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Bayer and J&J Hit with New Lawsuit over Irreversible Xarelto Side Effects

Elizabeth DiNardo, Esq. | Associate Counsel


Although filed separately, the wives of Thomas Walsh and Joseph Roman are the latest to officially accuse Bayer HealthCare Pharmaceuticals Inc. and Janssen Pharmaceuticals of concealing life threatening risks associated with the use of their blood thinner, Xarelto. On July 10,2017 in New York State court, the couples filed claims alleging negligence, strict products liability, breach of warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation and fraud and deceit, and are seeking compensatory damages.

According to each couple’s filing, “Upon information and belief, defendants concealed and failed to completely disclose its knowledge that Xarelto was associated with or could cause life-threatening bleeding as well as its knowledge that they had failed to fully test or study said risk.” Plaintiffs point to an $11 million marketing campaign launched by Defendants in 2013 which targeted consumers and proved to have some major shortcomings. The campaign provided faulty information about the drug’s effectiveness in preventing stroke and systemic embolism, plus failed to alert users that there was no treatment for excessive bleeding, a side effect that many consumers faced under the use of Xarelto.

While the campaign was ongoing, the U.S. FDA received innumerable complaints, known as Serious Adverse Event reports, regarding the side effects associated with Xarelto. Some even brought to light hemorrhage-related deaths caused by the drug. The complaints filed by the plaintiffs referred to these reports and questioned why Bayer did nothing to alert the public or to continue testing the drug to monitor its effect on its users. However, both companies have since updated the product label to include slightly more information on the serious risks associated with the use of their product. For the Walsh and Roman families, Defendants “still failed to provide adequate disclosures or warnings” on the safety risks and lack of treatment for the excessive bleeding.

Bayer and Janssen are currently involved in multidistrict litigation pertaining to the incurable hemorrhage events that Xarelto allegedly caused and have won the first two bellwethers to date. Bayer believes that the outcomes in the MDL cases are an indicator of subsequent case outcomes and has released in a statement that, “its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine…Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

The suits are Thomas Walsh and Cindy Walsh v. Janssen Research & Development LLC et al., case number 156162/2017, and Joseph Roman and Rosa Roman v. Janssen Research & Development LLC et al., case number 156166/2017, both in the Supreme Court of the State of New York, County of New York.

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