An LA couple is suing a California company that produces an oil used in IVF treatments, claiming a “toxic” batch destroyed the pair’s nine embryos.
The suit, filed Thursday in Orange County court, alleges Fujifilm Irvine Scientific did not properly test the oil before distributing it or adequately publicize a recall of four production lots of the product, the Los Angeles Times reported.
Fujifilm Irvine Scientific is a major producer of the heavy mineral oil, which is used to protect embryos as they are cultured.
On Jan. 16, Fujifilm Irvine Scientific issued an urgent recall of four lots of the oil after receiving complaints from a “small number of customers” reporting problems with fertilized egg development. The Post reached out to the company for comment Friday.
The unidentified couple who filed the suit claim they may no longer be able to have biological children due to maternal age.
“This is not like a company just messing up a widget,” the couple’s 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.”
“This will have life-long consequences for everyone affected,” he added.
In its recall notice, Fujifilm Irvine Scientific noted the four recalled lots “met all final product release specifications as reported on the Certificate of Analysis (CofA) before distribution,” but three lots were found to have “oil toxicity” after an “extensive investigation.” The fourth derived from the same raw material as the other three lots.
The “toxicity” was believed to cause an “impairment of embryo development … resulting in the inability to perform the procedure.”
Wolf claimed one fertility clinic tested the recalled oil on mouse embryos and reported none survived.
He blasted Fujifilm Irvine Scientific in a press conference Thursday for allegedly not publicizing the recall to patients, calling the move “unforgivable.”
“[The California couple], like thousands upon thousands of people in the U.S., turned to a fertility clinic for help having children,” said Wolf, adding that he’s representing a dozen other couples around the world.
“Never in your worst nightmare do you think some of the products that a clinic uses would contaminate your incredibly precious, irreplaceable embryos.”
It’s unclear how many embryos were affected by the recalled oil, but attorney Ashlie Sletvold, who is also representing the couple, told NBC Los Angeles the number could be anywhere from thousands to tens of thousands.
About one in eight US couples suffer from infertility. More than 5 million children worldwide have been conceived via IVF since 1978, according to statistics published last year.
A study recently found that male alcohol consumption negatively affects IVF success rates.