Product Liability Defenses
Strict liability is not absolute liability. There are several defenses for products in general,
and additional defenses for medical devices. The most fundamental is that the defective product did not cause the injury at all. This defense arises frequently in clinical engineering because the most critically ill patients tend to be the most instrument. If a pacemaker fails and the patient dies of an arrhythmia that the pacemaker was implanted to control, then it is highly likely that the defective device caused the injury. The hospital itself also could be liable if the nursing staff failed to notice the arrhythmia because they were not monitoring the patient properly. If an electronic thermometer fails, masking a patient’s fever, it is unlikely that it is what caused the patient’s death from pulmonary embolism a few minutes later.