In 2011, the FDA approved Xarelto as a one-a-day New Oral Anticoagulant (“NOAC”) for patients suffering from the medical condition Atrial Fibrillation. The drug—manufactured by Bayer and distributed by Johnson & Johnson—is one of the fastest selling blood thinners in the world, raking in nearly $2 billion in 2015 alone. But as a result of allegedly profit-driven motives and minimal oversight, there have been thousands of lawsuits filed against Bayer and Johnson & Johnson.
Xarelto came under increased scrutiny for multiple reasons. Not only has this blood-thinner allegedly resulted in dozens of wrongful deaths, but also it has caused severe bleeding problems and other unforeseen side effects. Users of Xarelto have experienced increased blood loss and strokes, as the one-a-day formula backfired and physicians could not properly monitor its patients without an antidote or a comprehensive treatment plan. As of this date, there has been no recall on Xarelto, and doctors are still treating these symptoms in various and indeterminate ways.
A New York Times article in February of this year examined a potential cause of this problem. It postulated that a blood-monitoring device could have led to incorrect results in the trial studies from 2006 to 2010, which led to the FDA approval. While the Duke researchers who conducted the review of the blood-monitoring device concluded it did not affect the trial results, many researchers have claimed otherwise. No matter what the cause, thousands have filed lawsuits stating they have been injured because of this product.
Currently, there are over five thousand claims consolidated in Louisiana federal court under MDL – 2592 for Xarelto Products Liability litigation. The main purpose of this litigation is to determine whether Bayer and Johnson & Johnson worked with Duke researchers who publishes the results of the trial, or if the research for the trials were conducted independently. In this point in the litigation, discovery is being conducted on both sides.
As there are still years of pre-trial litigation and discovery to commence, patients may have other causes of actions under related theories. There are many Xarelto claims being pursued in state courts throughout the country. Aside from a products liability claim, patients taking Xarelto may have a claim under medical malpractice. If patients suffered any symptoms relating to excessive bleedings, blood clots, difficulty breathing, as well as other related symptoms, and received medical treatment that exacerbated these symptoms or resulted in death, they may also have claims under negligence related theories.
The amount of damages a patient who has taken Xarelto is still undetermined, as it is a relatively new drug without much information why the defects happened without discovery being conducted. Bayer and Johnson & Johnson, as well as doctors administering Xarelto and related treatment, may be quick to settle as they could face millions in liability. Settlement awards for Xarelto will depend on a variety of factors, including: severity of injury related to Xarelto, amount of pain suffered by the patient, past and future medical expenses, lost wages, or wrongful death actions, which could result in loss of consortium claims from loved ones. If you or a loved one has taken Xarelto, contact the Berniard Law firm today to immediately begin a review of your case.