Barbara Kaiser had surgery to implant the Prolift Anterior Pelvic Floor Repair System, a transvaginal mesh medical device that supports the pelvic muscles. Within a few years of her surgery, she began to experience severe pelvic pain, bladder spasms, and pain during intercourse. Her doctor attributed these conditions to contractions in the mesh of the Prolift. Kaiser had revision surgery to remove the device, but her surgeon could not completely extract it. The physician informed Kaiser that the painful complications she was experiencing were likely permanent.
Kaiser sued Ethicon Inc., Prolift’s manufacturer, and Johnson & Johnson, its parent company, seeking damages under the Indiana Products Liability Act.
After a two-week trial, a jury found Ethicon liable for defectively designing the Prolift device and choosing not to adequately warn about its complications.
The jury signed a verdict for $10 million in compensatory damages and $25 million in punitive damages; the punitive damages were reduced to $10 million. That would bring the jury’s total verdict to $20 million after the motion for remittitur punitive damages.
Ethicon’s appeal was a broad-spectrum attack on the judgment, starting with an argument about federal preemption and moving through several issues of the state’s product liability law, a claimed evidentiary error, and challenges to the compensatory and punitive damages. The 7th Circuit Court of Appeals in Chicago rejected these arguments and affirmed the jury’s verdict including the punitive damage award reduced to $10 million.
As background, Ethicon began marketing Prolift in 2005. The company included an “Instructions for Use” package insert that warned: “Potential adverse reactions are those typically associated with surgically implantable materials, including infection potentiation, inflammation, adhesion formation, fistula formation, erosion, extrusion and scarring that results in implant contraction.” Ethicon also cautioned that “[t]ransient leg pain may occur and can usually be managed with mild analgesics.”
It was found that patients were reporting serious problems with the Prolift. Relevant to this case, the mesh would often contract, causing severe pain and bladder problems. Scar tissue could also form around the device, preventing a complete removal if complications occurred. In these cases, Prolift’s complications frequently became permanent. Following years of complaints and FDA scrutiny, Ethicon took Prolift off the market in 2012.
Although the jury signed a verdict for $10 million for compensatory damages, the punitive damage award of $25 million was reduced to $10 million. The trial judge did grant Ethicon’s remittitur motion and reduced the punitive damage award accordingly.
Ethicon had argued that an award of punitive damages was unwarranted as a substantive matter and that the size of the award was excessive even after remittitur. The parties agreed that New Jersey law applied to this issue, which lays out a two-step process for awarding punitive damages. First, the jury must decide whether the defendant’s conduct warrants punitive damages, which requires the plaintiff to prove “by clear and convincing evidence” that the defendant’s acts or omissions caused the harm and were “actuated by actual malice or accompanied by a wanton and willful disregard of persons who foreseeably might be harmed.” The jury was instructed that when making a punitive damage determination they must consider four factors:
- The likelihood, at the relevant time, that serious harm would arise from the defendant’s conduct;
- The defendant’s awareness of reckless disregard of the likelihood that the serious harm at issue would arise … ;
- The conduct of the defendant upon learning that its initial conduct would likely cause harm; and
- The duration of the conduct or any concealment of it by the defendant.
In addition to these elements, the jury must consider “[t]he profitability of the misconduct to the defendant,” “[w]hen the misconduct was terminated,” and “[t]he financial condition of the defendant.”
There is an affirmative defense available for punitive damages which is known as the “FDA defense” that applies in two situations: (1) when the medical device at issue is “subject to premarket approval or licensure” by the FDA or (2) when the device “is generally recognized as safe and effective pursuant to conditions established” by the FDA.
The trial court, with the court of appeals affirming, stated that even under the heightened burden of proof as to punitive damages, on this record a reasonable jury could find that Ethicon acted recklessly when releasing Prolift and crafting its warnings.
Finally, the court of appeals, in affirming, stated that a reasonable jury could credit this evidence and conclude that Ethicon knew of the risk of serious complications and acted with reckless indifference by choosing not to warn surgeons. In the final note, the court of appeals stated that Ethicon objected that the punitive damage award was excessive even after the remittitur. That Ethicon raised this objection only in its reply brief and even then, the argument was undeveloped. The court stated that that was a waiver. See Harris v. Warrick County Sheriff’s Department, 666 F.3d 444, 448 (7th Cir. 2012).
Kaiser v. Johnson & Johnson and Ethicon, Inc., No. 18-2944 (U.S. Court of Appeals for the 7th Circuit, Jan. 14, 2020).
Kreisman Law Offices has been handling product liability lawsuits, hernia mesh defect lawsuits, transvaginal mesh medical device lawsuits and medical negligence cases for individuals, families and loved ones who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 40 years in and around Chicago, Cook County and its surrounding areas, including Mundelein, Berwyn, Stickney, Oak Lawn, Bridgeview, Elmwood Park, Evergreen Park, Riverside, Westmont, Willowbrook, Countryside, Chicago Ridge, Downers Grove, Aurora, Wheaton, Naperville, Winfield, Elk Grove Village, Mount Prospect, Northbrook, Lincolnshire, Vernon Hills, West Dundee, Chicago (Near West Side, Belmont Cragin, Jefferson Park, North Park, Ravenswood Manor, Andersonville, West Rogers Park, Near East Side, Grand Boulevard, Indian Village, Avalon Park, Pocket Town, Jackson Park Highlands, Parkway Gardens, Washington Park, Jackson Park, West Elsdon, West Lawn, Marquette Park, Roseland, West Pullman, Morgan Park, Altgeld Gardens, Eden Green, Riverdale), Calumet Park, Summit, Waukegan, Joliet, Forest Park, and Villa Park, Ill.
Robert D. Kreisman has been an active member of the Illinois and Missouri bars since 1976.
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