For IVF, the Law Runs Away From Science

On February 16, the Alabama Supreme Court ruled that embryos destroyed at an IVF facility were children subject to the state’s Wrongful Death of a Minor Act, opening the door to civil and criminal liability. The state’s largest fertilization centers immediately “froze” their services. Two weeks later, now aware of the implications of this ruling, the Alabama legislature undid (some of) the court’s damage, providing legal immunity for IVF providers and receivers. But fear remains.

The process of IVF necessarily entails creating "excess" embryos – the just “in case” ones used if the first round doesn’t implant or the parents later seek additional children. Necessary hormonal adjuvants to boost ovulation and surgical oocyte removal can be hazardous. To minimize or prevent these problems, “extra” embryos are created. Destruction of these excess embryos is thus an anticipated result. The destruction can be intentional, i.e., because the embryos are no longer needed, wanted, or usable. Sometimes, however, destruction happens inadvertently, even negligently.

IVF is a billion-dollar business, and business is booming here and globally. IVF is essentially unregulated in the US – meaning profit margins are high, and insurance comparatively low (until now, perhaps). Accidents happen. Negligence is wanton. Wrong embryos are transferred to the wrong parents. Unvetted sperm carrying hereditary diseases have been utilized – and legal redress is unavailable. Warehousing damage – failure in refrigeration of the frozen sperm, egg, or embryo—is a not infrequent occurrence, and this is what triggered the headline-making Alabama case, LePage v. Center for Reproductive Medicine. [1]

According to a 2020 study by Professor Dov Fox, between 2009 and 2019, 133 lawsuits were filed nationally claiming destroyed or damaged embryos. [2] Most cases arose from two incidents: In 2018, a failure at a Cleveland IVF facility destroyed some 4000 eggs and embryos; the same day, a similar accident happened at a San Francisco facility. In both clinics, the liquid nitrogen storage tanks failed. 700 patients were affected in Cleveland and 500 in San Francisco. Individual cases and two class action suits sought damages for negligence, breach of contract, and bailment. [3]

These were the first US cases to assign significant values to gametogenic material:  The jury awarded the claimants 15 million dollars pending appeal. The cases were later settled for an undisclosed amount. No one wanted to risk an appeal where the law is unsettled and where large verdicts have never been upheld.

It’s not only IVF: The Broader Implications of Refrigerant Failure

The legal and ethical quagmire behind outdated values placed on gametes surfaced in a 2009 UK case, Yearworth v. North Bristol. There, the plaintiffs deposited their sperm before undergoing chemotherapy, fearing damage to their sperm and being unable to create genetically related children. Similar to the Alabama case, the refrigerant failed, and the sperm were lost, indeed rendering the men infertile. While IVF was not involved, the impact is the same, regardless of the driving circumstances, whenever gametes entrusted to a third party for preservation are destroyed. This same situation applies to cancer patients about to receive chemotherapy, or trans people prior to hormone treatment and surgery, or people treated for certain blood diseases:  Whenever a prospective parent houses their reproductive material to preserve the possibility of fertility, the loss [4] is, nonetheless, tragic. The freezing process has broader implications. Eggs and sperm can be donated for use by relatives, e.g., mothers with daughters having Turner’s syndrome who can carry to term but are incapable of generating viable eggs. These 1% of women with primary ovarian insufficiency, many of whom are infertile, depend on donated eggs. Some women donate eggs for their own later use. These people, too, are impacted.

The Yearworth court, like some American jurisdictions, held that once voluntarily removed from the body, loss of body parts is no longer subject to claims for personal injury, limiting recovery of property damage under contract or bailment theory– which isn’t much.

Seeking to compensate the Alabama plaintiffs for more than the “nuisance” value allowed in contract or bailment cases, the lawyers “conceived” a creative solution: invoking Alabama’s  “Wrongful Death of a Minor Act: Damages under Alabama’s Wrongful Death of a Minor Act require a relatively low standard of proof, a seeding ground for unbounded damages as Alabama has no damage cap for wrongful death cases and allows punitive damages, as well.

The statute – originally enacted in 1872 –creates a civil cause of action “[w]hen the death of a minor child is caused by the wrongful act, omission, or negligence of any person, persons, or corporation.” It surely was not intended to be used in the case of refrigeration failure for gametogenic materials, as stated by the dissent. Even the 1975 version, amended before IVF became a reality in 1978, should be inapplicable. Nevertheless, the Alabama Supreme Court applied it to deaths caused in the “cryogenic nursery” by considering the embryo to constitute a minor child and ruled that the statute “applies to all unborn children, regardless of their location.” 

Alas, the Alabamian view of abortion –holds life begins at fertilization  (and ends at death) and excludes embryos prior to implantation, rendering the state’s abortion laws at odds with the LePage ruling: Specifically, Alabama’s abortion ban defines abortion as a procedure that causes the death of an unborn child in utero; “it is a total ban on abortion …but [the statute]… specifically says in utero,” to make clear that it was not the legislature’s intention to interfere with IVF.

This Court has long held that unborn children are "children" for purposes of Alabama's Wrongful  Death of a Minor  Act…”

Language Matters

“Legal strategies that avoid alleging embryo personhood in tort cases are informed by the universal rejection of these claims in prior lawsuits. To-date, every court that has considered the wrongful death of an in vitro fertilization (IVF) embryo has rejected that claim on the ground that the term “person” or “human being” does not apply to frozen embryos under the meaning of state law.”

-Judith Daar, Dean and Professor of Law Chase College of Law.

So far, every court has rejected the notion of personhood applying to IVF-created embryos -- that is, until the Alabama case. While effectively overturned by the legislature, the shadow of the holding remains. According to Bloomberg Law, some 14 states “allow a cause of action for the wrongful death of an unborn child at any stage of development., and about a dozen have “fetal personhood laws.” Whether those laws will enable suits for IVF failures in the wake of the Alabama case remains to be seen.  

While many believe human life begins at conception, the rationale and the language used to explain matters will undoubtedly complicate things when it comes to novel fertility techniques. Calling the embryo a human being may trigger tort and personal injury liability, thereby also endangering embryo and stem cell research.

“Whether human embryos are human beings --- living members of the species Homo sapiens- is a question resolved by human embryology and developmental biology. It isn’t any more distinctly theological than the age of the earth is.”

- Robert P. George, Professor of Jurisprudence, Princeton

George defines human beings as living members of the Homo sapien species. But what about a human who has died? Per George’s definition, that corpse is no longer human. [5] His definition also contradicts the definition of personhood in at least half the states. It conflicts with the views of about 80% of Americans, The American Society for Reproductive Medicine Ethics Committee, and medical and biology texts.  I will leave it to our biologists to debate George’s views on embryology. However, his word choice will affect law, legislation, and court rulings and impact broader policy, including end-of-life decision-making, along with embryo and stem cell research.  Most recently, cryopreservation has been used to store ovarian tissues with egg fragments. Whether the anti-abortion bills and rulings will affect this use remains to be seen.

The message: we are so enamored with new science, so tantalized by the prospect of giving children to the childless, that we forged ahead, failing to consider the demons of societal discord and legislative controversy that unlocking Pandora’s box might produce. The conflicts between social views, law, policy, and its back-tracking signal that broad and integrated societal discussion is long overdue. Today’s fractious political climate does not lend itself to this exercise, but we will need to find a way. As awesome as this new technology is, it has generated an uncertainty at odds with the needs of individuals and business.

Most of all, language matters. The words we use, the terms we employ, and the very way we frame the issues in a legislative context, legal brief, or medical article impact the societal outcome and affect individual lives. 

 

[1]Three parents who “warehoused” their embryos learned of a mishap that caused the refrigerant to fail and the destruction of – what, until Feb. 16, the law regarded as – their property. Till now, these cases – even where egregious negligence was present- generally allowed only minuscule damages, if any. Interestingly, freezer failures are relatively rare in the UK, where IVF is regulated under the Human Fertilisation & Embryology Authority (HFEA)).

[2] Of the cases Fox identified, 87 involved freezer failures in California and Ohio. The others claimed comparatively nominal damages for breach of contract or warranty, product liability, unfair business practices, and miscellaneous tort. During this interval, 398,256 embryo-thaw procedures were reported.

[3] Bailment is a legal relationship between two parties where one person, the bailor, delivers goods to another person, the bailee, for a specific purpose. The bailor transfers physical possession to the bailee for a specific time while retaining ownership.

[4] Loss of chance is a legal doctrine that allows plaintiffs to seek compensation for their chance of recovery. In this case, the preservation of the gamete or embryo is unnecessarily diminished. Successful IVF is estimated to range between 10% and 50%; loss of the gametes or embryos reduces that to 0.

[5] Justice Alito, in Dobbs, called the fetus “the unborn human being