A Texas jury returned a massive verdict—nearly $500 million—in a bellwether trial brought over DePuy Orthopaedics’ Pinnacle metal-on-metal hip implant device. The bellwether included five plaintiffs who were awarded approximately $360 million in punitive damages and about $130 million in compensatory damages. This is the second bellwether brought against Johnson & Johnson, the parent company of DePuy Orthopaedics.
The five cases were consolidated for this bellwether in the U.S. District Court for the Northern District of Texas. The multidistrict (MDL) is in the same court; U.S. District Judge Ed Kinkeade is presiding on both the bellwether and the MDL.
The five bellwether plaintiffs alleged that their DePuy Pinnacle metal-on-metal hip implant devices failed. They also allege to have endured significant health problems, including bone erosion, inflammation of surrounding tissue, and metallosis (metal poisoning). On January 8. 2016, Judge Kinkeade ruled 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,” Law360 reported. Plaintiff allegations also included that DePuy Orthopaedics neglected to warn that the Pinnacle could cause problems, including pain, implant loosening, tissue damage, and metallosis.
As the name suggests, metal-on-metal hip implants consist of all-metal surfaces. Federal regulators have advised that metal ion testing be conducted in some patients to determine whether the implant device has failed. Adverse reactions allegedly associated with metal hip devices 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.
During this bellwether, 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—as well as more than 10 mistrial requests. All requests were denied. Meanwhile, 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. Following jury selection, the trial lasted two months of trial days, which were followed by several days of deliberations.
J&J previously faced litigation over another of its metal-on-metal hip devices, the ASR, which was recalled in August 2010. When metal-on-metal hip devices were released to the market they were advertised as being more durable and better suited for younger, more active patients. In recent years, metal-on-metal hip implant safety has led to significant controversy and mounting concerns that metal hip implants shed metal debris when the surfaces of the implant rub together during normal activities, such as walking.
Many lawsuits have also included allegations that metal-on-metal hips were not clinically tested. In August 2015, the U.S. Food and Drug Administration (FDA) sought to change this by mandating device makers to go through a stricter approval process before metal-on-metal hips are released. In the United States, device makers may seek FDA clearance through what is known as a 510(k) application if that device is substantially similar to another 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. Johnson & Johnson has since halted sales of the metal-on-metal version of the Pinnacle device following the FDA decision.