Time line:1. 2005 the DePuy ASR is first sold in the Untied Stated to unsuspecting victims as a safe medical devise, the sales representative who were representing J&J were calling the Depuy ASR the rolls Royce of Hip replacement apparatus.
2. In 2005 the J&J obtained special permission to skip clinical trials and went straight from animal testing to human recipients. This is called a 510k Clearance from the FDA.
3. Three years later in 2008 the British FDA called the Medicines and Healthcare Products Regulatory Agency issue a notice that there appeared to be medical problems associated with recipients of the DePuy ASR, that same year the FDA received hundreds of complaint from recipients in the US. Data revelaed the the Depuy ASR hip replacement prosthetics had a 13% failure rate, which was much higher then the national industry average.
4. In 2009 DePuy voluntarily withdrew the ASR system from the market, this was the first sign of concession by the manufacturer that there were problems.
5. In 2010 the first lawsuit against DePuy was filed by a Florida women claiming total failure of the device.
6. In march 2010 the NY Times reported that Depuy had warned doctors that it had sold Prosthetics to that the prosthetics were failing at an unusually high rate and that , many considered this a silent recall.
7. In May of 2010 Doctors were warning that metallic debris originating from the defective prosthetic implants can cause non cancerous tumors as well as severe swelling and damage.
8. In July 17th, 2010 the FDA notifies the public the Depuy is recalling the ASR, this was followed by an August 2010 Depuy worldwide recall of the ASR, see FDA recall letter here.
9. On August 19th 2010 the FDA sent a letter to DePuy warning them of noncompliance.
10. On August 26th , 2010, J&J/DePuy issues a worldwide recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System. The decision is the result of a determination that the failure rate for both systems was over 12%.
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