Hundreds of lawsuits have been filed against Xarelto manufacturers Johnson & Johnson and Bayer Healthcare alleging that the manufacturers failed to warn consumers of the gravity of the risks involved in taking the blood-thinning drug.

Xarelto, generically known as rivaroxaban, is an anticoagulant or blood thinner developed by Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The FDA approved the drug for use in 2011 for individuals suffering from Atrial Fibrillation (Afib), Pulmonary Embolism (PE), and Deep Vein Thrombosis (DVT).

Xarelto belongs to a class of drugs called direct thrombin inhibitors and functions by inhibiting the Factor Xa, which is an enzyme needed for blood clots to form. The drug functions differently from traditional blood thinners, like Coumadin (Warfin), which instead interferes with vitamin K.

Manufacturers of Xarelto have promoted the product to the public as a more convenient alternative to the popular Coumadin because, unlike patients taking Coumadin, Xarelto users do not need to undergo regular blood tests to continually adjust their dosage. Patients taking Coumadin are also advised to stay away from leafy greens in order to keep vitamin K levels low, whereas Xarelto users have no dietary restrictions.

However, Xarelto, unlike Coumadin has no antidote to stop hemorrhaging. Xarelto has a low therapeutic index, which means that the difference between safe levels of the drug does not significantly differ from dangerous dosages. If severe hemorrhaging occurs while using Xarelto doctors are left with no other solution than to perform a blood transfusion.

Just one year after the FDA approved Xarelto for public use, the agency revealed that three times as many people died as a result of adverse events caused by Xarelto as compared to patients using Coumadin. QuarterWatch the quarterly adverse drug event report published by the Institute for Safe Medication Practices reported that in the first quarter of 2012 alone there were 356 reports of serious, disabling, or fatal injury involving Xarelto use.

In August 2013, the FDA sent a warning letter to Janssen advising the drug maker that changes to the labeling of Xarleto had to be made immediately. Specifically, the FDA stated that the labeling on Xarelto medication boxes was misleading to consumers, as were the Xarelto advertisements running at the time.  The labeling and advertisements in question at the time minimized the risks associated with the drug. Out of six possible categories of safety labeling listed by the FDA in 2013 Janssen had to alter four categories—boxed warnings, precautions, adverse reactions, and warnings in general. In 2014, the FDA once again notified Janssen that it had to alter the Xarelto box warnings.

Plaintiffs in the Xarleto lawsuits allege that defendants, Bayer Healthcare and Johnson & Johnson, recklessly placed Xarelto on the market and knowingly promoted the drug despite being aware that no antidote was available once a patient started hemorrhaging. Plaintiffs also allege that had they been made aware of the true extent of the serious risks involved with Xarelto they would not have taken the drug. The injuries alleged by the plaintiffs in the litigation include: gastrointestinal bleeding, brain hemorrhage, subdural hematoma, epidural hematoma, pulmonary hematoma, heart attack, stroke, blood clots, rectal bleeding, and liver issues.

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