Could The DePuy Artificial Hip Recall Have Been Prevented?
In August 2010, approximately 37,000 recipients of artificial hip replacement devices were notified of a massive DePuy ASR hip implant recall. Prior to the DePuy ASR artificial hip recall, an estimated 93,000 hip implants were sold worldwide. Moreover, a recent U.K. study suggests that 49 percent of the ASR XL Acetabular hip replacements, one of the devices included in the DePuy ASR hip implant recall, could potentially fail – this staggering amount is four times greater than originally claimed by the company when it issued the DePuy ASRartificial hip replacement recall in August 2010. This has left many patients and health care providers wondering whether the federal regulatory system currently in place is failing to protect the safety and welfare of consumers.
Flawed FDA 510(k) Process Factor In Artificial Hip Replacement Recall
In the United States, medical devices must receive approval from the U.S. Food and Drug Administration (“FDA”) before they can be sold on the market. Although the process is often rigorous, manufacturers can bypass the stringent requirements by utilizing the 510(k) process, which only requires that manufacturers show that their medical device is substantially similar to others already available on the market. DePuy used this expedited process in order to receive approval for its artificial hip implants. Had the company been forced to undergo more rigorous testing, the massive DePuy ASR artificial hip replacement recall could have been avoided.
United States Should Adopt Early Detection Procedure In Light Of DePuy ASR Artificial Hip Replacement Recall
If the United States had an artificial joint registry that tracked and documented adverse event reports associated with the artificial hip implants, it is possible that the DePuy ASR artificial hip replacement recall could have been initiated earlier. Unlike the United Kingdom and Australia, the United States does not have an artificial joint registry. Because the United Kingdom and Australia had artificial joint registries in place, they were able to record adverse events stemming from the artificial hips as early as 2005. In fact, a DePuy ASR hip implant recall was issued in Australia in 2009 – a year before the worldwide artificial hip replacement recall. If the United Stated had established an artificial joint registry, complications arising from the artificial hip implants might have been detected earlier, DePuy would likely have had to address the adverse event reports, and thousands of patients could have received medical attention or altogether avoided being implanted with a DePuy ASR metal-on-metal artificial hip.
DePuy ASR Artificial Hip Recall Lawsuit
If you or a loved one has experienced any artificial hip replacement complications following the DePuy ASR hip implant recall, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.
Contact one of our DePuy ASR hip implant recall lawyers today for a free and confidential DePuy ASR artificial hip implant lawsuit evaluation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our DePuy ASR artificial hip recall injury lawyers also provide personal attention to guide you through the complex litigation process.