An Alabama couple filed a new lawsuit against a major women’s health company, saying its failure to inspect one of its products led to the destruction of embryos created with in vitro fertilization.
The couple decided to pursue IVF after a health condition limited their options to have children, according to the lawsuit.
During the process, they said their embryos were placed into embryo culture media, an essential component of IVF meant to mimic the natural circumstances of a developing embryo.
But the embryo culture media produced by Connecticut-based company CooperSurgical was faulty and rendered their embryos unusable, hindering their family planning process, according to court documents.
This isn’t the only lawsuit the company is facing as a result of the defective product. Earlier this year, eight lawsuits were filed by families across the United States for embryos destroyed after the product was used in 2023, The New York Times reported.
Experts at that time estimated that thousands of patients were affected, according to the outlet.
As of July 2024, about 30 lawsuits have been filed against CooperSurgical for defective IVF fluid, according to a law firm.
The new complaint, filed Dec. 6, said the company began getting concerns about the media as early as Nov. 21, 2023, but did not immediately alert the public or those seeking IVF.
According to a Food and Drug Administration recall notice posted in February, the company notified customers in December of the product’s defects and instructed them to separate it from use.
“Had (CooperSurgical) immediately notified clinics regarding the defective Global Media, rather than waiting two weeks to issue a recall, the catastrophic failures at issue could have been avoided,” the complaint said.
McClatchy News reached out to CooperSurgical on Dec. 10 but did not immediately receive a response. The company declined to comment to the Times in February about the other eight lawsuits.
Alabama couple’s predicament
For the Alabama couple, the communication delay is devastating and has caused “emotional trauma, including shock, hopelessness, fear, devastation, anger and grief,” the lawsuit said.
The woman underwent an egg retrieval on Dec. 1, 2023, where her eggs were fertilized and placed into the embryo culture media, according to the lawsuit.
Four days later — after having already received complaints about the media — the company issued a recall, but it was too late to have saved the couple’s embryos, the complaint said.
In a medical recall follow-up notice, issued on March 1, CooperSurgical said an investigation found that magnesium — a necessary nutrient — was not added to the batch of media, according to the lawsuit.
The couple said CooperSurgical “failed to adequately monitor its manufacturing systems and processes” and “did not properly test or inspect the impacted lots of global media until after receiving numerous complaints from fertility clinics,” according to the complaint.
The lawsuit accuses the company of negligence, manufacturing defect, unjust enrichment and breach of contract and is seeking damages in excess of $15,000.
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