Fertility centers that perform procedures like in vitro fertilization (IVF) are in the national spotlight again after a California clinic was accused of “effectively (doing) a child swap” in a new lawsuit.
The lawsuit, filed by parents Alexander and Daphna Cardinale, said that the California Center for Reproductive Health and Dr. Eliran Mor implanted Cardinale with a different couple’s embryo. In fall 2019, she gave birth to a child who was not genetically related to either her or her husband.
The couple later discovered that another family, who has not been publicly identified, was implanted with the Cardinale’s embryo. Eventually, the children were returned to their biological families in a process that Daphna Cardinale described as “impossible.”
“I was losing a baby at the same time that I was getting a baby,” she said. “It’s truly impossible nightmare ... So there’s grief, and so then your heart starts breaking for their family at the same time. Because at the same time, everyone’s gaining a child but everyone’s losing a child.”
How do these lab mix-ups this happen?
Dov Fox, a professor of law at the University of San Diego, explained the regulatory gaps that can lead to situations like these.
“In reproductive medicine, no authority or agency tracks or polices embryo mixups and freezer meltdowns,” Fox told TODAY.
States oversee medical licensing, education requirements and discipline for physician misconduct, while federal regulations require the reporting of certain data to the Centers for Disease Control and Prevention and the Food and Drug Administration, and regulate the use of drugs, devices and donor tissues within clinics.
There is also professional self-regulation among groups like the American Society for Reproductive Medicine (ASRM) and Society for Assisted Reproductive Technology (SART) to develop and practice ethical guidelines and programs for laboratory accreditation.
But there is no single government agency empowered to crack down on mistakes made by fertility clinics, and no single government entity oversees the fertility industry as a whole.
“In fertility medicine, it’s very different than any other field, where we regulate very closely what’s called ‘never events,’” Fox explained to NBC News in 2019. “These are major, avoidable mistakes ... We have nothing like that for what you might call ‘never events’ in reproductive technology.”
Dr. Nicole Noyes, chief of endocrinology and infertility at Northwell Health, told TODAY that most mix-ups happen because the clinic doesn’t have appropriate protocols in place. Doctors and technicians should only have one set of genetic material out in a lab at any given time, to avoid mix-ups, and all work should have a second person overseeing it to double-check that everything is correct.
How can potential parents protect themselves?
Dr. Timothy Hickman, the president of SART, said that the first thing people should do is make sure that the clinic they are looking at is a SART clinic, which means that the clinic has “agreed to follow” the organization’s guidelines. Hickman said that depending on the year, between 85 and 90% of clinics nationwide are affiliated with SART.
Clinics affiliated with SART “must adhere to the highest standards” in the field, according to the organization’s website.
Hickman also emphasized that research is important: Future parents should look up the clinic they are thinking of doing IVF through, and make sure there aren’t any recorded FDA violations or other concerning statistics.
One thing that Hickman said could be a red flag is a high rate of multiple embryo transfers: In the early days of IVF, it was common for a person to be implanted with two or even three embryos, since technology at the time did not allow doctors to assess the chromosomes of an embryo. Multiple implantations made it more likely for at least one baby to be healthy, Hickman said, but now technology has reached a point where it’s possible to look at those chromosomes in advance and reduce the need for multiple embryos.
“A lot of multiple births (like twins or triplets) would be a red flag,” said Hickman, noting that it is still possible to naturally have twins after the embryo is implanted. “If they’ve had any FDA violations or lost their status (as a SART clinic), that would be a red flag.”
Noyes said that hopeful parents should also observe their surroundings and trust their instincts.
“What does it look like? Is is the clinic clean? Does the staff seem to know what’s going on? Do they mix up your paperwork when you come in?” Noyes said, as examples for what patients should look out for. “All those kinds of things are important to pay attention to.”
Most IVF clinics also report their data to the CDC. The information reported includes how many cycles of IVF the clinic did in a year, how many live births they experienced, and more. Noyes said that she would be wary of any clinic that didn’t report that data.
“Why wouldn’t you report? It’s weird that you wouldn’t report,” Noyes said. “We’ve always reported (for the past 30 years). I’ve never even thought about ‘Maybe we won’t report to the CDC this year.’ We’ve never even talked about it.”
In the end, Hickman said that parents should feel comfortable asking plenty of questions — including asking clinics if they have had any mix-ups or other mishaps. Parents can also ask about how clinics keep genetic material organized and what steps they take to avoid any errors.
“I think that is absolutely fair game for a patient to ask. There is absolutely no reason why you would not want to know that if you are patient,” Hickman said. “And if you were a provider that had that happen, you would want to own it and say ‘This is what happened, this is how we corrected it, this is how we’re making sure it doesn’t happen again,’ if something like that ever occurred.”
What sort of ramifications can this have for families?
The Cardinale family said that their situation has been an “impossible nightmare,” even after being reunited with their biological child.
“She was four months old, we missed everything,” Daphna Cardinale told TODAY. “We missed, like the whole newborn phase we missed with her. We missed the whole pregnancy.”
Misplaced genetic material is not the only way that families can be let down by these clinics. Two tank failures at facilities in 2018 wiped out thousands of stored eggs and embryos, dashing dreams for many families.
In 2019, a New York City couple filed a lawsuit against the CHA Fertility Center in California after giving birth to two children who were not related to the couple — or even to each other. One baby was the biological child of California couple Anni and Ashot Manukyan. The parents of the second baby have not been publicly identified.
Ashot Manukyan told NBC News in 2019 that the clinic “put (his) family through living hell.” He and Anni Manukyan fought a months-long custody battle to regain custody of their child after the New York City couple wanted to keep the baby. The Manukyans also sued CHA Fertility for emotional and punitive damages, and the New York City couple sued the center in a separate lawsuit.
“I wasn’t there for his birth, I did not carry him, I did not feel him kick inside of me, I didn’t do the skin to skin, I didn’t breastfeed him,” Anni Manukyan told NBC News in 2019. “All of that was just robbed from me because of this company that messed up, you know.”
This story was originally published in 2019 and was updated on November 11, 2021.