Obstetrics, genetics, and litigation.

INTRODUCTION: Claims of medical negligence are universal. Unexpected adverse pregnancy outcome may trigger litigation. Such outcomes, especially with neurodevelopmental sequelae, may be compounded by a genetic disorder, congenital abnormality, or syndrome. MATERIAL AND METHODS: This is a report of 297 cases in which a pregnancy complication, error, or incident occurred that was followed by progeny with a genetic disorder, congenital abnormality, or syndrome that spawned litigation. The author assessed, opined, and in many cases, testified about causation. RESULTS: Pregnancies complicated by hypoxic ischemic encephalopathy were not infrequently compounded by offspring with a genetic disorder, congenital abnormality, or syndrome. Multiple cases were brought because of missed ultrasound or laboratory diagnoses, or failures in carrier detection. Teratogenic medication prescribed before or during pregnancy invited legal purview. Failure to refer (or confer) for genetic evaluation or counseling in the face of significant risk, occurred repeatedly. Ethical breaches and hubris promptly led to litigation. CONCLUSIONS: Many lessons and recommendations emerge in this report. These include the realization that the vast majority of errors in this series involved at least two caregivers, serial ultrasound studies are important, decreased fetal movements may signal a genetic disorder, congenital abnormality, or syndrome, family history and ethnicity are vital, cognitive biases profoundly affect decision-making. Finally, the simplest of errors have the potential for causing life-long grief.

Use of Telemedicine and Smart Technology in Obstetrics: Barriers and Privacy Issues.

While telemedicine had been utilized in varying ways over the last several years, it has dramatically accelerated in the era of the COVID-19 pandemic. In this article we describe the privacy issues, in relation to the barriers to care for health care providers and barriers to the obstetric patient, licensing and payments for telehealth services, technological issues and language barriers. While there may be barriers to the use of telehealth services this type of care is feasible and the barriers are surmountable.

Learning from the law. A review of 21 years of litigation for nerve injury following central neuraxial blockade in obstetrics.

Medicolegal claims for neurological injury following the use of central neuraxial blockade in childbirth represent the second most common claim against obstetric anaesthetists. We present an analysis of 55 cases from a database of 368 obstetric anaesthetic claims. Common themes that emerge from the analysis include: consent; nature of nerve injury (non-anaesthetic; direct; chemical; compressive); recognition; and management. Specific advice arising from these cases includes: the importance of informing patients of the risks of nerve damage; keeping below the conus of the cord for intrathecal procedures; responding appropriately if a patient complains of paraesthesia; and having a high index of suspicion if recovery of normal neurological function is delayed. As ever, principles of good practice, including respect for patient autonomy, early provision of information, good communication and a high standard of record-keeping, will minimise the frustration of patients that can then lead them to seek a legal route to redress if they suffer an injury following central neuraxial blockade.

Using medico-legal claims for quality improvement in maternity care: application and revision of an NHSLA coding taxonomy.

OBJECTIVE: To validate the NHSLA maternity claims taxonomy at the level of a single maternity service and assess its ability to direct quality improvement. DESIGN: Qualitative descriptive study. SETTING: Medico-legal claims between 1 January 2000 and 31 December 2016 from a maternity service in metropolitan Melbourne, Australia. POPULATION: All obstetric claims and incident notifications occurring within the date range were included for analysis. METHODS: De-identified claims and notifications data were derived from the files of the insurer of Victorian public health services. Data included claim date, incident date and summary, and claim cost. All reported issues were coded using the NHSLA taxonomy and the lead issue identified. MAIN OUTCOME MEASURES: Rate of claims and notifications, relative frequency of issues, a revised taxonomy. RESULTS: A combined total of 265 claims and incidents were reported during the 6 years. Of these 59 were excluded, leaving 198 medico-legal events for analysis (1.66 events/1000 births). The costs for all claims was $46.7 million. The most common claim issues were related to management of labour (n = 63, $17.7 million), cardiotocographic interpretation (n = 43, $24.4 million), and stillbirth (n = 35, $656,750). The original NHSLA classification was not sufficiently detailed to inform care improvement programmes. A revised taxonomy and coding flowchart is presented. CONCLUSIONS: Systematic analysis of obstetric medico-legal claims data can potentially be used to inform quality and safety improvement. TWEETABLE ABSTRACT: New taxonomy to target health improvement from maternity claims based on NHSLA Ten Years of Maternity Claims.

Defensive medicine among obstetricians and gynaecologists in Turkey.

In recent years, there has been a remarkable increase in medical malpractice litigations against OB/GYNs in Turkey and globally. This high litigation atmosphere may have changed attitudes, behaviour and practice of OB/GYNs. In the current study, opinions and attitudes of OB/GYNs regarding defensive medicine and to what extent they practice it were investigated. One hundred and eight OB/GYNs participated in the study. All participants found obstetrics and gynaecology riskier when compared with other medical branches and reported that they were increasingly practising defensive medicine. The majority of the OB/GYNs stated that they abstained from many risky interventions and expressed their belief that the high caesarean section (C-section) rate was associated with medico-legal concerns. The majority of the participants supported enacting of a specific medical malpractice law and supported the establishment of medically specialised courts. These regulations demanded by OB/GYNs should be taken into account by health authorities. Impact statement What is already known on this subject: In recent years, there has been a remarkable increase in medical malpractice litigations against OB/GYNs in Turkey and globally. Turkey has serious problems with the high C-section rate, which has been suggested to be related to medicolegal issues in a previous research. Fifty-one percent of babies, namely most of them, are delivered via C-section. There is no specific medical malpractice law and medically specialised court in Turkey. What the results of this study add: It seems like there is a professional liability crisis among OB/GYNs in Turkey. OB/GYNs reported that they were increasingly practising defensive medicine, and stated that they abstained from many risky interventions. A high C-section rate was found to be related to medicolegal concerns in OB/GYNs' perspective in the current study. OB/GYNs demanded some reasonable regulations. What the implications are of these findings for clinical practice and/or further research: Regulations demanded by OB/GYNs, which were probed in the current study, such as enacting a specific medical malpractice law and establishment of a medically specialised court, should be taken into account by health authorities in Turkey. The findings of the current study is believed to produce important results for the success of Health transformation programme put into practice in Turkey, which was not able to stop increasing C-section rates. Studies evaluating the direct or indirect costs related to defensive medicine practices of OB/GYNs in Turkey should be performed in subsequent research.

A Violent Birth: Reframing Coerced Procedures During Childbirth as Obstetric Violence.

In the United States, women are routinely forced to undergo cesarean sections, episiotomies, and the use of forceps, despite their desire to attempt natural vaginal delivery. Yet, the current American legal system does little to provide redress for women coerced to undergo certain medical procedures during childbirth. Courts and physicians alike are prepared to override a woman's choice of childbirth procedure if they believe this choice poses risks to the fetus, and both give little value to the woman's right to bodily autonomy. This Note proposes a solution for addressing the problem of coerced medical procedures during childbirth by importing a framework created in Venezuela and Argentina that characterizes this issue as "obstetric violence." First, this Note contains an overview of the shortcomings of the existing American legal framework to address the problem. Second, it explains the advantages of the obstetric violence framework and argues that its adoption in the United States would address many of the failures of the existing system. And third, this Note introduces a few legislative and litigation strategies that can be used to implement this framework in the United States and briefly addresses some of the challenges these strategies may pose.

Is the policy of allowing a female labor companion feasible in developing countries? Results from a cross sectional study among Sri Lankan practitioners.

BACKGROUND: Companionship during labor is known to have both physical and psychosocial benefits to mother and baby. Sri Lanka made a policy decision to allow a labour companion in 2011. However, implementation has been unsatisfactory. Given the leading role Obstetricians play in the implementation of policy, a study was undertaken to assess the knowledge, attitudes and practices among them. METHOD: A descriptive cross sectional study was conducted among consultant obstetricians working in the state hospitals using the platform 'Survey Monkey'. RESULTS: Out of the 140 consultant obstetricians invited, 68(48.5%) participated. Among the study participants, 40 (58.8%) did not allow labour companions in their wards. Lack of space (n = 32; 80%) and the volume of work in the labor wards (n = 22; 55%) were the commonest reasons for not allowing a companion. Only 16.7% (n = 5) of the obstetricians handling more than 300 deliveries per month allowed a companion (p = 0.001). Less than 50% of the obstetricians were aware of the advantages associated with the practice such as shorter labor, lesser analgesic requirement, higher chances of a normal birth, improved neonatal outcome and reduced requirements for labor augmentation for slow progress of labor. Knowledge on advantages on breast feeding and reduced need of instrumental delivery also remained low. CONCLUSION: In an individual unit, the consultant often decides policy. The study points out the need to improve awareness among the practitioners.

Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process.

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT.

US and territory telemedicine policies: identifying gaps in perinatal care.

BACKGROUND: Perinatal regionalization is a system of maternal and neonatal risk-appropriate health care delivery in which resources are ideally allocated for mothers and newborns during pregnancy, labor and delivery, and postpartum, in order to deliver appropriate care. Typically, perinatal risk-appropriate care is provided in-person, but with the advancement of technologies, the opportunity to provide care remotely has emerged. Telemedicine provides distance-based care to patients by consultation, diagnosis, and treatment in rural or remote US jurisdictions (states and territories). OBJECTIVE: We sought to summarize the telemedicine policies of states and territories and assess if maternal and neonatal risk-appropriate care is specified. STUDY DESIGN: We conducted a 2014 systematic World Wide Web-based review of publicly available rules, statutes, regulations, laws, planning documents, and program descriptions among US jurisdictions (N = 59) on telemedicine care. Policies including language on the topics of consultation, diagnosis, or treatment, and those specific to maternal and neonatal risk-appropriate care were categorized for analysis. RESULTS: Overall, 36 jurisdictions (32 states; 3 territories; and District of Columbia) (61%) had telemedicine policies with language referencing consultation, diagnosis, or treatment; 29 (49%) referenced consultation, 30 (51%) referenced diagnosis, and 35 (59%) referenced treatment. In all, 26 jurisdictions (22 states; 3 territories; and District of Columbia) (44%), referenced all topics. Only 3 jurisdictions (3 states; 0 territories) (5%), had policy language specifically addressing perinatal care. CONCLUSION: The majority of states have published telemedicine policies, but few specify policy language for perinatal risk-appropriate care. By ensuring that language specific to the perinatal population is included in telemedicine policies, access to maternal and neonatal care can be increased in rural, remote, and resource-challenged jurisdictions.

Concept of defensive medicine and litigation among Sudanese doctors working in obstetrics and gynecology.

BACKGROUND: Obstetrics and gynaecology always has reputation for being a highly litigious. The field of obstetrics and gynaecology is surrounded by different circumstances that stimulate the doctors to practice defensive medicine. METHODS: This study was directed to assess the extent and the possible effect of defensive medicine phenomenon (in term of knowledge and prevalence) on medical decision making among different grades of obstetric and gynaecologic Sudanese doctors, and to determine any experience of medical litigations with respect to sources and factors associated with it (in term of area of work, characteristics of the area at which the doctors worked, professionalism, hospitals systems…ect). RESULTS: A total of 117 doctors were approached, their distribution according to job description was as follow: consultants (42.7%, 50\117) registrars (34.2%, 40\117) and specialists (23.1%, 27\117). The majority 89.7% had the impression that litigation against doctors are increasing and 27.6% had a direct experience of litigation. In this study less than one half (42.7%) of the surveyed doctors knew the concept of defensive medicine and 71.8% reported practicing one or another form of defensive medicine. The different sources of the litigations reported by the doctors included: maternal death (n = 15), perinatal death (n = 5), other {misdiagnosis, intra-uterine fetal death, uterine perforation, rupture uterus} (n = 4), fetal distress (n = 3), injury to viscera (n = 3) and shoulder dystocia (n = 2). In this study the experience of medical litigation was significantly observed among those who worked in area of blame culture (90.6% Vs 56.5%, P = 0.000). In logistic regression model, there was no significant difference between those who knew the concept of defence medicine and those who didn't. CONCLUSION: There should be strategic plan to reduce the practice of defensive medicine and medical litigation against doctors.

Intra- and interobserver agreement among obstetric experts in court regarding the review of abnormal fetal heart rate tracings and obstetrical management.

OBJECTIVE: The objective of the study was to evaluate the intra- and interobserver agreement among obstetric experts in court regarding the retrospective review of abnormal fetal heart rate tracings and obstetrical management of patients with abnormal fetal heart rate during labor. STUDY DESIGN: A total of 22 French obstetric experts in court reviewed 30 cases of term deliveries of singleton pregnancies diagnosed with at least 1 hour of abnormal fetal heart rate, including 10 cases with adverse neonatal outcome. The experts reviewed all cases twice within a 3-month interval, with the first review being blinded to neonatal outcome. For each case reviewed, the experts were provided with the obstetric data and copies of the complete fetal heart rate recording and the partogram. The experts were asked to classify the abnormal fetal heart rate tracing and to express whether they agreed with the obstetrical management performed. When they disagreed, the experts were asked whether they concluded that an error had been made and whether they considered the obstetrical management as the cause of cerebral palsy in children if any. RESULTS: Compared with blinded review, the experts were significantly more likely to agree with the obstetric management performed (P < .001) and with the mode of delivery (P < .001) when informed about the neonatal outcome and were less likely to conclude that an error had been made (P < .001) or to establish a link with potential cerebral palsy (P = .003). The experts' intraobserver agreement for the review of abnormal fetal heart rate tracing and obstetrical management were both mediocre (kappa = 0.46-0.51 and kappa = 0.48-0.53, respectively). The interobserver agreement for the review of abnormal fetal heart rate tracing was low and was not improved by knowledge of the neonatal outcome (kappa = 0.11-0.18). The interobserver agreement for the interpretation of obstetrical management was also low (kappa = 0.08-0.19) but appeared to be improved by knowledge of the neonatal outcome (kappa = 0.15-0.32). CONCLUSION: The intra- and interobserver agreement among obstetric experts in court for the review of abnormal fetal heart rate tracing and the appropriateness of obstetrical care is poor, suggesting a lack of objectivity of obstetrical expertise as currently performed in court.

A comparison of medical litigation filed against obstetrics and gynecology, internal medicine, and surgery departments.

BACKGROUND: The aim of this study was to review the typical factors related to physician's liability in obstetrics and gynecology departments, as compared to those in internal medicine and surgery, regarding a breach of the duty to explain. METHODS: This study involved analyzing 366 medical litigation case reports from 1990 through 2008 where the duty to explain was disputed. We examined relationships between patients, physicians, variables related to physician's explanations, and physician's breach of the duty to explain by comparing mean values and percentages in obstetrics and gynecology, internal medicine, and surgical departments with the t-test and χ(2) test. RESULTS: When we compared the reasons for decisions in cases where the patient won, we found that the percentage of cases in which the patient's claim was recognized was the highest for both physician negligence, including errors of judgment and procedural mistakes, and breach of the duty to explain, in obstetrics and gynecology departments; breach of the duty to explain alone in internal medicine departments; and mistakes in medical procedures alone in surgical departments (p = 0.008). When comparing patients, the rate of death was significantly higher than that of other outcomes in precedents where a breach of the duty to explain was acknowledged (p = 0.046). The proportion of cases involving obstetrics and gynecology departments, in which care was claimed to be substandard at the time of treatment, and that were not argued as breach of a duty to explain, was significantly higher than those of other evaluated departments (p <0.001). However, internal medicine and surgical departments were very similar in this context. In obstetrics and gynecology departments, the proportion of cases in which it had been conceded that the duty to explain had been breached when seeking patient approval (or not) was significantly higher than in other departments (p = 0.002). CONCLUSION: It is important for physicians working in obstetrics and gynecology departments to carefully explain the risk of death associated with any planned procedure, and to obtain genuinely informed patient consent.

Obstetric litigation: the importance of the quality of clinical files and its influence on expertise conclusions.

To appreciate the Portuguese circumstances concerning situations of obstetric medico-legal conflicts and to evaluate the influence of the quality of files in expert conclusions, an analysis of all cases of obstetric medical responsibility from 2001-11 was carried out. File quality was evaluated by absence or insufficiency of clinical information supplied, by poor quality of document copies and by the registered incongruities among all the health professionals involved. Clinical files sent for forensic analysis were defective in most cases (89.5%). In about 11% of cases, expert opinion was inconclusive as a result of the poor quality of the clinical files sent for technical and scientific analysis. This situation is particularly serious in cases where the reason for the dispute was asphyxia, traumatic lesions of the newborn following instrumented delivery or shoulder dystocia and maternal sequelae, where the lack or absence of information, and poor quality copies were significantly associated with inconclusive opinions.

Medical devices; obstetrical and gynecological devices; classification of the assisted reproduction embryo image assessment system. Final order.

The Food and Drug Administration (FDA) is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the Assisted Reproduction Embryo Image Assessment System classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

[Surrogacy, yes or no? Case report]. / Surogace, ano ci ne? Kazuistika.

OBJECTIVE: Case study of surrogacy which did not come up to client-couple´s expectation. DESIGN: Case report. SETTING: Department of Gynaecology and Obstetrics, Uherske Hradiste Hospital a. s., Uherske Hradiste. METHODOLOGY: Description of the case, case study. CONCLUSION: In the Czech Republic, missing legislation when subject matter is surrogacy does not allow to make a complex legal contract. This fact causes legal uncertainty to all participants. Irresponsible approach of doctors, surrogate mother, client-couple, and in the upshot care of disabled child at government expense can be results.

Towards midwifery education and regulation in Nepal.

This is a short reflection of four wonderful weeks spent in Nepal supporting, advocating and strengthening the existing work of the Midwifery Society of Nepal and the Global midwifery twinning project (GMTP) with the Royal College of Midwives. Although Nepal is on target to achieve reduction in its maternal mortality rate for millennium goal 5 there is still no registered protected title of 'midwife' In order to establish a strong midwifery workforce in Nepal, the three pillars that need to be highlighted are: midwifery education, midwifery regulation and professional midwifery association. The four-week programme led by GMTP volunteers helped towards building capacity in leadership, advocacy and campaigning skills in Nepal.

Retained placental tissue as an emerging cause for malpractice claims.

BACKGROUND: Removal of retained placental tissue postpartum and retained products of conception (RPOC) abortion is done by uterine curettage or hysteroscopy. Trauma to the endometrium from surgical procedures, primarily curettage, can cause intrauterine adhesions (Asherman's syndrome) and subsequent infertility. The incidence of malpractice claims relating to intrauterine adhesions is rising, justifying reevaluation of the optimal way of handling these complications. OBJECTIVES: To review malpractice claims regarding intrauterine adhesions, and to explore the clinical approach that might reduce those claims or improve their medical and legal outcomes. METHODS: We examined 42 Asherman's syndrome claims handled by MCI, the largest professional liability insurer in Israel. The clinical chart of each case was reviewed and analyzed by the event preceding the adhesion formations, timing and mode of diagnosis, and outcome. We also assessed whether the adverse outcome was caused by substandard care and it it could have been avoided by different clinical practice. The legal outcome was also evaluated. RESULTS: Forty-seven percent of the cases occurred following vaginal delivery, 19% followed cesarean section, 28% were RPOC following a first-trimester pregnancy termination, and 2% followed a second-trimester pregnancy termination. CONCLUSIONS: It is apparent that due to the lack of an accepted management protocol for cases of RPOC, it is difficult to legally defend those cases when the complication of Asherman syndrome develops.