January 23, 2013 — The first DePuy ASR hip implant lawsuit went to trial last week in California state court. Newly unsealed documents indicate that DePuy Orthopedics knew about serious problems with the ASR in 2008, but waited two years to issue a recall. Furthermore, an internal company analysis in 2011 found a 37% five-year failure rate, when the industry’s “acceptable” five-year failure rate is about 5%. The company is currently embroiled in a litigation involving more than 10,000 people who were implanted with the recalled hip implants, and plaintiffs’ lawyers have rejected the company’s offer to pay each plaintiff a $200,000 settlement.
DePuy learned about potential problems with the ASR in 2008, after clinical data showed “extreme” levels of metal ions in patients who were implanted with the ASR. This complication is one of the first indications that a hip implant is failing. However, DePuy officials did not recall the device. Instead, the company phased out production of metal-on-metal hip implants in 2009, and recalled the ASR in 2010. The ASR was implanted in about 93,000 people worldwide, and 37,000 people in the United States.
When DePuy recalled the ASR, they said it was because surgeons were replacing it at twice the industry average (approximately 10%). This estimate was less than data from the National Joint Registry of England and Wales, which found that the ASR Hip Resurfacing System and ASR XL had a 12-13% five-year failure rate. The 10% estimate was also significantly lower than the 37% five-year failure rate that DePuy reported in 2011. However, company officials caution that the data “was based on a small, limited set of data that could not be used to generalize.”
The evidence regarding DePuy’s knowledge of ASR problems was unsealed last week in the first personal-injury lawsuit to go to trial. The lawsuit was filed in California state court by a man named Loren Kransky, who was injured after his ASR hip implant failed within five years.
The problem with the ASR and other metal-on-metal hip implants is that the all-metal “ball and socket” design can grind together when a patient walks, shedding toxic particles of chromium and cobalt into a patient’s body. This metal debris can destroy tissue or bone around the implant. Cobalt ions can also leach into a patient’s bloodstream and cause metal poisoning (metallosis).
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