In a rush to bring Xarelto to market, drugmakers Bayer and Janssen Pharmaceuticals skipped needed testing that would have provided the basis for a more accurate warning label, plaintiffs counsel in the latest trial over the blood thinner told a Philadelphia jury Wednesday.
Pensacola, Florida, attorney Neil Overholtz of Aylstock, Witkin, Kreis & Overholtz told jurors during closing arguments in Cooney v. Janssen that, after learning about the efficacy and risks of a 20 milligram dose of the blood thinner, the defendants should have worked to develop a 10 milligram dose—a dose that Overholtz told jurors likely would not have caused the severe bleed that his client, Kevin Cooney, suffered while taking Xarelto.
“‘Comfortable enough,’” Overholtz said, citing a Bayer email about whether its researchers should perform additional testing. “Is that what we want from our drug companies when they have a chance to find out more information?”
The arguments came in the third Xarelto trial that has been held in state court in Philadelphia, where there have been somewhat mixed results. Although the first trial, which was held late last year, ended in a $28 million award, that verdict was set aside by the trial court. Earlier this year, another Philadelphia jury rendered a defense verdict.
According to court records, more than 1,900 Xarelto cases are pending in the mass tort program in the Philadelphia Court of Common Pleas. The parties are currently in the process of wading through 12 cases to determine which cases should go to trial next year.
Although some of the theories have differed slightly, all of the cases are based on claims that Bayer and Janssen failed to adequately warn about the dangers of the blood thinner.
Cooney involves a man who was prescribed Xarelto after he suffered a pulmonary embolism. Soon after he was prescribed the drug, he suffered a severe bleed where he lost nearly one-third of his blood.
Overholtz told jurors during his closing arguments that internal emails from Bayer, which initially developed the drug, showed that some researchers believed there should have been more studies aimed at lower doses of the drug. He said the company didn’t want to delay the drug’s launch, fearing it could lose out on as much as $4 billion. The company, he said, only decided to study the lower doses when it became clear that Eliquis, a competing blood thinner, was set to hit the market after Xarelto’s initial release.
Wilkinson Walsh + Eskovitz attorney Tamarra Matthews Johnson, who gave part of the closing arguments for the defendants, told jurors that Cooney had been in danger of suffering a fatal blood clot when he was prescribed the medication, and that his treating doctor properly weighed the risks of a serious bleed with the risk of another stroke. She also contended that the label adequately warned about the risks, and that the bleed Cooney suffered could have happened with any blood thinner.
Alexandra Walsh, also of Wilkinson Walsh, also told the jury that researchers had definitely considered additional testing of lower doses, and none of the emails were meant to be secretive. She said that any company would want to consider what additional testing may be needed, but, given the severity of the blood clots that Xarelto is meant to treat, the company did not feel that testing the efficacy of lower doses was needed at that time.
“When you push for a lower dose in patients with risk for [pulmonary embolism] and [deep vein thrombosis], people have more PE and DVT,” Walsh said.
In between the closing arguments, defendants made a motion for mistrial, saying the closing focused on theories regarding testing, rather than failure to warn, and that references Overholtz made to some defense witnesses having spoken in German prejudiced the jury.
Following the first trial, Bayer, citing social media posts and statements made during closing arguments, had argued that the plaintiffs counsel had attempted to link Bayer to Nazis in the minds of the jury. Although the verdict was later tossed for unrelated reasons, two lawyers were later punished for their social media posts.
On Wednesday, Judge Teresa Sarmina, who has overseen the three-week trial, denied the mistrial motion.