Medical devices come onto the market having been reviewed by the FDA under one of two regulatory standards: (1) Premarket Approval or (2) Premarket Notification. The Premarket Approval (PMA) process is the most stringent type of device marketing application required by the FDA. In the PMA process, the manufacturer must produce evidence in the form of controlled clinical trials sufficient to show the device is safe for its intended use. The Premarket Notification process, on the other hand, allows for marketing clearance from the FDA for a device substantially equivalent in safety and effectiveness to a device already on the market without clinical testing. Premarket Notification, often referred to as the “501(k) process” from its origins in the Federal Food, Drug and Cosmetic Act, allows successful applications through the 501(k) process to be “cleared,” but such clearance is not an approval process.
Depuy Orthopaedics, owned by Johnson & Johnson, sought clearance of its ASR XL Acetabular System through the much less stringent 501(k) process, rather than the PMA process. Of course, PMA approval carries significantly higher costs to the device manufacturer in the form of clinical trials and testing, along with a delay getting the product to market. Clearance through the 501(k) process reduces the manufacturer’s overhead, often at the expense of the public the device was intended to help, and abuse of the 501(k) process and lack of regulation has become evident.
A recent study published by the Archives of Internal Medicine examined all medical devices recalled between 2005 and 2009. Of the 133 devices recalled in this period, only 19% went through the more stringent PMA process supported by clinical testing. Conversely, 71% only went through the 510(k) process.* Since the manufacturers appear more concerned with profits than the public welfare, the article concludes that its findings suggest that “reform of the regulatory process is needed to ensure the safety of medical devices.”
If you are experiencing pain or have required surgery after a DePuy Hip Replacement, you need to be evaluated by your surgeon and you need to discuss your legal options.
At Pope McGlamry, our product liability attorneys are presently investigating DePuy Hip Replacement claims. If you suffer chronic pain, limited mobility, or difficulty walking due to a hip replacement, you may be entitled to compensation for your suffering.
Contact our Georgia DePuy Hip Replacement lawyers to discuss your potential lawsuit. We will evaluate your claim and explain your legal options.
* 11% did not go through either process because they were exempt, counterfeit, categorized as other.
Disclaimer: All use of the ASR mark is for informational and product identification purposes only. This post should not be taken as either medical or legal advice, but instead should act as a resource in providing general information that may be useful to the general public. Pope McGlamry is not affiliated with DePuy Orthopaedics, Johnson & Johnson, or their distributors.