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Abstract
Patients who have undergone treatment that has included the surgical implantation of
a prosthetic device can become dissatisfied for many reasons. One cause for
dissatisfaction is any adverse event where there is a demonstrable causal nexus with
the failure of a device that is defective or at risk of being so. The magnitude of
therapeutic product failure is considerable and therapeutic goods such as Vioxx,
Thalidomide, silicon-gel-filled breast implants, contaminated blood products, cardiac
pacemakers and valves, and orthopaedic devices are testimony to this. Many of these
events have exposed a greyish area of Australian law that balances medical
negligence with consumer protection and contract law. Australian product liability
legislation that regulates the use of therapeutic goods is a complex amalgam of law
that has at its foundations the Trade Practices Act 1974 (Cth) and the Therapeutic
Goods Act 1989 (Cth). When a surgical device fails there can be exposure to liability.
This thesis explores those important issues that can impact on individuals or on
organisations and it is evident that where issues of product liability concern implanted
surgical devices the current regulations for consumer protection may not always be
the most appropriate. It is evident that there is a culture of under-reporting of adverse
events to a Therapeutic Good Administration that does not have the resources to
investigate the cause for failure of a surgical device. Furthermore, there is a potential
for bias and conflict of interest in an environment where the regulator depends on the
regulated for the funding of its existence. Other issues include the complex and often
undesirable consequences of those partnerships that can evolve with the development
of an implantable device and with the undertaking of clinical trials, the role of the
learned intermediary, that interface between manufacturer and consumer, and the role
of the expert witness, that interface between justice and injustice. These and other
matters that can significantly influence any debate of implantable surgical device
product liability are explored and recommendations are made that might form the
basis of a Therapeutic Goods (Safe Medical Devices) Amendment Act.