Emerging post-Dobbs liability concerns for providers handling embryos.

PURPOSE OF REVIEW: This review outlines novel, emerging legal risks for in-vitro fertilization (IVF) providers and patients. RECENT FINDINGS: This article reviews recent antiabortion legal developments that create novel legal risks to IVF. This article examines new potential liability for the handling or managing of embryos, and threats to safe, efficient, standard-of-care practice of IVF. It reviews established US and international judicial and regulatory frameworks based on scientifically grounded recognition of IVF embryos as deserving of 'special respect', and finds this approach to be an alternative for law and policy makers. SUMMARY: Defining life as 'beginning at fertilization' (or 'conception') or otherwise embracing 'embryonic personhood' creates emerging legal vulnerabilities and concerns for IVF patients and professionals who handle embryos and threatens standard-of-care IVF. Internationally and domestically established, scientifically grounded understandings of IVF embryos, rather than religious beliefs, should be the basis for legal frameworks that accord appropriate - but not unlimited - protections to IVF embryos. This article presents this framework as an alternative to the current path being embraced by some US policymakers and courts, as a means of protecting the rights of patients, providers and the families they create.

In Vitro Fertilization, State Wrongful Death Statutes and State Fetal Homicide Statutes: The Reaction to LePage v. Center for Reproductive Medicine.

The Alabama Supreme Court recently held, in LePage v. Center for Reproductive Medicine, that the parents of human embryos that were negligently destroyed at a fertility clinic could bring an action for damages under the State's wrongful death statute. Although the Alabama legislature promptly enacted a law essentially overturning the state supreme court's decision, concerns have been raised that the court's decision might influence courts in other States to interpret their wrongful death statutes, or possibly even their fetal homicide statutes, to apply in similar circumstances, thereby threatening the availability of in vitro fertilization (IVF) technology. This article addresses those concerns.With respect to wrongful death statutes, only fourteen States (excluding Alabama) have interpreted their statutes to apply to unborn children without regard to their stage of gestation or development. The majority of States impose a gestational requirement (typically, viability) which would preclude their application to the destruction of human embryos. Even with respect to the minority of States that impose no limitation on the cause of action, those statutes, either by their express language or by fair interpretation, would not apply to unimplanted human embryos.With respect to the fetal homicide statutes in thirty-one States that do not have any gestational or developmental limitation, the statutes in twenty-six of those States apply only to acts causing the death of an unborn child in utero. As to the statutes in the other five States, the structure of the statute, considered in light of the applicable case law, strongly suggests that there would be no liability for causing the death of an unborn child before implantation. In sum, the Alabama Supreme Court's decision in LePage is not likely to be followed as a precedent in interpreting either the wrongful death statutes or the fetal homicide statutes of any other State.

Alabama IVF ruling may halt uterus transplants.

Scientists fear wider research impacts if other states label frozen embryos "children".

Regulación legal de la fecundación asistida post mortem en España / Legal regulation of assisted post-mortem fertilisation in Spain

El avance en las técnicas de reproducción humana asistida ha hecho posible que el fallecimiento de una persona ya no necesariamente derive en el fracaso de su proyecto parental. La regulación de la fecundación post mortem en España es poco profusa, deja vacíos legales y posibilita interpretaciones diversas. Pese a ello, resulta posible establecer la filiación paterna a favor del hijo póstumo con los efectos legales que lleva aparejada la filiación. (AU)

Advances in assisted human reproduction techniques have made it possible that thedeath of a person no longer necessarily results in the failure of his parental project. The regulation of post-mortem fertilisation in Spain is not very profuse, leaves legal gaps and allows for different interpretations. Despite this, it is possible to establish paternal filiation in favour of the posthumous child with the legal effects that filiation entails. (AU)

In vitro fertilization and andrology laboratory in 2030: expert visions.

The aim of this article is to gather 9 thought leaders and their team members to present their ideas about the future of in vitro fertilization and the andrology laboratory. Although we have seen much progress and innovation in the laboratory over the years, there is still much to come, and this article looks at what these leaders think will be important in the future development of technology and processes in the laboratory.

The ethics of human-embryoids model: a call for consistency.

In this article, we discuss the ethics of human embryoids, i.e., embryo-like structures made from pluripotent stem cells for modeling natural embryos. We argue that defining our social priorities is critical to design a consistent ethical guideline for research on those new entities. The absence of clear regulations on these emerging technologies stems from an unresolved debate surrounding natural human embryo research and one common opinion that one needs to solve the question of the moral status of the human embryo before regulating their surrogate. The recent NIH funding restrictions for research on human embryoids have made scientists even more unlikely to raise their voices. As a result, the scientific community has maintained a low profile while longing for a more favorable socio-political climate for their research. This article is a call for consistency among biomedical research on human materials, trying to position human embryoids within a spectrum of existing practice from stem cell research or IVF to research involving human subjects. We specifically note that the current practices in infertility clinics of freezing human embryos or disposing of them without any consideration for their potential benefits contradicts the assumption of special consideration for human material. Conversely, creating human embryoids for research purposes could ensure that no human material be used in vain, always serving humankind. We argue here that it is time to reconsider the full ban on embryo research (human embryos and embryoids) beyond the 14-day rule and that research on those entities should obey a sliding scale combining the completeness of the model (e.g., complete vs. partial) and the developmental stage: with more advanced completeness and developmental stage of the considered entity, being associated with more rigorous evaluation of societal benefits, statements of intention, and necessity of such research.

COVID-19: A review and considerations for the resumption of activities in an IVF laboratory and clinic in Brazil.

COVID-19 has caused radical effects on the daily lives of millions of people. The causal agent of the current pandemic is SARS-CoV-2, a virus that causes symptoms related to the respiratory system, leading to severe complications. In the in vitro fertilization (IVF) universe, there are several protocols for infection control and laboratory safety. Some professional associations have issued guidelines recommending measures involving patient flow and IVF practices. This study presents a review and considerations for the resumption of activities in IVF laboratories and clinics in Brazil during the COVID-19 pandemic, according to the guidelines and statements from professional organizations and societies in reproductive medicine.

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.

Is there anything left of the Italian law governing medically-assisted procreation?

Medically-assisted-procreation via in vitro fertilization, an integral part of of the so-called "reproductive revolution", is a valuable option for couples with sterility or fertility issues. That has however brought about three relevant results: the rift between procreation and sexual intercourse, the opportunity to use heterologous fertilization through donated gametes, and the ensuing increase in the number of "reproductive contributors" (male and/or female gamete donors, surrogate mothers). In Italy, Law n. 40 has put in place several restrictions, stricter than in most other European countries. Before being declared partly unconstitutional, Law 40 used to impose an array of bans and restrictions other than the ones still currently in force, such as the still unchanged prohibition to use human embryos for experimentation purposes and the ban on surrogacy. For same-sex couples who travel abroad to get around the Italian ban on heterologous fertilization, surrogacy, and MAP for homosexual couples. The authors have attempted to lay out a short analysis of how Italian courts have attempted to uphold the best interests of children born abroad in homosexual families, by taking into account the latest decisions on the subject.

In Vitro Fertilization Informed Consent: Revisited, Empirically.

BACKGROUND: A thorough informed consent (IC) process is required before in vitro fertilization (IVF) treatments can begin because these treatments are by and large elective and they have expectable and preventable complications, such as ovarian hyper-stimulation syndrome and multi-fetal pregnancies. OBJECTIVES: To empirically examine whether patient knowledge and understanding of potential hazards associated with IVF treatment are better after the IC process compared to before. The authors hypothesized that patients' better understanding of potential complications would be translated and expressed as rational choices of treatment alternatives. METHODS: Responses of 48 IVF patients after IC process (study group) from two IVF units in northern Israel were compared to those of 46 patients before IVF (control group). Only women undergoing IVF for first time who were older than 18 years of age were eligible for the study. RESULTS: Socio-demographic parameters were found to be quite similar between the study group and the control group. Contrary to our expectations, in the study group 12 women (25.5%) considered delivery of a single baby as their optimal result, compared to 15 (32.6%) in the control group. Furthermore, preferences shifted toward triplets: eight patients (17%) after IC considered this option as their best result, compared to only five patients (11%) before IC. CONCLUSIONS: C process goals are not achieved under current practices, at least as far as IVF treatment are concerned. New tools and incentives should be implemented to meet the requirements dictated by the laws regarding patient rights.

The social paradoxes of commercial surrogacy in developing countries: India before the new law of 2018.

BACKGROUND: Commercial surrogacy is a highly controversial issue that leads to heated debates in the feminist literature, especially when surrogacy takes place in developing countries and when it is performed by local women for wealthy international individuals. The objective of this article is to confront common assumptions with the narratives and experiences described by Indian surrogates themselves. METHODS: This qualitative study included 33 surrogates interviewed in India (Mumbai, Chennai and New Delhi) who were at different stages of the surrogacy process. They were recruited through five clinics and agencies. This 2-year field study was conducted before the 2018 surrogacy law. RESULTS: Surrogates met the criteria fixed by the national guidelines in terms of age and marital and family situation. The commitment to surrogacy had generally been decided with the husband. Its aim was above all to improve the socioeconomic condition of the family. Women described surrogacy as offering better conditions than their previous paid activity. They had clear views on the child and their work. However, they declared that they faced difficulties and social condemnation as surrogacy is associated with extra-marital relationships. They also described a medical process in which they had no autonomy although they did not express complaints. Overall, surrogates did not portray themselves as vulnerable women and victims, but rather as mothers and spouses taking control of their destiny. CONCLUSIONS: The reality of surrogacy in India embraces antagonistic features that we analyze in this paper as "paradoxes". First, while women have become surrogates in response to gender constraints as mothers and wives, yet in so doing they have gone against gender norms. Secondly, while surrogacy was socially perceived as dirty work undertaken in order to survive, surrogates used surrogacy as a means to upward mobility for themselves and their children. Finally, while surrogacy was organized to counteract accusations of exploitation, surrogates were under constant domination by the medical system and had no decision-making power in the surrogacy process. This echoes their daily life as women. Although the Indian legal framework has changed, surrogacy still challenges gender norms, particularly in other developing countries where the practice is emerging.

E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan.

BACKGROUND: The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial. METHODS AND DESIGN: E-Freeze is a two-arm parallel-group, multi-centre, individually randomised controlled trial to determine if a policy of freezing embryos, followed by thawed frozen embryo transfer, results in a higher healthy baby rate when compared with the current policy of transferring fresh embryos. Couples undergoing their first, second or third cycle of in vitro fertilisation at fertility centres in the UK were randomised to either fresh or frozen embryo transfer. The primary outcome is a healthy baby, defined as a live singleton baby born at term with an appropriate weight for gestation. This paper describes the statistical analysis plan for the trial, including the analysis principles, definitions of outcomes, methods for primary analysis, pre-specified subgroup analysis and sensitivity analysis. This plan was finalised prior to completion of recruitment to the trial. TRIAL REGISTRATION: ISRCTN registry: ISRCTN61225414 . Registered on 29 December 2015.

Restatement (Third) of Torts Section 47(b) Bypasses Traditional Barriers and Offers Aspiring Parents a Clear Path to Recover Stand-Alone NIED when Their Cryopreserved Reproductive Material is Lost or Destroyed.

"[T]he tissue or embryo is not the primary victim at all. The victims are the parents who have been deprived of the potential to conceive a child together."1.

No more only one mom? European Court of Human Rights and Italian jurisprudences' ongoing evolution.

The author has delved into the most significant Italian and European court rulings related to heterologous fertilization and surrogate motherhood between 2012 and 2019, with a close focus on same-sex couples seeking to have their donor-conceived children born abroad legally registered in their country of origin. Undeniably, surrogacy has brought about a crisis in the traditional family model, made up of a mother and a father. The paper draws upon European Court of Human Rights established jurisprudence that upholds the children's best interests. Italian Court rulings are expounded upon as well, which have been instrumental in establishing the principles by which parental figures do not necessarily coincide with those who have generated the children (through biological bonds or delivery), but rather with those who wish to be recognized as parents. The cases herein examined involve homosexual couples who decided to travel abroad in order to gain access to surrogacy, from which children were born. In the case regarding two fathers, the child had no genetic tie with either one intended parent. The Italian Supreme Court's joint sessions have ruled that such children cannot be legally registered in Italy, since their foreign-issued birth certificates indicate no genetic connection between the children and their intended parents. The Author believes that the Supreme Court decision is valuable, but further legislative interventions will be necessary on account of scientific advancements; the issue of surrogacy is utterly complex and multi-faceted.

The American Democratic Deficit in Assisted Reproductive Technology Innovation.

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely those who work within the U.S. Food and Drug Administration, the public is unable to participate in the decision-making process. This lack of a public discourse undermines the goals of the administrative state, which include democratic participation, transparency, and accountability. The United Kingdom, on the other hand, has had a markedly divergent experience with assisted reproductive technology innovation. Instead of ignoring the various ethical, social, and legal issues surrounding assisted reproductive technology innovation, the United Kingdom engaged in a five-strand public consultation on the topic of mitochondrial transfer, a form of assisted reproductive technology that uses genetic modification in order to prevent disease transmission. This article argues that after a multi-decade standstill in terms of the public discourse related to ethical issues associated with assisted reproductive technology and germline modification, it is time for the United States to institute a more democratic inquiry into the scientific, ethical, and social implications of new forms of assisted reproductive technology and ultimately, forthcoming medical innovations that involve genetic modification.

Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation.

BACKGROUND: Infertility affects one in seven couples; many of these need in vitro fertilisation (IVF). IVF involves external hormones to stimulate a woman's ovaries to produce eggs which are harvested surgically. Embryos, created in the laboratory by mixing eggs with sperm, are grown in culture for a few days before being replaced within the uterus (fresh embryo transfer). Spare embryos are usually frozen with a view to transfer at a later point in time - especially if the initial fresh transfer does not result in a pregnancy. Despite improvements in technology, IVF success rates remain low with an overall live birth rate of 25-30% per treatment. Additionally, there are concerns about health outcomes for mothers and babies conceived through IVF, particularly after fresh embryo transfer, including maternal ovarian hyperstimulation syndrome (OHSS) and preterm delivery. It is believed that high levels of hormones during ovarian stimulation could create a relatively hostile environment for embryo implantation whilst increasing the risk of OHSS. It has been suggested that freezing all embryos with the intention of thawing and replacing them within the uterus at a later stage (thawed frozen embryo transfer) instead of fresh embryo transfer, may lead to improved pregnancy rates and fewer complications. We aim to compare the clinical and cost effectiveness of fresh and thawed frozen embryo transfer, with the primary aim of identifying any difference in the chance of having a healthy baby. METHODS: E-Freeze is a pragmatic, multicentre two-arm parallel group randomised controlled trial where women aged ≥18 and < 42 years, with at least three good quality embryos are randomly allocated to receive either a fresh or thawed frozen embryo transfer. The primary outcome is a healthy baby, defined as a term, singleton, live birth with appropriate weight for gestation. Cost effectiveness will be calculated from a healthcare and societal perspective. DISCUSSION: E-Freeze will determine the relative benefits of fresh and thawed frozen embryo transfer in terms of improving the chance of having a healthy baby. The results of this pragmatic study have the potential to be directly transferred to clinical practice. TRIAL REGISTRATION: ISRCTN registry: ISRCTN61225414 . Date assigned 29/12/2015.