Revealed: How Sheba and the Health Ministry Bungled the Mistakenly Implanted Embryo Affair

No court order and no discussion in the hospital’s ethics panel; it now turns out that the genetic tests given to the parents of Sophia – the ‘disputed Assuta embryo’ – were improvised and misguided. Sheba in response: ‘A byproduct of the tests is genetic linking to the mother.’ Health Ministry: ‘All of the tests were done legally’. A Shomrim Investigation, also published at ynet

No court order and no discussion in the hospital’s ethics panel; it now turns out that the genetic tests given to the parents of Sophia – the ‘disputed Assuta embryo’ – were improvised and misguided. Sheba in response: ‘A byproduct of the tests is genetic linking to the mother.’ Health Ministry: ‘All of the tests were done legally’. A Shomrim Investigation, also published at ynet

No court order and no discussion in the hospital’s ethics panel; it now turns out that the genetic tests given to the parents of Sophia – the ‘disputed Assuta embryo’ – were improvised and misguided. Sheba in response: ‘A byproduct of the tests is genetic linking to the mother.’ Health Ministry: ‘All of the tests were done legally’. A Shomrim Investigation, also published at ynet

Chen Shalita

Illustration: Shutterstock

November 11, 2022

Summary

In September this year, a pregnant Israeli woman who underwent in vitro fertilization discovered through genetic testing that the fetus in her womb does not genetically match either her or her husband. The mistake, which happened at the Assuta Hospital in the central Israeli city of Rishon Letzion, was obviously egregious, but the behavior of various bodies and authorities once the problem was discovered is simply inconceivable.

The shocking case has exposed the fact that Israel does not have any working protocols in place for cases when there is no genetic match between a child and its parents. Put simply, there are no guidelines regarding what should be done in such cases. In the absence of guidelines, the Health Ministry and Sheba Hospital improvised their responses to at least some of the issues that emerged.

How, for example, should officials inform a woman that the fetus she is carrying in her womb is not hers? In this case, the life-shattering news was delivered to the couple as if it were nothing more than a medical note, without any emotional, psychological or moral ramifications. This is a relatively straightforward issue, compared to the other questions that the case poses. Such as: Why was the father also given genetic tests, even though it was clear that the mother was not the genetic mother? Was this not the stage at which alarm bells should have starting ringing and the whole matter should have been referred to the hospital’s ethics committee (as is the case when there is a genetic mismatch between relatives undergoing organ transplants)? Another significant point is why, once the mismatch had been discovered, was a request not submitted to the courts for parental genetic testing, as required by law.

Sheba Hospital. Photo: Bea Bar Kallos
The fact that the hospital tested the couple even after it understood that the fetus did not match the mother’s DNA – and then repeated that test for both of them – raises questions about its handling of the matter.

‘The doctors told me: You can’t be the mother’

The baby Sophia – or, as she is known in the Israeli media, the ‘disputed Assuta embryo’ – underwent an in vitro catheterization at the end of the 30th week of the pregnancy. During that procedure, doctors also took a sample of amniotic fluid, to investigate a heart defect that had been detected. The tests compared her DNA to that which her parents provided during blood tests. Sophia’s mother, in an interview on Channel 12’s ‘Friday Studio’ show, described how things unfolded from that moment. “I had an operation and they took amniotic fluid, and the next day they said that it didn’t match me or my blood. And they also gave my husband a blood test and said it didn’t match,” she said. “The cardiologist and gynecologist told me: ‘Listen, the sample we took isn’t a match with you, you cannot be her mother.’ But they said, ‘Wait a minute, we’ll do another test, maybe it’s a mistake.’ About a week later, they took more blood and no, it wasn’t a mistake.”

It is important to remember that parental genetic testing is not a commonplace occurrence. It is certainly not something that is done almost incidentally, as the mother’s description would seem to suggest. In fact, a court order is required for any test performed in Israel to ascertain parentage, in accordance with Clause 28 of the Genetic Information Law (200) – even if the subject of the test is a fetus. The fact that the hospital tested the couple even after it understood that the fetus did not match the mother’s DNA – and then repeated that test for both of them – raises questions about its handling of the matter. Why did Sheba’s Institute of Human Genetics not stop the process once it realized that the mother is not, in fact, the baby’s genetic mother, opting to go ahead and test the father, too? Comparing it to the mother’s blood test was viewed by Sheba as a standard procedure, to ensure that there was no “maternal infection.” In the case of the father, there can be no such concern, of course, because he has no impact on the course of the pregnancy.

The official body within Sheba that deals with parental testing is the Genetic Laboratory, which, under normal circumstances, works with the courts. These tests were carried out by the Institute of Human Genetics. Are researchers at this facility not aware of the legal requirements and the ramifications, which go far beyond those of medical investigations?

Illustration: Shutterstock
The official body within Sheba that deals with parental testing is the Genetic Laboratory, which, under normal circumstances, works with the courts. These tests were carried out by the Institute of Human Genetics. Are researchers at this facility not aware of the legal requirements?

The Genetics Institute went above and beyond

When conducting tests for parental matches, doctors are looking at certain sections of the genome; when looking for possible genetic defects, they look at different sections. Sheba did not specify ahead of time that the purpose of the test was looking for parents matches with the fetus, but the moment they discovered that the mother was not a genetic match for her fetus – even if that was a byproduct of a test for genetic defects – alarm bells should have started ringing. But they did not ring and, according to Sheba, it decided to test the father as a possible source for the defect. When they discovered that he, too, was not a genetic match for the fetus, Sheba concluded that it was more likely that the results of the test were incorrect – that maybe they had compared the parents’ bloodwork to the wrong amniotic fluid – than that the wrong embryos had been implanted.

A Sheba source said that the hospital had apologized to the mother and asked for her permission to conduct another amniotic fluid test, which they ended up doing when she was in her 32nd week. For a high-risk pregnancy, in an advanced stage of the pregnancy and with a fetus that has a complicated medical condition, this is not something to be undertaken lightly. Testing amniotic fluid requires an invasive procedure that could lead to a miscarriage. In any case, the repeat test was described by Sheba as ‘quality control’ – ensuring the reliability of the first test – since no reasonable physician could imagine that the wrong embryo had been implanted. But is that really the case? If it is, why are there safety instructions exactly designed to prevent such cases? It is no coincidence that the Puah Institute, a fertility clinic catering to the ultra-Orthodox community, has looked into this lacuna and, at a cost, provides female supervisors to accompany the would-be parents through every stage of the IVF treatment. This supervision, according to Puah, is recognized by all of the health maintenance organizations in Israel and most of the hospitals (including Assuta in Rishon Letzion). The concern is recognized and there have also been cases when mismatches between parents and offspring were discovered during routine genetic tests. Either way, the testing process continued even though, by that stage, Sheba staff already realized that the upshot of the test results seemed to indicate that there was no genetic connection between the fetus and either of the parents – and yet, the hospital did not ask the court for an order, as required by law.

This case was only brought to court when the woman who in all probability was the genetic mother of the fetus was located and she asked for a court order allowing her to use the amniotic fluid test to determine whether she was the genetic mother of the fetus. The order was granted, but the test proved that she was not the mother. A ruling issued by the Central District Regional Court, which heard the case of Anonymous et all versus Assuta Rishon Letzion et al, the judges wrote the following in regard to the parents’ permission to carry out a second amniotic fluid test: “Informed consent was given for a repeat test in order to examine the possibility of a genetic match between the fetus and the parents.” What, then, is this ‘genetic match’ if not a test designed to also determine the parents’ identity?

The judges did not dwell long on the significance of such a test without a court order, since that was not the question being discussed in the case before it. The test had already been conducted and the judges had to decide whether it could be used for another potential couple, or whether the pregnant woman had the right to refuse for the test results to be used in this way. But questions about the working protocols in play still need to be asked.

As stated, Sheba did not ask for a court order and did not send the repeat test to a tissue-typing laboratory. It relied on tests from its own Genetics Institute and relayed them to the Health Ministry as a report about an unusual incident. The ministry determined that these tests were reliable, even when it saw that they were conducted without a court order and not in the same laboratory generally used to check genetic relations. Why?

In response, the Health Ministry told Shomrim that, “In cases where there is no genetic match to the parents, the relevant genetic laboratory reports to the Health Ministry about an unusual incident that must be reported. The fact that the mother and the fetus underwent two comprehensive genetic tests at different times at Sheba’s genetic laboratory is sufficient, and there is no medical need for any other test. It should be made clear that all of the tests conducted in this case were done so legally. These tests were conducted in order to detect a genetic defect in the fetus, therefore no court order was necessary. Only tests designed to find a genetic connection between the fetus and the mother require a court order, in accordance with the Genetic Information Law.”

The ministry opted not to respond to Shomrim’s question regarding the existence or not of clear and precise guidelines for such cases.

Sheba Medical Center submitted the following response: “In any case of prenatal diagnoses, the Institute of Human Genetics at Sheba always conducts QF-PCT tests, which the fetus in this case underwent. The result of these test is returned within 48 hours and the goal is to answer three questions.

  • Have there been any major chromosomal changes in the fetus, such as Down Syndrome?
  • To ensure that, at the time of the test, there has been no mingling of material between the mother and the fetus, which could interfere with future genetic tests.
  • A byproduct of this test is checking whether the fetus is genetically linked to the mother.

“The Institute of Human Genetics carries out dozens of other tests, whereby the parents and the fetus are tested together; some of these tests could potentially reveal genetic matches, even though this is not the main purpose. The father underwent a genetic test and not a paternity test.”

Assuta Rishon Letzion. Photo: Shutterstock
Prof. Roy Gilbar: "The court would have to decide on a question that is as much an ethical one as it is a legal one. Despite the tendency toward the genetic link, Israeli law really does not know how to respond in cases like this. We’re all just fumbling in the dark.”

What next? ‘We’re all just fumbling in the dark’

The pregnant woman, who is 44 years old and has a 5-year-old son, decided to put up a fight for Sophia. She is already registered as the baby’s mother in the Population Administration despite the genetic mismatch. The court, for its part, decided not to name a state-appointed guardian for Sophia and – along with the recognition granted by Chief Rabbi David Lau, who ruled that the woman who gave birth to Sophia should be considered the mother, but, at the same time, said that the search for the genetic parents should continue to prevent the possibility of incestual relations in the future – it seems that the birth mother has a strong case to claim parenthood, especially given that in Israel there is great importance attached to rabbinical rulings when it comes to family law.

“The chief rabbi’s comments are not the end of the story, but they are certainly an opinion that helps to determine facts on the ground,” says Adi Niv-Yagoda, an attorney specializing in medical law, who also points to internal failings. “If there is (halachic) justification for identifying the biological parents, does that mean that the birth mother is only the ‘conditional’ biological mother? It would have been the right thing to recognize her as the legal guardian of the baby, without getting into the biological issue. Now, legally and practically, the standing of the biological mother is as the legal mother in every respect.”

The Family Courts and the Rabbinical Courts – the only two courts with the authority to order a parental test – only give permission for these tests on rare occasions. The Health Ministry decided this week not to instruct the parents who may be located and many have likely genetic matches with Sophia to undergo tests; rather, four women who were recently identified as potential mothers have already been instructed to be tested. The ministry also decided that genetic tests to find matches between women undergoing IVF and embryos that are still in the lab, could be conducted without a court order under exceptional circumstances.

Experts interviewed for this article believe that there is very little chance that the courts will approve requests by dozens of women who underwent IVF treatment at Assuta in Rishon Letzion and who now want retroactive tests to ensure that their children or the fetuses they are carrying are genetically matched to them. “This case has created a lot of stress for couples who always joked that their child doesn’t look anything like either of them or maybe it’s the neighbor’s,” says the attorney working on the case. “Suddenly, a real-life event plays into this doubt. The reason for not approving these tests is the child’s welfare.”

“The solutions that have been found in the rest of the world for conflicts created by wrongly implanted embryos do not show any clear preference for one side or another,” says Prof. Vardit Ravitsky, an expert on reproductive ethics and the ethics of genetics and genomics at the University of Montreal. “In the United States, the two sets of parents sat down for mediation and decided that, after the birth, the baby would be handed over to the genetic parents and the birth mother would remain in contact with the child. Each legal system holds a different concept – whether it is in the best interests of the child to grow up with its genetic parents or in the best home that it can be given? And who defines what is a good home? Before adoption, the socio-economic condition of the prospective parents is checked, so should that be the criteria here, too? It sounds very intuitive, but the welfare of the child is not something that is easy to gage. And in vitro fertilization has only existed for 44 years. We still perceive of motherhood in a way that connect between the mother’s genetic pool, we don’t have enough experience to separate between the issues.”

Prof. Roy Gilbar, an expert in bioethics from the Netanya Academic College’s School of Law, believes that Israeli law and legal rulings give preference to genetic connections. “That was clearly visible in the High Court ruling from 2017, which ordered the return of a 1-year-old adopted infant to his 19-year-old biological father – who did not even know about the pregnancy, because his girlfriend broke up with him before the birth.

And a recent ruling issued by the Family Court, in response to a request by a lesbian couple who had split up and wanted to get legal standing regarding their parenthood, determined that both women would be registered as the biological mothers of the child they had together. The child was born from a sperm donation and the eggs of one of the women, and the embryo was subsequently implanted in the womb of the other partner. They sought a court order recognizing the woman who donated her eggs as the biological mother and were not satisfied with the definition of her as the adoptive mother. The attorney general opposed, partly because she was concerned that the state would effectively be recognizing three parents, which is not possible under Israeli law, but the court rules that the genetic link is unarguable and it is beyond question that the woman who donated the egg is the mother.”

Will there also be a legal battle in this case, if Sophia’s genetic parents are located soon and if they are determined that the baby is theirs?

“If that were to happen, the court would have to decide on a question that is as much an ethical one as it is a legal one. Can a woman be retroactively turned into a surrogate, after risking her life with a complex medical procedure and forming a strong emotional bond with the fetus? Can you ask a couple that created genetic material, worked hard for it, to donate it without intending to? Which set of values do you choose? Despite the tendency toward the genetic link, Israeli law really does not know how to respond in cases like this. We’re all just fumbling in the dark.”

This is a summary of shomrim's story published in Hebrew.
To read the full story click here.