CHICAGO — Johnson & Johnson failed to escape a $20 million verdict awarded to a woman who claimed a surgically implanted pelvic mesh device caused bladder spasms and other problems.
A three-judge panel from the U.S. Seventh Circuit Court of Appeals issued an opinion on Jan. 14 in support of plaintiff Barbara Kaiser, who said Johnson & Johnson’s transvaginal Prolift Anterior Pelvic Floor Repair System, made by subsidiary Ethicon, caused severe pelvic pain, made sex painful and led to bladder spasms. Kaiser’s doctor said contractions in the Prolift’s mesh caused the conditions, but her surgeon could not fully remove the device.
Kaiser sued Ethicon in federal court in West Virginia, where a 28,000-case multidistrict litigation was pending. Her case was moved to Indiana's Northern District in Hammond over Ethicon’s objections, arguing federal regulations pre-empted the state law. A two-week jury trial resulted in an award of $10 million in compensatory damages and $25 million in punitive damages, though Judge Phillip Simon reduced the punitive award to $10 million.
Ethicon appealed, raising several points about Indiana products liability law, claiming an evidentiary error and challenging the damages.
Seventh Circuit Judge Joel Flaum wrote the appellate opinion; Circuit Judges Michael Kanne and Diane Sykes concurred. The panel noted precedent from the Indiana Supreme Court conflicts with the Seventh Circuit's prior holdings, as the state court doesn’t require plaintiffs in design defect cases, such as Kaiser's, to supply “evidence of a reasonable alternative design." But the state supreme court’s decision takes precedent in this case, the panel said.
Ethicon started marketing Prolift in 2005 to people suffering from pelvic organ prolapse. Kaiser’s surgery was in 2009, when she was 60 years old, and Ethicon took the product off the market in 2012 “following years of complaints and FDA scrutiny,” Flaum wrote.
On appeal, Ethicon said its state-law duty to ensure Prolift was safely designed conflicted with its federal law obligation to obtain FDA clearance, because the clearance request had to precede substantive changes to the device. The panel disagreed and said the opposite was true — Ethicon “lost independent control over Prolift’s design only after it received” FDA clearance. The panel drew a comparison to a company’s ability to strengthen warning label language for a brand name product without prior FDA approval, because the agency reserves the right to reject changes after they’re made.
The panel also said trial evidence allowed the jury to properly consider arguments from both sides regarding whether Prolift was unreasonably dangerous. Further, it determined instructions for Prolift had limited warnings, such that “a reasonable jury could conclude that Ethicon breached its duty to warn surgeons of its risks,” Flaum wrote. “Whether Ethicon breached its duty to warn was a question for the jury, and we see no reason to disturb its determination on this element of the claim.”
Although Kaiser’s surgeon said he might have recommended Kaiser use the device even if Ethicon had provided additional warnings, the panel noted he also testified he could’ve recommended another procedure that didn’t have the same risks of extrusion and erosion, but at the time he lacked “all the subsequent information about how some patients fared and how some complications occurred.” Again, the panel determined the trial jury was properly equipped to resolve the factual dispute.
The panel also rejected Ethicon’s call for a new trial, saying Judge Simon didn’t err in declining to give jury instructions concerning determinations of manufacturer negligence. Flaum wrote that Ethicon offered “highly generalized statements (that) fall far short of satisfying the legal standard” required to determine Simon erred. Simon also barred Ethicon’s evidence concerning FDA clearance for Prolift, saying the agency process “speaks to equivalency, not safety” and could have misled or confused the jury.
Finally, the panel said the compensatory damages award wasn’t excessive under state law given Kaiser’s corrective surgery and injuries, and the punitive damages also were appropriate, as “a reasonable jury could find that Ethicon acted recklessly when releasing Prolift and crafting its warnings.”
Johnson & Johnson and Ethicon were represented on appeal by attorneys Lisa S. Blatt and Sarah M. Harris, of the firm of Williams & Connolly LLP, of Washington, D.C.; Stephen D. Brody and Jason Zarrow, of O'Melveny & Myers LLP, of Washington, D.C.; Amy M. Pepke, of Butler Snow LLP, of Memphis, Tenn.; and R. Stanton Jones, William C. Perdue, Stephen K. Wirth and Samuel F. Callahan, of the firm of Arnold & Porter Kaye Scholer LLP, of Washington, D.C.
Kaiser has been represented by attorneys Edward A. Wallace, Mark R. Miller and Timothy E. Jackson, of Wexler Wallace LLP, of Chicago.