Fertility clinic mistakes clash with redefinition of ‘personality’

For the fertility patients whose embryos were destroyed at an Alabama clinic, the circumstances must have been shocking. Somehow, at the hospital where the clinic was located, a patient had walked into a storage room, removed the embryos from a tank of liquid nitrogen, and then dropped them on the floor – probably because the tank was kept at -360 degrees .

The bizarre incident was at the center of lawsuits filed by three families that ultimately reached the Alabama Supreme Court. On Friday, a panel of judges ruled that the embryos destroyed at the clinic should be considered children under state law, a decision that sent shockwaves through the fertility industry and raised pressing questions about how treatments could potentially proceed in the state.

Still, the accident at the Alabama clinic reflects a pattern of serious errors that are all too common in fertility treatments, a fast-growing industry with little government oversight, experts say. From January 2009 through April 2019, patients spent more than 130 lawsuits on destroyed embryos, including cases where embryos have been lost, mishandled, or stored in freezer tanks that have broken down.

These errors have taken on new gravity as the anti-abortion movement aims to extend “personality” to fetuses and embryos conceived through in vitro fertilization, arguing that they are “unborn children” and to an increasingly polarized judiciary open to considering the idea. .

“If something goes wrong with IVF, it opens the door for this kind of strategy,” said Sonia Suter, a law professor at George Washington University who has studied in vitro fertilization litigation. “To the extent that there is little regulation, it does provide an opportunity to promote the personality agenda.”

Denise Burke, a senior adviser at 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 valuable from the moment of conception,” Ms. Burke said in a statement.

Patients often turn to the courts when fertility treatment goes wrong, leaving judges to decide what clinics are owed in situations involving emotional, physical and financial losses. Lawsuits against clinics typically allege that negligent conduct led to the destruction of embryos.

But in the lawsuits against the clinic, the Alabama Center for Reproductive Medicine, the couples who lost embryos took a different course, arguing that the accident resulted in wrongful deaths under state law.

From one couple complaint described the embryos as “cryopreserved embryonic human beings” and argued that the storage facility should be viewed as a daycare facility, which the regulations require to be “secured and closely monitored” because “small children, including embryos, cannot protect themselves.”

The state Supreme Court agreed, ruling that plaintiffs could bring a wrongful death claim on behalf of an embryo, a fertilized egg that grew for five or six days before being implanted in a patient or stored in tanks of liquid nitrogen .

“The text of the Wrongful Death of a Minor Act is sweeping and unqualified,” Alabama Supreme Court Justice Jay Mitchell wrote, citing state law. “It applies to all children, born and unborn, without disability.”

Attorneys for the Alabama Center for Reproductive Medicine did not respond to a request for comment.

More than 2 percent of children born in the United States each year are conceived using assisted reproductive technology. In 2021, more than 97,000 children were born after IVF

Although clinics in the United States do not report how many embryos they store, an oft-cited RAND Corporation study from 2002 (when IVF was much less common) estimated that nearly 400,000 embryos were frozen in tanks nationwide.

Experts who study the fertility industry said they were not surprised to see the Alabama clinic apparently operating with lax safeguards, as is common in many clinics.

“These kinds of things don’t surprise me at all,” said Dov Fox, director of the Center for Health Policy and Bioethics at the University of San Diego School of Law. “This is a perfectly avoidable outcome.”

One of the largest cases of negligence to date involved the 2018 failure of two large embryo freezing tanks – one in California and one in Ohio – each destroying thousands of eggs and embryos.

In Ohio’s case, the clinic admitted to out-of-network alarm system that should have alerted the staff that the tank was no longer functioning. More than 4,000 embryos were destroyed.

An affected couple who filed a lawsuit tried to make a personality argument, fighting that ‘a person’s life begins at conception’. The case was ultimately settled out of court.

“This has been an ongoing debate: Is this property, is this a person, or is this something special that is not any of these things?” Dr. Suter said about frozen embryos.

More recently, eight couples filed lawsuits against the medical device company CooperSurgical, claiming that a fluid the company makes that is intended to help fertilized eggs develop into embryos was defective and caused their embryos to stop developing .

Collectively, the patients say they have lost more than 100 embryos immersed in the failed product. Experts estimate that thousands of additional patients may be affected. The company declined to comment.

Other lawsuits are more similar to the Alabama case, brought by families who claim an act of negligence led to the destruction of their embryos. One case involved an embryo that was thawed so it could be replaced in a patient’s uterus, but was subsequently lost. In another case, a shipping company opened a package of frozen embryos to inspect them and accidentally left them to thaw.

“These are not anomalies,” said Mr. Fox, noting that the first-ever IVF lawsuit filed in 1995involved two Rhode Island couples whose clinic had lost their nine embryos.

It is difficult to know how often embryos are accidentally destroyed during fertility treatment because, unlike countries such as Britain, that is a health agency dedicated to overseeing IVF, no regulator or government agency tracks that information in the United States.

Although federal regulations require hospitals to report and detect serious errors, fertility clinics are not subject to these requirements. They do report certain data to the government, such as the number of patients they see and the pregnancy success rate of their patients, but no accidents or errors.

Many errors don’t even make it to court because some clinics make patients sign contracts requiring them to use private arbitration instead. “That keeps everything secret and minimizes public awareness of the magnitude of the problems,” says Sarah London, a San Francisco attorney who specializes in fertility disputes.

There are relatively few professional guidelines for the safe storage of frozen embryos. The 2022 American Society for Reproductive Medicine guidelines, published after the Alabama incident, state that IVF labs “should have the ability to restrict access through badge readers or a similar method.” It does not require laboratories to consistently lock their doors or secure their freezer tanks.

In Alabama, “a stranger chose to open the tank and see what was inside and take it out,” said Amy Sparks, director of the in vitro fertility laboratory at the University of Iowa and past president of the Society for Assisted Reproductive technology.

“It’s a tragedy that it wasn’t adequately secured and it brings it clearly to everyone’s attention, including me.”

Dr. Sparks, who has given presentations on the safety of fertility labs and visited clinics across the country, said it wouldn’t be unusual for a clinic to sometimes leave the door open to embryo storage.

Laboratory workers are constantly carrying sloshing shoebox-sized containers filled with liquid nitrogen. They might sometimes open a door rather than risk spilling the icy liquid on their arms, she said.

Even advanced monitoring systems, like the one Dr. Sparks installed in its freezer tanks to monitor temperatures and liquid nitrogen levels would not have alerted staff quickly enough to prevent the problem in Alabama.

Other problems that harm embryos can arise in routine medical practice, Dr. Sparks said, such as an embryo sticking to the side of a pipette, or a biopsy that doesn’t go well.

The new ruling in Alabama could raise the stakes for fertility providers across the country, she added.

“I’m very concerned about the patients and providers in Alabama, but it’s not necessarily going to be limited to the borders of that state,” said Dr. Sparks, who lives in Iowa, where six-week abortions are available. ban is being challenged in court.

On Wednesday, the University of Alabama at Birmingham health care system announced it would suspend all in vitro fertilization treatments other than egg retrievals as it weighed the potential risks of continuing to do so.