The Medical Device Amendments of 1976 call for federal oversight of medical devices, which varies with the type of device at issue. The most stringent oversight is reserved for a Class III medical device, which is one used in sustaining human life, one of substantial importance in preventing impairment of human health, or one that presents a potential unreasonable risk of illness or injury. 21 U.S.C.S. Section 360c(a)(1)(C)(ii). As a result, Class III devices undergo a rigorous pre-market approval process before the Food and Drug Administration (FDA) will allow them to be sold and used. Therefore, Congress has expressly pre-empted state law tort claims regarding Class III medical devices approved by the FDA via the pre-market approval process. Based on Congress’ express pre-emption, courts throughout our nation have preempted all types of state law claims, including manufacturing defect, design defect, failure to warn, breach of express and implied warranty and fraud. For a thorough breakdown, see Riegel v. Medtronic, 552 U.S. 312 (2008).

For many years, the pre-emption defense has served as a Goliath in the courtroom for Class III medical device manufacturers. Manufacturers were able to wield the pre-emption defense as a mighty sword during the pleadings stage to obtain early victory and avoid the high costs of discovery and trial. In recent years, however, we have seen new liability theories raised to circumvent pre-emption by asserting claims of negligent advice of the device sales representative.

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