The motion requested the U.S. Joint Panel of Multidistrict Litigation (JPML) to consider the Southern Illinois District court, to be the most ideal venue in light of the recent MDL involving another new anticoagulant, Pradaxa.
MDL coordinated proceedings are common in complex pharmaceutical litigation, where a large number of lawsuits have been brought involving similar injuries associated with the same medication or product.
What is Xarelto?
Xarelto is a Bayer drug that is marketed in the US by Johnson & Johnson and its subsidiary, Janssen Ortho LLC. Xarelto was initially approved by the FDA in July 2011 to reduce deep vein thrombosis and pulmonary embolism in patients who had knee or hip replacement surgery (preventive use).
Xarelto use was expanded in November 2011 to reduce stroke and blood clot risks in patients with atrial fibrillation. Xarelto received FDA approval again in November 2013 to treat deep vein thrombosis and pulmonary embolism.
Xarelto is part of a class of drugs called New Oral Anticoagulants (NOACs). This class of NOACs, which also includes Pradaxa and Eliquis, has been marketed as the next generation of blood-thinning drugs designed to replace warfarin. Xarelto carries a significant risk of severe, and sometimes even fatal, internal bleeding, and there is no reversal agent available if serious bleeding occurs with Xarelto use.
Xarelto Aggressive Marketing
According to plaintiffs, Xarelto advertisements run by the drug makers have “flooded the airwaves” in recent years, claiming that the new generation anticoagulant as superior to warfarin because it does not require routine blood monitoring.
Xarelto is a Blockbuster Drug
As a result of manufacturers’ aggressive marketing and promotion efforts, sales for Xarelto reached approximately $2 Billion for the fiscal year, reaching “blockbuster” status (as referred to in the pharmaceutical industry when sales clear the $1 Billion threshold). In the United States alone, there were approximately 1 million Xarelto prescriptions written by the end of 2013.
The manufacturers’ website touts that over 7 million people worldwide have been prescribed Xarelto. Xarelto is considered the leading new anticoagulant on a global scale in terms of sales and number of prescriptions.
Xarelto Increased Adverse Reports
As the usage of Xarelto increases in the United States, many Xarelto uncontrollable bleeding lawsuits are being filed against Bayer AG, and Johnson and Johnson. In the first quarter of 2013, industry consumer watchdog, the Institute of Safe Medication Practices (ISMP) found 680 serious adverse event reports associated with Xarelto, compared to 528 complaints for Pradaxa. According to ISMP the trend is mostly due to doctors changing prescriptions for their patients from Pradaxa to Xarelto.
Xarelto and Pradaxa: No Antidote
Warfarin, the traditional go to blood thinner drug, was approved by the FDA in 1954 and marketed under the brand names of Coumadin. There is no approved antidote for oral anticoagulants, such as Xarelto and Pradaxa. If significant bleeding should occur in patients taking the blood thinners then this lack of an antidote means that patients who suffer seemingly minor injuries are at risk of uncontrolled bleeding that could be fatal.
As part of their marketing tactics, the manufacturers widely disseminated direct-to-consumer (DTC) advertising campaigns designed to influence patients to inquire about Xarelto and/or request a Xarelto prescription from their prescribing physician. In their DTC advertising, the manufacturers allegedly not only overstated the benefits of Xarelto, but also failed to adequately disclose to patients that there is no means to reverse the anticoagulation effects of Xarelto.
One of the key allegations in all of the lawsuits, is that the drug makers should have recommended blood monitoring with Xarelto, so that doctors can adjust the dose based on test results and avoided high concentrations that may lead to serious bleeding events.
But that testing would destroy any advantages of Xarelto over Warfarin, since studies have not shown it to be safer or cheaper than Warfarin, which is now generic.