It’s official – the first bellwether trial regarding the blood thinner Xarelto started at the end of April in a courtroom in New Orleans, LA.
First Plaintiff Bravely Takes The Stand
The first plaintiff of thousands who have filed against Bayer Inc and Johnson & Johnson, the manufacturers of Xarelto, filed a lawsuit because he believes that he was harmed by the drug. In his complaint, he alleged that after taking the drug for less than 30 days, he developed serious GI bleeding which doctors were only able to stop after administering multiple blood transfusions, requiring extensive hospitalization. He also claims that the manufacturers were negligent because they didn’t initially inform the medical community or patients about the fact that Xarelto has no antidote.
Without an antidote, when a patient on the blood thinner begins to bleed from any part of the body, their doctors are unable to reverse the effects that Xarelto has on the blood. This means that the blood may never clot properly and the patient could potentially bleed out. In fact, hundreds of the more than 18,000 lawsuits filed are wrongful death lawsuits.
The Manufacturer’s Response
Both companies have stated that they believe their drug is safe and more effective than older blood thinners like Warfarin. In fact, the two have tried to have many of the lawsuits filed against them thrown out on the grounds that plaintiffs are unable to prove that their doctors would have prescribed them a different drug even if they had known of possible side effects, however, Judge Fallon who is overseeing the cases that have been consolidated under MDL 2592 denied the motion.
The manufacturers have also filed a motion, requesting information regarding how the plaintiffs are funding their complaints because they believe there many be a third-party seeking to complicate things for them by encouraging people from across the country to file.
FDA Still Stands Behind Their Approval
Despite the number of lawsuits filed and the fact that the administration itself has issued several “black box” warnings, the FDA issued a statement on October 11th, 2016, saying that they believe the study used for the approval of Xarelto was still accurate and that they stand by their approval. Yet, when the time came to approve a potential antidote, they refused and instead informed the manufacturers that additional studies and information needed to be provided.
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