The New York Times article cites an internal e-mail written in August 2009, from a DePuy executive regarding its all-metal ASR Hip Resurfacing System. The e-mail informs others that the US Food and Drug Administration (FDA) rejected one of the DePuy hip replacement devices because of a high failure rate. According to the e-mail, the FDA refused the device because the company's own studies showed a high premature failure rate in patients.
The device in question, the DePuy ASR Hip Resurfacing System, was sold overseas, while a similar device—the DePuy ASR XL Acetabular—was used in the US. Both devices are all-metal hip replacement systems—based on the use of an all-metal hip socket—and have been linked to an increased risk of premature failure. Furthermore, as with other all-metal hip devices, the DePuy hip replacements have been linked to an increased risk of metallosis, a condition in which metal debris comes loose from the device and is absorbed by the patient's surrounding tissue.
The DePuy e-mail seemingly contradicts assertions from DePuy executives that the company was not aware of the high failure rates prior to the recall and, furthermore, that the company's own studies showed that the all-metal hip replacement implants were safe. Initially, when reports came in about the DePuy premature failures, the company blamed the issue on surgeons rather than the device.
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What effect news of the FDA's rejection of the DePuy device will have on the lawsuits filed against the company remains to be seen. Approximately 93,000 patients in the US and overseas received one of the devices. It is not illegal for DePuy to keep the non-approval letter private, nor is it illegal to market products overseas that were rejected by the FDA.
Lawsuits have been filed against DePuy and Johnson & Johnson, alleging their DePuy hip replacement devices had unreasonably high premature failure rates. In 2009, DePuy Orthopaedics announced that it was phasing out the ASR implant due to business reasons. A recall of the ASR systems was announced in 2010.