What the first Xarelto lawsuit that hit the courts was, and how did people end up asking for a lawyers’ help? Let’s backtrack the history of the litigations filed by plaintiffs who were injured by the infamous blood thinner since their first appearance. In November 2011, the Food and Drugs Administration (FDA) approved the use of a new anticoagulant used to treat patients who were diagnosed with atrial fibrillation (AFib). Atrial fibrillation is a condition that causes palpitations and an irregular heartbeat, increasing the risk for cardiovascular events as well as strokes. In January 2012, William Packard, a patient suffering from AFib, took an appointment with his physician to talk him about his new medication.
Why people do keep filing lawsuits against Bayer?
Mr. Packard’s doctor believed that Xarelto (rivaroxaban), a newer drug from the Novel Oral Anticoagulants category (NOACs), would be more successful than the old treatment because it did not require the patient to go through the extensive monitoring he had previously endured. After just six months of taking the medication, William Packard began suffering from headaches and recurrent episodes of confusion. As soon as he complained his side effects, he was promptly admitted to a hospital where he was diagnosed with a subdural hemorrhage, a life-threatening condition where blood starts leaking outside the brain. Although emergency surgical attempts were made to inhibit the Xarelto brain bleeding, William Packard was pronounced dead only five days after being admitted.
Later that year in mid-July 2012, Thomas Dunkley’s physician prescribed him the same new anticoagulant medication to treat his AFib: rivaroxaban. His first Xarelto side effect made its appearance on July 26th when Dunkley began to experience severe head pains. He suffered through the agonizing pain for five more days until he was pronounced dead on August 1st. Dunkley died within two weeks since he started taking the new drug. The new blood thinner medication that killed them both was Xarelto (rivaroxaban), a drug that was widely advertised as safer than his competitors. Dunkley and Packard’s histories were just the first of a long collection of Xarelto lawsuits. Since then, many attorneys brought their plaintiffs’ stories to court, blaming Bayer AG and Janssen Pharmaceutical of releasing to the market a dangerous and unsafe medication.
Xarelto is a Novel Oral Anticoagulant (NOAC), a new category of blood thinners that has been linked to fatal bleeding that lacks a proper antidote to reverse their effects. As many lawyers pointed out, reversal agents are of critical importance during emergency situations. Unlike rival medications such as Pradaxa, emergency dialysis is not able to safely remove the drug from the patient’s system, leading him or her to a slow, painful death. Bayer knew about the serious health risks associated with this medication but failed to indicate them in any warnings. Why would such a well-known company fail to mention something so important? Despite the apparent dangerousness of the medication, Bayer and its partner, Johnson & Johnson, continued to engage in a major marketing campaign. The Xarelto advertisement campaign was so successful that sales totaled approximately $1 billion in the last year.
However, Bayer now faces an unusually high amount of injury and wrongful death lawsuits brought to court by angry personal injury attorneys. Bayer’s primary defense is based on only two studies, the first one of which was paid for by Bayer while the other was paid for by Janssen, a subsidiary of Johnson & Johnson. The first study was published in the New England Journal of Medicine on September 8th, 2011, and was titled “ROCKET AF”. The study compared Xarelto with Warfarin in the prevention of stroke and the treatment of AFib. It was determined that there were “no significant differences in rates of major and clinically relevant non-major bleeding” among patients being treated with Xarelto or Warfarin.
The second study, titled “EINSTEIN PE” was also published in the New England Journal of Medicine on April 5th, 2012. The study focused on the comparison of rivaroxaban, a direct Factor Xa inhibitor, and a whole different type of anticoagulant, Enoxaparin Sodium, a low molecular weight heparin. The study determined Xarelto to have “superiority for major bleeding” when compared with Enoxaparin. There were no mentions about the dangerous uncontrolled bleedings.
Both studies failed to mention the lack of Xarelto antidote, which is a critical factor when producing this type of drug. The idea that the manufacturer was ignorant about the potential dangers of their product is preposterous and alarming. Bayer and Janssen continue to praise and recommend their product, regardless of the fact that its adverse reactions have been linked to more than 2,000 adverse reaction reports throughout 2013.
The families of the deceased claim that the dangers of the medication were not only known by the companies but that the information was intentionally withheld. Bayer, a company with a history of covering up deadly complications, has made an immense effort to hide any prior knowledge of potentially lethal effects to avoid profit loss. However, they cannot protect themselves from the rain of litigations that’s going to shower them. Almost 5,000 total Xarelto lawsuits have been, in fact, merged to form the Multidistrict Litigation number 2592, which is being overseen by Judge Eldon Fallon in the Eastern District of Louisiana.
Article written by: Dr. Claudio Butticè, Pharm.D.
Last Updated: 2016/07/25