Bioethical perspectives on the Israeli Assuta case of embryo mix-up

Cases where an embryo created by one couple is implanted by mistake in the uterus of another (genetically unrelated) IVF patient are heart wrenching, ethically complex, and detrimental to the infertility ecosystem. A recent Israeli case raises some unique bioethical challenges and provides an opportunity to learn some potential lessons (see BioNews 1160).

Background

In February 2022, a 44-year-old woman became pregnant following IVF conducted at Assuta Medical Centre in Israel. At 28 weeks gestation, a cardiac problem was identified in the fetus and amniocentesis was performed to check for possible genetic factors. The test revealed that the pregnant woman is genetically unrelated to the fetus, and a subsequent test showed a non-paternity result. The test was repeated, and results were confirmed.

At 30 weeks gestation, Assuta informed the Israeli Ministry of Health of an embryo mix-up incident, seemingly the first of its kind in the country. Assuta was subsequently instructed by the Ministry to reduce its activity by half, from 10,000 to 5000 cycles a year, to reduce the chances of additional mistakes.

The scandal that followed was complex. At first, Assuta identified a couple who had a high probability of being related to the fetus, due to the proximity in time of treatment and of the embryos of both couples in the freezer, which could have led to the mistake in implantation. This identified couple asked the court to permit genetic testing to confirm their genetic relatedness, despite the objection of the pregnant couple. The request was possible since it did not require further invasive testing on the pregnant woman to obtain fetal DNA – such DNA was already available for testing from the previously done amniocentesis (see BioNews 1164).

The court allowed the test, arguing that 'the best interest of the fetus is to know immediately at birth its genetic origins', for 'medical, religious–ethical, and spiritual reasons'.

As the nation held its breath expecting the results, the drama unfolded in the media. The potential 'genetic mother' claimed that if the fetus is 'hers' she will fight for custody after birth, while the 'biological mother' wrote her a letter pleading 'let me have my baby in peace' and announced in a TV interview that she will never agree to let go of the baby, claiming prior to birth: 'I already raised this girl, she is mine'.

The test, however, revealed that the identified couple is not genetically related to the fetus.

In the midst of this turmoil, baby Sofia was born on 26 October 2022, and shortly after needed open heart surgery, adding layers of stress to the already excruciating situation.

Consequently, 900 past Assuta patients signed a petition to allow genetic testing to identify the genetic progenitors and dozens of patients reported stress and anxiety related to the possibility of being implicated. Assuta identified 22 potential couples who may be genetically related to the baby, and of them, six applied to the court for permission to undergo testing, as reported by the Times of Israel. The court approved the request but an appeal blocked it and none of the couples was eventually tested.

The issue of 'who should be recognised as the mother' was being debated around dinner tables across the country. Professor Bar Ilan from Tel Aviv University, wrote an op-ed arguing that the pregnant woman is the mother; and Professor Gilbar from Netanya Academic College responded in an op-ed titled 'Bar-Ilan is wrong, the best interest of the child is to find her genetic parents'. Even the Ashkenazi Chief Rabbi of Israel chimed in, as reported by the Times of Israel, adding the perspective of Jewish orthodox law according to which the birth mother is the mother. Strong cultural forces and values were at play as public debate surrounded the case.

Currently, the baby is in the care and under the custody of her birth parents (see BioNews 1165). The search for the genetic progenitors was first halted in October, but then in January 2023 a court ruled that any woman who thinks she may be genetically related to baby Sofia could get tested, as reported by the JPost.

Bioethical perspectives

What are some of the bioethical issues emerging from this drama and what lessons can be learned?

First, the media exposure of the case deserves some reflection. While the identity of the birth parents and the other couples involved was protected, the public scandal generated much stress for many couples who have been previously treated in Assuta. Is it ethically preferable to manage such cases in private, contacting only those who are implicated, to prevent anxiety for others? Or does the public have a 'right to know' in real time?

Some couples mentioned wanting to test children they are raising to alleviate concerns, but Israeli law only allows paternity testing when specifically court ordered. Further, in countries where such testing would be permitted, or if commercial direct-to-consumer testing is used, what are the bioethical ramifications in terms of family dynamics and best interest of the child? The notion that public scandal can trigger an increase in maternity and paternity testing in the general public, knowing that about two to three percent of children are not genetically related to their legal/social father, should give us pause.

Second, what are the bioethical implications of embryo mix-up cases for counselling and consent prior to IVF? Should infertility patients be advised ahead of time that such mistakes, albeit rare, can occur? Should they be counselled regarding legal ramifications if such a tragic event happens to them? Including such information in the informed consent process may generate unnecessary anxiety, but is it not relevant to the decision-making surrounding IVF? I have previously written on this topic in Policy Options, arguing that patients should be counselled in advance about such scenarios.

Third, this case highlights the urgent need for all clinics in all jurisdictions to develop clear guidelines and protocols for the management of such circumstances, that align with local policies and reflect local cultural values. Scrambling to make decisions under time pressure and public scrutiny is far from ideal when so much is at stake. In the Israeli case, for example, the shocking results were communicated to the parents inappropriately and the ethics committee of the hospital was consulted too late.

Finally, the issue of 'who should be recognised as the mother' is morally and socially fraught, and such discussions are always embedded within an intricate fabric of social norms and values. IVF has only been around for the past 44 years, and we have not yet developed robust moral intuitions to cope with the distinction between genetic mother and birth mother, unprecedented in the history of our species. Reasonable people may disagree, and indeed such cases have been resolved differently in various jurisdictions in the past.

Nobody wishes to be in a position of delivering a wanted baby and being afraid it would be taken away. Nobody wants to feel that they cannot raise their wanted genetically-related child due to a mistake. In light of this profound ethical dilemma, legal clarity is of particular importance and is required if prospective parents are to provide truly informed consent to IVF. Jurisdictions should thus strive to develop regulations, informed by a robust societal conversation, to guide decision making in such cases.

As for baby Sofia, let's wish her to grow up in good health and a happy home.