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.

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.

Medicolegal Review: Perinatal Effexor Lawsuits and Legal Strategies Adverse to Prescribing Obstetric Providers.

Objectives This study was aimed to familiarize obstetricians with the legal environment surrounding Effexor lawsuits and emphasize the importance of documenting informed consent in the medical records when prescribing a medication that is being targeted for litigation. Study Design We used the LexisNexis legal search engine to review legal documents from Effexor-related cases and also used Google to search for Effexor-related lawsuits online, further researching these cases via publically available court records from district clerk offices. Finally, we conducted a year-by-year literature review from 1993 to 2017 to establish the history and evolution of scientific studies surrounding Effexor use during pregnancy. Results Litigation involving Effexor typically arises due to congenital cardiac birth defects in the neonate allegedly associated with maternal Effexor use in pregnancy. Medication manufacturers have employed a legal strategy termed the learned intermediary doctrine in an attempt to shift liability away from themselves and on to prescribing obstetricians. Manufacturers claim they adequately inform obstetricians of the risks and benefits of prescribing their product and it is the duty of the obstetrician to relay those risks and benefits to their patients. Conclusion To reduce the risk of liability exposure, obstetricians must adequately document informed consent in the medical records when prescribing medications to their pregnant 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.

Understanding the Legal Essentials of a Bowel Injury Lawsuit in Minimally Invasive Gynecologic Surgery.

Bowel injury is a known inherent complication of minimally invasive gynecologic surgery; however, it does not automatically signify medical malpractice. Plaintiff attorneys representing patients seeking legal recourse from a bowel injury typically allege claims of intraoperative negligence, delay in diagnosis, or lack of informed consent in an effort to circumvent the assertion that it is a known inherent complication. In addition, damage awards in bowel injury lawsuits can easily exceed the amount covered by the policy limits of a medical malpractice insurance plan, leaving the gynecologist financially responsible for the difference. Therefore, it is crucial to understand when it may be appropriate to consent to a settlement offer, which can relieve the gynecologist from financial liability for amounts awarded above the medical malpractice policy limits. The purpose of this medical-legal review is to make minimally invasive gynecologic surgeons more aware of the legal strategies used by plaintiff attorneys representing patients who have incurred bowel injuries, and how to limit liability in lawsuits.

Medicolegal Review: Essure Lawsuits and Legal Strategies Adverse to Gynecologists.

The minimally invasive Essure procedure for hysteroscopic sterilization is an ongoing target for litigation. Although efficacious, this device has been scrutinized by the US Food and Drug Administration (FDA) owing to alleged complications. Patients affected by these potential complications are filing lawsuits against Bayer, the manufacturer of Essure. Many of these lawsuits have been barred by preemption, a legal doctrine that limits what can be required of a product by state lawsuits once the FDA approves it; however, in the lawsuits that have been allowed to proceed, the manufacturer has used a legal strategy termed the "learned intermediary doctrine" in an effort to shift blame to the gynecologist to absolve itself of liability. The learned intermediary only requires that a manufacturer inform the gynecologist of the risks associated with the device, and the gynecologist, in turn, must notify the patients through adequate informed consent. To incorporate the necessary components of informed consent, a gynecologist should include what a reasonable practitioner would consider pertinent to the discussion, as well as what a prudent patient would want to know to make a treatment decision. This disclosure entails explaining the risks, benefits, and alternatives, which should be clearly documented in the medical records. Understanding the importance of proper documentation and the legal strategies used in suits will help gynecologists lessen liability exposure when using a medical device, such as Essure, that is being targeted for litigation.

Medicolegal Review of Methotrexate Administration to Viable Intrauterine Pregnancies.

Objective: To examine 3 legal cases in which physicians prescribed methotrexate to women with a viable intrauterine pregnancy, presumed to be ectopic, resulting in adverse fetal outcomes. Study Design: We conducted an electronic literature search for legal cases using the keywords "methotrexate" and "pregnancy" in the LexisNexis legal research engine as well as an Internet-wide search using the additional keyword "verdict." We manually searched the resultant list of identified cases and categorized the studies identified in the search by verdict, award amount, and outcome of the embryo exposed to methotrexate. Results: The monetary awards are typically greater when the embryo exposed to methotrexate lives and requires continuous medical and custodial care as compared to when the fetus dies in utero or shortly after birth. Conclusion: Physicians who, with all good intentions, prescribe methotrexate to women with a viable pregnancy, presumed to be ectopic, could find them-selves liable for an adverse fetal outcome. For the benefit of patients, their unborn offspring, and the liability exposure of the physician, it is important to be very cautious when prescribing methotrexate.

Management of the Jehovah's Witness in Obstetrics and Gynecology: A Comprehensive Medical, Ethical, and Legal Approach.

IMPORTANCE: Obstetricians and gynecologists frequently deal with hemorrhage so they should be familiar with management of patients who refuse blood transfusion. Although there are some reports in the literature about management of Jehovah's Witness patients in obstetrics and gynecology, most of them are case reports, and a comprehensive review about these patients including ethicolegal perspective is lacking. OBJECTIVE: This review outlines the medical, ethical, and legal implications of management of Jehovah's Witness patients in obstetrical and gynecological settings. EVIDENCE ACQUISITION: A search of published literature using PubMed, Ovid Medline, EMBASE, and Cochrane databases was conducted about physiology of oxygen delivery and response to tissue hypoxia, mortality rates at certain hemoglobin levels, medical management options for anemic patients who refuse blood transfusion, and ethical/legal considerations in Jehovah's Witness patients. RESULTS: Early diagnosis of anemia and immediate initiation of therapy are essential in patients who refuse blood transfusion. Medical management options include iron supplementation and erythropoietin. There are also some promising therapies that are in development such as antihepcidin antibodies and hemoglobin-based oxygen carriers. Options to decrease blood loss include antifibrinolytics, desmopressin, recombinant factor VII, and factor concentrates. When surgery is the only option, every effort should be made to pursue minimally invasive approaches. CONCLUSION AND RELEVANCE: All obstetricians and gynecologists should be familiar with alternatives and "less invasive" options for patients who refuse blood transfusions.

Enmeshed in Controversy: Use of Vaginal Mesh in the Current Medicolegal Environment.

UNLABELLED: Vaginal mesh has been a valuable tool in the treatment of stress urinary incontinence and pelvic organ prolapse. As our knowledge of the long-term outcomes and complications of this product has evolved, however, vaginal mesh has become the subject of legal scrutiny. Therefore, it is imperative that physicians understand pertinent litigation techniques to optimize their informed consent and documentation processes and protect themselves. OBJECTIVES: Our objective is to familiarize physicians who use vaginal mesh with how law suits involving transvaginal mesh are construed. We also describe the current medicolegal environment surrounding the use of these products. METHODS: The food and drug administration public safety communications, food and drug administration Manufacturer and User Facility Device Experience database, and LexisNexis legal search engine were used to review data relevant to current vaginal mesh litigation. This information was used to create a medicolegal review. RESULTS: Litigation involving transvaginal mesh follows 3 paths. The first consists of claims against the manufacture of transvaginal mesh with allegations, such as design defects, failure to warn, and misrepresentation. The second is a defensive legal strategy called the learned intermediary doctrine, used by manufacturers to shift liability from themselves to surgeons. The manufacturers claim that the duty to inform patients of potential complications lies with the surgeon. The third involves claims by patients against surgeons for lack of informed consent, alleging that they were not sufficiently informed of potential complications associated with transvaginal mesh before insertion. CONCLUSIONS: To lessen the liability, a surgeon using transvaginal mesh should inform patients of potential complications associated with the products and document informed consent in their medical records.

A medical-legal review of power morcellation in the face of the recent FDA warning and litigation.

Minimally invasive gynecologic surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014, the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Despite the best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. This article is not meant to further deter gynecologists from using laparoscopic power morcellators, but rather to provide an interpretation of the FDA statement as to the patients for whom the use of power morcellation may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellation in the face of the recent FDA warning and litigation.

Bioethical considerations.

The clinical literature notes that pregnancy has become an expected benefit of solid organ transplant. Establishing "best practices" in the management of this particular transplant population requires careful consideration of the ethical dimensions, broadly speaking, of posttransplant pregnancies and these women's lived experiences. In this article, we present the current clinical and social science posttransplant pregnancy research. We specifically address the psychosocial and ethical issues surrounding preconception counseling and posttransplant health quality of life and mothering and suggest areas for future research.

Preimplantation genetic diagnosis: a systematic review of litigation in the face of new technology.

OBJECTIVE: To study legal cases against IVF facilities pertaining to preimplantation genetic diagnosis (PGD) misdiagnosis. DESIGN: Systematic case law review. SETTING: University medical center using US legal databases. PATIENT(S): The IVF recipients using PGD services. INTERVENTION(S): Lawsuits pertaining to PGD against IVF facilities. MAIN OUTCOME MEASURE(S): Lawsuits, court rulings, damage awards, and settlements pertaining to PGD after the birth of a child with a genetic defect. RESULT(S): Causes of action pertaining to PGD arise from negligence in performing the procedure as well as failure to properly inform patients of key information, such as inherent errors associated with the PGD process, a facility's minimal experience in performing PGD, and the option of obtaining PGD. Courts have sympathized with the financial burden involved in caring for children with disabilities. Monetary damage awards are based on the costs of caring for children with debilitating defects, including lifetime medical and custodial care. CONCLUSION(S): Facilities offering PGD services expose themselves to a new realm of liability in which damage awards can easily exceed the limits of a facility's insurance policy. Competent laboratory personnel and proper informed consent--with particular care to inform patients of the inherent inaccuracies of PGD--are crucial in helping deter liability.

Liability exposure for surgical robotics instructors.

Surgical robotics instructors provide an essential service in improving the competency of novice gynecologic surgeons learning robotic surgery and advancing surgical skills on behalf of patients. However, despite best intentions, robotics instructors and the gynecologists who use their services expose themselves to liability. The fear of litigation in the event of a surgical complication may reduce the availability and utility of robotics instructors. A better understanding of the principles of duty of care and the physician-patient relationship, and their potential applicability in a court of law likely will help to dismantle some concerns and uncertainties about liability. This commentary is not meant to discourage current and future surgical instructors but to raise awareness of liability issues among robotics instructors and their students and to recommend certain preventive measures to curb potential liability risks.

Ethical and Psychosocial Impact of Female Infertility.

This manuscript reviews research from the past year on the ethical and psychosocial impact of infertility on women and men. We discuss several issues surrounding ovarian stimulation, particularly high-order multiple births, egg banking (especially for research purposes), and diminished ovarian reserve. We also present recent work on distress and counseling, which includes greater attention to subgroups of infertile women. More research on issues confronting men has emerged recently, and we outline these with regard to their relationships with infertile women, or as the infertility patient. Last, we outline some ethical issues posed by newer procedures of fertility preservation and uterine transplant.

Transvaginal hydrolaparoscopy.

Transvaginal hydrolaparoscopy (THL) is being performed regularly in Europe and China, but rarely in the United States. The reasons may be physicians' unfamiliarity with the procedure and their uneasiness over potential rectal puncturing due to the proximity of the rectum to the vaginal trocar insertion site. THL has the advantage over hysterosalpingography (HSG) in that it allows for direct visualization of the tubal mucosa in addition to determining tubal patency. THL has advantages over traditional laparoscopy in that it does not require an abdominal incision and has the capability of being conducted in an outpatient office setting with local anesthesia. Studies have shown that THL has comparable accuracy to laparoscopy with 96.1% concordance between THL and laparoscopic findings. THL may be combined with chromopertubation and salpingoscopy. In addition to diagnostic purposes, THL may be used for operative intervention including adhesiolysis, endometriosis ablation, and ovarian drilling. Studies from France and China report the occurrence of rectal injury from 0% to1%. Despite the advantages of THL and low reports of rectal injury, THL has not gained popularity in the United States. The purpose of this article is to familiarize gynecologists in the United States with THL.