U.S. District Judge Ed Kinkeade, who is overseeing multidistrict litigation over the DePuy Orthopaedics Pinnacle hip implants, has refused to stay further trials pending the appeal of a $497.6 million verdict.
Judge Kinkeade has issued an order designating seven bellwether cases to be prepared for trial starting September 6, 2016, Law360 reports. These cases are part of a multidistrict litigation (MDL); the rest of the cases in the MDL are on hold until after the trials.
In late May, DePuy and Johnson & Johnson, the parent company, asked Judge Kinkeade to pause the bellwether trials pending the outcome of the appeal of a number of issues they say will have a significant effect on how the rest of the cases are tried, Law360 reports. An attorney involved in the appeal said J & J and DePuy are concerned that continuing with trials before the appellate review of those issues is done “will undermine the efficiency and fairness of the MDL proceeding.”
Metal-on-metal hip devices, like the DePuy Pinnacle, introduced to the market as more durable than older designs and affording a greater range of motion, have instead been prone to high early failure rates and other problems. Metal-on-metal hips from manufacturers including DePuy, Stryker, Wright, and Smith & Nephew are now the subject of thousands of lawsuits. Metal-on-metal hips have exhibited higher than expected failure rates and higher rates of revision surgery—surgery to correct or remove and replace the device—than hip replacement devices made of other materials. Revision surgery is often more difficult for the patient and less successful than the original surgery because of bone and tissue damage caused by the defective implant.
Among the complications allegedly caused by Pinnacle hips are:
- difficulty standing or walking
- limited mobility
- loosening of the implant
- severe pain that spreads to the groin and/or back
- tissue death or soft tissue damage
- elevated levels of cobalt and chromium ions
- bone loss or damagw
- fluid collection (pseudotumors)
- revision surgery (second surgery needed to correct or replace implant)
In April 2015, the Food and Drug Administration (FDA) issued an advisory describing the concerns about MoM hips. Health agencies including the FDA, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, and Australia’s Therapeutic Goods Administration have all issued health advisories for these devices. Recommendations include regular blood testing for metal ions in the blood stream of metal-on-metal hip recipients.
The verdict under appeal was delivered on March 17, 2016. A Dallas jury found in favor of all five plaintiffs in the trial and the verdict included $360 million in punitive damages, according to Law360. The jury agreed with the plaintiffs’ failure-to-warn and design defect claims, for which the jury held both J&J and DePuy liable. The trial consolidated the claims of five plaintiffs who had all undergone hip replacement with a DePuy Pinnacle hip device. The plaintiffs said their DePuy hips caused serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition caused when the hip’s metal components rub against each other and shed metal debris into the bloodstream.