CooperSurgical Faces Lawsuits Over Defective IVF Product
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People who utilized in vitro fertilization (IVF) services are suing CooperSurgical, Inc., claiming the fertility company’s product caused their embryos to be destroyed.
During the IVF process, fertilized eggs are bathed in the media created by CooperSurgical, which is supposed to encourage the development of an embryo. But plaintiffs claim it caused the opposite to occur. While the reason the solution turned out to be toxic to embryos isn’t publicly known, one lawsuit claims it lacked magnesium, a nutrient vital for embryonic development and growth.
Earlier this year, the company issued a recall for nearly 1,000 bottles of the solution. The company previously warned clinics to stop using the media because it could “lead to impaired embryo development,” according to the U.S. Food and Drug Administration notice.
It’s unclear how many embryos were impacted by the recalled solution, which was distributed to 33 states and 24 countries around the globe.
Multiple patients can use one bottle of the solution. Embryologist Mitchel C. Schiewe told The New York Times that just half of the impacted solution could have affected an estimated 20,000 patients.
Lawsuit: California Couple Lost 34 Fertilized Eggs
A California couple filed a lawsuit against CooperSurgical in mid-December claiming they lost 34 fertilized eggs after being placed in the defective embryo culture media.
After four failed rounds of IVF, the unnamed couple found an egg donor and created 34 fertilized eggs on day one, according to the lawsuit filed in the Superior Court of California for Los Angeles County.
The clinic estimated it would result in 20 blastocysts (an early stage of an embryo) and at least eight healthy and viable embryos. But by day five, none of the embryos had developed to the next stage. The infertility doctor told the couple it “did not make sense.”
Later, the lab director at the plaintiff’s fertility clinic decided to investigate the embryonic deaths and reached out to other embryologists at other labs, according to the lawsuit. He found in his research that other clinics also experienced similar unexplained embryonic deaths.
The common factor was CooperSurgical’s embryo culture media, the lawsuit states.
The company has faced at least seven additional lawsuits since then. It remains unclear how many people were impacted by the inadequate media and resulting embryo loss.
What Is CooperSurgical?
CooperSurgical is owned by The Cooper Companies, Inc., a California-based medical device company that operates two divisions: contact lenses and women’s health care.
CooperSurgical reported $1.2 billion in revenue last year. It owns a large human sperm and egg bank and also deals in the genetic testing of embryos.
In a late February press release, the company announced its revenue in the first quarter was up 12% over last year’s first quarter with 2024 figures reaching over $310 million.