Implantable surgical devices issues of product liability

摘要

Patients who have undergone treatment that has included the surgical implantation ofa prosthetic device can become dissatisfied for many reasons. One cause fordissatisfaction is any adverse event where there is a demonstrable causal nexus withthe failure of a device that is defective or at risk of being so. The magnitude oftherapeutic product failure is considerable and therapeutic goods such as Vioxx,Thalidomide, silicon-gel-filled breast implants, contaminated blood products, cardiacpacemakers and valves, and orthopaedic devices are testimony to this. Many of theseevents have exposed a greyish area of Australian law that balances medicalnegligence with consumer protection and contract law. Australian product liabilitylegislation that regulates the use of therapeutic goods is a complex amalgam of lawthat has at its foundations the Trade Practices Act 1974 (Cth) and the TherapeuticGoods 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 onorganisations and it is evident that where issues of product liability concern implantedsurgical devices the current regulations for consumer protection may not always bethe most appropriate. It is evident that there is a culture of under-reporting of adverseevents to a Therapeutic Good Administration that does not have the resources toinvestigate the cause for failure of a surgical device. Furthermore, there is a potentialfor bias and conflict of interest in an environment where the regulator depends on theregulated for the funding of its existence. Other issues include the complex and oftenundesirable consequences of those partnerships that can evolve with the developmentof an implantable device and with the undertaking of clinical trials, the role of thelearned intermediary, that interface between manufacturer and consumer, and the roleof the expert witness, that interface between justice and injustice. These and othermatters that can significantly influence any debate of implantable surgical deviceproduct liability are explored and recommendations are made that might form thebasis of a Therapeutic Goods (Safe Medical Devices) Amendment Act.