$775M Settlement to End ‘Virtually All’ 25,000 Xarelto Lawsuits

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Makers of the powerful blood thinner Xarelto have agreed to pay $775 million to settle about 25,000 lawsuits that claim the drug caused serious injuries such as internal bleeding, stroke and death.

“It may have taken more than four years and six separate trials but litigation like this is an important way for consumers to have a voice in matters of drug safety,” attorney Brian Barr, co-lead counsel for plaintiffs in the litigation, said in a news release.

Bayer and Johnson & Johnson jointly sell Xarelto and will each pay half of the settlement. Neither company admitted liability.

Bayer said the settlement will resolve “virtually all” of the approximately 25,000 lawsuits pending in state and federal courts across the United States.

In addition to resolving all existing lawsuits, the settlement covers a limited number of new claims. People may be eligible for the settlement if they retained a lawyer to investigate Xarelto-related personal injury claims before March 11, 2019, registered their claim by March 28, 2019, and file a lawsuit by April 4, 2019.

Under the settlement, 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.

Payments are also capped for anyone who spent two consecutive days or less in the hospital because of serious side effects of Xarelto.

“This is a fair and just resolution for thousands of consumers who have substantial claims,” Andy Birchfield, co-lead counsel for plaintiffs in the litigation, said in the news release. 

Bleeding Injuries Spurred Lawsuits

Xarelto lawsuits claimed the companies failed to adequately warn patients and doctors about the risks associated with the drug. They also claimed the companies aggressively marketed the drug as an alternative to warfarin for patients who need blood thinners to avoid dangerous clots.

A federal panel combined the first 21 Xarelto lawsuits into a mass litigation in December 2014. As of March 2019, patients or their survivors had filed 25,888 lawsuits in the litigation, and 23,534 of the lawsuits were still pending in a Louisiana federal court. Other lawsuits have been filed in state courts.

Bayer said in a statement that although it agreed to settle the lawsuits, it continues to believe the claims are without merit. Six trials over the drugs all ended in wins for Bayer and Johnson & Johnson.

“However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation,” Bayer said in its statement.

In a separate statement, Johnson & Johnson echoed Bayer’s sentiments and said it stands behind Xarelto. The company said it decided to settle because litigation demands an enormous amount of time and resources.

It also noted that news coverage of the litigation has confused and concerned patients while lawyer advertising may have caused deaths, strokes and other issues in patients who viewed the advertisements and stopped taking their medication as prescribed.

“[Xarelto] is the most studied medicine in its class in the world today and has been prescribed more than 40 million times,” Johnson & Johnson said in its statement.

Now that both sides have reached an agreement, a claims administrator and special master will be appointed to handle the claims process and any appeals, and will decide how the settlement payments will be distributed.

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Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Edited By

12 Cited Research Articles

  1. Bayer. (2019, March 25). Bayer Reaches Settlement to Resolve Xarelto Litigation. News Release. Retrieved from https://media.bayer.com/baynews/baynews.nsf/id/Bayer-reaches-settlement-to-resolve-Xarelto-litigation?Open&parent=news-overview-category-search-en&ccm=020
  2. Beasley Allen Law Firm. (2019, March 25). Settlement Reached Resolving Xarelto Multidistrict Litigation Claims. Cision PR Newswire. Retrieved from https://www.prnewswire.com/news-releases/settlement-reached-resolving-xarelto-multidistrict-litigation-claims-300817795.html
  3. Bellon, T. (2019, March 25). Bayer, J&J Settle U.S. Xarelto Litigation for $775 Million. Reuters. Retrieved from https://www.reuters.com/article/us-bayer-xarelto/bayer-jj-settle-u-s-xarelto-litigation-for-775-million-idUSKCN1R61O8
  4. Coppock, K. (2019, March 25). Litigation Resolved With $775M Settlement for Patients Prescribed Blood Thinner. Pharmacy Times. Retrieved from https://www.pharmacytimes.com/news/litigation-resolved-with-775m-settlement-for-patients-prescribed-blood-thinner
  5. Janssen Pharmaceuticals. (2019, March 25). Moving Forward for Cardiovascular Disease Patients and Their Doctors. News Release. Retrieved from https://www.janssen.com/moving-forward-cardiovascular-disease-patients-doctors
  6. Sagonowsky, E. (2019, March 25). What’s It Cost to Resolve 25,000 Xarelto Lawsuits? For Bayer and J&J, $775M. FiercePharma. Retrieved from https://www.fiercepharma.com/pharma/what-s-it-cost-to-resolve-25-000-xarelto-lawsuits-for-bayer-and-j-j-775m
  7. Thomas, K. (2019, March 25). Bayer and Johnson & Johnson Settle Lawsuits Over Xarelto, a Blood Thinner, for $775 Million. The New York Times. Retrieved from https://www.nytimes.com/2019/03/25/health/xarelto-blood-thinner-lawsuit-settlement.html
  8. U.S. Food and Drug Administration. (2011, July 1). FDA Approval Letter; NDA 22406 (Xarelto). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf
  9. U.S. Food and Drug Administration. (2018, December 31). FDA Adverse Event Reporting System (FAERS) Public Dashboard. Accessed March 26, 2018. Retrieved from https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard
  10. U.S. Food and Drug Administration. (2018, May 3). Accelerated Approval Letter (Andexxa). Retrieved from https://www.fda.gov/media/113285/download
  11. U.S. Judicial Panel on Multidistrict Litigation. (2014, December 12). In re: Xarelto (Rivaroxaban) Products Liability Litigation; MDL No. 2592; Transfer Order. Retrieved from http://www.laed.uscourts.gov/sites/default/files/xarelto/MDL%202592%20Xarelto%20transfer%20order.pdf
  12. U.S. Judicial Panel on Multidistrict Litigation. (2019, March 15). MDL Statistics Report. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2019.pdf
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