Abortion laws, accidents and lax regulations now endanger the fertility industry

For fertility patients whose embryos were destroyed at an Alabama clinic, the circumstances must have been shocking. Somehow, a patient at the hospital that housed the clinic entered a storage room, removed the embryos from a tank of liquid nitrogen, and then dropped them to the floor, probably because the tank was kept at -360 degrees.

The strange episode was at the center 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 the treatments could be performed in the state.

However, the accident at the Alabama clinic reflects a pattern of serious errors that occur too often during fertility treatment, a rapidly growing industry with little government oversight, experts say. From January 2009 to April 2019, patients filed more than 130 lawsuits for destroyed embryos, including cases in which embryos were lost, mishandled, or stored in freezer tanks that went bad.

These errors have taken on new gravity as the anti-abortion movement seeks to extend “personhood” to fetuses and embryos conceived through in vitro fertilization, arguing that they are “unborn children” and taking cases to an increasingly polarized and open to considering the 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 in vitro fertilization litigation. “To the extent that there is little regulation, it does provide an opportunity to advance the personhood agenda.”

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

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

Patients often turn 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 often 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 tack, 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 storage room should be considered a day care center, which state regulations required to be “secured and closely monitored,” because “young children, including the embryos, “They can’t protect them.” themselves.”

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

“The language of the Wrongful Death of a Child Act is broad and unconditional,” wrote Justice Jay Mitchell of the Alabama Supreme Court, referring to the state law. “It applies to all children, born and unborn, without limitation.”

Lawyers 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 with assisted reproductive technology. In 2021, more than 97,000 babies were born through IVF

While clinics in the United States do not report the number of 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 tanks nationwide.

Experts who study the fertility industry said they were not surprised to see that the Alabama clinic appeared to be operating with lax safeguards, 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 Legal Policy and Bioethics at the University of San Diego School of Law. “This is a perfectly avoidable outcome.”

One of the largest negligence cases to date involved the 2018 failures of two major embryo freezing tanks, one in California and one in Ohio, which 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 embryos were destroyed.

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

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

More recently, eight couples filed lawsuits against medical device company CooperSurgical, alleging that a liquid the company makes, intended to help fertilized eggs become embryos, was defective and caused their embryos to stop developing.

Collectively, patients say they lost more than 100 embryos that had been dipped in the failed product. Experts estimate that thousands more patients could have been affected. The company declined to comment.

Other lawsuits have been more similar to the Alabama case, brought by families who allege that an act of negligence caused 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 for inspection and inadvertently let them thaw.

“These are not aberrations,” said Fox, who noted that the first IVF lawsuit, filed in 1995, involved two Rhode Island couples whose clinic had lost all nine of their 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 tracks that 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 do report some data to the government, such as how many patients they see and their patients’ pregnancy success rates, but not accidents or errors.

Many mistakes don’t even make it to court, because some clinics make patients sign contracts that require them to resort to private arbitration. “That 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 guidance, released after the Alabama accident, states that IVF labs should have “the ability to limit access through badge readers or similar methods.” It does not require laboratories to constantly close their doors or secure their freezing tanks.

In Alabama, “a stranger chose to open the tank, look 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 former president of the Assisted Fertility Society. reproductive technology.

“It is a tragedy that it was not properly secured and clearly draws everyone’s attention, including mine.”

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

Lab workers constantly carry shoebox-sized containers filled with liquid nitrogen. Sometimes they might leave a door open rather than risk spilling the icy liquid all over their arms, she said.

Even advanced monitoring systems, like those Dr. Sparks installed in her 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 damage embryos can arise in routine medical practice, Dr. Sparks said, such as an embryo stuck to the side of a pipette or a biopsy that goes wrong.

The new ruling in Alabama could increase risks for fertility providers nationwide, he added.

“I’m very concerned for patients and care providers in Alabama, but it won’t necessarily be limited to the borders of that state,” said Dr. Sparks, who resides in Iowa, where a six-week abortion is performed. The ban is being challenged in court.

On Friday, three fertility clinics in Alabama, including the defendant clinic, had announced they would suspend IVF procedures, citing the new ruling.

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