Philadelphia Jury Hands Bayer & Janssen Defense Win in Xarelto Litigation
The verdict marked the second straight defense verdict out of Philadelphia for drugmakers Bayer and Janssen Pharmaceuticals, which saw similar wins in a string of cases tried last year in federal court.
August 30, 2018 at 02:36 PM
5 minute read
A Philadelphia jury has handed up a defense verdict in the latest trial over the adequacy of the warning labels for the blood thinner Xarelto.
The verdict marked the second straight defense verdict out of Philadelphia for drugmakers Bayer and Janssen Pharmaceuticals, which saw similar wins in a string of cases tried last year in federal court. The decision Thursday was rendered after three weeks of trial, and less than a day of jury deliberation.
In statements emailed Thursday morning the defense companies said the verdicts underscore the safety of the drug and its warning label.
“Plaintiffs' attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims have ultimately been rejected under applicable laws,” Bayer spokesman Dan Childs said.
“The jury's decision affirms that the FDA-approved labeling for Xarelto adequately informs doctors of the potential risks and benefits of this important life-changing medicine,” Janssen spokeswoman Sarah Freeman said.
Wilkinson Walsh + Eskovitz attorneys Alexandra Walsh and Tamarra Matthews Johnson and Mike Zellers from Tucker Ellis represented the defendants during trial. Neil Overholtz of Aylstock, Witkin, Kreis & Overholtz, Ellen Relkin of Weitz & Luxenberg and Brad Honnold from Goza & Honnold tried the case for Cooney.
In a statement emailed Thursday, Overholtz said, “We are disappointed in the verdict but believe the evidence presented showed that Bayer and Janssen rejected requests of the FDA and outside experts to study the lower safer dose of Xarelto for a decade for economic reasons. Instead the evidence showed that dosing decisions were driven by investor relations and profit concerns instead of patient safety.”
In addition to the two defense verdicts out of Philadelphia state court, the defendants won three defense verdicts in federal court trials. The only plaintiffs win so far, which was a $28 million verdict awarded late last year, was later tossed out by the trial court.
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 that have been presented at trial have differed slightly, all of the filed cases are based on claims that Bayer and Janssen failed to adequately warn about the dangers of the blood thinner.
Thursday's verdict comes in a case involving Kevin Cooney, who suffered a severe bleed while taking the blood thinner, which had been prescribed after he suffered a pulmonary embolism.
During closing arguments Wednesday, Overholtz told jurors that, in a rush to bring Xarelto to the market, the drugmakers had failed to perform needed testing of lower doses of the drug. He argued 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, 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?”
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.
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.
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.
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