CooperSurgical sued over recalled IVF culture medium

Two Californian couples are suing a health technology company after their embryos failed to develop.

CooperSurgical issued a recall notice in December 2023 for three batches of its embryo culture media, after they received complaints about 'impaired embryo development prior to the blastocyst stage'. The lawsuits, filed in the California state court in Los Angeles County, claim that the product was defective in its design and manufacture, and that the recall was not shared widely or quickly enough.

'We do know that CooperSurgical recalled at least three lots of its embryo culture media, and it appears that the company intentionally did not more broadly disseminate notice of the recalled lots and has failed to indicate the scale of this disaster,' said lawyer Adam Wolf, from Peiffer Wolf Carr Kane Conway and Wise, California, who is representing the couples.

Embryos are kept in cultue media while they grow after being created through IVF or ICSI, before they are ready to be transferred to the patient's uterus, or frozen for later use.

Both couples were having IVF treatment in November 2023, when the embryos stopped growing or became nonviable after they were placed in the culture media provided by CooperSurgical. According to the lawsuit, one of the couples lost all but one of their embryos, with the remaining being deemed nonviable, and as such, lost the chance to have a biologically related child.

CooperSurgical has not responded to the claims directly, but the recall letter said the recall was issued to 'proactively address any possible issue with our products while we continue to investigate.' It continued: 'We regret any inconvenience caused by this recall. CooperSurgical is committed to high quality products and is investigating to determine and address any identified root cause of these complaints.'

'The families deserve answers,' said Wolf, who also speculated that these could be the first of many more cases, as CooperSurgical ships its products worldwide.