An all-metal version of DePuy Orthopaedics’ Pinnacle hip implant system has been named in over 900 product liability lawsuits by people who claim the device caused severe pain, dislocation of the hip implant, early hip replacement failure or the need for additional revision surgery. The DePuy Pinnacle hip implant lawsuits also allege that the metal-on-metal version of the device is similar in design to DePuy’s ASR hip implant, which was recalled in 2010, and should be recalled as well.
Last year, all federally filed DePuy Pinnacle hip implant lawsuits were consolidated in a multidistrict litigation before Judge James E. Kinkeade in the U.S. District Court for the Northern District of Texas (In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, MDL No. 2244). Leadership roles have been assigned to attorneys involved in the litigation, and a Special Master has been named by Judge Kinkeade. The next phase of the litigation will involve discovery and motion practice.
DePuy Orthopaedics, a division of Johnson & Johnson, also faces more than 3,500 lawsuits over the ASR hip replacement devices. Both the DePuy ASR Hip Resurfacing System and the DePuy ASR Acetabular System were named in a worldwide recall in August 2010, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it.
The DePuy devices, along with other metal-on-metal hip implants, have been raising serious safety concerns for several years now. Last May, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, including DePuy, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.
Late last month, The Sunday Telegraph reported that regulators in the United Kingdom are growing increasingly concerned that all-metal hip implant devices could be doing even more damage than once thought. Among other things, there are worries that increased cobalt and chromium levels in the blood could be toxic to kidneys and, in the case of pregnant women, be passed on to the unborn child.
In a separate report, The Sunday Telegraph revealed that a new study conducted at Bristol University had found that patients with metal-on-metal hips could be in danger of developing cancer. The study involved a review of 72 patients with all-metal hips. According to the researches, 17 exhibited genetic changes to the cells of the bladder, while 3 actually developed cancer. The concern is that the cellular changes could be a precursor to cancer. The study has yet to be published, and is currently udergoing data analysis.