Johnson & Johnson’s DePuy unit is facing its first trial of a lawsuit alleging that the metal-on-metal version of its Pinnacle hip implant is defective and caused serious injuries. According to Bloomberg, Kathleen Herlihy-Paoli alleged that the implant caused metal debris to be released into her bloodstream, leading to an infection and ultimately required surgery to remove the devices. Jury selection for the trial began on September 2nd.
There are over 6,000 similar lawsuits pending in court; they have been consolidated before U.S. District Judge Ed Kinkeade in Dallas. The Honorable Kinkeade will be presiding over the bellwether trial. Carl Tobias, a professor of product-liability law at the University of Richmond in Virginia, told Bloomberg that such trials have an important role in affecting the rest of the litigation. “The first trials in any of these consolidated litigations set the tone for the following cases,” he said. “If J&J loses the first couple of these Pinnacle trials, they better start seriously thinking about coming up with a settlement similar to what they signed off on for the ASR hips.”
Last year, J&J set aside $2.5 billion to settle 8,000 lawsuits alleging that its ASR metal-on-metal hips were defective. In August 2010, the company recalled 93,000 ASR hip implants worldwide due to reports showing that the hips failed at a rate of 12 percent in five years. However, internal documents show that the rate is higher at 37 percent in 4.6 years. The failure rate was 44 percent in seven years for Australia in 2012.
Herlihy-Paoli was implanted with two Pinnacle hip implants in 2009, Bloomberg reports. Court documents show that she complained of pain from the devices soon afterwards, and had them removed in 2011. Tests conducted before the devices were removed showed that “implants had released dangerous levels of cobalt and chromium into her bloodstream,” she stated in court filings. “Tests indicated that Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal,” Court filings indicate that when the surgeons removed the left implant, they “discovered the implant had turned black with metallosis,”
Like thousands of other metal hip recipients, Herlihy-Paoli accuses J&J continuing to sell the flawed device despite known about its risks. “In their continued marketing of the Pinnacle devices in spite of known deficiencies and defects, defendants’ actions were beyond all bounds of decency, were atrocious and of a kind utterly intolerable in a civilized society,” she alleged.