In a devastating turn of events, a couple’s dreams of parenthood were shattered when they lost all their embryos during in vitro fertilization (IVF). The mysterious culprit? A recalled solution used for embryonic growth. As legal battles unfold, questions arise about the rights of families, the definition of embryos, and the responsibilities of fertility clinics.
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 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 lawsuits says the solution was missing a key ingredient for embryonic growth: Magnesium.
CooperSurgical, the company that makes the solution, 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.
The Waldens’ heartbreaking experience sheds light on the delicate balance between hope and tragedy in the world of IVF. As families grapple with loss, legal battles, and unanswered questions, the IVF industry faces scrutiny and the need for clearer regulations. For Kearsten and Zach, the dream of parenthood remains elusive, but their fight for justice continues.
Disclaimer: The information provided in this article is based on available facts and legal developments as of the publication date. Readers are encouraged to consult legal professionals and stay informed about any updates or changes related to IVF and fertility treatments.