Is the FDA To Blame for the DePuy Hip Implant Debacle?
As more and more metal on metal hip implants fail and are recalled, many are wondering how they passed FDA scrutiny in the first place. How was such a flawed medical device approved in the first place?
The answer is the 510(k) clearance process for medical devices, a now controversial system of clearing moderate risk devices for market. Under this system, a device maker uses another device that has already passed 510(k) clearance as a predicate to its own device. If there is a substantially similar predicate to this new device, it will receive FDA clearance without requirement of any patient testing or proof of safety.
Notice that this clearance is available for moderate risk devices on the market. But should hip implants really fall under the category of moderate risk? Few would argue that the success or failure of such a device determines the ability of the patient to live a normal and productive life.
Unfortunately, metal on metal hip implants received the moderate risk classification as an oversight. When the Medical Device Amendments of 1976 were passed, it was established that different medical devices would be classified according to their perceived risk. Hip implants, though they were potentially high risk, were already on the market. The FDA decided to temporarily classify hip implants as moderate risk, and then revisit the issue and reclassify them at a later time. The FDA never went back and reevaluated it. Therefore when all the new metal on metal hip implants were created, manufacturers were able to get approval using the 510(k) clearance process available to moderate risk devices. No testing in advance was required.
To compound this problem, DePuy gained clearance for the ASR implant through the 510(k) route, but it didn’t even have to disclose that there were certain parts of the device that were completely new on the market, for which there was no predicate. It was this completely new, untested part of the hip implant that failed so completely that the device had to be recalled.
DePuy was undoubtedly responsible for allowing its defective metal-on-metal hip implants to remain on the market when it knew of the complications being reported. But is the FDA not also responsible for allowing these hip implants to basically fall through the cracks? After the debacle that has ensued, the FDA is finally proposing a new rules that would require manufacturers of metal on metal hip implants to prove safety before they can continue selling their products. The FDA is already requiring pre-approval clinical trials for hip-resurfacing devices.
When device manufacturers and the FDA both fail to keep the public safe, it is the patients themselves that demand attention be brought to these serious public health issues. By demanding to be heard, patients finally force change. If you or a loved one have received a metal on metal hip implant, you may be eligible for compensation. Contact a medical device attorney at Kirkendall Dwyer LLP today for more information.
