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Accidents, lax rules and abortion laws now jeopardize the fertility industry


For fertile patients whose embryos were destroyed at an Alabama clinic, the circumstances must have been shocking. Somehow, a patient at the hospital housing the clinic had broken into a storage room, removed the embryos from a tank of liquid nitrogen, then dropped them on the floor – probably because the tank was held at minus 360 degrees.

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

Still, the accident at the Alabama clinic echoes a pattern of serious errors that happen too frequently during fertility treatments, a fast-growing industry with little government oversight, experts say. From January 2009 to April 2019, patients filed more than 130 lawsuits over destroyed embryos, including cases where embryos were lost, mishandled, or stored in freezer tanks that broke down.

These errors have taken on new gravity as the anti-abortion movement aims to extend “personhood” to fetuses and embryos conceived through in vitro fertilization, arguing that they are “unborn children” and by bringing cases before a justice system that is increasingly polarized and open to consideration of this idea. .

“When things go wrong with IVF, it opens a window for this type of strategy,” said Sonia Suter, a law professor at George Washington University who has studied litigation over in vitro fertilization. “To the extent that there is little regulation, this provides an opportunity to promote the personhood agenda. »

Denise Burke, senior attorney for the Alliance Defending Freedom, which opposes abortion rights, called the Alabama ruling “a tremendous victory for life” that protected “unborn children created through assisted reproductive technology.

“Regardless of the circumstances, all human life has value 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 owe in situations where emotional, physical and financial losses are at stake. Lawsuits against clinics typically claim 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 took 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 claimed that the storage room should be considered a daycare, whose regulations required it to be “secure and closely guarded” because “the young children, including embryos, cannot protect them.” 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 transferred to a patient or stored in liquid nitrogen tanks.

“The text of the Wrongful Death of a Minor Act is sweeping and unqualified,” Justice Jay Mitchell of the Alabama Supreme Court wrote, referring to the state law. “This 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 infants born each year in the United States are conceived using assisted reproductive technology. In 2021, more than 97,000 infants were born following IVF

Although U.S. clinics do not report how many embryos they store, a frequently 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 were not surprised to see the Alabama clinic apparently operating with lax safeguards, as is common at many clinics.

“This type of case doesn’t surprise me at all,” said Dov Fox, director of the Center for Health Law Policy and Bioethics at the University of San Diego School of Law. “This is a completely avoidable outcome.”

One of the most significant cases of negligence to date involved the 2018 breakdowns of two large embryo freezing tanks – one in California and another in Ohio – which each destroyed thousands of eggs and d embryos.

In the Ohio case, the clinic admitted to deactivating an alarm system that should have alerted staff members that the tank was no longer working. More than 4,000 embryos were destroyed.

One concerned couple who filed a lawsuit attempted to make the personhood argument, claiming that “a person’s life begins at conception.” The matter was ultimately settled amicably.

“It’s an ongoing debate: Is it a property, is it a person, or is it something special that is neither of those things?” Dr. Suter talked about frozen embryos.

Most recently, eight couples filed lawsuits against the medical device company CooperSurgical, claiming that a liquid made by the company, intended to help fertilized eggs develop into embryos, was defective and prevented their embryos from developing.

Collectively, patients claim to have lost more than 100 embryos that had been bathed in the botched product. Experts estimate that thousands more patients may have been affected. The company declined to comment.

Other lawsuits are more like the Alabama case, brought by families alleging that a negligent act led to the destruction of their embryos. One case involved an embryo that was 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 to inspect it, allowing them to inadvertently thaw.

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

It is 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 regulatory body No regulatory or governmental authority tracks this information in the United States.

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

Many errors don’t even go to court because some clinics make patients sign contracts requiring them to resort to private arbitration. “It keeps everything secret and minimizes public awareness of the extent of the problems,” said Sarah London, a San Francisco attorney who specializes in fertility litigation.

Professional guidelines on how to safely store frozen embryos are relatively scarce. The American Society for Reproductive Medicine’s 2022 guidelines, released after the Alabama crash, state that IVF labs should have “the ability to limit access via badge readers or a similar method.” It does not require laboratories to routinely lock their doors or secure their freezer tanks.

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

“It’s a tragedy that it wasn’t properly secured and it’s clearly drawing 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 to embryo storage open.

Lab workers constantly carry 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 those Dr. Sparks installed in his freezer tanks to monitor temperature and liquid nitrogen levels, would not have alerted staff quickly enough to avoid 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 patients and health care providers in Alabama, but it’s not necessarily going to be limited to the borders of this state,” said Dr. Sparks, based in Iowa, where six-year-old abortions are performed. weeks. The ban is being challenged in court.

By Friday, three fertility clinics in Alabama — including the clinic being sued — had announced they were suspending IVF procedures, citing the new ruling.


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