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Jury selections began this week in the first bellwether trial for thousands of Xarelto lawsuits pending throughout the federal court system, involving allegations that the drug makers failed to adequately warn about the gastrointestinal bleeding risks associated with the controversial new-generation anticoagulant.

Xarelto is one of a new class of anticoagulants used to reduce the risk of blood clots and strokes, particularly among patients with atrial fibrillation or following hip or knee replacement surgery.  It was developed and is distributed jointly by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary and Bayer Healthcare.

Approved in 2011, Xarelto brought in over $2 billion in 2016 alone, according to the company’s annual report.  People injured by the drug say its makers put profit before safety.  The most dangerous side effect for people who take Xarelto is internal bleeding.  The drug does not have an antidote and former Xarelto users filed lawsuits saying they were not sufficiently warned about the medication’s risk.  Some plaintiffs filed wrongful death suits after loved ones died from Xarelto bleeding.

Another issue with Xarelto – though less publicized than its bleeding complications – is its link to a greater occurrence of wound infections following surgery for total hip or knee replacements.  The medication increases wound leakage and infection risk by more than 10 times.  The complication often sends patients back in for more surgery.

Plaintiffs who filed lawsuits against Bayer, Janssen and J&J claim the drug companies misrepresented the safety and effectiveness of Xarelto.  Despite their knowledge of Xarelto’s defects and dangers, defendants did not warn patients or doctors about the severity of side effect risks, according to court documents.

There are currently more than 15,611 cases consolidated in federal multidistrict litigation (MDL).  Hundreds more are pending in state courts.  The result of this first bellwether trial could set the tone of future Xarelto trials and possible settlements.

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