Embryo culture and IVF-related legal disputes are not new
If anyone found good news in the current brouhaha over the Alabama Supreme Court’s holding that frozen IVF-created embryos are “unborn children,” it would likely be executives at CooperSurgical, Inc.
The Connecticut-based subsidiary of CooperCompanies ($3.6 billion in revenues) is a maker of medical devices and fertility and genomic products. Just days before the Alabama ruling, the U.S. Food & Drug Administration (FDA) issued a Class 2 Device Recall for what’s known among fertility specialists as culture media – a carefully designed culture fluid for growing human embryos to blastocyst stage (typically five days or more) for surgical transfer to a woman’s uterus for implantation and gestation.
Lawsuits against CooperSurgical & Fujifilm Irvine Scientific
The CooperSurgical recall is the outcome of a swelling number of lawsuits by IVF patients claiming that the fluid destroyed their zygotes and parenting hopes. Collectively, the plaintiffs say they lost more than 100 embryos due to the omission of a key nutrient that halted cellular growth. (Under the Alabama ruling, the loss might be construed as 100 murders.)
The lawsuits represent the second wave of litigation in barely a year over allegedly flawed IVF culture fluid. In January 2023, Fujifilm Irvine Scientific recalled four lots of its “Oil for Embryo Culture,” after IVF patients learned their embryos, too, had been destroyed by contact with the oil. According to FDA filings, as many as 20 IVF patients may have been affected. A company announcement indicates the product had been on the market less than a year.
Both recalls had generated coast-to-coast press coverage. Then, in the wake of the Alabama Supreme Court decision, IVF-related headlines have all but exclusively focused on the legal and political ramifications of the highly controversial 8-to-1 opinion of that state’s highest court.
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Many IVF malpractice lawsuits allege embryo errors
The frequency of IVF-related lawsuits points to the value would-be parents place on five-day human embryos, which are so microscopically tiny that 10 to 20 would fit into the volume occupied by a peanut.
In a twenty-year analysis published in the scientific journal Fertility and Sterility, on average an IVF patient files a malpractice lawsuit somewhere in the United States every few months. The most common issues involve embryology lab processes and genetic testing errors.
Nearly half the suits evaluated (45.3%) alleged embryology errors such as lost specimens and incorrect sperm donors. The second most common claim (20.8%) were over children born with genetic illnesses despite preimplantation testing of the embryos.
A little more than half of the suits evaluated (54.7%) were decided in favor of the defendant IVF clinics or providers. Plaintiffs won about one-quarter (24.5%) of the time, while the rest involved ongoing proceedings at the time of the analysis.
$15 million award for cryopreservation accident
Even with the odds stacked against plaintiffs, the rewards can be tempting for contingency-motivated counsel. The largest award uncovered in the study amounted to a payout of nearly $15 million in a class-action case involving a cryostorage accident.
Estimates of the size of the global IVF market are all over the place, ranging from $628 million in 2021 to $25 billion in 2023. Whatever the scale, not only can IVF errors and embryo mix-ups generate national press coverage of couples’ heartbreaks, but it’s a safe bet that certain legal practitioners will continue keeping a close eye out for the next IVF calamity.
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