Illustration of fetus, DNA, lab supplies

The Legal Challenges of the Medicine of Miracles

On September 10 at 4:00 PM, join Prof. Fox in a discussion of his new book, Birth Rights and Wrongs: How Medical Mix Ups Are Remaking Reproduction and the Law (Oxford University Press, 2019). Learn more here.

By Dov Fox

Every year, millions of Americans rely on the likes of birth control, IVF, and genetic testing to carry out decisions as intimate and important as 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 life on their own terms. But 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. More often it’s human failures and flawed quality controls to blame. But political and economic forces conspire against meaningful regulation to prevent those errors from happening in the first place. And however egregious the offense, no statute or doctrine says that these injuries matter, legally speaking.

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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

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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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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What if Trump Censors Climate Science? Scientific Research Policy and Law under the Trump Administration

Cross-posted from the Take Care blog.

By Dov Fox

Global warming embarrasses President Donald Trump’s insular creed of “America First.” The National Oceanic and Atmospheric Administration recently confirmed all-time record-high temperatures and sea levels around the world. Yet President Trump has promised that the United States will be virtually alone in refusing to honor the commitments it had made in the Paris climate agreement. Indeed, his administration has systematically deregulated previous efforts to reduce greenhouse gas emissions, while dismantling efforts to protect the country’s air, water, and wildlife.

More elusive threats to climate science are lurking behind the scenes. The Trump administration ordered the Environmental Protection Agency (EPA) to shut down its climate webpage, gagged EPA and U.S. Department of Agriculture employees from using terms like “climate change” and “emissions reduction” in any written communications, and forbade scientists there from discussing their (taxpayer-funded) research with anyone outside of the agency. The White House has at the same time defunded climate science and terminated ongoing studies into environmental threats ranging from the toxicity levels of Midwestern streams to the health risks of Appalachian mining. Read More

When is a juror too biased?

A new Op-Ed by Bill of Health Contributor Dov Fox on CNN:

The upcoming Supreme Court term promises to be a sleeper. Still down a justice, the court isn’t slated to hear its usual blockbusters on the likes of abortion, affirmative-action or same-sex marriage. But its first day back in session does feature at least one intriguing controversy in the case of Peña Rodriguez v. Colorado.

At the heart of the case are two incompatible visions of what a jury is supposed to be. The first ideal emphasizes objective decision-making. It demands that jurors arrive at verdicts free of any influence beyond the testimony and evidence that’s presented in court. The second ideal stresses jurors’ subjectivity. It insists on a jury of peers that can speak as the voice of the community. How can jurors remain unbiased, however, while relying on the very experiences and perspectives that bias them? […]

Read the full article here.

For more on the connection between jury bias and cognitive neuroscience, see his law review article, Neuro-Voir Dire and the Architecture of Bias.

The Reproductive Rights Case the Supreme Court Decided *Not* to Decide

By Dov Fox

The landmark abortion decision in Whole Woman’s Health v. Hellerstedt eclipsed quieter reproductive rights news out of the Supreme Court at the end of its term. It involves a couple’s claim that the Tennessee Supreme Court violated their equal protection rights by refusing to recognize “disruption of family planning as either an independent cause of action or element of damages.” You won’t have heard about this case. It wasn’t a merits judgment, but a decision not to decide. The Court’s denial of certiorari in Rye v. Women’s Care Center of Memphis has gone all but unremarked. It shouldn’t. This post lays out the arguments and why the Court (most likely) declined to hear it on appeal (without explaining its decision, as standard for cert denials). My updated article out in next year’s Columbia Law Review elaborates on the significance of professional wrongdoing that imposes, deprives, and confounds procreation in the face of people’s best efforts to plan a family.

The dispute arose during Michelle Rye’s third pregnancy. Rye has Rh negative blood, meaning that she produces antibodies that attack the blood cells of a Rh-positive fetus, potentially leading to serious harm in a born child. Doctors nowadays easily prevent this Rh-sensitization by injecting the pregnant woman with a compound called RhoGAM. But Rye’s doctor didn’t give her that injection. Now the couple couldn’t have more children of their own without risking serious health problems. Their Catholic faith took fetal testing and abortion off the table. They couldn’t even use birth control to prevent a risky pregnancy. Rye and her husband sued the doctor (who admitted negligence) for disrupting their family plans. Tennessee courts, all the way up to the state’s Supreme Court, rejected their claim. The courts held that the couple had not suffered the kind of injury that would support a legal cause of action. The Ryes’ petition to the U.S Supreme Court argued that the state Court’s refusal to recognize their claim denied them equal protection under the law. Read More