In every case there are legal hurdles that must be overcome. In some defective medical device cases, like Essure or InFuse Bone Graft, the legal hurdles are higher. That does not mean they cannot be overcome, we just have to fight harder.
The main legal hurdle people injured by specific defective medical devices must leap over is the legal defense of preemption. Typically, the medical device manufacturers use this defense to focus the litigation on whether an injured person has the right to pursue a claim against the manufacturer. Their strategy is to dismiss cases under the legal theory of preemption. Briefly, the theory is based on the fact that a medical device, like Essure or InFuse, received premarket approval (“PMA”) by the FDA, which is claimed to be a more rigorous approval process. Thus, a medical device can be said to be FDA approved. John Oliver does a great job explaining the difference between an FDA approved medical device and a FDA cleared medical device.
In 2008, the Supreme Court ruled in Riegel v. Medtronic that some tort claims for defective medical devices are preempted by federal law if the device received PMA, meaning some cases cannot be litigated. As a result of Riegel, this left people injured by a FDA approved medical device without recourse or a remedy.
Manufacturers of defective medical devices try capitalize on Riegel and use it to escape accountability. We fight hard to hold them accountable and overcome the preemption hurdle. While it is challenging, it is not impossible. Yaeger Law is up to the challenge.