30 Apr Inside the opaque world of IVF, where errors are rarely made public

It was one of the worst accidents in the history of reproductive medicine.

A storage tank at a San Francisco fertility center imploded, its trove of 4,000 human eggs and embryos damaged or destroyed. A jury later found that a manufacturing defect was largely to blame for the disaster but also implicated the center. The lab director had unplugged a malfunctioning computer, muting 128 alarms that warned of trouble. Lab personnel did not transfer the contents of the vessel to a backup tank when the computer failed. And there is no evidence that repairs were initiated for the 13 days between these first problems and the implosion.

The missteps were revealed only because a lawsuit and 2021 civil trial offered a rare glimpse inside the closed world of U.S. fertility care. Most of the time, experts say, errors and accidents go unreported in the burgeoning fertility industry, which is largely self-policed. It is not mandated to report errant episodes to the government, the public, any professional organization or even patients — despite a code of ethics that explicitly says practitioners should promptly tell patients about lost or destroyed genetic material.

This opaque system is under scrutiny again after the Alabama Supreme Court ruled this year that frozen embryos are children. That case involved a patient who accidentally dropped and destroyed embryos belonging to three couples at a fertility clinic.

“In other areas of health care, states require hospitals to monitor and report major avoidable errors, things like mismatched blood transfusions or surgery on the wrong body part,” said Dov Fox, a law professor and director of the Center for Health Law Policy and Bioethics at the University of San Diego, who studies the fertility industry. “They call these ‘never events’ because these are things that just shouldn’t happen.

“No agency or authority tracks or polices what might be called ‘reproductive never events.’”

In vitro fertilization (IVF) is the most common form of assisted reproduction. Doctors retrieve eggs from a patient’s ovaries and an embryologist combines them with sperm to create embryos in a lab. The embryos can be frozen for future use or transferred to the uterus days after they are created.

States license clinics and professional groups govern practitioners. But the inspection and accreditation of labs are handled mostly by private, voluntary organizations that consider that information the property of clinics. Many inspectors are the directors of labs themselves, a fraternity of scientists who review one another’s work, looking for systemic problems, not lost reproductive material, according to the College of American Pathologists.

[…]

But most lawsuits result in settlements with nondisclosure provisions, reinforcing the secrecy that surrounds the multibillion-dollar fertility industry. Many cases are settled even before lawsuits are filed, attorneys said.

“The vast, vast supermajority of mistakes in fertility clinics, the public doesn’t even know about,” said Adam B. Wolf, a prominent attorney for fertility plaintiffs, including those in the San Francisco case.

Hopes destroyed by tank defect, human error

All of Monica Coakley’s 18 eggs were in cryopreservation Tank 4 at Pacific Fertility Center when it crumpled like an empty soda can, devastating nearly 500 people’s hopes of having children. She was 42, did not have a partner and was not ready to get pregnant, but freezing her reproductive material had given her assurance that she had time.

And suddenly that was gone. She tried to have more eggs retrieved, but the procedure did not work. She said she accepted settlements from the San Francisco clinic and Chart Inc., the tank manufacturer, and is prohibited from disclosing the terms.

“It makes me sick, still,” Coakley, now 47, said in an interview. “I look at this money now that’s in my account and it doesn’t make me feel any better. I wake up most mornings and still go, ‘I can’t believe I don’t have kids.’”

Officials and lawyers representing Pacific Fertility and Chart Inc. did not respond to numerous requests for comment.

Joseph Conaghan, the lab director who disconnected the computer that monitored conditions in the tank, no longer works at Pacific Fertility. Neither he nor his attorneys responded to requests for comment.

[…]

The same March 2018 weekend that Tank 4 imploded, a cryopreservation tank more than 2,200 miles away in suburban Cleveland also failed. That accident, which caused temperatures in the tank to rise rapidly, destroyed 4,000 eggs and embryos belonging to about 950 people.

That disaster, clinic officials acknowledged, was due to human error. Staff at University Hospitals Ahuja in Beachwood, Ohio, had deactivated the remote alarm that should have notified lab employees of a problem with the tank on a Saturday.

All the lawsuits filed over the Cleveland failure were settled out of court. No terms were disclosed.

IVF labs facing increased pressures

The boom in egg and embryo freezing became possible a decade ago after new techniques allowed for quick freezing without harming delicate cells. That is one of many advances in assisted reproduction since Louise Brown was born in Britain 46 years ago as the first human conceived by IVF.

In the United States, there were 167,689 cycles to freeze eggs and embryos in 2021, nearly double the number in 2017, according to the Centers for Disease Control and Prevention. The demand to perform increasing numbers of procedures has put pressure on IVF labs, where a shortage of trained lab workers — known as embryologists — has grown worse. Embryologists generally learn the painstaking craft of handling 60-cell bundles on the job.

In most clinics, reproductive material is preserved in liquid nitrogen in double-walled tanks at nearly minus-200 degrees Celsius. These tanks use a vacuum between the two walls to keep material cold, like a Thermos. Liquid nitrogen evaporates and must be added and monitored 365 days a year. Computers, alarms and auto-fill devices help, but ultimate responsibility falls on the people running the lab.

Private equity firms have purchased many fertility clinics in recent years, building large chains and placing increasing emphasis on profitability. In one study, the authors concluded that private equity appears to own a larger share of fertility clinics than it does in any other medical specialty or service.

Without data on errors, it is impossible to measure the quality of U.S. reproductive care. Most embryologists and fertility lab directors interviewed by The Washington Post described misplaced or destroyed reproductive material as rare occurrences, but “no one has a solid handle on what is actually going on,” said Michael Reed, lab director at a tiny fertility clinic in New Mexico, who would like to see more transparency.

An array of government organizations play limited roles in the assisted reproduction field. The CDC collects data on success rates from more than 450 clinics. The Food and Drug Administration inspects equipment and tissue to prevent transmission of disease through eggs and sperm. The Centers for Medicare and Medicaid Services, which administers laboratory laws, exerts some oversight. Some states add other requirements and may investigate accidents.

But generally the federal government stays out of fertility clinics because of the fraught politics, for both Democrats and Republicans, of regulating the creation and destruction of embryos.

In the United Kingdom, where fertility clinics are required by law to report mistakes, the government’s Human Fertilisation and Embryology Authority reported that fewer than 1 percent of 90,000 cycles resulted in a mistake of any kind in 2021-2022.

Tipton, of the American Society for Reproductive Medicine, noted that it is much easier for European governments to collect such data and more tightly regulate fertility practices because, for the most part, they also control the delivery of health care.

“When government pays for something, they can exert a whole lot more control,” he said.

In one of the only academic studies of errors in U.S. fertility labs, Boston IVF, a large chain of fertility clinics, reported mistakes in 0.23 percent of 36,654 IVF treatment cycles in a review of its own records from 2003 to 2015. Mistakes included discarding healthy embryos because a patient had signed a form giving “consent to thaw and discard embryos” rather than a document providing “consent to thaw embryos” for implantation. The vast majority of errors had no impact on patients, according to the study.

The two organizations that accredit most clinics in the United States are the College of American Pathologists and the Joint Commission. The pathology group acknowledges that it investigates only if a clinic reports an error, a lawsuit is filed or a problem reaches the media. But other mistakes should surface during biennial inspections, officials said.

“Is it theoretically possible that a serious mistake would happen and we wouldn’t know about it? Of course,” said Richard Scanlan, chairman of the College of American Pathologists’ accreditation committee.

The Joint Commission, which employs paid surveyors to inspect labs, reviews complaints and may ask for responses or conduct follow-up inspections. But details are kept confidential.

Secret settlements

Hundreds of people who lost genetic material in the Pacific Fertility disaster initially sued both the clinic and the tank manufacturer. But contracts between Pacific Fertility and its patients require such disputes to be settled by arbitration, ensuring they remain confidential. All cases against the clinic have been resolved, according to lawyers, who would not say more.

Chart Inc. lost the lawsuit brought by five patients that led to the 2021 civil trial. The jury awarded the patients a total of $15 million, setting the benchmark that helped determine payments to hundreds of others in a March 2023 settlement, court records show. Jurors said Chart was responsible for 90 percent of the damage, and negligence by Pacific Fertility caused the rest. Terms of the larger settlement were not disclosed.

Desperate to have children, some couples nevertheless tried to use the embryos in Tank 4 despite warnings from experts of health risks to both mother and child posed by the uncontrolled thaw of their reproductive material. A report cited as evidence in the trial showed those couples had much less success becoming pregnant or having a live birth than others whose eggs and embryos were not in Tank 4. They also had a significantly higher incidence of low-birth-weight babies.

When an expert witness compared the genetic material from the imploded tank with eggs and embryos thawed purposely from another Pacific Fertility tank, he found that only about a quarter as many eggs and half as many embryos were viable after the catastrophe. A lawyer for Chart suggested there was no way the expert could predict what might happen with the rest of the material that had not yet been implanted.

Kevin and Laura Parsell, an Ohio couple, had a boy and a girl from previous in vitro fertilization at Pacific Fertility. A third pregnancy assisted by the fertility clinic ended in miscarriage. But their plan had always been seven healthy children.

The Ohio couple asked the fertility clinic to examine the four embryos they had stored in Tank 4 for signs of viability. They had the best two implanted, or “transferred” to Laura, in the parlance of fertility care, according to testimony in the trial. But neither produced another child. Under questioning from a Chart attorney, one expert acknowledged it is impossible to be completely certain the tank implosion was responsible for those two failures.

The couple took the remaining two embryos home and buried them in a cemetery. Each Christmas, they hang seven snowflake ornaments on their tree in memory of the family they don’t have.

The couple received a settlement and declined to be interviewed by The Post.

“It is like me asking you to pick four of your family members … and they are ripped out of your life,” Laura Parsell testified. “It doesn’t matter if you picked a son or a daughter, or your grandparent, the whole family tree is gone.”

Full Story: The Washington Post April 28 2024