CooperSurgical IVF Lawsuit Filed Over Recalled LifeGlobal Embryo Culture Media

Recalled LifeGlobal culture media allegedly damaged embryos during in vitro fertilization (IVF), according to lawsuit filed against CooperSurgical, which indicates the manufacturer failed to adequately design and test the device.

A North Carolina couple has filed one of the most recent CooperSurgical IVF lawsuits over problems caused by the company’s recalled LifeGlobal embryo culture media, which was supposed to promote the growth of fertilized eggs, but instead destroyed embryos.

The complaint (PDF) was filed by Brooke and Michael Oxendine in the U.S. District Court for the Northern District of California on April 11, joining a growing number of similar CooperSurgical IVF lawsuits filed in recent months seeking compensation for damages caused by the embryo culture media, which was recalled after the manufacturer determined it creates a “risk to health” and “impaired embryo development prior to the blastocyst stage.”

During in vitro fertilization (IVF), health care professionals remove a woman’s eggs and fertilize them with sperm. The eggs are then placed in an embryo culture medium, which is intended to promote their growth to the blastocyst stage before being implanted back into the woman’s uterus to be carried to term. However, according to the Oxendine’s lawsuit, CooperSurgical’s recalled IVF embryo media instead caused damage to embryos, making them unusable. The lawsuit indicates the manufacturer knew, or should have known, of these risks, but failed to warn the healthcare community or patients undergoing the costly process.

The CooperSurgical IVF lawsuit indicates that Brooke Oxendine and her husband had struggled to conceive a child before she underwent egg retrieval in November 2023. The eggs were fertilized with her husband’s sperm and then placed in CooperSurgical IVF embryo media for three days before being frozen.

Weeks later, the couple learned that instead of assisting in the growth of the embryos, the media had damaged them instead, and that the product was being recalled.

“On December 5, 2023, Defendants issued a recall of three lots of media, only after Plaintiffs’ embryos were placed in the defective media, stating the recalled media does the opposite of its intended use, creating a ‘risk to health’ due to ‘impaired embryo development prior to the blastocyst stage’,” the lawsuit states. “Defendants’ manufacturing, marketing, promoting, distributing, and/or selling their defective media resulted in damage to, destruction of, or otherwise made useable Plaintiffs’ developing embryos and has caused panic, confusion, anxiety, devastation, and irreparable damage to Plaintiffs.”

The CooperSurgical IVE embryo LifeGlobal global culture media recall (PDF) was a field safety notice issued to CooperSurgical customers and distributors, but not to patients whose embryos had been exposed to the recalled media, the lawsuit indicates.

“CooperSurgical has become aware of a sudden increase in complaints regarding the aforementioned lots of this product,” the recall notice stated. “While we do not know the cause of the performance concern, due to the high volume of customer complaints for the three associated lots, we wish to proactively address any possible issue with our products while we continue to investigate.”

The lawsuit accuses the company of failing to adequately monitor their manufacturing systems and processes, which allowed for the culture media to be manufactured without sufficient amounts of magnesium or other critical elements. It also argues that the company failed to adequately test or inspect the recalled batches until after complaints from fertility clinics, warning that LifeGlobal media was destroying embryos rapidly.

“Plaintiffs were devastated. After years of fertility struggles and undergoing a series of physically and mentally fatiguing preparations and procedures to create their embryos, they were heartbroken to learn that their embryos had been cultured in the recalled Global Media manufactured by Defendants,” the lawsuit states. “Plaintiffs’ embryos were profoundly important to them – their most sacred possessions, These embryos represented Plaintiffs’ hopes and drams to build their family.”

The lawsuit presents claims of strict product liability due to manufacturing and design defects and failure to warn, as well as negligence, gross negligence, negligent failure to recall, trespass to Chattels and unjust enrichment. They seek both compensatory and punitive damages.