Outbreak Summary
On January 16, 2023, Fujifilm Irvine Scientific issued an “Urgent Field Safety Notice (product removal)” with respect to its “Oil for Embryo Culture, Catalog #9305, Lots 0000011351,0000011367, 0000015999, 00000160001.” The recall notice stated that Irvine Scientific had received numerous complaints regarding these particular lots of the Embryo Oil, including complaints that human embryos had died after coming into contact with the oil. The notice further stated that after receiving these complaints, Irvine Scientific had tested the lots in question and found oil toxicity in many of the lots.
Crucially, this recall notice was not directly publicized to the actual patients whose embryos were lost after coming into contact with the toxic oil. Instead, the recall notice went to the fertility clinics, who then had to reach out to their patients with the devastating news that their precious embryos had been destroyed because of the toxic oil.
In fact, it was fertility clinics—not Irvine Scientific—that first discovered the toxicity of the oil. The doctors at the fertility clinic at Brigham & Women’s Hospital at Harvard noticed that the quality of the embryos they were creating was decreasing. Their review identified the Irvine Scientific oil as the likely source of the problem, and they confirmed this through experiments on mouse embryos. They promptly notified Irvine Scientific, which led to the recall. According to Irvine Scientific, the recalled oil was in the market place from August of 2022 until January of 2023.
OFT Law’s Brendan Flaherty has been retained to pursue legal compensation for clients whose embryos were lost, and we have filed a lawsuit on their behalf in federal court in Massachusetts. If you have been affected by this recall, please call us or use the contact form above to set up a free consultation.
More Details
OFT Food Safety & Injury Lawyers have filed their first federal lawsuit arising out of allegedly toxic oil used in the preservation of human embryos. The defendant is FujiFilm Irvine Scientific. The lawsuit has been filed in the United States District Court for the District of Massachusetts (Case No. 1:23-cv-10486).
The Plaintiffs are a married Massachusetts couple who had long dreamed of having children. They were undergoing in vitro fertilization treatment at the world-renowned Brigham & Woman’s Hospital fertility clinic in Boston, Massachusetts. According to the complaint, FujiFilm Irvine Scientific, a biotechnology company focused on providing fertility doctors, clinics and laboratories a variety of IVF supplies, sold the clinic an embryo oil that was toxic and destroyed the couple’s embryos.
Companies like FujiFilm owe a heightened duty to fertility patients like his clients. “One’s fertility and the decision to have children is deeply personal and emotional,” attorney Brendan Flaherty said. “We are talking about nascent human life deserving of the highest level of respect. FujiFilm knew of this awesome responsibility but badly betrayed the trust of fertility patients, doctors, and laboratories.”
Assisted reproduction technology, like IVF, calls for exacting and painstaking efforts to extract a woman’s eggs, inseminate them, and then grow and preserve human embryos. FujiFilm, according to the lawsuit, produced a mineral oil product that was intended to help preserve these embryos but proved toxic to them. The toxicity was apparently discovered after the Plaintiffs’ fertility clinic recognized a potential problem and tested the oil with mice, confirming the product’s toxicity. FujiFilm then sent an urgent safety notice to its customers not to use four lots of its oil product.
In vitro fertilization (IVF) is the most common type of assisted reproductive technology, and it has helped millions of people have babies since it was first pioneered in the 1970s. The IVF process entails extracting eggs from a woman, which are then fertilized with sperm to create a viable embryo, which is later implanted into a uterus. In many cases, it is necessary to store the embryos for a period of time prior to implantation, and in such cases the embryos must be carefully preserved.
The oil recalled by Fujifilm Irvine Scientific is used to help preserve embryos between the time they are created and the time they are implanted. It is crucial that this oil be pristine and completely free from contamination. Irvine Scientific markets its oil as being “highly purified” and “non-reactive” and therefore ideal to use as an overlay to keep embryos safe by preventing evaporation and changes in pH while they are stored. Instead, the oil had the opposite effect and caused the death of an untold number of embryos.
With over five decades of combined experience, the lawyers at OFT Law have recovered millions on behalf of victims of contaminated products, including infant formula, food, and medical products. If you have been affected by this recall, contact OFT Law for a free consultation today. Call or text 888-828-7087 or email advice@oftlaw.com.