A second trial in a Xarelto bleeding lawsuit recently started in hopes of a different outcome.

After the original $28.5 million verdict was overturned last year in post-trial motions in their Xarelto bleeding lawsuit, a second trial has begun in the Philadelphia County Court of Common Pleas. Plaintiffs in the case are hoping to earn a win and make it stick this time as they argue that Bayer Healthcare Pharmaceuticals and Johnson & Johnson’s subsidiary Janssen Pharmaceuticals failed to warn doctors about the internal bleeding risks associated with Xarelto.

Plaintiff Daniel R. filed the Xarelto bleeding lawsuit alleging he suffered a massive bleed after a seven day course of treatment with Xarelto. He claims he was prescribed Xarelto after he underwent emergency surgery for a blocked coronary artery and an irregular heartbeat in April 2013. He was prescribed aspirin, Plavix, Xarelto to prevent further clotting after he had a stent placed.

One week later he was admitted into the hospital with life threatening internal bleeding. He argues that the drug manufacturers knew combining Xarelto with certain antiplatelet medications could significantly increase the risk of internal bleeding but opted to keep the information out of the warning label.

“Who paid the price for their decision to remain silent? Dan did,” Daniel’s attorney said to the jury. “He paid that price when he nearly died after losing half of the blood in his body. All they had to do was tell people what they knew.”

Xarelto Risk with Other Drugs

During the time that Daniel was undergoing treatment, Bayer and Janssen were allegedly putting together a clinical study aimed at understanding the risk of Xarelto for patients also undergoing treatment with antiplatelet medication. However, Daniel’s attorney argues that participants in the study were on a lower dose than patients are typically prescribed because the risk was too great.

“The defendants made an intentional decision not to tell doctors in their labeling that Xarelto was too dangerous for a patient like Dan,” he said.

However, Bayer and Janssen argue that Xarelto’s label clearly states that there is an increased risk of bleeding events when prescribed with antiplatelet drugs. They also argue that the two doctors who prescribed Xarelto to Daniel testified that they knew about the risks about bleeding events but the risk was outweighed by the benefit of preventing a stroke. These testimonies were involved with the court overturning the first verdict in Daniel’s favor.

The manufacturers claim that they did not include the dosage recommendation in the label because there was no good data at the time that the label was written. “This is what a responsible company does,” the defense attorney said. “It says, ‘We’re going to give recommendations based on data and not just guess.’”

Daniel’s lawsuit is the fifth case that Bayer and Janssen have faced in state and federal courts regarding Xarelto bleeding side effects. Three federal cases in a multidistrict litigation program tried in Louisiana all recently ended in a defense verdict.

The Xarelto Bleeding Lawsuit is Case No. 150500362 in the Court of Common Pleas of Philadelphia County, Pennsylvania.