Each year more than 130,000 people die from a type of heart arrhythmia called atrial fibrillation. Up to six million people in the United States alone may be living with the abnormal heart rhythm, according to the Centers for Disease Control and Prevention.1
That’s why when the drug Xarelto was introduced in 2011 as a newer and safer way to reduce the risk of stroke and blood clots in those with atrial fibrillation, people were excited.
Patients quickly discovered Xarelto was not as safe as it seemed, as they became injured or died from unexpected side effects like severe bleeding. Now more than 20,000 federal lawsuits have been filed against the makers of the blood thinner over claims that they failed to warn the public about potentially deadly side effects.
Xarelto (rivaroxaban) is an anticoagulant jointly developed by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer.
The drug is taken orally and used to treat and prevent deep vein thrombosis (DVT)2, a condition in which blood clots are formed in blood vessels in the legs. It was first approved by the U.S. Food and Drug Administration in July 2011 to prevent DVT in patients undergoing knee or hip replacement surgery.
Then, in November 2011, it was approved to prevent strokes in people with atrial fibrillation.3 At that time, it was seen as a newer and better alternative to existing drugs like warfarin. Xarelto was perceived as safer than warfarin because although Xarelto has a similar risk of bleeding, patients bleed more into the stomach and intestines than the brain.
A year later in November 2012, the FDA expanded the use of Xarelto to treat and reduce the recurrence of blood clots.4 Its use was again expanded in October 2017 to reduce the continued risk of DVT and pulmonary embolism.
Due to the expansion of uses, Xarelto has become a highly profitable drug for Janssen and Bayer. According to Bloomberg, Xarelto generated $3.24 billion in sales for Bayer in 2016.5
Xarelto, like any drug, may have side effects.
Some of the more common side effects include (but are not limited to):
Since it was approved in 2011, Xarelto has been linked to incidence of internal bleeding.
In 2017, the Institute for Safe Medication Practices analyzed adverse event data collected by the FDA. The patient advocacy group found that new oral anticoagulants like Xarelto accounted for “large numbers of reported serious injuries and deaths in the U.S.”
In fact, Xarelto accounted for 15,043 cases of adverse events out of the roughly 22,000 reports. Hemorrhages accounted for the vast majority of those events.
The CDC also released a study the year before with similar findings. Adverse events related to anticoagulants were severe, with the majority of people requiring hospitalization. Using the information, the Institute for Safe Medication Practices estimated that 6.3% of people taking anticoagulants like Xarelto for 12 months would need to visit an emergency room.
Other studies have singled out Xarelto from competitors. In a 2016 paper published in JAMA Internal Medicine, researchers found a significantly increased risk of intracranial hemorrhage, major gastrointestinal bleeding, and mortality in those taking Xarelto compared to those taking competitor Pradaxa.6
Countless patients taking Xarelto have ventured into emergency rooms for unexpected side effects like lightheadedness and low blood pressure.
As a result, lawsuits against Bayer and Janssen have piled up.
According to one estimate, there are about 20,000 current lawsuits against the makers of Xarelto over allegations of severe bleeding, blood clots, and even death.
In one case, Joseph Boudreaux started taking Xarelto to help reduce his risk of stroke.5 Instead, it landed him in the hospital for internal bleeding. He had to have several blood transfusions and procedures on his heart.
Johnson & Johnson and Bayer have been accused of falsely marketing the drug as safer and more effective than competitors. Plaintiffs claim there is no antidote to stop bleeding in patients taking Xarelto. In contrast, several competing drugs have antidotes to slow uncontrolled bleeding.
In response, the companies claim that the label does warn of bleeding and that millions have used the drug without issue.
Despite the thousands of pending lawsuits, there has been no talk of a settlement.
The likelihood and value of a Xarelto settlement will likely become clearer after more bellwether cases have gone to trial. These test cases act as a bellwether to determine the strength of plaintiff’s claims against the makers of Xarelto.
The first three trials resulted in verdicts in favor of the drug manufacturers. The jury deliberated for hours in each case but ultimately did not agree with the claims that the plaintiffs’ injuries could have been prevented with adequate warnings and tests.7
In December 2017, a jury found in favor of the plaintiffs and ordered the companies to pay $27.8 million.8 However, a judge reversed the verdict upon appeal the following month because of an issue related to the prescribing physician.
Even though no settlement has been discussed, other cases involving similar anticoagulant drugs can give a picture of the possible value.
In May 2014, thousands of lawsuits were settled related to the blood thinner Pradaxa. Drug maker Boehringer Ingelheim agreed to pay $650 million after Pradaxa allegedly caused serious and occasionally fatal bleeding in patients.9
The Pradaxa settlement took place months before the first case was set to go to trial.
Even though thousands have already filed lawsuits against Bayer and Janssen, people continue to add their names to the list of those suing the companies.
According to Law360, the children of Florence Bourgeois filed a lawsuit in Louisiana where thousands of cases are already pending.10 They say Bourgeois bled uncontrollably and died as a result of taking Xarelto.
About 1,500 cases are currently pending in a Philadelphia court while an additional 19,000 are pending in federal court.
Those who have experienced adverse side effects from Xarelto are encouraged to contact an attorney to find out whether they have a case.
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