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.

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.