Registries Save Lives and Protect the Health of Citizens
When a company wants to introduce a new drug or medical device to the U.S. market, it needs approval from the U.S. Food and Drug Administration (FDA). However, under a provision known as a "510(k)" approval, companies that claim their products are "substantially similar" to products already on the market can circumvent the clinical trial process. These trials protect the health of citizens and keep dangerous products off the market. DePuy used 510(k) approval to get its ASR implants to the market quickly despite significant differences between the ASR implants and the implants to which they were supposedly substantially similar.
Another startling example of how necessary an early warning system is in this country is that currently manufacturers are trusted to provide the FDA with information about problems with their products. Any time there is an adverse reaction to a drug or medical device failure, the manufacturer is required to send reports to the FDA, but has no legal obligation to collect this information except for rare situations where the FDA requires it. Years before the 2010 DePuy hip replacement recall in the U.S., the company knew of serious problems with their ASR XL Acetabular System and ASR Hip Resurfacing System. Everyone assumed that DePuy was aware of the problems and would report them to the FDA. Yet, because it had no legal obligation to collect this information, DePuy could claim ignorance and continue marketing and selling their defective implants.
You May Be Eligible to Claim Damages in a Hip Replacement Lawsuit
If you have a DePuy ASR implant, you may be entitled to compensation for your pain and suffering, the considerable discomfort of having to undergo a replacement surgery and the risks to your health these devices present. The hip replacement lawyers at the Rottenstein Law Group will advocate for your rights and will work hard to help you receive the fair and just compensation you deserve.