The ASR XL hip implant that is the subject of 10,000 lawsuits failed to meet Johnson & Johnson’s own safety test, according to a consultant who testified at the bellwether trial in Los Angeles.
Internal company documents revealed the chromium and cobalt debris produced by the ASR was 16 times the amount created in a comparable product. The elevated metal levels meant the ASR did not meet DePuy’s standards, which stated that the all-metal hip must at least be as good as previous devices from the company. The trial witness said the company chose to change the test rather than fix the design of the product.
J&J, DePuy’s parent company, recalled 93,000 ASR hips in 2010 while reporting a five-year failure rate of 12 percent. According to testimony from the trial, Australian data showed a failure rate of 44 percent within seven years. DePuy’s internal documents show a failure rate of 37 percent after 4.6 years.
An attorney for J&J suggested negative publicity from the recall resulted in the high replacement rate, but experts said clinicians would not remove a hip without having a good reason.
A physician who examined the plaintiff testified that he found “alarming” levels of chromium and cobalt in the man’s body.