The abstract of ‘Class Actions and Regulatory Failures – Medical Devices and the TGA’ by Wendy Bonython and Bruce Arnold presented at yesterday's Civil Law conference at Melbourne University
Class actions are increasingly serving as a vehicle for litigation in Australia by plaintiffs who have been affected by defects in medical appliances and pharmaceuticals, typically products from multinational corporations based in the northern hemisphere, and initially regulated by bodies such as the US Food & Drug Administration.
To date, Australian litigation has focussed on the negligence of manufacturers; however in many instances it could be argued that regulatory failure was a contributing factor, given that gatekeepers such as Australia’s Therapeutic Goods Authority (TGA) have been described by critics as slow to recognise and act upon substantive indications from overseas of problems with particular products such as breast and hip implants and pharmaceuticals. Bureaucratic incapacity or indifference on the part of the gatekeepers means that consumers are likely to have suffered an injury whose direct financial cost outweighs the cost of running the particular agency. Are those gatekeepers immune from negligence action? Should they be immune?
In this paper, we consider the historical liability of statutory authorities in negligence, based on the public/private activity distinction, and whether it remains appropriate in the context of market regulators, such as the TGA, or whether regulators should be identified as defendants more often in class actions of this type. We provide figures that are useful in making sense of public policy conundrums and outline work in progress.
Somewhat of a change from my paper on 'A Privacy Tort? Phar Lap, Possum Pie, Prince Albert and the HCA'
