Last week, the General Accounting Office (GAO) released its review of the FDA’s 510(k) approval process. The 510(k) process allows manufacturers to get a device “cleared” for marketing a medical device without extensive study if the manufacturer submits evidence that the device is “substantially equivalent” to another device, known as the “predicate” device. Basically, this means that the device is either the same technologically and intended for the same use, or intended from the same use, but its differences don’t seem to raise any serious questions about the device’s safety.
The GAO report was a follow-up of its 2009 consideration of the 510(k) process, where it recommended that 27 types of devices it classified as “high risk” should not be allowed to utilize the 510(k) process because there was just too much risk that even minor technological changes could lead to potentially disastrous consequences. In at least one of these types of devices (hip implants), the GAO report seems to have been highly prescient. However, in the two years following the GAO’s recommendation, action has been taken on only one of the device types. The other 26 device types still allow 510(k) clearance, and at least 67 “high-risk” devices have been approved through the 510(k) process since 2009.
Despite the GAO’s recommendations, the FDA hasn’t limited access to the 510(k) process, and as a result thousands of people have been injured by devices that were not properly evaluated before hitting the market. And obviously manufacturers are not shy about using the process, which lets them market technologies quicker and cheaper than utilizing the pre-market approval process.
However, you can help persuade manufacturers to go through the pre-market approval process rather than elect the 510(k) shortcut. According to Supreme Court decisions (starting with Riegel v. Medtronic), medical devices approved through the pre-market approval process are immune from state-based lawsuits. It makes sense. If the FDA worked with manufacturers to thoroughly evaluate the safety of a medical device (not prescription or over-the-counter drugs, for which the law is different), the law says that the manufacturer cannot be considered negligent if the device later turns out to be dangerous. After all, mistakes happen.
But, 510(k) clearance offers no such protection. Medical devices that have only been cleared by the FDA are not protected by Federal law. For now, at least, if you have been hurt by a medical device that has only been cleared by the FDA, you can pursue compensation for your injuries. If all victims of defective medical devices that were not adequately screened get together to pursue compensation, the profit margin for taking the 510(k) shortcut will be cut down dramatically or even erased, encouraging manufacturers to take responsibility for their defective medical devices.
If you have been hurt by the DePuy Hip Implant or another medical device that was only cleared by the FDA, but not approved, the product liability lawyers of Robert W. Kerpsack, CO, LPA can help. Please call or email us today to schedule your free case evaluation.