An estimated one out of eight (1/8) patients who underwent a hip replacement or hip resurfacing procedure with a DePuy ASR have experienced failure associated with defects of the implant.
Known problems include:
- Metallosis - build-ups of metal debris left behind by the corroding and loosening metallic components of the hip implants, and adverse soft tissue reactions
- Bone staining
- Nerve and muscle damage
- Component misalignment
In reference to the misalignment of the components, DePuy has accused surgeons of improperly implanting the acetabular cup of the hip implant, which is a hemispherical ball that fits into the hip socket. However, the company has more recently acknowledged that the cups of the ASR hip replacement devices are more difficult to properly place than competing systems.
How Did The ASR Hip Get Approved?
Cleared by the Food and Drug Administration (FDA) in August 2005, DePuy was able to take the far less expensive route of filing a 510k Application of marketing clearance for their ASR hip replacement product.
The 510k application does not require clinical trials, and its cost compares favorably to the price tag of the Permanent Application of Approval. DePuy’s hip resurfacing technology was not approved for use in the United States.
Whereas tested hip implants have an average lifespan of 15 to 20 years, many patients receiving the DePuy ASR were forced to undergo replacement surgeries soon after having the prostheses installed. Although DePuy ordered a recall in August 2010, the U.S.-headquartered firm has been reproached for not issuing the recall sooner knowing the relatively high rate of implant failure.
DePuy ASR Settlements
In an attempt to settle with individual litigants, DePuy has earmarked $2.5 billion for compensation. Settlements are starting at $250,000 at the individual level, although the exact figure depends on the severity of the ASR-related problems. Persons who suffered “extraordinary” personal injury are eligible for additional compensation. When factoring in the possibility of higher individual payouts, the total settlement package may rise to $4 billion.
The ordeal has not yet ended; some estimates of the five-year replacement rate are as high as 40 percent, suggesting that additional litigation against the company will continue for some time.