After three years of fertility treatments, a Massachusetts couple was 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.
Her pregnancy failed.
In June, the couple, along with three others, filed a lawsuit against the manufacturer of the faulty solution, CooperSurgical, alleging that key ingredients to keep IVF embryos alive were missing due to quality control failures. More than 100 households are taking legal action against the company, one of the largest manufacturers of fertility supplies in the world.
The Cooper incident is just one of numerous high-profile mishaps that have arisen with the growing popularity of in vitro fertilization and egg freezing in the U.S. That has put fertility treatments at a dangerous crossroads: Critics argue the industry suffers from regulatory blind spots that leave it vulnerable to mistakes, but more rules could threaten access to IVF at a time when it is already seen as the next target in the country’s erosion of reproductive rights.
At stake is a $40 billion U.S. industry that is expected to triple in size over the next decade as more people put off having children until later in life and more women freeze eggs early. It’s a complicated and confusing landscape that patients are largely left to navigate on their own, as Bloomberg explores in a new podcast series, Misconception. And when things go wrong, the cost is immense, sometimes depriving those who have spent tens of thousands of dollars on fertility treatments of the chance to have biological children.
“The field is totally underregulated,” said Art Caplan, a bioethicist at New York University. “It’s all caught up in America’s agony over abortion policy. The minute you mention the word embryo, every lawmaker in the world runs away, no matter what their views are.”
Mistakes have made headlines across the country. Last year, the manufacturer 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 case of Alabama, where the mistaken destruction of embryos led to a state Supreme Court ruling that the embryos should legally be considered children, jeopardizing the future of IVF in the state.
Despite the technical marvel of producing life in a petri dish, IVF is labor-intensive and prone to human error. Embryologists fertilize, freeze and biopsy eggs and embryos by hand. There are no reporting requirements for errors in fertility treatments and many complaints are settled before lawsuits are filed, making it difficult to know how often problems actually occur.
“What you need in this system is multiple layers of safety,” said Sarah London, an attorney at Lieff Cabraser who has represented patients in lawsuits against several fertility companies, including the Massachusetts couple who sued CooperSurgical. “You can expect bad things to happen, especially with eggs and embryos. They are extremely fragile. They are very valuable. They cannot be replaced.”
Last year, Jason Diaz and his family sued a California fertility clinic after an embryo mix-up gave the Diazes’ son the potentially deadly gene they had tried to avoid passing on through IVF. Diaz had stomach cancer at age 32 and carries a genetic mutation that carries an extremely high risk of cancer.
“I almost felt like I had been diagnosed with cancer again,” Diaz said shortly after his lawsuit was filed. “As a father, I failed to protect my son.”
ABORTION POLICY
Compared with other countries, the United States 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 was tantamount to the destruction of life. Other countries embraced the technology but issued special rules for it; the United Kingdom, for example, established a new regulatory authority to license IVF clinics and set standards. In the United States, however, it proved too politically explosive.
As a result, fertility is generally approached in the same way as most medicine in the United States: It is left up to individuals and their doctors to decide who gets treatment and what they get. American clinics are guided by voluntary guidelines set by professional groups and state medical boards that can intervene against unscrupulous doctors. That wide latitude has allowed for practices that other countries consider unethical or illegal, such as embryo sex selection or polygenic risk testing for diseases and other traits, such as eye color.
The U.S. government’s hesitancy to intervene in IVF has also made the field work differently than other types of medicine. Federal funding for research, which often helps set ethical and medical standards early on, has been barred for embryos by a rider to the appropriations act since 1996. That has contributed to a dearth of large, randomized clinical trials that help prove what is evidence-based — what works, and for whom — in the first place.
Insurance also often plays a role in determining which practices are evidence-based and therefore worth paying for. New techniques often gain popularity quickly, whether they’ve been proven to work or not. And IVF coverage isn’t widespread, as insurers often argue that fertility procedures aren’t medically necessary. Only about half of large employers offered fertility coverage in 2022.
The only real regulation of IVF in the United States is a law requiring clinics to report success rates. Critics have long argued that the industry should have more rules that would prevent mistakes from happening or at least track them when they do occur.
But in America’s divisive political climate, it’s difficult to grant special protections to 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 broke into a fertility clinic’s cryogenic storage facility. Anti-abortion groups seized the opportunity to advocate for new regulations. The Susan B. Anthony Foundation has suggested expanding rules like Louisiana’s banning the destruction of IVF embryos. The Southern Baptist Convention last month spoke out against IVF in general.
It’s a natural next step for the anti-abortion movement after the overturn of Roe v. Wade, said Margaret Marsh, a historian at Rutgers University who has written several books about the fertility industry.
“It really does feel like we’re back in the 1970s,” she said. “If you really believe that life begins when sperm meets egg and that destroying the resulting embryo is destroying life, then you end up being opposed to IVF.”
These political complications make it easier to maintain the status quo. Bills by both Republicans and Democrats to protect IVF in the wake of the Alabama Supreme Court ruling have failed because the two parties cannot agree on the proper approach.
KEY INGREDIENT
Weeks before the Massachusetts couple discovered their embryos were damaged, the U.S. Food and Drug Administration issued a recall of CooperSurgical’s solution, known as culture medium, alleging it could harm embryo development. Lawsuits against the company allege that quality control lapses led to the exclusion of key components of the medium, which is meant to mimic the environment of the female body.
Cooper had already recalled mislabeled media last year. A company representative declined to comment.
The industry’s problems extend beyond any one clinic or manufacturer. The products are regulated like a medical device, and once approved by the FDA, the agency relies on “voluntary compliance” to ensure quality, along with inspections. Manufacturers aren’t required to disclose ingredients, making what’s inside often a black box for clinics. Cooper only became aware of his problem after several clinics complained about lower success rates.
“The problem with the fertility industry is that it has been a business from its inception,” said Caplan, the New York University bioethicist. “It never did what most medical procedures do, which is go through a phase of experimentation and research, determine safety and determine efficacy.”
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