January 23, 2013 — According to documents unsealed in a California state court trial last week, Johnson & Johnson knew about problems with the DePuy ASR hip implant in 2008, but waited two more years to officially recall the devices. Furthermore, in 2011, DePuy associated the ASR with a 37% five-year failure rate, which is significantly higher than the industry’s “acceptable” 5% five-year failure rate. Approximately 10,000 lawsuits have already been filed, and plaintiffs’ lawyers recently rejected DePuy’s offer of a $200,000 settlement per case.
The documents indicate that DePuy officials were concerned about “extreme” levels of metal ions in ASR patients in 2008. An elevated level of metal ions is one of the first symptoms that a metal hip implant is failing. Instead of recalling the device, DePuy phased out production of metal hip implants in 2009 and recalled their remaining stock of the ASR in 2010. By the time the ASR was recalled, nearly 100,000 people had been implanted with the device worldwide, including about 37,000 Americans.
After the 2010 recall, DePuy said the problem with the ASR was that it was failing at about twice the rate of the national average — approximately 10%. Around the same time, data from the National Joint Registry of England and Wales associated the ASR XL and the ASR Resurfacing System with a 12-13% five-year failure rate. Both these estimates were significantly lower than the 37% five-year failure rate DePuy found in 2011. According to DePuy, the failure-rate “was based on a small, limited set of data that could not be used to generalize.”
The documents were unsealed last week in California state court, in the first ASR hip implant lawsuit to go to trial. The plaintiff, Loren Kransky, filed the lawsuit in California state court after his hip implant failed within five years.
According to the U.S. Food and Drug Administration (FDA), the problem with metal-on-metal hip implants like the ASR is that they convey unique risks in addition to risks associated with plastic and ceramic hip implants. One problem is that the metal parts grinding together can shed toxic nano-particles of chromium and cobalt. This metal debris can destroy soft tissues and bone, leading to extreme pain, decreased walking ability, and failure of the hip implant. Increased levels of metal ions in a patient’s blood can also lead to metal poisoning (metallosis).
Do I have a Hip Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a defective metal 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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