Hip Recall Law

Recently, recipients of the defective hip implants from DePuy Orthopaedics have been busy consulting lawyers, gathering their documents and airing out their rage. Have they thought about how this even started in the first place? Going back to the production of these implants, and the consequent entry of these devices to the market, you might wonder how the government has ever allowed such process to occur. The Food and Drug Administration should hold responsibility for that matter.

By all means, products designed for health care and medical-surgical procedures should pass standard testing protocols set forth by the FDA. DePuy, however, was able to detect a loophole in one of the regulations from the government agency. Eventually, they were able to outsmart the 510(k) process, or the premarker notification process. To cut to the chase, DePuy used this process, and simply claimed that their ASR devices were 'substantially equivalent' to earlier hip implants endorsed by the FDA. Victory comes for the company, because they can skip the routine clinical testing procedures to sell their implants in a jiffy. This means more money for them. This 'substantial equivalence' is a unique trait of the premarker notification process. In as much as DePuy should review their process of creating their hip implants, the FDA should perhaps revise their lax policies as well. Had they implemented more rigid regulations, the FDA would have controlled the upsurge of defective implants into the international market.

Looking at the bigger picture, you can imagine how future manufacturers can follow this scheme. They can also claim that their products are 'substantially equivalent' to similar previously approved devices. Worse, they can compare their products as 'substantially equivalent' to that of DePuy's. The consequences of this mad string are left for the innocent people to suffer.

The recipients of the metal hip implants did not see this coming, because all that they ever wished for was to achieve optimum health. They invested too much money, time and effort for the sake of justice. If you have been affected by the DePuy hip recall, it is high time for you to consult a lawyer so that your claims can be evaluated.