According to The New York Times (3/22/12), Johnson & Johnson executives decided to stop marketing the DePuy ASR just weeks after receiving the request for information from the FDA. The Times article notes that the letter, called a non-approvable letter because the FDA issued its decision to deny DePuy's application to sell the hip device in the letter, focused on problems with study data submitted by DePuy in support of its application.
The FDA's letter, dated August 13, 2009, requests safety information from the device maker about the DePuy ASR Hip System and notes that information from other countries indicated a high failure rate associated with the ASR system.
DePuy had two similar versions of its metal-on-metal hip device. One version was sold in the US, while the other version was sold overseas. DePuy applied to have the overseas version approved for sale in the US, but that request was denied by the FDA in the non-approvable letter because of concerns about the safety of the devices. Following receipt of the letter, according to The New York Times, DePuy executives decided to sell off remaining units of the hip device rather than recall it.
Data from Europe and Australia regarding the ASR hip devices indicate they had a higher than usual early failure rate and an added issue of metallic debris from the metal-on-metal devices.
Lawsuits have been filed against DePuy, alleging the company knew about the device's early failure rate but failed to take appropriate action to recall the hips. DePuy finally issued a recall in 2010, a year after receiving the letter from the FDA, when the hip device had been mostly phased out. DePuy has said it acted appropriately in announcing its recall, believing that the metal-on-metal hip replacement devices worked as intended.
An internal e-mail from a company executive, however, suggests that DePuy knew that its ASR was not approved because of concerns about the early failure rate.
READ MORE DEPUY HIP REPLACEMENT LEGAL NEWS
Patients who were allegedly affected by the DePuy metal-on-metal devices say they experienced extreme pain, decreased mobility and other injuries following the failure of their hip devices. Many underwent hip revision surgery once their device failed.