A Los Angeles couple sued the makers of oil used by fertility clinics to maintain embryos during in-vitro fertilization (IVF), alleging that a "toxic batch" of this oil destroyed nine of their fertilized eggs.
The unidentified couple, represented by attorney Adam Wolf, accused Fujifilm Irvine Scientific (FIS) of negligence in the complaint filed in the Superior Court of Orange County. The said complaint indicated the product's manufacturing and design defect, alongside its failure to warn hopeful parents and recall the oil. According to Wolf, he is also representing a dozen other traumatized families victimized by the same incident.
According to the Daily Mail, FIS quietly recalled four of its production lots on Jan. 16 following complaints of embryos' complete degradation. In the initial recall notice for the four batches, the Santa Ana, California-based firm said clients reported "blastocyst development, including complete degradation in some cases during culture of human embryos." However, Wolf noted that the said recall notice was not widely broadcast.
The oil plays a vital role by serving as "an extra layer of protection" for embryos cultured during IVF. According to the FIS website, the said oil "prevents evaporation, changes in osmolality and pH shifts, while providing the optimal in vitro environment for development." It added that any "potential deficiencies in the affected lots for oil for embryo culture may result in impairment of embryo development."
The plaintiffs are also asking for both economic and non-economic damages, as well as an injunction to ensure that their biological material does not come into contact with any more contaminated oil.
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According to the attorney, one fertility clinic had tested the recalled oil on mouse embryos to determine its toxicity – and true enough, all the embryos were destroyed. He dubbed the company's failure to quickly publicize the recall as "outrageous," adding that its procrastination on the matter could have resulted in more embryos needlessly being destroyed.
"Only FIS knows exactly what was in its oil that made it toxic," Wolf remarked.
FIS goes on the defensive
The Jan. 16 recall notice issued by FIS to fertility clinics said the company received "a small number" of complaints. It added that FIS performed "an extensive investigation" following these complaints.
The notice, penned by FIS Chief Compliance and Quality Officer Marlin Frechette, said that the oil product had met specifications before being shipped out. However, the internal investigation revealed toxicity in three lots – which were then pulled out. A fourth lot was also pulled out because it was made from the same batch of raw materials as the three recalled earlier.
"It is important that these devices are not used," wrote Frechette. However, her letter was not widely shared – a point Wolf noted in the lawsuit.
FIS spokesman Joe Metzger seconded the points in the notice through a statement. He noted that the company "promptly initiated a comprehensive investigation" after receiving the complaints, and recalled the four lots of IVF oil "out of an abundance of caution."
"We will respond to legal claims in the legal process," Metzger emphasized.
"We want to make sure [FIS] ensures this doesn't happen again," Wolf said. "I would hope that a company that has committed such a wrong would apologize, take accountability and right the issue."
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Watch this video that discusses ethical issues regarding IVF and other forms of procreation.
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