Advancements in fertility medicine have allowed people to achieve their dream of parenthood as never before. While scientific advancements have made fertility medicine more accessible, the same advancements have opened the door to uncharted legal territories. As assisted fertility treatments such as in vitro fertilization become more common, so do instances in which the treatment goes unthinkably wrong, with catastrophic consequences. Unfortunately, patients who suffer from reproductive negligence have few options for recourse as the current legal system does not adequately protect against this form of injury. The evolving medical landscape necessitates a more robust system of legal accountability and regulation of the fertility industry than that which currently exists. This article will discuss the current lack of fertility industry oversight, emergent problems and possible causes of action for victims of fertility negligence.

While fertility medicine encompasses many types of treatment, this article will focus on one of the most common: in vitro fertilization. In vitro fertilization (IVF) is an assistive fertility treatment method that combines a woman's egg and a man's sperm in a laboratory to create a fertilized embryo. The embryo(s) are then transferred to the uterus in hopes of a viable pregnancy. The egg and sperm come from either the hopeful parents themselves or from donors. Likewise, the fertilized embryo may be implanted in the biological mother or a gestational surrogate. The process of in vitro fertilization is physically invasive, emotionally taxing and financially demanding. To increase success rates, doctors select the healthiest embryos for implantation and may freeze unused embryos through a process called cryopreservation.

Legal Issues

In the United States, IVF is performed at fertility clinics that vary widely in size and in the services they provide. Some clinics associate with large hospitals while others are private clinics run by specialized medical personnel. Regulations and standards of care vary from state to state and federal oversight remains minimal. This lack of accountability lets errors go unchecked and leaves patients vulnerable to harm.

Furthermore, patients who are harmed due to negligence or misconduct in their fertility treatment currently have few options for redress. Dov Fox, director of the Center for Health Law Policy & Bioethics at the University of San Diego School of Law and one of the premier scholars on this issue, observes that in the absence of property loss or physical injury, reproductive negligence amounts to little more than disrupted family planning in the eyes of the law. However, as incidents of reproductive negligence come to light as never before, the time has come to recognize the legal rights of patients who suffer from this type of wrongdoing. The following types of injuries represent just a few of the potential quandaries faced by IVF patients.

IVF Mix-Up Cases

In July 2019, a California couple learned that their biological child was born to another couple living in New York City. Both couples had had their embryo transfers on the same day at the same California fertility clinic, CHA Fertility Center. The California couple's transfer failed, while the New York City couple's transfer led to a pregnancy of twins. When the twins were born, a DNA test showed the children were not genetically related to each other nor the birth parents. One of the twins was the embryo from the California couple, and the other twin was from a third couple. This mix-up resulted in multiple lawsuits and untold trauma for the patients involved. One couple was forced to surrender the children they thought were their own; the other couples were informed that their babies had been carried and cared for by strangers on the other side of the country.

As shocking as this scenario may be, it is certainly not the first case involving erroneous implantation. In 2004 a California woman undergoing IVF was mistakenly implanted with someone else's embryo, a fact not revealed until the child was 10 months old. The embryo Susan Buchweitz received belonged to a married couple and consisted of the husband's sperm and a donor egg. While doctors knew of the mistake at the time of implantation, the three parents were not informed until a whistleblower issued a complaint. The married couple, to whom the embryo belonged, fought for custody. The judge eventually granted partial custody to the boy's biological father and to Bucheweitz (by the time this decision came down, the boy was 3 years old). The man's wife, for whom the embryo was intended in the first place, had no legal claim to the child. Because of the doctor's mistake—and deliberate decision not to inform his patients—Bucheweitz was forced to share custody of the child with his biological father, a stranger. She was awarded $1 million in damages after filing a malpractice lawsuit.

We do not know how often these kinds of mistakes occur. In the absence of racial discrepancies or other obvious clues, it is entirely possible for IVF mistakes to go undetected. What's more, when IVF mix-ups result in court battles, there is no definitive answer as to who should have custody of the child, and state laws vary widely.

Destroyed Embryos

In March 2018, 4,000 frozen embryos were lost as a result of a freezer tank failure at University Hospitals Fertility Center in Cleveland, Ohio. Hundreds of would-be parents, including some cancer survivors who preserved their embryos before chemotherapy left them sterile, lost their hope of having children. Days later, a storage tank malfunction occurred at Pacific Fertility Center in San Francisco, California, resulting in the loss of additional thousands of eggs and embryos.

These failures further illustrate the lack of regulatory oversight of fertility centers and their equipment. While the Food and Drug Administration (FDA) regulates medical devices, the tanks used for storing cryopreserved eggs and embryos are not marketed as medical equipment by their manufacturers.

Abuse and Fraud by Doctors

In the 1970s and 1980s, Indianapolis fertility doctor Donald Cline used his own sperm, rather than that of donors, to impregnate patients, without their knowledge or consent. The count of the doctor's biological children is more than 50. What is even more shocking, Indiana had no law that specifically prohibited the doctor's use of his sperm in patients. Cline lost his medical license and received a $500 fine after being found guilty of felony obstruction of justice for denials he made of the allegations.

However, in 2019, some states finally began taking action. With the passage of Act 174, Indiana became the first state in the country to allow victims of this kind of negligence to seek damages in a civil lawsuit. The law also increases the penalty for fertility deception from a misdemeanor to a Level 6 felony. Soon after, legislators in Texas passed a law that criminalized doctors' use of their own sperm in patients, classifying it as a form of sexual assault. Similar bills have been proposed across the country.

Legal Remedies

For patients who suffer harm from the aforementioned types of errors, the law offers a narrow path to justice. Causes of action for victims such as breach of contract, property loss, medical malpractice or negligent infliction of emotional distress do not adequately address these kinds of injuries. Contract law provides little protection as reproductive clinics seldom make promises about their ability to bring about a specific result, and in many cases require patients to sign a liability waiver. Claims for loss of property devalue the injuries caused by reproductive negligence; damages based on the cost of replacing a destroyed embryo do not come close to compensating for the loss of potential procreation. Medical malpractice actions require plaintiffs to demonstrate that substandard care resulted in a bodily injury, something that is sometimes missing from even the most egregious cases of reproductive negligence. Even a claim for negligent infliction of emotional distress is unlikely to succeed without accompanying physical or economic damages.

Fox argues that existing legal remedies do not provide adequate protection, and instead proposes a new paradigm for defining and addressing reproductive wrongs. Fox divides reproductive wrongs into three categories: procreation imposed, procreation deprived and procreation confounded (when reproductive negligence frustrates parents' plans to have not just any child, but one with particular genetic traits). He defines causes of action for each of these categories, and a framework for determining damages based on the severity of the injury and the extent to which misconduct is responsible for having caused the injury.

The time has come for law and policy to catch up to the advancements made in fertility medicine and technology. The changes required to protect patients and parents in this new landscape are twofold: First, the fertility industry must have the kind of careful regulatory oversight that exists in other areas of medicine, including regulation of its equipment and standard reporting on adverse events at fertility clinics. Second, we need a new framework through which victims of reproductive negligence or fraud may seek damages, such as the model Fox proposes. These changes will not only bring restitution for those who have suffered, but they will also improve the safety and standard of care for this branch of medicine.

Conclusion

The medical, legal and ethical issues raised in this article represent the proverbial tip of the iceberg when it comes to the future of assisted reproductive medicine. Advancements in fertility medicine transform our world and make the impossible possible for families around the globe, but they also present a host of complex legal challenges that we must navigate. While misconduct and negligence in assisted reproductive medicine went undiscovered in the past, the advent of home DNA testing such as 23andMe and Ancestry.com have made it more difficult to keep these offenses secret. Revelations of past misconduct, along with increased use of assisted reproductive technology, make it clear that the time for change has come. The fertility industry requires the careful oversight that exists in other areas of medicine, and patients who suffer from fertility negligence deserve a path to justice.

Marion Munley, of Munley Law, is a board-certified personal injury lawyer and passionate advocate for victims' rights. She focuses her practice on commercial truck accident and products liability cases.