Awhile back I blogged about the FDA’s massive recall of DePuy A.S.R. artificial hips. The DePuy artificial hips were touted as a leap forward in artificial hip technology when they debuted. They were supposed to last to last for fifteen years or more (much longer than other artificial hips) and their Articular Surface Replacement (A.S.R.) technology was supposed to help resurface portions of the hip once implanted.
As it turned out, the DePuy ASR artificial hips have worn out quickly due to metal-on-metal contact within the device and this metal-on-metal contact has resulted in toxic heavy metal ions being deposited in the bloodstream of patients, causing chronic pain, toxic reactions and, in some patients, the development of pseudotumors.
As I originally blogged about, the shocking part of all this is that the DePuy ASR never had to be subjected to clinical testing prior to its being marketed to the public. The FDA regulatory process contains a loophole – known as the “510(k) process” – that allows medical device manufacturers to sell new medical devices without any clinical trials of the device if the new device is “equivalent” to one already on the market. Even though the DePuy ASR was touted as offering next-generation advances – like the Articular Surface Replacement technology and being more durable – Johnson & Johnson, its manufacturer, never had to subject the DePuy ASR to clinical testing because it was deemed “equivalent” to other artificial hips already on the market.
Now, as reported by The New York Times, comes a new study from the Institute of Medicine showing that 81 percent of the medical devices recalled by the FDA from 2005-2009 were devices that made it to market through the 510(k) loophole. Only one-fifth of the medical devices subject to recall had been clinically tested prior to approval.
I think the DePuy ASR recall and this new study from the Institute of Medicine show that the 510(k) loophole needs to be tightened up a little. Medical devices subject to FDA regulation run the gamut from ear wax cleaning kits you buy at the drug store to implantable defibrillators that are supposed to restart your heart after cardiac arrest. Having a regulatory loophole for new-to-market devices that are equivalent to older technology benefits consumers by driving down the prices of medical devices and fostering competition. However, medical device manufacturers cannot be allowed to get away with selling cutting-edge surgically-implanted devices without any prior testing on the grounds that such technology is “equivalent” to older devices.
This blog is maintained by the Boston product liability lawyers at The Law Office of Alan H. Crede, P.C. It should not be regarded as a source of legal advice relative to product liability claims that you may have.