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.

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.

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.

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.

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.

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.

Medicolegal review of liability risks for gynecologists stemming from lack of training in robot-assisted surgery.

The advances in robot-assisted surgery in gynecology evolved after most practicing gynecologists had already completed residency training. Postgraduate training in new technology for gynecologists in practice is limited. Therefore, gynecologists with insufficient training who perform robot-assisted surgery may potentially be at risk for liability. In addition to the traditional medical negligence claims, plaintiff attorneys are seeking causes of actions for lack of informed consent and negligent credentialing. Thus, it is essential that gynecologists be aware of these potential liability claims that arise in a robot-assisted malpractice suit. This commentary provides an overview of the current medicolegal liability risks originating from lack of training in robotic surgery and seeks to raise awareness of the implications involved in these claims. A better understanding of the doctrine of informed consent and seeking assistance of proctors or experienced co-surgeons early in robotics training are likely to reduce the liability risks for gynecologic surgeons.

A legal-ethical analysis of reproductive endocrinologists' right to refuse ovulation induction to patients with diminished ovarian reserve.

PURPOSE: Review of the legal and ethical basis for reproductive endocrinologists to refuse ovulation induction to patients with diminished ovarian reserve. METHODS: The Lexis-Nexis search engine was used to perform a legal review pertaining to refusal of treatment. Ethical opinions of medical organizations were also reviewed. RESULTS: Federal antidiscrimination laws provide legal recourse for patients with diminished ovarian reserve who are denied ovulation induction. However, the same laws also permit refusal of care when there is bona fide medical justification to decline services. In addition, the codes of ethics for relevant professional organizations support physicians' decisions to refuse treatment when treatment is futile. CONCLUSION: Although it is ethically and legally permissible to deny ovulation induction to patients with diminished ovarian reserve when medically justified, refusal may invite retaliatory litigation. Counseling remains a cornerstone in directing these patients to options with more potential for success, such as donor eggs and adoption.

Avoiding legal pitfalls in surrogacy arrangements.

The goal of this article is to discuss the legal pitfalls that reproductive endocrinologists face when participating in gestational surrogacy contracts. This paper was composed using Westlaw and LexisNexis commercial legal search engines to perform a review of statutes and cases pertaining to gestational surrogacy. The search results demonstrated that in the absence of suitable preparation, there is significant potential for litigation while participating in gestational agreements. Providers caring for gestational carriers have been named as parties in lawsuits for failure to provide psychological screening, failure to screen for infectious disease and participation in gestational contracts that are not compliant with state law. There is great disparity in state laws and court rulings pertaining to gestational agreements. When legal disputes arise, individual state laws and court rulings are controlling over the Uniform Parentage Act. Likewise, recommendations by the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine do not supersede state laws. The failure to abide by individual state laws unnecessarily exposes reproductive endocrinologists and their IVF facilities to potential litigation. In order to lessen exposure to litigation, an understanding of individual state legislation or historical court rulings is advised.

Use of vaginal mesh in the face of recent FDA warnings and litigation.

Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent.

Reproduction beyond menopause: how old is too old for assisted reproductive technology?

BACKGROUND: Due to the recent media attention on postmenopausal women giving birth, there has been an increased scrutiny on the utility and safety of assisted reproductive technology in postmenopausal women. OBJECTIVE: The purpose of this commentary is to discuss the following: 1) the limitations and complications of ART in women of advanced reproductive age; 2) the balance between the welfare of the mother and that of the child; 3) the double standards of advanced reproductive age; and 4) the importance of financial and social support systems and preconception counseling with advanced reproductive age. CONCLUSION: When providing in-vitro fertilization services to women of advanced reproductive age, special considerations must be given to ensure the welfare of mother and the child and that the principles of beneficence and nonmaleficence are guaranteed.

Spontaneously developed tail swellings (SDTS) influence the accuracy of the hypo-osmotic swelling test (HOS-test) in determining membrane integrity and viability of human spermatozoa.

PURPOSE: To investigate the prevalence of spontaneously developed tail swellings (SDTS) in human sperm samples that are commonly encountered in the laboratory, and their influence on the hypo-osmotic swelling test (HOS-test). METHODS: Ejaculated, epididymal, and testicular sperm were evaluated for SDTS. Further, HOS-test scores were compared with those of vital stains using column washed sperm maintained in the laboratory. RESULTS: SDTS, at <10%, was present in all types of sperm samples. The highest and lowest occurrences of SDTS were found in cryopreserved sperm, and column-washed sperm respectively. SDTS can inflate the HOS-test score, and so lower the accuracy of the HOS-test. However, the HOS-test efficiency can be improved by assessing SDTS in the sample. CONCLUSION: HOS-test and vital stain cannot be used interchangeably in all circumstances for sperm viability determination. The accuracy of the HOS-test can be enhanced by incorporating SDTS as a correction factor.

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.

Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation.

Recent changes in U.S. Food and Drug Administration (FDA) labeling and news reports of lawsuits resulting in million-dollar settlements understandably may deter gynecologists from prescribing the transdermal contraceptive patch Ortho Evra (Ortho-McNeil Pharmaceutical, Inc., Titusville, NJ). Gynecologists who, with all good intentions, prescribe an FDA-approved drug such as the contraceptive patch potentially could find themselves liable for an adverse drug reaction. Although much of the current focus by plaintiff attorneys and the news media is on the contraceptive patch, no prescription contraceptive method is without medical risks to the patient or legal risks to the prescribing gynecologist. The purpose of this commentary is to provide an overview of the medical-legal controversies and pitfalls in prescribing the contraceptive patch as well as to outline how gynecologists can avert legal liability by providing proper informed consent. Despite FDA labeling changes and ongoing litigation, with proper informed consent, the contraceptive patch still may be the best choice for many patients who prefer the convenience of a weekly patch over a daily oral contraceptive. Also, regardless of the contraceptive option chosen, the principles of providing and documenting proper informed consent in medical records are applicable not only to providing quality care to patients, but also to protecting the legal interests of the prescribing gynecologist. By documenting proper informed consent in medical records, gynecologists should feel more at ease in prescribing the contraceptive method that best fits their individual patients' needs, even in the presence of ongoing litigation.