Johnson & Johnson (NYSE:JNJ) is appealing a $20 million verdict in a 2018 Indiana pelvic mesh trial, but a federal appeals court panel pushed back against the device maker’s argument this week, according to a published report.
J&J’s Ethicon subsidiary claims it was wrongly barred from presenting evidence from the FDA saying that its Prolift pelvic mesh device was safe and effective, said the report by Law360. The Seventh Circuit judges’ panel was hesitant to agree, given that other federal appellate courts have decided differently.
“We would be running upstream against other circuits reversing on that ground,” Judge Diane Sykes said during oral argument, Law360 reported. “Federal law did not prohibit your client from redesigning this implant to be safer and submitting a request for a safer design.”
Ethicon’s lawyers claimed the trial jury heard “one-sided fiction,” partly because the company wasn’t allowed to present the FDA findings. The jury found that the company negligently designed Prolift and then failed to warn healthcare providers and patients about its problems.
Indiana resident Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012, after learning that the Prolift mesh her doctor implanted in 2009 to treat her pelvic organ prolapse might be causing her low pelvic pain.
The lawsuit accused J&J and Ethicon of concealing the problems with Prolift, which allegedly include high failure, injury, and complication rates and “frequent and often debilitating re-operations,” according to the Kaisers’ complaint. Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” the complaint said.
The U.S. District Court for Northern Indiana jury awarded Barbara Kaiser $10 million in damages and $25 million in punitive damages in March 2018 but gave nothing to her husband. The trial court judge reduced the punitive damages award to $10 million.
“Excluding the FDA evidence in this case is equivalent to dropping a soldier in the middle of a battlefield with no weapon or even shoes,” Ethicon attorney Lisa Blatt told the appeals court panel, according to Law360.
Ethicon also claims that the trial judge should have used federal law requiring FDA approval for device designs as the standard for this case rather than Indiana’s design defect law, and therefore should have dismissed Kaiser’s lawsuit. The company also claims that Kaiser did not prove that the mesh was unreasonably dangerous, that a different design would have prevented her injuries, or that her surgeon failed to understand the device’s risks to patients, the report said.
The jury’s verdict “contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications,” J&J spokeswoman told MassDevice following the 2018 trial.