July 12, 2012 — Johnson & Johnson’s DePuy Orthopedic unit manufactured the Pinnacle metal-on-metal hip implant as a successor to the DePuy ASR, which was recalled in 2010 amid safety concerns. As the ASR litigation wraps up, Pinnacle lawsuits are mounting in courts around the nation — nearly 1,600 Pinnacle hip implant lawsuits have been filed.
Like the ASR, the Pinnacle hip implant is designed with a metal femoral head, which pivots inside a metal cup. The problem with this metal-on-metal hip implant design is that the scraping surfaces can shed toxic nano-particles of chromium, which corrode and release charged genotoxic cobalt ions. The chromium forms an irritating residue, while the highly-soluble cobalt ions leak into tissues, the bloodstream, and organs. Within less than five years, approximately 6% of people with metal-on-metal hip implants must undergo revision surgery due to pain, swelling, decreased mobility, metal poisoning, pseudotumors, or other side effects. It is unknown what long-term effect these metal particles have on a person’s health.
As scrutiny increases over the side effects of metal-on-metal hip implants, a survey form the American Academy of Orthopedic Surgeons found that doctors are implanting them far less frequently. Today, only 10% of hip implants are the metal-on-metal design.
Even so, at least 500,000 people in the United States have a metal-on-metal hip implant. Of these people, around 150,000 have the DePuy Pinnacle hip implant, and 37,000 have the ASR hip implant. J&J has already set aside $3 billion to deal with 3,000 ASR hip implant lawsuits. Because the Pinnacle has the same problems as the ASR, it is possible that J&J will face significant additional costs in dealing with the impending Pinnacle litigation.
Many people who have had problems with their Pinnacle hip implant have suffered enormously. Revision surgery can be very painful, debilitating, and expensive. Although J&J has reimbursed many people for their out-of-pocket expenses for the ASR recall, many people with defective hip implants have suffered for years. Multiple hip implant repairs can also cause severe physical trauma. Furthermore, it is unknown what long-term health complications could be caused by chromium or cobalt that remains in the body after the hip is replaced.
So far, J&J has claimed that the Pinnacle hip implant performs at least as well as other metal-on-metal hip implants. The company has refused to pay for revision surgeries for people whose Pinnacle hip implant failed. The Pinnacle is designed with a smaller femoral head, which is associated with a lower failure rate than the ASR.
There is no way of knowing exactly how many of the Pinnacle hip implants have failed — the U.S. lacks a program to monitor the performance of implantable medical devices. Furthermore, there are multiple Pinnacle designs, including plastic and ceramic. Journalists have been unable to isolate adverse events for the metal-on-metal Pinnacle hip implant from the FDA’s adverse event reporting system. Another issue is that DePuy will not say how many Pinnacle hip implants have been implanted, so it is difficult to estimate the failure rate.
The FDA has attempted to increase monitoring of metal-on-metal hip implants. They are requiring 31 different manufacturers to conduct safety studies, but the results of those studies could be up to a decade away. An FDA advisory panel met recently to discuss the future of metal-on-metal hip implants, and concluded that there was little reason to choose the metal-on-metal design over plastic or ceramic designs.
Do I have a DePuy Pinnacle Hip Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting DePuy Pinnacle hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by the DePuy Pinnacle hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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