Nine months after DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson, issued a voluntary recall of its defective product, ASR XL Acetabular Hip Resurfacing System, it is evident that DePuy's reaction to the product's defects may have been a classic example of: "too little, too late."
While much of the controversy surrounding the DePuy ASR XL System, a product designed for patients undergoing total hip replacement, has centered on the adverse health effects of metallic debris that the product deposits in a patient's body, an equally concerning issue exists: the likelihood that the implanted device will fail.
A recent study by the British Orthopaedic Association revealed that patients who have been implanted with a DePuy ASR System will experience a revision rate of between 21% after just four years, to 49% after just six years. This means that after only six years post implantation, as many as half of all implanted patients will need a second surgery to remove and replace the failed DePuy ASR System.
This new study conflicts with the information that originally accompanied the DePuy recall, where DePuy claimed that only about 12% of patients who had received the device would require revision surgery.
This is just one of many questionable representations made by DePuy. For example, DePuy had represented that the DePuy ASR XL System was a safe medical device, substantially similar to devices already approved for use in the United States market, thereby allowing DePuy to speed the product through the FDA regulation process, bypassing the rigorous safety testing generally required of new medical devices. In marketing the device to orthopedic surgeons, DePuy represented that the DePuy ASR XL System was simple to implant, reduced the risk of dislocation, and was ideal for patients will smaller body frames and those who lead a more active lifestyle. When DePuy finally recalled the product, it claimed to have done so promptly after receiving "new" data relating to the DePuy ASR XL System revision rate. However, all of these representations were made with knowledge of substantial evidence to the contrary. In fact, DePuy had been aware of warnings contained in studies and medical literature relating to "metal-on-metal" devices such as the ASR XL System years before the August 2010 recall. Nevertheless, DePuy continued to sell the DePuy ASR XL System for implantation in patients requiring total hip replacement.
Based on the new data, DePuy's sale of an unsafe product will have resulted in up to an estimated 46,500 revision surgeries, representing half of the 93,000 DePuy ASR Systems sold worldwide. To date, approximately 700 lawsuits have been filed in the United States federal courts against DePuy and Johnson & Johnson by patients who have received and been injured by the defective device. Additional lawsuits have been filed in New Jersey and California state courts.
As of January 2011, Johnson & Johnson had arranged a $922 million set-aside for litigation costs and potential settlements associated with the recalled DePuy ASR XL System. However, given the serious injuries caused by the device and the growing number of lawsuits, it is anticipated that the company may end up paying much more to compensate victims.
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