For about two weeks in September 2015, Ohio resident Louise R. says she took the widely popular blood-thinner, prescribed by her doctor for the treatment of pulmonary embolism.
Thirteen days in, Louise claims to have experienced gastrointestinal bleeding and suffered a life-threatening bleed from , according to a lawsuit filed earlier this month in Louisiana federal court, the site of some 18,000 federal and state lawsuits related to the drug. Louise has joined a multi district litigation against drugmakers Janssen and Bayer.
(rivaroxaban) hit the U.S. market in 2011 and is prescribed for several reasons, including reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (a heart rhythm disorder), to treat deep vein thrombosis and pulmonary embolism, to reduce the risk of recurrence of deep-vein thrombosis and pulmonary embolism, and to prevent deep-vein thrombosis in patients undergoing hip and knee replacement surgery.
But unlike its competitor Coumadin (warfarin) — the only anticoagulant on the market for decades — there is no reversal agent in the event of a life-threatening bleed from.
is promoted as superior to Coumadin because it does not require routine blood monitoring or a restricted diet low in vitamin K, both of which are necessary for those who take Coumadin.
However, when it first came out, ’s label failed to warn about the lack of an antidote in the event of a hemorrhage, according to the lawsuit. Instead, this risk was listed in the overdosage section.
Louise and the thousands of other plaintiffs suing over a life-threatening bleed from allege that the drug companies fraudulently represented to the medical and healthcare community, the Food and Drug Administration and the public that the drug had been tested and found to be safe and effective for its indicated use.
The plaintiff claims Janssen and Bayer concealed research and intentionally omitted that:
- was not as safe as other treatments;
- The risks of adverse events with were higher than those using other treatments for the same issues;
- The risks of adverse events with were not adequately tested and/or known by the defendants;
- The defendants knew of’s dangers;
- was defective;
- Patients needed to be monitored more regularly than normal while using .
In June 2013, the FDA sent a letter to the defendants notifying the companies that a print ad for atrial fibrillation violated FDA regulations because it was “false or misleading because it minimizes the risks associated with and makes a misleading claim” about dosing adjustments.
Louise says she continues to suffer serious and dangerous side effects including life-threatening bleed from and what her lawsuit characterizes as “other severe and personal” injuries which cause physical pain, mental anguish, diminished enjoyment of life and expenses for hospitalization and medical treatment.
The FDA has received at least 370 reports of patients from -related complications.
If you’ve suffered from a life-threatening bleed from, contact the experienced attorneys at McDonald Worley today for a FREE case review.