On Tuesday, a Philadelphia jury awarded a $28 million verdict to a woman who developed gastrointestinal bleeding while taking the popular blood thinner Xarelto. Though many have claimed similar injuries, this Xarelto verdict is the first of its kind.

Manufactured and distributed by Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc., Xarelto is used by more than 30 million patients in 130 countries to treat and prevent life-threatening blood clots.

But while the drug has been effective for many people, some have experienced serious bleeding side effects that have led to lawsuits.

The Xarelto Verdict

Xarelto Case Specifics

  • Hartman v. Janssen Pharmaceuticals Inc. et al.
  • Case number 160503416
  • Court of Common Pleas of Philadelphia County, Pennsylvania

The case centers around Lynn Hartman, a woman from Indiana, who developed gastrointestinal bleeding while taking Xarelto. The Xarelto verdict includes nearly $2 million in compensatory damages and $26 million in punitive damages.

The charges include strict liability, defects in manufacturing and design, failure to warn, negligence, breach of express warranty, breach of implied warranty, misrepresentation, fraud, and violation of consumer protection laws.

This isn’t the first time Bayer AG and Johnson & Johnson have been to court over Xarelto’s risks. It is, however, the first win for an injured patient. The companies won three previous bellwether trials when juries in the federal multidistrict litigation were in favor of the manufacturers.

The jury in Philadelphia examined a few key issues:

  • Xarelto's label says it “can cause serious and fatal bleeding.” Though the drug labeling does indicate an associated risk of bleeding, the courts have argued the warning is inadequate.
  • A global Xarelto clinical trial found a higher rate of bleeding for patients in the United States, 8.1 percent compared to 3.6 percent annually.
  • The trial also brought to light how the drug mixes with aspirin.
  • The attorneys also mentioned some patients having higher levels of medication in their blood.
  • The attorneys advocating for Harman claimed Xarelto is more likely to cause adverse events than comparable options like Eliquis and Pradaxa. The drugmakers argue there is no evidence indicating that.

David Kessler, the former FDA commissioner, said he believes doctors should have been informed about the higher risk of bleeding adverse events in the United States. He said the information is important, according to Law360.

“They did not adequately notify physicians that some patients are at higher risk than others,” Kessler said. “That’s what I believe.”

“I would want to know about it. It’s a clinically significant adverse event, it’s a demographic characteristic, and it should be on the label.”

Hartman’s physician was called to testify by the defense attorney. The physician claimed that Hartman wouldn’t have done anything differently had she known the risks. Because she never received the risk information, it's difficult to say whether she would have changed her mind.

There are more than 1,500 product liability claims in the Philadelphia County Court of Common Pleas mass tort. The mass tort consolidates the claims. There are also more than 18,500 pending cases in federal multidistrict litigation at the U.S. District Court for the Eastern District of Louisiana.