Recalled DePuy Hip Implants Sold Overseas Were Rejected by FDA

Although federal regulators in the United States had serious safety concerns about one variation of a recalled DePuy hip implant, Johnson & Johnson went ahead and sold thousands of the devices in Europe, before later acknowledging that all versions of the ASR hip implant may be prone to early failure.

According to a recent New York Times investigation, the FDA rejected the DePuy ASR Hip Resurfacing System after a detailed review of its safety profile raised concerns. However, because of the secrecy associated with the FDA approval process, DePuy Orthopaedics, a division of Johnson & Johnson, was able to market the device in Europe without the concerns of U.S. regulators being relayed to their European counterparts.

Although the ASR Hip Resurfacing System was rejected by the FDA, DePuy was able to gain permission to market a variation of the device in the United States, known as the DePuy ASR XL Acetabular Hip System. That variation of the implant was approved under the FDA’s controversial 510(k) fast-track approval process, which only requires that a device be substantially equivalent to one that has already been approved. DePuy argued that the ASR implant was similar to their previously approved DePuy Pinnacle metal-on-metal hip replacement.

FDA officials say that the ASR Hip Resurfacing System had more rigorous requirements because resurfacing was a fairly new technique at the time. However, both devices were metal-on-metal hip implant systems, which have since been linked to a number of safety concerns.

In August 2010, Johnson & Johnson recalled all variations of the DePuy ASR hip implant after acknowledging that the devices may be prone to fail within a few years of surgery. By the time of the recall, more than 93,000 of the two hip systems were implanted in people worldwide.

As it turns out, the resurfacing variation that the FDA rejected may have been the safer of the two systems. However, there is also a good chance that if both hip implant systems had required the more stringent approval process, no individuals in the United States would have been subjected to DePuy ASR hip problems.

Since the recall, a growing flood of lawsuits over the DePuy ASR hip have been filed against Johnson & Johnson in state and federal courts throughout the United States. So far, about 3,500 DePuy ASR metal hip recipients have filed a lawsuit against the company.

Johnson & Johnson also faces over 900 DePuy Pinnacle hip lawsuits filed by individuals who have experienced problems with the older metal-on-metal hip replacement, which was used to gain approval for the ASR hip implant under the FDA’s 510(k) process.