A Virginia couple has sued a scandal-hit IVF company, claiming defective freezing fluid destroyed their embryos and ruined their dreams of becoming birth parents.
Kearsten and Zachary Walden, both 39, filed a lawsuit against CooperSurgical on Thursday, becoming the eighth American family to do so in two months.
It is not clear exactly how many patients are affected, but experts estimate it to be thousands.
The Connecticut-based company is also facing scandal in Britain over claims that its freezing fluid was missing a key ingredient that prevented embryos from developing.
The Waldens endured a decade of desperate attempts to conceive before starting IVF in the fall of 2023.
On Thanksgiving morning, they received the devastating news that all six healthy embryos had suddenly stopped growing, rendering them useless.
Kearsten and Zachary Walden endured a decade of desperate attempts to conceive before beginning IVF in the fall of 2023
Thousands of women are believed to be affected, with a significant proportion in the US.
The Waldens, from Norfolk, Virginia, adopted their son six years ago but were ecstatic when they saw that Mr. Walden’s health insurance plan began offering fertility coverage.
The couple underwent an initial round of treatment that gave them six fertilized eggs.
They were hopeful, they told the New York Times, until they received a phone call on Thanksgiving morning informing them that all the embryos had stopped developing.
Mrs Walden, 39, said: ‘I’ve really blamed myself for being older.’
In January, the clinic told her they had used the defective CooperSurgical solution on her embryos.
The fluid is thought to lack magnesium, which is necessary for the growth of the embryo.
The mineral plays a crucial role in nerve and muscle function and helps a baby build strong teeth and bones.
“It was a roller coaster of emotions,” Ms Walden said. “It was, wait a minute, so it’s not our fault, it’s not our fault. Then it was: how could something like this happen?’
Sarah London, partner at Lieff Cabraser Heimann & Bernstein, which represents the Waldens, said: ‘The combination of lax regulation and the huge potential for profits from hopeful parents makes fertility a perfect space for companies to cut back and prioritize their shareholders.
“Unfortunately, the Waldens and too many others are paying the price for CooperSurgical’s focus on profit over safety.
“Our company has held fertility companies accountable before, and we look forward to calling attention to CooperSurgical for the irreparable harm and pain they have caused.”
CooperSurgical, an American pharmaceutical giant based in Connecticut, is at the center of the fertility scandal
CooperSurgical, which previously worked with model and TV personality Chrissy Teigen, is facing lawsuits over a type of solution used to help embryos grow.
The company, one of the largest of its kind in the world, supplies fluid used by fertility clinics around the world to freeze eggs and embryos as part of IVF treatment.
Federal regulators this week issued CooperSurgical’s recall of three lots of the liquid, known as culture media, used by clinics in November and December.
Grieving parents-to-be undergoing fertility treatment claimed that embryos they hoped would become their children failed to grow because the fluid they were placed in lacked a key nutritional ingredient.
The Waldens’ lawsuit alleges that the three groups of media lacked a key ingredient: magnesium, meaning the fluid prevented the embryos from developing and ultimately made them unviable.
Another lawsuit involved a Los Angeles couple who lost 34 embryos as a result of the contaminated fluid.
The couple dreamed of becoming parents for years and even sold their car to pay for fertility treatments.
Their 34 embryos developed perfectly, but the clinic told them they had all inexplicably stalled.
In total, the couples lost more than 100 embryos stored in the defunct fluid.
On Wednesday, the FDA issued a recall for nearly 1,000 bottles of culture media, about half of which were purchased by clinics in America.
The company notified clinics on Dec. 13, it said, warning them that “performance issues may lead to impaired embryo development” and advising customers to stop using the product.
CooperSurgical, whose parent company raked in nearly $1 billion in revenue in America last year, more than 40 percent of which came from its fertility services.
IVF is one of many fertility treatments available to conceive a baby. During the process, an egg is removed from the ovaries and fertilized with sperm in a laboratory. This embryo is then implanted into the woman’s uterus to grow and develop.
The chance of successful IVF decreases rapidly as women age, from 32 percent for women under 35 to just four percent for women over 44, declining by about six to seven percent every few years.
The procedure costs between $12,000 and $14,000 for one cycle in the US.