In the past week, two fertility clinics—the University Hospitals Ahuja Medical Center’s Fertility Center in Beachwood, Ohio and the Pacific Fertility Center in San Francisco—reported malfunctions, potentially damaging hundreds of patients’ stored eggs and embryos.
In both instances, the problem occurred in the liquid nitrogen freezer, which is responsible for maintaining the temperature of the thousands of specimens.
Now, two lawyers told the Washington Post that they’ve received a deluge of requests to pursue legal action against the Cleveland clinic. According to the Post, members of the American Academy of Assisted Reproductive Technology Attorneys said they expect similar action in California. The cases depend on the specific contracts the clients had with the clinics, and whether or not they were negligent in failing to protect the eggs and embryos. The cases could, theoretically, also introduce the thorny issue of how much a lost potential life is worth.
The two major incidents, occurring only days apart, highlight both the riskiness of the increasingly popular method of cryopreservation, a method of prolonging fertility adopted by a generation of people who are, for whatever reason, not ready to have children but think they may be one day—and one cheerfully promoted as a perk by companies like Google and Facebook. A study from the UK’s Human Fertilisation and Embryology Authority found that, of women who used frozen eggs in 2014, only 14 percent of implantation cycles worked; other studies put the success rate around 60 percent.
But it also highlights how flimsy-to-nonexistent federal regulations over fertility clinics are. From the Post:
Within the federal government, the Centers for Medicare and Medicaid Services and the Food and Drug Administration oversee only certain aspects of fertility labs, and the Centers for Disease Control and Prevention collects data about in vitro fertilization. The agencies do not inspect clinics’ storage tanks or track reports of eggs or embryos being damaged.
Naomi R. Cahn, the Harold H. Greene Professor of Law at The George Washington University Law School and author of Test Tube Families: Why the Fertility Market Needs Legal Regulation, echoed that egg freezing was a poorly-regulated industry, at least on the federal level.
“There are very few national standards that are in play here. The only federal law that actually applies is one that requires clinics to report their success rates,” she told Jezebel on a phone call. “While the industry itself generally does a good job of regulation, the regulations that exist are not legally enforceable.”
“We’re putting such faith in technology to preserve our fertility and we’re finding something we all know—which is that technology sometimes fails,” she continued. “And it’s an incredible disappointment. What we need to do is… adopt regulations that ensure we make the technology as good as possible.”
The Post reports that currently, regulations are on the state level—California requires clinics to be accredited, but Ohio doesn’t.
Denise Driscoll, the [College of American Pathologists, which accredits more than 400 fertility laboratories]’s senior director of accreditation and regulatory affairs, described a rigorous biannual inspection process that involves about 560 checklist items, including backup systems for cryopreservation tanks and 24-hour monitoring of alarm systems. Both the Cleveland clinic, on April 26, 2016, and the San Francisco clinic, on Jan. 23, 2017, met those criteria.
Michele Goodwin, Chancellor’s Professor and Director at the Center for Biotechnology & Global Health Policy at the University of California, Irvine School of Law, told Jezebel in an email that establishing regulations is tricky on a baseline level, because it isn’t clear what legal language should be used to describe what these clinics do.
“For example, could they be described along the lines of other institutions that temporarily safeguard objects of value? Some people might be deeply offended to think of them like a valet car service—but are they much different[?] Or like a bank that hosts safe deposit boxes, or like a cemetery where there are vaults?” she continued. “Within the law, although reproductive technology is not new, many of the questions related to matters such as this have yet to be fully answered.”
In a statement, the American Society for Reproductive Medicine said that the organization would review the incidents and meet with experts and leadership to determine recommendations.
The statement continues: “While no technology can be perfect, and we do not yet know exactly what happened here, we do know that cryopreservation and subsequent use of reproductive tissue is a technology that has been used reliably for years around the world, and we can assure our current and future patients we will do everything we can to understand how these incidents occurred and how we can help our members work to prevent other such incidents from occurring.”