Virginia Stuntebeck sued Johnson & Johnson and Bayer AG in Pennsylvania Court earlier this year, alleging that she suffered severe internal bleeding stemming from use of the blood-thinning drug Xarelto. In the Xarelto lawsuit, which appears to be the first tort suit filed over the medication in Philadelphia, Stuntebeck said the drug should not be sold because of the high risks surrounding its use.
Stuntebeck confessed that she was hospitalized in February 2013 for severe internal and gastrointestinal bleeding as a result of using the drug. As the manufacturers and distributors of Xarelto, Johnson & Johnson knew or should have known that Xarelto use was associated with irreversible bleeds. Stuntebeck’s lawsuit claims the warning label on Xarelto fails to properly convey the true risks of the drug as it relates to uncontrolled bleeding events and other serious injuries including death.
Xarelto is now being likened to its competitor Pradaxa which is the subject of more than 2,000 injury lawsuits in a multidistrict litigation and occasionally referred to as “the most complained about drug” in the U.S.
Both Pradaxa and Xarelto claim in their marketing that you don’t need to monitor a patient taking the drug to prevent blood clots and stroke. This is supposedly an advantage of these blood thinners since the more well-established anticoagulant warfarin (Coumadin) frequently requires medical monitoring and doctor supervision.
The U.S. Food and Drug Administration originally approved Xarelto in July 2011 to reduce the risk of blood clots and pulmonary embolism. They extended the recommendation to include the treatment of abnormal heart rhythm or a-Fib which leads to strokes later that same year. But the subsequent approval was against the recommendation of FDA staff who noted serious safety concerns with Xarelto. Recently, the FDA has refused a third expansion of the Xarelto’s use.
At Childers, Schlueter and Smith LLC, we feel that drug manufacturers and medical professionals should be at fault when their treatments cause serious side effects and put people in danger. If you suffered internal bleeding event or some other injury as a result of Xarelto, you may have a legal claim.