For the fertility patients whose embryos were destroyed at an Alabama clinic, the conditions must have been shocking. Somehow, a patient at the hospital that housed the clinic had wandered into a warehouse, pulled the embryos from a tank of liquid nitrogen, and then dumped them on the floor—probably because the tank was kept at minus 360 degrees.
The strange episode was the focus of lawsuits filed by three families that eventually reached the Alabama Supreme Court. On Friday, a panel of judges ruled that embryos destroyed at the clinic should be considered children under state law, a decision that shocked the fertility industry and raised urgent questions about how treatments could proceed in the state.
But the accident at the Alabama clinic echoes a pattern of serious mistakes that occur all too often during fertility treatment, a fast-growing industry with little government oversight, experts say. From January 2009 to April 2019, patients filed more than 130 lawsuits over damaged embryos, including cases where the embryos were lost, mishandled or stored in freezer tanks that went bad.
Those mistakes have taken on new weight as the anti-abortion movement aims to extend “personhood” to embryos and fetuses conceived through IVF, claiming they are “unborn children” and bringing cases to an increasingly polarized justice open to review the idea .
“When things go wrong with IVF, it opens a window for this kind of strategy,” said Sonia Suter, a law professor at George Washington University who has studied IVF litigation. “To the extent that there is little regulation, it provides an opportunity to advance the personality agenda.”
Denise Burke, senior counsel for the Alliance Defending Freedom, which opposes abortion rights, called the Alabama decision “a huge victory for life” that protected “unborn children created through assisted reproductive technology.”
“Regardless of the circumstances, all human life is precious from the moment of conception,” Ms Burke said in a statement.
Patients often go to court when fertility treatment goes wrong, leaving judges to decide what clinics owe in situations where emotional, physical and financial losses are at stake. Lawsuits against clinics typically allege that negligence led to the destruction of the embryos.
But in lawsuits against the clinic, the Alabama Center for Reproductive Medicine, the couples who lost the fetuses took a different tack, arguing that the accident resulted in wrongful death under state law.
One couple’s complaint described the embryos as “cryopreserved fetal human beings” and argued that the warehouse should be considered a day care, which state regulations require to be “secured and closely guarded,” because “small children, including fetuses , they cannot protect themselves.”
The state Supreme Court agreed, ruling that plaintiffs could pursue a wrongful-death claim on behalf of an embryo, a fertilized egg that has been developing for five or six days before being transferred to a patient or stored in tanks of liquid nitrogen.
“The text of the wrongful death of a trifle is sweeping and without reservation,” wrote Alabama Supreme Court Justice Jay Mitchell, referring to the state law. “Applies to all children, born and unborn, without limitation.”
Attorneys for the Alabama Center for Reproductive Medicine did not respond to a request for comment.
More than 2 percent of babies born in the United States each year are conceived using assisted reproductive technology. In 2021, more than 97,000 babies were born after IVF
While clinics in the United States do not report the number of embryos they store, an often-cited RAND Corporation study from 2002 (when IVF was much less common) estimated that nearly 400,000 embryos were frozen in reservoirs across the country.
Experts who study the fertility industry said they weren’t surprised to see the Alabama clinic operating with lax safeguards, as are many clinics.
“This kind of case surprises me zero,” said Dov Fox, director of the Center for Health Policy and Bioethics at the University of San Diego School of Law. “This is a completely preventable outcome.”
One of the largest malpractice cases to date involved the failures of two large embryo freezer tanks — one in California and another in Ohio — that each destroyed thousands of eggs and embryos.
In the Ohio case, the clinic admitted to turning off an alarm system that should have alerted staff members that the tank was no longer working. More than 4,000 fetuses were destroyed.
An affected couple who sued sought to make a personality argument, arguing that “a person’s life begins at conception.” The case was eventually settled out of court.
“That’s been an ongoing debate — is that property, is that a person, or is that something special that’s not one of those things?” Dr. Suter said about frozen embryos.
More recently, eight couples filed lawsuits against the medical device company CooperSurgical, alleging that a liquid the company produces, which is intended to help fertilized eggs grow into embryos, was defective and caused their embryos to stop growing.
Collectively, patients say they lost more than 100 embryos that were bathed in the inappropriate product. Experts estimate that thousands more patients may have been infected. The company declined to comment.
Other lawsuits have been more similar to the Alabama case, brought by families who claim that an act of negligence led to the destruction of their embryos. One case involved an embryo that was thawed so that it could be transferred to a patient’s uterus, but was subsequently lost. In another, a shipping company opened a package containing frozen embryos for inspection, accidentally allowing them to thaw.
“These are not diversions,” said Mr. Fox, who noted that the first IVF lawsuit, filed in 1995, involved two Rhode Island couples whose clinic had lost nine of their embryos.
It is difficult to know how often embryos are accidentally destroyed during fertility treatment because, unlike countries such as Britain, which has a health service dedicated to overseeing IVF, no regulator or government body monitors these information in the United States.
While federal rules require hospitals to report and track serious errors, fertility clinics are not subject to those requirements. They report some data to the government, such as how many patients they see and the pregnancy success rates of their patients, but not accidents or errors.
Many mistakes don’t even end up in court because some clinics have patients sign contracts that require them to use private arbitration. “This keeps everything secret and minimizes public awareness of the scope of the problems,” said Sarah London, a San Francisco attorney who specializes in fertility litigation.
Professional guidelines for the safe storage of frozen embryos are relatively rare. The American Society for Reproductive Medicine’s 2022 guidance, published after the Alabama accident, says IVF labs should have “the ability to restrict access through reader tags or a similar method.” It does not require laboratories to constantly lock their doors or secure their freezer tanks.
In Alabama, “a stranger chose to open the tank and look and see what was in it and take it out,” said Amy Sparks, director of the in vitro fertility lab at the University of Iowa and former president of the Society for Assisted Reproductive Technology. .
“It’s a tragedy that it wasn’t adequately secured and it clearly brings everyone’s attention, including mine.”
Dr. Sparks, who has given presentations on fertility lab safety and toured clinics around the country, said it would not be unusual for a clinic to sometimes leave the door unlocked to store embryos.
Lab workers constantly carry tilted shoebox-sized containers filled with liquid nitrogen. They may sometimes open a door rather than risk coolant spilling on their hands, he said.
Even advanced monitoring systems such as those installed by Dr. Sparks in the freezer tanks to monitor temperature and liquid nitrogen levels, would not have alerted staff quickly enough to prevent the problem in Alabama.
Other problems that harm embryos can occur in routine medical practice, Dr. Sparks said, such as an embryo sticking to the side of a pipette or a biopsy that goes wrong.
The new decision in Alabama could raise the stakes for fertility providers across the country, he added.
“I’m very concerned for patients and care providers in Alabama, but it’s not necessarily going to be confined to the borders of that state,” said Dr. Sparks, who is based in Iowa, where he performed a six-week abortion. the ban is being challenged in the courts.
By Friday, three fertility clinics in Alabama — including the clinic being sued — had announced they were halting IVF procedures, citing the new ruling.
