A California couple is suing the manufacturer of an oil used during IVF, claiming a faulty batch of oil destroyed their embryos.
Fujifilm Irvine Scientific's oil is used to prevent evaporation during the process of culturing and storing embryos. Several batches of the oil were recalled after complaints were received, but the couple was subsequently notified that their nine embryos had been destroyed. As a result, they may no longer be able to have genetically-related children.
Documents filed by the couple's lawyers claim that 'Irvine Scientific did not sufficiently test the oil… As a result it sold defective lots of oil which turned out to be toxic to embryos.' They allege that the manufacturer's 'defective product and negligent conduct destroyed the Plaintiffs' precious and irreplaceable embryos'.
The manufacturer issued an urgent safety notice to fertility clinics on 16 January, stating 'FUJIFILM Irvine Scientific has received reports from a small number of customers concerning the performance of [four oil lots]. The complaints reported reduced blastocyst development, including complete degradation in some cases, during culture of human embryos.'
The company indicated that while these oil lots met final release specifications, they conducted further testing that detected toxicity in three lots. A fourth lot derived from the same batch of raw material was also withdrawn.
Adam Wolf, the couple's lawyer, said: 'Only Fujifilm Irvine Scientific knows exactly what was in its oil that made it toxic.' He added that the company failed to properly publicise the urgent recall, which could have prevented more embryos from being destroyed.
In terms of how many patients may be affected, reproductive endocrinologist Dr Jeffrey Steinberg, director of The Fertility Institutes told CBS News: 'Almost all clinics these days use oil… There's a number of different manufacturers but FUJI is one of the big ones.' Dr Steinberg's clinic did not receive any oil from the affected batches.
Wolf has said that he is in contact with 11 further couples with similar stories:
'There needs to be accountability here,' he said. 'Our clients, in this particular case, found out like all of our clients found out because their clinic told them that their embryos died upon coming into contact with this particular oil.'
Sources and References
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An L.A. couple's embryos were destroyed by toxic oil — and others could be at risk, lawsuit alleges
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California couple sues maker of oil used in IVF after a 'toxic' batch destroyed nine of their embryos - as their lawyer reveals he's representing a dozen traumatised families
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Couple sues Fujifilm Irvine Scientific over recalled embryo culture oil
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Their embryos were allegedly destroyed by bad oil. Now they’re suing.
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Couple says 'toxic' fertility oil destroyed their embryos
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FUJIFILM Irvine Scientific, Inc. – Urgent Field Safety Notice (product removal)
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