Ethicon Women’s Health & Urology, maker of the Gynecare Prolift Pelvic Floor Repair System, is appealing an $11 million verdict awarded to a South Dakota women injured by the defective mesh implant.
According to the company’s lawyers, the damages should be stricken because of the learned intermediary doctrine.
The case took place in Atlantic County, where a jury decided on $3.35 million in compensatory damages and $7.76 million in punitive damages to Linda Gross.
Gross’ attorney argued against the premise that the duty to warn a patient about a pharmaceutical is entirely that of the surgeon. Instead, the duty should fall on the manufacturer.
“The problems with the product were known from day one,” Adam Slater said in the journal story, titled “Appeals Court Hears Arguments Over $11M Pelvic Mesh Verdict.” “There was no learning curve, no ambiguity within the company.”
Slater is right. The Gynecare Prolift Pelvic Floor Repair System has been linked to a growing number of adverse events reported to the U.S. Food and Drug Administration. The device often is proscribed for pelvic organ prolapse, or POP, as well as urinary incontinence. Although minimally invasive (it is implanted through the vagina), the product leads to litany of problems including bleeding, infection and organ perforation caused by the erosion of the mesh over time.
Gross had 20 corrective surgeries to try to fix the damage.
“Her body has been decimated,” Slater said.
His defense: Officials at Ethicon Women’s Health & Urology knew about the defects and failed to adequately warn the public, and he strongly stated so in his litigation.