How Do Defective Medical Devices Get Past The FDA?

If you or a loved one has been the victim of a defective medical device, you are not alone. Over 100,000 defective medical device cases have passed through U.S. courts in the last year.

One of the questions you may be asking is how do defective medical devices get past the Food and Drug Administration (FDA) and onto the market where they are sold, bought, and can ultimately injure unsuspecting consumers?

Well, what most people are unaware of is the fact that the FDA does not test drugs or medical devices. They rely on the pharmaceutical companies themselves to submit honest safety reports about their products. This is like asking the fox to guard the hen-house and, of course, large pharmaceutical companies have learned how to take advantage of the system so that the FDA doesn’t look too closely at their products.

Here is how they do it:

If you have a brand new type of medical device, the FDA approval process is very involved and takes a long time. A company seeking to sell a brand new type of medical device is required to conduct many studies and provide the FDA with scientific proof of the product’s safety and effectiveness, and this data must be vetted by the FDA itself.

On the other hand, if a company is seeking approval for a device that is substantially similar to a device that has already being produced and marketed, the process will be very different. Under the FDA’s 510k process, a device that is substantially similar to a product that is already on the market can be cleared for sale without clinical trials being done and without the manufacturer having to prove to the FDA that the device is safe.

The FDA’s 510k process has been taken advantage of by medical device manufacturers for years. What’s ironic is that these companies tell the FDA that their product is nothing new, so that they can avoid rigorous scrutiny. While on the other hand, they tell doctors and patients that their products are groundbreaking, innovative, and more effective than all those that came before.

Pharmaceutical companies are at war with each other to get products on the market as fast as possible and then to convince the public that their product is the best. It is essentially a bidding war for market share where American consumers, specifically those who are injured by unsafe products that were rushed to market, ultimately pay the price.

If you or a loved one has been a victim of a defective medical device, you may be entitled to substantial compensation for your losses. Call The Hayes Firm: Attorney Finding Service. We help families find skilled defective medical device lawyers who can assist them in seeking the compensation they need and deserve. Call us today at 1-800-603-6833, or contact us online to arrange a free consultation.