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Xarelto Lawsuits

Xarelto users are suing Johnson & Johnson and Bayer Corporation, claiming they 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.

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Thousands of patients who say they’ve been seriously injured by Xarelto (rivaroxaban) filed lawsuits against drug companies for compensation. Others allege their loved ones suffered fatal injuries as a consequence of taking the anti-clotting drug.

In all, more than 20,000 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.

Status of Xarelto Lawsuits

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 Lawsuit Claims

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.

Accusations Against Xarelto Makers

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 were also not aware that – until recently – there was 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:
  • Use “due care” in the Xarelto’s development
  • Adequately test, research and study Xarelto
  • Provide adequate warnings about Xarelto safety risks, specifically uncontrolled, irreversible bleeding
  • Adequately warn that it is impossible to measure Xarelto’s affect
  • Warn patients and doctors about not having an antidote
  • Provide adequate warning that seniors are at increased risk of Xarelto bleeds
  • Adequately warn of the increased risk of gastrointestinal bleeds, especially in patients with a history of gastrointestinal issues
  • Adequately train health care providers about how to use Xarelto
  • Include a boxed warning — the FDA’s most serious warning — about serious bleeding with Xarelto
  • Inform the FDA, the health care industry and the public at large about dangers of Xarelto
  • Remove Xarelto from the market when they knew, or should have known, of side effects and injuries

Xarelto Multidistrict Litigation

More than 20,000 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 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 July 2018, there were 22,319 lawsuits pending in the MDL.

Plaintiffs include the following people:
Joseph Boudreaux
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.
Joseph Orr

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.

Dora Mingo

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 Settlements

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.

Pradaxa 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 Trials in Pennsylvania State Court

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.

Philadelphia City Hall
Philadelphia City Hall, where the first Xarelto bellwether took place

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.

Xarelto Class Action

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.

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15 Cited Research Articles

  1. U.S. District Court Eastern District of Louisiana. (2018, January 12). In Re: Xarelto (Rivaroxaban) Products Liability Litigation. MDL No. 2592. Amended Order. Retrieved from http://www.pacer.gov.
  2. U.S. Judicial Panel on Multidistrict Litigation. (2014, December 12). Xarelto (rivaroxaban) Products Liability Litigation. Transfer Order. Retrieved from https://www.unitedstatescourts.org/federal/nyed/360190/28-0.html
  3. Johnson & Johnson. (2016). Johnson & Johnson Reports 2016 First-Quarter Results: Sales of $17.5 Billion Increased 0.6% Versus 2015 First Quarter First-Quarter EPS was $1.54 Adjusted 2016 First-Quarter EPS of $1.68 increased 7.7%*. Retrieved from http://files.shareholder.com/downloads/JNJ/1922283046x0x886528/EE097E51-DF15-430F-923C-3C00865CD3D7/1Q2016_Final_combined_file.pdf
  4. Krajelis, B. (2013, January 10). Herndon reports steady progress in Yaz, Pradaxa litigation. The Madison-St. Clair Record. Retrieved from http://madisonrecord.com/issues/895-product-liability/251351-herndon-reports-steady-progress-in-yaz-pradaxa-litigation
  5. U.S. District Court for the Southern District of Florida. (2014 June 23). Nancy Packard v. Janssen Research & Development LLC, et al. Jury Demanded. Retrieved from https://www.unitedstatescourts.org/federal/flsd/444053/1-0.html
  6. Pierson, R. (2012, June 14). Pradaxa and Xarelto: Top Heart Doctors Concerned Over New Blood Thinners. Retrieved from http://www.huffingtonpost.com/2012/06/14/pradaxa-xarelto-blood-thinner-doctors-heart_n_1595971.html
  7. Raymond. N. (2017). Bayer, J&J win first trial over Xarelto bleeding risks. Retrieved from http://www.reuters.com/article/us-bayer-xarelto-idUSKBN17Z2HW
  8. Salvatore, C. (2017). Bayer, Janssen Win 2nd Xarelto Bellwether Trial. Retrieved from https://www.law360.com/articles/933887/bayer-janssen-win-2nd-xarelto-bellwether-trial
  9. Feeley, J. and Fisk, M.C. (2017, December 5). J&J, Bayer Ordered to Pay $28 Million in First Xarelto Loss. Retrieved from https://www.bloomberg.com/news/articles/2017-12-05/j-j-bayer-ordered-to-pay-29-million-in-first-loss-over-xarelto
  10. Skolnick, A.H. (2014, September 29). Know Your NOACs. Retrieved from https://www.medscape.com/viewarticle/831524?pa=Zj5OSUKEi9BsQ9jPpXbgrK9UUrbJh8blc6Z0azCcSXZAC8PnRzc3b6t5skoe7bBnNFsYxDuz%2Fz2hge3aAwEFsw%3D%3D
  11. Bellon, T. (2017, December 5). Jury orders Bayer, J&J to pay $28 Million in Xarelto lawsuit. Retrieved from https://www.reuters.com/article/us-bayer-xarelto/jury-orders-bayer-jj-to-pay-28-million-in-xarelto-lawsuit-idUSKBN1DZ2NH?il=0
  12. Mitchell, M. (2017, December 5). Phila. Jury Slams Makers of Xarelto with $27.8M Verdict. Retrieved from https://www.law.com/thelegalintelligencer/sites/thelegalintelligencer/2017/12/05/phila-jury-slams-makers-of-xarelto-with-27-8m-verdict/
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  14. By Antoine Taveneaux (Own work) [CC BY-SA 3.0 (creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons. Retrieved from https://commons.wikimedia.org/wiki/File%3APhiladelphia_City_Hall_7.jpg
  15. U.S. Judicial Panel on Multidistrict Litigation. (2018, July 16). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-July-16-2018.pdf
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