The New York Times reports that the government’s system for regulating many medical devices, like artificial hips, should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to one of the nation’s top scientific groups. The report calls for and integrated premarket and post-market approach to insure that a device is safe and effective for the life of a device. As expected the medical device industry rejected the

The New England Journal of Medicine reports that at an April 13, 2011 hearing before the Senate Special Committee on Aging focused on a Government Accountability Office report identifying safety concerns about the FDA’s process for approving medical devices. According to the report, the FDA has reclassified only 1 of 27 types of high-risk devices that, in 2009, could still enter the market through the less stringent 510(k) process instead of being submitted to the

WHO GETS TO KEEP A REMOVED DEFECTIVE DEPUY HIP IMPLANT? The issue of who should obtain possession and control of a Depuy hip implant that has been removed because of its failure is an important issue in the litigation.  A removed hip implant is valuable evidence, and its preservation is critical. Attorneys for Depuy want to maintain control and the attorney for a Depuy client also wants control of the defective hip implant. At the

The issue of who should obtain possession and control of a Depuy hip implant that has been removed because of its failure is an important issue.  A removed hip implant is valuable evidence, and its preservation is critical. Attorneys for Depuy want to maintain control and the attorney for a Depuy client also wants control over the defective implant. A solution has not been decided.  It is expected that soon Judge Katz will decide this

Recently, DuPuy Companies announced a recall for artificial hip replacement of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System.    The DuPuy hip recall is based on information that approximately 12% of patients have needed “revision surgery” based upon defects inherent in the original hip replacement system and how the original system functions.  In some instances patients have suffered pain, difficulty walking, bone problems, and other symptoms associated with the original implants.