WHEELING, W.Va. (CN) - Johnson & Johnson and other makers of the DePuy Pinnacle metal hip-replacement system manufactured a product that led a woman to develop unsafe blood levels of cobalt and chromium, according to a federal complaint.
Delores Hatcher underwent a full left-hip-replacement surgery in November 2009. After her doctors implanted the DePuy Pinnacle metal-on-metal device, however, she experienced severe pain that hindered her ability to walk.
In April 2011, Hatcher's physician found high levels of meta-cobalt and chromium-1 in her blood.
Many orthopedic surgeons have stopped using metal-on-metal hip implants because they have been linked to dislocation, disarticulation and early failure rate, as well as tissue loss and bone damage caused by metallosis and biologic toxicity, according to the complaint.
The Medicines and Healthcare products Regulatory Agency in Britain investigated DePuy's hip replacements to evaluate the soft-tissue reactions and tumor growth of patients who had increased cobalt and chromium ion levels after receiving the implants, according to the complaint.
In addition to suing for product liability, Hatcher contends that DePuy and Johnson & Johnson, its parent corporation, concealed the defects of the hip replacements when marketing the products.
DePuy marketed "second generation" metal-on-metal implants as being more durable than previously sold metal-on-metal implants, which were widely used from 1960 to 1975 but abandoned after the Medical Device Amendments to the Food, Drug and Cosmetics Act of 1938 were passed in 1976.
The Pinnacle hip replacement did not go through the FDA's premarket-approval testing process, as required under the FDCA amendments, and was certified for sale on the basis of DePuy's claim that it was "substantially equivalent" to an older metal-on-metal implant DePuy sold prior to 1976.
In December 2009, the DePuy recalled over 90,000 units of its ASR metal-on-metal total hip replacement, a product similar to the Pinnacle, due to early failure, metallosis and cobalt toxicity.
Like the Pinnacle, the ASR was certified for sale by being "substantially equivalent" to an older device.
Hatcher also alleges unjust enrichment against DePuy and Johnson & Johnson, noting that the U.S. Attorney's Office charged the companies for aggressively marketing the metal-on-metal implants by paying illegal kickbacks to doctors and medical facilities.
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