Friday, November 19, 2010

Depuy Orthopedics ASR Hip Implant Recall

In 2005, DePuy, a division of Johnson & Johnson, introduced the ASR and ASR XL hip replacement systems in the US after winning “510(k) clearance” from the Food and Drug Administration (FDA). This type of clearance meant that the product was approved without having to pass clinical trials to ensure it was safe. In 2008, The British equivalent to the FDA recognized “evidence of genetic damage in patients with certain metal hip implants,” such as the ASR system. Also in 2008, the FDA received higher than expected complaints from patients who received ASR hips. In 2009, DePuy voluntarily withdrew the ASR system from the Australian market due to higher than expected failure rates. In early 2010, DePuy notified physicians that the ASR system would be phased out by the end of the year. It was not until August 24, 2010, that DePuy recalled the ASR hip replacement system in the US and worldwide.
DePuy Orthopedics, Inc., and Johnson & Johnson are working hard to control the problems created by the DePuy ASR hip prosthesis. Part of this effort includes using physicians to ask patients to sign waivers and authorizations allowing DePuy access to patient records. DePuy is using Broadspire to manage this process. While DePuy promises to cover certain medical expenses associated with revision surgery, there remain a number of important concerns patients should have regarding this process. First, when a patient signs the waivers and authorizations, the manufacturer is given access to private medical information. Second, once the manufacturer gets copies of private medical records and the parts of the prosthesis removed during revision surgery, the manufacturer may not preserve that information properly. Third, while the manufacturer has promised to pay certain costs, the manufacturer is not volunteering to compensate for harm suffered as a result of the defective prosthesis. To be fully compensated for all of the injuries caused by the defective prosthesis, a patient may need to sue the manufacturer.