The vitro fertilization (IVF) industry has been rocked by a series of lawsuits against fertility technology company CooperSurgical Inc. Patients from across the United States are accusing the company of manufacturing a faulty product that destroyed their hopes of having children through IVF. The allegations center around a crucial IVF solution CooperSurgical used to foster embryo development, which reportedly lacked a key nutrient, leading to the destruction of hundreds, if not thousands, of embryos.

The CooperSurgical IVF Solution Recall

The FDA revealed in February 2024 that CooperSurgical had issued a recall for approximately 1,000 bottles of defective embryo culture media. The company had previously warned healthcare providers to stop using the product, acknowledging that it could “lead to impaired embryo development.”

The first CooperSurgical IVF lawsuit was filed in December 2023 by a California couple who claimed to have lost 34 fertilized eggs due to the tainted solution. According to court documents, the couple had successfully created 34 embryos through IVF, anticipating the development of 20 blastocysts and at least 8 viable embryos. However, by day five, none of the embryos had progressed.

Further investigation by the clinic’s lab director revealed that CooperSurgical’s embryo culture media was the common factor linked to these unexplained embryonic failures across multiple fertility clinics. This discovery laid the groundwork for the wave of lawsuits that followed.

Lawsuits Filed Against CooperSurgical Over Destroyed Embryos

Since the initial embryo loss lawsuit was filed against CooperSurgical, a growing number of individuals and couples have come forward with similar claims. As of April 2024, at least eight lawsuits have been filed in the U.S. District Court for the Northern District of California, alleging that the company’s defective IVF solution destroyed their embryos and jeopardized their chances of having children. 

The lawsuits against CooperSurgical each involve similar allegations that the company’s culture media, a nutrient-rich liquid designed to support embryo development, was fundamentally flawed. Specifically, the plaintiffs claim that the solution lacked a key ingredient – magnesium – which ultimately suspended the development of their embryos. 

Two of the latest embryo loss lawsuits against CooperSurgical, filed just last week, bring claims of negligence and defective design and manufacture, alleging that the company should have recalled the defective IVF solution sooner.

The Devastating Scope of the CooperSurgical IVF Issue

While the exact number of affected patients remains unclear, experts estimate that the impact could be staggering. Embryologist Mitchel C. Schiewe told The New York Times that if fertility clinics used about half the affected media, as many as 20,000 patients could have been impacted. According to reports, the defective IVF solution was distributed to fertility clinics in 33 states and 24 countries. 

For individuals and couples affected by this IVF crisis, the emotional toll is immeasurable. Lawsuits against CooperSurgical paint a heartbreaking picture of shattered dreams and irreplaceable losses. “If you think about all of your future children wiped out in one blow, that’s what our clients are grappling with,” says one attorney representing several of the plaintiffs. This profound sense of grief and the loss of their reproductive potential has left many struggling to cope.

The Need for Increased IVF Regulation and Oversight

The CooperSurgical IVF solution recall has sparked calls for greater regulation and oversight in the IVF industry. Experts argue that the lack of mandatory disclosure requirements for the ingredients and proportions of culture media used in IVF procedures leaves patients vulnerable to potential product failures. As the lawsuits against CooperSurgical continue to mount, the fertility community and the broader public await the resolution of this deeply concerning issue. The stakes are high, as the outcome of these legal proceedings could have far-reaching implications for the IVF industry, potentially driving reforms to enhance transparency, quality control, and patient safeguards.