The First Xarelto lawsuits have been filed against drug giant Bayer and Johnson and Johnson related to safety concerns for their popular blood thinner. After taking Xarelto and being sent to the hospital for severe internal bleeding, patients blamed the blood thinning drug and filed suit. Xarelto has been marketed as an update to the almost 50 year old drug Warfarin. Unlike the established drug Warfarin, Xarelto has no antidote to stop uncontrolled bleeding which can be fatal. A Kentucky woman Virginia Stunteneck, was hospitalized severe gastrointestinal bleeding in 2013 after taking Xarelto. Ms. Stunteneck has since filed a lawsuit in the U.S. District Court of the Eastern District of Pennsylvania. She claims that Bayer and Johnson and Johnson knew the risks to patients taking the drug and continued to sell it without telling the public about the dangers. Stunteneck’s complaint alleges, “As the manufacturers and distributors of Xarelto, defendants knew or should have known that Xarelto use was associated with irreversible bleeds.” Boehringer Ingelheim settled thousands of cases involving its blood thinner Pradaxa in May of 2013. Over $650 million was paid to patients that took Pradaxa and suffered similar bleeding side effects as Xarelto patients. Attorneys expect more lawsuits as patients become aware of the danger this drug poses to the public.
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If you or a loved one took Xarelto and suffered internal bleeding or pulmonary embolism you could be owed substantial compensation.
FDA Rejects New Uses for Xarelto
The firt lawsuits come only a few months after the United States Food and Drug Administration’s (FDA) advisory panel rejected Xarelto as a treatment for patients with rapid loss of blood flow to the heart, inlcuding chest pain and heart attacks, also known as acute coronary syndrome. Approval of treatment for ACS would have given Xarelto access to the 1.2 million patients in America that are taken to the hospital for the condition. The rejection was the last straw for Bayer and Johnson and Johnson for FDA approval. The advisory panel ruled that there was not enough clinical data to support approval of the drug for prevention of new heart attacks and strokes in ACS patients. Panel experts added that some data from the trial was actually missing. Paul Burton, VP of clinical development for Johnson and Johnson said in a statement, “We appreciate the thoroughness of the committee’s review and continue to believe rivaroxaban, in addition to the current standard of care, may help provide patients with ACS additional protection against life-threatening cardiovascular events such as death, heart attack and stroke.”
Sales of Xarelto Expected to Increase
Despite lawsuits concerning the safety of another drug manufactured by the partnership of Bayer and Johnson and Johnson, Xarelto sales appear to be strong. Bayer and Johnson and Johnson report sales of over $431 million in Europe and $239 million in the U.S. In fact, sales continue to climb despite the risks of internal bleeding. And like its its predecessor Pradaxa, doctor’s continue to prescribe the drug in spite of the danger. Despite being denied for ACS treatment, Bayer and Johnson and Johnson continue to seek FDA approval for new uses including chronic artery disease and heart failure. Analyst predict Xarelto sales to top 3.68 billion in annual sales by 2018.