Johnson & Johnson subsidiary Ethicon Inc. did not persuade the 7th Circuit Court of Appeals to reverse a multi-million-dollar verdict for a northern Indiana woman who was injured by a transvaginal mesh implant produced by the company.
A few years after having surgery to implant the mesh device known as Prolift, Barbara Kaiser began experiencing severe pelvic pain, bladder spasms and pain during intercourse. Although she underwent revision surgery to remove the device, it could not be completely extracted.
Kaiser’s surgeon informed her that the pain would be likely permanent. The device was later taken off of the market in 2012 following years of complaints and U.S. Food and Drug Administration scrutiny.
Kaiser sued Johnson & Johnson and Ethicon, and a jury found that she had established both her claims of negligent design defect and negligent failure to warn. It awarded her $10 million in compensatory damages and $25 million in punitive damages. Indiana Northern District Court Judge Phillip Simon, however, granted Ethicon’s motion for remittitur and reduced the punitive award to $10 million.
Ethicon appealed in Barbara Kaiser v. Johnson & Johnson and Ethicon, Inc., 18-2944, with arguments concerning federal preemption, Indiana product liability law, claimed evidentiary error and the compensatory and punitive damages. But calling Ethicon’s appeal a “broad-spectrum attack on the judgment” in a Tuesday decision, the 7th Circuit Court rejected the company’s arguments and affirmed the district court.
“One issue in particular warrants special mention upfront,” Circuit Judge Diane Sykes wrote for the 7th Circuit. “Our caselaw interprets the Indiana Product Liability Act to require a plaintiff in a design-defect case to produce evidence of a reasonable alternative design for the product. The Indiana Supreme Court disagrees. See TRW Vehicle Safety Sys., Inc. v. Moore, 936 N.E.2d 201, 2019 (Ind. 2010).
“The state supreme court’s decision controls on a matter of state law, so we apply TRW rather than our own contrary precedent,” Sykes continued. “… Sitting in diversity, we are required to follow TRW rather than our own cases to the contrary, which are not accurate interpretations of state law.”
On its other arguments, Ethicon alleged it could not independently redesign Prolift to satisfy its duties under the Indiana Product Liability Act because the federal § 510(k) regulatory scheme required it to seek FDA clearance before making any substantive changes to the device, therefore directly conflicting with its state duties.
The 7th Circuit disagreed, finding the requirements of the § 510(k) premarket notification process do not directly conflict with Indiana law under the principles announced in Wyeth v. Levine, 555 U.S. 555 (2009). It thus concluded Ethicon’s design-defect claim was not preempted.
Additionally, the 7th Circuit found that a reasonable jury could conclude Prolift was unreasonably dangerous and that, given the limited scope of the warnings in Prolift’s instructions for use, Ethicon breached its duty to warn surgeons of its risks.
“As a fallback, Ethicon asks us to reverse for a new trial, arguing that the judge failed to instruct the jury on two of the IPLA’s evidentiary presumptions and improperly excluded evidence of Prolift’s § 510(k) clearance,” the 7th Circuit wrote. “… Ethicon’s evidence in support of the presumption was thin at best.
“It presented no expert testimony on the issue, nor did it produce evidence of existing industry standards. Ethicon conceded that it hadn’t conducted any human trials before releasing Prolift, so it couldn’t present a safety record. Instead, it offered testimony that Prolift was generally an improvement over its predecessor.”
The panel therefore concluded that Ethicon’s highly generalized statements fell far short of satisfying the legal standard for the presumption, also finding Prolift’s § 510(k) clearance insufficient to support the presumption.
Lastly, Ethicon appealed its denied motion for remittitur of the jury’s $10 million award of compensatory damages. The 7th Circuit affirmed, however, noting that although the district judge’s use of the federal standard to review the jury’s award was legal error, the error was harmless and the damages award was not excessive under Indiana law.
As to Ethicon’s assertion that an award of punitive damages was unwarranted as a substantive matter, the 7th Circuit found no basis to disturb the jury’s conclusion. It also noted Ethicon’s argument that the size of the damages was excessive even after remittitur was raised only in its reply brief, and was ultimately underdeveloped.