The tears were automatic. Kearsten Walden couldn’t hold them back when the doctor called on Thanksgiving morning to say she’d lost the last of her six embryos.
She’d already experienced so much loss during a long journey with infertility.
Doctors couldn’t tell the Norfolk, Virginia woman what went wrong. Kearsten and her husband Zach, both 39, later learned they were not alone, other couples undergoing in vitro fertilization (IVF) at the same fertility clinic had also inexplicably lost their embryos.
The couple was later told the culprit was a solution used to facilitate embryonic growth, which manufacturers voluntarily recalled in December – after the Waldens lost their embryos.
The Waldens have joined a growing list of families suing CooperSurgical, the company that makes the solution.
CooperSurgical offered the Waldens a reimbursement through the clinic, but Kearsten considered that “a Band-Aid for a bullet hole.”
The company says it is investigating the impact of the recalled solution, according to a statement shared with USA TODAY. Officials did not respond to a request for comment on the lawsuits.
The broader picture, in terms of the rights of families like the Waldens, remains unknown. The monumental Alabama Supreme Court ruling this month that found embryos from IVF are “extrauterine children” likely won’t impact the CooperSurgical suits, legal experts said. But families who sued the solution manufacturer could pursue new legal avenues, including wrongful death suits in the wake of that ruling – especially in Alabama.
Some of the affected solution, known as “culture media” was delivered to clinics in Alabama, according to a notice from the Food and Drug Administration.
The ruling could alter everyday operations of IVF clinics, said Sonia Suter, a law professor and founding director of George Washington University’s Law School of Health Law Initiative.
“Once you call a frozen embryo a person, it has a lot of potential implications,” she said.
The suits over the IVF solution also touch on who is responsible for things that go wrong in a fertility clinic, given that the infertility industry operates in a mix of regulated and unregulated spaces.
Adam Wolf, an attorney for two families suing CooperSurgical, believes this patchwork of regulations “clearly led” to the outcome in Alabama.
“The Wild West days of the U.S. fertility industry need to end,” he said. Wolf said he expects, in the wake of the Alabama decision, that courts in other states could rule on a revised definition of embryos if federal officials or industry leaders don’t intervene.
‘Everybody was rooting for us’
The recall of the IVF solution affected three lots distributed to clinics in more than 30 states and over 20 countries, according to the FDA notice this month.
The string of suits says the solution was missing a key ingredient for embryonic growth: Magnesium.
The cause of the embryo loss has been especially gutting, Kearsten Walden said, since there were so many unknown factors at play in IVF. The process of IVF was already fraught. Couples like them go in ready for a variety of possible outcomes, including real loss.
But no one going through IVF would expect the solution, which should be “kind of foolproof,” to affect the outcome, she said. “We need justice for what we’ve been through.”
Fertility experts say this solution, or culture media, plays a pivotal role in the IVF process. After eggs are extracted, sperm is mixed with the eggs in a laboratory to create embryos. The embryos are then submerged in the solution, which contains key nutrients that mimic the fluids in a woman’s reproductive tract.
Embryos typically remain in the laboratory for five days to ensure they’re developing properly before they’re implanted in the uterus. However, the Waldens and other families suing CooperSurgical never got that far.
Kearsten had eight eggs extracted at the clinic and she entered the IVF phase with six embryos. The entire medical team at the facility was “really optimistic,” she recalled. They only needed one of the six embryos to make it through five days.
“Our doctor, embryologists, everybody was rooting for us,” she said. “I wasn’t planning on getting a phone call that we had zero embryos.”
Embryo loss: When IVF fails
IVF outcomes vary widely depending on several factors. Doctors assess the likelihood of success based on whether the eggs belong to the person planning to carry the pregnancy or were donated. They also weigh outcomes based on whether the eggs were extracted before fertilization or frozen. The age of the parents or donors is the most important variable.
About 44% of egg retrievals result in a live birth for patients under 35, according to preliminary data for 2021 published by the Society for Assisted Reproductive Technology. That figure drops to 20% for people between 38 and 40.
Embryonic loss is not uncommon and it’s hard to definitively point to a cause, said John Graves, senior embryologist at Mate Fertility, a network of fertility clinics in California and Oklahoma. It can be due to chromosomal abnormalities or, in many instances, eggs and sperm that just “don’t work well together.”
“It really is on an individual basis,” he said. “It’s hard to say why things happen.”
The tools used for IVF are also so precisely designed that any interruption could result in an unfavorable outcome. The solution could be tainted in the manufacturing process or during transportation, experts said.
Families have sued alleging a range of problems in the IVF process caused their loss during fertility treatment. There were 130 suits by parents whose embryos were frozen, discarded, lost or damaged between 2009 and 2019, according to a 2020 study. But that count may be low. Wolf said he’s represented thousands of hopeful families who had experienced this type of loss.
Officials in the industry note that there are standards that fertility clinics are expected to uphold if they wish to be accredited, although there isn’t across-the-board regulation of the industry.
The American Society for Reproductive Medicine (ASRM) and the College of American Pathologists issue national guidelines through an accreditation program, said ASRM spokesperson Sean Tipton. Accredited clinics are monitored for their adherence to the guidelines, which include the number of embryos that can be transferred, as well as the quality of embryology labs, qualification of staff and data submission to federal agencies.
Wolf, who has brought many suits against fertility operations, said it’s mostly a “toothless” program full of “voluntary” guidelines and he’s seen little consequences for accredited fertility clinics that have failed to follow recommendations.
“Hopefully, the chaos and confusion for fertility patients in Alabama will help motivate federal lawmakers to finally create a system of regulation for this industry,” he said.
Hoping for a happy ending
While the IVF process is highly scientific and increasingly political, Kearsten Walden thinks many people fail to grasp the emotional toll of embryonic loss.
Losing the last of their embryos triggered memories of her last heartbreaking loss six years ago. After the Waldens failed attempt at intrauterine insemination, another form of assisted reproductive technology, the couple decided to pursue adoption.
The process eventually brought them to a small Atlanta hospital waiting room, where they were anxiously awaiting the birth of their child. Their hopes were dashed when they learned the birth parents had decided not to go through with the adoption.
“We were left by ourselves with a baby taken out of our arms,” Zach said. “Here we are, six years later, and it’s the same thing.”
After a decade of struggling with infertility, the Waldens still hope to grow their family. They plan to try IVF again. But this time, their fertility clinic assured them they wouldn’t be using a solution made by CooperSurgical.
“We’ve still got a ways to go (in) completing our family,” Kearsten said. “Hopefully, in our story, there’s a happy ending.”
Source: USA Today February 27 2024
