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. DePuy received a non-approvable letter for the DePuy ASR Hip Resurfacing System from FDA in August 2009. In that letter, the FDA indicated that significant additional data would be required before approval of the device could be granted.
At the same time that the company received this FDA letter, market demand for hip resurfacing was declining rapidly. In weighing the significant resources that would be required to produce the new clinical dataset requested by FDA against the declining market interest in resurfacing, DePuy decided to withdraw the PMA. This was purely a business decision.
Particularly disturbing is the NYT’s reliance on a summary of the non-approvable letter from an undisclosed source of unknown credibility to develop its assumptions. The non-approvable letter is a confidential correspondence between the FDA and the company, and therefore is not in the public domain. Late in the article, the reporter acknowledged, “It is not known precisely what the agency’s letter stated nor is it clear how, or if, the agency’s concerns about the resurfacing version of the hip implant applied to the model used in this country in standard replacement surgeries. The agency can reject approving a device for various reasons, including cases where it is seeking only small amount of added data.”
When faced with such unbalanced news coverage, it’s important to remember the facts about the recall:
• DePuy continuously reviewed collective post-market data regarding ASR from a variety of sources – including national joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports. We issued a voluntary recall of the device after receiving new information from the UK National Joint Registry which was not in line with data previously reported. • Since the recall decision was made, DePuy has worked diligently to provide patients and surgeons with the information and support they need. • DePuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall.
We know that this recall is concerning for patients, their family members and surgeons. I am proud of the unprecedented efforts and measures this organization has taken to address the needs of patients and surgeons. When faced with media coverage that often fails to recognize the Company’s response to this situation, please remember that DePuy takes our responsibilities surrounding this recall extremely seriously and has made patient safety the top priority throughout the lifecycle of ASR.