In 2005, DePuy Orthopaedics received the 510(k) clearance from the Food and Drug Administration (FDA) to sell the ASR XL hip replacement device in the United States. The 510(k) process does not require the manufacturer to conduct any clinical tests on the device, but merely requires that the device be similar to another hip implant already on the market. DePuy received the FDA’a approval to sell the ASR hip replacement by simply stating similarity to other hip replacement devices. In the last six years, this lack of testing has led to disastrous consequences for patients implanted with the DePuy hip replacement device.
The Australian National Joint Replacement Registry (NJRR) reported in its 2007 annual report that the DePuy ASR XL hip replacement device had a higher revision rate than other competitive devices. The NJRR continued to report on high revision rates in subsequent annual reports until the ASR was pulled out of the Australian market in December 2009. In the fall of that same year, DePuy had stated it would phase out production of the ASR due to decreasing sales, but made no mention of the high revision rates reported in the Australian NJRR or the fact that experienced surgeons in the UK (who had been using the ASR before it was available in the U.S.) had expressed concerns to the company about problems with the ASR. Surgeons in the U.S., consequently, continued to use the ASR hip replacement well into 2010. In a New York Times article in March 2010, Dr. Thomas Schmalzried, one of the designers of the DePuy ASR hip replacement device, admitted that in the last two years DePuy had realized the ASR had a narrower window for positioning than other hip implants. That same month, the company issued a field safety notice based on data from the United Kingdom that showed 8-9% revision rates after three years for patients implanted with femoral heads smaller than 50mm in diameter. The notice was followed up by a letter to clinicians warning of higher than expected failure rates reported in Australia and emphasized the importance of proper positioning of the implant.
In August 2010, DePuy finally issued a recall for the ASR hip replacement, based on data from the British National Joint Registry reporting high revision rates for the ASR. The recall was long overdue, especially since experienced surgeons who were using the DePuy hip replacement device had been reporting problems to the company about the implant years before the recall. The Austrialian NJRR had, of course, also reported on and confronted DePuy officials of the ASR’s exceedingly high failure rates.
The company has stated that it will reimburse patients for ‘reasonable and customary’ out-of-pocket expenses such as medical treatments or services, lost wages and revision surgery. These are expenses a patient has to pay because the insurance company, Medicare or Medicaid will not cover. The consequences due to the DePuy hip replacement recall has left many patients injured for life. Many recipients of the DePuy hip replacement have reported tissue and bone damage, metallosis, and dangerously high levels of cobalt chromium in the blood system, all of which pose significant threats to a patient, especially years from now. That is why a lawsuit is necessary in order to recover damages for lost wages, medical costs, pain and suffering from the injury. Borri Law Offices filed one of the first cases in the country against DePuy Orthopaedics, months before the recall. You deserve the attention and care that DePuy failed to provide you with. Our offices offer a free and personal consultation to discuss your case.