Couple sues bio company for oil used during IVF treatments

Fertility clinic supplier sued for defective oil that allegedly killed embryos

Attorneys for a Los Angeles couple announced that they are suing a Santa Ana-based company called "FUJIFILM Irvine Scientific" for manufacturing an oil that allegedly killed their embryos during in vitro fertilization treatments.

"We can't revive people's embryos," said one of the couple's attorneys Adam Wolf. "The damage that's been done is irreparable."

The lawsuit states FUJIFILM issued a recall in January when it received complaints that human embryos were dying when coming into contact with the defective oil.

"During IVF, this oil is used to protect the embryo being cultured in the lab," said attorney Ashlie Sletvold. "It prevents the embryo from drying out and dying ... The oil FIS manufactured and sent to fertility clinics was actually toxic."

In a statement, FUJIFILM said it "received a small number of complaints from a limited number of customers."

"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.

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."

The couple's attorneys said the company did not publicly release information about the recall. They also claimed their clients are devastated they may no longer be able to have children with their genetic material because of this. 

"There needs to be accountability here," said Wolf. "Our clients, in this particular case, found out like all of our clients found out because their clinic old them that their embryos died upon coming into contact with this particular oil."

The attorneys said they represent around a dozen people, so far, and added that their outreach spans locally, nationally and internationally. 

"Almost all clinics these days use oil," said Dr. Jeffrey Steinberg, medicinal director of The Fertility Institutes. "There's a number of different manufacturers but FUJI is one of the big ones." 

Steinberg is also a reproductive endocrinologist who also uses FUJIFILM as well as another company's products. He didn't receive any notice of a recall so he believes only certain clinics received bad batches. He added that human embryos are extremely sensitive. 

"Toxic means that it didn't support the ability of embryos to develop normally," said Steinberg. "Certainly toxins are our big enemy." 

Steinberg said couples currently going through IVF shouldn't panic. 

"The big thing to look for is the longterm success rates of the clinic," he said. "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."

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