On Dec. 5, 2017, a jury in the Philadelphia Court of Common Pleas returned a unanimous verdict against the makers of Xarelto (Bayer and Johnson & Johnson’s Janssen Pharmaceuticals) in the amount of $27.8 million. The verdict for Plaintiff Lynn Hartman included $1.8 million in compensatory damages and $26 million in punitive damages.

After taking Xarelto for more than a year, Ms. Hartman, an Indiana resident, was hospitalized for severe gastrointestinal bleeding in 2014 that she attributed to Xarelto. The internal bleeding caused Ms. Hartman to lose nearly 40 percent of her blood volume and required her to undergo four blood transfusions. She spent several days in the hospital undergoing treatment for the internal bleeding.

At trial, in addition to proving that Xarelto caused her internal bleeding, Ms. Hartman’s lawyers presented evidence that Xarelto’s label failed to adequately warn about the risks of taking Xarelto with aspirin, which Defendants knew to increase the risk of bleeding by 93 percent. There was also evidence that Xarelto’s label failed to inform doctors that Xarelto’s clinical trials showed a 50 percent increased risk of bleeding for patients taking Xarelto in the U.S. compared to patients in other countries.

The Defendants relied on Xarelto’s U.S. Food and Drug Administration (FDA) approval as their primary defense to liability, but Dr. David Kessler, former commissioner of the FDA, told the jury that FDA approval is not a “get out of jail free card” for pharmaceutical companies. Dr. Kessler testified that it is Bayer and Janssen’s responsibility to include clinically significant data in Xarelto’s label to warn doctors of the full extent of Xarelto’s risks. He told the jury that Xarelto’s label understated the drug’s bleeding risks and failed to warn doctors that some patients have higher risks for bleeding on Xarelto.

After a month-long trial, the 12-person jury found that Bayer and Janssen were negligent with respect to Xarelto’s warning label and that their negligence caused harm to Plaintiff Lynn Hartman, awarding $1.8 million to compensate Ms. Hartman for her injuries. The jury also found by clear and convincing evidence that Bayer and Janssen engaged in willful and wanton misconduct, triggering the $26 million punitive damage award.

Ms. Hartman’s case was the first case tried in the Philadelphia Court of Common Pleas, where there are approximately 1,500 other Xarelto cases pending. Four additional cases are set for trial in March, April, May and June of 2018. The parallel multidistrict litigation (MDL) in the Eastern District of Louisiana now contains approximately 19,000 additional Xarelto cases. Andy Birchfield, the head of Beasley Allen’s Mass Torts Section, continues to serve as Co-Lead Plaintiff Counsel for the Xarelto MDL.

Beasley Allen lawyers continue to work in both the MDL and the Philadelphia litigations on behalf of thousands of individuals injured by Xarelto. If you need more information on this litigation, please contact Joseph VanZandt or Sonny Wills, lawyers in our Mass Torts Section, at 800-898-2034 or by email at Joseph.VanZandt@beasleyallen.com or Sonny.Wills@beasleyallen.com.

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