The journey to parenthood is not the same for everyone. Some women are very fertile and able to get pregnant the first time they have sex. Others may struggle, causing them to take six months or longer. Some couples try for years without any success and are deemed infertile.
While there may be just one natural way to create a baby, there are many other methods for those who are having trouble conceiving. Many couples opt for in vitro fertilization (IVF), which is a process that is fairly successful but requires various steps. In a nutshell, IVF involves the fertilization of an egg by sperm in a laboratory. The fertilized egg, called an embryo, is then transferred to the uterus to establish a pregnancy. IVF is an expensive process that can be physically and emotionally painful.
Sadly, the equipment used to accomplish this pregnancy may be defective, delaying or even ruining a couple’s dreams of having a child. This is what happened to a couple from Georgia. They sought IVF treatment at a clinic in Sarasota, Florida. The device was defective, causing their 16 embryos to be destroyed.
The couple filed a lawsuit in early January. Now, dozens of couples have joined in on the product liability lawsuit, which is suing CooperSurgical over the defective IVF product. At this point, there are individual cases as well as a federal class action lawsuit. The couples are devastated that their embryos — and hopes of having a child of their own — have been destroyed.
CooperSurgical manufactures a product used in the IVF process that helps embryos grow. In December 2023, the product was recalled by the Food and Drug Administration (FDA). According to the lawsuit, 481 bottles of the product were purchased by clinics in the United States. It is believed that as many as 20,000 patients could have had their embryos destroyed by the product.
These cases show a lack of regulation in the fertility industry. It is a fairly new industry, so it is normal to see some sort of lag between their innovation and when regulators start taking a closer example of them. With defective products and devices increasing around the country, more attention needs to be given to this industry.
One couple lost precious time trying to start their family. Most of their embryos were destroyed outright by the defective product. But there were some that grew in ways that would be unhealthy to transfer, so it is a frustrating situation, especially since destroying an embryo is against their religion. They don’t know what to do with the embryo, so it is sitting on ice and the couple is paying for that.
CooperSurgical has responded by filing a separate lawsuit accusing another company of failing to test the product appropriately.
Types of Defects in IVF Products
IVF products and devices can develop defects such as the following:
- Defective embryo culture media. Embryo culture media provide essential nutrients for fertilized eggs to develop into embryos before implantation. If the media are contaminated with bacteria, fungi, or toxic substances, embryos may fail to develop properly. Errors in the formulation, such as incorrect pH balance or missing growth factors, can compromise embryo viability.
- Faulty cryopreservation equipment. IVF clinics rely on liquid nitrogen storage tanks to preserve embryos, eggs, and sperm. If the tanks malfunction, frozen specimens may become non-viable. Cases have arisen where tanks unexpectedly failed, destroying thousands of embryos and leading to emotional distress and legal action. Poorly maintained monitoring systems can also fail to alert clinics of storage failures in time to prevent damage.
- Defective catheters or needles. Catheters and needles used for egg retrieval and embryo transfer must be sterile and precisely manufactured. Defects such as rough edges, improper sizing, or weak structural integrity can cause trauma to the uterine lining, leading to implantation failure or internal injury. Contaminated instruments increase the risk of infections, which can affect reproductive health and future fertility. Poorly designed transfer devices may also reduce embryo survival rates due to stress.
- Hormonal medication issues. Fertility drugs such as gonadotropins and progesterone are critical for stimulating ovulation and preparing the uterus for implantation. Defective medications may have incorrect dosages, improper chemical compositions, or contamination, leading to treatment failure or adverse reactions. Expired or improperly stored drugs may lose potency, affecting hormone levels necessary for successful conception.
Contact Us Today
Product liability cases like this can be devastating. Even though the affected families did not suffer any direct physical injuries, they have to deal with the emotional effects of knowing that their embryos got destroyed and their family plans may be ruined for good.
Contact the Florida lawyers at Brill & Rinaldi, The Law Firm today. We have the experience, dedication, and knowledge to help you prosecute your products liability case. We will work hard to hold the manufacturers liable for their actions. Call (954) 876-4344 or fill out the online form to schedule a consultation today. We have offices in Weston, Coral Gables, and Daytona Beach.