In late 2023, three bad batches of an important component of in-vitro fertilization (IVF) known as "culture media" caused healthy human embryos in Maine fertility clinics to halt development. Individuals and couples in Maine aiming to conceive through IVF lost not only these precious embryos but also all the effort, time and money they had invested to that point. Individuals and couples who lost embryos in Maine as a result of CooperSurgical's defective IVF culture media are filing claims against the company to recover damages. This page provides a comprehensive look at the role of embryo solution in the IVF process, how CooperSurgical's culture media went wrong, and details on filing a defective IVF culture media lawsuit for Maine residents.
Culture media is a medical product sold to Maine clinics by fertility supply companies that is designed to mimic the environment in the human uterus. Also known as embryo solution, culture media is used in Maine during a type of assisted reproduction known as in-vitro fertilization, or IVF. IVF is often described as a harrowing process, exposing individuals to physical discomfort, pain, and emotional distress over the course of weeks or months.
An expensive process, IVF in Maine relies on numerous medical products and devices to achieve pregnancy. The basic steps of IVF include:
Fertilization is the point in the process where IVF culture media comes into use, providing the environment for fertilization to take place. If the formula is not perfectly calibrated, all the effort up to this point will be lost. CooperSurgical released three lots of defective IVF embryo solution to clinics in Maine and around the nation that halted the healthy development of thousands of embryos.
In order for this development to progress to the stage of a healthy embryo that can be implanted, the culture media must be formulated perfectly. The pH must exactly match the pH found in a healthy uterus, and an array of nutrients must be present. In the case of CooperSurgical's defective IVF embryo solution, a lack of magnesium prevented the healthy embryos of Maine couples from advancing from fertilized eggs to rapidly-dividing blastocysts. The company has not released information about how this oversight occurred or why it was not detected before the product reached the market.
It took the loss of hundreds or even thousands of healthy human embryos in Maine and around the nation for CooperSurgical to notice a problem with its IVF culture media. In November and December of 2023, the company received reports from embryologists in Maine and around the country that embryos were failing to develop past the zygote, or fertilized egg, stage when CooperSurgical's IVF culture media was used. By mid-December, based on this pattern of reports, the company quietly issued its IVf culture media recall to clinics in Maine and elsewhere that had made use of this defective product.
In damage-control mode, CooperSurgical notified fertility clinics of its IVF embryo solution recall. The recall notice asked clients in Maine to stop using three lots of the IVf culture media and requested the defective product be sent back for a refund. No information about communicating with patients in Maine was included in the CooperSurgical culture media recall. This is surprising given that CooperSurgical claims individuals and couples who are struggling to conceive are at the heart of their mission. It was not until the FDA issued a Class 2 Global Medical Device Recall for CooperSurgical IVF culture media in February of 2024 that Maine residents became aware of the problem.
It is no surprise that Maine individuals who lost embryos as a result of the defective embryo solution would be devastated. What is shocking is that a company that claims to have individuals suffering from infertility at the heart of its mission would so callously avoid communication about its mistakes. Individuals and couples who lost one or more embryos in Maine are now filing claims against CooperSurgical to recover compensation for damages. For some Maine residents, the promise of holding CooperSurgical accountable matters more than the potential for compensation.
Our attorneys serving Maine residents specialize in holding large corporations accountable when they've placed profits ahead of safety. Through settlements and winning verdicts, our attorneys have obtained millions for our clients. Let us help you today.
Filing a lawsuit will allow you to hold CooperSurgical accountable for the loss of your embryos, while also providing real compensation for the emotional anguish and costs associated with your loss. Contact us today for a free consultation.