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.
The U.S. JPML wil hear oral arguments on the motion to establish a Xarelto MDL at an upcoming hearing session scheduled for either December 4, 2014 in Charleston, South Carolina, or January 29, 2015 in Miami, Florida.
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. In addition, Xarelto has been marketed as a single daily dose pill that does not require the need to measure the blood plasma levels, and thus touted as the more convenient option to warfarin (which does require testing and monitoring).
Xarelto is a Blockbuster Drug
As a result of manufacturers’ aggressive marketing and promotion efforts, Xarelto raked in approximately $582 million in global sales in its first year on the market. In 2012 fiscal year, worldwide sales of Xarelto steadily increased to approximately $658 million.
Then in 2013, sales for Xarelto reached approximately $2 Billion for the fiscal year, thus 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.
Institute of Safe Medication Practices Report
According to an industry consumer watchdog, the Institute of Safe Medication Practices (ISMP), noted that the number of serious adverse events with Xarelto bleeding side-effects is significant and worse that for another new blood thinner, Pradaxa. Xarelto prescriptions increased to nearly 1 million prescriptions per quarter, according to ISMP. ISMP monitors and analyzes serious adverse drug events reported to the U.S. Food & Drug Administration (FDA).
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, the manufacturers and distributors of Xarelto. In the first quarter of 2013, 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.
Hundreds of adverse event reports have been submitted to the FDA suggesting a link between Xarelto and bleeding injuries or death. Similar allegations have been raised in lawsuits, that the drug makers failed to adequately warn about the bleeding risk or lack of an effective Xarelto reversal agent. Xarelto was heavily marketed as superior to warfarin because it is easier to take and require no monitoring to maintain the correct dosage.
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. Through their DTC advertising, the manufacturers allegedly not only overstated the efficacy of Xarelto, but also failed to adequately disclose to patients that there is no means to reverse the anticoagulation effects of Xarelto. Similarly for ‘The Xarelto Medication Guide’, prepared and distributed by the manufacturers and intended for patients in the United States taking Xarelto, which failed to warn patients of the lack of reversal agent and that if serious bleeding occurs, it could have permanently disabling, life-threatening and fatal consequences.