Therapeutic Corporation makes medical devices that are subject to extensive government regulation and undergo a rigorous premarket approval process. In a design defect product liability suit against Therapeutic by a party allegedly
injured by one of the devices, the company can most successfully raise the defense of

a. preemption.
b. assumption of risk.
c. comparative negligence.
d. knowledgeable user.

A. Preemption

Explanation:

In the case of injury, the company can raise a defense of preemption given that a state is prohibited from safety requirements different from the federal requirements. Hence, since the medical device underwent rigorous premarket approval process, the company could get complete immunity for design defect liability. For devices that go through the premarket approval process (PMA), companies are assumed to be immunize from common personal injury caused by device defect.

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