In parts I and II we discussed the basis for personal liability of engineers. It was pointed out that there are at least three ways that legal liability can arise for engineers. The first, breach of contract, was discussed in Part II. Here we discuss the second basis for engineering liability: professional malpractice based on negligence. Negligence is conduct which falls below the standard established by law for the protection of others from unreasonable risk of harm. Negligent conduct can be either an act or an omission to act. The unreasonableness of a risk of harm is determined by weighing the danger and the utility of the act in question. The utility of the act is determined by considering the social value of the conduct, the probability that this societal interest will be advanced by the conduct, and the extent that the interest could have been advanced by less dangerous conduct.
It is more important that engineers note carefully the last requirement. For biomedical engineers, the utility of a medical device lies in its benefit to patients. The potential for harm is common to all technology, but it is particularly large in the case of devices used to treat the ill. According to the last requirement, a medical device that merely advances the healing art may be insufficient: it can then be the basis for a negligence action against an engineer if a less dangerous device could have been provided. In the language of costs and benefits, the choice is not a qualitative one between using or not using a medical device, but a quantitative one of selecting the least dangerous conduct from the universe of possible actions. Because the standard is so strict when judged on this utilitarian basis, it is not in the interest of engineers and other professionals to try to justify conduct solely in terms of costs and benefits.
A certain dangerous surgical procedure had a risk rate of 1 death per 1000 operations. A biomedical engineer (Smith) invented a device which, when used during the procedure, would reduce the risk rate substantially. Smith estimated that the device could be marketed for $7,000 with a set of monitoring gauges or $5,000 without the gauges. Further, the gauges could be marketed separately for $2,200 and used with the $5,000 model. Since the gauges were a standard item already on hand in most hospitals, Smith marketed the $5,000 version of the device and the $2,200 gauges as an option. During the next four years, over five million procedures were performed with the aid of Smith's device, mostly without the monitoring gauges. Smith's device was quite successful medically in that the risk rate for the surgical procedure using the device was reduced to only about 1 death per 100,000 operations. The device was also very successful financially in that Smith sold 3,350 devices, although only 16 gauges were purchased as options. However, when a surgeon used the device without the monitoring gauges on Jones, unexpected complications which could have been avoided with the gauges arose, and Jones died. Jones' widow and four children sued the surgeon and Smith for professional malpractice. Since the surgeon followed normal procedures for her profession, she was found not liable. Smith argued that his device saved 4,950 lives and $6,664,800. Jones' widow argued that the gauges would have cost only $1.34 per operation and would have saved the life of the father of her four children. The jury found Smith's conduct to be negligent and awarded judgment for Jones' widow and children.
Medical devices are different from many other products in that the user is a skilled professional, but the beneficiary (or injured person, if the device harms someone) is a third-party nonuser. Historically, the courts have been very sympathetic to injured third-party nonusers of harmful products, because, by their very nature, such users are innocent bystanders. Thus, biomedical engineers should not view their role as merely assisting physicians. Biomedical engineers have a clear professional responsibility of their own to patients to provide the least dangerous medical device available. Engineers who acquiesce to physicians' demands for less risk being found guilty of professional malpractice.
A standard for the protection of others from unreasonable risk of harm may
be established by administrative regulation. Since a primary purpose of many
product standard regulations is to reduce risk to consumers, their effect is
to increase product standards. It seems clear that in practice, product standard
setting establishes, both in the private sector and by federal regulation, the
minimum standard for a defendant in a negligence action. Note that while such
standards may establish necessary conditions, they do not define conditions
that are sufficient to establish that conduct is not negligent. Thus, neither
private sector product standards nor standards set by the FDA are sufficient
to establish criteria for identifying non-negligent biomedical engineering conduct.
Professional service done without the competence recognized in the profession as necessary to prevent it from creating an unreasonable risk of harm to another falls below the standard for non-negligent behavior. In general, one who undertakes to render services in the practice of a profession is required to exercise the skill and knowledge normally possessed by other members of the profession. Professional skill is thus required of any person who provides services in the practice of a profession such as engineering. This represents the minimum skill required: if the engineer actually has greater skill than that common in the profession, s/he is required to exercise that skill. Further, if an engineer represents that s/he has superior skill or knowledge, s/he incurs a legal obligation to exercise that superior skill or knowledge. Thus, an engineer who represents that s/he is a specialist in biomedical engineering is required to use the skill and knowledge common to other biomedical engineering specialists. Further, an act is negligent if done without the preparation recognized by the profession as necessary to prevent the creation of unreasonable risk of harm.
While studying for his bachelor's degree in electrical engineering, Smith took
a three-hour course in biomedical engineering. Upon graduating cum laude, Smith
set up a biomedical engineering consulting service for clinics and small hospitals.
A client hired Smith to advise them about medical device maintenance. Smith
provided advice about a wide variety of medical instruments. One instrument
was improperly maintained because Smith erroneously thought it was of a type
he learned about in engineering school. The device malfunctioned during a surgical
procedure, and the surgeon (Jones) cut off two fingers. Jones sued Smith for
malpractice, and Smith defended by claiming that his services were performed
with the skill and knowledge provided by engineering school. However, the court
held for Jones, noting that Smith had represented that he had superior skill-that
of a specialist engineer-which required more than a regular engineering degree
supplemented by a three-hour course.
It is important to realize that, generally, the law does not permit individuals to avoid liability for negligence by warning others that s/he intends to do an act which involves a risk of harm to them. If the person who is likely to be harmed reasonably remains in the danger zone, the effect of the warning may be nil.
Since engineers usually do not deal directly with parties injured by their products, it is important to realize that negligent conduct includes acts involving an unreasonable risk of harm to others through the foreseeable action of the other, a third person, or a force of nature. It also includes acts likely to cause a third person to do something carelessly, unskillfully, or without adequate preparation or warning, as well as acts wherein the risk arises through the continuous operation of a force started by the act. Thus, engineers may be negligent for failing to anticipate the foreseeable actions of others, or for failing to take into account the ultimate consequences of their professional decisions this principle may also apply if the engineer should have realized that the negligent, reckless, or criminal conduct of others would create an unreasonable risk of harm. For example, a biomedical engineer who designs a medical device according to specifications provided by physician-users, rather than according to safety considerations for the patient, may be negligent.
There are no fixed rules about when it is necessary to guard against the unlawful conduct of others. If the probability of such conduct is relatively slight, and the utility of the action relatively great, it may be acceptable to ignore the risk and proceed on the assumption that others will not act negligently, recklessly or in a criminal manner. On the other hand, if, as is usual with medical devices, there is a serious chance of grave harm to others, it may be necessary to take precautions against the unlawful conduct of others. The risk of such conduct may be increased by the fact that the engineer knows that there are irresponsible persons who are likely to be negligent, or it may be decreased by the fact that competent and responsible persons will be in charge of subsequent events. For example, it might not be negligent to design a medical device to be used by a team of competent physicians, whereas providing the same device, without additional safeguards, to a less competent team might be negligent.
St. Ann's Hospital hired an independent biomedical engineer (Smith) to build an instrument cart to hold surgical instruments during procedures and to transport them to the sterilization area afterwards. Smith built a nifty chrome cart with canister wheels and a sectioned top for separation of the various instruments. One day, after being used in the operating room, a cart and instruments were being wheeled by a nurse to the sterilization area. A despondent patient ran from his room, took a scalpel from the top of the cart, and attacked another patient (Jones). Jones sued Smith for failure to include a secure chamber on the cart of securing the instruments during transport. Smith defended by claiming that the act of a despondent patient was unforeseeable and therefore, failure to include a securing device was not negligent. The court disagreed and awarded damages to Jones, noting that the biomedical engineer should know that hospital patients may become despondent and exhibit unpredictable behavior.
It may be negligent conduct to use an instrumentality, whether a human being or a thing, that is inappropriate, incompetent, or defective. If the use of the instrumentality is particularly dangerous unless the person entrusted with it possesses special skill, it is negligent to entrust the use to an individual without taking reasonable care to ascertain that s/he possesses the competence necessary for its safe use. It is important to realize that when a person possessing professional skill in biomedical engineering turns a medical device over to a non-engineer, the recipient will ordinarily assume that the device is fit for the purpose for which it was engineered. If the user is an expert in another field (e.g., a medical doctor), s/he should inspect it for functional safety, but she cannot be relied upon to understand the underlying engineering principles with which it was constructed. Thus, an engineer who knows (or should know) that a medical device is unsafe, but nevertheless permits it to be used, may be negligent, if, as is usually the case with medical devices, the use creates an unreasonable risk of harm to others.
Finally, a misrepresentation of fact may be negligent conduct. A conscious misrepresentation which is likely to induce action which involves an unreasonable risk of physical harm to others subjects the maker to liability even if s/he did not intend the harm. Negligence in ascertaining the accuracy of information or the manner in which it is communicated may also subject the maker of a mistaken-representation to liability, even if s/he did not intend to misrepresent the fact. This rule finds particular application where professionals give information upon which the safety of the recipient or a third person depends. Thus, it is as much a part of the professional duty of an engineer to give correct information about the safe use of a medical device, as it is to build the device in such a manner that it is capable of safe use. While the duty to provide safety information falls to the user of the device, liability for failing to do so extends to others. For example, a biomedical engineer who fails to give correct information to a physician-user of a medical device would be liable for patient injuries resulting from the incorrect or missing safety information.
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