J&J hip recall: Internal emails detail FDA's non-approvable letter (MassDevice)
Uncovered internal emails from Johnson & Johnson subsidiary DePuy Orthopaedics highlight the company's decisions to abandon a PMA bid for the now-defunct ASR hip resurfacing implants amid "a significant number of revisions" during clinical trials.
A newly uncovered Johnson & Johnson email may pose problems for the health care giant in the ongoing lawsuits over defunct hip implants made by subsidiary DePuy Orthopaedics.
DePuy has insisted that the recalled ASR metal-on-metal hip resurfacing implants had failed due to improper positioning during surgery, but those arguments may lose some of their luster in light of an internal email from 2009 in which a company employee notes "a significant number of revisions" associated with the device in clinical trials.
The email, written by DePuy executive Pam Plouhar, outlines the FDA's decision not to grant pre-market approval to the ASR implant and notes the higher of corrective surgeries required by patients who received the device compared to a control group, according to a report by the New York Times.
While the FDA non-approval letter remain...
