On the first day of the third bellwether trial involving DePuy Orthopaedics metal-on-metal replacement hips, attorneys told the jury that the company avoided standard regulatory review and then convinced doctors that a dangerous design was safe.
In the early 2000s, DePuy, a unit of Johnson & Johnson, sold 150,000 metal-on-metal artificial hips, Law360 reports. This case being tried is one in an 8,500-case multidistrict litigation. The six plaintiffs in this case hope for a similar outcome to an earlier trial’s $500 million verdict. The current trial will use California law, and therefore any award would be not be subject to the Texas punitive damages cap the $500 million to about $150 million under Texas law.
All six plaintiffs in this trial needed “revision surgeries” after having a hip replacement with a DePuy metal-on-metal artificial hip. At the heart of this case are allegations that friction between the device’s metal socket and metal ball head releases microscopic metal particles with every movement. These particles can cause metal poisoning and can damage surrounding tissue, Law360 reports. Over time, wear on the device can cause device failure, resulting in the need for revision surgery. The plaintiffs’ attorneys argue that DePuy and Johnson & Johnson knew metal-on-metal hips were riskier than other available hip but nevertheless the company aggressively market the hips, and even used bribes and kickbacks to get doctors to use the hips.
DePuy was able to market the Pinnacle Ultamet hip — the one with the metal socket liner rather than polyethylene or ceramic liner — without any real clinical testing because the device was deemed similar to a device on the market before1976 regulations mandating premarket review, Law360 reports. This falls under the Food and Drug Administration’s 510(k) clearance process, a streamlined approval process for medical devices, which many experts say is not rigorous enough and allows dangerous devices to come to market. An attorney told the jury that the company “never solved any of the metal-on-metal problems. But they went to market anyway.” The only test, the attorney claimed, was on patients who had the Pinnacle Ultamet implanted.
Patients have reported that their Pinnacle hips have caused painful complications, including difficulty standing or walking; loosening of the hip implant; pain that spreads to the groin and/or back; tissue death; soft tissue damage; and metal poisoning.
Metal-on-metal hips like the DePuy Pinnacle are associated with high rates of failure and complications. Many recipients need additional surgery—revision surgery—to remove and replace a failed implant. DePuy recalled the similar ASR metal-on-metal hip and in 2013 the company set up a settlement program to resolve lawsuits filed by ASR recipients.
Attorneys for Johnson & Johnson objected to mention of bribes and kickbacks because the company had not been convicted of such charges; they requested a mistrial. But Judge Ed Kinkeade, who is presiding over the trial, denied the motion, Law360 reports.