BREAKING NEWS: EMBRYO MIX-UP between two couples several years ago at California IVF clinic makes headlines once again
By Norbert Gleicher, MD, Medical Director and Chief Scientist at The Center for Human Reproduction in New York City. He can be contacted though The Reproductive Times or directly at either ngleicher@thechr.com or ngleicher@rockefeller.edu.
Briefing: The unfortunate embryo mix-up between two infertile couples several years ago in a Los Angeles area in vitro fertilization (IVF) clinic was just resurrected by The New York Times Magazine in a terrific cover story on December 1, 2024 (see figure below) (1). There are several reasons why this article deserves special attention. First, though considering the millions of IVF cycles performed in the U.S. since the birth of the first U.S. IVF offspring in 1981, fortunately, it is an extremely rare event, it never hurts, from time to time, to steer-up easily setting-in administrative complacency to minimize such occurrences. But what really makes this article so special are the writer’s descriptions of the discovery of the mix-up and what then followed. And, yes, some incorrect comments cited in the article by—who else—malpractice lawyers, are here also addressed.
A truly remarkable story
Everything started in 2019, when two infertile couples in short succession celebrated the births of their respective second child, in both instances the result of a successful IVF cycle in a small Los Angeles area IVF clinic. Obviously delighted to have brought a healthy second child home after the often-arduous IVF process, both couples settled into their new routines, which in both households, of course, included the introduction of the new sister to her older sibling, allowing for parents and siblings to proceed through their natural bonding processes.
But in one of the couple’s households something was apparently amiss: In expression of increasing concern that he “was reluctant to voice,” the father started joking about the fact that their daughter showed no physical similarities to either one of her parents. He was Italian (but with fair hair and light brown eyes) and his wife was Ashkenazi Jewish with bright red hair. And he even joked that the IVF clinic might have mixed up embryos. And their daughter had deep dark hair.
Behind those jokes, the father had, however, developed increasing concern which also started affecting his wife. And it was she who in the end set into motion what would turn the couple’s life completely upside down. Unclear what she was supposed to do, she called her husband’s best friend for advice, and he did his job by leaving no doubts that he was convinced that at least one of the parents was genetically not really a parent (with the suspicion, of course, falling on the husband).
This is when in November of 2019 the couple sent off genetic DNA home tests to a commercial laboratory. The results arrived three weeks later in December and reported that with over 99% certainty neither husband nor wife were the genetic parents of their daughter. These reports ended up reshaping the lives of two Los-Angeles-area families forever. Coincidentally, they lived only minutes apart from each other.
The December 1 cover page of
The New York Times Magazine
With those test results in hand, the first family informed their small fertility clinic which, after reviewing their records, concluded that on the day of the couple’s embryo transfer at the clinic a mix-up of embryos must have occurred with one other couple which also had their embryo transfer on that day. After informing this second couple of this likely conclusion, their DNA testing confirmed it, leading to the heartbreaking recognition for both couples that they for months had raised and bonded with a daughter which wasn’t theirs.
The rest of the beautifully written article then tells in detail how these two obviously deeply shell-shocked couples not only found the strength to overcome the situation by, in a carefully and delicately managed transition process, introducing themselves to their genetic daughters (and their older siblings) before formally switching parenthood (legally the births of both girls ended up being defined as “birth by gestational carrier”) and, in the process, establishing a new, combined family unit that allowed all four children of these two families to consider themselves as siblings.
How can embryo-switching still happen in IVF laboratories?
How in modern-day IVF practice embryo switching can – and on, fortunately, only exceedingly rare occasions does – still occur is, indeed, difficult to understand, considering the various safety rules every certified IVF laboratory in the U.S. must follow. One prominent embryologist when recently asked about this subject offered an interesting analogy: “If babies can and—on similarly rare occasions—are still mixed up in neonatal hospital nurseries, who can be surprised that, despite so many well-working precautions in embryology laboratories, on very rare occasions such errors still occur.”
Though this of course, is, not an excuse for something that, simply, never can be allowed to occur, it is likely the most reasonable explanation for why errors still do occur. When system failures under all circumstances must be avoided, nature as well as industry—interestingly—resort to the same rather simple solution: both increase redundancy processes until safety is virtually 100%. There really are no good reasons why embryology laboratories (and neonatal nurseries), through redundancies in safety procedures, should not be able to avoid such mix-ups with at least 99.99% certainty.
And it appears not too far-fetched to assume that—at least in the U.S.—if this goal has not already been reached, considering how rare such reported occurrences have been in millions of IVF cycles in over 40 years of IVF practice, we, at least, must be very close to reaching the goal. A 2021 paper in the Journal of Assisted Reproduction and Genetics (JARG) confirmed this fact and, moreover, also demonstrated that the extraordinary media attention each one of such cases attracts, makes numbers of cases appear to be much bigger than they in reality are (2).
There, of course, have been other cases reported in the U.S. since above-described California events, including a relatively recent one involving a New York City (NYC) couple undergoing IVF at another small California IVF clinic (3), which because of financial difficulties, has since been acquired by another fertility clinic in the Los Angeles area. And then there was also a relatively recent case in NYC proper, which in contrast to the two Los Angeles cases, led to the closure of the IVF clinic where the mix-ups happened (4).
Like the two Los Angeles clinics, the NYC clinic was also a relatively small program, leading to the suggestion that the availability of fewer financial resources at smaller IVF clinics may contribute to risk. This hypothesis, however, based on a recent similar occurrence in one of the largest IVF laboratories in Israel (a country with one of the world’s most sophisticated IVF clinic systems) likely does not apply (5).
Legally speaking
One cannot address embryo mix-ups without a word on the legal consequences of such events. Moreover, whenever something happens in medicine that with proper medical care is considered preventable and, therefore, under no circumstances should be allowed to happen, there exists
in almost all cases an “owner” for what happened. And this “owner” has legal liability. There exists also societal consensus that victims of such transgressions in medical care are entitled to payments in compensation for practical and often mental damages that have resulted from such events.
That, of course also applied to above-described California case which, as usually happens, was settled between the parties before reaching trial. By allowing several lawyers to comment on IVF in general rather than keeping their comments restricted to embryo-switching, the article in The New York Times Magazine, however, unfortunately and inappropriately, allowed the plaintiff malpractice Bar to offer some rather biased cliché opinions about IVF, giving the wrong impression that malpractice suits in the IVF field are common (which in comparison to most other medical practice fields is not at all the case).
One of the two couples’ lawyers in article, unsurprisingly “specializing in suing fertility clinics,” for example, thumped his chest by noting a plaintiff’s case he filed which had absolutely nothing to do with embryo-switching (an incorrect genetic testing result was reported to an IVF patient; of course such an error is not necessarily typical of IVF alone, as embryo switching clearly is). He also cited a case of alleged failure of an IVF clinic to respond to alarms of freezers where embryos were stored (as if that occurs only in IVF labs) and expressed unhappiness about some IVF clinics still relying “on pen and paper labeling systems” (again, quite obviously not an issue restricted only to IVF laboratories, if that, indeed, does represent an issue at all).
A law professor with alleged focus on bioethics (whatever that means) is quoted as making what is likely the most frequently made false claim by malpractice lawyers—widely used in their advertisements (6)—namely that IVF “is underregulated in comparison to most other medical procedures.” In reality, IVF is among the most—maybe even the most—regulated procedure in medicine. We, for example, know of no other procedure in medicine which under Congressional mandate (the so-called Fertility Clinic Success Rate and Certification Act) has to report every single event to the Food and Drug Agency (FDA), as IVF is obliged to do (7). Unsurprisingly, above-noted plaintiff’s attorney beats the same dead horse by claiming that, if it weren’t for the malpractice plaintiff’s Bar, “nobody else would hold the IVF field responsible.”
Who gets the children?
One final note: In the U.S. legal precedent has established that in case of an embryo mix-up as in the here-discussed case, genetics rule the day. In other words, the genetic parent(s) is/are becoming the legal parents of any born child. This is, however, not the case everywhere else in the world: In Israel and several other countries, for example, unless otherwise settled by the involved parties, any born child is assigned to the birth mother.
In conclusion, mix-ups of embryos among infertile couples in IVF clinics are exceeding rare events. Our quick review of the literature suggests that, likely, only somewhere between 15-20 cases have been reported in the literature. This is very obviously an underestimation even for the developed world; but, considering that so-far over 12 million IVF babies have been born worldwide, these numbers suggest that embryo mix-ups indeed are extremely rare, even though, as The New York Times Magazine article again so well demonstrated, each case is one case too many.
References
1. Dominus S. The New York Times Magazine. December 1, 2024. https://nytimes.pressreader.com/the-new-york-times-magazine-8326/textview
2. Rasouli et al. J Assiste Reprod Genet 2021; 38:1101-1107
3. Boniello K. New York Post. December 30, 2023. https://nypost.com/2023/12/30/metro/nyc-couple-in-twin-embryo-mix-up-settles-suit-against-california-clinic/
4. Manno A. Dailymail.com. April 3, 2022. https://www.dailymail.co.uk/news/article-10681315/Massachusetts-couple-says-mother-carrying-wrong-embryo-mix-New-York-clinic.html
5. The Times of Israel.. November 28, 2024. https://www.timesofisrael.com/slow-and-clumsy-health-ministry-report-pans-tel-aviv-hospital-over-ivf-foul-ups/
6. Fertility Advocates for Justice. https://www.fertilitylawsuits.com/?gad_source=1&gclid=EAIaIQobChMIsqjXkrGHigMVL2hHAR28shNPEAAYASAAEgKYefD_BwE; accessed 12/1/24
7. CDC.https://www.cdc.gov/art/nass/policy.html#:~:text=In%20response%20to%20concerns%20about,government%20in%20a%20standardized%20manner.