Recently, an internal DePuy Orthopaedics email was released that reveals the company’s knowledge of the defects and high failure rate of their ASR hip implants. The message was written by DePuy’s Vice President in August 2009–a year before the device manufacturer recalled their product.
The email was sent to three other DePuy executives and addressed why the Food and Drug Administration decided to not approve the sale of one of their ASR hip implants. The FDA did not approve the device because of studies that showed they had high rates of premature failure. The hip implant turned down by the FDA was not sold in the U.S.–only overseas–but a related version included in the recall was implanted in 30,000 Americans.
After the email was sent, and up until the device was recalled about a year ago, DePuy Orthopaedics and parent company Johnson & Johnson repeatedly denied rumors that their device was unsafe. Part of the email’s message addressing the FDA’s disapproval reads, “The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority, with additional downside risk.”
If you or someone you know has experienced hip implant failure with a DePuy ASR hip replacement, contact the DePuy hip implant defect lawyers of Williams Kherkher by calling 800-761-3187 today.