A federal jury in Miami has awarded nearly $27 million to four plaintiffs injured by vaginal mesh implants. The women argued that the Pinnacle implants were made from substandard materials and often eroded, causing pain and organ damage. Additionally, they presented evidence showing that the mesh had not been approved for use in humans.
The manufacturer of these implants is Boston Scientific Corporation. Boston Scientific is a Massachusetts-based company and the second-largest maker of heart-rhythm devices.
In the first federal trial for vaginal mesh implants, jurors found Boston Scientific had defectively designed the Pinnacle pelvic-organ implant. The jury also found the company did not properly warn physicians and patients about the risks. The jury awarded each woman from $6.5 to $6.7 million in compensatory damages.
One of the plaintiff’s attorneys said, “The evidence we presented showed that the company completely mishandled this product, and I think the jury’s damage award reflects that.” Plaintiffs had also provided evidence that officials within Boston Scientific called for more testing of the implant, but that executives ignored those warnings and instead rushed the device to market to increase its profits against competitors’ products. In 2011, the company took the Pinnacle implant off the U.S. market.
A spokesperson for Boston Scientific said the company did not agree that the implants had design flaws and disputed the fact that the company didn’t warn about the risks. Lawyers for the manufacturer had told the jury, “There’s no such thing as a risk-free surgery. Because somebody develops a complication, which they’ve been clearly warned of, that doesn’t mean there’s a defect with the product.” Boston Scientific says it has strong grounds to appeal the verdict.
This case was the first verdict in a federal trial against Boston Scientific over the Pinnacle implants. It was also the first case to include more than one plaintiff. Last year, a Texas state jury awarded $73 million to a woman who used one of Boston Scientific’s implants and alleged the device caused her constant pain. The trial judge reduced the verdict $34.6 million. In other state cases, the company has been able to successfully defend vaginal mesh implant suits.
The Miami Herald estimates there are currently more than 20,000 vaginal implant suits pending in state and federal courts, and in Canada and the U.K. courts, based on the company’s SEC filings.