After two months of trial days and several days of deliberation, a Texas jury found in favor of five plaintiffs who alleged failure of DePuy Orthopaedic’s Pinnacle metal-on-metal hip device in the second bellwether trial brought against Johnson & Johnson. The massive award was for approximately $130 million in compensatory and $360 million in punitive damages.
The plaintiffs alleged that DePuy Pinnacle metal-on-metal hip implant device failure led to significant health problems, such as bone erosion, inflammation of surrounding tissue, and metallosis (metal poisoning). Law 360 reported that Judge Kinkeade ruled on January 8, 2016 that the five cases had significant common issues that should be consolidated for trial. All five plaintiffs underwent similar Pinnacle implant surgeries, “their doctors received similar warnings, and the patients all alleged similar injuries, according to his ruling.” The five plaintiffs also alleged DePuy Orthopaedics, an orthopedic unit at Johnson & Johnson, failed to warn that the Pinnacle could cause problems such as pain, implant loosening, tissue damage, and metal poisoning.
As the name suggests, metal-on-metal hip implants consist of all-metal surfaces. When the devices were first released to market, they were touted as being more durable and better suited for younger, more active patients. In recent years, however, the safety of metal-on-metal hip implants has been called into question and there have been significant concerns that metal hip implants shed metal debris when the implant surfaces rub together during normal activities, such as walking. An array of adverse reactions are allegedly associated with metal hip devices that include, but are not limited to, increased blood metal ion levels and metal poisoning; dislocations; pain; fracture; difficulty ambulating, rising, standing, and balancing; noise emanating from the joint; and pseudotumors.
Meanwhile, J&J has previously faced litigation over another of its metal-on-metal hip implant devices, the ASR, which was recalled in August 2010. Federal regulators have also advised metal ion testing in some patients to determine whether the implant has failed.
During the recent bellwether case, DePuy Orthopaedics called for numerous bifurcations (requests to divide the trial in two parts so as to render a judgment on a set of legal issues without looking at all aspects), and more than 10 requests for a mistrial. All requests were denied. Also, the plaintiffs’ legal team was able to show that the DePuy legal team had called forth a paid expert that had earned over $900,000 by consulting for the defendants.
Many lawsuits point out that metal-on-metal hips were not clinically tested before they were approved. In the United States, device makers may seek U.S. Food and Drug Administration (FDA) clearance through a 510(k) application if the device is substantially similar to a device that has already been approved. Under this speedier clearance route, device makers are only required to file paperwork with the FDA and pay a fee. In August 2015, the FDA sought to change this practice by mandating device makers go through a stricter approval process when seeking approval to release metal-on-metal hip devices. Johnson & Johnson halted sales of its metal-on-metal version of the Pinnacle device following this decision.