DePuy Hip Implant Recall: The Result of Minimal FDA Review
The fallout from the infamous August 2010 DePuy hip implant recall has not only lead to mounting lawsuits filed by individuals who sustained serious hip replacement complications, but finger pointing at both the manufacturers of the device and the U.S. Food and Drug Administration (“FDA”). Although evidence suggests that DePuy received complaints of hip replacement complications from orthopedists as early as 2005, many are placing additional blame on the FDA for failing to properly review and test the DePuy products.
Expedited 510(k) Approval Process Leads to DePuy Hip Implant Recall
A recent study published in the Archives of Internal Medicine reviewed the number of medical device recalls between 2005 and 2009, and uncovered that out of the 113 recalled devices, 80 were cleared through the 510(k) process. Additionally, another eight devices were exempt from FDA regulation. In order for a manufacturer to employ this expedited process, all that needs to be shown is that the medical device is substantially similar to devices available on the market. Manufacturers are able to bypass pretrial testing and FDA inspection. The DePuy hip implant recall and its aftermath is a prime example why this process is dangerous to the safety and welfare of the public. If DePuy had been required to undergo the standard approval process, it is probable that the severe hip replacement complications stemming from the metal-on-metal implants would have been detected and not been cleared for patient use. The DePuy hip implant recall and the disastrous aftermath could have been avoided altogether. However, because of the lack of adequate safeguards with the 510(k) process, the DePuy hip implant recall was issued after 37,000 individuals received the defective prosthesis – many of whom are now dealing with serious hip replacement complications.
DePuy Hip Implant Recall Lawsuit
If you or a loved one has experienced any hip replacement complications following the DePuy 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 hip implant recall lawyers today for a free and confidential DePuy hip implant recall 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 hip implant recall injury lawyers also provide personal attention to guide you through the complex litigation process.