A surge of lawsuits has been launched against a major American medical supply company – CooperSurgical – with patients claiming that one of its products destroyed embryos created with in vitro fertilisation.
The product, a nutrient-rich liquid that helps fertilised eggs develop into embryos, was used by fertility clinics around the world, reports The New York Times.
Last week federal regulators revealed that the company had recalled three lots of the liquid, which was used by clinics in November and December. The number of affected patients is unclear, although experts estimated that it is in the thousands.
The most recent legal challenge is from a couple in Virginia, the eighth in two months from families around the US.
Collectively, the patients say they lost more than 100 embryos that had bathed in the defective product, known as culture media.
The plaintiffs claim that the three batches of media were missing a key nutrient, magnesium, a defect that stopped their embryos from developing, and rendered them unusable.
The company declined to comment on the lawsuits.
The US Food and Drug Administration (FDA) posted a recall notice two weeks ago saying that nearly 1 000 bottles of culture media had been affected, about half of which were bought by clinics in the United States.
The filing said that the company had notified affected clinics on 13 December, telling them that “performance issues may lead to impaired embryo development” and instructing customers to stop using the product.
Each bottle holds enough liquid for multiple patients, though it’s unclear how many bottles were opened before the December recall. If clinics used even half of the affected bottles, as many as 20 000 patients could have been affected, said Mitchel Schiewe, an embryologist and a laboratory director at California Fertility Partners, which had briefly used the botched media in November.
Fertility medicine is a relatively new field with limited oversight from federal regulators. With demand for IVF climbing, CooperSurgical has raced to position itself as an industry leader. Over the past decade it has acquired five smaller fertility companies.
Last year it brought in $1.2bn in revenue, with 40% of that coming from its fertility services and supplies. The firm owns large sperm and egg banks and sells genetic tests to ensure that embryos are healthy.
The eight lawsuits describe a similar pattern of events. Couples had struggled for years to conceive. Many learned they had created healthy embryos in the latter part of November, only to hear by Christmas that the embryos had suddenly stopped growing.
The first lawsuit involved a Los Angeles couple who claim that 34 embryos were destroyed by the defective media. Their lawyer, Tracey Cowan, said that the case represented a recent trend in manufacturing problems, the result of rapid growth and consolidation in the companies supplying the fertility industry with everything from freezers and pipettes to embryo media.
“Ten years ago, most of my cases were all clinic negligence,” said Cowan, who has filed five cases related to the CooperSurgical liquid. “It’s only recently, in the past few years, that we’ve started to see a lot more of these product recall cases.”
In the newest case, the couple from Virginia described a decade of painful efforts to conceive before turning to in vitro fertilisation last autumn.
They had consulted a local fertility clinic, and an initial round of treatment yielded six fertilised eggs. They were optimistic – until they received a phone call in November telling that all of the embryos had stopped growing.
In January, the clinic told them they had used the defective CooperSurgical media on their embryos.
See more from MedicalBrief archives:
Unregulated US fertility industry a haven for controversial services
US couples file lawsuits over ‘worst ever’ IVF mix-up
A fifth of IVF cases in UK are now over-40s women