In an article published just yesterday by The New York Times, we learned that newly disclosed court records show that Johnson & Johnson, and its subsidiary DePuy Orthopaedics, Inc., were aware of an alarmingly high failure rate in their metal on metal hip implants back in 2011. According to the article, the manufacturers conducted an internal analysis in 2011 that revealed nearly a forty percent (40%) failure rate in the metal on metal hip implants within five years of implantation. In August of 2010, Johnson & Johnson and DePuy recalled both the ASR XL Acetabular System and the ASR Hip Resurfacing System after data revealed that both DePuy ASR hip replacement products have excessively high failure rates. The manufacturers are facing thousands of lawsuits consolidated in several courts across the country.
The ASR device is an implant in which both the acetabular cup and the ball component are made of metal. While the ASR device has grabbed most of the headlines for its unusually high failure rate, other manufacturers are moving away from the metal on metal design in hip replacements due to edge loading, excessive wear, and the likelihood of the metal components grinding and releasing metallic ions and debris into the patients’ surrounding bone and soft tissue. The New York Times article sheds some light on what the manufacturers knew and when they knew it.
The internal analysis that is now making headlines was never publically released by Johnson & Johnson or DePuy. Rather, it was during the discovery process in the various lawsuits that the internal analysis came to light. Not surprisingly, at the same time that Johnson & Johnson and DePuy were conducting the internal analysis, they were also publically down-playing reports from the British implant registry finding an excessively high failure rate in the implants. Indeed, in 2011, DePuy actually challenged the British joint registry’s findings regarding the excessive failure rate. As a benchmark, an early failure rate of five percent (5%) within five years would be normal for hip implants, which can fail for a variety of reasons. In the fall of 2011, DePuy itself estimated that thirty-seven percent (37%) of those that received the ASR would require a replacement within five years of receiving it.
It is estimated that approximately 93,000 patients were implanted with an ASR device, with about one-third of them implanted in the U.S. Given that the recall took place in August of 2010, there are likely thousands of patients whose implants will prematurely fail in the next several years. Indeed, just doing the math, this appears to be a certainty.
If you or someone you know have been injured by a defective product or medical device, contact the attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling (713) 222-7211 or 713-222-7211.