Casting aside Ethicon’s “broad-spectrum attack on the judgment,” the 7th US Circuit Court upheld a $20 million verdict to a woman who was permanently injured by the company’s Prolift pelvic mesh device.
Ethicon appealed in Barbara Kaiser v. Johnson & Johnson and Ethicon, Inc., No. 18-2944. An Indiana state jury had awarded $35 million to Barbara Kaiser on March 8, 2018 for negligent design defect and negligent failure to warn about the dangers of the mesh. The trial judge reduced the verdict to $20 million.
It was the latest in a long string of jury verdicts. Kaiser had the mesh implanted in January 2009. Afterwards she experienced 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 sued in March 2012. She claimed the defendants offered exaggerated and misleading information about the safety of Prolift. The device was later taken off of the market in 2012 following years of complaints and U.S. Food and Drug Administration scrutiny.
Ethicon’s “Kitchen Sink” Appeal faces
The company threw in every legal argument plus the kitchen sink in its appeal, 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,” the court said.
The 7th Circuit was not impressed, criticizing Ethicon’s “flurry of arguments,” and “its highly generalized statements fall far short of satisfying the legal standard.”
“One issue in particular warrants special mention upfront,” Circuit Judge Diane Sykes wrote for the 7th Circuit, that the plaintiff does not have to produce evidence of a reasonable alternative design for the product. It applied TRW Vehicle Safety Sys., Inc. v. Moore, 936 N.E.2d 201, 209 (Ind. 2010), which specifically rejected an alternative-design requirement.
The court also held that the plaintiff’s state-law judgment was not preempted by federal law. Ethicon started marketing Prolift in 2005 and in 2007 submitted a 510(k) premarket application for Prolift when the FDA demanded one. The trial judge rejected Ethicon’s argument that the federal regulatory scheme preempted Indiana law, and the 7th Circuit affirmed.
The 7th Circuit ruled that “On this record a reasonable jury could conclude that Prolift was unreasonably dangerous.”
“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.”
Ethicon’s many losses in the courtroom
A total of 1,213 lawsuits against Ethicon have been consolidated before US District Judge Joseph R. Goodwin in MDL 2327, IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation.
Of all the mesh manufacturers, J&J’s Ethicon has been the slowest to offer settlements, despite many losses in the courtroom, most notably a 2019 verdict from a Philadelphia jury that awarded $120 million:
In February 2013, Johnson & Johnson lost the first bellwether trial involving its transvaginal mesh implants. A New Jersey jury returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift. Linda Gross claimed that she required 18 revision surgeries after receiving the mesh implant.In September 2014, Johnson & Johnson’s Ethicon Inc. unit lost a $3.27 million verdict to a West Virginia woman who claimed she was injured by the company’s Gynecare TVT Obturator, or TVT-O, transvaginal mesh device.In December 2015, Johnson & Johnson lost a $12.5 million verdict to a woman who claimed she was injured by the company’s Prolift implant. Patricia Hammons claimed complications from the device forced her to have multiple revision surgeries.In August 2017, Peggy Engleman filed a lawsuit against Ethicon and claimed the company’s TVT-Secur mesh caused serious complications including infections, bleeding and severe pain. A jury awarded her $20 million.In December 2017, a New Jersey jury awarded $15 million to Elizabeth Hyrmoc. The jury awarded $4 million for pain and suffering, $10 million for punitive damages and $1 million for loss of consortium.In January 2019, a Philadelphia jury awarded $41 million to Suzanne Emmett and her husband, Michael. The award included $25 million in punitive damages. She had Ethicon mesh implanted in 2007 and had multiple revision surgeries for bleeding, infections and painful sex.In April 2019 a Philadelphia jury awarded $120 million to Susan McFarland, including $100 million in punitive damages. McFarland had a strip of TVT-O mesh implanted in 2008. She had surgery that did not alleviate pain and constant urinary tract infections. She has not been able to have sex since she received the implant.In May 2019, a Philadelphia jury awarded $80 million to Patricia Mesigian, $50 million of which was for punitive damages. Mesigian had a Prolift implanted in 2008. The mesh eroded tissue and caused pelvic pain, inflammation and infections.
Ethicon does have some success in court. In April 2014, Linda Batiste won a $1.2 million state lawsuit against Johnson & Johnson. A Texas jury found that the mesh bladder sling that Batiste received was defective. Batiste claimed the sling eroded inside of her, causing severe pain and medical problems. An appeals court judge later overturned the verdict, saying Batiste failed to prove that the sling caused her injuries.