Xarelto users have sued Johnson & Johnson and Bayer Corporation, claiming patients suffered from internal bleeding, wound leaks and infections after taking the popular anti-clotting drug. Three trials ended in victories for the drug’s makers. One jury sided with a former Xarelto user, but the judge reversed that verdict.
Number of Lawsuits: More than 20,800
Plaintiff Injuries: Severe bleeding, blood clots, wound leaks and infections
Defendants: Janssen Pharmaceuticals Inc. (parent company Johnson & Johnson); Bayer Health Care Pharmaceuticals Inc. (Bayer Corporation)
MDL Location: Eastern District of Louisiana
Litigation Status: Ongoing
Notable Verdict: $27.8 million verdict for a former Xarelto user (later overturned)
Thousands of patients who say they’ve been seriously injured by Xarelto (rivaroxaban) have sued drug companies for compensation. Others have sued asserting that their loved ones suffered fatal injuries as a consequence of taking the anti-clotting drug.
In all, more than 20,800 federal lawsuits allege the companies are getting rich while putting “American citizens at risk of severe bleeds and death.” Lawsuits also claim the drug caused wound leaks and infections.
Wilson & Peterson is not currently accepting Xarelto cases. Other law firms are handling claims.
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.
Did You Know
A jury in December 2017 awarded a former Xarelto user $27.8 million, but a judge later overturned the verdict.
One state jury in Philadelphia in December 2017 ordered Xarelto makers to pay nearly $27.8 million to an Indiana woman for failing to warn about bleeding risks associated with their blood thinner. The judge later overturned the verdict.
Litigation in state and federal court was ongoing as of Jan. 25, 2018. There have not been any major settlements announced to date.
The judge overseeing thousands of federal Xarelto cases was slated to hear arguments on Jan. 30, 2018, over how to proceed with the cases that had not yet gone to trial. The parties submitted conflicting suggestions to the court.
Xarelto lawsuits say people suffered from internal bleeding as a result of taking the drug. Lawsuits also say patients had brain hemorrhage or experienced a bleeding type of stroke 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.
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.
People are also not aware that there is no antidote for uncontrolled bleeding caused by 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.”
Xarelto Lawsuits Say Drugmakers Failed to:
More than 20,800 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 MDL, known as MDL-2592 IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.
Bellwether trials are cases the court chooses so both sides can test their arguments. The results of these trials can influence the outcome of remaining cases in an MDL.
Three Xarelto bellwether trials have resulted in wins for the manufacturers, meaning there have been, as of yet, no jury awards in federal court in favor of people who were injured taking Xarelto. As of Jan. 16, 2018, nearly 19,800 lawsuits remained pending in the Xarelto MDL.
The federal judge presiding over the MDL was to decide how to proceed with the majority of the cases following a hearing Jan. 30, 2018. The parties had until Jan. 25, 2018, to file briefs detailing their suggestions for moving forward.
Plaintiffs include the following people:
Joseph Boudreaux of Louisiana was the first plaintiff to have his case go to trial. The trial was held in April 2017.
The jury heard how the 75-year-old was prescribed Xarelto in 2014 to treat his heart condition, and subsequently suffered gastrointestinal bleeding that led to his hospitalization and numerous blood transfusions.
The jury ruled in favor of Xarelto’s makers. 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 dying.
The jury sided with Janssen and Bayer.
The third federal bellwether trial took place in Mississippi in August 2017. Plaintiff Dora Mingo 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 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 information in a new study by Bayer scientists renders key defense testimony misleading and supports Mingo’s position on a key issue. Mingo argued 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.
Xarelto has not yet been the subject of any large-scale or public settlements. Yet, similar cases involving Boehringer Ingelheim’s blood thinner Pradaxa ended with settlements.
Boehringer Ingelheim in 2014 settled 4,000 lawsuits over its blood thinner Pradaxa (dabigatran) for $650 million.
Boehringer Ingelheim settled 4,000 Pradaxa lawsuits for $650 million in May 2014. The FDA reported hundreds of people lost their lives to the drug, and thousands complained of bleeding side effects in situations consistent with those seen in patients taking Xarelto.
Attorneys have referred to the Pradaxa cases as a possible model for Xarelto litigation and settlement possibility. The size of Xarelto litigation grew to more than four times the size the Pradaxa litigation was at the time of settlement.
Xarelto users and their families have filed more than 1,600 cases in Pennsylvania state court. Judge Michael Erdos is overseeing the cases in Philadelphia.
The first Xarelto trial in Philadelphia took place in November 2017 and ended in a $27.8 million award for the plaintiff, Lynn Hartman of Indiana.
The 75-year-old was hospitalized for gastrointestinal bleeding after taking Xarelto.
The jury determined Johnson & Johnson and Bayer failed to warn about bleeding risks with the drug and ordered the companies to pay $1.8 million in actual damages. Jurors added another $26 million in punitive damages.
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.
There are currently no known class action lawsuits involving Xarelto. However, nearly 20,000 federal Xarelto cases were transferred to a court in Louisiana under a multidistrict litigation (MDL).
Class actions and multidistrict litigations are different.
Members of a class-action lawsuit share the same settlement amount regardless of injuries. In an MDL, each plaintiff can choose to participate in the settlement. Plaintiffs who suffer more serious injuries may be eligible for more compensation than those with minor injuries.
Please seek the advice of a medical professional before making health care decisions.
Elaine Silvestrini is a career journalist with a strong desire to learn, explain, and help people. At Drugwatch, Elaine has reported about trials over whether talcum powder caused ovarian cancer and allegations that Androgel causes heart problems in patients who use it. She has chronicled the billions of dollars generated for big pharmaceutical companies by certain drugs and efforts to warn consumers about the dangers of specific medical problems. Elaine has received six health literacy certificates for completing courses offered by the Centers for Disease Control and Prevention. She brings more than 20 years of experience covering state and federal court systems, learning the intricacies of criminal and civil law, developing investigative pieces about how the law affects people’s lives and digging through and digesting reams of court records on a daily basis.