Thousands of patients who say they’ve been seriously injured by Xarelto (rivaroxaban) filed lawsuits against drug companies for compensation. Others alleged their loved ones suffered fatal injuries as a consequence of taking the anti-clotting drug.
In all, more than 25,000 federal lawsuits have alleged the companies are getting rich off the “blockbuster” drug while putting American citizens at risk.” Lawsuits also claim the drug caused surgical wounds to develop leaks, infections and other problems.
Ongoing Litigation After $28M Award Reversal
Three federal lawsuits have gone to trial so far. All ended in victories for the drugmakers. In at least one case, the judge denied a plaintiff’s motion for a new trial. More than 22,000 lawsuits are still pending in a Louisiana federal court.
One state jury in Philadelphia in December 2017 ordered Xarelto makers to pay nearly $27.8 million to an Indiana woman for allegedly failing to warn about bleeding risks associated with their blood thinner.
The plaintiff, Lynn Hartman, 75, was hospitalized for gastrointestinal bleeding after using Xarelto for a year to treat atrial fibrillation.
The trial judge later overturned the verdict. Hartman’s attorney, Michael Weinkowitz, told the Philadelphia Inquirer that the ruling was based on a narrow issue relating to Hartman’s doctor. Hartman is appealing that decision to the Superior Court of Pennsylvania.
Xarelto lawsuits say people suffered from internal bleeding as a result of taking the drug. Lawsuits also say patients experienced hemorrhagic strokes, or brain bleeds, while taking Xarelto.
Other Xarelto claims include wound leakage, drainage or infection after a total hip or total knee replacement (arthroplasty) that required a return to the operating room.
Xarelto manufacturers deny claims that they did not warn patients of the risks of bleeding. In court documents, lawyers for Janssen Pharmaceutical and Bayer Corp. noted that the drug’s label makes more than 70 mentions of the possibility of bleeding, which is a serious side effect of Xarelto.
Litigation in state and federal court was ongoing in 2018. There have not been any major settlements announced to date.
Lack of Antidote Contributed to Risks
Lawsuits accuse Xarelto makers Janssen Pharmaceuticals Inc. (parent company Johnson & Johnson) and Bayer Health Care Pharmaceuticals Inc. (Bayer Corporation) of failing to adequately research Xarelto and then downplaying the serious risks for patients.
According to attorney Ellen Relkin, Xarelto has a narrow therapeutic index, meaning there is too small a window between a safe dose and a dangerous one. This makes it easy for a person to get too much or too little Xarelto.
“In other words, it can be safe at a certain point and dangerous within a very close range,” said Relkin, a Weitz & Luxenberg attorney who sat on a panel overseeing federal Xarelto litigation in Louisiana. “Someone can be 110 pounds or 200 pounds, old or young [and] with varying kidney functions and get the same dose and have a very different impact.”
People were also not aware that, until recently, there was no antidote for uncontrolled bleeding caused by Xarelto.
In 2018, the FDA finally approved the first and only bleeding antidote for Xarelto and other similar drugs, including Eliquis. But the reversal agent, called Andexxa, isn’t cheap. The drug’s wholesale cost is $27,500, and distribution has been limited.
In addition to these accusations, lawsuits claim the drugmakers failed to provide adequate warning that seniors are at an increased risk of Xarelto bleeds, as are patients with a history of gastrointestinal disorders.
Xarelto Makers Win Early Cases in MDL
More than 24,000 federal Xarelto cases have been consolidated in Louisiana in what is known as multidistrict litigation (MDL).
U.S. District Court Judge Eldon E. Fallon is overseeing pretrial proceedings and bellwether trials in the combined case, known as MDL-2592 IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.
Three Xarelto bellwether trials — test trials that may influence the outcome of remaining MDL cases — have resulted in wins for the manufacturers, meaning there have been no jury awards in federal court to people who were injured taking Xarelto. As of November 2018, there were 23,143 lawsuits pending in the MDL.
Joseph Boudreaux of Louisiana was the first plaintiff to have his case go to trial. The trial was held in April 2017.
The jury ruled in favor of Xarelto’s makers after listening to how the 75-year-old was prescribed Xarelto in 2014 to treat his heart condition, and subsequently suffered gastrointestinal bleeding that led to hospitalization and numerous blood transfusions.
After the verdict, lawyers for Boudreaux said that they were “disappointed, but would press on in similar cases,” according to Reuters.
Widower Joseph Orr’s case involving his wife, Sharyn Orr of Louisiana, was the focus of the second federal bellwether trial, which took place in June 2017.
Sharyn Orr died in May 2015 after taking Xarelto. Orr said drug companies were responsible for his wife’s death from hemorrhagic stroke (bleeding on the brain). She was in a coma for 10 days before she died.
The jury sided with Janssen and Bayer.
The third federal bellwether trial took place in Mississippi in August 2017. Plaintiff Dora Mingo had developed deep vein thrombosis after hip surgery. Doctors prescribed her Xarelto.
Mingo blamed the blood thinner for gastrointestinal bleeding and acute blood loss. Her lawsuit alleges that her doctor would have acted differently had the drug companies provided adequate instructions. The jury sided with Bayer and J&J.
Mingo asked the court for a new trial, claiming that information in a new study by Bayer scientists renders key defense testimony misleading and supports Mingo’s position on a key issue. Mingo said the information directly contradicts Bayer’s testimony that the anticoagulant effects of Xarelto can’t be monitored via standard laboratory testing. The court denied Mingo’s motion.
Cases for Similar Drug Resulted in $650M Settlements
Xarelto has not yet been the subject of any large-scale or public settlements. But similar cases involving Boehringer Ingelheim’s blood thinner, Pradaxa, ended with settlements.
Boehringer Ingelheim settled 4,000 Pradaxa lawsuits for $650 million in May 2014. The FDA reported that hundreds of people lost their lives to the drug and thousands complained of bleeding side effects similar to those seen in patients taking Xarelto.
Attorneys have referred to the Pradaxa cases as a possible model for Xarelto litigation and settlements. The size of Xarelto litigation has grown to more than four times the size of the Pradaxa litigation at the time of settlement.
There are currently no known class action lawsuits involving Xarelto.
Please seek the advice of a medical professional before making health care decisions.