This article has been updated with a comment from Ethicon.
Despite the “flurry of arguments” in its appeal, the company failed to convince the three-judge panel that it should overturn the 2018 verdict in favor of Barbara Kaiser. (The jury awarded Kaiser $35 million, which the judge later reduced to $20 million.)
“Ethicon’s appeal is a broad-spectrum attack on the judgment, starting with an argument about federal preemption and moving through several issues of Indiana product liability law, a claimed evidentiary error, and challenges to the compensatory and punitive damages,” Seventh Circuit Court of Appeals Judge Diana Sykes wrote for the panel. “We reject these arguments and affirm.”
Kaiser had Prolift implanted in 2009 to treat pelvic organ prolapse, according to the decision. Within a few years, Kaiser began experiencing severe pelvic pain, bladder spasms, and pain during intercourse. Kaiser’s physician attempted to remove it but was unable to do so completely. Ethicon took Prolift off the market in 2012, following years of complaints and FDA scrutiny.
Ethicon started marketing Prolift in 2005 without applying for a 510(k) premarket notification from the FDA, because it believed the device didn’t depart materially from a transvaginal mesh product that the agency had previously cleared, Sykes wrote. Ethicon ultimately submitted 510(k) premarket application in 2007 when the FDA demanded one.
In its post-trial motions, Ethicon argued that the 510(k) process preempts a design-defect claim under Indiana law and that the state’s product liability law required Kaiser to present evidence of a reasonable alternative design for the device (she had none), and that the evidence otherwise failed to establish that Prolift was defective and unreasonably dangerous as required for liability.
Ethicon also argued that its warnings about the risks of Prolift were adequate and that Kaiser’s evidence stating Prolift caused her symptoms was insufficient. Ethicon moved for a new trial because the trial judge excluded of evidence of Prolift’s 510(k) clearance and his refusal to instruct the jury on a pair of “rebuttable presumptions” under Indiana product liability law, including the “state of the art” presumption. Finally, Ethicon challenged the jury’s award of compensatory damages and attacked the award of punitive damages as both substantively unwarranted and excessive.
In its appeal, Ethicon argued that the FDA’s 510(k) clearance of Prolift blocked it from updating the device’s labeling to warn patients and physicians of possible risks, as required by Indiana law. The appeals court disagreed, saying that no direct conflict between federal and state law exists. Kaiser was also not required to provide an alternative design, the panel said.
Ethicon also failed to convince the appeals court that the jury was wrong to find Prolift unreasonably dangerous, and that it gave surgeons and patients adequate warning of the product’s possible risks. The appeals court also denied the company’s motion for a new trial.
In an email to MassDevice, a spokeswoman for Ethicon said the company is considering its options regarding further appeal in the case.