Internal documents released this week before the start of a trial in California Superior Court in Los Angeles reveal that Johnson & Johnson estimated a near 40 percent five-year failure rate for its DePuy ASR hip implant device.
The DePuy ASR all-metal hip implant was recalled in 2010 amid concerns over early failure, bone and tissue damage, metal toxicity, and the need for costly and complicated surgery to replace failed devices, according to The New York Times. The California trial is the first of over 10,000 lawsuits brought by people who received ASR implants. What DePuy Orthopedics officials knew about the device’s problems prior to the recall and what actions they took or failed to take are crucial questions. DePuy has already settled a few ASR cases and, the Times said, it may settle the California case as well.
About 93,000 people worldwide have received ASR implants, with about one-third of those recipients in the United States. According to The New York Times, when the device was recalled in 2010, DePuy said it was doing so because data from the National Joint Registry of England and Wales showed that it was failing prematurely at a higher rate than competing implants. DePuy later challenged a revised British estimate, projecting a one-third failure rate for ASR patients who had had the device the longest. But DePuy’s own review in late 2011, based on the number of patients who had already undergone revision surgery, led them to estimate that 37 percent of ASR patients might need a replacement less than five years after receiving the implant. DePuy has offered to pay patient costs for replacement surgery, the Times says.