Infertility is a widespread issue affecting millions worldwide, not only individuals but also their families. Statistics indicate that roughly one in six people of reproductive age struggle with infertility.
For many couples, in vitro fertilization (IVF) emerges as either their last resort or their sole option for realizing their dream of parenthood. Placing their trust in safe and effective fertility treatments, these couples invest hope and resources into the IVF process.
What happened when their hope was disrupted by negligence?
Lawsuits emerge…
Let’s explore the IVF process, the negligence of a leading medical device company, which devastated many women’s dreams, and how to file a CooperSurgical IVF lawsuit.
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In Vitro Fertilization: What is it?
In vitro fertilization is referred to as IVF. It’s among the forms of assisted reproductive technology (ART). IVF works by assisting sperm in fertilizing an egg and assisting the fertilized egg in implanting in the uterus through a combination of medication and surgical techniques.
Currently, IVF stands as the most successful fertility procedure. IVF success rates are influenced by various factors, including the source of the eggs (whether from the intended parent or donated), the timing of egg extraction (before or after fertilization), and the age of the parents or donors, with age being the most significant factor.
Data from the Society for Assisted Reproductive Technology indicates that approximately 44% of egg retrievals result in live births for patients under 35, while this figure decreases to 20% for individuals aged 38 to 40.
Process of In Vitro Fertilization
An IVF process consists of several stages, each with distinct procedures. The five main steps of the IVF process are:
Ovarian Stimulation: Fertility medications are prescribed to stimulate egg production, which is monitored by ultrasound and hormone tests. Healthcare providers assess the size and number of ovarian follicles, which contain the developing eggs. Follicle size indicates egg maturity, with those over 14mm likely containing mature eggs.
Egg Retrieval: Eggs are retrieved through a minor surgical procedure guided by ultrasound, with medication to manage discomfort.
Sperm Collection: The male provides a sperm sample, which is prepared for fertilization.
Fertilization: Sperm and eggs are combined in a laboratory dish for fertilization, with options like ICSI if needed. Fertilized eggs are monitored as they develop into embryos. Around 50% of fertilized embryos advance to the blastocyst stage, which is optimal for uterine transfer.
Embryo Transfer: Embryos are transferred into the woman’s uterus, typically 3 to 5 days after fertilization. The procedure is usually painless, with implantation expected within 6 to 10 days.
Role of Culture Media in IVF
Culture media play a vital role in the IVF process, serving as a solution used by embryologists to nurture cell growth from fertilization through implantation. Designed to replicate the natural environment of the developing embryo, these media mimic the composition of fluids found in the oviduct and uterus.
Comprising a basic salt solution supplemented with essential components like carbohydrates (such as pyruvate, lactate, and glucose) and amino acids, culture media provide the primary energy sources for embryo development.
Immersed in this medium, fertilized eggs undergo crucial developmental stages. Any slight deviations in pH, nutrient levels, or the presence of contaminants can potentially harm or even destroy the delicate embryos.
The success of the IVF process can be greatly impacted by the culture medium used in the procedure.
CooperSurgical Company
CooperSurgical Inc., is a leading provider of supplies for IVF and reproductive clinics around the world. Founded in 1990 and headquartered in Trumbull, Connecticut, it is dedicated to women’s health and fertility solutions.
CooperSurgical is a leader in Assisted Reproductive Technology (ART) media, offering various products like vitrification solutions, reproductive genetic testing kits, and IVF culture oils.
Beyond fertility, they offer a broad range of solutions for various women’s health needs, encompassing contraception, general gynecological care, and surgical gynecology.
CooperSurgical is recognized as a pioneer in the industry, developing technologies that have impacted how women, babies, and families receive care. Their mission statement emphasizes putting “time on the side of women, babies, and families at the healthcare moments that matter most in life.”
However, it’s important to note that CooperSurgical has also faced recent IVF lawsuits related to claims of destroyed embryos due to a product they manufacture.
CooperSurgical Media Recall
On December 5, 2023, CooperSurgical issued an urgent recall concerning its LifeGlobal global® Media. This embryo culture media recall arose after clinical embryologists noticed unusual statistical patterns, with few or no on-site embryos developing properly. Instead of directly notifying individuals, recall letters were sent to fertility clinics.
On February 14, 2024, the FDA posted a global recall of medium on behalf of CooperSurgical, listing specific batch numbers of the global culture media mentioned below:
- LGGG-020: UDI-DI 00815965020044, lot 231020-018741
- LGGG-050: UDI-DI 00815965020051, lot 231020-018742
- LGGG-100: UDI-DI 00815965020068, lot 231020-018743
CooperSurgical conducted a “quiet recall,” notifying clinics without informing fertility patients promptly. They stated that certain culture media batches lacked the necessary magnesium concentration for proper embryo development.
Physicians and couples who had used these affected products during IVF treatments reported unexpected outcomes, with embryos either ceasing growth or becoming nonviable shortly after creation.
CooperSurgical’s subsequent investigation suggested that the observed issues were likely due to reduced magnesium levels in the culture medium. Lower magnesium levels could impact embryo development, potentially preventing embryos from reaching the blastocyst stage.
CooperSurgical IVF Lawsuit 2023
The first IVF lawsuit was filed on December 14, 2023, by a Los Angeles couple against CooperSurgical companies. The lawsuit alleges that CooperSurgical provided contaminated media to reproductive clinics, resulting in the death of numerous human embryos.
There were 34 embryos belonging to the couple that developed successfully after years of trying. The couples longed to become parents and had sacrificed financially for IVF. The clinic then informed them that there was an unexplained halt to the embryos’ development.
The lawsuit alleges that CooperSurgical produced, advertised, and sold their embryo culture media under the pretense that they had undergone superior testing—such as a mouse embryo assay—to guarantee that there would be no embryotoxic exposure.
Allegations against CooperSurgical
- Manufacturing defect
- Design Defect
- Failure to warn
- Gross negligence
- Negligence failure to recall
- Unjust enrichment
Virginia Couple Sues over Defective IVF Solution
On February 15, 2024, a Virginia couple filed a IVF solution lawsuit against one of the world’s most profitable medical companies, CooperSurgical.
Kearsten and Zach Walden, both 39, discovered they were among many couples affected by a defective IVF solution from CooperSurgical. This solution, responsible for embryonic growth, was recalled after Walden lost their embryos.
The discovery of this defect came as a devastating shock to the couple, who initially blamed themselves for the unsuccessful outcomes. In response, Kearsten and Zachary filed a lawsuit against CooperSurgical.
Allegations in their CooperSurgical lawsuit include:
- Manufacturing Defect
- Design Defect-Consumer Expectations Test
- Design Defect-Risk-Utility Test
- Failure to Warn
- Gross Negligence
- Negligent Failure to Recall
- Trespass to Chattels
- Unjust Enrichment
CooperSurgical Incorporated is currently facing eight lawsuits related to the flawed liquid IVF product.
Legal experts doubt a recent Alabama Supreme Court ruling on IVF embryos will directly impact these lawsuits. However, it may lead to new cases, such as wrongful death suits, especially in Alabama. Some of the defective solution was delivered to clinics in Alabama, as per the FDA.
Alabama Supreme Court Ruling on Embryos
On February 16, 2024, the Alabama Supreme Court ruled that under state law, frozen embryos can be considered children. This ruling came from cases where couples sued due to the destruction of their frozen embryos at a fertility clinic.
Alabama lawmakers have passed laws to ensure IVF treatments remain accessible following a state Supreme Court ruling that categorized frozen embryos as children, causing nationwide concern.
This bill aims to protect those offering in vitro fertilization (IVF) services from being sued or criminally charged, unless their actions are intentional and unrelated to IVF. It will apply to past cases as well and will be in effect until June 1, 2025.
The legislation, which aims to protect doctors from civil and criminal liabilities related to the discarding of unused embryos, has received strong support. This move comes after several IVF clinics in Alabama paused treatments due to fears of legal repercussions.
The legislation is expected to be signed into law by Governor Kay Ivey soon, providing reassurance to doctors and allowing the resumption of IVF treatments without legal risks.
Lawsuit Blames CooperSurgical for IVF Embryo Loss
Major medical supply company CooperSurgical is dealing with a flurry of lawsuits from patients alleging that one of its products killed in vitro fertilized babies.
On February 21, 2024, a married Illinois couple sued CooperSurgical, Inc. and The Cooper Companies, Inc. in the Northern District of California. According to the embryo loss lawsuit, CooperSurgical—a company that produces, distributes, and advertises products to reproductive clinics—sold faulty culture material intended to promote the development and growth of embryos produced by in vitro fertilization.
Nine of the couple’s embryos are said to have been killed or harmed during the IVF process due to a faulty culture medium. The plaintiffs are seeking compensation, equitable relief, and other forms of remedies from the defendants.
Numerous families have sued over IVF-related losses, indicating broader concerns within the industry.
Wylie Couple Suing CooperSurgical
A couple from Wylie, Texas, had embarked on their IVF journey with hopes of starting a family, only to face devastating news when they discovered that 19 of their embryos had been destroyed.
The liquid culture medium, intended to support the growth of fertilized eggs into viable embryos, instead led to the destruction of their hopes and dreams.
On February 28, 2024, the couple filed a lawsuit against the fertility company. The lawsuit claimed that the company advertised that their medium offered “an optimized in vitro environment,” which is a requirement for the survival of fertilized human eggs and the development of viable embryos for implantation.
The CooperSurgical IVF lawsuit identifies the most likely cause as a CooperSurgical recalled solution that was lacking in magnesium, an essential mineral.
The current incident fits into a bigger pattern; incidents like this have been documented in Canada and the United States.
CooperSurgical and IVF Solution Failures
CooperSurgical is accused of distributing defective IVF solutions, potentially causing embryos to fail unexpectedly. This is financially and emotionally taxing for families undergoing IVF, especially considering the demanding procedures involved.
Women may need to repeat the process, which is costly and time-consuming, potentially affecting their chances of success due to the limited number of eggs and the natural aging process.
The emotions that arise when someone finds out that their chances of becoming parents were lost due to a large corporation’s failure to notify the public on time about the faulty embryo culture media are unimaginable.
Filing a claim against CooperSurgical may be necessary to seek accountability if you experienced a nonviable pregnancy due to their defective product.
How to File CooperSurgical IVF Lawsuit?
You might be able to file a lawsuit against CooperSurgical if your doctors utilized one of the recalled product during your IVF procedure and your treatment didn’t work out. In addition to compensation for all losses brought on by a botched treatment plan, victims may also seek compensation for the loss of their priceless embryos.
Seek legal advice from an attorney experienced in product liability and medical malpractice cases. They can evaluate your situation, determine if you have a valid claim, and guide you through the legal process.
Collect any relevant documentation related to your IVF treatment, including medical records, receipts, correspondence with the fertility clinic, and any information about the defective product.
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Throughout this process, it’s essential to work closely with your attorney, follow their guidance, and stay informed about the progress of your case.
To conclude
The consequences of embryo loss on affected families are profound. Individuals invest a lot of money and have emotional hope in IVF procedures, often representing their only chance at parenthood.
The destruction of embryos not only results in substantial financial loss but also shatters their expectations and inflicts emotional trauma.
Remember, you are not alone; seek justice for your loss. Through your courage and determination, you have not only sought justice for yourselves but have also paved the way for a safer future in fertility treatments.
