WRONGFUL BIRTH AND WRONGFUL LIFE LAWSUITS IN OBSTETRICS AND GYNECOLOGY.

Developments in preconception and prenatal technologies have led to undeniable advances in how healthcare 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 two 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 a 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 healthcare providers offering high quality healthcare.

Left-Handedness in Obstetrics and Gynecology: A Nationwide Survey of U.S. Trainees and Educators.

OBJECTIVE: This study aimed to evaluate the views and influence of left-handedness among obstetrics and gynecology (OBGYN) trainees and educators and to identify perceived obstacles in training by left-handed (LH) trainees. STUDY DESIGN: An online survey was sent to the U.S. Obstetrics and Gynecology training programs. All participants were asked questions on hand preference for various medical and nonmedical activities, as well as on demographics. Participant responses to handedness and their role as a learner or educator directed them toward further questions. Trainees were surveyed on their experience and outlook as a LH physician in OBGYN. Educators were surveyed on their experience and attitudes in working with LH trainees. LH educators were also surveyed on their experience as a LH physician, similar to the LH trainees. Chi-square or Fisher's exact analysis was used as appropriate, with p-value <0.05 considered statistically significant. RESULTS: Responses were received from 21 training programs, totaling 304 individuals. Participants included 205 learners (156 right handed and 49 left handed), and 99 faculty (82 right handed and 17 left handed). A lack of LH surgical instrument availability (93.6%) and difficulty using right-handed (RH) instruments (83%) were notable obstacles reported by LH learners. The majority of LH learners (57.4%) did not consider their handedness to be disadvantageous but did note added difficulty when training under RH mentors when compared with training under LH mentors (66%). In contrast to LH educators, RH educators endorsed added difficulty in instructing operative procedures to LH learners (32.1 vs. 13.3%, p = 0.012). CONCLUSION: LH trainees face unique challenges during their OBGYN training. Educators would benefit from guidance on how best to manage these trainees. Educators should work to adapt surgical and procedural techniques to accommodate LH trainees. KEY POINTS: · LH learners reported more difficulty in training under RH mentors.. · RH mentors reported increased difficulty in educating LH trainees.. · Neither trainees nor educators considered being LH a significant disadvantage..

Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator: A Randomized Clinical Trial.

OBJECTIVE: To assess whether outpatient cervical ripening with a synthetic osmotic dilator shortens the length of hospital stay in term pregnancies undergoing labor induction. METHODS: Pregnant participants scheduled for labor induction at term with unfavorable cervix (less than 3-cm dilated and less than 60% effaced) and not requiring inpatient maternal or fetal monitoring were consented, and synthetic osmotic dilator rods were inserted on the day of scheduled induction. After reassuring fetal heart tracing, patients randomized to the outpatient group were asked to return 12 hours after insertion or sooner if needed. Those randomized to the inpatient group remained in the hospital. After the first round of ripening, additional ripening, oxytocin, and labor management were left up to the clinical health care professionals. The primary outcome was the proportion of participants with hospital stays longer than 48 hours. We estimated that a sample size of 338 would provide 85% power to detect a 30% difference between groups. RESULTS: From November 2018 to November 2021, 339 participants were randomized (171 inpatient, 167 outpatient, one withdrawal). Four patients in the outpatient group were admitted before12 hours for suspected labor and rupture of membranes, and 19 in the inpatient group had the device removed before 12 hours. The proportion of participants with hospital stays longer than 48 hours was lower in the outpatient group compared with the inpatient group (89 [53%] vs 152 [89%], relative risk [RR] 0.60, 95% CI 0.52-0.70). Patients in the outpatient group had a shorter total length of stay and time from admission to active labor. They were more likely to have a vaginal delivery within 24 hours of admission and were less likely to receive analgesics during ripening. Route of delivery and other maternal and neonatal outcomes were not significantly different between groups. CONCLUSION: Outpatient cervical ripening with a cervical osmotic dilator decreased hospital stay compared with inpatient ripening, without significant adverse outcomes. FUNDING SOURCE: Medicem Technology s.r.o., Czech Republic. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03665688.

Pregnancy After 40: Recommendations for Counseling, Evaluation, and Management From Preconception to Delivery.

IMPORTANCE: Pregnant patients over age 40 often have unique risk factors and potential complications before and during pregnancy that play a role in their counseling and management. OBJECTIVE: To provide practitioners an overview on how to approach preconception evaluation and counseling, prenatal care, and management of associated comorbidities, as well as potential complications, in pregnant patients over age 40. EVIDENCE ACQUISITION: Literature review was performed using OVID and PubMed, with further relevant information queried from guidelines of professional organizations. RESULTS: Pregnant patients over age 40 should receive preconception evaluations by their obstetrician-gynecologist and other appropriate specialty care providers as they pertain to preexisting medical comorbidities. In the preconception period, attention should be given to managing and optimizing preexisting medical conditions and associated pharmacotherapeutics. Referral to specialists in assisted reproductive technologies or maternal-fetal medicine should be considered if indicated for appropriate evaluation and counseling. During pregnancy, accurate dating and counseling on aneuploidy screening, with consideration for early diabetes screening, should be performed in the first trimester. A detailed anatomy scan and fetal echocardiogram should be completed by 22 weeks' gestation, along with routine and high-risk (if indicated) prenatal care. Close attention should be given to the development of pregnancy-related complications associated with advancing age. Third-trimester fetal surveillance can be considered. Given that no contraindications exist, these patients should be encouraged to pursue a vaginal delivery with consideration for induction at 39 to 40 weeks' gestation. CONCLUSIONS AND RELEVANCE: Pregnancy rates are increasing in persons over age 40. As a result, preconception evaluation and counseling tailored to that demographic are essential. In addition to standard prenatal care, they should have early screening and diligent monitoring for pregnancy-related comorbidities associated with advancing age. RELEVANCE STATEMENT: With the increased pregnancy-associated comorbidities in patients over age 40, providers should be familiar with how to evaluate, counsel, and manage them during the preconception and pregnancy periods.

FGF1 and insulin control lipolysis by convergent pathways.

Inexorable increases in insulin resistance, lipolysis, and hepatic glucose production (HGP) are hallmarks of type 2 diabetes. Previously, we showed that peripheral delivery of exogenous fibroblast growth factor 1 (FGF1) has robust anti-diabetic effects mediated by the adipose FGF receptor (FGFR) 1. However, its mechanism of action is not known. Here, we report that FGF1 acutely lowers HGP by suppressing adipose lipolysis. On a molecular level, FGF1 inhibits the cAMP-protein kinase A axis by activating phosphodiesterase 4D (PDE4D), which separates it mechanistically from the inhibitory actions of insulin via PDE3B. We identify Ser44 as an FGF1-induced regulatory phosphorylation site in PDE4D that is modulated by the feed-fast cycle. These findings establish the FGF1/PDE4 pathway as an alternate regulator of the adipose-HGP axis and identify FGF1 as an unrecognized regulator of fatty acid homeostasis.

Embryo quality, ploidy, and transfer outcomes in male versus female blastocysts.

PURPOSE: The goal is to determine if variations exist between male and female blastocysts in preimplantation measurements of quality and ploidy and in vitro fertilization elective single-embryo transfer (eSET) outcomes. METHODS: A retrospective chart review was conducted from a private fertility center's database of blastocysts undergoing preimplantation genetic testing for aneuploidy, along with details of eSET from this screened cohort. Main outcomes included preimplantation embryo quality and sex-specific eSET outcomes. RESULTS: A total of 3708 embryos from 578 women were evaluated, with 45.9% male and 54.1% female. The majority were High grade. No difference existed between embryo sex and overall morphological grade, inner cell mass or trophectoderm grade, or blastocyst transformation day. Female blastocysts had a higher aneuploidy rate than male blastocysts (P < 0.001). Five hundred thirty-nine eSETs from 392 women were evaluated, with High grade embryos more likely to have implantation (P < 0.001), clinical pregnancy (P < 0.001), and ongoing pregnancy (P = 0.018) than Mid or Low grade embryos. Day 5 blastocysts were more likely to have implantation (P = 0.018), clinical pregnancy (P = 0.005), and ongoing pregnancy (P = 0.018) than day 6 blastocysts. Male and female embryos had similar transfer outcomes, although female day 5 blastocysts were more likely to result in clinical pregnancy (P = 0.012), but not ongoing pregnancy, than female day 6 blastocysts. Male eSET outcomes did not differ by blastocyst transformation day. CONCLUSION: Male and female embryos have comparable grade and quality; however, female embryos were more likely to be aneuploid. Ongoing pregnancy rates did not differ by embryo sex. Day 5 embryos had more favorable transfer outcomes than day 6 embryos.

Liability for embryo mix-ups in fertility practices in the USA.

PURPOSE: To study recent legal cases involving the transfer of the incorrect embryo into patients and learn how fertility clinics can better serve clients, protect themselves financially, and safeguard their physicians' personal assets. METHODS: The Nexis Uni database was used to review legal cases, news, and business publications of previous cases of embryo mix-ups. County and district courthouse dockets were also queried for filings and court documents related to lawsuits involving embryo mix-ups using Public Access to Court Electronic Records (PACER). Emphasis was placed on court decisions, awarded damages, and legal and media coverage related to embryo mix-up events. RESULTS: A case law review of US legal databases and courthouse dockets was conducted for cases between 2000 and 2020, focusing on lawsuits against reproductive endocrinologists and in vitro fertilization (IVF) facilities offering embryo transfer (ET). Improper labeling and ineffective communication led to errors in the cases reviewed. CONCLUSION: It is prudent for clinics to protect themselves from embryo mix-ups, which can subsequently lead to undesirable clinical outcomes, as well as lawsuits stemming from these errors. This article emphasizes following labeling guidelines when storing embryos, employing a two-step read back method prior to ET, and offering genetic testing when a discrepancy is found in the record. In the case an embryo mix-up does occur, it is recommended to protect personal assets through business organizing procedures and consider settlement offers for policy limits.

Negative Patient Reviews and Online Defamation: A Guide for the Obstetrician-Gynecologist.

Physician review websites can serve as a means for patients to address physician actions, both good and bad. At times, patient reviews may be negative and perceived as defamatory. Yet there are specific legal requirements that must be met for an online review to be considered defamatory. Prior cases indicate that pursuing a defamation lawsuit, although appropriate in some circumstances, is oftentimes a difficult and futile endeavor. To avoid litigation, physicians can take proactive approaches to address questionable reviews and to bolster their online reputations.

Postmenopausal Pregnancy in the Era of Assisted Reproductive Technologies.

Assisted reproductive technologies allow women to achieve pregnancy at ages beyond the limits of their natural reproductive lifespans. As women seek pregnancy later in life, physicians are challenged with balancing their professional autonomy against patient autonomy. Increased parental age increases risk to mother and fetus. Legal aspects of postmenopausal women desiring fertility services will vary by location. Ethically, the principles of beneficence, nonmaleficence, and justice become important factors in a physician's evaluation process. This article aims to highlight current guidelines for postmenopausal women desiring fertility services and address medical, legal, and ethical concerns that may arise when assessing these patients.

Cryostorage failures: a medicolegal review.

PURPOSE: To heighten awareness of the potential legal and financial burdens faced by those providing cryopreservation storage services of embryos and gametes in light of recent lawsuits involving inadvertent thawing of specimens. METHODS: Case law review of US legal databases and courthouse dockets with a focus on lawsuits against reproductive endocrinologists and cryostorage facilities offering cryopreservation. Emphasis was placed on court decisions, awarded damages, and legal and media coverage related to cryostorage failure events. RESULTS: Lawsuits pertaining to two notable ongoing cases of cryostorage failure that occurred at fertility clinics in the US in 2018 were reviewed. Media coverage of these events and plaintiff and defense attorney strategies were evaluated. Legal documents from previous, similar cryostorage failures were also reviewed. Common claims in cryostorage system failures include breach of contract and negligent handling of property. Facilities offering cryostorage services are vulnerable to significant burden, legally and financially, if they are to experience a storage system failure. CONCLUSION: Providing cryostorage services is not without significant financial risk. Inadvertent thawing of specimens can lead to high damage awards against cryostorage facilities and those individuals linked to a cryostorage failure event. Because monetary damages can surpass insurance policy limits, those providing cryostorage services should be aware of plaintiff attorney strategies, common legal defenses, and basic asset protection principles to safeguard themselves if ever faced with these situations. Facilities should also carry out regular maintenance and safety checks on equipment and alarm structures to deter such events.

FGF1 - a new weapon to control type 2 diabetes mellitus.

A hypercaloric diet combined with a sedentary lifestyle is a major risk factor for the development of insulin resistance, type 2 diabetes mellitus (T2DM) and associated comorbidities. Standard treatment for T2DM begins with lifestyle modification, and includes oral medications and insulin therapy to compensate for progressive ß-cell failure. However, current pharmaceutical options for T2DM are limited in that they do not maintain stable, durable glucose control without the need for treatment intensification. Furthermore, each medication is associated with adverse effects, which range from hypoglycaemia to weight gain or bone loss. Unexpectedly, fibroblast growth factor 1 (FGF1) and its low mitogenic variants have emerged as potentially safe candidates for restoring euglycaemia, without causing overt adverse effects. In particular, a single peripheral injection of FGF1 can lower glucose to normal levels within hours, without the risk of hypoglycaemia. Similarly, a single intracerebroventricular injection of FGF1 can induce long-lasting remission of the diabetic phenotype. This Review discusses potential mechanisms by which centrally administered FGF1 improves central glucose-sensing and peripheral glucose uptake in a sustained manner. Specifically, we explore the potential crosstalk between FGF1 and glucose-sensing neuronal circuits, hypothalamic neural stem cells and synaptic plasticity. Finally, we highlight therapeutic considerations of FGF1 and compare its metabolic actions with FGF15 (rodents), FGF19 (humans) and FGF21.

Loss of functional NADPH oxidase 2 protects against alcohol-induced bone resorption in female p47phox-/- mice.

BACKGROUND: In bone, NADPH oxidase (NOX)-derived reactive oxygen species (ROS) superoxide and/or hydrogen peroxide are an important stimulus for osteoclast differentiation and activity. Previously, we have demonstrated that chronic ethanol (EtOH) consumption generates excess NOX-dependent ROS in osteoblasts, which functions to stimulate nuclear factor kappa-ß receptor ligand (RANKL)-RANK signaling, thus increasing osteoclastogenesis and activity. This activity can be blocked by co-administration of EtOH with the pan-NOX inhibitor diphenylene idonium (DPI). METHODS: To test whether EtOH-induced bone loss is dependent on a functional NOX2 enzyme, 6-week-old female C57BL/6J-Ncf1/p47phox(-/-) (p47phox KO) and wild-type (WT) mice were pair-fed EtOH diets for 40 days. Bone loss was assessed by 3-point bending, micro-computed tomography and static histomorphometric analysis. Additionally, ST2 cultured cells were co-treated with EtOH and NOX inhibitors, DPI, gliotoxin, and plumbagin, after which changes in ROS production, and in RANKL and NOX mRNA expression were analyzed. RESULTS: In WT mice, EtOH treatment significantly reduced bone density and mechanical strength, and increased total osteoclast number and activity. In EtOH-treated p47phox KO mice, bone density and mechanical strength were completely preserved. EtOH p47phox KO mice had no changes in osteoclast numbers or activity, and no elevations in serum CTX or RANKL gene expression (p < 0.05). In both WT and p47phox KO mice, EtOH feeding reduced biochemical markers of bone formation (p < 0.05). In vitro EtOH exposure of ST2 cells increased ROS, which was blocked by pretreating with DPI or the NOX2 inhibitor gliotoxin. EtOH-induced RANKL and NOX2 gene expression were inhibited by the NOX4-specific inhibitor plumbagin. CONCLUSIONS: These data suggest that NOX2-derived ROS is necessary for EtOH-induced bone resorption. In osteoblasts, NOX2 and NOX4 appear to work in tandem to increase RANKL expression, whereas EtOH-mediated inhibition of bone formation occurs via a NOX2-independent mechanism.