Think your brand-new, state-of-the-art medical device received rigorous approval before being approved? Most likely not. A significant proportion of medical devices (approximately 3000 per year) receive what is known as 510 (k) approval. Under section 510(k) of the Food, Drug, and Cosmetic Act, devices are allowed to get approval for marketing if they are “substantially equivalent” to another device already approved for the same purpose.

Some have questioned whether this is a good standard. After all, “substantially equivalent” doesn’t mean identical, and approved devices may have unthought-of significant differences. Some notable defective medical devices that recently received 510(k) approval include the DePuy Hip implant and Zimmer knee replacement implant. In both cases, there are reasons to believe that “substantially equivalent” does not mean “safe” or “effective.” As a response to devices like this, the FDA was considering reviewing its procedures for handling these types of applications, but decided to back off last week in response to industry pressure.

However, where the government fails to protect people from dangerous medical devices, you can help. The Supreme Court decision Riegel v. Medtronic prevents people from bringing state-based lawsuits for failure to warn or implied warranty violation for medical devices that have been approved using the FDA’s more rigorous premarket approval process. However, the decision may not cover devices approved under the 510(k) system. If lawsuits target these devices, manufacturers will learn that skirting the rules is not profitable and will turn to the more rigorous approval process that will hopefully identify defective medical devices before they hit the market.

If you have been hurt as a result of a medical device, you are entitled to more than compensation. You are entitled to know that the company that hurt you with its defective device is not profiting from your pain. To begin a product liability lawsuit over a defective medical device, please contact Robert W. Kerpsack, CO, LPA today for a free consultation.