The case was filed by an Indiana woman who said she suffered a serious gastrointestinal bleed after using Xarelto. It was the first Xarelto verdict for a plaintiff. Juries in three previous federal multidistrict litigation trials in 2017 sided with the drugmakers.
Related: Xarelto Lawsuit
The Lynn Hartman case is one of more than 1,500 pending as part of mass tort litigation in the Philadelphia County Court of Common Pleas. Xarelto-related product liability claims were consolidated there, despite defense protests.
U.S. Patient Bleeding Events Misrepresented
Ms. Hartman’s trial centered around claims that J&J’s Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. failed to include vital information in Xarelto’s warning label. The companies were charged in the lawsuit with failing to properly report the rate of bleeding events observed in a clinical trial. The trial showed the rate was significantly higher among U.S. patients compared with patients elsewhere in the world.
According to evidence shown in the trial, the rate of bleeding events among people in the U.S. was 8.1 percent yearly versus 3.6 percent among people globally.
Ms. Hartman’s lawyers also accused the two companies of failing to adequately warn about the higher bleeding risks in using the drug with aspirin. They also charged that the companies failed to inform doctors that some patients end up with significantly higher levels of the medication in their blood than others.
Higher Risk than Elizuis, Pradaxa
The woman’s lawyers argued that adverse event risks linked with Xarelto were significantly higher than that of Xarelto’s competitors, Eliquis and Pradaxa.
“Xarelto is the worst in class of the new blood thinners,” argued Ms. Hartman’s lawyer. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks, and if patients were given the choice to switch to Eliquis and Pradaxa, which are safer and far more effective.”
Ms. Hartman’s case was supported by testimony from former FDA head David Kessler. He told the jury he believed that Xarelto’s warning label lacked key information concerning the severity of the drug’s potential bleeding risks.
Xarelto Defense Respose
The drugmakers’ lawyers focused Xarelto’s defense on the language included in the Xarelto label, which warned that Xarelto “can cause serious and fatal bleeding.”
The defense also pointed to testimony from Ms. Hartman’s doctor that she would not have changed her decision to prescribe Xarelto even with the additional information that she agreed (with the plaintiff) should have been included on the label.
Xarelto Verdict $28M
The case is Hartman v. Janssen Pharmaceuticals Inc. et al., case number 160503416, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
A Janssen spokeswoman said the company will appeal the verdict, which was not a shock to anyone, as no drug company has ever accepted any verdict against it without appealing to have it thrown out of court. Hence the importance of corporations lobbying and bankrolling state and D.C. beltway politicians who then work endlessly to stack the appeals courts against citizens and their rights.
According to court records, a second Xarelto case is scheduled for a trial in Philadelphia in January 2018.
Stay tuned. . .
- Xarelto Lawsuit
- Xarelto Dangers Rival Pradaxa
- Xarelto Maker, Marketer fight MDL
- Xarelto Makers win First Trial
- Pradaxa Lawsuit