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How Is An Anesthesia Machine Like A Lawnmower? The Problem Of The Learned Intermediary

by Edward P. Richards, III, J.D. and Charles Walter, Ph.D., J.D., 8 IEEE Engineering in Medicine and Biology Magazine #2, pg. 55 (June 1989)

Not too long ago, unhappy kings ordered the execution of messengers who brought bad news. Today, it is more fashionable to blame lawyers for bad news. The bad news, however, is that problems exist in our society. Lawyers are the messengers who report this bad news through the development of "Band-Aid" solutions such as the exclusionary rule (to protect innocent individuals accused of a crime from heavy-handed interrogation tactics) and products liability (to protect consumers from injury caused by dangerous products).

Products Liability Revisitied[1]

This article is the first in a series about the dilemmas posed by products liability law. Criticism of products liability has roots deeply embedded in our free enterprize system. The basic question is whether the costs of injuries caused by a commercial product should be borne solely by those who are actually injured by the product, or spread more or less evenly over all beneficiaries of the product. Without products liability law, the costs of injury due to a dangerous product that was not made negligently is borne sole by the individual injured, i.e., the costs are not included in the purchase price of the product. With product liability law, the anticipated costs are shared more or less evenly by all beneficiaries of the product, i.e., the costs are included in the purchase price. Profiteers dealing with products that cause more injury than competitive products favor assigning the costs to those actually injured. This keeps the price of their products competitive with their less injurious competitors. Manufacturers and sellers of products for which there is no competitive counterpart, and consumers who are never injured also tend to favor assigning the costs to those actually injured. On the other hand, manufacturers and distributors of products that cause less injury than competitive products and consumers who are actually injured have an interest in spreading the injury costs over all consumers.

Our solution to the products liability dilemma facing manufacturers and distributors of medical equipment involves using a new approach to managing the legal risks of medical devices.

While there is a liability crisis in the medical device industry, it is not completely the fault of lawyers. As this article illustrates, manufacturers of complex medical devices may have an unrealistic expectation about user expertise which often causes injury to patients, thereby leading to litigation over the devices. Sometimes patients die because complex devices are used by unskilled personnel. It is impossible to manage the legal risks of complex medical devices without addressing this problem.

INDEX
What Is the Learned Intermediary Problem?
A Classification System For Machines
Classifying Medical Devices
Real Users Versus Ideal Users
The Real Users of Medical Devices
Conclusions

ENDNOTES

Walter, Charles, Engineering and the Law, Part IV: Products Liability, IEEE Eng. Med. Biol. 6(1) 62 (1987).]. [return to text]


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