February 15th, 2012
We occasionally use JNJBTW to respond to media reports that we feel are inaccurate or mischaracterize events involving members of the Johnson & Johnson family of companies. Today, The New York Times published a story about the ASR® Hip System recall, and I wanted to share a letter from DePuy Orthopaedics President Andrew Ekdahl in response to the story. Ekdahl shared this letter with employees, and we post it here with his permission.
February 15, 2012
Dear DePuy Colleagues:
I’d like to address an article that appeared today in the New York Times about the ASR™ Hip System recall. Specifically, this article focuses on the non-approvable letter DePuy received from the U.S. FDA in August 2009 for the ASR Hip Resurfacing System. Citing a summary of the non-approvable letter from an undisclosed source, the article implies that the FDA letter concluded that there was a safety problem with the ASR Hip Resurfacing System, and DePuy knowingly continued to market an unsafe product in other regions. That is simply untrue.
By way of background, the ASR XL total hip replacement system was cleared by the FDA for marketing in the U.S. in 2005 via the 510k process. We also had filed a PMA in July 2007 for the hip resurfacing version of the device.