Xarelto users sued Johnson & Johnson, Janssen Pharmaceuticals and Bayer Corporation, claiming they suffered from internal bleeding, wound leakage and infections after taking the popular anti-clotting drug. The drug’s makers won six trials but agreed to settle thousands of lawsuits for $775 million in March 2019.
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 Americans at risk. Lawsuits also claim the drug caused surgical wounds to develop leaks, infections and other problems.
$775 Million Settlement
Johnson & Johnson and Bayer agreed in March 2019 to settle virtually all remaining Xarelto lawsuits for $775 million. As of April 2019, there were 23,866 lawsuits still pending in a Louisiana federal court. The cases had been combined there as part of a multidistrict litigation. More cases had been filed in state courts.
Each company agreed to pay half the settlement costs.
The settlement payments will vary from case to case under the agreement. Payments will be “substantially reduced” for people who were prescribed Xarelto on or after Dec. 1, 2015, or who first experienced an alleged Xarelto-injury on or before March 1, 2016, according to lawyers for the plaintiffs. The settlement also caps payments for anyone who was hospitalized for two consecutive days or less because of a Xarelto-related injury.
People who retained a lawyer for a Xarelto lawsuit prior to March 11, 2019, registered their claim by March 28, 2019, and filed a lawsuit by April 4, 2019 may still be allowed to join the settlement.
Under the terms, Bayer and Johnson & Johnson did not admit any liability. Both companies issued statements saying they stood by the safety of the drug. The companies also said they saw no point in continuing litigation.
Court Reversed $28M Award
Six lawsuits went to trial. All ended in victories for the drugmakers. In at least one case, the judge denied a plaintiff’s motion for a new trial.
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.
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.
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 25,000 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.
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.
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