April 14, 2020 Feature

Infertility Treatments: Can the Law Keep Up with the Pace of Change?

Elizabeth Sparks

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A patchwork of unsettled legal theories and inconsistent oversight is leaving people seeking infertility treatment inadequately protected.

A patchwork of unsettled legal theories and inconsistent oversight is leaving people seeking infertility treatment inadequately protected.

Courtesy of BlackJack3D/E+ via Getty Images

Kim Kardashian and Kanye West, Sarah Jessica Parker and Matthew Broderick, Neil Patrick Harris and David Burtka, Gabrielle Union and Dwyane Wade are all celebrity faces of infertility. Union has spoken openly about her years of failed IVF attempts and her eventual turn to surrogacy. The others in the list have all relied on surrogates to grow or expand their families.

Because of these vocal celebrities, infertility has increasingly made headlines, normalizing what is a common but stigmatized reality for people trying to conceive, especially for those who begin that journey later in life. Culturally, we have been encouraged to wait to start our families. We are encouraged to wait and build our relationship, our careers, have financial stability and a plan for parenting in place. But the reality of this means a higher risk of infertility.

For college-educated, married women, the average age of first-time motherhood is 30. For those living in San Francisco or Manhattan, it’s 33. This fact highlights the ways that financial concerns impact starting a family in places with a higher cost of living. We are seeing this trend around the world. The average age for first-time motherhood in Japan, South Korea, and Switzerland is 31. But waiting means biological changes that can make conceiving difficult. In her 20s, a woman has between a 20 percent and a 25 percent chance of conceiving in any given month; by her early 30s this drops to between 15 percent and 20 percent, and by age 40, the drop is dramatic: a 5 percent chance of conceiving each month. And, for men, sperm count begins notably declining at age 40.

For people trying to conceive, facing infertility can be a distressing experience. Emotional tolls, economic considerations, and life changes can be traumatic. There are reevaluating life plans, financial burdens that can come from expensive treatments that may or may not be covered by health insurance, and other curveballs. On the other hand, with today’s medical and technological advancements, these unexpected turns are countered by how many remedies and treatments for infertility exist. And advancements and success rates are only increasing.

The question for our purposes is has the law caught up? Are there legal protections for people seeking treatments and surrogates and for those surrogates as well?

Legal Protections and Alternative Reproductive Technology

Infertility is commonplace, and the social stigmas and taboos that have long surrounded this reality have begun to dissipate in American culture. With more women, trans men, and nonbinary people attempting to access alternative reproductive technology (ART), concerns about the safety and efficacy of these technologies increase. For clinics that cater to non-celebrity clients, the cost is high. The starting price for egg freezing hovers around $8,000, while in vitro fertilization (IVF) costs an average of $11,000. Just storing a frozen egg or embryo for a year costs $600 . This financial burden can be staggering when successful, devastating when unsuccessful. As members of the legal community, we know that this falls in line with a need for the law to catch up—by providing protections to those using these technologies, to the clinics and hospitals providing them, as well as to any potential children.

IVF is a complex process, and, despite the best of intentions and multiple precautions on the part of practitioners, many things can and do go wrong. On March 3, 2018, at the University Hospitals Ahuja Medical Center in Cleveland, Ohio, temperature fluctuations caused thousands of stored eggs and embryos to thaw, leaving the genetic material that was being held totally destroyed. An estimated 700 couples were affected by the loss. Similarly, on March 4, 2018, a worker at the Pacific Fertility Center in San Francisco noticed that the nitrogen levels in one of that clinic’s freezing tanks were unusually low. The tank was immediately filled, and the tissues it contained were transferred to a different tank, but, even with mitigating interventions, an estimated 500 patients were affected by that system failure—having lost all or some of their stored eggs and embryos.

The repercussions of a loss of this magnitude are not only monetary but highly emotional. Imagine you decide that the time is right to start a family. Finding out that your body isn’t able, or your partner’s isn’t, could be damaging to a relationship on a good day. Consider now the compounded effect of getting through that, spending copious amounts of money, time, tears, hope, and prayer only to find out that the law hasn’t caught up and is still stumbling to find an appropriate way to compensate you if a nitrogen tank stops working somewhere. Perhaps now your chances for that family are lost, or, at the very least, lost in the way you had visualized them. This is a tremendous loss, and what transpired after the facilities failures in Cleveland and San Francisco indicates that this new and emerging area of the law is not yet in place to protect and compensate those who turn to this technology.

As a result of the Cleveland breach, a couple filed a class action lawsuit on behalf of the affected parties. Brickel, et al. v. University Hospitals Ahuja Medical Center, Cuyahoga Case No. CV 18 894332. The case posed a very important question: Is this medical malpractice? In answering this question, the legal protections for the affected individuals were unclear and untested. Because Ohio has a rule limiting medical claims, the suit had been brought on the basis of a breach of contract. University Hospitals Ahuja Medical Center filed a motion to dismiss based on the idea that all the claims within the plaintiffs’ filings fell under the definition of “medical claims.” This was tricky, as it was unclear whether or not this event constituted the type of event that would normally be litigated as medical malpractice. The legislative history of the Ohio rule in question indicated that it was intended to have a broad application in order to limit medical claims and their remedies.

Clearly the storage of embryos and eggs for IVF exists at all because of a potential medical procedure. All the genetic material that the hospital was storing was intended for use in medical treatment. This genetic material is not separate from or even incidental to that fertility service, but essential to it. However, perhaps out of an awareness that whatever precedent they set on this matter might have far-reaching repercussions for those struggling with infertility, the court denied the hospital’s motion. But, if not medical malpractice, what is this? Perhaps it is a destruction-of-property claim. This doesn’t feel adequate either, especially in light of the deep, emotional investments in one’s genetic material and the hope for a specific life that this material represents.

This led to trickier legal territory. Some of the plaintiffs wanted to pursue this matter as wrongful death. Of course, arguing this is a loss of life creates all sorts of problems when reconciled with abortion jurisprudence. This claim was ultimately rejected. As the judge in the case stated, we might be looking at something more like loss of potential life, and we just don’t have such a claim. So, how do we create claims that reflect this emerging intersection of law and medicine? It is a multi-faceted question—ethical, moral, jurisprudential, and also legislative.

There are currently between 450 and 500 fertility clinics operating in the United States and, at this point, the tank failures in San Francisco and Cleveland appear to be anomalies. This is likely because this type of storage tank technology generally has backup systems that prevent overall failure when an individual failure occurs. But just how irregular or uncommon are these breakdowns? University Hospitals Ahuja Medical Center and the Pacific Fertility Center are both large institutions subject to multilayer oversight—a combination of internal, state, and federal regulations. However, some smaller clinics lack this oversight, and it’s plausible that, without the safeguards and stopgaps in place at these two larger facilities, breaches occur but no one hears about them. In the aftermath of the incidents in Cleveland and San Francisco, some facilities undertook improvements to stave off similar failures, but no notable governmental intervention has occurred. There’s no individual government oversight agency. Instead, what exists is a patchwork of state and federal regulations, and the rest is filled in by industry standards. At least, this is the case in the United States.

In 1990, the UK created the Human Fertilisation and Embryology Authority, a governmental oversight division responsible for ensuring that fertility centers comply with UK law (https://www.hfea.gov.uk). The UK has limits on how many embryos can be implanted at one time via IVF, an important measure because more than half of all children born via IVF are part of a multiple birth. Multiple births carry increased risks for mothers and children, so a procedure that dramatically increases their likelihood should be subjected to government oversight. While increasingly common in European countries and Canada, such oversight is lacking in the United States. We have a National Assisted Reproductive Technology Surveillance System (https://www.cdc.gov/art/nass/index.html), implemented under the Fertility Clinic Success Rate and Certification Act of 1992, but this oversight division is mainly concerned with the accuracy of data and IVF success rates and less focused on safety.

Surrogacy and the Law

Another area where the law of infertility is struggling to keep up with market and technological demands is surrogacy. While many people use domestic surrogates for their pregnancies in the United States, both here and abroad there is a market for international surrogates. There are a variety of reasons for this, but cost and lack of oversight are primary factors.

This can be a problematic arrangement. Not all countries have in place vigorous (or even adequate) protections for surrogates and their families. International commercial surrogacy, such as the type we have seen in India, has increased in popularity over the years but is wrought with human rights concerns. The deleterious effects for marginalized women in India and other countries who provide this service to American people can be severe. In India, for example, surrogates are taken to dormitory-style facilities, where they await childbirth for the entirety of the pregnancy. They are separated from their families, including their own children, and their every move is monitored. These women and their families are far too vulnerable to be fully protected by what can be a greedy industry without the implementation of an international oversight system. The protection provided by the countries in which these women reside has been insufficient. That being said, India is an example of a country that has stepped in to regulate this industry after receiving negative attention for a lack of human rights protections for surrogate mothers. In 2019 the legislature there passed the Surrogacy Regulation Bill, effectively ending commercial surrogacy in what had previously been the commercial surrogacy capital of the world.

We are under the illusion that women in the developing world make these decisions of free will. This is an insulated view, based on our ideological, cultural understandings about contracts. The fact that a woman agrees to carry a child for someone in another country does not mean that her reasons for doing so are not so heavily weighted that the resulting decision is far closer to coercion than free will. The reality for most of these women is a level of poverty that we cannot fully comprehend in the United States. This type of poverty—and its resulting lack of choice—means that many of these women are not in a position to say “no” to a large sum of money, such as that received for surrogacy. The idea that there is free choice in these decisions ignores the intense pressures of the daily realities of life in the developing world.

Because women in the United States are getting a great benefit at very little cost (and here I do not refer simply to a monetary cost, but to a health and even life cost), the moral burden should shift to oversight on our end. This should mean establishing international industry standards as to the care of these women prior to, during, and after pregnancy, as well as providing care and protections for their families. Of course, the reality is that the implementation of these standards will result in higher cost, lowering the desirability of “reproductive tourism.” In other words, the result may mean that there is less incentive for American families to use this service and may result in domestic surrogacy being no more expensive than international. If this is the result, then that should also indicate to us the vast unfairness that likely existed before this implementation.

The Future of Infertility Treatments and the Law

The United States is facing a reckoning over how we deliver and receive health care. ART may be affected by changes to our health care industry in the future. If our insurance industry shifts, changes, or is eliminated, how might these modifications affect the use of these technologies? There are many unknowns. What we do know is that what exists now is a patchwork of unsettled legal theories and inconsistent oversight, leaving people seeking infertility treatment inadequately protected. The Cleveland case has resulted in 150 settlements so far, with others pending. It will certainly act as a pivotal moment for the law in this area, but, as is often the way, little is settled at this point, and the law is still playing catch-up.

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Elizabeth Sparks, JD, LLM, is a human rights advocate and scholar who writes on women’s health, focusing on issues of reproduction and other areas of feminist jurisprudence. A documentary filmmaker and musician, she has toured and released albums under the nom de plume Liz Capra. She lives in Southern California with her partner and four children, where she teaches law in an adjunct capacity.