Contrary to the good corporate responsibility of Boston Scientific for their quickly recalled defibrillators, DePuy seems to have taken their sweet time with their ASR hip implants, in addition to trying (and failing) to direct public misinformation on the issue.
First the background: the DePuy ASR hip implant is used for hip resurfacing (which is apparently not an issue), and more traditional hip replacement, which is at issue. The device is a metal-on-metal ball and socket, which can cause metal debris early in the life of the implant. That metal debris causes inflammation, and can lead to damaged muscles and soft tissue. The end result is that a very expensive and painful replacement surgery intended to last about 15 years ends up needing revision within two or three years.
Use of the device in the United States started in 2005. Since 2008, the FDA has received approximately 300 complaints (most people don’t complain to the FDA, so this indicates that the problem is much larger) from patients or their doctors about the early failure of the device.
Here’s where DePuy and Johnson & Johnson try to hide the ball from consumers. The product is more heavily used in Australia, and it was withdrawn from the Australian market in December of 2009—three to four months ago. A few months ago, the public was informed that DePuy would be phasing out the ASR hip implant here in the U.S. because of “slowing sales.” Indeed, last month DePuy’s worldwide vice president for regulatory affairs stated that “With declining sales of this particular product in its market segment, we are focusing on newer technologies.” So, according to the manufacturer, there was no safety issue. This “phasing out” seems to me to be diction-wrangling in order to avoid a technical recall, with its incumbent bad publicity.
But, with two years of reports of device failures, the experience of the Australian market, and DePuy’s own statements now indicate that the ASR has significant problems, and the failure rate directly impacts patient safety. The March 6 letter from DePuy states that the device has a higher failure rate when used on “certain types of patients,” which include those of short stature (often women) and people with certain bone weaknesses. This very statement seems to encourage doctors to stop using it. I wouldn’t be surprised if DePuy is offering surgeons a refund (or perhaps DePuy credit) on returned ASR hip implants.
Add to this the fact that there is no information for consumers about the hip replacement problems anywhere on DePuy’s website or Johnson & Johnson’s website, and it is clear that the manufacturers are simply trying to avoid their responsibilities. The “phasing out” should have come sooner (at least at the same time as the Australian “withdrawal” from the market), and the manufacturer should have confessed its problems early, instead of lying to the public about “slowing sales.”
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