Shattered LA couple sues firm after ‘toxic’ oil used in IVF destroys NINE embryos
LOS ANGELES, CALIFORNIA: A couple, who were not identified by name, filed a lawsuit against a Santa Ana-based company called Fujifilm Irvine Scientific on Thursday, February 16, for manufacturing an oil that was "toxic" and destroyed their embryos. One of the couple's attorneys, Ashlie Sletvold, told, “During IVF, this oil is used to protect the embryo being cultured in the lab. It prevents the embryo from drying out and dying ... The oil FIS manufactured and sent to fertility clinics was actually toxic."
"We can't revive people's embryos. The damage that's been done is irreparable," explained the couple's other attorney Adam Wolf, reports CBS News. The lawsuit, which was filed in Orange County Superior Court, states that the company failed to test the oil before distributing it. It also stated that the couple's fertility clinic informed them that the oil had destroyed their nine embryos, after January 16 notice, which left them “devastated” because they may no longer be able to have genetic children, states Yahoo!
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'There needs to be accountability'
On January 16, 2023, in its recall notice to fertility clinics, the company said, as per CBS News, "We received a small number of complaints from a limited number of customers suggesting that our Oil for Embryo Culture did not perform as intended. Upon initial receipt of the complaints, we promptly initiated a comprehensive investigation. We performed sensitive bioassay testing and detected oil toxicity in three of four lots made with the same raw material. In addition, we tested the lot retention samples and individual raw material containers to try to understand the potential source of the issue." And added While the natural variability of embryo development can be a substantial obstacle to successful fertility treatments, many factors may influence the success of IVF procedures. However, in consideration of the customer complaints, the results of our internal analysis and out of an abundance of caution, on Monday, January 16, 2023, FUJIFILM Irvine Scientific issued a voluntary recall of four lots of the company's Oil for Embryo Culture product. We will respond to legal claims in the legal process."
However, the couple's attorneys said the company did not publicly release the information. "There needs to be accountability here. 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," said Wolf.
Dr Jeffrey Steinberg, medicinal director of The Fertility Institutes, who is also a reproductive endocrinologist and uses Fujifilm as well as another company's products, said, "Almost all clinics these days use oil. There's a number of different manufacturers but FUJI is one of the big ones." And further said, "Toxic means that it didn't support the ability of embryos to develop normally. Certainly, toxins are our big enemy." However, he suggested, "The big thing to look for is the long-term success rates of the clinic. Things happen very fast in IVF including toxicity. You can start off with an oil that's not toxic and by the time the bottle is open and used something contaminates it — something makes it toxic. I would say talk to the physician and look at the results of the laboratory."
Who owns FujiFilm Irvine Scientific?
The global holding company bought Irvine Scientific Sales Co in Santa Ana, California, in 2018 for about $800 million. Fujifilm, which is headquartered in Tokyo, is part of Sumitomo Mitsui Financial Group financial conglomerate. Yutaka Yamaguchi, is the CEO and president of the company. Irvine Scientific, which was founded in 1970, has specialized in development and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians, reports Genetic Engineering & Biotechnology News.