DePuy Email Discussed ASR Failures Prior to 2010 Recall
The New York Times reports that approximately one year before it recalled the DePuy ASR metal-on-metal hip in 2010, DePuy Orthopedics executives discussed Food and Drug Administration ("FDA") findings that the ASR Hip Resurfacing Device was failing in a significant number of patients. The Times obtained an internal email from August 21, 2009, in which a DePuy executive reported that the FDA refused to approve the device after clinical studies (which were "run by surgeons hand-picked by DePuy") showed that a significant percentage of patients required revision surgeries after being implanted. To read the full Times article, click here.
Prior to recalling the device in 2010,DePuy officials maintained that the device was safe and that the problems reported were likely caused by improper implantation procedures by the surgeons and not the defectiveness of the implant itself . In contrast, the email suggests that DePuy officials knew about the device's problems that the FDA had concerns with, but nonetheless continued to sell and market the device for another year prior recalling it in 2010.
DePuy's metal-on-metal hips have been linked in studies to myriad problems including, loosening, the need for revision surgery, metalosis, and tissue damage caused by the release of microscopic metallic particles from the hip systems.
Dreyer Boyajian LLP is representing persons in Upstate New York and elsewhere that have been harmed by these defective products. If you or someone you know has been so harmed, contact our offices for a free consultation.