For the first time in South Africa, the concept of strict liability across the supply chain is provided for by the controversial section 61 of the Act. In short, this means that the consumer, who suffered damages due to a defect or danger in a product or in the provision of an unsafe product, now has the right to file suit against any person or entity within the supply chain without having to prove negligence. The consumer need only prove that the product was dangerous or defective and that he suffered damages as a consequence thereof.
According to many, the application of this provision is very simple. The doctor is responsible for damages suffered by a patient if the prescribed medication issued by that doctor to the patient is dangerous or defective or does not work satisfactorily and the patient suffered damages as a result thereof. But is it really that simple? To answer this question one will have to take out the stethoscope and carefully analyse the Act.
It is clear that our courts will have to assume a leading role in helping to clarify the issue of liability of doctors in terms of the Act for the medication prescribed by him/her. The following will have to be taken into account when considering such liability:
- Does the doctor who simply prescribes medication form part of the supply chain? Doctors may strongly argue here that they merely make a recommendation based on a diagnosis. The patient can always exercise his discretion regarding the pharmacy, whether he will request a generic alternative and whether he will, in fact, make use of the prescription at all.
- Can clinical medication be regarded as “dangerous” or “defective” in light of the nature thereof and intent of the Act? Medication is strictly regulated and only approved (registered) medication is provided to consumers. The medicinal purpose of medication is to provide a relative therapeutic result, taking into consideration acceptable possible side effects. In this light one would be able to argue that all medication could to a certain degree be seen as defective and dangerous. So what now? A further question that then arises is whether a faulty diagnosis and prescription by a doctor now renders the medication defective or dangerous? In such a case, it is more likely that the doctor will be held liable on grounds of negligence and not necessarily on the basis of strict liability.
- Reasonableness? The Act makes provision for reasonableness as a defence. The question that will have to be answered is whether it is reasonable to hold the doctor liable for defective or dangerous medication given the doctors’ role in the supply chain. It may be difficult to hold a doctor liable given their traditional role of merely prescribing medication.
- Division of blame? The Act empowers the courts to divide liability within the supply chain. This provision may count in favour of the doctor should the courts decide to rather allocate blame for defective or dangerous medication to the manufacturer and distributor of the medication.
We will have to wait and see how the courts will address the aforementioned questions, but one suspects that the Act will likely only have a limited application on doctors and the prescription of medication. The Act may very well provide bigger headaches for pharmacists and pharmaceutical distributors and manufacturers and the decisions of our courts will be highly relevant to these members of the supply chain.
In conclusion, it is important to note that although the Act, in the circumstances discussed herein, may only have limited application to doctors, doctors may still be held liable for traditional common law civil claims should they not act as a reasonable doctor when prescribing medication.