Cystic Fibrosis and the Law: The Ramifications of New Treatments.

Until the discovery of the gene for cystic fibrosis (CF) in 1989, diagnostic developments were limited, and treatment focused on symptom alleviation. However, following the genetic breakthrough, some 2,000 mutations of the gene have been identified. More recently CF transmembrane conductance regulator modulator triple therapy (CFTRm) has been introduced in the form of triple therapy with ivacaftor, lumacaftor and tezacaftor (ETI), in the United States from 2019, Europe from 2020 and then Australia from 2021. The new treatment option has revolutionised both the quality of life and life expectancy of many persons diagnosed with CF. This editorial reviews major developments in the clinical care that can now be provided to patients, and reflects on the legal and ethical ramifications of the improved situation for many patients in the contexts of medical negligence, damages assessment, family law and criminal law. It also considers the difficult issues of access and equity caused by the limited availability of the triple therapy in low- and middle-income countries.

The Perils of Cosmetic Surgery Tourism: Evolving Knowledge, Awareness, and Challenges.

Concern has been expressed for some years about the risks of complications and the need for revision procedures after cosmetic surgery tourism. Such tourism is large and growing. Recent literature and coroners' inquests have provided a new evidence base for evaluating the extent of the dangers posed by a variety of overseas cosmetic surgery procedures. This article reviews such literature and identifies reason for considerable concern about cosmetic surgery tourism as well as about the deficits in regulatory and legal liability that might otherwise inhibit substandard practice. Provision of carefully drafted information about risk issues which patients can factor into their decision-making before embarking on overseas trips for the purpose of cosmetic surgery is a constructive initiative deserving of further attention by relevant Colleges, professional association and health advocacy groups.

The changing face of cosmetic surgery regulation: a review of controversies and potential reforms.

Cosmetic surgery is becoming increasingly popular in Australia with the industry estimated to be worth over 1 billion dollars annually. Regulators both in Australia and internationally have been criticized for not keeping up with the rapidly changing field and keeping patients sufficiently safe in an environment that is problematically entrepreneurial. In this article, we explore the current regulation of and controversies surrounding cosmetic surgery in Australia, including the use of the title 'cosmetic surgeon', consent processes and the phenomenon of medical tourism. Lastly, we review the potential future reforms in Australia and how other countries have regulated the industry to keep patients safe.

Considerations surrounding remote medicolegal assessments: a systematic search and narrative synthesis of the range of motion literature.

Remote telehealth practices were forced to advance 10 years in a few short weeks in March 2020 due to the onset of a global pandemic. In the sphere of non-clinical medicine, a dramatic element of uncertainty entered the psyche of doctors and lawyers in relation to the validity of remote or virtual independent medical examination (vIME). This paper considers the key issues surrounding the virtual assessment of clients for medicolegal purposes. Our main hypothesis was that, within certain defined parameters, the vIME technique can deliver reliable and accurate assessments. To explore this, a systematic literature search focusing on advanced device-based range of motion measurement was conducted, along with an historical snapshot of observation-based range of motion measurement considering application to remotely performed IME. While some specialists are of the view that observational measurement may be applied reliably to some joints when conducted by experienced orthopaedic surgeons, evidence for this is scant. The results, instead, support the notion of using task substitution, that is specialists appropriately assisted in conducting vIMEs by musculoskeletal trained allied health practitioners, regardless of the measurement tool, for permanent impairment assessments. Moreover, self-performed examinations by injured individuals using advanced technology are not reliable in this setting. Our final contention is that remote examinations with limited clinical assessment have utility for legal matters, such as the assessment of causation of injury, treatment advice or approvals and fitness for pre-employment tasks or safe variations, with objective clinical adjunct support such as Picture Archiving and Communication System-based modern radiology systems.

Legal and ethical considerations of artificial intelligence in skin cancer diagnosis.

Artificial intelligence (AI) technology is becoming increasingly accurate and prevalent for the diagnosis of skin cancers. Commercially available AI diagnostic software is entering markets across the world posing new legal and ethical challenges for both clinicians and software companies. Australia has the highest rates of skin cancer in the world and is poised to be a significant benefactor and pioneer of the technology. This review describes the legal and ethical considerations raised by the emergence of artificial intelligence in skin cancer diagnosis and proposes recommendations for best practice.

Guidance on Prescription of Homeopathic Treatments: Ramifications of a Failed Administrative Law Challenge.

In R (on the application of British Homeopathic Association) v National Health Service Commissioning Board [2018] EWHC 1359 (Admin) Supperstone J of the High Court of England and Wales delivered an internationally significant judgment on the processes required to be engaged in when guidance is given to medical practitioners about their involvement in homeopathic prescribing. This column explores the bases upon which the challenge by the British Homeopathic Association was lost and the repercussions of the judgment for the practice of non-evidence-based modalities, such as homeopathy.

Narcissistic Rage and the Murder of Allison Baden-Clay.

The trial and the appeals in relation to the killing of Allison Baden-Clay in Queensland in 2012 focused attention upon the role of relevance of motive and thereby intention in what was ultimately found to be the murderous conduct of her husband Gerard Baden-Clay. There are strong grounds for concluding that he had narcissistic personality disorder, a consequence of which can be particular susceptibility to narcissistic injury and thereafter narcissistic rage if the person perceives themselves threatened by attack to their reputation and integrity. This article reviews the extensive clinical literature on narcissism, insofar as it has potential relevance to the commission of crimes of violence and argues that identifying Baden-Clay as having the disorder provides a useful psychological insight into his conduct.

Parents' Opposition to Potentially Life-saving Treatment for Minors: Learning from the Oshin Kiszko Litigation.

This article reviews a series of high-profile decisions made during 2016 by the Western Australian Family Court in relation to a child with a brain tumour whose parents were resistant to his being treated with chemotherapy and radiotherapy by reason of their commitment to natural therapies and their belief at an early stage after his diagnosis that orthodox medical treatment should be abandoned in favour of palliative care. The article argues that the decisions in Director Clinical Services, Child & Adolescent Health Services v Kiszko [2016] FCWA 19, 34 and 75 constitute a problematic precedent in terms of the potential for certain forms of parental behaviour being able to engineer a desired outcome that may not be in the best interests of a vulnerable child. It contends that efforts should be made to hear the voice of a child in such cases, that it is important that collateral agendas which may be influencing antagonism to treatment be identified early, and that a constructive role may be able to be played by child protection authorities in prompt initiation of litigation where attempts at non-adversarial resolution of a treatment impasse have failed.

Misplaced hope: misleading health service practitioner representations and consumer protection.

A series of court and tribunal decisions in the course of 2012 in Australia has highlighted the vulnerability of seriously ill patients to overtures and advertising by charismatic health practitioners offering panaceas of unproven efficacy. Drawing upon the findings of the Victorian Court of Appeal in relation to Noel Campbell, the Deputy State Coroner of Western Australia in relation to Helfried Sartori, and the Victorian Civil and Administrative Tribunal in relation to Reza Ghaffurian, it is argued that there is a strong public interest in the capacity for effective early intervention by government in relation to unscrupulous and unethical conduct by health practitioners, whether they are registered or unregistered. For Australia a constructive reform would be nationally consistent legislation to regulate unregistered health practitioners.

Heterodoxy, iconoclasm and spuriousness: the limits of novel expert evidence.

A difficult issue arises for courts' decision-making at common law and under statutory evidentiary regimes when expert opinions are significantly unorthodox, iconoclastic or methodologically flawed. This editorial analyses the relevant evidentiary principles and the Australian jurisprudence on the subject, giving particular attention to the decisions of the South Australian Supreme Court in R v Parenzee [2007] SASC 143 and R v Parenzee [2007] SASC 316 in which expert opinions about the existence, identifiability and transmissibility of HIV and its relationship to AIDS adduced on behalf of the defence in a criminal trial were found to be seriously wanting. A variety of factors indicative of low probative value in expert opinions are distilled.

Gynaecological cytopathology and the search for perfection: civil liability and regulatory ramifications.

The article analyses the potential for false negative and false positive results from Pap smear testing by gynaecological cytopathology laboratories. It also reviews case law in relation to the liability of general practitioners, gynaecologists, cytoscreeners and pathologists in respect of cervical cancer diagnoses. It argues that the concerns expressed in the 1990s about unfair findings of liability against cervical screeners have not been borne out, liability only having been found by the courts where culpable failure to adhere to the standards to be expected of professional behaviour has been established by probative evidence. It argues that the challenge for the future is for cytology screening to articulate definitively where the distinctions lie between acceptable and unacceptable error and for the medical profession and the legal profession to accommodate to the limitations of gynaecological cytopathology.