Claim of Death in Xarelto MDL
January 25, 2017 – A new claim has emerged after a Louisiana woman has died due to internal bleeding, anemia, sepsis and kidney failure allegedly caused by Xarelto, the popular blood thinner developed by Janssen Pharmaceuticals of Johnson & Johnson and Bayer.
The children of Florence Bourgeois have claimed in the lawsuit that their mother’s death could have been avoided had the drug makers warned the public and medical communities of Xarelto’s risks. They allege that the companies were negligent in stating that the medication was safe when it actually wasn’t, showing a “callous, reckless, willful, depraved indifference to the health, safety and welfare” of people such as their mother.
Xarelto (rivaroxaban) is most commonly prescribed to patients with non-valvular atrial fibrillation at risk of life-threatening blood clots and stroke. It can also be used in patients with a blood clot lodged in an artery of the lungs or who suffer other cardiovascular issues.
In a separate lawsuit against Janssen and Bayer, plaintiff Joseph Bourdreux says he took the drug to help control his atrial fibrillation, which resulted in gastrointestinal bleeding and multiple blood transfusions. He also alleges misrepresentation of the drug’s safety. That trial is set for March, 2017.
Both plaintiffs specifically note that there is no antidote for Xarelto, which means if a hemorrhage occurs, there is nothing available to stop the bleeding.
A spokesperson for Janssen has maintained the drug’s risk-benefit profile is “favorable and consistent with clinical trials”, citing over four million patients that have taken the drug. Further, that all blood thinners carry risks and that Xarelto’s prescribing information did indeed give sufficient warning.
The case is In re: Xarelto (Rivaroxaban) Products Liability Litigation, case number 2:14-md-02592, in the U.S. District Court for the Eastern District of Louisiana
Xarelto® Poses a Risk of Irreversible Internal Bleeding
There have been numerous lawsuits filed by people who have taken Xarelto and suffered from severe bleeding events, as well as lawsuits filed by the families of people whose bleeding events proved fatal.
These lawsuits allege that the makers of Xarelto, Johnson & Johnson and Bayer, have failed to adequately warn about the dangers of irreversible bleeding and have misrepresented that safety and effectiveness of the drug. Many claims filed have also called for the recall of Xarelto alleging without an effective antidote to the bleeding it can cause, the drug is unreasonably dangerous and defective.
Due to number of lawsuits that have been filed across the United States, a coordinated proceeding was set up by a panel of federal judges. In December of 2014 an order was issued establishing a Xarelto MDL (multidistrict litigation) in the U.S. District Court for the Eastern District of Louisiana.
A similar consolidated litigation against another drug in the $10 billion dollar anticoagulant market has recently yielded significant settlements. Thousands of lawsuits were filed against Boehringer Ingelheim alleging their failure to warn about serious bleeding problems associated with their blood thinner Pradaxa®. Boerhringer Ingelheim agreed to pay $650 million dollars to settle roughly 4,000 claims.
Xarelto® is an Anticoagulant
Xarelto (rivaroxaban) is a prescription oral anticoagulant otherwise known as a blood thinner. Xarelto was created jointly by Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals. It is marketed as safer and easier alternative to other anticoagulant medications.
First approved by the FDA in July of 2011, Xarelto is prescribed by doctors to reduce the risk of blood clots or stroke. More specifically, it is used to prevent deep vein thrombosis or pulmonary embolism in patients whom have undergone knee or hip replacement surgery, or to reduce the stroke risk in patients with atrial fibrillation, an irregular heartbeat.
The makers of Xarelto have also applied with the FDA to approve the use of Xarelto for more treatments such as being prescribed to reduce the risk of heart attacks in patients with acute artery disease, but the FDA has denied Xarelto’s approval for such uses.
Xarelto works to stop the clotting process by inhibiting a protein called factor Xa, which is a protein involved in the process of coagulation, this in turn prevents the protein thrombin from forming. While most blood thinners require specific dosing for each individual user, Xarelto is prescribed in one uniform dose. Like most blood thinners, the usage of Xarelto comes with a risk of internal bleeding.
Xarelto® Usage Comes With Serious Risks
While previous blood thinner medications required regular doctor visits and alterations to a person’s lifestyle and dietary habits, Xarelto is sold and marketed as an alternative which does not require the constant check-ups and the drastic lifestyle changes.
These intended benefits do not come without certain risks though. Xarelto like many blood thinners can cause serious internal bleeding, but unlike other blood thinners Xarelto does not have an antidote for emergency situations. The lack of an antidote can cause the bleeding to become uncontrolled, and the manufacturers of Xarelto have yet to provide doctors with information on how to combat such a situation.
A double-blind ROCKET AF study coordinated by the Duke Clinical Research Institute and published in the New England Journal of Medicine compared Xarelto to warfarin. The study which included over 1400 patients concluded that while the effectiveness of the two drugs were similar, the instances of gastrointestinal bleeding and internal bleeding which required transfusion were more frequent with Xarelto.
The risks associated with Xarelto are numerous, but the most severe are those associated with internal bleeding. Side effects such as brain hemorrhage, gastrointestinal bleeding, kidney bleeding and fatal bleeding events can occur on Xarelto. There is also evidence that patients on Xarelto whom have spinal injections or epidurals are at a higher risk of forming blood clots in the spine which can lead to paralysis.