Patients who underwent in vitro fertilization treatment are taking legal action against CooperSurgical, accusing the company of producing a faulty product that destroyed their embryos.
The IVF media solution, manufactured by CooperSurgical, Inc., to foster embryo development, allegedly failed due to a missing key nutrient leading to embryonic death and lack of development, according to the latest lawsuit filed against the company by a Virginia couple.
Earlier this year the company recalled approximately 1,000 bottles of the defective solution, according to the U.S. Food and Drug Administration. CooperSurgical previously alerted health care providers to stop using the product as it could “lead to impaired embryo development,” the FDA notice states.
According to embryologist Mitchel C. Schiewe in a statement to The New York Times, 20,000 patients could have been impacted if fertility clinics used about half the affected media. The true number of patients impacted by the compromised solution, which was distributed to 33 states and 24 countries, is unknown.
Lawsuit Claims Couple Lost 34 Fertilized Eggs
In mid-December, a California couple who claimed the loss of 34 eggs because of the faulty media lodged the first lawsuit against CooperSurgical. After four unsuccessful attempts at pregnancy via IVF, the couple found an egg donor and managed to create 34 fertilized eggs, according to the lawsuit filed in Los Angeles County.
The lawsuit documents that the clinic anticipated these would develop into 20 blastocysts and at least eight viable embryos. However, by day five, none had progressed further, a result their infertility doctor described in court paperwork as not making “sense.”
Further investigations into the embryonic failures by the lab director at the couple’s fertility clinic, discovered with discussions with his peers at other clinics that they were also experiencing similar unexplained losses, court paperwork states.
The lab director’s investigation found that CooperSurgical’s embryo culture media was the common element linked to these incidents, the lawsuit claims.
Since the first lawsuit was filed, several more people have filed against the company claiming a similar situation.
What To Know About CooperSurgical
Owned by The Cooper Companies Inc., the medical device firm is based in California with divisions in contact lenses and women’s health care. CooperSurgical is a significant player in the fertility industry.
Last year it reported revenues of $1.2 billion. CooperSurgical operates a major human sperm and egg bank and also performs genetic testing of embryos.
In a February press release, CooperSurgical announced a 12% increase in its first-quarter revenue over the previous year, amounting to $310 million.