Doctors, Devices and Defects: Product Liability for Defective Medical Expert Systems in Australia

Australia is committed to the adoption of electronic decision support (Medical Expert Systems or MES) as a vehicle for the reduction of medical error. The take up of these technologies, however, will depend in part on the balance achieved by the law, between the appropriate regulation of such technologies and the extent to which manufacturers and developers may face direct liability for injuries associated with their use. Presently, manufacturers of such systems may face strict liability under Australia's product liability laws for injury caused by 'defective goods'. As 'medical devices', such systems are also regulated under the Australian therapeutic goods regime. For a number of historical and interpretational reasons, product liability provisions are unlikely to provide an effective cause of action in relation to MES. This is because computer systems and the information contained within them are not easy to characterise as 'goods', the question of whether software defects are manufacturing or design defects, difficulties in determining whether a defect arose before or after supply, and the issue of whether reliance on information (mediated or otherwise) can itself be said to be a proximate cause of injury. This paper takes the view that were product liability laws to have operation, it is unlikely to be such as to impose strict liability on the manufacturers of MES for design defects. A regulatory balance may, however, be achieved through legislative regime regulating the use of therapeutic goods. This regime is not affected in its operation by the interpretational difficulties referred to above in connection with product liability, and allows for the assessment of the devices on the basis of the purpose for which, and the conditions under which, the devices were intended to operate.