The third bellwether trial involving the metal-on-metal version of DePuy’s Pinnacle hip implant is underway. DePuy Orthpaedics and parent company Johnson & Johnson allegedly engaged in deception when marketing its hip implant product. On the first day of trial, attorneys for the plaintiff told jurors that J&J dodged standard regulatory review and misled physicians into thinking the device was safe.
J&J sold some 150,000 metal hip implants in the 2000s, Law 360 reports. Plaintiffs allege that the company failed to warn about the risks of the hip implants, which are allegedly defective in design. Lawsuits allege that the metal-on-metal design of the implant causes metal surfaces to rub against one another in the body. This can lead to metal poisoning, inflammation, tissue death and other complications, plaintiffs allege.
According to Law 360, the multidistrict litigation (MDL) contains 8,500 lawsuits. Previously, a $500 million verdict was awarded to the plaintiffs. The six plaintiffs are hoping that their case will have a similar outcome. Law 360 notes however, that this time the case uses California Law. This means that an award would not be subject to a punitive damages cap. This caveat lowered the earlier award to $150 million.
A “revision surgery”, in which the hip implant is removed due to complications, was performed in all six plaintiffs. They allege that injuries stem from the shedding of metal debris. J&J is accused of knowing about these risks but failing to inform patients or their physicians. Instead of notifying the medical community, plaintiffs allege, the company continued to aggressively market the device. The company is also accused of paying illegal kickbacks to certain surgeons.
The metal-on-metal version of the Pinnacle hip implant uses the Ultamet liner, which is made of metal as opposed to plastic or ceramic. Plaintiffs argue that this device was approved without any clinical testing due to a regulatory loophole. Hip implants are meant to last long-term, but attorneys for the plaintiff argued that the all-metal Pinnacle success rate was only 53 percent after 11 years. J&J had touted a 99.9 percent success rate but plaintiffs say this only referred to one of the Pinnacle system’s four components.
Metal-on-metal hip implants came under public scrutiny after DePuy issued a worldwide recall for its ASR hip implants in 2010. The hips were recalled due to a high failure rate, and subsequent high-profile recalls were issued among other companies in the aftermath. The safety concerns are all relatively similar; the hips can release metal debris, leading to early failure and revision surgery.