A recent NY times article suggests that Johnson & Johnson knew of the premature failure rate of their hip replacement system, prior to the 2010 recall.
In 2003, Johnson & Jonson subsidiary, Depuy Orthopaedics introduced a hip resurfacing device to the overseas market. Because resurfacing was a fairly new procedure at that time, DePuy was required to run clinical trials before the FDA would allow the device to be sold in the United States.
However, in 2005, due to a regulatory loophole, Depuy was able to market an American version of the implant in the United States for Standard hip replacements. Like the resurfacing device, the standard replacement used the same critical component that experts are saying was flawed in design.
In 2009, the FDA rejected the resurfacing device, and refused to allow DePuy to market the device in the U.S. The Device did not meet FDA standards largely due to the concern of its high early failure rate, which showed up significantly in the clinical trials. Though this device was not released in our country, over 30,000 patients received the companion device that was released in 2005.
The NY times recently reported on an e-mail that was sent from one DePuy executive to three other top executives informing them of the FDA’s decision not to approve the device, and their reasons for their decision.
This recent finding are contrary Johnson & Johnson’s stance that the company’s internal studies refute complaints by surgeons and regulators abroad that the device was flawed and that they believed the device was safe prior to the 2010 recall.
This recent finding, and DePuy's decision to continue to market the device without notifying doctors and patients of the FDA's findings may just be in favor of the 5,000 Plus victims currently involved in a lawsuits against DePuy for premature hip implant failure.
Lawyers representing clients in over 5,000 lawsuits related to the device's failure are hoping that DePuy’s decision not to publish the FDA’s findings while continuing to market the device may help their client’s cases.