After recalling more than 90,000 DePuy ASR XL Acetabular Systems and DePuy ASR Hip Resurfacing Systems, Johnson & Johnson and its subsidiary, DePuy Orthopaedics, reported to patients and doctors that about 12% to 13% of these hip replacement systems may fail within five years. New data uncovered from the manufacturer's internal documents reveals that Johnson & Johnson may have known that these failure estimates were grossly inaccurate.
As reported on the front page of the New York Times yesterday, an internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled its metal-on-metal hip implant systems estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it. A 40% failure rate!
Johnson & Johnson never released those projections for the device, the Articular Surface Replacement (ASR). But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate. Back then, the British registry was suggesting a failure rate of around 30%, and J & J insisted that the failure rate was 12% to 13%.
The company’s analysis also suggests that the DePuy ASR hip implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it. Thus, the nightmare is not over for hip implant patients.
The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an ASR prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades, and has resulted in the FDA questioning the safety and efficacy of all metal-on-metal hip implant devices. One suspects that as more of Johnson & Johnson's internal documents become public, the pressure will mount for them to resolve this litigation.
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