Lawsuit Alleges Oil for Embryo Culture Caused Wrongful Death of Unborn Child

North Carolina couple indicates recalled FujiFilm IVF culture oil destroyed their implanted embryo, claiming unborn child’s “right to life” vested at fertilization.

A wrongful death lawsuit has been filed against FujiFilm, alleging that the company’s defective IVF culture oil caused a North Carolina couple to lose their implanted embryo, which they maintain was already a human life under state law.

The unborn child died after it was conceived through in vitro fertilization (IVF), which is a process in which a human egg is removed from a woman’s ovary and fertilized in a laboratory setting. The resulting embryo is often kept in mineral oils until it is able to be implanted back into the woman’s body, which is supposed to help maintain the embryo’s stability.

However, the lawsuit indicates that FujiFilm’s Irvine Scientific Oil killed the embryo it was meant to protect, after it was already implanted back into the mother’s body.

Caroline and Joseph Mastrosonte filed the complaint (PDF) in the U.S. District Court for the Western District of North Carolina on August 20, indicating that under North Carolina law a fertilized embryo is a human life. Therefore, they claim that FujiFilm should be held responsible for the wrongful death of their unborn child.

FujiFilm IVF Oil Recall Issued After Embryos Were Destroyed

The lawsuit stems from a FujiFilm recall of Irvine Scientific Oil for Embryo Cultures issued in early 2023, after the manufacturer discovered toxicity in several lots of the mineral oil. As a result of the problems, fertility clinics across the U.S. were instructed to immediately stop using the oil and destroy any unused bottles, due to the risk it posed to fertilized embryos.

The Mastrosontes indicate that the recalled IVF oil was sold to Reproductive Endocrinology Associates of Charlotte, North Carolina, where they were undergoing fertility treatment, and it ultimately destroyed their embryos.

“Plaintiffs’ unborn implanted embryo was negatively affected by Defendant’s product, causing the embryo to not develop properly and ultimately causing the death of the embryo,” the Mastrosontes state in the lawsuit. “The right to life for each born and unborn human being vests at fertilization.”

This case is at least the fourth IVF lawsuit filed against FujiFilm over the defective oil, including a class action lawsuit brought in California, as well as individual lawsuits filed in Massachusetts and South Carolina, each raising similar allegations that embryos were lost as a result of the company’s recalled mineral oil.

The complaints filed against FujiFilm raise similar allegations to those presented in dozens of CooperSurgical IVF lawsuits filed in recent months, which also seek financial compensation for couples who lost embryos due to that company’s LifeGlobal culture media that was recalled in December 2023.

CooperSurgical IVF Lawsuits Over Recalled Culture Media

CooperSurgical issued its LifeGlobal media recall (PDF) in December 2023, after it became aware of a sudden increase in the number of failed embryos that had been treated with certain lots of its culture media product.

LifeGlobal media is commonly used during IVF, when fertilized eggs are placed in an embryo culture media, which is intended to promote the eggs’ growth before being implanted back into the woman’s uterus. However, lawsuits against CooperSurgical allege that the recalled media did not support the growth of eggs, instead killing fertilized embryos before they were implanted back into patients.

Given common questions of fact and law raised in a growing number of complaints brought throughout the federal court system, a motion to centralize the CooperSurgical IVF lawsuits was filed in June 2024, indicating that there were already at least 30 complaints brought by families nationwide. In addition, more lawsuits are expected as couples learn that their destroyed embryos may be the result of CooperSurgical’s recalled culture media.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to hear arguments on the motion to centralize on September 26, at the Fred D. Thompson U.S. Courthouse and Federal Building in Nashville, Tennessee. At that time, the JPML will determine whether the issues covered in all of the CooperSurgical IVF recall lawsuits raise sufficiently common questions to justify establishing an MDL.

If the JPML does establish a CooperSurgical IVF lawsuit MDL, each of the claims will be transferred to one judge for coordinated discovery and pretrial proceedings. In that instance, the Court will usually select a small group of representative cases to be prepared for early bellwether trials, which can help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.