DePuy Hip Recall Reveals Failure in US Regulatory System

Today’s article in the Business section of the NY Times underscores the fundamental flaws and failures in the US medical device regulatory system. The article notes that DePuy Orthopaedics, the world’s manufacturer of artificial hip components in the world, created a faulty product and then convinced the market that the DePuy ASR XL hip replacement was performing as well as other comparable hip replacements even though it was aware of numerous complaints from patients and physicians alike who said the hips were failing frequently and prematurely. When it was introduced to the marketplace the DePuy ASR (Articular Surface Replacement) XL was supposed to be a revolution in technology and design. It was supposed to be a hip that lasted 15 years or more in patients. Not only did it fail in that regard, some DePuy patients are now suffering from severe metallosis or metal poisoning as a result of the metal-on-metal hip joint grinding together and leaving tiny particles of cobalt and chromium to be released into the bloodstream.
While we have documented the DePuy failures in this blog, the NY Times article takes a slightly different view of the issue. The Times’ article focuses on the failed US regulatory system that allows such a faulty medical device onto the marketplace in the first place. According to the Times, unlike a pharmaceutical drug which must endure a series of critical clinical trials before approval, a medical device faces no such scrutiny. If a particular medical device, such as the DePuy ASR XL resembles a previously approved device, it can skip the trials and proceed to the marketplace. Most experts agree this is a huge problem with the regulatory system. Until such problems are fixed, patients will continue to suffer as they are now with the failed DePuy hips.