A common question among consumers who suddenly find themselves affected by a product recall is, “What is the process for FDA approval?” As a DePuy Hip Implant Recall attorney, I hear the question quite often. Surprisingly, the process is rather simple for products such as hip, knee, and shoulder replacements and parts.
DePuy Hip Implant Approval Process
According to the FDA, DePuy’s first step towards FDA approval is the successfull completion of a number of clinical testing procedures set up by the FDA. However, in this instance, DePuy was able to avoid FDA scrutiny and it’s screening process by using a legal ‘back door,” which allowed it to circumvent the normal approval channels. This legal backdoor is known as a “510(k),” which permits pharmaceutical companies like DePuy (a subsidiary of Johnson & Johnson), to avoid the normal screening process by claiming that their hip implants would be a “substantial equivalent” to other implant devices that have already been approved by the FDA. By claiming that their product was the “substantial equivalent,” DePuy was able to gain quick approval by the FDA to market and sell it’s ASR XL Acetabular hip implant system within the United States.
Unfortunately, the United States does not have an effective hip implant registry system to determine what the failure rates were for DePuy ASR hip implants and other substantially equivalent implants. This data had to come from the United Kingdom and Australia. Those hip implant registries demonstrated their ability to prevent patient harm. In both the United Kingdom and Australia, the registries were so successful in revealing data that showed the early and unacceptable failure rate of the DePuy hip implant system, DePuy phased out the hip implants long before the American recall. Now, given the debacle over the DePuy hip implant recall, the United States and the FDA are considering creating their own registry for implants, so that potential defects and patient harms can be identified sooner rather than later.
DePuy Hip Implant Recall Attorneys in New Jersey and Philadelphia
By cutting corners and dodging red tape, DePuy was able to skirt their responsibilities to their consumers. Had those implants been properly tested and assessed by the FDA, approval would have been halted and kinks worked out before patients could be harmed. If you or a loved one have been affected by a defective DePut hip implant, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
Let the team at the Mininno Law Office earn you the compensation you deserve.