A Virginia couple is suing a scandal-hit IVF company, alleging that its defective freezing fluid destroyed their embryos and ruined their dreams of becoming biological parents.
Kearsten and Zachary Walden, both 39, filed a lawsuit against CooperSurgical on Thursday, making them the eighth American family to do so in two months.
It is unclear exactly how many patients have been affected, but experts estimate it is in the thousands.
The Connecticut-based company is also facing a scandal in the United Kingdom over claims that its freezing liquid was missing a key ingredient that prevented embryos from developing.
The Waldens spent a decade desperately trying to conceive before starting IVF in the fall of 2023.
On Thanksgiving morning they were given the devastating news that their six healthy embryos had suddenly stopped growing, leaving them unusable.
Kearsten and Zachary Walden spent a decade desperately trying to conceive before starting IVF in the fall of 2023.
Thousands of women are believed to be affected, a significant proportion in the United States.
The Waldens, of Norfolk, Virginia, adopted their son six years ago, but were delighted to see that Mr. Walden’s health insurance plan had begun offering fertility coverage.
The couple received an initial round of treatment that provided them with six fertilized eggs.
They were feeling hopeful, they told the New York Times, until they received a call on Thanksgiving morning informing them that all the embryos had stopped developing.
Mrs Walden, 39, said: “I blamed myself a lot for being older.”
In January, the clinic told her they had used the defective CooperSurgical solution on her embryos.
The fluid is believed to be lacking magnesium, which is necessary for embryo growth.
The mineral plays a vital role in nerve and muscle function and helps the baby develop strong teeth and bones.
“It was a rollercoaster of emotions,” Mrs. Walden said. ‘It was, wait a minute, so we’re not to blame or to blame. So it was, ‘How does something like this happen?’
Sarah London, a partner at Lieff Cabraser Heimann & Bernstein, who represents the Waldens, said: “The combination of lax regulations and the enormous profit potential of hopeful parents makes fertility a perfect space for corporations to cut corners and prioritize to its shareholders”.
‘Unfortunately, the Waldens and many others are paying the price for CooperSurgical’s focus on profits over safety.
“Our firm has held fertility corporations accountable before, and we hope to shine a light on 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 television 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 worldwide, supplies liquid used by fertility clinics around the world to freeze eggs and embryos as part of IVF treatment.
Federal regulators this week announced CooperSurgical’s recall of three lots of the liquid, known as culture media, that had been used by clinics in November and December.
Grieving parents-to-be undergoing fertility treatment claimed embryos they hoped would become their children failed to grow because the liquid they were placed in lacked a key nutritional ingredient.
The Waldens’ lawsuit claims that all three batches of media lacked a key ingredient, magnesium, meaning the liquid prevented embryos from developing and ultimately made them unviable.
Another lawsuit involved a Los Angeles couple who lost 34 embryos due to contaminated fluid.
The couple dreamed of becoming parents for years and even sold their car to pay for fertility treatments.
Their 34 embryos had been developing perfectly, only to be told by the clinic that they had all inexplicably stalled.
In total, the couples have lost more than 100 embryos that remained in the extinct liquid.
On Wednesday, the FDA issued a recall notice for nearly 1,000 bottles of culture media, about half of which were purchased by clinics in the United States.
The company notified clinics on Dec. 13, he said, warning them that “performance issues may lead to poor embryo development” and ordering customers to stop using the product.
CooperSurgical, whose parent company made nearly $1 billion in revenue last year in the United States, of which more than 40 percent came from its fertility services.
IVF is one of several 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 odds of successful IVF decline rapidly as women age, from 32 percent for women under 35 to just four percent for women over 44, decreasing by about six or seven percent for every two year old.
The procedure costs between $12,000 and $14,000 per cycle in the United States.