Johnson & Johnson’s DePuy Orthopaedics subsidiary has been ordered to pay a combined $1.04 billion to six individuals who suffered serious complications associated with a metal-on-metal version of the Pinnacle Hip Replacement System. According to court documents, jurors agreed with the plaintiffs’ assertion their all-metal Pinnacle hips were defectively designed and that the companies failed to warn consumers about their serious risks.
The massive verdict followed a two month trial in the U.S. District Court, Northern District of Texas, where more than 8,600 similar DePuy Pinnacle lawsuits have been centralized for the purpose of coordinated pretrial proceedings. All six plaintiffs had experienced adverse local tissue reactions, bone deterioration and other debilitating complications following their hip replacement surgery, which they attributed to the Pinnacle’s all-metal design.
The trial was the third to conclude in the federal Pinnacle litigation. Another group of plaintiffs was awarded a total of $500 million in March at the conclusion of the proceeding’s second trial. However, the judge overseeing the trial ultimately reduced that award to $151 million, in order to comply with Texas law governing punitive damages. The first trial ended in October 2014 with a finding for the defense.
The latest judgment included more than $30 million in actual damages for the six plaintiffs and more than $1 billion in punitive damages. According to Bloomberg News, it was the third-largest verdict awarded by jury during 2016, while the punitive damages were the largest to be levied against any company this year. All six plaintiffs were residents of California, which places no cap on punitive damages.
“The jury is telling J&J that they better settle these cases soon,” one of the plaintiffs’ attorneys told Bloomberg. “All they are doing by trying more of these cases is driving up their costs and driving the company’s reputation into the mud.”
The implant at the center of the DePuy Pinnacle litigation is a metal-on-metal device that uses the Ultamet liner. In January 2013, the U.S. Food & Drug Administration warned that all-metal hips were associated with higher rates of early failure compared to hips with alternative configurations.
“In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect,” the FDA stated. “Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an ‘adverse local tissue reaction (ALTR)’ or an ‘adverse reaction to metal debris (ARMD).’”
The agency also warned that the metal ions shed from all-metal hips will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body.
In May 2011, DePuy Orthopaedics announced that it would phase out metal-on-metal hip implants, including the device named in Pinnacle hip lawsuits. According to The New York Times, the company cited slowing sales, as well as the FDA’s actions in regard to all-metal implants, as factors in its decision.