The DePuy Hip Recall – Did This Have to Happen?
The permanent damage that DePuy hip replacements have inflicted on those who received them is not simply a failure of technology. The DePuy hip implant recall came about because of a lack of sufficient quality control on the part of the the company that manufactured the implant, aided by a broken regulatory process. Now, with some reports saying that almost half of the implanted devices may fail, and calls for a congressional investigation into the approval process, we ask did this have to happen?
The Medical Device Loophole
Johnson & Johnson, the parent company of DePuy, has recently been under scrutiny for multiple product recalls, including such popular and well-known products as Tylenol and Rolaids. These problems became so persistent that in August of 2010, Johnson & Johnson announced that it would revamp its entire quality control system.
The FDA approval process that is intended to protect patients who receive implanted medical devices was described as “piecemeal and broken” in an investigative report in the New York Times. A significant loophole in FDA regulations allowed DePuy to sell its ASR hip replacement systems without FDA testing.
The Medical Device Act is the legislation that authorizes the FDA to regulate medical devices. A section of this legislation provides the rules for a process known as “premarket notification”, which allows certain classes of medical devices to be sold if a company can demonstrate that the device is “substantially equivalent” to a medical device already on the market.
These rues are laid out in section 510(k) of the legislation. While this legislation was intended to allow minor changes or improvements to medical devices already on the market to be sold without having to start from the ground up in the testing process, this premarket notification exception has become so widely abused that this part of the legislation is commonly referred to as the “510(k) loophole”. The FDA itself has recently issued reports suggesting that this loophole severely inhibits its ability to perform its regulatory duties, and in 2011 congressman Henry Waxman called for a congressional investigation of the medical device approval process.
But for now, this loophole is still wide open. And it's what allowed DePuy to sell its ASR hip replacement systems – hip replacements that contained new technology and new materials – without having to go through the more rigorous FDA “premarket approval” process. To win approval of the ASR hip implants, DePuy in fact presented the FDA with findings from the clinical trials of another device called the Ultima hip implant, a device with a completely different design than the ASR. Essentially, DePuy turned the thousands of patients who received ASR hip implants into unwitting human guinea pigs.
DePuy’s Response
Soon after DePuy began selling the ASR hip implants it began to receive information from surgeons and physicians that patients were experiencing difficulty with the implants. DePuy hip replacement recipients experienced pain, elevated levels of cobalt in their blood, unusual growths of bone and tissue around the area of the implant, and outright failure of the device.
Reports from surgeons who attempted to inform DePuy of the unusually high failure rates of the ASR hip implants suggest that DePuy attempted to shift blame back on to the surgeons themselves, saying that their implant techniques were faulty.
In early 2010, In the face of growing worldwide evidence that DePuy hip replacements were failing at a much higher rate than comparable devices, DePuy quietly announced that it would stop selling the devices, citing “declining sales”. Scrutiny of the device became even more intense after this, and in August of 2010 DePuy formally recalled its ASR hip replacement devices. In 2011, a study from the U.K. suggested that the hip replacement failure rate was even higher than suspected, with as many as 49% of implanted devices failing.
Now, as patients are forced to make difficult choices, DePuy has undertaken a massive campaign to attempt to limit its damages. DePuy has been offering to pay patients medical expenses if they forego lawsuits. DePuy representatives have been agressively approaching recipients of their defective hip implants, even going so far as to be present in the operating rooms when the implants are being removed.
These steps are encouraging patients, who have already been victimized once by DePuy’s faulty hip replacement and by an ineffective regulatory system, to act against their own best interest.
If you have been harmed by a recalled DePuy ASR hip replacement, the law firm of Blizzard, McCarthy & Nabers can help you file a lawsuit against DePuy. We are a nationwide law firm serving clients from all over the country. We handle all hip replacement recall injury cases on a contingency basis.
To learn more, or for a free consultation with an experienced hip replacement attorney, please contact us by email or call us at 1-800-349-0127.
