the same answer. The drug was approved without an antidote, leaving patients all but helpless in the event of a severe bleed.
In their lawsuits, thousands of patients and families accuse Bayer and Johnson & Johnson of downplaying Xarelto's risks. Plaintiffs say that the two companies failed to adequately warn them that there was no antidote for the drug's blood-thinning effects, leaving them unable to make well-informed healthcare decisions.
Beyond the inherent bleeding risks of Xarelto, patients claim that the drug is far more dangerous than alternative drugs. Many research studies have found this to be the case. In a paper published by the Journal of the American Medical Association, researchers from the FDA found that Xarelto significantly increased the risk of both intracranial bleeding and gastrointestinal bleeding compared to Pradaxa.
Versus warfarin, the drug doesn't seem to fare much better. When analysts took a second look at the clinical trial used to support Xarelto's initial approval, they found that the new-generation blood thinner was associated with higher rates of gastrointestinal bleeding than warfarin.
Xarelto has also been associated with an increased risk for infections after surgical hip and knee replacements. Tragically, the drug was approved to treat patients undergoing these specific operations, but may actually make wound complications and additional surgical procedures more likely.
Injured patients say that Xarelto is an unreasonably dangerous drug. More than that, many people believe that Xarelto was defectively designed - since it never came with an antidote.
While a potential reversal agent for Xarelto bleeding was discovered in 2011, the antidote was recently denied approval by the Food & Drug Administration. According to FiercePharma, the FDA doesn't yet feel comfortable approving the antidote and has requested more information on the substance's manufacturing process. An antidote for Pradaxa, another next-generation anticoagulant, was approved in October of 2015.
In short, there's still no way to reverse the anticoagulant effects of Xarelto. Despite this serious safety concern, sales for the drug continue to climb. In 2015, Bayer and Johnson & Johnson reported revenues of around $2 billion. Signs suggest that sales for the drug have only increased in 2016.
Around 7,200 patients and surviving family members have now filed lawsuits against the manufacturer and marketer of Xarelto, demanding compensation for medical expenses, pain, and emotional trauma. This is not a class action; people are filing individual product liability lawsuits, including claims for the wrongful death of a loved one.
The lawsuits, however, have been brought into a single court, due to their similar concerns. Xarelto lawsuits are now "consolidated," centralized in a single federal court: the US District Court for the Eastern District of Louisiana. As a Multi-District Litigation (MDL), the cases will proceed through pre-trial phases, like the evidence-gathering step called discovery, as a group.
After pre-trial proceedings are finished, several Xarelto lawsuits will go to trial. Three cases have already been chosen by the Court as "bellwether trials," the results of which often inform settlement negotiations. The Xarelto bellwether trials are slated to begin in March, April, and May of 2017.
In New Orleans, the cases are being presided over by Judge Eldon E. Fallon, a pioneer in the use of multi-district litigation and bellwether trials. During his distinguished judicial tenure, Judge Fallon has overseen several high-profile litigations, including the MDL surrounding non-steroidal anti-inflammatory drug Vioxx. After Vioxx was linked to an increased risk for stroke and heart attack, tens of thousands of injured patients filed suit against Merck, the drug's manufacturer. Thousands of these cases came under the purview of Judge Fallon, who was instrumental in guiding the litigation to a $4.85 billion settlement.
Our attorneys are investigating potential lawsuits on behalf of anyone who believes that Xarelto contributed to a severe bleeding event or wound infection. If you or a loved one suffered injuries after taking Xarelto, you may be entitled to pursue significant financial compensation. Time, however, is limited. The Xarelto MDL is progressing quickly, and strict statutes of limitation may restrict the amount of time you have to file suit.
Contact the experienced attorneys at Banville Law today to secure a free consultation. You can learn more about your rights and legal options at no charge and no obligation.