IVF clinics need to clean up their act to end baby mix ups

When I was pregnant seven years ago, I joked that after our daughter was born, we should do a paternity test because I had so little faith in our disorganized fertility clinic.

That joke became less funny over the years, as I’ve learned about the November lawsuit against a California clinic for mixing up two couples’ IVF babies, the Queens woman who gave birth to two strangers’ babies, and the New Jersey woman who claimed she was unknowingly impregnated by her fertility doctor. 

IVF mix-ups have been happening for years. Just last week, it was revealed that Jessica Harvey Galloway, 29, is suing an Ohio fertility clinic and doctor, after she took a test on Ancestry.com only to discover her father was not her biological father, but another man who used the same fertility clinic as her mother.

“Our lives were shattered by misconduct in the fertility industry. This has to stop,” Jessica said. “This can’t be happening in 2020.”

Jessica Harvey Galloway (center) is suing an Ohio fertility clinic, after she discovered that her father (right) is not her biological father, but another man who used the same fertility clinic as her mother (left).

But, as an increasing number of women are turning to fertility treatment to conceive, it’s happening more than ever. Although there are no official numbers on how many children have been born to the wrong parents, lawyer Adam Wolf, whose firm Peiffer Wolf specializes in fertility industry misconduct, estimates they have worked with thousands of families over the past eight years.

“Today we think of the fertility industry as governed by strict rules,” Wolf told me, noting that this is not the case. “Nail salons have tighter controls than labs in fertility clinics. The current state of regulation is the Wild West.”

Not all fertility misconduct results in babies born to the wrong parents. 

Many of the mistakes lead to babies not being born at all. Last June, a jury awarded $15 million dollars in damages to five patients after a freezer failure prematurely thawed 3,500 frozen eggs and embryos. In 2018, an Ohio fertility clinic said 4,000 eggs and embryos were ruined due to a freezer failure in 2018. 

Anni and Ashot Manukyan (above) are suing Los Angeles CHA Fertility Center after the clinic placed two embryos — one belonging to them and one to another couple — into a woman from New York.Anni and Ashot Manukyan (above) are suing Los Angeles CHA Fertility Center after the clinic placed two embryos — one belonging to them and one to another couple — into a woman from New York.AFP/Getty Images

As a reporter covering the fertility industry, I have visited a number of IVF laboratories. While some seem state-of-the-art, I was shocked at how antiquated the equipment can be. And all rely on people paying very close attention: to making sure the freezers are working, to labeling the eggs, sperm and embryos, to putting them in the right place and then transferring them to the right woman. (That’s why Orthodox Jews require a special supervisor for all fertility treatment.)

According to a recent piece in Fertility and Sterility, most doctors “are overcome with horror and profound disappointment” when hearing about negligence or deception. “Errors are a rare occurrence,” the report said, citing a review of 36,000 procedures showing that 99.9% progressed with no errors. However, another study mentioned in the same piece showed between 2.7-12% of reported lab errors or non-compliance.

“I don’t think there are a lot of errors,” said Dr. Marcelle Cedars, president of the American Society for Reproductive Medicine (ASRM). For all the steps that go into one IVF cycle, plus the total number of cycles that occur, “the number of events and errors, I think, are very small.”

Daphna and Alexander Cardinale (above) were given the wrong embryo due to a mix up at a fertility clinic and didn’t realize the baby (inset, blurred face) wasn’t theirs for several months.Daphna and Alexander Cardinale (above) were given the wrong embryo due to a mix up at a fertility clinic and didn’t realize the baby (inset, blurred face) wasn’t theirs for several months.AP; Courtesy of Daphna and Alexander Cardinale

ASRM states on its Web site that “Assisted reproductive technology is one of the most highly regulated of all medical practices in the US,” pointing out various ways the CDC, the FDA and the Clinical Laboratory Improvement Act (CLIA), are involved. 

More regulation, Cedars added, cannot improve “human error.”

But the $1.2 billion fertility industry must do better. The US government needs to start a national oversight agency monitoring all aspects of fertility treatment, much like the UK’s Human Fertilization and Embryology Authority (HFEA), as recommended by Peffer Wolf’s 2019 white paper.

If not regulation, there are other ways fertility clinics can improve — such as adopting an automated platform for the safe management and care of frozen eggs and embryos.

A jury awarded $15 million in damages after a freezer failure at Pacific Fertility Center in San Francisco (above) prematurely thawed 3,500 frozen eggs and embryos.A jury awarded $15 million in damages after a freezer failure at Pacific Fertility Center in San Francisco (above) prematurely thawed 3,500 frozen eggs and embryos.

“Fertility clinics are facing real challenges keeping up with demand, and the manual systems that haven’t been updated in decades are no longer sustainable,” said Tara Comonte, CEO of TMRW Life Sciences, a company that provides automated platforms to clinics. “There is too much room for human error right now: Technology can solve these problems by automating the identification, tracking and storage of these millions of specimens under care.” 

In 2019, almost 84,000 babies were born through fertility treatment, according to the CDC. I, for one, am grateful for all the children the fertility industry has ushered into the world in the last 40 years, allowing same-sex couples, single mothers and older women like me to have a child. 

As for our 6-year-old, she can test her DNA when she comes of age. I hope by then the fertility industry manages to reduce errors, malfunctions and mix-ups to zero.

 Amy Klein is the author of “The Trying Game: Get Through Fertility Treatment and Get Pregnant Without Losing Your Mind.” 

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