Barbara Anderman  |  August 21, 2014

Category: Legal News

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Xarelto Side Effects Class Action Lawsuit InvestigationXarelto (rivaroxaban) is a member of the family of anticoagulants known as “direct thrombin inhibitors,” which are used to reduce the risk of blood clots, deep vein thrombosis and stroke. And like its sister drugs, it is alleged to cause uncontrollable internal bleeding.

Pradaxa is the name that most often comes to mind in this group, but it’s not the only one out there. It is, however, at the heart of thousands of lawsuits in which the victims have suffered irreversible internal bleeding. Florida plaintiff Edwin Nicholson joins the list of Xarelto users who has filed a lawsuit, suing Johnson & Johnson, its subsidiary Janssen, and Bayer Pharmaceuticals, for damages alleged caused by the drug.

Nicholson used Xarelto to “reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation,” according to the Xarelto lawsuit. Xarelto is also used to treat and reduce the risk of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE). His physician prescribed it to him in March 2013.

Less than six months later, Nicholson experienced a lower gastrointestinal bleed and suffered a life-threatening, irreversible bleed, as well as severe pain and suffering. His Xarelto lawsuit alleges this is due to use of the drug.

Nicholson’s Xarelto lawsuit claims the drug manufacturers and their subsidiaries concealed their knowledge that Xarelto can cause life threatening, irreversible bleeds from the public and the medical community, and that the marketing had no warnings. He says that the defendants, in their marketing, pushed Xarelto over warfarin (Coumadin). “Defendants emphasize the supposed benefits of treatment with Xarelto over warfarin, which they refer to as the Xarelto Difference – namely, that Xarelto does not require periodic monitoring with blood tests and does not limit a patient’s diet.”

In actuality, the defendants spent significant money promoting Xarelto, including close to $11 million in 2013 alone on advertising in journals targeted at prescribers and consumers in the United States. But the advertising lacked sufficient mention of risks. If Nicholson had known of the risks, he could have chosen an alternative treatment like Coumadin, which has been a long-established safe treatment for preventing stroke and systemic embolism for over 50 years.

Nicholson is suing defendants for negligence, strict product liability, breach of implied and express warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, and violation of consumer protection laws.

The Xarelto Lawsuit is Edwin Nicholson v. Janssen Research & Development, et al., Case No. 5:14-cv-00173-RS-EMT, in the U.S. District Court for the Northern District of Florida, Panama City Division.

Anticoagulant Therapies

Supposedly easier to use and requiring less monitoring than their predecessor Coumadin (warfarin), Xarelto and Pradaxa are part of a new class of anticoagulation therapy drugs. Pradaxa (dabigatran), introduced by Boehringer Ingelheim in October 2010, was the first drug in this class to hit the market, and the first with adverse bleeding events reported to the FDA. Xarelto soon followed suit.

In the year leading up to June 30, 2012, there were “1,080 Xarelto-associated ‘Serious Adverse Event’ Medwatch reports filed with the FDA, including at least 65 deaths.” Of the hemorrhage events reported associated with Xarelto, those that resulted in death were two times the risk of those with warfarin. By the end of 2012, the first full year that Xarelto was on the market, a total of 2,081 SAE reports were filed with the FDA. This ranked Xarelto as 10th among pharmaceuticals in direct reports to the FDA. Moreover, of those reported, 151 resulted in death compared to warfarin’s 56.

Many of these deaths are due to the new breed of drugs not having a reversal agent for the bleeding risks. Bleeding risks are common with all blood thinners, but there has always been a way to stop this effect. With warfarin, doctors can use Vitamin K to stop the bleeding. Xarelto does not have a cure, so doctors have to improvise treatments to stop the bleeding effects.

These on-the-fly or off-label treatments can help, but according to plaintiffs and experts, they have led to confusion over what is appropriate treatment. It has also led to serious injuries and death. But this was marketed as a drug that didn’t need supervision and easy for a patient to use. Now finding a possible antidote is at the forefront of the pharmaceutical companies’ research.

In general, Xarelto bleeding lawsuits are filed individually by each plaintiff and are not class actions.

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