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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.

One of the claims, that Bayer and Johnson & Johnson were negligent in introducing the drug Xarelto, comes directly on the heels of the Pennsylvania Supreme Court declaring pharmaceutical companies can be held responsible for marketing drugs that are too harmful for use. A number of observers speculate that that decision could lead to a surge of claims in the state.

Stuntebeck said in her complaint 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, defendants knew or should have known that Xarelto use was associated with irreversible bleeds,” Stuntebeck said. Stuntebeck also cited the warning label on the drug, saying that Bayer and Johnson & Johnson never properly advised customers about the risks of the drug.

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. Xarelto may have some serious issues with marketing claims, similar to Pradaxa’s, which say that you don’t need to monitor a patient taking Xarelto to prevent blood clots and stroke.

One of the supposed “advantages” of Xarelto was that it did not require the monitoring that was associated with the well-established anticoagulant warfarin, which goes by the brand name Coumadin.

The U.S. Food and Drug Administration approved Xarelto in July 2011 to reduce the risk of blood clots, deep vein thrombosis and pulmonary embolism after knee or hip replacement surgery, and extended the recommendation to treatment of abnormal heart rhythm, which leads to strokes, in November 2011. The latter approval, however, was against the recommendation of FDA staff who noted serious safety concerns relating to Xarelto. Recently, the FDA refused a third expansion of the drug’s use.

When questioned, a representative for Bayer declined to comment on the complaint filing, emphasizing that Johnson & Johnson had the U.S. rights to the drug.

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 or some other injury as a result of Xarelto, you may have a legal claim.

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