Given the increasing number of complaints from the metal-on-metal (MOM) hips, medical device experts now believe that the DePuy hip should have been recalled sooner. The company recalled its ASR XL Acetabular MOM hip replacement system and the ASR Hip Resurfacing System in August 2010, almost two years after the FDA had received about 400 complaints from patients suffering with the ASR hip.
At first, DePuy said that the five-year revision rate was approximately 12–13 percent, which was still more than double the failure rate of similar hip replacement systems. According to some lawsuits, the ASR device is failing in one out of eight patients who received a DePuy hip after July 2003. Other evidence indicates that the revision rate is 25 percent, while some experts predict that within six years, as more of the devices fail, it could reach up to 49 percent, or almost half.
Revision surgeries spell further costs for DePuy as attorneys are suing the company to cover patients' medical costs of revision surgery, along with pain and suffering, and emotional suffering and financial loss. The latest blow to DePuy came from the California Technology Assessment Forum (CTAF). On October 19, 2011, it released a study titled Metal on Metal Hip Resurfacing as an Alternative to Total Hip Arthroplasty, which found that metal-on-metal hip resurfacing is not as safe and effective as a traditional hip replacement. The findings contradicted the CTAF's previous assessment of MOM hips, as this recent report gathered information from foreign orthopedic registries and studies about metal poisoning in hip replacement recipients.
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Now, two separate MDLs have been formed to handle DePuy's ASR hip implants and its Pinnacle hip systems claims that have been filed in federal courts. ASR Hip Implant Products Liability Litigation ("MDL No. 2197") is a consolidation of all federal DePuy ASR lawsuits, and DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation ("MDL No. 2244") is a consolidation of the federal DePuy Pinnacle hip replacement lawsuits.
The DePuy lawsuit alleges that the ASR hip replacement "was defectively designed and that DePuy knew that there were problems with the implant early on but didn't do anything to let patients or their surgeons know about the possible problems."