Xarelto (Rivaroxaban) Lawsuit

Lawsuits have been filed against Bayer AG and Janssen Pharmaceuticals, manufacturers of the prescription medication Xarelto. The lawsuits claim that Bayer and Janssen failed to adequately warn consumer about the risks association with the Xarelto, a blood thinning medication.

According to Johnson & Johnson's 2017 annual report, there were 16,900 pending lawsuits related to Xarelto, and that number has risen since the report was issued:

"Claims for personal injury have been made against Janssen Pharmaceuticals, Inc. and Johnson & Johnson arising out of the use of XARELTO ® , an oral anticoagulant. The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases.

Cases filed in federal courts in the United States have been organized as a multidistrict litigation in the United States District Court for the Eastern District of Louisiana. In addition, cases have been filed in state courts across the United States. Many of these cases have been consolidated into a state mass tort litigation in Philadelphia, Pennsylvania; and there are coordinated proceedings in Delaware, California and Missouri. Class action lawsuits also have been filed in Canada."

In December 2017 a jury in first bellwether case to be tried in Philadelphia awarded an Indiana couple, $26 million in punitive and $1.8 million in compensatory damages. Lynn Hartman suffered a serious gastrointestinal bleed while using the blood thinning medication. The jury found that the pharmaceutical companies failed to provide adequate warnings regarding the risks for bleeding associated with Xarelto. The verdict was significant as the first Xarelto bellwether case to yield a win for the plaintiff. Three previous bellwether cases in the Louisiana MDL resulted in defense verdicts. As of December 2017 more than 18,500 additional cases were pending in the Louisiana mass tort litigation.

In August 2015, two third-party payers filed a purported class action in the United States District Court for the Eastern District of Louisiana against Janssen Research & Development, LLC, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Johnson & Johnson (as well as certain Bayer entities). The plaintiffs alleged that the defendants improperly marketed and promoted XARELTO as being safer and more effective than less expensive alternative medications while failing to fully disclose Xarelto's risks.

In Nov. 2015, Ashley Fluitt filed a wrongful death lawsuit Ashlie Fluitt v. Janssen Research & Development et al, Case No. 2:15-cv-05874, US District Court, Eastern District of Louisiana against Janssen and certain of its subsidiaries after her grandmother, Hattie Deville-Goodwin died after taking Xarelto. Deville-Goodwin allegedly suffered "uncontrolled internal bleeding, brain hemorrhage and untimely death," according to the lawsuit.

Xarelto was approved by the US Food and Drug Administration (FDA) in 2011. In 2013, the FDA issued a warning letter to the maker of Xarelto, noting that a print advertisement for the drug minimized the risks associated with it and made a misleading claim. Specifically, the FDA warned that including the risk information without any of the emphasis that was included on the benefits section made it seem as though the risks were not important. The agency noted in its letter that the most common adverse reactions with Xarelto were bleeding complications.

Xarelto (known generically as Rivaroxaban) is a new-generation anticoagulant, in a class of drugs known as direct thrombin inhibitors. It is a blood thinner used to reduce the risk of blood clots and strokes. Xarelto has also been marketed as being easier to use than warfarin (known by the brand name Coumadin), an older anticoagulant, because it does not require medical monitoring.

"Xarelto increases the risk of bleeding and can cause serious or fatal bleeding," according to Xarelto's product safety warning. "When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis." Premature discontinuation of Xarelto can also increase the risk of blood clots, thrombotic events and stroke.

Xarelto has reportedly been linked to an increased risk of uncontrollable bleeding (hemorrhaging). A risk of hemorrhaging exists in many blood thinners; however, warfarin has an antidote in that can reduce the risk of uncontrollable hemorrhaging. Some newer blood thinners do not have an antidote. This means that injuries—including minor cuts or internal bleeding—can result in uncontrolled bleeding, which can be fatal.

Injuries alleged to be associated with Xarelto include:

• Stroke
• Retinal hemorrhages
• Death
• Epidural hematoma
• Intracranial hemorrhages
• Pulmonary embolism
• Hemoglobin decrease
• Gastrointestinal hemorrhages
• Deep vein thrombosis
• Adrenal bleeding

Xarelto and Pradaxa (another anticoagulant medication) are both anticoagulants that do not have an antidote, meaning they could potentially lead to uncontrollable bleeding. Both drugs are the subject of lawsuits filed against their makers for failing to warn about the lack of an antidote to the drugs.

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Last updated on Dec-20-17