Legal Case Study of Severe IVF Incidents Worldwide: Causes, Consequences, and High Emotional, Financial, and Reputational Costs to Patients and Providers

Abstract

Background In light of the changing legislative and regulatory landscape concerning reproductive rights and fertility treatments worldwide and a growing number of patients who use assisted reproductive technology (ART)/in vitro fertilization (IVF) treatments to overcome their reproductive challenges (cancer patients, those needing genetic screening, members of the LGBTQIA+ community, and patients who have trouble conceiving naturally) and achieve their family-building goals, ART/IVF clinics face numerous operational and legal challenges, which come at great emotional, reputational, and financial costs to patients and providers. Objectives Fertility treatment related incidents and resulting legal cases vary in severity, scope, and outcomes. Local legal and regulatory environment for patients and ART/IVF providers increase the complexity. The authors aimed to identify the causes of lawsuits against ART/IVF providers and how legal outcomes varied between cases. Study design The data on U.S. IVF incidents was collected from Lexis Nexis, Westlaw, Bloomberg Law, and CaseLaw databases, newspaper and magazine articles, legal reviews, peer-reviewed journals, and online publications. For international cases, HFEA reports, and industry and online publications were queried. The searches were not time restrained but was carried out from January 2022 to April 2023. RESULTS Two hundred five IVF incidents (84.9% U.S., 2.9% U.K., 12.2% other), excluding large-scale tank and alarm failures and power disruptions, which affected 307 people (79.8%, 3.3%, 16.9%) and/or 258 specimens (84.5%, 2.7%, 12.8%), resulting in 76 lawsuits (65.8%, 7.89%, 26.3%) were identified worldwide, and categorized by error types. Specimen mix-ups were the most prevalent type (95.0%). Meanwhile, ten failed storage and alarm incidents caused most damage, affecting >1800 patients and >8100 specimens, and resulting in 181 initial lawsuits. CONCLUSIONS Overreliance on manual protocols, irregular/skipped audits, and human error were responsible for IVF incidents reviewed. Damaged, destroyed, or lost embryos and embryo transfer to the wrong recipient have lifelong devastating effects on patients, for many of whom IVF was their last chance for parenthood due to cancer treatment, infertility, and/or age. To complicate the cases, embryo mix-ups resulted in custody disputes over the newborn child(ren), as in Manukyan v. CHA Health Systems, and loss of identity in children and parents. U.S. babies born to embryo mix-ups are reunited with their genetic parents, following the legal precedent of Perry-Rogers v. Fasano. Many countries, however, grant the custody of the child(ren) to birth parents. Most lawsuits were dismissed or settled. The combination of changing abortion and personhood laws in several states of the US can further complicate the issue, as they might put patients and providers in legal jeopardy, following routine ART/IVF procedures. This may include preimplantation genetic testing, short- and long-term embryo storage, and embryo disposal. These state laws will limit patient options and restrict ART/IVF clinic operations. Owing to all these factors, in this study, we can only make educated estimates about the true scope of the issue and its financial cost to ART/IVF providers, which might range from thousands to millions of USD. Lawsuits also come at a great reputational cost for patients, their families and providers, so the latter might benefit from embracing digitization of records, automation, robotics, and AI as a standard of care in their practice.