Mass embryo destruction, reproductive never events, and the not-quite-Wild West

By Dov Fox

Information found in this new post by Dov Fox is also available in Slate’s March 19th article In Vitro Injuries: How should courts compensate would-be parents when assisted reproductive technology goes terribly wrong?

More than 1 in 10 Americans seek fertility treatment. IVF and similar technologies result in 64,000 babies—1.6% annually—of all those born in the U.S. each year. For people willing to move heaven and earth to form a family, this is the medicine of miracles. But reproductive mishaps turn these dreams into nightmares. Some result in unplanned pregnancies. Others, lost chances for parenthood. I’ve considered the legal complexities elsewhere at law review length. (A reply to critics Robert Rabin, Carol Sanger, and Gregory Keating is out shortly with Columbia.) But it’s the facts that have made headlines of late.

The Today Show and Nightly News interviewed me in the wake of recent storage tank malfunctions at two major fertility clinics—one in San Francisco, the other outside Cleveland—that destroyed more than 4,000 cryopreserved eggs and embryos. The Cleveland facility said that “alerts that should have been sent to staff were never sent.” These incidents have left over a thousand affected couples mourning future children who would never be; practitioners wondering how something like this could have happened; and prospective parents around the country worrying that tragedy could strike again.

It’s not the first time. NBC News uncovered a history of freezer malfunctions. Over a decade ago in Florida over 60 cancer survivors lost their stored sperm “when a tank made by the same manufacturer failed.” Exact figures for such breakdowns are hard to come by, however. Elsewhere in health care delivery, most states mandate reporting of “never events,” such as surgery on the wrong body part or patient. But the United State has no public or private system for tracking what I’ve referred to as “reproductive” never events, let alone less serious errors. So it’s impossible to know with any reliability or precision the incidence of professional mistakes in matters of procreation.

Available data points are bracing. A 2008 survey of nearly half of all U.S. fertility clinics found that more than one in five misdiagnosed, mislabeled, or mishandled reproductive materials. A 2014 study revealed that popular methods of prenatal screening for fetal abnormality sound “a false alarm half of the time.” And in 2016, a national ratings website found that 18-24% of fertility patients reported damaged or destroyed samples among a host of other errors.

None among regulators, agencies, insurers, medical boards, or professional societies require safeguards that might prevent mistakes like these from happening in the first place. The U.S. stands out among developed countries for its failure to rein in wrongdoing that forces parenthood on people who don’t want it or that denies it to those who do. In the United Kingdom, by contrast, a national agency requires that all facilities comply with a standard of professional conduct that covers “all details of the clinical and embryological practice associated with assisted reproductive technology.”

That agency—the Human Fertilisation and Embryology Authority—maintains rigorous laboratory inspections, often without notice. And even under its careful oversight, the agency reports that 1 out of every 100 fertility procedures—over 500 each year—involve reproductive materials that’s lost, damaged or destroyed. It stands to reason that these errors are at least as common in the United States, where fertility clinics, sperm banks, and surrogacy agencies aren’t monitored or supervised in any meaningful way. My own research uncovered hundreds of American cases in which procreation was negligently imposed, deprived, or confounded.

U.S. legislatures and agencies decline to regulate reproductive negligence. The only federal laws that deal with reproductive technology ask practitioners to do no more than screen donors for communicable diseases and disclose estimated rates at which patients get pregnant. And even then, it imposes no penalty on clinics that refuse to report or deliberately embellish these outcomes. The 12% that don’t comply are free to continue operating. It’s hardly surprising that, according to a recent study, pregnancy outcomes for 3.3% to 7.4% of all pregnancies initiated at fertility clinics were left out of the self-reported data under this law.

Agencies like the Food and Drug Administration (FDA) can’t ensure that reproductive practice is performed properly. The federal statute that gives the agency its regulatory power covers any reproductive drugs or devices, but nothing about which procedures are used or how they’re carried out. The FDA can set standards for screening human cells or tissues like skin, blood, and bone that are meant to be put into another person. But these rules exempt reproductive donors and materials. And regulation by local government is limited to embryonic stem cell research and insurance coverage for infertility treatment. Louisiana, for example, makes it a crime to “intentionally destroy[]” a viable embryo, effectively barring their use research. Not a single state, however, has adopted measures designed to protect against reproductive negligence.

U.S. regulation reduces to the unenforced guidelines issued and incomplete data collected by professional associations like the American Society for Reproductive Medicine (ASRM) and its reporting arm, the Society for Assisted Reproductive Technology (SART). ASRM, for example, issues minimum standards for reproductive practices to its members of fertility clinics and sperm banks. Those recommendations are entirely voluntary, however, and routinely ignored. This hands-off approach to reproductive practice has, in the words of one legal scholar-turned-policy analyst at the American Medical Association, “left a gaping hole for a booming, unregulated market fraught with fraud and abuse.”

SART seeks to provide “[a]ccurate and complete reporting of ART success rates.” But the organization warns that “differences in patient selection, treatment approaches, and cycle reporting practices” among providers distort its data in ways that discredit its use “for comparing clinics,” doctors, or procedures. Crowd-sourcing platforms like FertilityIQ have begun filling this reporting vacuum for reproductive errors. User-generated websites struggle, however, to collect accurate information from enough reproductive patients about the quality of care that they receive. These difficulties go beyond the usual concerns about patient-review systems: that they face about unrepresentative samples, distorted metrics, and the risk of misleading evaluations. The stigmatized character of reproductive care makes many patients reluctant to report openly, for example, while allowing patients to decline identifying themselves leaves anonymous reviews vulnerable to falsification or misuse.

The 2009 “Octomom” case, in which a doctor implanted twelve embryos to initiate a single pregnancy, for example, focused national attention on what some call “the Wild West” of fertility medicine. That characterization isn’t quite right, as Judith Daar has noted. Professional recommendations and barriers to entry make this field more like a fragmented cartel of mostly Mom-and-Pop shops. While certified training is required to practice as an ultrasonographer or reproductive endocrinologist, for example, it’s not as if medical boards revoke that license for repeat offenders. And while the FDA has the authority to regulate assisted procreation, the agency declines to for any procedures or equipment—from labeling systems to cryopreservation tanks—that haven’t been marketed explicitly as medical devices. This tells part of the story of how incidents like this happen.

What it all means, how we should respond, and where we go from here are questions that I answer in a forthcoming book, Birth Rights and Wrongs: How Medical Mix-Ups Are Remaking Reproduction and the Law (Oxford University Press).

This entry was posted in Abortion, Bioethics, Dov Fox, FDA, Judith Daar, Medical Quality, Reproductive Technology by Dov Fox. Bookmark the permalink.

About Dov Fox

Dov Fox is Professor of Law and founding Faculty Director of the Center for Health Law Policy and Bioethics at the University of San Diego School of Law. He has published dozens of articles in leading journals of law and medical ethics, most recently “Reproductive Negligence” in 117 Columbia Law Review 149 (2017). His current book project, Birth Rights and Wrongs, is under contract with Oxford University Press. His work has been featured in CNN, ABC, NPR, BBC, Reuter’s, Bloomberg, the Boston Globe, and the Washington Post. Fox is a regular columnist for The Huffington Post and contributor to the Bill of Health blog. He also serves on the advisory boards of the American Constitution Society and Appellate Defenders, the non-profit law firm that administers all appointed counsel for indigent defendants in California's Fourth Appellate District. Prior to teaching, Fox served as a law clerk to the Honorable Stephen Reinhardt of the U.S. Court of Appeals for the Ninth Circuit. He has also worked at the law firm of Wachtell, Lipton, Rosen & Katz; the consulting firm of McKinsey & Company; and the Civil Appellate Staff at the U.S. Department of Justice. Fox was awarded a Rhodes Scholarship to attend Oxford University, where he earned his DPhil and then received a Soros Fellowship for New Americans to attend Yale Law School, where he served as projects editor for the Yale Law Journal and all three years was awarded the prize for best student paper in law and the sciences.