Simply put, DePuy was able to spot an ambiguity in FDA regulations to bypass the routine clinical testing procedures required for many health-care devices to pass. Particularly, the company outwitted the FDA’s premarker notification process, also called 510(k). All they did was claim that their hip implants were ‘substantially equivalent’ to those previously approved by FDA. In short, this allowed the company to smoothly sell their metal implants to the market, without having to undergo the lengthy clinical testing.
On a much bigger picture, this premarket notification process can be even more detrimental. Other companies might claim that their products are also ‘substantially equivalent’ as those products who have also used the same loophole. The older predecessors of the hip implants might not even be reliable, so a series of unfortunate events can likely happen because of this mad and senseless regulation. Undeniably one of the most infamous government agencies, FDA ought to review their rules regarding this matter. There would have been less defective implants if stricter policies from the FDA were implemented beforehand.
Moreover, DePuy spent an estimated amount of $5,000 in 3-6 months worth of time to gain a successful FDA approval of their hip replacements. Sadly, this does not outweigh the damages it has caused to 93,000 recipients at a global scale. Victims lost money, self-esteem and even the hope of achieving well-being because of the complications of the faulty implants. Are you a victim of this negligence? A hip recall lawyer specializing in personal injury and medical malpractice cases can help you deal with your situation.