FDA Approval Process And DePuy Pinnacle Recall Raise Related Questions
With the U.S. Food and Drug Administration (FDA) receiving thousands of complaints stemming from the defective DePuy Pinnacle hip replacement, questions are raised about the efficiency of the FDA’s approval process and its association with a potential DePuy Pinnacle recall.
Most medical manufacturers use the FDA’s approval process because of its lax approach in approving new devices that are “substantially equivalent” to a device that was marketed before 1976. During this year, an amendment to the Food, Drug, and Cosmetics Act, known as the 510(k) process, gave the FDA authority to review new medical devices.
The FDA acknowledges that substantial equivalence “is determined by regulation by a comparison to a medical device that was lawfully marketed prior to 1976, or to a device that has been cleared through the 510(k) process.” In other words, not all devices need to be substantially equivalent to a pre-1976 device, only to another device that gained approval through the 510(k) process.Consequently, a device approved through the 510(k) process could have several degrees of separation from the original product, losing any similarity to it.
This disparity can be found comparing the DePuy ASR hip replacement systems and the DePuy Pinnacle system. The recently recalled ASR XL Acetabular System and the ASR Hip Resurfacing System were not subjected to pre-market testing because of their substantial equivalence to the DePuy Pinnacle device. Though the devices may be similar, the fact that the ASR Systems rely on natural bone growth and that the Pinnacle devices is attached by screws demonstrates a major difference between the devices.
Most medical manufacturers avoid the slower and more expensive traditional product approval process. It can take 1 year and $36 million for pre-market approval, in comparison to the 3 months and $13 million for the 510(k) approval. It shouldn’t come as a surprise to find that the vast majority of new medical devices are approved via the 510(k) process.According to researchers from the National Research Center for Women and Families, only 1% of new medical devices are subjected to pre-market testing. This group also determined that of the 113 medical devices recalled by the FDA between 2005 and 2009, eighty devices (71%) were given 510(k) clearance.
DePuy has set aside as much as $1 billion in the past for those suffering from their defective devices. If you are suffering from pain caused by DePuy’s defective hip replacement, fight for the compensation that you are entitled to. Start by going to the DePuy Pinnacle recall website to have your case evaluated by an experienced attorney free of charge.