By: Daniel Nigh
October 9th 2012 4:00pm
The Australian National Registry has dealt another blow to the already crippled Johnson & Johnson efforts to defend a product manufactured by one of its subsidiaries. The Australian National Registry recently released its 2012 Annual Report revealing that the DePuy ASR total hip replacement has a whopping 44% revision rate at 7 years. The average revision rate of all other total hip replacement products is only 6% at 10 years, according to the 2012 Annual Report. In addition, this 44% revision rate does not actually show the percentage of the products that have failed inside of patients at 7 years, and it does not account for patients who had faulty products. For example, it does not include patients who are awaiting revision, patients who cannot afford medical treatment, patients who cannot have a revision due to other medical conditions, patients who would rather suffer from the failed product than go through the pain of another hip replacement, patients whose surgeons have not yet detected the failed product, and patients who have passed away. Therefore, the percentage of DePuy ASR XLs that have failed at 7 years is likely much great than 44%.
DePuy recalled its ASR XL total hip replacement implant in August 2010 after the England & Wales National Registry reported a 13% five-year revision rate. The revision rates were likely not as high at that time because many patients and surgeons were not as aware of the problems caused by metal ions being released into the body. Specifically, the ASR XL design defects cause unusually high levels of cobalt and chromium ions to be shed from the implant and go into the surrounding tissue, bone, joint fluid, blood and muscle. Published journal articles have explained in detail the substantial damage caused locally around the hip from these elevated cobalt and chromium ion levels and have diagnosed this metal poisoning condition as ALVAL (Aseptic Lymphocytic Vasculitis-Associated Lesions). The 2012 Annual Report also showed that the number-one cause for revision of the ASR XL was metal sensitivity, which relates to the damage caused by elevated metal ions. Over 39% of ASR total hip replacement implants were revised due to metal sensitivity compared to an average of only 1.7% for all other total hip replacement implants.
Unfortunately, the United States does not have a registry to compare the revision rates of various products; therefore, we must look to the reliable data generated from the Australian registry for these specific revision rates. However, the ASR XL was the same product both in the United States and Australia, and FDA reports, surgeon complaints, and patient testimonies confirm that we can expect similar failure rates of the DePuy ASR XL in the United States as we have already seen in Australia.
Contact a DePuy hip replacement attorney to find out if you have a case.
Daniel Nigh handles primarily ATV and Depuy cases in the Mass Torts Litigation Department at Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, PA. He has spoken at several conferences and co-authored a journal article regarding the DePuy ASR Hip recall and Stryker Hip recall, the science behind the defect, and injuries/damages resulting from the defect.