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Real Users versus Ideal Users

Products liability law is largely judge-made law derived from cases involving real product users, not idealized users who read manuals and follow instructions. Most products liability cases involve either mass market devices such as power saws and lawnmowers or industrial machine tools such as lathes. These cases have shaped the definition of a reasonable product user in a very contentious way. As an illustration, reasonable lawnmower users have used lawnmowers as hedge trimmers, given children rides while cutting the grass, and used their hands to remove debris from the turning blade. Lawnmower manufacturers have been found liable for not engineering protection to prevent these reasonable misuses.

It is important to understand how the law reaches the conclusion that a manufacturer should foresee that people will stick their hands in running lawnmowers. People do not always use machines wisely. Physicians, attorneys, and even engineers stick their hands in lawnmowers because they are unskilled in the use of these machines. When otherwise reasonable people have these sorts of accidents, jurors assume that the accident should have been prevented by the manufacturer. In contrast, the law does not require that airplanes be error proof because airplanes are used only by trained pilots. If airplanes were flown by untrained users, they would have to be designed like lawnmowers. Since it would be impossible to design an airplane for these users, the airplane industry exists only because various legal restrictions prevent untrained or incompetent pilots from flying airplanes.

The vast majority of states do not require medical device users to be licensed, trained, or tested for competence. It is not unheard of for a general practitioner to perform surgery while supervising a nurse's aide delivering anesthesia. Even board certification is no guarantee of a competent user of an anesthesia machine. Certified anesthesiologists are not retested for competence in the rapidly changing field of anesthesia technology. Anesthesia machine manufacturers, like most other medical device manufacturers, have not attempted to restrict the sale or use of their machines to trained users. They have delegated the assessment of user skills to the medical profession.

Physicians, however, treat medical devices like lawnmowers: they use them without training and sometimes figuratively stick their hands (or the patient's hand) into the blade. Faced with this user group and the failure of anesthesia machine manufacturers to attempt to control the use of their machines, the courts have rationally concluded that medical devices are like lawnmowers rather than airplanes. This caused a crisis in anesthesia machine manufacture but one that has abated because of increased pressure to ensure the competence of persons providing anesthesia services. Physicians in other specialties that are technology dependent should heed the lesson from anesthesia and demand that complex devices be used only by properly qualified personnel.

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