As we have previously reported, DePuy Orthopedic, Inc., a subdivision of Johnson & Johnson, Inc., issued a recall in August 2010, for the ASR XL Acetabular System and the ASR Hip Resurfacing System after data suggested that about one out of every eight may fail within only five years. Specifically, the recall targeted individuals who received the implants after July 2003.
Now, with the legal pressure continuing to mount, David Floyd, CEO of DePuy Orthopaedics since 2007, has announced his resignation. A spokeswoman for DePuy advised that Floyd “made a personal decision to pursue interests outside of DePuy.”
Johnson & Johnson began selling the metal-on-metal devices outside the U.S. in 2003. The ASR XL was then introduced in the U.S. market in 2005. However, DePuy did not seek FDA approval for the ASR Resurfacing System until June 2007. Instead, DePuy relied on a grandfathering process, which did not require clinical trials as long as DePuy was able to demonstrate that the ASR XL was “substantially similar” to the company’s other metal-on-metal devices.
According to a recent article in Bloomberg Businessweek (April 4- April 10, 2011), following its introduction to the U.S. market, the FDA received 87 reports of adverse incidents in 2007, which subsequently rose to 239 reports in 2008 and to 426 reports in 2009. Not until August 2010, did DePuy finally recall the allegedly defective devices. In March 2011, the British Orthopaedic Association and the British Hip Society reported that preliminary research showed the ASR XL’s failure rate in the U.K. as high as 49% after 6 years.