Abstract
One of the defences within Part 3-5 of the Australian Consumer Law is the state of the art, or development risk defence. This defence, although significant, has often been neglected in Australian jurisprudential analysis and has triggered at most generic academic analysis. However, with the rise of pharmaceutical and medical device litigation in Australia, it could become a vital weapon for Australian manufacturers against product liability claims. This paper will firstly review the two ways this defence could operate. It will also discuss the three types of defects which the defence could apply to. This paper aims to determine exactly when and how this defence should apply in Australia, in the context of pharmaceutical product liability claims.
Highlights
This paper aims to determine exactly when and how this defence should apply in Australia, in the context of pharmaceutical product liability claims
The defence was included in the Trade Practices Act 1974 (TPA), Part VA2 which was enacted in 1992 by the Trade Practices Amendment Act 1992 (Cth). (In 2010, the TPA regime was replaced by the Competition and Consumer Act 2010, which contains the Australian Consumer Law (ACL) in Schedule 2.) Controversial in nature, the defence has spawned numerous pieces of literature debating its scope, limits and benefits, as well as questioning the overall wisdom of including a defence in a purportedly strict liability regime.[3]
The aim is to deduce from the literature and overseas case law the answers to two questions for the Australian legal landscape, in the context of pharmaceutical products
Summary
Two roads diverged in a yellow wood And sorry I could not travel both – Robert Frost.[1]. Section one will review the historical background of the defence and what limited case law there is available in Australia, to date. This exercise will reveal a rather sporadic and incomplete approach towards this defence by the Australian courts; in part possibly caused by the fact that parliament was not clear about how their objectives for the defence were to be prioritised. Section two reviews five cases from overseas jurisdictions which have either applied or considered the defence in obiter. Section three puts the two roads in context as the academic literature explains the two approaches – the narrow versus the reasonable interpretation. This paper will conclude with some final recommendations which will hopefully guide future law reform initiatives
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