In Waltenburg v. St. Jude Medical, Inc., a man received an implantable cardioverter defibrillator (“ICD”) that was manufactured by St. Jude Medical, Inc. The electrical ICD device was inserted into the man’s body through a vein and then attached to his heart in an effort to correct irregular heart rhythms. Not long after the device was implanted into the man’s chest, he apparently began experiencing unexpected and unnecessary electrical shocks. Several years later, the man’s physicians reportedly told him that the ICD device implanted into his body was faulty, but it was too risky to remove it. The man filed a products liability lawsuit seeking damages for physical injury and emotional distress from the manufacturer of the ICD in the Western District of Kentucky.
In his complaint, the man claimed the medical device manufacturer was strictly liable for the allegedly defective ICD. He also claimed the company manufactured the product in a negligent fashion, negligently failed to warn him about the product defect, and alternately should be held accountable through the doctrine of negligence per se. A negligence per se cause of action normally arises when someone is injured after another party violates a law that was designed to protect the public or a specific class of individuals from the type of harm that the injured person sustained. In general, negligence per se is easier to prove than other types of negligence because the reasonableness of an at-fault actor’s conduct is not at issue.
The medical device manufacturer countered by alleging the man’s claims were preempted by the Medical Device Amendments (“MDA”) to the federal Food, Drug, and Cosmetic Act and argued the lawsuit should be dismissed because the man failed to state a claim on which relief may be granted. Preemption occurs when a state law conflicts with a federal law in such a way that the purpose of the federal law is thwarted. According to the Supremacy Clause of the United States Constitution, federal law controls in such cases.