DePuy Orthopaedics, Inc.’s Decision to Phase Out its ASR Hip Implant Devices followed an FDA Data Request

When it comes to the timing of DePuy Orthopaedic, Inc.’s (“DePuy’s”) recall of its ASR hip implant devices, it is important to understand what DePuy knew about the safety and effectiveness of the hip implants and when they knew it. A recent New York Times article reminds us that DePuy, a unit of Johnson & Johnson, manufactured and sold two types of its ASR hip implant devices – a resurfacing model called the DePuy ASR Hip Resurfacing System and a traditional hip replacement model called the DePuy ASR XL Acetabular System. According to The New York Times article, both models were based on the same metal-on-metal hip socket component, which experts say was flawed in design.

The XL Acetabular version, which was sold in the United States and used in traditional hip replacement surgery was cleared by the Food and Drug Administration (“FDA”) in 2005 via a regulatory pathway that did not require it to undergo clinical studies, says The New York Times. On the other hand, The New York Times reports that the FDA confidentially notified DePuy in 2009 that it would turn down the company’s application to sell the ASR Hip Resurfacing System version of the implant in the United States. According to The New York Times, the FDA was concerned with the high concentration of metal ions that were found in patients who got the all metal hip implant, and the FDA requested that DePuy provide added safety data if it wanted to pursue its application of the resurfacing version of the ASR hip implant. The recent article in the The New York Times also states that officials from the FDA also told DePuy that reports from countries where the implant was then being used showed it was performing somewhat more poorly than data submitted by DePuy indicated. Rather than provide additional safety data or recalling the ASR hip devices in 2009 amidst the FDA’s concerns, DePuy decided not to disclose the FDA’s confidential notice to doctors or patients and to continue to use the ASR devices in patients while phasing out ASR models over time, reports The New York Times.

In addition to the FDA’s 2009 non approval letter, The New York Times also reports that a 2009 email from Pamela Plouhar, a top DePuy executive, told colleagues that the resurfacing version of the ASR hip implant device was not approved for sale in the United States because of its high rate of early failure during clinical trials. If what The New York Times reports is true, then it suggests that DePuy knew as early as the year 2009 that its ASR hip implant devices were defective and unsafe. If that is the case, one can only wonder why DePuy would wait until August of 2010 to finally recall the defective ASR hip implant systems.

Many of the patients who received an ASR hip implant device have suffered crippling injuries and thousands of lawsuits are pending against DePuy in state and federal courts in connection with DePuy ASR hip implant devices as well as other DePuy metal-on-metal hip implants, including the DePuy Pinnacle hip implant system. The New York Times article is careful to note that DePuy executives have insisted that they acted appropriately in recalling the ASR hip implant devices when they did. Hopefully, the litigation that is under way on behalf of patients who claim to have been injured by the ASR hip implant devices will establish whether the timing of the ASR hip implant device recalls was appropriate considering what DePuy might have known.

To read the entirety of The New York Times Article, click here.

If you have any questions or concerns about DePuy’s ASR Hip Implant device, its Pinnacle hip implant device or any other metal-on-metal or metal hip implant including the Wright Conserve Cup hip implant, do not hesitate to contact an attorney at the law firm of Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C.