Thursday, April 25

Fertility clinic errors collide with a redefinition of the “person”

For fertility patients whose embryos were destroyed at an Alabama clinic, the circumstances must have been shocking. Somehow, a patient at the hospital hosting the clinic had entered a storage room, removed 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 eventually reached the Alabama Supreme Court. On Friday, a jury ruled that embryos destroyed at the clinic should be considered children under state law, a decision that sent the fertility industry into shock and raised urgent questions about how treatments might eventually proceed in the state.

However, experts say the incident at the Alabama clinic echoes a pattern of serious errors that occur too frequently in fertility treatment, a fast-growing industry with little government oversight. From January 2009 to April 2019, patients filed more than 130 lawsuits over destroyed embryos, including cases in which embryos were lost, mishandled or stored in freezing tanks that ruptured.

These errors have taken on a new gravity as the anti-abortion movement seeks to extend “personhood” to fetuses and embryos conceived through in vitro fertilization, claiming that they are “unborn children” and subjecting cases to a judicial increasingly polarized and open to considering 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 controversies. “To the extent that there is little regulation, this provides an opportunity to advance the personhood agenda.”

Denise Burke, senior counsel at the Alliance Defending Freedom, which opposes abortion rights, called Alabama’s decision “a stunning victory for life” that protected “unborn children created through reproductive technology assisted”.

“No matter the circumstances, all human life is precious from the moment of conception,” Ms. Burke said in a statement.

Patients often turn to the courts when fertility treatment goes awry, leaving judges to decide what clinics owe in situations where emotional, physical and financial losses are at stake. Lawsuits against the clinics typically allege that negligent behavior led to the destruction of the embryos.

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

One couple’s complaint described the embryos as “cryopreserved embryonic human beings” and argued that the warehouse should be viewed as a nursery, which state regulations require to be “protected and closely guarded,” because “young children, including embryos, they cannot protect themselves.”

The state Supreme Court agreed, ruling that plaintiffs could bring a wrongful death lawsuit 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 statute is broad and unqualified,” Alabama Supreme Court Justice Jay Mitchell wrote, referring to the state law. “It applies to all children, born and unborn, without limitations.”

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

More than 2% of children born each year in the United States are conceived with assisted reproductive technologies. In 2021, more than 97,000 babies were born after IVF

Although clinics in the United States do not report the number of embryos they store, an oft-cited RAND Corporation study from 2002 (when in vitro fertilization was much less common) estimated that nearly 400,000 embryos were being frozen in tanks across the country.

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

“These types of cases 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 failures of two large embryo freezing 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 was supposed to alert staff that the tank was no longer working. More than 4,000 embryos were destroyed.

One interested couple who filed the lawsuit attempted to argue personhood, arguing that “a person’s life begins at the moment of conception.” The case eventually settled out of court.

“There has been an ongoing debate: Is this a property, a person, or something special that is none of those things?” Dr. Suter said about frozen embryos.

More recently, eight couples filed a lawsuit against the medical device company CooperSurgical, alleging that a liquid made by the company, intended to help fertilized eggs turn into embryos, was defective and prevented the embryos from developing.

Overall, patients say they lost more than 100 embryos that had been immersed in the substandard product. Experts estimate that thousands of other patients may have been affected. The company declined to comment.

Other lawsuits have been more similar to the Alabama case, brought by families who claimed that a negligent act led to the destruction of their embryos. One case involved an embryo that had been thawed so it could be transferred to a patient’s uterus, but was then lost. In another, a shipping company opened a package containing frozen embryos for inspection, inadvertently letting them thaw.

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

It’s difficult to know how often embryos are inadvertently destroyed during fertility treatment because, unlike countries like Britain, which has a health agency dedicated to overseeing IVF, no regulator or government body keeps track of such information in the United States.

While federal regulations require hospitals to report and track serious errors, fertility clinics are not subject to such requirements. They report some data to the government, such as the number of patients they see and their patients’ pregnancy success rate, but not accidents or errors.

Many mistakes don’t even make it to court, because some clinics make patients sign contracts requiring 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 lawyer who specializes in fertility disputes.

Professional guidelines on how to safely store frozen embryos are relatively scarce. The American Society for Reproductive Medicine’s 2022 guidance, released after the Alabama incident, states that IVF labs should have “the ability to restrict access via badge readers or similar methods.” It does not force laboratories to constantly close doors or protect freezer tanks.

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

“It is a tragedy that it was not properly protected and clearly brings this to everyone’s attention, including mine.”

Dr. Sparks, who has given presentations on fertility lab safety and visited clinics across the country, said it would not be unusual for a clinic to sometimes leave the door open for embryo storage.

Lab workers constantly carry shoebox-sized containers full of liquid nitrogen. Sometimes they might open a door rather than risk having the freezing liquid spilled onto their arms, he said.

Even advanced monitoring systems, like those Dr. Sparks installed in her freezing tanks to monitor temperature and liquid nitrogen levels, would not have alerted staff quickly enough to prevent the problem in Alabama.

Other problems that damage embryos can crop up in routine medical practice, Dr. Sparks said, such as an embryo sticking to the side of a pipette or a biopsy that doesn’t fit.

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

“I’m very concerned about patients and health care workers in Alabama, but the problem won’t necessarily be limited to the borders of that state,” said Dr. Sparks, who lives in Iowa, where a six-week abortion ban has been challenged in court.

On Wednesday, the University of Alabama at Birmingham Health System announced it would suspend all IVF treatments aside from egg retrieval while it evaluates the possible liability of continuing to do so.