Therac-25 Medical Device Litigation and Product Liability

Introduction and Initial Action

As counsel for the family of a Therac-25 victim, I will begin by formally informing AECL that my clients are pursuing a legal action against it for the death or physical injury suffered by a relative and suggest that the firm consider meeting with my clients to explore the possibility of an out-of-court settlement. If this initial action proves ineffective, I shall file an action in court for damages arising from the victim's loss of earning capacity, compensatory damages for expenses incurred in the treatment of the injuries, and moral damages for the mental agony being experienced by the victim, if he or she is still alive. The claims shall be for present and future losses.

If the victim has passed away, the action shall be filed on behalf of his heirs for actual, compensatory, and moral damages plus attorney's fees. In either case, the suit shall be predicated on the negligence of the manufacturer, pursued as a tort suit based on judicial decisions. There is no federal law on product liability; such matters are governed by state tort law and common law principles.

The query, as submitted, presupposes that the death or injury to the victim was the immediate or proximate result of a defect in the machine built by AECL. In practice, a case of this nature is always pursued alternatively against both the hospital and the producer of the machine and, in some cases, also includes the operator or administrator of the equipment. The purpose is to increase the chances of the complainant for an award in the event the manufacturer can effectively show that the responsibility was due to error on the part of the operator who was then under the direct control and supervision of the hospital. This strategy will also force the several defendants to produce evidence putting the blame on one another while the complainant observes the proceeding. However, for purposes of this paper, we shall confine ourselves to the query as submitted.

The accident could not have occurred for any reason other than through the negligence, lack of foresight, or lack of skill of the operator or a defect in the equipment used—manifestations of a tortious act that is legally actionable. Initially, a complainant in a case of this nature must allege and prove that he or she submitted himself or herself to a medical institution for treatment of an ailment requiring exposure to a certain amount of radiation.

Establishing Negligence and Proximate Cause

The complainant must show that he or she conferred with a hospital that represented itself as having and using equipment and machines necessary for the delivery of the required treatment, in this case the Therac-25. The complainant must then allege that he or she was admitted for treatment at that hospital. As the suit is directed mainly against the producer of the Therac-25, there is not much necessity to produce proof that AECL deviated from its representations concerning the machine. The fact that its product was placed in the market, sold to the hospital concerned, which used it, and thereafter an accident occurred injuring a patient as a result of or during treatment are sufficient circumstances to give rise to a presumption of responsibility against its warranty that the equipment shall work in the manner that it was advertised. Also applicable is the legal maxim that the result "speaks for itself"—meaning the injury would not have occurred if not for the negligence of the defendant or defect of its equipment.

Next to be alleged in the complaint and proven during the trial is the direct or proximate connection between the damage, injury, or death of the patient and the negligence or want of care and precaution by the defendant AECL. While abstract allegations may be made in the complaint, a more detailed explanation must be shown during the trial. For example, it can be shown that in the development of software for the Therac-6, Therac-20, and Therac-25, only one programmer was utilized whose qualifications have been concealed and therefore are subject to challenge.

It may also be shown that in the development of the Therac-25 software, it was given more critical functions than the previous versions, such as "turning off the treatment beam after treatment or upon malfunction," "detecting hardware malfunction and delivering diagnostic messages," and "either pausing or suspending treatment." This increase in functions should have warranted a more thorough evaluation of its design by a complete team rather than by a single individual of questionable capabilities. Also relevant is the lack of sufficient testing of the software and system to achieve the level of machine safety that, as declared by AECL engineers themselves, would take "a hundred years" to accomplish.

In sum, what must be shown is the failure and inability of AECL to take such precautionary measures as the circumstances demand in order to assure the safety of persons who faithfully relied on its representations concerning its product. This negligence—in design, in development process, in testing, and in disclosure—directly caused the harm that the victim suffered.

I now take the position of defense counsel for AECL. By way of defense, the following may be shown, collectively or alternatively:

1. Patient Negligence: The injury to the complainant was not the direct or proximate result of the improper doses of radiation but rather by reason of the patient's own defiant or negligent actions.

2. Operator Liability: The improper doses of radiation were caused by the negligence of the operator of the machine who, at the time of the accident, was under the direct and immediate control of the hospital, an entirely separate and distinct legal entity.

3. Adequate Precautions: The defendant has taken all necessary actions and precautions, undertaken all tests and examinations to assure the effectiveness and reliability of its products.