Surgical innovation presents a vital, albeit controversial, platform for scholarly discussion in health law and ethics. As recently observed in the Lancet, (1) many crucial medical advances, including organ transplantation, hip replacement and substituting heart valves, could not have occurred without the efforts of innovative surgeons. Nevertheless, achieving advances in biomedicine can also present substantial risks for patients, which may continue well beyond the initial stage of innovation as practitioners acquire and perfect new skills. Conflicts of interests were flagged as a particular point of contention, both with regard to patients' interests as well as the potential to compromise the integrity of the innovation process itself. (2) Within such an enquiry about the ethical limits of professional practice, it behoves us to consider the legal foundations of the doctor-patient relationship upon which regulatory and theoretical frameworks might be erected to reconcile the conflicting interests, roles and duties of innovative surgeons in relation to their patients.
This article will review the current Australian law on the nature of the doctor-patient relationship with a view to establishing a point of departure for further discussion on how to regulate innovation in surgical practice. (3) In providing this comparative perspective, it is submitted that neither approach is ultimately necessary. Arguably, rather than endorsing or opposing the current state of the law in Australia, the aim should be to reach beyond polarised legal paradigms and instead embrace a more interdisciplinary response that aligns with modern theories of healthcare governance. In the meanwhile, it is submitted that a concise restatement of the Australian position, contrasted with the Canadian approach, can provide a useful launching point for legal policy development.
A. The Contractual Characterisation of the Doctor-Patient Relationship
The Australian characterisation of the doctor-patient relationship derives from British common law tradition. Lord Scarman's ruling in Sidaway v Board of Governors of Bethlem Royal Hospital (4) stated it plainly: "[t]he relationship between doctor and patient is contractual in origin, the doctor performing services in consideration for lees payable by the patient". (5) As such, the doctor-patient relationship is essentially a commercial transaction, namely, "a private contract for supply of professional services". (6)
In general terms, "a doctor offers a patient diagnosis, advice and treatment", the objectives of which are "the prolongation of life, the restoration of the patient to full physical and mental health and the alleviation of pain" (7) While the majority of contracts pertaining to healthcare are not reduced formally in writing, this does not affect the validity of the agreement.(8) In the vast body of cases that have required courts to determine whether an alleged breach of a doctor-patient contract occurred, the existence of that contract has scarcely been in contention. Indeed, as noted by Lord Wilberforce in Liverpool City Council v Irwin, (9) the function of the courts has become "to establish what the contract is, the parties not having themselves fully stated the terms". (10) This is achieved by implying terms into healthcare contracts in accordance with legal principles outlined by Deane J in Hawkins v Clayton. (11)
In Australia, there are five general requirements for a legally enforceable contract: an intention to create legal relations, an agreement (otherwise phrased as "offer" and "acceptance"), consideration (the exchange of something of value by the parties), legal capacity (the capacity to understand the nature and effort of the agreement) and genuine consent (wherein any instance of fraud or duress will void the agreement). (12) Within the context of healthcare, the first three requirements are typically fulfilled by: (a) the presumption that there is an intention to create legal relations, given that the services provided by health workers takes place in a professional setting; (b) an assumption that the patient has accepted the health worker's offer to receive services by opting to receive treatment; and (c) where consideration may be "a payment, or promise of payment, of reward of submission by the patient, or an undertaking by the patient to submit, to the proposed treatment". (13) The latter two requirements, however, are potentially more problematic, given the general vulnerability of patients due to their diminished state of health, as well as specific dilemmas concerning minors, unconscious persons and the mentally ill. (14)
The traditional contractual model of the doctor-patient relationship is entrenched in Australia by the landmark High Court decision of Breen v Williams. (15) Beyond its seminal importance as a test case for a patient's access to medical records, Breen demonstrated the High Court's commitment to the contractual paradigm. The Court was not persuaded by arguments for the expansion of duties and corresponding liabilities under a wholly fiduciary model, and explicitly refused to follow the ratio of the Supreme Court of Canada in McInerney v MacDonald. (16)
B. The Facts of Breen v Williams
In 1977, Julie Breen (the appellant and patient) underwent cosmetic surgery to have silicone breast implants inserted. She later developed bilateral breast capsules and consulted the respondent, Dr Williams, in 1978, who performed an operative procedure in which he neither inserted implants nor removed the existing ones. Ms Breen had corresponded with Dr Williams about the possibility of having the implants removed; however, he performed no such surgery. It was subsequently discovered that silicone gel had leaked from the implant in Ms Breen's left breast, which required corrective surgery.
The appellant later became involved in a class action lawsuit in the United States against Baxter, Bristol-Myers Squibb Co, 3M and Downing Corning (manufacturers of the silicone gel implants who were deemed to have not adequately warned of the risks associated with their products). (17) A condition of settlement was that Australian claimants were required to "opt in" to the class by 1 December 1994 for a share of the $US4.2 billion settlement. This required claimants to provide copies of medical records to support their claims. As Parkinson notes, (18) a …