The second round between DePuy Synthes and patients implanted with the company’s metal-on-metal hip, the Pinnacle, has gone to the plaintiffs. Each side has now won a federal court victory.
On March 17, 2016, following a two-month trial and one week of deliberation, a jury found that the hips were defectively designed, and that the company failed to warn the public about the risks. The jury then awarded five Texas patients $140 million in total compensatory damages and $350 million in punitive damages.
The company said it will appeal the award.
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.
The five Texas patients argued that design flaws caused the device to fail more frequently and quickly than expected, leading to injuries including tissue death, bone erosion and high levels of metal in their blood.
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.
The company stopped selling the device in 2013, the same 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.
While not binding on the remaining 8, 000 Pinnacle lawsuits consolidated in a Texas federal court, the verdicts help gauge the value of the remaining claims. If the DePuy Synthes attorney is right and punitive damages are reduced to $10 million for the five plaintiffs, that’s still $30 million per patient. If the company settles with the Pinnacle patients at the same level as the ASR patients, that settlement could top $2.5 billion.
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.
