Congressmen Request Investigation On Artificial Metal Hip Implants
On October 12, 2011, Representative Henry Waxman of California led House Democrats from the Energy and Commerce Committee in writing a letter to several Republican chairmen, requesting that an investigation into metal-on-metal hip implants, as well as brain stents be commenced. This request was made in response to the growing numbers of adverse event reports associated with medical devices, such as the DePuy Pinnacle and DePuy ASR metal-on-metal hip implants. In order to support their request for a congressional investigation, the congressmen stated, “we write to urge that we hold hearings that examine medical devices that have developed serious defects after being implanted in patients. Specifically, we believe that looking further into the ‘metal-on-metal’ hip implants and brain stents, two high-profile devices that appear to have resulted in significant harm to human health, would shed further light on the regulation of medical devices.” In support of their request, the legislators noted that “[b]oth items are examples of devices that were found to be associated with major health problems after being approved or cleared by the FDA. As such, we believe they could provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.”
Metal-On-Metal Hips Subject Of Increased Criticism
In August 2010, Johnson & Johnson recalled its DePuy ASR metal-on-metal hip implants. Although the DePuy Pinnacle hip replacement system remains on the market, these artificial metal-on-metal hip implants have also been experiencing high failure rates. Complications stemming from metal-on-metal artificial hip implants include early hip replacement failure as well as metal poisoning, which occurs when metal debris sheds from the implant damaging the surrounding tissue and entering the bloodstream. These types of complications often require patients to undergo painful revision surgeries to have the defective metal-on-metal hip implants removed. The congressmen stated that “[i]n addition to the local reactions, ‘high levels of metal ions in the bloodstream may cause symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.’” Moreover, the FDA reported that it received more than 5,000 complaints from patients and health care providers involving artificial metal hip implants in the first six months of this year, which was more than the agency had received in the prior four years combined. Currently, an estimated 500,000 patients have metal-on-metal hip implants. In May 2011, the FDA requested that medical device manufacturers provide data on the risk of metal poisoning and failure rates associated with the artificial metal hip implants.
Artificial Metal Hip Implants Cited As Example Of Flawed FDA Approval Process
Many believe that the core issue is the flawed FDA approval process, which cleared these defective medical devices. Medical device manufacturers, such as Johnson & Johnson, utilized the FDA’s fast-track 510(K) process in order to receive market approval for the metal-on-metal hip implants. The expedited 510(K) process only requires manufacturers show that their medical device is substantially similar to others already on the market. Under the 510(K) process, medical devices do not have to go through rigorous clinical testing or trials in order to receive market approval. Although the House Democrats recognized that the FDA has held four hearings on FDA regulation of medical devices during the past year to address these issues, they noted that “while working to reduce inefficiencies at FDA, it is critical that we also protect patient safety. Unfortunately, we believe the hearings to date have provided members with an incomplete record. We should also be examining evidence as to whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices.” House Democrats also cited recent recommendations made by the Institute of Medicine, which “concluded that our current review system needs to be strengthened – not weakened – to ensure that medical devices are safe and effective.” In its report, the Institute of Medicine urged that the FDA’s 510(K) process be abolished.
DePuy Metal-On-Metal Hip Replacement Lawsuit
If you or a loved one received a DePuy ASR or Pinnacle metal-on-metal implant and have experienced any problems as a result of the defective hip system, you may be able to file a DePuy hip replacement lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.
Contact one of our lawyers today for a free and confidential DePuy hip replacement lawsuit evaluation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our hip replacement injury lawyers also provide personal attention to guide you through the complex litigation process.