On April 13, 2011, the Senate Special Committee on Aging held a hearing on how medical devices are approved for sale by the Food and Drug Administration. The recall of hip replacement devices by DePuy was also discussed, placing emphasis on the importance of the testing and post-market surveillance of medical devices.
The FDA has two processes to approve medical devices: the Premarket Approval Process, which requires clinical trials, and the fast-track process, which only requires that a product is similar to others already approved for the market. The DePuy ASR hip replacement device was approved through fast-track process, which only conducted minimal testing. This process has come under scrutiny because hip implants are considered a high-risk device.
Patient safety advocates testified at the hearing, as well as industry representatives, and an ASR hip implant recipient. The patient explained that her doctor received $600,000 in consulting fees from DePuy Orthopaedics, which is consistent with a bribery complaint recently settled by Johnson & Johnson, DePuy’s parent company. The company admitted that it bribed health-care providers in order to sell their products, including the DePuy hip replacement device.
See this special report on the recall.
If you, or someone that you love, was affected by the Johnson and Johnson DePuy ASR hip implant device recall, consider getting a free consultation with defective product attorneys. They can tell you whether or not it is advisable to pursue your case, as well as explain all your legal options as a victim of a faulty product.
IW