CooperSurgical IVF Embryo Fluid Lawsuit

During an IVF procedure, doctors use a laboratory process to fertilize mature egg cells with sperm to create a viable embryo. Some viable embryos have been lost because of defective IVF culture medium made by CooperSurgical. This led people to file embryo loss lawsuits against the pharmaceutical giant.

IVF can help people facing fertility issues conceive a baby with an embryo created with medical assistance at a fertility clinic. Before implanting the embryo in the patient’s uterus, doctors place the combined sperm and egg cells in a culture medium (a nutrient-rich IVF fluid) to help it grow to the blastocyst stage and begin the early phases of development.

Plaintiffs allege that CooperSurgical not only manufactured and distributed a defective embryo fluid for use at IVF clinics across the country, but they also knew of problems with several lots of its culture fluid but was too slow in issuing a recall. This delay resulted in the loss of the plaintiffs’ embryos.

The IVF process is complex, emotionally taxing and full of variables. The loss of otherwise viable embryos can jeopardize the plaintiffs’ chances of ever having children.

IVF is also a costly procedure that insurance providers might not cover. This could make it difficult or impossible for affected couples to afford another round of IVF if one fails.

How many people are suing for embryo loss from the defective IVF solution?

As of July 2024, approximately 30 cases have been filed against CooperSurgical for defective IVF fluid in the U.S. District Court, for the Northern District of California as well as a handful of other state and federal courts. These defective IVF fluid lawsuits against CooperSurgical are still in the early stages. As news about the defective fluid comes to light, more plaintiffs may come forward.

The details of each lawsuit vary. For example, one plaintiff lost six embryos. The plaintiff of an earlier lawsuit in Los Angeles claimed to lose 34 embryos. 

The IVF solution — also known as an embryo culture media or global media — used to grow embryos was missing magnesium, which is a critical nutrient for embryo development. The affected lots contained nearly 1,000 bottles of culture media that were shipped worldwide. One bottle provides enough fluid for multiple patients.

After the distributors received the culture media, they sent it to fertility clinics. CooperSurgical, is the entity that made the defective embryo fluid and shipped it to distributors. CooperSurgical has not disclosed why the culture media was made and shipped without magnesium.

Mitchel C. Schiewe, an embryologist and a laboratory director at California Fertility Partners, told the New York Times, “If clinics used even half of the affected bottles, as many as 20,000 patients could have been affected.”

Not sure how IVF works? Jump down the page to learn about key terms and concepts.

How do I know if my embryo loss was caused by defective fluid?

If you’ve gone through the IVF process and lost embryos, it’s difficult to say whether the defective CooperSurgical IVF solution is the cause. In most cases, patients don’t know what IVF solutions were used during their procedures. Additional research is needed, starting with your fertility clinic provider.

Motley Rice attorneys can help you investigate whether your fertility process may have been impacted by the defective fluid. This information will determine whether or not the recalled batches of fluid were used during your IVF treatments. Lawyers can also analyze applicable laws to see if you might be eligible to file a lawsuit seeking financial compensation.

The IVF solution — also known as an embryo culture media or global media — used to grow embryos was missing magnesium, which is a critical nutrient for embryo development. The affected lots contained nearly 1,000 bottles of culture media that were shipped worldwide. One bottle provides enough fluid for multiple patients.

After the distributors received the culture media, they sent it to fertility clinics. CooperSurgical, is the entity that made the defective embryo fluid and shipped it to distributors. CooperSurgical has not disclosed why the culture media was made and shipped without magnesium.

Mitchel C. Schiewe, an embryologist and a laboratory director at California Fertility Partners, told the New York Times, “If clinics used even half of the affected bottles, as many as 20,000 patients could have been affected.”

Not sure how IVF works? Jump down the page to learn about key terms and concepts.

How do I know if my embryo loss was caused by defective fluid?

If you’ve gone through the IVF process and lost embryos, it’s difficult to say whether the defective CooperSurgical IVF solution is the cause. In most cases, patients don’t know what IVF solutions were used during their procedures. Additional research is needed, starting with your fertility clinic provider.

Motley Rice attorneys can help you investigate whether your fertility process may have been impacted by the defective fluid. This information will determine whether or not the recalled batches of fluid were used during your IVF treatments. Lawyers can also analyze applicable laws to see if you might be eligible to file a lawsuit seeking financial compensation.

Embryo loss plaintiff details

More than 30 plaintiffs have filed IVF lawsuits against CooperSurgical, and that number is likely to grow as tens of thousands of patients undergoing IVF may have been affected. Currently, the plaintiffs include:

• A couple undergoing fertility treatment in Los Angeles. They claim to have lost 34 embryos.
• A couple from Virginia who were unable to conceive via IVF after a decade of other unsuccessful efforts.

The CooperSurgical embryo lawsuits are still in the early stages of litigation. Motley Rice has represented women harmed by defective birth control devices, breast implants and transvaginal mesh devices. Our lawyers have the knowledge and experience necessary to file a CooperSurgical IVF lawsuit.

The Food and Drug Administration (FDA) originally posted a recall notice about the defective CooperSurgical IVF fluid in December 2023, with an updated recall notice confirming the absence of magnesium in March 2024. The Class 2 recall affected three lots of products totaling nearly 1,000 bottles, which may have affected up to 20,000 patients .

The FDA defines a Class 2 recall as a situation where:

• The affected product may cause temporary or medically reversible adverse health consequences
• There's a remote probability of serious adverse health consequences

Class 1 is the most serious of the three recall classes. There are also recall categories for market withdrawals and medical device safety alerts .

More about CooperSurgical

According to the New York Times, CooperSurgical, Inc.’s 2023 revenue reached $1.2 billion. Forty percent of that came from its fertility products and services.  According to some estimates, the total IVF market in the US was worth more than $25 billion in 2023.

CooperSurgical is also involved in other litigation besides the defective IVF media recall. Plaintiffs in a multidistrict litigation (MDL) action claim the company knowingly sold defective Paragard intrauterine devices (IUDs). These defective IUDs caused injuries and serious health problems to thousands of people. 

The goal of IVF is to implant an embryo into a uterus, where it can develop into a healthy baby. An entire IVF cycle takes 4-8 weeks. Here are some of the key steps in the IVF process.

• Initial screening: This step includes various analyses such as determining how many eggs are available, a semen analysis, infectious disease screening and a uterine exam.
• Egg development: Your IVF team might use hormones to stimulate the ovaries to make eggs. The process requires multiple eggs because some won’t fertilize. Other medicines might help the eggs mature, prepare the uterine lining or delay ovulation until the opportune moment. 
• Egg retrieval: Fertility specialists retrieve the eggs from the ovaries.
• Sperm retrieval: Doctors harvest sperm cells from a semen sample.
• Fertilization: At this point, the IVF clinic will attempt to fertilize the eggs in a petri dish and place them in the embryo culture media.
• Embryo transfer: The embryo is implanted in the uterus. If the process is successful, the embryo will attach to the uterine lining. It will take approximately 12 days to determine whether or not the patient is pregnant.

This process can help people conceive children when they would otherwise not be able to. For many, successful IVF procedures provide them with the opportunity to build the family they desire. If your IVF procedure did not work and you believe you may have been impacted by the defective CooperSurgical, fluid, contact us today.

Did CooperSurgical know its IVF fluid was defective?

Yes, CooperSurgical was aware of its defective product. The company voluntarily recalled three batches of IVF fluid in December 2023. IVF lawsuits, however, argue that the company should have been quicker to recall the affected batches.

How many people were affected by the defective IVF fluid?

The number of people affected by the defective CooperSurgical IVF product could reach many thousands. The company recalled three batches containing nearly 1,000 bottles. Each bottle can provide culture media for multiple patients.

Lab director Mitchel C. Schiewe of California Fertility Partners told The New York Times that up to 20,000 patients could be impacted if even half the affected bottles were used.

How much is an embryo loss settlement?

No defective IVF fluid lawsuits have gone to trial or been settled yet, so it’s difficult to estimate settlement amounts and a settlement is not guaranteed. Any compensation amounts may depend on the economic losses from the IVF treatment as well as the pain and suffering of the plaintiffs. The possibility of the plaintiffs producing another embryo may also be a factor. 

The attorneys at our law firm have experience representing people alleging harm by defective medical devices, breast implants and birth control measures affecting women and children. Our involvement with cases affecting women and children includes:

• Birth control litigation: Motley Rice attorneys served in court-appointed  leadership positions for lawsuits against the Mirena® IUD, the permanent birth control device Essure® and the NuvaRing® vaginal ring. Currently, Motley Rice attorney Fidelma Fitzpatrick is court-appointed to the Paragard® IUD Plaintiffs’ Executive Committee (PEC) and attorney Kristen Hermiz is court-appointed to the Paragard Plaintiffs’ Steering Committee (PSC).
• Breast implant litigation: People with defective Allergan breast implants have developed BIA-ALCL, a type of lymphoma. Motley Rice is involved in these lawsuits, representing harmed plaintiffs.
• Hair relaxer litigation: Women exposed to toxic chemicals in chemical hair relaxers may be at a higher risk for endometrial, ovarian and uterine cancers. Motley Rice attorney Fidelma Fitzpatrick is co-lead counsel for the federal MDL and Tope Leyimu serves on the Leadership Development Council and co-chairs a liability committee.
• Talcum powder litigation: Products like baby powder have been linked to ovarian cancer. Motley Rice attorneys Daniel Lapinski and Carmen Scott are members of the Plaintiffs’ Steering Committee for the talcum powder MDL.
• Birth defect litigation: Motley Rice attorney Kimberly Barone Baden was instrumental in winning damages for parents with birth defect claims. The case alleged that the makers of Paxil failed to disclose the risk of using the antidepressant medication.

Learn more about our experience advocating for women’s health.