On July 5, 2016, a $650 million verdict against DePuy Synthes over its metal-on-metal Pinnacle hip implant was slashed by $500 million by a Texas federal judge.
However, the U.S. District Judge Ed Kinkeade, ruled a day later that a September trial in the ongoing multidistrict litigation will proceed.
The judge said that he was compelled to reduce the verdict under a Texas state law limiting punitive damages according to a specific formula.
This past March, following a two-month trial, five plaintiffs had collectively won a $360 million award for punitive damages, along with $140 million in compensatory damages. After the trial, John Beisner, an attorney for the company, reportedly said he expected the verdict to be a “pyrrhic victory for plaintiffs’ counsel” that could be slashed significantly. He said that appeals courts often reduce massive personal-injury verdicts, and Texas law limits the amount of punitive damages that can be awarded to plaintiffs. He estimated that punitive damages could be reduced to as little as $10 million.
In the first trial won by DePuy Synthes, the company argued successfully that the failure of the patient’s surgery was due to surgeon error related to the surgical positioning of the implants. After that verdict, legal experts said it would be hard for the company to make that argument in all cases.
8, 400 Lawsuits
There are roughly 8, 400 lawsuits over the Pinnacle devices, which plaintiffs say contain design flaws that cause them to fail. The lawsuits claim friction between the devices’ metal components can shed ions into the bloodstream, leading to injuries such as tissue death, bone erosion and high levels of metal in their blood.
The company has denied any wrongdoing in connection with developing and marketing the devices. DePuy Synthes stopped selling the device in 2013. That year, it paid $2.5 billion to settle more than 7, 000 lawsuits over another metal-on-metal hip device, the ASR, which was recalled in 2010.
Mark Lanier and Richard Arsenault, lead lawyers for the Pinnacle plaintiffs, reportedly said they disagreed with Texas’ cap on punitive damages but were pleased J&J’s bid for a new trial had been rejected. Beisner said the company is “confident that the trial verdict will be reversed on appeal.”
Metal-on-Metal and the FDA
The FDA cleared the Pinnacle hips for sale in the U.S. through the 510(k) process and the company began selling the product in 2005.
On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement systems to conduct postmarket surveillance study of the devices. Five manufacturers were marketing metal-on-metal hip implants in the U.S. and all five had approved postmarket surveillance study plans. Data from these studies provided patients and healthcare providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
