- I. Introduction
- II. Industry Misconduct
- III. Regulatory Failure
- IV. A Legislative Solution
- A. Regulation Through Litigation
- B. Statutory Tort Liability
- C. Policy Choices Based on Political Considerations
- V. Conclusion
- Appendix I: The Model Statute
- Appendix II: Note on the Inappropriateness of Discounting Damages
In recent years, an estimated 170,000 women in the United States undergo artificial insemination annually using donated sperm or receiving donated eggs or embryos. However, not all these women get what they bargained for. Misrepresentation of donor information by reproductive tissue providers results in the birth of children with disabling medical conditions inherited from donors. In some cases, these children need extensive medical care, psychological therapy, and support services—the costs of which represent a significant financial burden for their families. Although no entity collects aggregate data that could support a reliable estimate of the full extent of misrepresentation by reproductive tissue providers, anecdotal evidence—from news articles, medical journals, court filings, and patient information websites—suggests that it is common and persistent.
When it comes to addressing this problem, the legal system has failed miserably. Inadequate regulation of reproductive tissue providers has left parents vulnerable to various forms of industry misconduct—ranging from sloppy screening procedures to outright fraud. And courts in some jurisdictions have dismissed legal claims seeking compensation for injuries resulting from such conduct and their associated financial burdens. Adding insult to injury, judges have criticized parents who sue, accusing them of implying—by filing a lawsuit—that the life of their child constitutes a legal harm.
This Article proposes model legislation that would eliminate doctrinal obstacles to holding unscrupulous reproductive tissue providers liable. These doctrinal obstacles have blunted the capacity of civil liability to deter misrepresentation by reproductive tissue providers and deprived parents of compensation for the resulting financial burdens when injury occurs. By making it easier for parents to bring tort claims, this Article aims to jump-start more effective government oversight and industry self-regulation. As a range of case studies have shown, litigation is a powerful tool for framing problems in terms of institutional failure, uncovering policy-relevant information, and influencing the agendas of both public and private decision makers. Even just a handful of high-stakes, high-profile tort claims against reproductive tissue providers can spur regulatory agencies and trade associations to protect reproductive tissue consumers.
The Article proceeds as follows. In Part II, we present a specific case of misrepresentation by a sperm bank and its impact on numerous families. We rely on this example, as well as aggregate data on artificial insemination in the United States, to convey the nature and scope of the problem. In Part III, we examine the inadequacy of current regulatory responses to the problem, explaining the failures of industry self-governance, government regulation, and tort liability. In Part IV, we argue that removing obstacles to tort liability is the key to effective regulatory governance of the reproductive tissue industry. We also specify the doctrinal reforms in the model legislation we propose, and we address potential sources of political opposition. The full text of the model statute appears in the Appendix.
II. Industry Misconduct
On October 18, 2000, James Aggeles walked into the offices of Atlanta-based sperm bank Xytex and offered to donate his sperm. He was a handsome man, six-feet-four-inches tall, with blue-green eyes and wavy brown hair. He presented himself as the ideal sperm donor, telling the Xytex employee who interviewed him that he possessed multiple academic degrees, was working toward a Ph.D., had a clean medical history, and had no criminal record. After a quick physical examination to check for physical deformities, he was assigned the donor number 9623 to protect his anonymity.
Xytex started selling Aggeles’s sperm immediately and continued to do so for the next sixteen years. The company touted him to potential buyers as “one of the[ir] most popular . . . donors [whose] sperm was rarely available” and “a man of high integrity, extremely intelligent, and college educated.” Through Xytex’s sales of his sperm, Aggeles became the biological father of at least thirty-six children.
In fact, almost nothing Aggeles told Xytex was true. He had just dropped out of college and was working as a janitor. His medical records contained diagnoses of schizophrenia, narcissistic personality disorder, drug-induced psychotic disorder, and grandiose delusions. He had been hospitalized for these conditions for extended periods as an adult at least twice. He had a criminal record that included multiple arrests for burglary, trespassing, DUI, and disorderly conduct. During his time as a sperm donor for Xytex, Aggeles was periodically admitted to psychiatric treatment centers for suicidal outbursts and psychotic episodes. He also served eight months in jail for burglary in 2005.
Throughout this time, Xytex promoted itself as “an industry leader in reproductive services with a commitment to unsurpassed quality controls.” The company’s website represented that trained counselors investigated donors’ personal and family health histories. Xytex assured prospective parents that donors underwent medical, psychological, and genetic evaluations with follow-up testing every six months and that it would update them with any new medically significant information about donors. However, in addition to failing to investigate any of Aggeles’s initial representations, upon discovering the truth about him in 2014, Xytex never informed parents who had conceived children with his sperm. Worse yet, the company continued to sell his sperm to eager buyers.
Despite Xytex’s failures to disclose, many parents who purchased Aggeles’s sperm eventually discovered the truth. Since 2014, plaintiffs have filed more than a dozen lawsuits against Xytex, alleging that the company’s misrepresentations caused genetic abnormalities in children conceived with the sperm, which burdened their families with the costs of treating a variety of resulting adverse health conditions. Plaintiffs’ theories of recovery have included fraud, negligent misrepresentation, professional negligence, product liability, breach of warranty, unjust enrichment, and unfair trade practices.
In Georgia, where most of the cases were filed, courts initially dismissed the lawsuits, reasoning that the plaintiffs’ claims amounted to claims for wrongful birth, a cause of action rejected by the Supreme Court of Georgia in 1990. Subsequently, in 2020, the Supreme Court of Georgia held that some of the causes of action could go forward. According to the court, the bar on wrongful birth claims precludes only claims for damages that characterize the life of the child as an injury. However, the court’s holding allows for only very limited damages—for example, “the difference in price between the cost of the sperm they received and the fair market value of the sperm that Xytex told them they were getting”—which are not nearly enough to compensate plaintiffs for the costs that they incurred due to Xytex’s behavior, to deter Xytex from engaging in similar conduct in the future, or to finance further litigation.
Xytex’s misrepresentations have traumatized many of the families who relied on them. For example, Georgia couple Wendy and Janet Norman purchased Aggeles’s sperm from Xytex and used it to conceive a son, born in June 2002, who suffers from Attention Deficit Hyperactivity Disorder (ADHD) and an inherited blood disorder that was not attributable to his biological mother. By the age of fifteen, the child had been hospitalized multiple times for extended periods for suicidal and homicidal ideations, uncontrollable behavior, erratic mood swings, and depression. His parents discovered that he “frequently searched the Internet for ways to kill his brother, and himself.” For years, his treatment included regular sessions with a therapist and a psychiatrist, antipsychotic medication and antidepressants, and almost constant supervision to monitor his behavior and mood. Since 2014, plaintiffs, including the Normans and at least eleven other families who conceived children with Aggeles’s sperm, have filed more than a dozen lawsuits against Xytex, alleging that the company’s misrepresentations caused genetic abnormalities in their children, burdening their families with ongoing costs of treating a variety of resulting adverse health conditions.
These families’ experiences exemplify the devastating effects of misrepresentation by reproductive tissue providers. Available data suggest that hundreds of thousands of families are at risk. Although no comprehensive registry of artificial insemination in the United States exists, a recent academic study estimated that between the years 2015–2017, over 440,000 women underwent artificial insemination with donor (i.e., non-spouse) sperm. The last official estimate of live births from donor insemination in the United States occurred in 1987 and calculated approximately 30,000 live births, although the current figure is probably about double that number. As for donated eggs and embryos, according to data collected by the Centers for Disease Control and Prevention (CDC), about 12,800 children were born in 2018 in the United States from donated eggs or embryos. Thus, combining the estimated numbers of donor-conceived persons (from non-partner sperm, eggs, or embryos) indicates that each year at least about 68,000 children are born from donated reproductive tissue in the United States.
Dov Fox, a leading expert in the industry, characterized mix-ups of reproductive tissue by fertility clinics as “shockingly common.” He adds that “[t]he most comprehensive study of U.S. fertility clinics, for example, found that more than one in five report errors in diagnosing, labeling, and handling donor samples and embryos for implantation.” Nascent reproductive technologies and demographic trends suggest that the problems of fraud and misrepresentation in the industry are likely to get worse.
III. Regulatory Failure
The problem of misrepresentation by reproductive tissue providers arises out of market failure due to information asymmetries between sellers and buyers. In markets where buyers desire products with attributes that are not easily discernable from a product’s appearance, unscrupulous sellers may be tempted to misrepresent the presence of “credence qualities” to charge the premium associated with such qualities without having to pay the cost of providing them. Moreover, by reducing the price they charge, unscrupulous sellers can make phony goods more attractive to buyers than genuine goods while still obtaining a portion of the premium associated with genuine goods. Left unchecked, this dynamic can lead to adverse selection, whereby phony goods price genuine goods out of the market.
Asymmetric information concerning donors and how they are vetted enables reproductive tissue providers to cut corners on verifying donor information or, worse, intentionally mislead buyers. As artificial insemination becomes a more common and familiar option for women seeking to conceive, sellers who forego quality controls or intentionally mislead buyers may begin to outcompete more reliable sellers. Some donors have even begun to offer sperm at lower prices than sperm banks by selling directly to buyers, foregoing the overhead costs of operating a sperm bank.
Remedies for this type of market failure typically include private governance, government oversight, and tort liability. However, in consumer markets for reproductive tissue, all three have, so far, been inadequate. In this part, we explain why.
A. Private Governance
Nongovernmental entities often play a significant role in protecting consumers. Trade associations implement accreditation systems, professional organizations define best practices, and auditing firms certify standards conformity. However, in the context of assisted reproduction, these forms of private governance do not adequately address the problem of misrepresentation by reproductive tissue providers.
In many industries, voluntary accreditation systems erect a barrier to market entry or create eligibility for benefits, both of which can incentivize widespread adherence to quality and ethics standards. Unfortunately, such incentives are missing from the voluntary accreditation regimes that govern tissue banks and fertility clinics. Two trade associations provide this accreditation. The American Association of Tissue Banks (AATB) accredits tissue banks. The Society for Assisted Reproductive Technology (SART) accredits fertility clinics providing in vitro fertilization (IVF) services.
AATB accreditation requires that donor suitability be evaluated based upon medical and social history, a physical examination, and laboratory tests. Donor evaluation under AATB standards includes assessment of potential donors for “any history of chemical and/or radiation exposure as well as family medical history and genetic background.” AATB standards also specifically mandate that donor evaluation be conducted by a person knowledgeable in clinical genetics, that the evaluation includes at least three generations of the donor’s family history, and that donors age be limited to forty years for semen donors and thirty-five years for egg donors. AATB standards hold that “[a]ny significant condition in a prospective donor or donor’s family history that would pose a risk of producing an offspring with a serious genetic disease or defect greater than the risk in the general population shall disqualify him/her as a donor” and that if there is an indication of risk of Tay-Sachs disease, Thalassemia, sickle cell anemia, or cystic fibrosis in the donor’s medical history, family history, or ethnic background, the donor should be tested for these conditions.
However, these standards lack teeth. AATB accreditation does not serve as a barrier to entry for tissue banks. As of July 2021, more than 1,600 entities engaged in storage of human tissue were registered with the U.S. Food and Drug Administration Human Cell and Tissue Establishment Registration. AATB membership consisted of only 120 registered entities internationally. Moreover, the sole sanction for noncompliance with AATB standards is withdrawal of accreditation, which occurs rarely. The conflict of interest that arises from the organization’s dependence on membership fees from the tissue banks it accredits disincentivizes rigorous oversight.
Furthermore, the AATB provides two “tiers” of membership: full membership for accredited institutions and “affiliate membership,” which is open to “any company or organization that shares [the AATB] vision, but is not eligible for accreditation.” In other words, tissue providers who are unable to meet AATB standards, may still be—and present themselves as—“affiliated” with the AATB. Consumers, to the extent that they are even aware of the AATB and interested in tissue providers’ membership status, are unlikely to be aware of this distinction in membership type and its implications. Thus, the branding benefits provided by AATB membership are available even to tissue banks that do not adhere to the organization’s accreditation standards.
SART describes itself as “the primary organization of professionals dedicated to the practice of IVF.” According to the CDC, of the 456 fertility clinics providing IVF services in the United States in 2018, 80% (about 365) were members of SART. SART requires all its members to also join the American Society of Reproductive Medicine (ASRM) and adhere to all ASRM Guidelines. SART’s primary focus, however, appears to be the advertising of its members’ IVF services to potential clients seeking such services.
According to the SART website, the society provides accreditation of embryology laboratories every two years and validates data submitted to CDC under the Fertility Clinic Success Rate and Certification Act of 1992 by approximately 8–10% of all IVF clinics each year. Just like the AATB, the sole sanction for noncompliance with SART standards is withdrawal of accreditation. The organization provides no publicly available data regarding compliance of its members with ASRM Guidelines or specific cases of denial or withdrawal of accreditation.
2. Professional Standards
Professional organizations frequently set minimum or best practice standards for a profession. Minimum standards define professional malpractice, and best practice standards set a benchmark for excellence. ASRM and the SART have issued standards of practice for assisted reproduction in numerous comprehensive guideline documents for their members.
The ASRM Guidelines require, for example, that sperm donors be less than forty years old and oocyte donors between twenty-one and thirty-four years old; strongly recommend psychological evaluation by a qualified mental health professional; forbid any owner, operator, or employee of a reproductive tissue provider to serve as donor; and hold that “[g]enetic screening for heritable diseases should be performed in potential . . . donors,” including for cystic fibrosis in all donors and for other genetic testing “as indicated by the donor’s ethnic background in accordance with current recommendations after obtaining a proper family history.” The guidelines further require that “[d]onors should be healthy and give no history to suggest hereditary disease” and that donors undergo medical evaluation “[b]efore acceptance, and every 6 months while remaining an active donor.” However, membership in ASRM is not in any way conditioned upon compliance with ASRM Guidelines, and ASRM does not seem to employ any mechanism for verifying or enforcing compliance.
3. Third-Party Verification
Third-party certification marks on product labels attesting to a wide variety of credence qualities are now commonplace. Examples include fire-safe home appliances, environmentally sustainable lumber, and gluten-free food products. Sellers typically obtain third-party certification in response to consumer demand or as a means of diffusing political pressure for more stringent government regulation, or a combination of the two.
Sellers of reproductive tissue currently lack these motivations for providing third-party verification of donor information and credentials. There are at least two plausible explanations for the lack of consumer demand in the donated tissue market. First, ignorance, emotional vulnerability, and aggressive marketing by reproductive tissue providers may make consumers credulous. Second, given the limited supply and high demand for donated reproductive tissue, consumers may lack the bargaining power to insist on verification. Additionally, as the next section explains, little political pressure for more stringent government regulation currently exists to motivate sellers of reproductive tissue to opt for private third-party verification as an alternative.
B. Government Oversight
Licensing and product approval are common ways that government agencies regulate professional services, medical care, and biomedical products. Federal law requires that all human tissue providers be registered with the U.S. Food and Drug Administration (FDA). Additionally, some states require sperm banks to obtain a license. However, these federal and state efforts fall far short of what is needed to address the problem of misrepresentation.
1. Federal Regulation
On the federal level, only two statutes directly address relatively narrow aspects of the reproductive tissue industry. The first is the Clinical Laboratory Improvements Amendment Act of 1988 (CLIA), which sets manufacturing standards for entities handling human tissue, including sperm, eggs, and embryos. CLIA, however, does not impose any specific requirements for the sale of reproductive tissue. It is entirely silent regarding the screening and testing of donors.
The second statute is the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), which mandates that clinics offering fertility services report success rates of IVF treatments to the CDC. However, these reporting requirements do not apply to procedures in which only sperm is being used in a fertility treatment. Moreover, the Act includes no sanctions for noncompliance with these limited reporting requirements.
The FCSRCA imposes no safety requirements on reproductive tissue providers. Indeed, the Act explicitly forbids the FDA from “establish[ing] any standard, regulation, or requirement, which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.” Instead, the FCSRCA makes a cursory nod to the need for additional regulation of the reproductive tissue and fertility industry by instructing the CDC to develop a model voluntary program for the accreditation of fertility clinics performing IVF to be carried out by the states. In 1999, seven years after the enactment of the FCSRCA, CDC published its voluntary model program for the accreditation of fertility clinics. Congress, however, has not allocated any federal funding to incentivize states to join the CDC program. Consequently, no state has joined the program.
Aside from these two statutes, a third body of federal law that applies to the reproductive tissue industry is the FDA’s Human Cells, Tissues, and Cellular and Tissue-Based Products, a.k.a. “the Human Tissue Regulations.” The Regulations, which the FDA issued incrementally between 2001 and 2005, and three guidance-for-industry documents that followed them in 2007, create a comprehensive regulatory scheme for entities involved in the recovery, processing, and distribution of human tissue. The Human Tissue Regulations require any such entity operating in the United States to register with the FDA and impose on such entities requirements pertaining to screening and testing of human tissue for infectious diseases.
However, the Human Tissue Regulations do not impose any requirements for screening and testing of donated tissue for genetic diseases. The reason for this intentional omission is the FDA’s belief that it lacks the necessary authority to regulate aspects of the assisted reproductive technology (ART) industry that do not involve communicable diseases and that such regulation ought to be left for the states. It is not clear why exactly the FDA has reached that conclusion. One possible explanation is that the agency was wary of the FCSRCA’s prohibition on FDA regulation of any aspects of the ART industry that would have the effect of regulating the practice of medicine. Whatever the reason, the Human Tissue Regulations do not require that providers evaluate donors for heritable diseases or genetic conditions; nor do they set limits on the age of donors.
2. State Regulation
State regulation of the ART industry is very limited. Colorado and New York are the only states that specifically regulate reproductive tissue providers. Colorado’s recently enacted Donor-Conceived Persons and Families of Donor-Conceived Persons Protection Act, the first of its kind, requires that, starting January 1, 2025, reproductive tissue providers collect, maintain, and release to donor-conceived persons who are at least eighteen years old or the parents of donor-conceived persons who are minors the medical histories of their gamete donors. The Act further requires reproductive tissue providers to make “a good-faith effort to maintain current contact information and updates on medical history of [donors] by requesting updates from the donor at least once every three years.” It sets a limit of twenty-five families, in or outside of Colorado, using a single gamete donor (with no limit on the number of children conceived by each family), sets a minimum (but no maximum) age limit of twenty-one years for gamete donors, and subjects reproductive tissue providers to inspections for compliance with the Act’s requirements. Noncompliance with the Act would subject a reproductive tissue provider to a corrective action plan and follow-up inspections to ensure the plan’s implementation as well as to civil penalties. Continued noncompliance may result in a denial or revocation of a reproductive tissue provider’s license. Uniquely, the Colorado Act also directly references the guidelines of ASRM and requires reproductive tissue providers to follow these guidelines as they pertain to collection, maintaining of records, and reporting of donor medical history information.
New York’s Tissue Banks and Nontransplant Anatomic Banks Regulations include hygiene, labeling, and consent standards regarding the collection, storage, and disposition of reproductive tissue. However, the Regulations do not impose any requirements for screening and testing of reproductive tissue. Notably, pending legislation in New York would require reproductive tissue providers to collect, verify, and store donor information related to “any genetic disorders, infectious diseases, mental disabilities and/or serious mental illnesses,” including any family history of such conditions, and to disclose this information in writing to purchasers of donated reproductive tissue as well as to donor-conceived persons with the consent of their parents or once they turn eighteen. Violation of these requirements would be punishable as a violation of the state’s public health law and may result in the revocation or suspension of a reproductive tissue provider’s license to operate. If enacted, the New York statute will be the first in the nation to require verification of donor medical information.
A few states have recently passed laws governing other issues related to donated reproductive tissue. In 2015, Utah enacted a law granting donor-conceived persons access to existing nonidentifying medical information regarding their biological parents. In 2018, Arizona passed a law governing the disposition of embryos in cases of spousal disputes. Subsequent to several highly publicized instances of fertility doctors using their own sperm to inseminate scores of women, some states passed fertility fraud laws (e.g., Indiana and Texas in 2019).
Two reasons might explain the absence of state screening and testing requirements for reproductive tissue. First, most state regulators lack the necessary scientific expertise and enforcement resources to regulate these aspects of the industry. Second, we presume that interest groups, including state medical associations and chambers of commerce, have successfully lobbied to prevent the imposition of regulations, which they likely view as too costly.
C. Tort Liability
Tort liability offers a third way to prevent misrepresentation by reproductive tissue providers. In theory, liability for fraud would deter reproductive tissue providers from intentionally misleading buyers. Additionally, liability for negligent misrepresentation would incentivize reproductive tissue providers to take reasonable measures to verify donor information. However, courts in many jurisdictions have shielded reproductive tissue providers from liability.
The lawsuit by Wendy and Janet Norman against Xytex, mentioned in Part II, offers an example. In that case, the Supreme Court of Georgia rejected the Normans’ claims for the cost of treating disabilities that their son inherited from the sperm donor whose information the sperm bank, Xytex, had misrepresented. The court held that, insofar as a sperm bank’s misconduct results in the birth of a child, recovery for any costs associated with raising the child would require characterizing the life of the child as a legal injury, which the court was unwilling to do.
In Norman v. Xytex Corp. (Norman III), the court reaffirmed its long-standing rejection of wrongful birth claims—meaning any claim arising out of a lost opportunity to avoid the birth of a child. Typical claims of wrongful birth are those brought by parents who, through the malpractice of a physician, are deprived of an opportunity to terminate a pregnancy that results in the birth of a disabled child. In the Norman III case, the Supreme Court of Georgia extended its categorical rejection of wrongful birth to claims arising out of misrepresentations by a reproductive tissue provider that deprived parents of an opportunity not to conceive in the first place.
In the Norman III case, the Supreme Court of Georgia did not entirely close the door to recovery. It held that the Normans could recover “damages for the difference in price between the cost of the sperm they received and the fair market value of the sperm that Xytex told them they were getting”—which amounted to approximately $1,600. It also held that the Normans could recover for any additional treatment expenses caused by Xytex’s wrongful failure to disclose information after the child’s birth, although such additional expenses are difficult to isolate from the general expenses of treatment due to the disability and are likely to be a small fraction of the total. Even allowing for punitive damages in the most egregious cases of fraud—which would be constitutionally capped at ten times the amount of compensatory damages—the resulting liability exposure for misrepresentation is likely, at best, to create a weak deterrent to a lucrative form of misconduct.
Although the barriers to recovery are perhaps starkest in Georgia—because the state’s supreme court has expressly foreclosed most claims—the problem is by no means limited to Georgia. Many other states also reject wrongful birth claims, suggesting that tort liability for misrepresentation by reproductive tissue sellers may also be unavailable or insufficient in those jurisdictions to deter misrepresentation by reproductive tissue providers. Further, even in those jurisdictions where wrongful birth cases are not foreclosed, traditional tort doctrines related to causation and damages make recovery difficult. Consequently, this problem requires a legislative solution.
IV. A Legislative Solution
We propose a statutory solution to address the problem of misrepresentation by reproductive tissue providers. Our model statute relies on expanded tort liability as a first step in developing a response to misrepresentation by reproductive tissue providers that includes more effective private governance and more robust government oversight. In this part, we justify our focus on expanded tort liability, discuss the political landscape of the reform we suggest, and analyze key provisions of our model statute.
A. Regulation Through Litigation
Tort liability can play a transformative role in overcoming regulatory failure. Our model statute is designed to encourage litigation and increase liability exposure in cases involving misrepresentation, both of which we believe are likely to enhance the regulation of reproductive tissue providers.
1. The Litigation Process
The litigation process—filing complaints, conducting civil discovery, and engaging in motion practice—can improve the regulatory performance of government and private entities. Here is how it works: Plaintiffs typically seek to recover sizeable damage awards from wealthy or well-insured institutional defendants. Consequently, they frame complaints in terms of grave injury caused by egregious institutional failure.
Stories about grave injury and egregious institutional failure are highly attractive to journalists, and they typically attract considerable media coverage. Given the protracted nature of litigation, this coverage often tends to be ongoing and episodic. Through this media attention, tort claims frame public policy issues in terms of a need for institutional reform, and media coverage of ongoing litigation places those issues before the public and policymakers. Tort litigation and the media coverage it generates also frequently mobilizes victims to organize and lobby for reforms. Moreover, civil discovery can compel defendants to disclose policy-relevant information that government regulators may not have attempted or been able to obtain.
These framing, agenda, mobilization, and information effects of the litigation process can influence the perspectives of legislators, administrative agencies, corporate executives, trade associations, and professional organizations and motivate them to develop and implement institutional reforms. In some instances, media coverage of tort litigation has been forceful enough to move the nation’s most powerful and wealthy industries and end decades of legislative deadlock, administrative ossification, and corporate impunity.
For example, lawsuits on behalf of sexual assault victims against institutions that provide youth services—such as schools, churches, and scouting organizations—have prompted more rigorous oversight of teachers, pastoral workers, and troupe leaders by administrators, as well as government investigations and prosecutions. High-profile lawsuits against food manufacturers have spurred reforms in government food safety regulation and industry supply chain management throughout the food system, from the cultivation of fresh produce to meat production. A study of police departments that reviewed litigation files to identify personnel and policy weaknesses found that “[l]awsuit data has proven valuable to these departments’ performance-improvement efforts: suits have alerted departments to incidents of misconduct, and the information developed during the course of discovery and trial has been found to be more comprehensive than that generated through internal channels.”
We believe that tort litigation against unscrupulous reproductive tissue providers could have a similar effect.
2. Liability Exposure
Liability exposure deters wrongdoing by incentivizing industry professionals to comply with government regulations, conform to industry standards, and adhere to their own company policies. The key to operationalizing these tort incentives is liability insurance. Insurance has traditionally been understood as a means of pooling risk to shield policyholders from the potentially ruinous financial consequences of unexpected harms. One downside of insurance is that by relieving policyholders of financial responsibility for accidents, insurance eliminates an important incentive for them to exercise care, which could increase the risk of accidents. Economists refer to this as the problem of moral hazard.
To address the problem, insurance providers frequently create new incentives for policyholders to reduce risk. As insurance scholars Tom Baker and Rick Swedloff explain: “Once an insurer underwrites a risk, the insurer has every reason to try to reduce its payouts by encouraging insureds to prevent the potential loss from materializing. That can, and sometimes does, lead insurers to attempt to regulate loss-producing activities.” Numerous case studies describe how insurers employ a variety of techniques to reduce risk. These techniques include premium discounts for policyholders who adopt precautions, coverage exclusions for high-risk activities, and loss-control advice about how to avoid accidents that might give rise to claims.
In designing these incentives to avoid liability, insurance underwriters look to the standard of care employed by courts in deciding tort claims. Courts frequently rely on regulatory requirements, trade and professional association standards, and individual company policies to determine the standard of care in deciding tort claims. Liability insurance has the capacity to penetrate deeply into an industry. Whereas government agencies, industry associations, and professional groups have limited resources to monitor industry safety practices and respond to noncompliance, insurance companies reap additional premiums and enjoy economies of scale as the number of clients they oversee grows.
A few highly publicized lawsuits can be enough to motivate industry members to purchase liability insurance. Numerous case studies have documented the impact of liability insurance in reducing auto accidents, medical errors, police misconduct, legal malpractice, cybersecurity breaches, and foodborne illness. We believe that, by increasing liability exposure, insurance liability is likely to play a similar role in reducing misrepresentation by reproductive tissue providers.
3. Leveraging Regulatory Reform
This brief discussion illustrates how tort litigation and liability exposure can contribute to regulatory governance alongside government and industry efforts. This is a story not of alternatives but rather of interdependence. Tort litigation serves as a catalyst to motivate government and industry policymakers to implement reform. The litigation process uncovers policy-relevant information, generates media coverage, and mobilizes victims’ groups, which puts pressure on policymakers in government and industry executives to act. Liability exposure creates a market for liability insurance that translates government regulations, trade and professional association standards, and company safety policies into financial incentives. Increasing tort liability is a lever by which to achieve reform within a regulatory governance system populated by a variety of public and private actors. The interdependence of tort liability, government regulation, and private governance means that feedback and learning over time will enhance the performance of all these components of the system.
B. Statutory Tort Liability
Liability under our model statute rests on existing doctrines of duty and breach and modified doctrines of causation and damages. The model statute also includes provisions governing the statute of limitations and preemption. We will discuss each of these in turn.
1. Duty & Breach
Our model statute subjects reproductive tissue providers to civil liability for breaching any common law or statutory duty of care owed to parents. This would include intentional fraud, negligent misrepresentation, and failure to warn. In the absence of specific statutory protections, parents can argue that providers who fail to take reasonable care to avoid misrepresentations or to provide adequate warnings have breached the general common law tort duty to exercise reasonable care in dealings with others, such as the provision of professional services.
In cases where courts characterize a provider’s misconduct as a failure to protect parents from risks posed by donors, parents can argue that, although common law imposes no general duty on individuals to protect injury victims from third-party injurers, such duties arise out of special relationships between the individual and the third-party injurer or between the individual and the victim. A special relationship between the individual and the third-party injurer is characterized by a unique level of knowledge of or control over the risk of injury posed by the third party. A special relationship between the individual and the victim is characterized by a unique level of knowledge of or control over the risk of injury faced by the victim or by the victim’s justified reliance on the individual for protection from that risk. In this context, a provider’s position as an exclusive broker between an anonymous donor and parents, as well as the quality assurances that providers typically offer parents in marketing materials and personal interactions, create special relationships that support imposing on providers a duty to protect parents from risks posed by donors.
In analyzing duty, courts sometimes exempt from liability certain types of conduct based on principles or policy considerations. For example, many courts exempt social hosts from liability for negligence in serving alcohol to their guests because of liability exposure’s adverse implications for social relations. Under this analysis, a social host who failed to exercise reasonable care in serving alcohol to her guests would not be subject to liability because she owes them no duty to exercise reasonable care in the context of a private social event. Some courts might similarly be inclined to exempt reproductive tissue providers from liability for misrepresentation. One could imagine courts finding that providers owe parents no duty to exercise reasonable care in representations concerning offspring characteristics—such as sex, race, or disability—out of a desire not to endorse attitudes that support undesirable social hierarchies. Our model statute preempts this type of judicial circumscription of the scope of providers’ liability under policy-driven duty analysis. The statute instead addresses the scope of liability and underlying policy concerns in damages provisions limiting parents’ recovery to extraordinary expenses associated with a medically recognized health condition. We discuss these matters in greater detail below when we discuss damages and preemption.
When it comes to the standard of care, plaintiffs may rely on a variety of sources in establishing what reasonable care requires to avoid liability. In cases involving common activities, such as driving, plaintiffs may ask jurors to make a collective judgment about the level of care that would be exercised by an ordinary prudent person under similar circumstances. Jurors may also be instructed to consider the cost-effectiveness of precautions to determine their reasonableness. In cases where jurors lack the personal experience necessary to support such judgments—for example, undertaking specialized or technically complex activities—plaintiffs may point to relevant statutory provisions, administrative regulations, industry standards, professional norms, and organizational policies as evidence of what reasonable care requires. By relying on these sources to define the standard of reasonable care, claims under our model statute will incentivize reproductive tissue providers to comply with applicable regulations, conform to industry and professional standards, and follow their own policies. The requirements of reasonable care will include any new demands of such regulations, standards, and policies as they develop.
As a general matter, liability requires a plaintiff to prove that their harm would not have occurred in the absence of the defendant’s wrongdoing. This standard creates a problem for parents suing reproductive tissue providers for misrepresentation. In the absence of the defendant’s misrepresentation, the parents would, presumably, not have purchased the sperm, eggs, or embryos and conceived the child. Under this analysis, the harm caused by the defendant’s misrepresentation is the existence of the disabled child. The filing of a lawsuit demanding money damages is a public declaration that the plaintiff would have been better off had the defendant not committed the alleged wrongdoing. Where a child is a result of that wrongdoing, the lawsuit implies that the parents would have been better off had the child never been born. It is understandable that parents would be reticent to articulate such claims and that some courts are unwilling to validate them for fear of denigrating or stigmatizing the child.
Under our approach, parents would be permitted to characterize their harm not as the existence of the child but only the extraordinary expenses associated with the child’s disability and to argue that the defendant’s misrepresentation led them to use the donor’s reproductive tissue, which caused their child’s disability. This would enable parents in some cases to satisfy the standard tort requirement of proving both general and specific causation. Questions of general causation ask whether an alleged source of harm is capable of causing the type of harm for which the plaintiff seeks recovery. Questions of specific causation ask whether the alleged source of harm caused the plaintiff’s harm. Parents could satisfy this standard causation requirement in cases where they can prove that genetic material in the reproductive tissue furnished by the reproductive tissue provider caused their child’s disability—for example, where parents can prove that the reproductive tissue furnished by the provider contains genetic material known to cause the disability and the non-donor biological parent’s reproductive tissue does not and that the disability is exclusively caused by genetic inheritance. However, parents whose children suffer from disabilities for which genetics is characterized as a risk factor but that may be instead triggered by environmental, behavioral, or external biochemical factors will be unable to prove specific causation. In such cases, there is no way to prove that genetic material in the reproductive tissue furnished by the provider played a role in bringing about a specific case of disability.
This latter group of parents might be able to overcome the challenge of causal attribution by using statistical probability as evidence of causation. By way of illustration, consider the example of parents whose child suffers from schizophrenia, for which genetics is a risk factor but may instead be caused by environmental, behavioral, or biochemical factors. Assume that a reproductive tissue provider misrepresented to the parents the health profile of a donor with a history of schizophrenia and that the parents purchased reproductive tissue from that donor and conceived the child with it. Assume additionally that the non-donor biological parent has no personal or family history of schizophrenia. Evidence that the lifetime risk of developing schizophrenia is approximately 1% in the general U.S. population and 10% among individuals with one parent with schizophrenia would support a conclusion that, statistically speaking, the child’s schizophrenia was more likely than not caused by genetic inheritance. This is because, statistically speaking, in any cohort of 100 individuals who have one parent with schizophrenia, one individual on average will suffer from schizophrenia caused by either inherited genetic or non-inherited factors (corresponding to the 1% chance of schizophrenia in the general population) and ten on average will suffer schizophrenia caused by inherited genetic factors (corresponding to the 10% chance among individuals with one parent with schizophrenia). Thus, although it may be impossible to prove the cause of any specific individual’s schizophrenia, it is more likely than not—indeed, in this example ten times more likely than not—that any individual’s schizophrenia is caused by genetic inheritance from a parent who is a carrier of a genetic marker for schizophrenia. Similar statistical reasoning would support a probabilistic causal inference for any condition where inherited genetic factors increase the risk of the condition.
Our model statute avoids the complexities of statistical analysis which have led many courts to eschew these doctrines. Under our approach, parents need only prove general causation. That is, they could satisfy their burden of proving causation if they demonstrate, by a preponderance of the evidence, that the reproductive tissue furnished by the provider includes genetic material that increases the risk of the disability from which the child suffers.
To summarize, our approach to causation combines two departures from standard tort doctrine concerning causation. First, it allows parents to characterize the harm caused by a reproductive tissue provider’s misrepresentation as the extraordinary expenses associated with their child’s disability. Second, it accepts proof of general causation as sufficient to establish cause in fact. Our aim is to avoid the unfairness of allowing reproductive tissue providers who intentionally defraud or negligently mislead parents to evade liability for the extraordinary expenses of caring for the resulting disabled child in jurisdictions that deny recovery for wrongful birth. Such innovation is not unusual in the law of torts. In cases where wrongful conduct causes harm to an innocent victim, tort law typically allocates the costs associated with the harm to the wrongdoer in the name of fairness, even when this requires doctrinal innovations that reduce well-established burdens on plaintiffs to prove causation. Moreover, our approach to causation will enhance parents’ prospects of succeeding in lawsuits. The resulting increase in litigation and providers’ liability exposure is likely to deter misrepresentation in the ways we outlined in our earlier analysis of regulation through litigation.
Our model statute allows for the recovery of extraordinary expenses associated with caring for a disabled child. This would include medical care, psychotherapy, physical and occupational therapies, special education, and job training that is incurred or reasonably likely to be incurred due to the disability over the lifetime of the child. The model statute neither authorizes nor preempts other types of damages that vary by jurisdiction. These include nonpecuniary losses due to pain and suffering, emotional distress, and loss of consortium. They also include the costs of medical monitoring to detect the onset of potential disabilities that are not manifest at the time of filing a lawsuit.
4. Statute of Limitations
When a plaintiff is unlikely to know of a defendant’s wrongdoing or of the injury it caused, statutes and caselaw in many jurisdictions delay the commencement of time limitations on filing a lawsuit until the plaintiff discovers or should discover these and other facts. In some cases, parents may not discover a reproductive tissue provider’s misrepresentation until many years later; any resulting disability may take years to emerge, and it may take parents time to figure out that the disability may have been inherited from the donor. Consequently, our model statute includes a version of the discovery rule for statutes of limitation. The statute of limitations would begin to run from the time at which a parent becomes aware of the child’s disability and that the provider’s misrepresentation increased the risk of the child acquiring that disability.
Where a tortfeasor’s wrongful conduct causes multiple harms, which manifest at different times, some courts have allowed plaintiffs to recover for both in separate actions. In some cases, a child might acquire from a donor multiple disabilities—for example, in the Norman case, the child allegedly inherited both a blood disorder and mental illness. Thus, our model statute allows parents to file separate claims for multiple harms that manifest or that parents associate with the donor at different times.
Our model statute raises two issues related to preemption. First, it states explicitly that nothing in the statute should be interpreted to limit recovery under any existing common law or statutory doctrine. Second, the statute preempts any judicial attempt to limit recovery not already contemplated in the statute by circumscribing the scope of the duties that reproductive tissue providers owe to their clients. Our approach allows recovery for medically recognized disabilities but does not authorize recovery for other types of disappointment or disadvantage that may result from misrepresentations regarding race, gender, or other traits within the normal range of human attributes and capacities. Our narrow focus on medically recognized disabilities is motivated by political considerations, to which we now turn.
C. Policy Choices Based on Political Considerations
We are not the first to propose holding reproductive tissue providers civilly liable for misrepresentation. Dov Fox, the preeminent legal scholar in this area, has advocated a new species of dignitary tort that would recognize a “private right of procreation.” Fox’s novel theory would subject reproductive tissue providers to civil liability for confounding clients’ reasonable expectations of exercising control over offspring traits that they “project would make the parenting experience more worthwhile for them.”
Our approach differs from Fox’s in several important respects. In some ways, our approach is more conservative. Whereas Fox proposes a new theory of recovery, we rely on traditional doctrines such as fraud, negligent misrepresentation, and failure to warn. Moreover, Fox would grant compensation to parents in the form of money damages for intangible losses based on “the extent to which the wrongful frustration of efforts to have or avoid having a child of a certain type can be expected to impair their lives, from the perspective of their own (not illegitimate) values and circumstances.” By contrast, our model legislation limits recovery to extraordinary healthcare expenses related to caring for a disabled child.
In another way, our approach is more ambitious than Fox’s. Parents who sue reproductive tissue providers typically lack specific evidence to prove that their child’s disability was inherited from the donor. Although genetics is a risk factor for many disabilities, other factors—environmental, behavioral, and biochemical—may cause or contribute to them. Fox responds to this causal attribution problem by characterizing the parents’ harm as the increased risk of disability, which he quantifies as the total parental losses (tangible and intangible) discounted by the increased percentage chance of the disability caused by use of the donor’s tissue.
We propose an alternative solution to the problem of causal attribution that does not involve discounting. Under our model statute, once a parent provides proof that the donor’s tissue included genetic abnormalities that are risk factors for the child’s disability—i.e., general causation—the parents would be entitled to recover the full measure of extraordinary healthcare expenses related to caring for the child. For a more detailed explanation of why we disagree with Fox about discounting damages in this context, see Appendix II.
Contrasting our proposal with Fox’s highlights two key policy choices that inform our proposal for reform. Our model statute would limit parents’ recovery to healthcare expenses while making it easier for them to prove causation. Our belief in the value of tort litigation and liability exposure as levers to improve regulatory governance of reproductive tissue providers, discussed in Section IV.A above, justifies our choice to make it easier to prove causation. As we explain below, a desire to avoid or minimize political controversies that would undermine the political viability of our proposed reform motivates our choice to limit damages.
1. Eugenics & Ableism
As Fox and other commentators have recognized, circumscribing parents’ recovery is a policy decision. As Fox rightly points out, judges routinely make such policy judgments in decisions regarding the scope of duty in torts. However, we believe that judgments concerning whether, when, and how to recognize the deprivation of white racial identity or male gender or medically recognized disabilities as harms are so highly contestable that it would be better to entrust these judgments to legislatures than to judges.
We appreciate the offense and stigma that characterizing the conception of a genetically atypical child as a legal injury might cause. However, we believe that this is the price for our practical proposal to provide needed financial support to improve the welfare of disabled children and their families—a goal that we share with disability rights advocates. We can see both sides of the argument, but we stand by our choice as a reasonable one that is motivated by child and family welfare. Moreover, we believe that compensating parents for the costs of treating a medical disability is a less controversial policy than compensating individuals for disadvantages due to structural racism and gender discrimination and, therefore, more likely to generate the political support necessary to pass legislation.
By contrast, we want to avoid altogether the debate over whether the law of torts should validate disappointed expectations of having a non-white or a female child. We recognize that there are many reasons for parents wanting their offspring to have particular racial or gender characteristics, notwithstanding that the legal recognition of such interests may have different implications for reinforcing socially undesirable racial or gender hierarchies. However, our primary concern is child welfare, not parental expectations, and, to serve that goal, our approach avoids this aspect of political controversy over eugenics.
2. Tort Reform
In advocating for the legal recognition of parents’ dignitary interests in procreation, Fox proposes characterizing parents’ harm as their loss of a chance for a better outcome. Fox recommends that juries place a monetary value on “the extent to which the wrongful frustration of efforts to . . . avoid having a child of a certain type can be expected to impair [the parents’] lives, from the perspective of their own . . . values and circumstances.” But attempting to compensate parents for harms to their dignitary interests is likely to embroil his proposal in current tort reform battles over recovery for nonpecuniary damages.
By characterizing parents’ damages in terms of their lost opportunity for a better outcome, Fox asks juries to monetize parents’ unrealized personal and professional projects and plans and their reasonable expectations of control over the selection of offspring traits that they think “would make raising a child more meaningful or gratifying.” However, as Fox himself points out:
There are several reasons why recovery for intangible injuries like these is vulnerable to charges of arbitrariness, unfairness, and abuse: the lack of any clear way to translate imprecise, case-specific harms into determinate fiscal terms; the lack of any objective test to measure the severity of injuries the appraisal of which tends to depend heavily on subjective testimony; the lack of obvious mechanisms to channel legislative or judicial deliberations about corresponding awards; and the lack of market value to confine damages within a ceiling or floor.
Fox dismisses these concerns by observing that “[i]ncommensurability is no greater problem for reproductive negligence than it is in other contexts in which juries determine recovery for intangible losses,” and he cites the examples of recovery for wrongful death, wrongful conviction, humiliation, betrayal of fiduciary duty, lost choice of uninformed consent, and wrongful living (an action for disregard by medical providers of a patient’s expressed wish to forego lifesaving treatment). Concerns about arbitrariness, unfairness, and abuse in the award of nonpecuniary losses is a persistent theme in attacks on the integrity of the tort system leveled by tort reform advocates. Fox’s citation of various causes of action that allow for recovery of nonpecuniary losses notwithstanding these concerns is more a recognition of the extent of the problem than a serious attempt to address the concerns of skeptics.
Fox himself worries about the competence of juries to determine this new category of nonpecuniary losses, and he concedes that judicial oversight would offer little protection against arbitrary and extravagant awards. He suggests that Congress could, alternatively, create a “special agency” to devise a schedule of “award ranges corresponding to subcategories of reproductive harm . . . that would be tailored to reflect objective indicators of the losses sustained in particular cases.” However, Fox does not explain why he believes that an administrative agency would be any less arbitrary in determining the monetary value of parents’ unrealized projects and plans or thwarted expectations of raising the child that they imagined. He provides no indication of what he has in mind when he refers to “objective indicators.” Nor does he explain how this administrative alternative squares with his initial insistence that “[t]hese are decisions best left to ‘the voice of the community.’”
Our approach seeks to avoid controversy over nonpecuniary damages by expressly authorizing only pecuniary losses associated with caring for a disabled child and neither preempting nor authorizing additional recovery for nonpecuniary damages, which can be decided in accordance with the existing law of each jurisdiction. We are concerned that Fox’s bold proposal to award highly impressionistic and speculative damages for parental disappointment is likely to become a new poster child for tort reform if implemented by juries. Additionally, we suspect that any effort to pass federal legislation delegating this task to an administrative agency, which Fox suggests would be modeled on the U.S. “Sentencing Commission,” is likely to be stillborn. Finally, by limiting damages to recovery of healthcare costs while making it easier for parents to recover, we propose a trade-off like that which earned legislative support for workers’ compensation statutes.
As Georgia’s supreme court explained in Norman, most theories of liability in such cases—and consequently, the vast majority of potential damages—are currently foreclosed to plaintiffs because the court had previously prohibited wrongful birth claims in Abelson. In one sense, then, a legislative action overturning Abelson and similar foreclosures of wrongful birth claims in other states is the quickest and easiest path toward opening the courtroom doors for those who have been misled by reproductive tissue providers: allow wrongful birth claims and claims against reproductive tissue providers can then follow. At that point, questions about causation, damages, and the other elements of the tort would remain, but the doctrine would develop organically in the courts—with legislative input as necessary—just as it does in other tort liability contexts.
Indeed, there may be sound substantive reasons for legislatively overturning Abelson and similar cases. Many scholars criticize the rejection of wrongful birth claims. To some, it is baffling that medical professionals are insulated from liability for their own malpractice in failing to meet standards of care in this particular reproductive context. We are sympathetic to this critique. Consequently, some may urge that we take aim directly at cases such as Abelson rather than to address reproductive tissue providers alone. But, in addition to our lack of certainty on this point, it is also a nonstarter for one primary reason: the politics of abortion. As discussed infra, decisions like Abelson are rooted, at least in part, in anti-abortion sentiment.
Although we cannot definitively prove that a statute overturning Abelson-like decisions cannot be passed in Georgia’s legislature and in other states that disfavor abortion, we do have several data points that strongly support this assumption. Consider the following:
Of all the legislatures in the country, only Maine has adopted a statute that explicitly recognizes wrongful birth claims.
No state legislature has adopted a statute permitting a wrongful birth claim after a court in the state has prohibited them.
Eight state legislatures have prohibited or limited wrongful birth claims.
We were unable to locate even a single legislative proposal in Georgia’s history to overturn Abelson.
Like in many other “red” states, Georgia’s legislature is dominated by Republicans, including many conservative Republicans.
Many states have recently enacted sweeping statutes that would severely curtail abortion rights.
In informal conversations with policymakers in Georgia and elsewhere, we have repeatedly been told that there would be no political appetite to legislatively recognize a wrongful birth claim.
Therefore, we are confident that it would be impossible to overturn Abelson in Georgia and similar decisions in other states at this time, regardless of substantive merits. Thus, our statute focuses narrowly on reproductive tissue providers, which does not implicate the abortion question.
In the broader context of wrongful birth, the abortion question casts a shadow over the debate because the suggestion is that if the parents had been informed of the doctor’s malpractice, they might have chosen to abort the fetus. In contrast, had the parents been properly informed of a potential donor’s known genetic condition, they might never have chosen to use the donor—in which case, there never would have been a fetus to abort. Likewise, if the donor’s genetic condition became known only after the child was born, timely reporting by the tissue provider could have allowed the parents to promptly seek a potential diagnosis and treatment for their child, thus avoiding costs due to a lack of awareness. In either case, the specter of abortion is not implicated, and the debate can be avoided.
Reproductive tissue providers have brought happiness to hundreds of thousands of people. But the lack of binding industry standards, government regulations, and accountability in the courts allows unscrupulous providers to act with near impunity. Passing a tailored tort statute that reopens the courthouse doors can compensate victims and kick the stalled system of industry governance into gear.
Appendix I: The Model Statute
- This Act shall be known and may be cited as the Reproductive Tissue Consumer Protection Act.
- Findings. The General Assembly finds the following:
- The State of _______ has a substantial interest in protecting the health and well-being of every child, regardless of how conceived, and every family.
- Assisted reproductive technologies are increasingly prevalent and widely used in the conception and birth of a growing number of children in the United States.
- Reproductive tissue providers sell products that have a direct effect on the health and welfare of children conceived with such tissue and should be held to rigorous legal and ethical standards of fair dealing, reliability, and accountability to protect children conceived with assisted reproductive technologies and their families.
- Robust civil damages are an essential means of compensating victims of wrongful conduct by reproductive tissue providers.
- Extensive liability exposure for wrongdoing provides an effective incentive to reproductive tissue providers to conduct their businesses in compliance with all applicable laws, professional standards, and ethical principles.
- Definitions. As used in this Act, the term:
- "Provider of reproductive tissue" means any individual or entity who sells or participates in the commercial transfer of reproductive tissue that is used for the purpose of conceiving a child.
- "Reproductive tissue" includes but is not limited to the whole or any part of any of the following:
- enucleated cells,
- cell nuclei,
- embryos, and
- any genetic material of any type in all forms that may be used to conceive a child.
- "Qualified health condition" means any medically recognized condition.
- "Extraordinary expenses" means any costs to the parents of a child conceived using reproductive tissue or to the child that were, or are reasonably likely to be, incurred as a result of the qualified health condition, including any such costs incurred, or reasonably likely to be incurred, after the child has reached the age of majority.
- A provider of reproductive tissue shall be subject to civil liability to the parents of a child conceived using reproductive tissue and to the child if:
- the provider breached any common law or statutory duty,
- the provider's breach of duty created or increased the risk of a qualified health condition in a child conceived with the reproductive tissue, and
- the child conceived using the reproductive tissue has the qualified health condition.
- A provider of reproductive tissue who is liable under Section IV(a) shall be liable for:
- extraordinary expenses and
- exemplary damages for reckless or intentional wrongdoing by the provider of the reproductive tissue.
- A provider of reproductive tissue shall be subject to civil liability to the parents of a child conceived using reproductive tissue and to the child if:
- No preemption. Nothing in this Act shall be interpreted to limit recovery under any other law.
- Statute of Limitations. The statute of limitations for actions under this Act shall commence from the time at which a claimant under this Act becomes aware
- of the qualified health condition and
- that a breach of duty by the provider created or increased the risk of the qualified health condition.
Appendix II: Note on the Inappropriateness of Discounting Damages
As mentioned in Section IV.C, Dov Fox advocates a novel dignitary tort to compensate individuals for violation of their “private right of procreation.” In developing his approach, he characterizes parents’ harm as the loss of a chance for a better outcome. In determining the measure of damages, he suggests a two-step process: (1) valuation of the parents’ lost opportunity for a better outcome (2) discounted to reflect uncertainty regarding the reproductive tissue providers’ responsibility for the outcome. To implement the valuation in step one, Fox recommends that juries place a monetary value on “the extent to which the wrongful frustration of efforts to . . . avoid having a child of a certain type can be expected to impair [the parents’] lives, from the perspective of their own . . . values and circumstances.” To calculate the discount in step two, Fox would have courts multiply the initial valuation by “the probability that negligence is responsible for those injuries.” In Section IV.C.2, we criticized step one as likely to provoke controversy over nonpecuniary damages that could be fatal to legislative reform. Here we wish to criticize Fox’s second step for inappropriately discounting the recovery of parents caring for a disabled child.
As explained above in our analysis of causation in Section IV.B.2, in jurisdictions that allow statistical probability as evidence of causation, parents will always be able to prove that, as a statistical matter, their child’s disability was more likely than not genetically inherited from the donor whenever the donated tissue increased the risk of the disability. Thus, parents suing for an existing disability in their child do not need loss-of-chance doctrine to establish probabilistic causation, and courts typically apply loss-of-chance doctrine only where the statistical probability that a defendant’s wrongdoing caused the plaintiff’s harm is less than 50%.
Loss-of-chance doctrine would be appropriate in claims by parents with a currently healthy child seeking to recover for a risk that the child will later develop a disability inherited from the donor. Such claims are analogous to claims by plaintiffs seeking recovery for toxic exposure that increases their future risk of disease. However, application of the doctrine outside of the medical malpractice context is rare and controversial. Moreover, even in the context of medical malpractice, where the adoption of loss-of-chance doctrine is widespread, there is a great deal of confusion and disagreement among judges about how to value the loss of a statistical probability. Our approach avoids loss-of-chance analysis altogether by limiting recovery to cases where a child is suffering from a disability at the time of the claim and to medical monitoring for future disabilities if otherwise permitted in the jurisdiction. So as not to bar claims where a child’s disability does not emerge until many years after conception of the child, we would delay commencement of the statute of limitations until after the parents become aware of the disability and that the donor’s tissue increased the risk of its occurrence.
Fox’s second step also inappropriately invokes apportionment principles to reduce parents’ recovery. According to Fox, parents’ recovery for losses should be reduced “by the extent to which they were caused by factors besides professional wrongdoing like . . . genetic uncertainty.” Fox explains:
So long as plaintiffs can demonstrate that the negligent conduct was at least as much to blame as other factors for the injuries to their reproductive interests, awards would be calculated based on this proportional-recovery rule that ‘apportion[s] damages consistent with the degree of fault.’ Whatever compensation would have attached for the injury to interests in . . . [choosing offspring] particulars would be reduced accordingly by the extent to which other forces caused them. The statistical uncertainty that these issues pose in the reproductive context is unlikely to be much more complex than the others in which loss-of-chance doctrine is readily and routinely applied.
Fox appears to conflate two different bases for reducing plaintiffs’ recovery. The first is loss-of-chance doctrine, which discounts plaintiffs’ damages due to causal uncertainty. The second is apportionment of liability, which allocates liability among multiple tortfeasors. As we explained above, there is no need to discount parents’ damages based on the loss of a chance in cases involving a child with an existing disability. Nor would it be appropriate to apportion liability in the absence of other negligent actors whose negligence contributed to the child’s disability. The mere presence of other causal “factors” or “forces” is not a basis for apportionment of liability. In other words: that a negligent defendant’s conduct was a necessary but not sufficient cause of a plaintiff’s harm does not trigger apportionment of liability among all persons who contributed causally to the harm unless those persons were also negligent. Unless a reproductive tissue provider can prove that the parents or other individuals were negligent and that their negligence contributed to the child’s disability, there would be no justification for reducing the parents’ damages based on “the extent to which other forces caused them.” Nothing in our model statute would preclude apportionment among multiple negligent tortfeasors or reductions in parents’ recovery based on their own negligence, but we do not endorse any reduction in the measure of damages based merely on the idea that a reproductive tissue provider’s wrongdoing was a necessary but not sufficient cause of a child’s disability.
Rachel Arocho et al., Estimates of Donated Sperm Use in the United States: National Survey of Family Growth 1995–2017, 112 Fertility & Sterility 718, 718 (2019) (estimating that between 2015–2017, 440,986 women received artificial insemination). These numbers are estimates because no government entity collects data on artificial insemination in the United States. See id.
CDC, 2018 Assisted Reproductive Technology: Fertility Clinic Success Rates Report 24 (2018) [hereinafter CDC 2018 Report], https://www.cdc.gov/art/pdf/2018-report/ART-2018-Clinic-Report-Full.pdf [https://perma.cc/3HHE-S88Y]. This estimate is based on CDC-reported numbers for assisted reproductive technology (ART) transfers among patients using eggs or embryos from donors. Id. We estimated that in 2018 about 22,700 women underwent egg or embryo transfer in the United States. 2018 Live Births from Donor Eggs or Embryos.xlsx, available at https://perma.cc/C6TL-RYS2 (detailing our calculation and explanation of this estimate).
In this Article, the term “reproductive tissue providers” includes all entities that sell or otherwise provide human sperm, eggs, and/or embryos for reproductive purposes. In the current U.S. fertility market, such entities predominantly include sperm banks and fertility clinics. However, as fertility technology advances and changes, reproductive tissue providers may also include other entities that procure, store, test, sell, use, or ship human reproductive cells or tissue for reproductive purposes.
See, e.g., Wuth v. Lab’y Corp. of Am., 359 P.3d 841, 864 (Wash. Ct. App. 2015) (discussing the significant costs associated with raising a child with severe genetic birth defects); Complaint at 15–16, Norman v. Xytex Corp. (Norman I), No. 2017CV298536 (Ga. Super. Ct. June 13, 2018) (discussing a child’s period of hospitalization due to homicidal tendencies and monthly psychiatrist visits).
Dov Fox, Birth Rights and Wrongs: How Medicine and Technology Are Remaking Reproduction and the Law 4–6 (2019) (citing anecdotal evidence from 2003 to 2012); Dov Fox, Reproductive Negligence, 117 Colum. L. Rev. 149, 152–54, 152 nn.7–8, 153 n.11, 154 n.28 (2017); see, e.g., D.D. v. Idant Lab’ys, 374 F. App’x 319, 320–21 (3d Cir. 2010) (discussing the negligent provision of sperm from a donor with Fragile X syndrome); Paretta v. Med. Offs. for Hum. Reprod., 760 N.Y.S.2d 639, 641 (Sup. Ct. 2003) (discussing the failure to inform plaintiffs that the donor used to conceive the child carried cystic fibrosis); Fruiterman v. Granata, 668 S.E.2d 127, 129 (Va. 2008) (discussing a wrongful birth case in which “the [d]octors breached the standard of care by failing to provide [plaintiff] with information about first trimester testing”); Wuth, 359 P.3d at 862 n.12, 863–64 (discussing damages resulting from a doctor’s failure to diagnose chromosomal translocation).
See, e.g., Norman v. Xytex Corp. (Norman III), 848 S.E.2d 835, 837–38 (Ga. 2020); Zelt v. Xytex Corp., 766 F. App’x 735, 737 (11th Cir. 2019) (per curiam); Roe v. CNTP MCB Inc., 21 Civ. 468, 2021 WL 2258297, at *3 (S.D.N.Y. June 3, 2021); Johnson v. Superior Ct., 124 Cal. Rptr. 2d 650, 654 (Ct. App. 2002); Donovan v. Idant Lab’ys., 625 F. Supp. 2d 256, 262–63 (E.D. Pa. 2009), aff’d sub nom., D.D., 374 F. App’x 319; see also Fox, Reproductive Negligence, supra note 5, at 154 (“Courts routinely decline to grant remedies when reproductive professionals negligently deprive, impose, or confound procreation.”).
Final Order Granting Defendants’ Motion to Dismiss, Collins v. Xytex Corp., No. 2015CV259033, 2015 WL 6387328 (Ga. Super. Ct. Oct. 20, 2015); Doe 1 v. Xytex Corp. (Doe III), No. 1:16-cv-1453, 2017 WL 1036484, at *3 (N.D. Ga. Mar. 17, 2017); Order on Defendants’ Motion to Dismiss, Doe 1 & Doe 2 (Doe I), No. 2016CV274895, at 13–14 (Ga. Super. Ct. Dec. 15, 2016).
Order on Defendants’ Motion to Dismiss at 2, Norman I, No. 2017CV298536; Doe III, 2017 WL 1036484, at *1 (“This is a wrongful birth case.”).
Fox, Birth Rights and Wrongs, supra note 5, at 6 (“In the United States, victims who take procreation specialists to court almost always lose.”); see also Fox, Reproductive Negligence, supra note 5, at 153 & n.16, 196–97 & nn.282–97.
See, e.g., Timothy D. Lytton, Using Tort Litigation to Enhance Regulatory Policy Making: Evaluating Climate-Change Litigation in Light of Lessons from Gun-Industry and Clergy-Sexual-Abuse Lawsuits, 86 Tex. L. Rev. 1837, 1841–42 (2008) [hereinafter Using Tort Litigation]; see also Timothy D. Lytton, Outbreak: Foodborne Illness and the Struggle for Food Safety 115–17 (2019); Charles R. Epp, Making Rights Real: Activists, Bureaucrats, and the Creation of the Legalistic State 16–17 (John M. Conley & Lynn Mather eds., 2009); Nora Freeman Engstrom & Robert L. Rabin, Pursuing Public Health Through Litigation, 73 Stan. L. Rev. 285, 354 (2021).
See, e.g., Lytton, Outbreak, supra note 10, at 96–99, 115–17, 170–71 (providing an example of how civil litigation arising out of an E. coli O157 outbreak caused by tainted hamburgers sold by Jack in the Box prompted reforms in the meatpacking industry).
All information regarding the events surrounding Xytex’s recruitment of James Aggeles as a sperm donor is from plaintiffs’ pleadings in the cases subsequently brought against Xytex as well as court decisions issued in those cases. See Plaintiffs’/Appellants’ Brief at 8, Zelt v. Xytex Corp., 766 F. App’x 735 (11th Cir. 2019) (per curiam) (No. 18-11164), 2018 WL 2096221; Appellants’ Principal Brief at 3, Norman III, 848 S.E.2d 835 (Ga. 2020) (No. S19G1486); see also Christine Van Dusen, A Georgia Sperm Bank, a Troubled Donor, and the Secretive Business of Babymaking, Atlanta Mag. (Feb. 13, 2018), https://www.atlantamagazine.com/great-reads/georgia-sperm-bank-troubled-donor-secretive-business-babymaking/ [https://perma.cc/GQB7-NW8B].
See Doe III, 2017 WL 1036484, at *1.
See Complaint at 9, Doe v. Xytex Corp. (Doe IV), No. 1:16-CV-01729 (N.D. Ga. Mar. 17, 2017), 2017 WL 1036485.
Id. at 9–10.
Plaintiffs’/Appellants’ Brief, supra note 12, at 7.
Complaint at 7, Zelt v. Xytex Corp., No. 1:17-CV-04851 (N.D. Ga. Feb. 22, 2018), 2018 WL 1014627 [hereinafter Zelt Complaint].
Id. at 11.
Id. at 5.
See id. at 10–11; see also Plaintiffs’/Appellants’ Brief, supra note 12, at 9.
See Zelt v. Xytex Corp., 766 F. App’x 735, 737 (11th Cir. 2019) (per curiam).
See Zelt Complaint, supra note 17, at 12.
Norman v. Xytex Corp. (Norman II), 830 S.E.2d 267, 268 (Ga. Ct. App. 2019), aff’d in part, rev’d in part, and remanded, 848 S.E.2d. 835 (Ga. 2020), vacated, 859 S.E.2d 826 (Ga. Ct. App. 2021).
Zelt Complaint, supra note 17, at 7–8.
Id. at 9.
Norman III, 848 S.E. 2d 835, 837 (Ga. 2020).
See Zelt Complaint, supra note 17, at 16, 20.
Id. at 17.
See the following Georgia filings: Zelt Complaint, supra note 17, at 2; Complaint, Doe IV, supra note 14, at 1, 2017 WL 1036485; Complaint at 1, Doe III, No. 1:16-cv-01453 (N.D. Ga. 2017), 2017 WL 1036484; Complaint at 1, Cruz v. Xytex Corp., 862 S.E.2d 733 (Ga. Super. Ct. 2018) (No. 2018CV307445) (mem.); Complaint, Norman I, supra note 4, at 1; Complaint at 1, Doe v. Xytex Corp. (Doe IX), No. 16EV002762 (Ga. Super. Ct. 2017); Complaint at 1–2, Doe I, No. 2016CV274895 (Ga. Super. Ct. 2016); Complaint at 1, Collins v. Xytex Corp., No. 2015CV259033 (Ga. Super. Ct. 2015), 2015 WL 6387328; see also filings outside of the state of Georgia including: Complaint at 1, Doe v. Xytex Corp. (Doe VIII), No. 1:16-cv-01692 (N.D. Ohio 2017); Complaint at 1, Doe v. Xytex Corp. (Doe VII), No. 8:16-cv-0291 (M.D. Fla. 2017), 2016 WL 8672404; Complaint at 1, Doe v. Xytex Corp. (Doe VI), No. 2:16-cv-06621 (C.D. Cal. 2017), 2017 WL 11633458; Complaint at 2, Doe 1 v. Xytex Corp. (Doe V), No. C16-02935WHA (N.D. Cal. 2017), 2017 WL 1112996; Complaint at 2, In re Xytex Corp. Sperm Donor Prods. Liab. Litig., 223 F. Supp. 3d 1351 (J.P.M.L. 2016) (No. 3:16-cv-02935).
See Zelt Complaint, supra note 17, at 17, 19–20; Complaint, Doe IV, supra note 14, at 14; Complaint, Doe III, supra note 30, at 19; Complaint, Cruz, supra note 30, at 5, 12; Complaint, Norman I, supra note 4, at 15, 25; Complaint, Doe IX, supra note 30, at 13–14; Complaint, Doe I, supra note 30, at 16, 18–19; Complaint, Collins, supra note 30, at 8; Complaint, Doe VIII, supra note 30, at 17, 19–20; Complaint, Doe VII, supra note 30, at 11, 15; Complaint, Doe VI, supra note 30, at 12–13; Complaint, Doe V, supra note 30, at 12, 15; Complaint, In re Xytex Corp., supra note 30, at 12, 15.
See Zelt Complaint, supra note 17, at 22–28, 32; Complaint, Doe IV, supra note 14, at 15–20; Complaint, Doe III, supra note 30, at 21–25; Complaint, 13, Cruz, supra note 30, at 6–10, 13; Complaint, Norman I, supra note 4, at 18–23; Complaint, Doe IX, supra note 30, at 13–17, 19, 22; Complaint, Doe I, supra note 30, at 21–26; Complaint, Collins, supra note 30, at 9–10, 12; Complaint, Doe VIII, supra note 30, at 18–23; Complaint, Doe VII, supra note 30, at 17–21; Complaint, 20, Doe VI, supra note 30, at 12–15; Complaint, Doe V, supra note 30, at 16–19, 21; Complaint, In re Xytex Corp., supra note 30, at 17–22.
See Zelt v. Xytex Corp., 766 F. App’x 735, 736 (11th Cir. 2019) (per curiam); Doe IV, No. 1:16-CV-01729 (N.D. Ga. Mar. 17, 2017), 2017 WL 1036485, at *3; Doe III, 2017 WL 1036484, at *3; Order on Defendants Motion to Dismiss, Doe I, supra note 7, at 3; Final Order Granting Defendants’ Motion to Dismiss, Collins, supra note 7, at 3, 13; Order on Defendants’ Motion to Dismiss, Norman I, supra note 8, at 3, 15. Interestingly, one of the cases filed against Xytex in Georgia was not immediately dismissed by the judge and was allowed to proceed on some of the plaintiff’s causes of action. See Order on Defendants’ Motion to Dismiss at 13–14, Doe IX, (No. 16EV002762H) (dismissing the parent-plaintiff’s products liability, negligence, and battery claims but allowing parent-plaintiff’s fraud, negligent misrepresentation, breach of express warranty, intentional infliction of emotional distress, and Georgia’s Fair Business Practices Act claims to proceed). Much like the other cases (except for Norman IV), that case eventually settled.
See Norman III, 848 S.E.2d 835, 842–43 (Ga. 2020) (holding that not all the Normans’ causes of action and types of damages sought were barred for being derived from a wrongful birth claim).
Id. at 840–42. For a more detailed analysis of the court’s holding in Norman, see infra Section III.C; see also Yaniv Heled et al., A Wrong Without a Remedy: Leaving Parents and Children with a Hollow Victory in Lawsuits Against Unscrupulous Sperm Banks, 96 Chi.-Kent L. Rev. 115, 122–24, 127–28 (2021) (analyzing viable claims under the Supreme Court of Georgia’s decision in Norman III).
Norman III, 848 S.E.2d at 843; Heled et al., supra note 35, at 126–28. The saga of Xytex donor #9623 has been ongoing for more than eight years, but it is, in all likelihood, far from over. See Doe IV, 2017 WL 136485, at *2 (“In June of 2014, Xytex inadvertently disclosed Aggeles’ identity, and the Plaintiff was then able to discover much of Aggeles’ educational and criminal history through a simple internet search. As a result, the Plaintiff filed the Complaint on May 27, 2016.”); Norman v. Xytex Corp. (Norman IV), 859 S.E.2d 826, 826–27 (Ga. Ct. App. 2021) (vacating, on remand, its previous opinion, adopting the overruling opinion set forth by the Supreme Court of Georgia, and remanding back to the Superior Court to make determinations consistent with the controlling opinion in 2021). Most cases filed to date against Xytex by parents of children conceived with donor #9623 sperm have been dismissed by the lower courts and, subsequently, settled for unknown, presumably low sums. See Heled et al*.,* supra note 35, at 117 (stating that over a dozen lawsuits were instigated; however, the claims were eventually dismissed). Yet, all of these cases portray a picture of families who have relied on Xytex and been traumatized by Xytex’s misrepresentations. See Van Dusen, supra note 12. Norman IV is the only case that is still ongoing against Xytex in connection with donor #9623. See Norman IV, 859 S.E.2d at 826–27. It remains to be seen how much further this specific litigation will go. It is also quite possible that additional complaints against Xytex will be filed in the future, as more parents of children conceived from donor #9623 sperm sue Xytex.
See Van Dusen, supra note 12.
See Norman III, 848 S.E. 2d at 837–38.
See Complaint, Norman I, supra note 4 at 14–16, 27.
Id. at 16.
See id. at 15–16; see also Van Dusen, supra note 12.
See Zelt Complaint, supra note 17, at 19–20; Complaint, Doe IV, supra note 14, at 14, 16; Complaint, Doe III, supra note 30, at 19, 22; Complaint, Cruz, supra note 30, at 6–7; Complaint, Norman I, supra note 4, at 15, 18; Complaint, Doe IX, supra note 30, at 13–14; Complaint, Doe I, supra note 30, at 18–19, 22; Complaint, Collins, supra note 30, at 8–9; Complaint, Doe VIII, supra note 30, at 17, 19; Complaint, Doe VII, supra note 30, at 15, 18; Complaint, Doe VI, supra note 30, at 12–13; Complaint, Doe V, supra note 30, at 15, 17; Complaint, In re Xytex Corp., supra note 30, at 15, 17.
See Arocho et al., supra note 1, at 722.
Id. at 718–20. The number may be much higher. See id. at 721. As acknowledged by the authors of the research, these are very rough estimates based on the National Survey of Family Growth (NSFG) during those years. Id.
U.S. Cong., Off. of Technology Assessment, Artificial Insemination: Practice in the United States: Summary of a 1987 Survey 3 (Linda Starke ed., 1987) [hereinafter Off. of Technology Assessment], https://www.princeton.edu/~ota/disk2/1988/8804/8804.PDF [https://perma.cc/XN5W-U9PA]. Given the proliferation of the use of ART, particularly artificial insemination by a donor, since the 1980s, it is likely that 30,000 live births per year is a gross underestimation for the 2020s. See Arocho et al., supra note 1, at 720 (finding that the 2011–2017 combined cohorts had an estimated 33,566,865 live births after using donated sperm).
According to the Office of Technology Assessment 1987 Study, during that time, live births were achieved in 37.7% of cases of artificial insemination. Off. of Technology Assessment, supra note 45, at 8. Assuming, conservatively, that current success rates of artificial insemination are at least as high as they were in 1987 and applying these rates to the estimated live births figures reported by Arocho et al., supra note 1, we estimate that there were about 165,880 live births from donor sperm between 2015–2017, which averages about 55,293 live births per year.
See CDC 2018 Report, supra note 2, at 24. We base this number on the CDC’s reported success rates for ART transfers among patients using eggs or embryos from a donor. See id. We multiplied the number of transfers (2,288) by the reported percentage of transfers resulting in live births (57.1%). Where the percentage of transfers resulting in live births was higher than the reported percentage of transfers resulting in singleton live births (i.e., a live birth of one child), we made the assumption that the difference in percentages indicates the birth of twins. Note that the number of donor-conceived persons is possibly higher, as the CDC report does not indicate whether the percentage of transfers resulting in live non-singleton births refers to live births of twins, triplets, quadruplets, etc. See id. at 18–19. Our detailed calculation of the estimated number of live births and explanation of this estimate by the Authors is available at https://perma.cc/C6TL-RYS2.
Fox, Reproductive Negligence, supra note 5, at 151–52; Dov Fox: Biography, U. San Diego, https://www.sandiego.edu/directory/biography.php?profile_id=3332 [https://perma.cc/7ZD4-SBD4] (last visited Sept. 21, 2022).
Fox, Reproductive Negligence, supra note 5, at 152 (first citing Susannah Baruch et al., Genetic Testing of Embryos: Practices and Perspectives of U.S. In Vitro Fertilization Clinics, 89 Fertility & Sterility 1053, 1055 (2008); then citing Sharon T. Mortimer & David Mortimer, Quality and Risk Management in the IVF Laboratory 40–44 (2d ed. 2015); and then citing J.P.W. Vermeiden*, Laboratory-Related Risks in Assisted Reproductive Technologies*, in Assisted Reproductive Technologies: Quality and Safety 127, 128–29 (Jan Gerris et al. eds., 2004)).
See Nicole Pierce & Edgar Mocanu, Female Age and Assisted Reproductive Technology, 3 Glob. Reprod. Health 1, 1–2 (2018), https://journals.lww.com/grh/toc/2018/06000 [https://perma.cc/G3YZ-EV3H] (discussing the rise in average maternal age worldwide and the concurrent 32% rise in ART usage in the United States between the years of 2006 and 2015); see also Henry T. Greely, The End of Sex and the Future of Human Reproduction 101–03 (2016) (detailing how scientific advances in preimplantation genetic diagnosis (PGD) and stem cell research may lead to significantly less burdensome ART techniques in the near future, a process Greely dubs “Easy PGD,” which is also likely to contribute to an increase in ART prevalence).
For the classic exposition of this form of market failure, see George A. Akerlof, The Market for “Lemons”: Qualitative Uncertainty and the Market Mechanism, 84 Q.J. Econ. 488, 495 (1970).
See Tonya Russell, The Sperm Donation Is Free, but There’s a Catch, Atlantic (May 21, 2021), https://www.theatlantic.com/family/archive/2021/05/free-sperm-donation-groups-facebook/618941/ [https://perma.cc/B5M7-YDRL]; Nellie Bowles, The Sperm Kings Have a Problem: Too Much Demand, N.Y. Times (Jan. 20, 2021), https://www.nytimes.com/2021/01/08/business/sperm-donors-facebook-groups.html [https://perma.cc/4CVQ-ECLB].
See Standards, Joint Comm’n, https://www.jointcommission.org/standards/ [https://perma.cc/66ST-M5TG] (last visited July 19, 2021); ACOG Endorsed, Am. Coll. Obstetricians & Gynecologists, https://www.acog.org/clinical/clinical-guidance/acog-endorsed [https://perma.cc/9H99-GA23] (last visited July 19, 2021); Medical Device Regulatory Testing and Certification, Underwriters Lab’ys, https://www.url.com/services/medical-device-regulatory-testing-and-certification [https://perma.cc/5DRL-HMCL] (last visited July, 19, 2021).
See What Is Accreditation?, Joint Comm’n, https://www.jointcommission.org/accreditation-and-certification/become-accredited/why-achieve-accreditation/ [https://perma.cc/DJ3D-E8ZH] (last visited July 19, 2021); 42 U.S.C.A. § 1395m(20)(A) (requiring suppliers of medical items and services to provide evidence of accreditation before submitting claims for reimbursement).
Join SART, Soc’y for Assisted Reprod. Tech., https://www.sart.org/professionals-and-providers/join-sart/ [https://perma.cc/Q6GS-2U49] (last visited Sept. 10, 2022).
See generally Am. Ass’n Tissue Banks, Standards for Tissue Banking (14th ed. 2016).
Id. § D4.140(R).
Id. §§ D4.110(R), D4.141(R).
Id. § D4.141(R).
A search conducted on July 1, 2021, for registered entities in the United States that engage in storage of human tissue yielded 1,683 results. See FDA, Human Cell and Tissue Establishment Registration, https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/index.cfm [https://perma.cc/H9ST-D5DB] (Under “Establishment Function,” choose “Store”; then under “Establishment Status,” choose “Registered”; then under “Country,” choose “United States”; and then click “Continue”).
See Accreditation, supra note 55 (“Over 120 tissue banks around the world are committed to the quality and safety of donated human tissue.”).
Tissue Banks: Is the Federal Government’s Oversight Adequate?: Hearing Before the Perm. Subcomm. on Investigations of the S. Comm. of Gov’t Affs., 107th Cong. 24–25 (2001) (statement of Robert Rigney, Jr., Chief Executive Officer, Am. Assoc. of Tissue Banks); see also President’s Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies ch. 2 (2004) [hereinafter 2004 Report], https://bioethicsarchive.georgetown.edu/pcbe/reports/reproductionandresponsibility/fulldoc.html [https://perma.cc/S9FE-H7Z5]; Fox, Birth Rights and Wrongs, supra note 5, at 28.
See American Association of Tissue Banks Inc, ProPublica, https://projects.propublica.org/nonprofits/organizations/521114697 [https://perma.cc/UGU9-3S67] (last visited July 31, 2022).
See Accreditation, supra note 55.
See CDC 2018 Report, supra note 2, at 7.
Join SART, supra note 56; see infra Section III.A.2 (discussing ASRM and its guidelines).
For a discussion of FCSRCA, see infra Section III.B.1.
Join SART, supra note 56.
Among the requirements for membership in SART is “[a]dherence to all ASRM/SART Guidelines including ethical, practice, advertising, and laboratory.” See Join SART, supra note 56; see also Fox, Birth Rights and Wrongs, supra note 5, at 28.
See Sandra K. Tunajek, Professional Standards and Public Accountability, 74 AANA J. 25, 25–26 (2006) (“Standards promulgated by a profession are representative models that delineate contemporary principles of practice, reflect he philosophic values and clinical priorities of the profession, and provide a foundation by which clinical practice can be evaluated and measured.”).
See generally, e.g., Prac. Comm. of the Am. Soc’y for Reprod. Med. & Prac. Comm. of the Soc’y for Assisted Reprod. Tech., Guidance Regarding Gamete and Embryo Donation, 115 Fertility & Sterility 1395 (2021) [hereinafter ASRM Guidelines]. SART has, apparently, not developed and issued its own guidelines but rather refers its members to ASRM guidelines. Join SART, supra note 56.
ASRM Guidelines, supra note 73, at 49–50, 54–55.
Id. at 50–51, 55.
See Ross E. Cheit, Setting Safety Standards: Regulation in the Public and Private Sectors 120–45 (1990) (Underwriters Laboratories for fire-safety certification); Benjamin Cashore et al., Governing Through Markets: Forest Certification and the Emergence of Non-State Authority 88–105, 109–22, 124–25 (2004) (forest certification); Timothy D. Lytton, Private Third-Party Verification of Product Claims: Lessons from Kosher Certification, in Research Handbook on International Food Law ch. 10 (Michael Roberts ed., forthcoming 2023) (food ingredients certification). See generally Michael E. Conroy, Branded!: How the ‘Certification Revolution’ Is Transforming Global Corporations 14–15, 18 (2007); Magnus Boström & Mikael Klintman, Eco-Standards, Product Labelling and Green Consumerism 50, 55–56 (2008). Cf. Genevieve Lebaron et al., Governing Global Supply Chain Sustainability Through the Ethical Audit Regime, 14 Globalizations 958, 960–65, 969–71 (2017), https://www.tandfonline.com/doi/full/10.1080/14747731.2017.1304008 [https://perma.cc/N2KW-HE3Z] (highly critical).
See, e.g., Timothy D. Lytton, Kosher: Private Regulation in the Age of Industrial Food 132 (2013); Lytton, Outbreak, supra note 10, app. D; Lesley K. McAllister, Harnessing Private Regulation, 3 Mich. J. Env’t & Admin. L. 291, 294 (2014).
See, e.g., supra Part II (demonstrating aggressive marketing).
Bowles, supra note 52 (discussing growing concern amongst sperm banks regarding high demand and a dwindling number of donors); Fox, Reproductive Negligence, supra note 5, at 152 (“[P]atients are ill equipped to bargain . . . against bad outcomes.”).
See Susan Thaul, Cong. Rsch. Serv., R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness 1–2 (2012) (product approval). See generally Morris M. Kleiner, Stages of Occupational Regulation: Analysis of Case Studies 15 (2013) (licensing).
Human Cells, Tissues, and Cellular and Tissue-Based Products, 21 C.F.R. § 1271.1 (2021).
Cal. Health & Safety § 1635.1 (2021); Md. Code Ann., Health–Gen. §§ 17– 301, 18–334 (2021); see also N.Y. Pub. Health §§ 4360:1,10, 4364:1 (2022); S.B. 22-224, 73d Gen. Assemb., 2nd Reg. Sess. (Colo. 2022) (“A gamete bank operating in Colorado or providing donor gametes for use in assisted reproduction in Colorado to obtain a license that is conditioned on compliance with the act and implementing rules.”).
See generally Clinical Laboratory Improvements Amendment Act, 42 U.S.C. § 263 (2018); Am. Soc’y for Reprod. Med., Oversight of Assisted Reprod. Tech. 6–7 (2021).
Fertility Clinic Success Rate and Certification Act, Pub. L. No. 102-493, § 2, 106 Stat. 3146, 3146 (1992) [hereinafter FCSRCA]. See summary of the reporting requirements of the Act at the CDC website, Policy Documents: The Fertility Clinic Success Rate and Certification Act, CDC, https://www.cdc.gov/art/nass/policy.html [https://perma.cc/CKX8-G9CP] (Mar. 7, 2022) (“The [FCSRCA] . . . mandates that clinics performing [IVF] annually provide data for all procedures performed to the Centers for Disease Control and Prevention.”); id. (noting that the Act “mandates that clinics performing ART annually provide data for all procedures performed to the Centers for Disease Control and Prevention (CDC) and sets forth definitions and reporting requirements”).
FCSRCA only applies to certain ARTs, which do not include artificial insemination. See FCSRCA, supra note 84, § 8(1) (“The term ‘assisted reproductive technology’ means all treatments or procedures which include the handling of human oocytes or embryos, including in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, and such other specific technologies as the Secretary may include.”).
See Fox, Birth Rights and Wrongs, supra note 5, at 26–27; see also 137 Cong. Rec. 35950–51 (1991) (statement of Rep. Wyden) (“I would like to alert my colleagues to another area deserving of vigorous Congressional oversight—the $170 million artificial insemination industry. A study by the Office of Technology Assessment has revealed a startling lack of oversight, particularly in doctor’s offices, which could have significant adverse public health effects. . . . [H]alf [of the physicians who provide artificial insemination services] don’t screen for genetic defects.”).
FCSRCA, supra note 84, § 2(i)(1). The heavy involvement of the American Fertility Society, ASRM’s predecessor, in drafting the Act likely accounts for its limited scope. Rep. Ron Wyden, FCSRCA’s sponsor, attested to this heavy involvement in his statement introducing FCSRCA to the House of Representatives. See 137 Cong. Rec. 35950–51 (1991) (statement of Rep. Wyden).
42 U.S.C. § 263a-2 (2018).
See Implementation of the Fertility Clinic Success Rate and Certification Act of 1992–A Model Program for the Certification of Embryo Laboratories, 64 Fed. Reg. 39374, 39382 (July 21, 1999).
E-mail from CDC Division of Reproductive Health, Aug. 3, 2022 (on file with Authors).
See Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment of Registration and Listing, 66 Fed. Reg. 5447, 5448 (Jan. 19, 2001) (to be codified at 21 C.F.R. pts. 207, 807, 1271); Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 69 Fed. Reg. 29786, 29787 (May 25, 2004) (to be codified at 21 C.F.R. pts. 210, 211, 820, 1271) [hereinafter FDA Final Donor Eligibility Rule].
See Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability, 72 Fed. Reg. 9007 (Feb. 28, 2007).
FDA Final Donor Eligibility Rule*, supra* note 91, at 29786–87.
See Fox, Birth Rights and Wrongs, supra note 5, at 25–31; see also Tissue & Tissue Products, FDA, https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products [https://perma.cc/J4BL-CFPM] (last visited Aug. 13, 2022); Testing Donors of Human Cells, Tissues, and Cellular Tissue-Based Products (HCT/P): Specific Requirements, FDA (May 3, 2019), https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/testing-donors-human-cells-tissues-and-cellular-and-tissue-based-products-hctp-specific-requirements [https://perma.cc/AW6Q-6DVJ]; Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases, FDA, https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/testing-human-cells-tissues-and-cellular-and-tissue-based-product-hctp-donors-relevant-communicable [https://perma.cc/QR8K-T5VB] (Feb. 10, 2021).
Telephone Interview with Patricia Harley, Consumer Safety Officer, FDA, Ctr. for Biologics Evaluation and Research (CBER) (July 11, 2007) (expressing the views that genetic testing of reproductive tissue is exclusively within the purview of state law because it pertains to the practice of medicine; that the FDA did not consider (at least at that time) genetic diseases in donor-conceived persons to be a public health concern; and that reproductive tissue providers and consumers are capable of sufficient self-regulation). That position was, apparently, shared by others within the Administration. See, e.g., 2004 Report, supra note 63, at 14 (embracing the fertility industry’s position that the FDA does not have the authority to regulate the fertility industry because such regulation would be an encroachment on the practice of medicine, which is the purview of the states); see also Naomi Cahn & Sonia M. Suter, The Art of Regulating ART, 96 Chi.-Kent L. Rev. 29, 43–44, 54–56 (2021) (discussing the FDA’s authority to regulate different types and aspects of ART).
2004 Report, supra note 63, at 14.
See, e.g., Naomi Cahn, When Fertility Clinics Get It Wrong, Forbes (Aug. 8, 2019, 7:51 AM), https://www.forbes.com/sites/naomicahn/2019/08/08/when-fertility-clinics-get-it-wrong/ [https://perma.cc/3NAM-EZ3N]; see also Tony Cox, Using Donated Sperm: What Does the Law Say?, NPR (Nov. 21, 2011, 12:00 PM), https://www.npr.org/2011/11/21/142594615/using-donated-sperm-what-does-the-law-say [https://perma.cc/3HUB-39EV]; Michael Ollove, States Not Eager to Regulate Fertility Industry, Pew Charitable Trs. (Mar. 18, 2015), https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2015/3/18/states-not-eager-to-regulate-fertility-industry [https://perma.cc/3SL9-97VH] (“States are split about whether surrogacy contracts, usually between prospective parents and an egg donor, are permissible. But other aspects of ART are simply unaddressed by the states. For example, states don’t regulate how many children may be conceived from one donor, what types of medical information or updates must be supplied by donors, what genetic tests may be performed on embryos, how many fertilized eggs may be placed in a woman or how old a donor can be.”). But see Michael Ollove, Lightly Regulated In-Vitro Fertilization Yields Thousands of Babies Annually, Wash. Post (Apr. 13, 2015), https://www.washingtonpost.com/national/health-science/lightly-regulated-in-vitro-fertilization-yields-thousands-of-babies-annually/2015/04/13/f1f3fa36-d8a2-11e4-8103-fa84725dbf9d_story.html [https://perma.cc/6DNP-PUQJ] (statement of Sean Tipton, Chief Advocacy, Policy and Development Officer at ASRM) (“Reproductive medicine is one of the most heavily regulated fields of medicine in the U.S.”).
S.B. 22-224, 73d Gen. Assemb., 2d Reg. Sess. (Colo. 2022); see Making History: Colorado SB 22-224, U.S. Donor Conceived Council, https://www.usdcc.org/2022/05/13/making-history-colorado-sb224/ [https://perma.cc/7E3R-PS5A] (last visited July 14, 2022).
S.B. 22-224, 73d Gen. Assemb., 2d Reg. Sess. §§ 25-57-104(1), 25-57-106(1) (Colo. 2022).
Id. § 25-57-109(1)(a).
Id. § 25-57-109(3).
Id. § 25-57-110(3)(a)(I).
Id. §* *25-57-110(3)(a)(II), (6)(b).
Id. § 25-57-110(6)(a).
Id. § 25-57-105(1)(c).
N.Y. Comp. Codes R. & Regs. tit. 10, § 52 (2000).
Id. § 52-8.7–8.8.
One possible exception is the Regulations’ prohibition on the creation of embryos from gametes of donors who are blood relatives “to a degree that their sexual contact would constitute incest under New York law.” Id. § 52-8.7(i).
S. 7602A, 2021 Leg., Reg. Sess. § 4370 (N.Y. 2021).
See N.Y. Pub. Health Law §§ 4364, 4366 (McKinney 2014).
Utah Code Ann. § 78B-15-708 (West 2015). The Utah law only applies to information already collected by the reproductive tissue provider and does not require the collection of any medical information beyond what the reproductive tissue provider already has. Id.
Ariz. Rev. Stat. Ann. § 25-318.03 (2021).
S. 174, 121st Gen. Assemb., 1st Reg. Sess. (Ind. 2019).
S. 1259, 86th Leg., Reg. Sess. (Tex. 2019).
See also Fox, Reproductive Negligence, supra note 5, at 163–64 (discussing the limited and varied nature of state regulation as part of the broader picture of the regulatory vacuum governing reproductive negligence); Ollove, supra note 83 (describing how neither the United States nor the states do much to oversee the multibillion-dollar ART industry and how state laws diverge in some aspects of ART and leave other areas untouched); Jody Lyneé Madeira, Fertility Fraud: Major Developments in Texas, Idaho, and Indiana, Bill of Health (June 10, 2019), https://blog.petrieflom.law.harvard.edu/2019/06/10/fertility-fraud-major-developments-in-texas-idaho-and-indiana/ [https://perma.cc/K592-EVZ3].
See, e.g., George J. Annas, The Shadowlands—Secrets, Lies, and Assisted Reproduction, 339 New Eng. J. Med. 935, 937 (1998); Stacey A. Huse, The Need for Regulation in the Fertility Industry, 35 U. Louisville J. Fam. L. 555, 556–57 (1996–1997).
Norman III, 848 S.E.2d 835, 837–38, 840 (Ga. 2020).
Heled et al., supra note 35, at 118.
Norman III, 848 S.E.2d 835 (Ga. 2020); see Atlanta Obstetrics & Gynecology Grp. v. Abelson, 398 S.E.2d 557, 560 (Ga. 1990).
See, e.g., id.; Dan B. Dobbs et al., The Law of Torts § 369 (2d ed. 2011). Accordingly, wrongful birth claims require accepting the premise that mothers have the right to abort their pregnancies and that they would have done so in the particular case before the court. In that regard, wrongful birth and wrongful life claims (i.e., claims brought on behalf of a child born with birth defects (Wrongful-Birth Action, Black’s Law Dictionary, 11th ed. 2019)) are different from wrongful conception/pregnancy (i.e., a parent’s claim for damages resulting from pregnancy following a failed sterilization (Wrongful-Conception Action, Black’s Law Dictionary, 11th ed. 2019)) in that the main premise of wrongful birth and wrongful life claims is the availability and probability of abortion services. For further discussion of how abortion politics shape the reality surrounding the issues discussed in this Article, see infra Section IV.C.3.
See Heled et al., supra note 35, at 121–22.
See, e.g., Norman III, 848 S.E.2d at 843; Heled et al., supra note 35, at 127.
See Heled et al., supra note 35, at 122–23.
Id. at 127.
See Catherine Palo, Cause of Action for Wrongful Birth or Wrongful Life, 23 Causes of Action 2d 55 § 4 (2022) (listing states in which wrongful birth actions are not allowed).
See Fox, Birth Rights and Wrongs, supra note 5, at 55–71.
See Lytton, Using Tort Litigation, supra note 10, at 1849.
See id. at 1843.
Id. at 1842.
See, e.g., id. at 1849–58.
See Timothy D. Lytton, Holding Bishops Accountable: How Lawsuits Helped the Catholic Church Confront Clergy Sexual Abuse 98 (2008).
See Lytton, Using Tort Litigation, supra note 10, at 1842, 1852, 1856–57.
See id. at 1842–58.
See Timothy D. Lytton, Suing the Gun Industry: A Battle at the Crossroads of Gun Control and Mass Torts 262–64, 269 (2005).
See, e.g., Taleed El-Sabawi, What Motivates Legislators to Act: Problem Definition & the Opioid Epidemic, A Case Study, 15 Ind. H