(Bloomberg) -- After three years of fertility treatments, a Massachusetts couple were waiting to see if their latest round of IVF would work when a devastating email arrived: All of their embryos had been exposed to a nutrient solution that had been recalled.
Their pregnancy failed.
In June, the couple, along with three others, filed a lawsuit against the maker of the flawed solution, CooperSurgical, alleging that key ingredients to keep IVF embryos alive were missing because of lapses in quality control. More than a hundred households are pursuing legal action against the company, one of the world’s largest manufacturers of fertility supplies.
The Cooper incident is just one of a number of high-profile mishaps that have come with the growing popularity of in vitro fertilization and egg freezing in the US. That’s put fertility treatments at a perilous crossroads: Critics argue that the industry suffers from regulatory blindspots that leave it vulnerable to errors, yet more rules could threaten access to IVF at a time it’s already seen as the next target in the nation’s erosion of reproductive rights.
At stake is a $40 billion US industry that is expected to triple in size over the next decade as more people delay having babies until later in life — and more women freeze eggs in anticipation. It’s a convoluted, confusing landscape that patients must navigate largely on their own, as Bloomberg explores in a new podcast series, Misconception. And when things go wrong, the toll is immense, sometimes robbing those who have spent tens of thousands of dollars on fertility treatments of a chance at having biological children.
“The field is utterly underregulated,” said Art Caplan, a bioethicist at New York University. “The whole thing is caught up in America’s agony over abortion politics. As soon as you mention the word embryo, every legislator on earth runs away, no matter what their views are.”
Mistakes have made headlines across the country. Last year, the maker of an oil used in fertility labs was sued after reports that its product was toxic. An employee at a California clinic cleaned an incubator with hydrogen peroxide, killing fertilized eggs. And there’s the Alabama case where mistakenly destroyed embryos led to a state Supreme Court ruling that found embyros should legally be considered children, putting the future of IVF in the state on the line.
Despite the technical marvel of producing life in a Petri dish, IVF is a high-touch endeavor that’s prone to human error. Embryologists fertilize, freeze and biopsy eggs and embryos by hand. There are no reporting requirements for fertility-treatment mishaps and many complaints are settled before ever lawsuits are even filed, making it difficult to know how often problems actually occur.
“What you need in this system are multiple safety layers,” said Sarah London, an attorney at Lieff Cabraser who has represented patients in suits against several fertility companies, including the Massachusetts couple suing CooperSurgical. “Bad things can be anticipated to happen, especially with eggs and embryos. They’re extremely fragile. They’re very precious. You cannot replace them.”
Last year, Jason Diaz and his family sued a California fertility clinic after an embryo mix-up gave the Diazs’ infant son the potentially deadly gene they had sought to avoid passing on by using IVF. Diaz had stomach cancer at 32, and carries a genetic mutation that comes with an extremely elevated risk of cancer.
“I almost felt like I got diagnosed with cancer again,” Diaz said shortly after his suit was filed. “As a parent, I couldn’t protect my son.”
Abortion Politics
Compared to other nations, the US is unique in its lack of rules governing assisted reproduction. Anti-abortion activists blocked early attempts to regulate IVF in the 1980s, arguing that the destruction of embryos in the normal course of treatment amounted to the destruction of life. Other nations embraced the technology but issued special rules for it; the UK, for example, established a new regulatory authority to license IVF clinics and set standards. In the US, though, it proved too politically explosive.
As a result, fertility is generally approached the way most medicine is in America: It’s left up to individuals and their physicians to decide who gets treatment, and what they get. US clinics are guided by voluntary guidelines set by professional groups and state medical boards that can intervene against unscrupulous doctors. That wide berth has allowed for practices that other countries deem unethical or illegal, like embryo sex selection or polygenic risk tests for disease and other traits, such as eye color.
The US government’s hesitancy to weigh in on IVF also set the field up to operate differently than other types of medicine. Federal funding for research, which often helps establish ethical and medical standards early on, has been barred for embryos by an appropriations bill rider since 1996. That has contributed to a dearth of large randomized clinical trials to help show what is evidence-based — what works, and for whom — in the first place.
Insurance also often plays a role in determining what practices are evidence-based and therefore worth paying. New techniques often gain popularity quickly — whether they have been proven to work, or not. And coverage for IVF isn’t widespread, with insurers often arguing fertility procedures aren’t medically necessary. Only about half of large employers offered fertility coverage in 2022.
The only real regulation for IVF in the US is a law that requires clinics to report success rates. Critics have long argued the industry is overdue for more rules that can prevent mistakes from happening in the first place, or at least track them when they occur.
But in America’s divisive political climate, it’s hard to issue special protections for IVF patients without also opening the door to special restrictions. In the case at the center of the Alabama Supreme Court ruling, embryos were destroyed by a hospital patient who wandered into a fertility clinic’s cryo storage facility. Anti-abortion groups seized the opportunity to argue for new regulations. The Susan B. Anthony Foundation has suggested the expansion of rules like one in Louisiana that forbids the destruction of IVF embryos. The Southern Baptists Convention came out last month in opposition to IVF altogether.
It’s a natural next step for the anti-abortion movement after the repeal of Roe v. Wade, said Margaret Marsh, a Rutgers University historian who has written several books on the fertility industry.
“We do indeed seem to be back to the 1970s,” she said. “If you truly believe that life begins when sperm meets the egg, and that destroying the resulting embryo is destroying life, then you end up opposed to IVF.”
These political complications mean it’s easiest to stick with the status quo. Bills from both Republicans and Democrats to protect IVF in the aftermath of the Alabama Supreme Court ruling have fizzled as the two parties can’t agree on the right approach.
Key Ingredient
A few weeks before the Massachusetts couple found out their embryos were damaged, the US Food and Drug Administration issued a recall of CooperSurgical’s solution, known as culture media, saying that it could impair embryo development. The suits against the company allege that lapses in quality control led to key components being left out of the media, which is meant to mimic the environment of the female body.
Cooper had already recalled mislabeled media the prior year. A representative for the company declined to comment.
The problems of the industry extend beyond any one clinic or manufacturer. Media is regulated as a medical device, and after it’s approved by the FDA the agency relies on “voluntary compliance” to assure quality, along with inspections. Manufacturers aren’t required to publish ingredients, making what’s inside often a black box for clinics. Cooper only realized its problem after several clinics complained about lower success rates.
“The problem with the fertility industry is that it’s been a business since its origins,” said Caplan, the NYU bioethicist. “It never did what most medical procedures do, which is to go through a phase of experimentation and research, determine safety, determine efficacy.”
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