A Texas woman is the latest to sue Bayer and Johnson & Johnson pharmaceutical companies, claiming that the anticoagulant Xarelto has inadequate warnings about the bleeding risk associated with the drug. Jeanne Jeffcoat filed the lawsuit in the U.S. District Court for the Eastern District of New York, she claimed that Xarelto caused life-threatening bleeding event that left her permanently injured.
Xarelto Aggressive Marketing
Plaintiffs are alleging that the drug makers aggressively marketed Xarelto as superior to warfarin without warning about the risk of bleeding and the lack of an antidote to reverse the blood thinning effects of the medication.
Jeffcoat began using Xarelto in March 2012, and 4 months later she suffered a life-threatening bleed that has left her with severe, permanent injuries, and pain and suffering.
What is Xarelto?
Xarelto (Rivaroxaban) is a new type of anticoagulant, known as “direct thrombin inhibitors,” which are used to reduce the risk of blood clots, deep vein thrombosis, pulmonary embolism and embolic strokes. The drug was developed by Bayer and Janssen and was approved in 2011.
Xarelto Misleading Marketing Claims
The lawsuit alleges that the companies purposefully mislead the doctors. Plaintiffs claim that the drug makers withheld information from patients and doctors about the lack of an antidote and about the severe bleeding risks with Xarelto.
The companies promoted three medical studies to get Xarelto approved as a stroke preventative for patients with atrial fibrillation, deep vein thrombosis and pulmonary embolism. All of the studies demonstrated an increased risk of serious bleeding events.
According to the lawsuit, the companies used the studies’ positive results to promote Xarelto to doctors in their promotional materials, but the “promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns.”
The companies allegedly spent at least $11 million on advertising in medical journals in 2013 alone, making Xarelto the number one pharmaceutical product advertised in professional health journals in the third quarter of 2013 based on pages and money spent.
Xarelto: No Reversal Agent
Xarelto was designed to replace Coumadin (warfarin) for the prevention of stroke in patients with atrial fibrillation. Atrial fibrillation is a common heart rhythm problem that increases the risk of strokes. All blood thinners increase the risk of suffering a bleeding event, but warfarin’s blood thinning side effects can be reversed with vitamin K.
Xarelto has no reversal agent. The lawsuit claims that the FDA had to issue a warning on June 6, 2013, saying that the companies direct to consumer ads were misleading because they minimized the risk of uncontrollable bleeding.
According to the FDA, the companies downplayed the risks and placed them so that they would not catch readers’ attention. Furthermore made misleading claims that there were no dosage adjustments required, when in fact there were.
Xarelto Scope of Bleeding Problems
According to the lawsuit, “In the year leading up to June 30, 2012, there were 1,080 Xarelto-associated ‘Serious Adverse Event’ (‘SAE’) Medwatch Reports filed with the FDA, including at least 65 deaths.”
The lawsuit goes on to allege, “At the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated SAR reports were filed with the FDA in its first full year on the market, ranking tenth among other pharmaceuticals in direct reports to the FDA. Of those reported events, 151 resulted in death, as compared to only 56 deaths associated with warfarin.”
According to the reports, Xarelto bleeding problems result in death in 8% of all cases, which is double the rate of death for warfarin bleeding events.
The Institute for Safe Medication Practices warned that the figures indicated a “strong signal” that there were safety problems with Xarelto and said that the public and scientific community needed to be warned and Xarelto safety needed to be further investigated.