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.

Read More

Reproductive Negligence under Maine Law

By Alex Stein

STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, Doherty v. Merck & Co., Inc., 154 A.3d 1202 (Me. 2017), featuring reproductive negligence.

This decision could benefit from Dov Fox’s excellent article, Reproductive Negligence, 117 Colum. L. Rev. 149 (2017).

The plaintiff, Kayla Doherty, visited a federally-supported health care center in Maine to inquire about birth control options. Her physician recommended an implantable drug manufactured by the defendant, the Merck company. The drug consisted of a single, four-centimeter-long rod inserted under the skin of the inner side of the patient’s upper arm with a syringe-like applicator. The drug works by inhibiting ovulation and is designed to be effective for at least three years unless the rod is removed sooner by a physician. The drug’s applicator, however, occasionally malfunctioned: it had a history of failed insertion attempts that occurred when the rod would remain stuck in the applicator following the procedure (unbeknownst to the treating physician and the patient).

Doherty was a victim of this malfunction. Read More

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

pregnant belly with "surrogacy" written on it

Surrogacy Contracts, Abortion Conditions, and Parenting Licenses

By Dov Fox

Everything went fine the last time for Melissa Cook, when the 48-year old mother of four carried a child for a family back in 2013 to supplement her office job salary. This time was different. First were the triplets. She had been impregnated with three embryos, created using eggs from a 20-something donor and sperm from the intended father who paid for everything. Then, it was that the man, Chester Moore, turned out to be a deaf 50-year-old postal worker who lived with his parents. Finally, was that Moore asked Cook to abort one of the fetuses. He said that he had run out of money to support a third child and worried the high-risk multiple pregnancy would endanger the health of any resulting children.

Cook, who is pro-life, refused. A battle over parental rights of the triplets, all boys, began even before they were born (prematurely, at 28 weeks). Moore argued that his surrogacy contract with Cook, explicitly enforceable under California law, made clear that he was the sole legal parent. Cook sued for custody, notwithstanding her prior agreement that any children resulting from the pregnancy would be his to raise. She argued that the statute, by authorizing private contracts for gestation of a human being, reduces children to “commodities” for sale, and a surrogate like her to a “breeding animal or incubator.” Read More

Reproduction Gone Awry

The Daily Journal published an op-ed article by Blogger and University of San Diego (USD) School of Law Associate Professor of Law Dov Fox titled, “Reproduction Gone Awry.”

In his article, Fox points to last month’s lawsuit against a Beverly Hills fertility clinic — the same one sued by Sofia Vergara’s ex in a dispute over control of frozen embryos — arguing it would be a mistake to write it off as another aberration. The clinic is accused of having negligently destroyed the only seven frozen embryos that a Sherman Oaks woman created using her donor-fertilized eggs.

The article argues that high-tech procreation goes largely unregulated makes these mistakes more common than you might think. A comprehensive study by Johns Hopkins University of U.S. fertility clinics found that more than one in five report errors in diagnosing, labeling and handling genetic samples or embryos. See “Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics” (2008).

Mistakes like these can also frustrate efforts to avoid parenthood or to have children who are born healthy. Fox refers to one recent case in which a pharmacist filled birth control prescriptions with prenatal vitamins.

Fox goes on to state that the victims of such transgressions have little recourse under the law and they almost always lose in court. Contract claims can’t vindicate patient interests where providers, despite their negligence, haven’t broken any specific promises. Like all doctors, reproductive specialists are careful to avoid guaranteeing particular results of their care. And they usually insist that patients waive liability for even implied breaches of contract.

Moreover, Fox also argues that ordinary medical malpractice won’t work either because patients in the reproductive context don’t sustain bodily intrusion or impairment beyond the treatment they agreed to. Nor can recovery for economic setbacks or emotional distress capture the deepest injury at stake. Indeed, it is one our law doesn’t recognize: namely, having been robbed of the ability to determine the conditions under which to become pregnant or have children.

Read the full article online. 

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

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Surrogacy Contracts Directly Enforcible in Pennsylvania

By John A. Robertson

Surrogacy is legal in many states.  Some, like California, directly enforce gestational carrier contracts.  Others, like Texas, Illinois, and Virginia, enforce only those contracts that are entered into by a married couple who need a surrogate for medical reasons which a judge approves before embryo transfer occurs.  A Pennsylvania court has now shown why gestational surrogacy contract should be directly enforced in the absence of legislation.  Its well-reasoned opinion suggests that more states may be open to this approach to surrogacy.

The Pennsylvania case, In re Baby S., arose out of a gestational surrogacy agreement involving embryos created with donor eggs and husband sperm. The written agreement was indisputably clear that that the intended parents would be the legal rearing parents, their names would appear on the birth certificate, and the carrier would have no rearing rights or duties.  Unlike previous cases questioning the validity of a surrogacy contract, the challenge here came not from the carrier who now wished to assert rearing rights (see In re Baby M and Calvert v. Johnson) but from the wife (the intended rearing mother).  She had praised the carrier’s willingness to help her have a child, which she repeated both at the embryo transfer and at a 20 week ultrasound at 20 weeks of pregnancy, which both intended parents attended.  A month later she informed the parties that “irreconcilable marital difficulties” would make it difficult for her to co-parent the child with the intended father.  She also refused to complete the paperwork for her name to appear on the birth certificate as the mother.

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Fixing the Broken Law of Military Medical Malpractice for Birth-Related Injuries

By Alex Stein and Dov Fox

Bill of Health bloggers Alex Stein and Dov Fox have just filed an amicus brief urging the Supreme Court to hear the case of U.S. Air Force Major Heather Ortiz and her baby, who were denied legal remedies for obstetric malpractice by military doctors that left the baby with severe brain damage. The case is No. 15-488 Ortiz v. U.S. ex rel. Evans Army Community Hospital. Professors Fox and Stein urge the Court to overturn the Tenth Circuit’s holding that the federal government’s immunity against liability for intramilitary torts extends to wrongful injuries like those sustained by Major Ortiz’s baby. They argue that this holding misinterprets the immunity, misapplies the Federal Tort Claims Act (FTCA), and constitutes no less than unconstitutional sex discrimination. Fox and Stein explain:

When a civilian spouse of a serviceman receives negligent prenatal care from military doctors and delivers an injured baby as a result of that malpractice, there is no question that Feres immunity does not apply and that the baby can sue the United States under the FTCA. When military medical malpractice injures the baby of a servicewoman, this baby should be equally able to obtain redress under the FTCA.  A system that would single out the civilian children of servicewomen for adverse treatment discriminates against women who serve in the armed forces. . . To interpret the FTCA as the Tenth Circuit did permits discrimination between these two classes of similarly situated victims of military malpractice and violates fundamental principles of equal protection.

To download this brief, click here.