How DePuy Obtained Approval From the FDA for its bad Product

DePuy obtained FDA approval for its ASR hip implant in 2005 through a shortcut process known as the 510(k) approval process.  That process pre-approves any product that is deemed “substantially equivalent” to those products already marketed for sale and requires no clinical trials.  DePuy gained its approval through this system by asserting that the subject device does not raise any new issues of safety or effectiveness.”

On March 6, 2010, DePuy issued a warning to surgeons in the United States that its ASR hip implant had a higher than expected failure rate.  This warning was finally provided a year after DePuy was presented with finding that the ASR implant was failing early and require revision surgery.  Shockingly, the March warning letter came nearly three months after DePuy voluntarily withdrew the ASR hip implant from the Australian market in December 2009.  DePuy continued to promote and sell the ASR hip implant in the United States for over six months after the Australian withdrawal before finally recalling the ASR device in the United States in August 2010.

If you have had a hip replacement and the artificial hip is defective – call us at 800-862-1260.