A Professional In Vitro Fertilisation Laboratory Microscope Closeup - Image

Professor: The Law Has No Straight Answer for Our High-Tech Baby Boom

This is an excerpt of an article by Alaina Lancaster that originally appeared on Law.com. Read the full interview here. 

After thousands of dollars of in vitro fertilization treatments and nine months of pregnancy, a New York couple was forced to give up the twins they birthed. It turns out CHA Fertility Center, the Los Angeles clinic where the couple sought IVF treatment, mixed up the embryos of three patients, resulting in two of the couples having to give up children to their genetic parents. Now, those parents are suing.

Dov Fox, professor of law at the University of San Diego and the director of the school’s Center for Health Law Policy & Bioethics, said the law has not caught up with reproductive technology and victims of this type of medical malpractice aren’t left with many legal options. Yet, legal frameworks are out there, Fox said. Judges and lawmakers just might need to look outside the U.S.

Read the full interview here.

Man and woman on holding hands on a couch, pictured from the neck down

What Happens When Reproductive Tech Like IVF Goes Awry?

It sounds like the setup to a bad joke: Three couples walk into a fertility clinic. But the punch line—what happened to those families at one Los Angeles medical facility in August 2018—is no laughing matter. The embryos from two couples hoping to conceive were mistakenly implanted into a third patient. That third woman and her husband, both of Korean descent, suspected that something was amiss when their two newborns didn’t look anything like them.

DNA testing confirmed that Baby A and Baby B (as court documents called them) weren’t genetically related to either of the birth parents, or to each other—they were related to two other couples who had been seeking fertility treatments at the same clinic. The birth parents were forced to give up their “twins” to their respective genetic parents.

The other two couples, while granted the surprise of children they thought they’d never have, missed out on the experience of pregnancy and early bonding. One of the women explained her sense of loss: “I wasn’t there for his birth, I did not carry him, I did not feel him kick inside of me, I didn’t do the skin to skin, I didn’t breastfeed him.” The mix-up at CHA Fertility Clinic leaves all three couples bereft. They’re left to wonder what happened to their other embryos, and to worry whether their biological children might be born to someone else without them ever knowing.

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A Professional In Vitro Fertilisation Laboratory Microscope Closeup - Image

How Technology is Changing Reproduction and the Law

Millions of Americans rely on the likes of birth control, IVF, and genetic testing to make plans as intimate and far-reaching as any they ever make. This is no less than the medicine of miracles. It fills empty cradles, frees families from terrible disease, and empowers them to fashion their lives on their own terms. But every year, thousands of accidents happen: Pharmacists mix up pills. Lab techs misread tests. Obstetricians tell women their healthy fetuses would be stillborn. These mistakes can’t be chalked up to reasonable slips of hand or lapses in judgment as often as human failures and flawed quality controls. Read More

An embryologist pulls out of the dewar with liquid nitrogen straws with frozenn embryos and egg cells in infertility treatment clinic - Image

The Legal Limbo of Lost Embryos

Last summer, a group of cancer survivors and others struggling to have children held a memorial service for their “hopes and dreams lost.” That’s the message they had engraved on a bench in the Ohio cemetery where these would-be-parents-who-won’t mourned.

More than 4,000 of their frozen embryos and eggs were destroyed when a high-capacity freezer tank failed at University Hospitals Fertility Center in Cleveland one Saturday in early March 2018. Another thousand were lost the same weekend, after a similar malfunction at an unrelated clinic across the country, Pacific Fertility Center in San Francisco.

Some of those affected had made appointments to try to initiate pregnancies the very next week. All had undergone painful procedures and paid, in some cases, thousands of dollars to keep their materials suspended in liquid nitrogen at a constant −196°C. But that weekend in March, tank temperatures began rising, and by the time the Ohio lab technicians returned for their next shift, everything inside had thawed beyond rescue or repair. It’s not clear why remote alarms were turned off; investigations are ongoing. So far, only coordinated cyberattacks have been ruled out. Read More

human embryos under a microscope

A Lawsuit Involving an Alabama Man and a Fetus Is Particularly Threatening to Reproductive Rights

Last week Alabama passed the most restrictive abortion law in the country, criminalizing abortion of “any woman known to be pregnant,” with very limited exceptions that do not include rape or incest. But a recent case in Alabama presents an even more threatening challenge to reproductive rights.

In a new paper published in JAMA, the Journal of the American Medical Association, authors Dov FoxEli Y. Adashi, and I. Glenn Cohen, discuss a recent Alabama state court case involving a man suing an abortion clinic and the manufacturer of a pill that enabled his then-girlfriend to terminate her pregnancy at 6 weeks.

In a troubling decision, the court permitted the fetus be a co-plaintiff alongside the man in a “wrongful death” lawsuit. Read More

Dov Fox on BYU Radio

dov fox headshotBill of Health contributor Dov Fox joined BYU radio’s Top of Mind with Julie Rose to discuss his new book, “Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law,” and the implications of the largely unregulated U.S. fertility industry.

Across the country, more and more Americans choose to put off starting families, with many relying on the lucrative U.S. fertility industry for family planning when the time comes. Though a booming enterprise, the industry remains distinct from other medical practices: it offers patients little recourse for medical mistakes and misconduct. Read More

doctor wearing gloves holding sperm sample in test tube while writing on clipboard

When Fertility Doctors Use Their Own Sperm, and Families Don’t Find Out for Decades

An Idaho U.S. District Court ruled this week that parents can provisionally sue the fertility doctor who, in 1980, used his own sperm to create their daughter—just so long as their claims aren’t barred by the many years that have passed since the alleged misconduct that DNA tests substantiate. The daughter—now almost 40—discovered the fraud when she tested her ancestry with a mail-order DNA kit.

The facts are scandalous—but not unique. A handful of similar cases have recently come to light.

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hand with a pencil drawing on DNA results

Silver Spoons and Golden Genes: Designing Inequality?

A recent web series sparked controversy with the headline that “Designer babies aren’t futuristic. They’re already here.” The online articles make the case that disparate access to frozen embryo screening for debilitating diseases—sickle cell anemia, Tay-Sachs, or cystic fibrosis—is “designing inequality into our genes.”

The authors are right that reproductive technology isn’t open to everyone. A single cycle of in vitro fertilization (IVF)—the tool that combines sperm and egg in a lab—costs 57% of the average American’s annual income in 2018. The multiple cycles it usually takes to get a baby costs upwards of $100,000. Just fifteen states make insurers cover reproductive technology. Even these often limit coverage mandates to married couples unable to conceive, thereby denying equal benefits to non-traditional families.

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Should courts treat destroyed embryos as “lost property” or “wrongful death”?

Bill of Health contributors Glenn Cohen and Dov Fox were featured in this week’s news coverage of novel claims related to recent freezer malfunctions at two major fertility clinics. A class-action suit by one Ohio couple who lost their embryos asks the court to afford embryos standing to use and declare that life begins at conception.Friday’s article asks: “Will Fertility Clinic Disaster Redefine Personhood?” From the piece:

Roe v. Wade made it clear that an embryo or fetus is not a person under the protections of constitutional and federal law. Since then, no [Supreme Court] ju[stices] have suggested otherwise, Dov Fox, a law professor at the University of San Diego, told The Daily Beast. That doesn’t mean that wrongful death claims cannot be filed on behalf of a fetus [or that] the fetus has legal standing as a person overall, but wrongful death can be brought on its behalf—”for lack of a better legal fiction,” Fox said.

Fox added that in similar cases dealing with the loss of embryos due to hospital or clinic in the past, the courts decide that an embryo is not a person for the purposes of wrongful death cases. He pointed to two cases where embryos were damaged—one in Arizona in 2005, and one in Illinois in 2008. Both held that the wrongful death statutes do not apply to the loss of an embryo that hasn’t yet been implanted in a womb. Therefore, it would be surprising if the Ohio court ruled differently. “It would fly in the face of all existing legal precedent,” Fox said. Read More

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.

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