Wrongful birth and wrongful life lawsuits in obstetrics and gynecology.

Developments in preconception and prenatal technologies have led to undeniable advances in how health-care providers screen and treat patients. Despite these advances, at any point errors can occur leading to misdiagnosis or a missed diagnosis. In some instances, the missed information can lead to the birth of a child with health issues where short of the error, the decision to avoid conception or terminate the pregnancy might have been made. When these lapses unfold, there exists the potential for a wrongful birth or wrongful life lawsuit to ensue. While these 2 actions are based on the same set of events, they are distinct legal claims with varying degrees of judicial permissibility. Global legal acceptability of wrongful birth and life lawsuits tends to resemble patterns in the United States. Analyzing prior wrongful birth and wrongful life claims can reveal common trends in events leading to these types of lawsuits, as well as an understanding of their potential outcomes. A familiarity with wrongful birth and wrongful life lawsuits demonstrates how these cases are unique from other forms of prenatal or birth injury tort lawsuits and can provide insights to common shortcomings in clinical practice. Applying these lessons to clinical practice highlights key approaches towards limiting the risk of certain errors leading to wrongful birth and wrongful life lawsuits, with the goal of health-care providers offering high quality health care.

Litigation claims in Urology in the UK National Health Service: an analysis of the trends, costs and causes over a 16-year period.

OBJECTIVE: To analyse the litigation trends and the reasons for claims within the specialty of Urology, within the UK National Health Service (NHS), over a 16-year period. MATERIALS AND METHODS: Data were requested from NHS Resolution under the Freedom of Information Act 2000. This included the total number of claims in Urology, the number of these that were successful (settled or closed), and the costs in damages paid out per financial year between 2006 and 2022. A breakdown of the successful claims by their primary cause was also collected. These were coded into the categories: 'non-operative', 'intraoperative', 'postoperative', and 'other'. RESULTS: A total of 4124 litigation claims were made between 2006 and 2022 and 60.9% (2511/4124) of these claims were successful. In all, £145 million (British pounds) was paid out in damages. The number of successful claims increased 2.9-fold from the start to end of this 16-year period, and the costs in damages paid out increased 10-fold. Regarding primary causes for the successful claims, failure or delay in treatment (20.9%, 525/2511), failure or delay in diagnosis (14.5%, 364/2511), and intraoperative problems (9.1%, 229/2511) accounted for the highest proportion. Overall, non-operative causes for successful claims accounted for 73.3% (1840/2511), intraoperative for 20.1% (504/2511), and postoperative for 3.9% (98/2511). CONCLUSIONS: The number of successful urological litigation claims, and their associated costs is rising. The majority are due to non-operative causes, which may be partially explained by NHS waiting lists alongside the effects of the coronavirus disease 2019 (COVID-19) pandemic.

Are Manufacturing Patents to Blame for Biosimilar Market Launch Delays?

OBJECTIVES: Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims. METHODS: We reviewed US Court document submissions for litigation data, including the details of patents asserted against biosimilar owners, and collated biosimilar market launch dates from publicly available databases. RESULTS: We find that, although approximately half of all patents asserted in litigation were manufacturing patents, a greater proportion of composition, active pharmaceutical ingredient, and treatment patents are associated with longer market launch delays, whereas a greater proportion of manufacturing patents are associated with shorter market launch delays. CONCLUSIONS: Our results suggest that manufacturing patents were having less of an impact on market launch delays than other types of patents. Our findings have implications for both biosimilar and originator developers, as well as patent policy and its association with healthcare accessibility.

Solid Organ Transplant Litigation at One of Europe's Largest University Hospitals.

Due to its intrinsic complexity and the principle of collective solidarity that governs it, solid organ transplantation (SOT) seems to have been spared from the increase in litigation related to medical activity. Litigation relating to solid organ transplantation that took place in the 29 units of the Assistance Publique-Hôpitaux de Paris and was the subject of a judicial decision between 2015 and 2022 was studied. A total of 52 cases of SOT were recorded, all in adults, representing 1.1% of all cases and increasing from 0.71% to 1.5% over 7 years. The organs transplanted were 25 kidneys (48%), 19 livers (37%), 5 hearts (9%) and 3 lungs (6%). For kidney transplants, 11 complaints (44%) were related to living donor procedures and 6 to donors. The main causes of complaints were early post-operative complications in 31 cases (60%) and late complications in 13 cases (25%). The verdicts were in favour of the institution in 41 cases (79%). Solid organ transplants are increasingly the subject of litigation. Although the medical institution was not held liable in almost 80% of cases, this study makes a strong case for patients, living donors and their relatives to be better informed about SOT.

AI and the nature of disagreement.

Litigation is a creature of disagreement. Our essay explores the potential of artificial intelligence (AI) to help reduce legal disagreements. In any litigation, parties disagree over the facts, the law, or how the law applies to the facts. The source of the parties' disagreements matters. It may determine the extent to which AI can help resolve their disputes. AI is helpful in clarifying the parties' misunderstanding over how well-defined questions of law apply to their facts. But AI may be less helpful when parties disagree on questions of fact where the prevailing facts dictate the legal outcome. The private nature of information underlying these factual disagreements typically fall outside the strengths of AI's computational leverage over publicly available data. A further complication: parties may disagree about which rule should govern the dispute, which can arise irrespective of whether they agree or disagree over questions of facts. Accordingly, while AI can provide clarity over legal precedent, it often may be insufficient to provide clarity over legal disputes. This article is part of the theme issue 'A complexity science approach to law and governance'.

Coalitions in international litigation: a network perspective.

We apply network science principles to analyse the coalitions formed by European Union nations and institutions during litigation proceedings at the European Court of Justice. By constructing Friends and Foes networks, we explore their characteristics and dynamics through the application of cluster detection, motif analysis and duplex analysis. Our findings demonstrate that the Friends and Foes networks exhibit disassortative behaviour, highlighting the inclination of nodes to connect with dissimilar nodes. Furthermore, there is a correlation among centrality measures, indicating that member states and institutions with a larger number of connections play a prominent role in bridging the network. An examination of the modularity of the networks reveals that coalitions tend to align along regional and institutional lines, rather than national government divisions. Additionally, an analysis of triadic binary motifs uncovers a greater level of reciprocity within the Foes network compared to the Friends network. This article is part of the theme issue 'A complexity science approach to law and governance'.

Bitter taste of the tobacco industry interference in Brazil.

OBJECTIVE: Although Brazil became the first country worldwide to ban the sale of all tobacco products with any additive that could alter their flavours and tastes in 2012, its implementation was effectively halted by tobacco industry lawsuits, including a constitutional challenge filed in the Federal Supreme Court in 2013. This study aimed at examining, for the first time in the country, the evolution over time of the new registrations of tobacco products with additives that would have been banned if not for the tobacco industry's interference ('counterfactual scenario'). METHODS: We used the newly available public database on the registration of tobacco products developed by the Health Regulatory Agency (from 2008 onwards). All types of tobacco products intended for the domestic market that contained 'banned additives in a counterfactual scenario' and were registered between January 1 and December 31 of each year were selected. RESULTS: Between 2012 and 2023, a total of 1112 new registrations of tobacco products with 'banned additives' were recorded. The spread of hookah tobacco registrations started in 2014, and by 2023, the cumulative incidence of registrations containing 'banned additives' was 641. Both manufactured cigarettes and hookah products reached their peaks in new registrations in 2020. CONCLUSIONS: After 12 years since the resolution intended to ban all additives that change the aroma and taste of tobacco products in Brazil, primarily to prevent smoking initiation, the tobacco industry's interference continues to successfully block its implementation. Countries facing similar challenges in tobacco control could consider generating comparable national data that might help expose the adverse impacts of tobacco industry interference on public health.

A 23-year analysis of litigation in orthopedic elbow surgery.

BACKGROUND: The reasons for malpractice litigation in elbow surgery are not well understood. The aim of this study is to report the most frequently litigated surgeries of the elbow and analyze the reasons for litigation and case outcomes. METHODS: A retrospective review of the Westlaw legal database was performed, and all federal and state jurisdiction litigation cases involving the elbow from 2000 to 2023 were queried. Cases were excluded if they did not involve an orthopedic surgeon, nor primary elbow injury or procedure. Cases were reviewed for demographic information, surgical procedure based on reference Current Procedural Terminology codes, complications, symptoms, and reasons for litigation. Quantitative information, including settlement and indemnity cost to the defendant orthopedic surgeon, was analyzed. Cases were subdivided based on United States Census Bureau regions and states to assess regional frequency of litigation with analyses of variance. RESULTS: There were 59 cases meeting inclusion criteria from 2000 to 2023. The most litigated cases involved were ulnar nerve transposition/release and open reduction and internal fixation of the proximal radius and/or ulna at the elbow. The most litigated complication was claimed nerve damage (46%) and permanent disability (27%). Of the total cases, the most frequently litigated symptoms were nerve damage (46%) and loss of function (37%), whereas the least frequent was postoperative stiffness (2%). The Pacific region demonstrated the highest litigation rate (20%), whereas the East South Central, Mountain, and New England regions had the lowest litigation rate (3% each). A favorable verdict was given to the defendant orthopedic surgeon in 59% of the cases. The average loss incurred through settlement was $245,590, whereas the average indemnity paid through verdict was $523,334. CONCLUSION: Operative fixation of the proximal ulna/radius and ulnar nerve release/transposition are the most litigated procedures of the elbow. Litigation is most associated with nerve injury. Across Census Bureau regions, there is no significant difference in monetary cost incurred through settlements and verdict losses. Although a majority of litigated cases are won by the defending orthopedic surgeon, thorough informed consent and perioperative expectation management may mitigate litigation risk.

Help, I've been sued! Demystifying the steps of malpractice litigation for the emergency radiologist.

Being sued can have significant emotional and psychological impact and has implications on the wellness of emergency radiologists. A better understanding of the steps involved in a medical malpractice suit can help defuse some of the anxiety of litigation. This process starts with the inception of the case, the summons, and complaint, then progresses to discovery, including document production, interrogatories, and deposition, and thereafter to settlement or trial. The discussion includes a number of tips and outlines a number of pitfalls inherent in litigation. It is hoped that this discussion will alleviate some of the anxiety that accompanies this long and arduous process.

Global Health Impact: Human rights, access to medicines, and measurement.

Should people have a legal human right to health? And, if so, what exactly does protecting this right require? This essay defends some answers to these questions recently articulated in Global Health Impact. It explains how these answers depend on a particular way of thinking about health and the minimally good life, how quality of life matters at and over time, what various agents should do to help people who are unable to live well enough, and many other things. Moreover, it suggests some ways of improving common metrics for measuring and advancing our collective global health impact.

Medical Malpractice Litigation Following Hindfoot Arthrodesis.

Given high patient expectations in the setting of complex surgeries, orthopedic surgeons are at risk of being subject to malpractice claims which can impose significant economic and psychological burden. This study investigates malpractice claims against orthopedic surgeons and podiatrists performing hindfoot arthrodesis and determine factors associated with plaintiff verdicts and settlements using the Westlaw legal database. The database was queried for all cases involving hindfoot arthrodesis using the terms "malpractice" and either "ankle fusion," "arthrodesis," "subtalar fusion," "tibiotalar fusion," "tibiotalocalcaneal fusion," "TTC fusion," or "tibiofibular fusion" from 1987 to 2023. Data regarding patient demographics, causes cited for litigation, case outcomes, and indemnity settlements were collected. Cases were excluded if the defendant was not an orthopedic surgeon or a podiatrist, the procedure involved was not a hindfoot arthrodesis, or if the patient was a minor. Forty-five cases of hindfoot arthrodesis met the inclusion criteria. The mean plaintiff age was 51.5 ± 13.8 years with 51.1% male. Thirty-three cases (73%) were in favor of the defendant, with an average inflation-adjusted payout of $853,863 (±456,179). The most alleged category of negligence was procedural/intraoperative error (75%) followed by postsurgical error (38%) and failure to inform (31%). The most common specific damages included functional/ROM limitation (49%), need for additional surgery (47%), continuing/worsened pain (27%), and nonunion/malunion (29%). Given the frequency of hindfoot arthrodesis performed, this study highlights the importance of effective communication with patients concerning potential postoperative complications, prognosis of their injury, and risks and benefits associated with each treatment modality.

Strategic and contested use of food laws to ban smokeless tobacco products in India: a qualitative analysis of litigation.

OBJECTIVE: To understand how food laws are used, contested and interpreted to ban certain forms of chewing tobacco in India. METHODS: A qualitative study analysing all the tobacco-related litigation under the food laws in India. We used an inductive thematic analysis of the litigation contents. RESULTS: The tobacco industry systematically deployed litigation to (1) challenge the categorisation of smokeless tobacco products as food, and hence, questioned the use of food laws for regulating these products; (2) challenge the regulatory power of the state government in banning tobacco products via the food laws; and (3) challenge the applicability of the general food laws that enabled stricter regulations beyond what is prescribed under the tobacco-specific law. CONCLUSION: Despite facing several legal challenges from the tobacco industry, Indian states optimised food laws to enable stricter regulations on smokeless tobacco products than were feasible through use of a tobacco-specific law.

Manufactured doubt and the EPA 2020 chrysotile asbestos risk assessment.

While all forms of asbestos have been determined to be carcinogenic to humans by the International Agency for Research on Cancer (IARC) as well as other authoritative bodies, the relative carcinogenic potency of chrysotile continues to be argued, largely in the context of toxic tort litigation. Relatively few epidemiologic studies have investigated only a single form of asbestos; however, one study that included an asbestos textile plant located in Marshville, North Carolina that processed chrysotile asbestos was used by the United States Environmental Protection Agency (EPA) in 2020 to help inform the agency's chrysotile asbestos risk assessment. During the EPA proceedings toxic tort defense consultants submitted comments to the EPA docket and made public presentations asserting that the Marshville plant had processed amphibole asbestos types and should not be used for the chrysotile risk assessment. A detailed evaluation of defense consultant assertions and supporting information and a full assessment of the available information concerning asbestos types used at the Marshville plant was undertaken. The preponderance of evidence continues to support the conclusion that neither amosite nor crocidolite were likely to have been processed in the Marshville textile plant. Defense consultants' assertions about chrysotile use are not supported by the preponderance of evidence and constitute an example of manipulation of information to cast uncertainty and doubt rather than to seek truth and contribute to the body of scientific evidence.

Practice of defensive medicine among surgeons in Ethiopia: cross-sectional study.

BACKGROUND: Defensive medicine is physicians' deviation from standard medical care which is primarily intended either to reduce or avoid medico legal litigation. Although the Federal Ethics Committee review in Ethiopia has shown that applications for medical/surgical error investigation claims are increasing at an alarming rate, there is no study to date done to estimate the degree of defensive practice done by the physicians with an intention of avoiding this increasing legal claim. This study assessed the practice of defensive medicine among highly litigious disciplines (surgery) and described factors associated with its practice. METHODS: Cross sectional quantitative study using online survey questionnaires was conducted to assess the degree of defensive practice and six factors (age, years of experience, specialty, monthly income, place of practice and previous medico legal history) associated with its practice were assessed among surgeons working in Ethiopia. RESULTS: A total of 430 surgeons directly received an online survey questionnaire and 236 of them successfully completed the questionnaire making the response rate 51.2%. Nearly half of the study participants (51.7%) were aware of the concept of defensive medicine and 174 (74%) reported performing one form of defensive practice. Twenty-nine (12.3%) of the participants have legal dispute history, though only 1.3% of them ended up in penalty. Avoiding high risk procedures was the commonest defensive act performed by 60% of the participants, followed by ordering tests unnecessarily (52.1%). Multinomial logistic regression model showed that there was no association between age of the participant, place of practice, year of experience and defensive practice. This model also showed that cardiothoracic and vascular surgeons perform less defensively than surgeons with other specialty with P value of 0.02. CONCLUSION: The practice of defensive medicine is widespread among surveyed Ethiopian surgeons and further studies are required to objectively estimate the effect of defensive practice on the health care system of the country. Policy makers need to develop strategy towards decreasing this high rate of defensive practice.

Disclosing medical errors: how do we prepare our students?

PURPOSE: Despite patient safety initiatives, medical errors remain common and devastating. Disclosing errors is not only ethical, but also promotes restoration of the doctor-patient relationship. However, studies show active avoidance of error disclosure and the need for explicit training. In the South African setting, sparse information exists in terms of undergraduate medical training in error disclosure. To address this knowledge gap, the training of error disclosure in an undergraduate medical programme was examined, against the background of the available literature. The objective was to formulate a strategy to improve error disclosure teaching and practice, with the goal of improving patient care. METHODS: Firstly, the literature was reviewed regarding the training of medical error disclosure. Secondly, the undergraduate medical training in error disclosure was probed, by looking at the pertinent findings from a broader study on undergraduate communication skills training. The design of the study was descriptive and cross-sectional. Anonymous questionnaires were distributed to all fourth- and fifth-year undergraduate medical students. Data were predominantly analysed quantitatively. Open-ended questions were analysed qualitatively using grounded theory coding. RESULTS: Out of 132 fifth-year medical students, 106 participated (response rate 80.3%), while 65 out of 120 fourth-year students participated (response rate 54.2%). Of these participants, 48 fourth-year students (73.9%) and 64 fifth-year students (60.4%) reported infrequent teaching in the disclosure of medical errors. Almost half of the fourth-year students (49.2%) considered themselves novices in error disclosure, while 53.3% of fifth-year students rated their ability as average. According to 37/63 (58.7%) fourth-year students and 51/100 (51.0%) fifth-year students, senior doctors seldom or never modelled patient-centred care in the clinical training setting. These results resonated with the findings of other studies that showed lack of patient-centredness, as well as insufficient training in error disclosure, with resultant low confidence in this skill. CONCLUSION: The study findings confirmed a dire need for more frequent experiential training in the disclosure of medical errors, in undergraduate medical education. Medical educators should view errors as learning opportunities to improve patient care and model error disclosure in the clinical learning environment.

Medical malpractice litigation after total shoulder arthroplasty: a comprehensive analysis based on the Westlaw legal database.

INTRODUCTION: Orthopedic surgery is one of the most common subspecialties subject to medical malpractice claims. Although total shoulder arthroplasty (TSA) is associated with favorable patient outcomes and relatively low complication rates, surgeons performing this procedure may be subject to malpractice litigation leading to significant economic and psychological burden on the provider. The purpose of this study is to characterize and describe malpractice claims against orthopedic surgeons performing TSA using the Westlaw legal database. METHODS: The Westlaw legal database was queried for all cases related to TSA using the terms "malpractice" AND "shoulder replacement" OR "shoulder arthroplasty." Cases were excluded if the defendant was not an orthopedic surgeon, the procedure involved was not a TSA, or if the patient was a minor. Patient demographics, causes cited for litigation, case outcomes, and indemnity payments were analyzed to determine common factors that lead plaintiffs to pursue legal action. RESULTS: Thirty-five TSA cases were identified that met inclusion criteria. The mean plaintiff age was 55 years with 63.6% female. The most common category of negligence alleged was intraoperative error, which occurred in 25 claims (71%). The most common types of damages incurred were nerve injury (23%), functional limitation (20%), and infection (17%). Overall, 27 cases (77%) resulted in a defense verdict. Four cases (11%) resulted in settlements and 4 cases (11%) resulted in plaintiff verdicts. The average inflation-adjusted monetary award in these cases was $1,619,919 (standard deviation, $1,689,452). DISCUSSION: This study provides a comprehensive summary of malpractice claims and associated outcomes in TSA. Given the rapidly increasing rate of TSA in the United States and the burden of associated malpractice claims, understanding potential legal implications of TSA is of great value to orthopedic surgeons. Intraoperative error was the category of negligence cited most commonly in TSA malpractice claims. Nerve injury, functional limitation, and infection were the most commonly cited specific damages. These findings highlight the need for orthopedic surgeons to educate patients regarding potential postoperative complications while continuing to focus on minimizing their occurrence.

Hip and Knee Are the Most Litigated Orthopaedic Cases: A Nationwide 5-Year Analysis of Medical Malpractice Claims.

BACKGROUND: Approximately 80% of hip and knee surgeons will face malpractice litigation. Understanding contemporary reasons for litigation and legal outcomes in our field may help surgeons deliver more effective and satisfying care, while limiting their legal exposure. This study aimed to determine: 1) which orthopaedic subspecialties were most frequently litigated; 2) malpractice damages and negligence claimed; 3) the proportion of different case outcomes; and 4) factors associated with defense verdicts. METHODS: A nationwide database was queried for all orthopaedic medical malpractice claims (2015 to 2020), obtaining 164 claims from 17 states. Variables included were as follows: case outcome, indemnity payment, damages, negligence claimed, treatment, and patient characteristics. A binary logistic regression determined if any collected variable increased the likelihood of a defense verdict. RESULTS: Hip and knee cases were the highest-represented (n = 49, 29.9%; knee: n = 26, 15.9%; hip: n = 23, 14.0%), followed by the spine (n = 36; 22.0%), trauma (n = 29;17.7%), hand and wrist (n = 16; 9.8%), sports (n = 16; 9.1%), foot and ankle (n = 7; 4.3%), pediatric (n = 6; 3.7%), and shoulder (n = 6; 3.7%). Within hip and knee surgery, defense verdicts occurred in 38 cases (77.6%), while 9 (18.4%) resulted in plaintiff verdicts (mean payment: $4,866,929) and 2 (4.1%) resulted in settlements (mean settlement: $1,550,000). Nonreversible damages (eg, paralysis, amputation, and death; P < .001) were associated with a decreased likelihood of a defense outcome. CONCLUSION: Hip and knee cases were the highest-represented in orthopaedic malpractice litigation. Surgeons were more frequently found negligent when nonreversible damages occurred. Orthopaedic surgeons should be cognizant of litigation patterns while ensuring patient-centered high-quality care.

Litigation Cases After Post-Bariatric Surgery: Lesson from the Past.

BACKGROUND: Due to the high demand of post-bariatric surgeries, the number of litigation cases is rapidly growing. Even if surgical mistakes still represent one of the main causes of medico-legal issues, many disputes depend on what happens in the post-operative course. In this article we analyzed the litigation cases that occurred in our Plastic Surgery Department, the current literature about medico-legal disputes and the importance of the doctor-patient relationship. PATIENTS AND METHODS: The medical records of 788 post-bariatric surgeries, the post-operative complications and the related litigation cases from January 2015 to December 2019 were collected, analyzed and compared. RESULTS: We performed 380 abdominoplasties, 28 torsoplasties, 65 breast reductions, 99 mastopexies, 94 brachioplasties, 52 thighplasties, 65 liposuctions and 5 facelifts between 2015 and 2019. Eight patients complained of medical issues and claimed for litigation. Despite in all cases the judges highlighted the risk of consent misinterpretation, the payout was granted only in one case. CONCLUSION: Post-bariatric patients often mistake their preoperative condition and consider body contouring procedures as an aesthetic surgery treatment. Patients should be therefore clearly informed about the complexity of body contouring procedures after massive weight loss, which should never be compared to aesthetic surgery. Surgeons should always promote the communication with their patients and build a strong and trustworthy relationship. This attitude will allow to deal more easily with complications and, in the worst situations, with medico-legal litigations. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

"Pediatric" Drug Studies Might Be the Largest Abuse in Medical Research in History. It Is Time for Lawyers to Step In.

A new type of research has emerged with United States and European Union pediatric laws that request/demand separate clinical studies for vaccines and drugs in minors less than 18 years of age. Physiologically, minors mature before their 18th birthday. Medicine treats the body, not the administrative status. Many "pediatric" studies are performed in minors that bodily are no longer children, which makes them pointless. Traditional malpractice litigation in clinical research involves patients that were harmed in clinical studies. In the new type of "pediatric" studies, drugs known to work in humans are retested, pretending that "children" are uniquely different, which is incorrect. Minors are not another species. Patients are not treated at all (placebo group) or below standard-of-care (comparison to outdated treatment). Pediatric laws are the law, but not a free pass for harming patients. Where "pediatric" studies violate accepted norms of medical practice, lawyers should be aware of this challenge at the interface of medicine and law.

The Statutory Standard of Care in Australia and its Application to Experimental Medical Practice.

Clinical innovation is essential in the development and improvement of interventions used to treat medical conditions. In Australia, the States and Territories have statutorily reintroduced the Bolam principle in a modified form which provides a defence for medical practitioners who have practised in a manner that, at the time, was widely accepted in Australia by peer professional opinion as competent professional practice. This article explores whether the standard could be successfully pleaded as a defence by experimental practitioners. In doing so, the obstacles to an experimental practitioner's ability to rely on the statutory defence are analysed. It finds that the standard effectively entrenches established practices without sheltering legitimate efforts to advance medicine.