A California couple is suing the maker of an oil used in in vitro fertilization, claiming a “toxic” batch destroyed nine of their embryos—and their lawyer says he’s representing a dozen such couples around the world.
“This is not like a company just messing up a widget,” attorney Adam Wolf told The Daily Beast. “There’s a reason people spend so much money on and have a deep emotional connection to their embryos.”
He added: “This will have life-long consequences for everyone affected.”
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The complaint claims the oil was produced by Fujifilm Irvine Scientific, one of the largest U.S. producers of oil used to protect embryos from evaporation and changes in pH. The company advertises its oil as “sterile filtered and aseptically processed to provide the highest quality oil available.” But last month, Irvine Scientific issued an emergency recall of four lots after receiving customer complaints—including reports of “complete degradation” of the embryos, according to a recall letter published online.
According to the company, the lots passed initial inspection, but it was able to “detect oil toxicity” on retests. The product could result in “impairment of embryo development … resulting in the inability to perform the procedure,” the recall letter said. The company instructed clinics to immediately stop using the product and return or destroy it.
But the damage was done. According to the suit filed Thursday in Superior Court of California in Orange County, the company did not recall the oil until after the California couple’s embryos were destroyed.
Wolff said the devastated pair may not be able to have children at all, given the woman’s age.
“They, like thousands upon thousands of people in the U.S., turned to a fertility clinic for help having children,” he said. “Never in your worst nightmare do you think some of the products that a clinic uses would contaminate your incredibly precious, irreplaceable embryos.”
Wolf also slammed the company in a press conference Thursday for not making the recall notice publicly available to patients, calling it “unforgivable.”
Fujifilm said in a statement that it had received a “small number of complaints from a limited number of customers ”and “promptly initiated a comprehensive investigation.” The company noted that many factors can influence the success of IVF procedures, but said it issued the recall letter out of an abundance of caution and in consideration of customer complaints.
Wolf said he’s been contacted by a dozen couples since January facing similar circumstances to the California couple, including some in Europe and South America. His firm is planning to file suits on behalf of all of them and expects to hear from many more. “Unfortunately, this is the tip of the iceberg,” he said in the press conference.
It is unclear what exactly made the oil allegedly harmful to embryos, but Wolf said at least one clinic re-tested the oil on mouse embryos and found that those perished, too. It is also unclear how many embryos were affected, though attorney Ashlie Sletvold said the number could be anywhere from the thousands to tens of thousands.
The suit claims Irvine Scientific “failed to properly inspect and/or test its oil” and “knowingly put its oil into the market when it knew or should have known that the Recalled Oil Lots posed a substantial and unacceptable risk to human embryos.”
The couple is suing for negligence and negligent failure to recall, among other claims.
Fujifilm Irvine Scientific did not immediately respond to a request for comment.
