Senate Panel Reviews FDA’s Regulatory Process in Light of DePuy ASR Hip Recall
On April 13, 2011, the U.S. Senate’s Special Committee on Aging will convene for a hearing entitled “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process.” Although the panel will undertake a review of the FDA and its role in “protecting patient safety as part of the medical device approval process,” the hearing is expected to focus on the recalled DePuy ASR hip implants as the disastrous consequences emanating from the ASR recall are a prime example of some of the FDA’s questionable regulatory procedures. The defective DePuy ASR hip implants received FDA clearance through the 510(k) loophole, which only requires medical device manufacturers to show that their product is substantially similar to others available on the market. Because DePuy received market clearance for its DePuy ASR hip implants using the 510(k) process, an estimated 37,000 ASR hip replacements were sold in the United States. The lawyers at Bernstein Liebhard LLP are currently investigating and litigating cases on behalf of Bernstein Liebhard’s clients who have undergone DePuy hip implant surgery and are offering free and confidential legal consultations to individuals who received the defective hip implants.
DePuy ASR Hip Recall
In August 2010, DePuy issued a nationwide recall of the ASR hip implant systems after it was found that the metal-on-metal devices had design defects, requiring many recipients to undergo painful revision surgery. Since the recall was initiated, lawsuits have been filed nationwide, alleging that DePuy knew of the design defects but failed to adequately warn both physicians and patients. Instead, DePuy used the 501(k) process to ASR hip implant system bypass stringent review and get the on the market. During today’s hearing, the panel is expected to hear testimony from patients who received the defective hip implants as well as experts on the 501(k) process and medical devices.
Since DePuy was forced to recall its defective hip implant in August, Bernstein Liebhard LLP has provided a wealth of consumer information concerning the defective DePuy implants on its website, www.consumerinjurylawyers.com. If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.
For more information about filing a DePuy hip recall lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at email@example.com.
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