Articles Tagged with failure to warn

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Xarelto Plaintiffs seek new trialsRecently, three cases in the Xarelto multi-district litigation (MDL) ended in defense verdicts in favor of Xarelto’s manufacturers, Bayer, Janssen, and Johnson & Johnson. These lawsuits, specifically the Orr trial, the Boudreaux trial, and the Mingo trial, stem from the manufacturers’ failure to provide instructions regarding routine prothrombin time (PT) testing for patients with a high risk of bleeding while on Xarelto. In addition, the plaintiffs argued that defendants misled doctors about whether tests were available to assess effects and risks of the medicine.

Since the cases ended in verdicts for the drug manufacturer, the Plaintiffs are now appealing for new trials. The plaintiffs argue that the defense verdicts are a result of the district court wrongfully admitting evidence, denying admission of other evidence, and giving improper instructions to the jury.

In the legal brief, these arguments for new trials are broken down into four main points:

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Opioids: Are Individual Lawsuits Imminent?
Have you been directly affected by the opioid epidemic in America? Millions of people have become addicted to these powerful drugs—and for many, that addiction started with a legally prescribed medication to treat legitimate pain. One report estimated that more than 59,000 people died from drug overdoses in 2016—and most of those were caused by opioids. The President has even declared opioid abuse a national public health emergency.

I’ve written before in this space about the opioid epidemic and the massive opioid litigation gearing up across America as well as the establishment of centralized multidistrict litigation. So far, these cases primarily involve state and local governments suing opioid manufacturers and distributors for their roles in the opioid crisis.

No doubt governments have suffered financial losses from the skyrocketing number of overdoses requiring emergency treatment. In North Carolina alone, the cost of opioid-related accidental overdose deaths was estimated at $1.3 billion in 2015.

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Xarelto Trial Verdict
Today, a jury in Philadelphia awarded approximately 28 million dollars to a woman who suffered serious gastrointestional bleeding after taking the blood-thinning drug Xarelto. It was a huge win for the plaintiff, Lynn Hartman. Ms. Hartman took Xarelto for over a year to treat atrial fibrillation. She suffered internal bleeding and was eventually hospitalized. She needed four blood transfusions. According to court documents, the internal bleeding eventually stopped, and Ms. Hartman was taken off the medication. After she stopped taking Xarelto and switched to another blood-thinner, she had no further internal bleeding.

Ms. Hartman sued Bayer Healthcare Pharmaceuticals, Janssen Pharmceuticals, and parent company Johnson & Johnson. Her primary claim was that the defendants failed to provide adequate warning of the bleeding risks associated with taking Xarelto.

One important witness for the plaintiff at trial was David Kessler, the former Commissioner of the Food and Drug Administration. Kessler testified that he believed the warning label on Xarelto was inadequate and lacked important information regarding the specific risks of internal bleeding.