Voices in Bioethics

Animal Ethics Concerns Could Be More Pronounced in Islet Xenotransplantation

Sheetal Mohanty — 2026-03-15

Photo by Towfiqu barbhuiya on Unsplash

Abstract

Type 1 diabetes mellitus (T1D) necessitates life-sustaining insulin therapy or islet allotransplantation, which is limited by organ scarcity. While islet xenotransplantation offers a solution to donor shortages, patient perceptions regarding this emerging therapy remain unexplored. This small-scale study tested what would happen to patient support for xenotransplantation when T1D patients learned that upwards of 50 pigs may be needed to treat one adult human patient. Patient viewpoints toward islet xenotransplantation are important to incorporate into xenotransplantation research, as they may impact future clinical uptake. While our sample size is limited, we cautiously suggest that animal ethics concerns regarding xenotransplantation may extend to the magnitude of animals required to treat a single patient. As clinical trials advance, addressing these specific patient-centered values and risk tolerances is essential for developing informed consent frameworks and therapies that are sensitive to patient concerns.

Introduction

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease characterized by immune-mediated destruction of pancreatic beta cells, resulting in absolute insulin deficiency. It affects over 8 million people globally, of whom 20 percent are under 20 years old.^[1] Despite advances in treatment, many patients face challenges related to insulin dependence, including risks of severe hypoglycemia and complications stemming from poor glycemic control. Treatment options for T1D also remain limited. Islet allotransplantation, an alternative treatment for T1D, remains limited by the scarcity of donor organs, the need for lifelong immunosuppression, and the decline in graft survival over time. Pancreatic beta cell islet xenotransplantation (genetically modified porcine-to-human transplantation) is an alternative to exogenous insulin therapy.^[2] Researchers estimate it would take between 25-50 piglets to provide enough islets to treat one adult human.^[3] This ratio of 25:1 or 50:1 is much different from the ratio in solid organ xenotransplantation, which is often framed as one pig to one or multiple patients.

Understanding how accepting the public and, more importantly, patients, are toward xenotransplantation is a critical component of it being accepted as a clinical alternative to exogenous insulin therapy or allotransplantation. Several studies have examined attitudes toward xenotransplantation, but most focus on solid organ transplantation rather than on islet xenotransplantation.^[4]

This study explores a research question that, to our knowledge, has never been tested empirically: Would learning that 25-50 piglets may be required to treat one adult change T1D patients’ attitudes toward islet xenotransplantation?

Methods

We conducted a cross‐sectional pilot study from June to December 2025. We gave our survey to patients with T1D who were part of a diabetes support group in New Jersey. The research team developed the survey in Qualtrics (Provo, Utah) in consultation with experts in endocrinology, bioethics, and quantitative methods, and the survey was informed by prior xenotransplantation studies conducted by the principal investigator and by a review of the literature.^[5] The initial draft of the survey was pilot-tested among a small sample at the research team’s university and then revised as needed for clarity.

After ethics approval was obtained,^[6] participants were recruited via two methods: in-person at insulin user support groups and through posting on the online social media support group. Participants were 18 years of age or older with a self-reported diagnosis of T1D. The electronic survey contained an informed consent form that asked for an acknowledgement before the participant was allowed to proceed with the survey. Qualtrics collected the data. Because of the small sample size, the research team used descriptive statistics (counts, percentages) to analyze attitudes.

Results

Nineteen complete responses were collected. Twenty participants began the survey; one stopped after the demographic section, resulting in a 95 percent completion rate. Due to the nature of participant recruitment, overall response rate was unable to be calculated as we were unable to determine how many potential participants viewed the survey flyer in the online support group. Demographic characteristics of participants can be viewed in Table 1. Eighteen of the nineteen participants relied on insulin injections daily to control their T1D.

Participants were informed about two emerging therapies–islet allotransplantation and islet xenotransplantation–and asked a series of questions about each of these (Table 2). Islet xenotransplantation is the focus here. Participants were told that researchers have been attempting to transplant islet cells from pigs into people with T1D, which could eliminate the need for insulin injections if effective, and asked how they felt about it. When given response choices ranging from very positive to very negative, initially, five participants (26 percent) checked off “very positive”; eight participants (42 percent) “somewhat positive”; only one participant (5 percent) responded “very negative,”; and five participants (26 percent) were neutral. When participants were asked how comfortable they personally would be if clinicians used pig islets to treat their T1D, six participants (32 percent) stated they were either “extremely uncomfortable” or “somewhat uncomfortable,” while five participants (26 percent) were neutral and eight (42 percent) stated they were “somewhat comfortable.”

Participants were then informed that it may take 25 or more piglet donors to treat one adult human with T1D and asked how they felt about that. The survey provided three options. Five participants (26 percent) responded that this would make them “much less willing to support this research,” and six participants (32 percent) responded that this would make them “somewhat less willing to support this research.” Eight participants (42 percent) responded that their view remained the same with the new information.

Discussion

When informed that treating a single adult might require islet cells from 25 or more piglets, over half of the participants (58 percent; 11/19) reported that this made them less willing to support the research. While we recognize the limitations inherent in a small-scale study, the findings cautiously suggest that patient objections to xenotransplantation grounded in animal ethics issues may extend beyond the mere use of animals to include concerns about the number of animals required. Ethically, this raises questions of proportionality—whether the therapeutic benefit to one human justifies the use of dozens of animal lives. For some patients, the 25:1 ratio may cross an ethical threshold. The survey question that revealed the need to use 25 or more animals for one person’s treatment asked whether the participants would change their view, but the response options used language about “supporting research”. The survey did not ask whether they would be willing to accept the therapy personally knowing 25 or more animals were necessary to treat one person. It is possible that the discomfort or negative view toward such research would be even more pronounced if people had to consider their own care, or alternatively, that when faced with a possible solution for themselves, participants may waver on their discomfort level and compromise their animal ethics position.

Limitations

The interpretation of these findings is constrained by the limitations of a small-scale study. With a small sample size (n=19), our results are descriptive and cannot be generalized to the broader T1D population. Furthermore, the sample was demographically homogenous, consisting primarily of white, female, and highly educated participants. As perceptions of medical trust, animal welfare, and risk tolerance vary significantly across cultural and socioeconomic lines, future studies must recruit a more diverse cohort to ensure that consent frameworks are inclusive and equitable.

Conclusion

This study provides preliminary insight into the complex attitudes of individuals with T1D toward islet xenotransplantation and will inform larger planned studies. The findings demonstrate that patient support for islet xenotransplantation may be fragile. In our sample, the ethical implications of the high donor pig-to-recipient ratio appeared to be a significant barrier to acceptance. As islet xenotransplantation moves from the laboratory to the clinic, biological success cannot be the sole measure of progress. Patient values must inform trial design and be evaluated within the specific context in which trials are conducted. Future research requires larger and more diverse cohorts to determine whether these findings hold in broader populations.

Table 1: Demographic information of participants

Table 2: Attitudes toward islet allotransplantation and xenotransplantation

[1]Gregory GA, Robinson TIG, Linklater SE, et al. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol. Oct 2022;10(10):741-760. doi:10.1016/s2213-8587(22)00218-2

[2] Groth CG, Korsgren O, Tibell A, et al. Transplantation of porcine fetal pancreas to diabetic patients. Lancet. 1994;344(8934):1402-1404. doi:10.1016/s0140-6736(94)90570-3

[3] Ekser B, Bottino R, Cooper DKC. Clinical Islet Xenotransplantation: A Step Forward. EBioMedicine. 2016;12:22-23. doi:10.1016/j.ebiom.2016.09.023; Cooper DKC, Mou L, Bottino R. A brief review of the current status of pig islet xenotransplantation. Front Immunol. 2024;15:1366530. doi:10.3389/fimmu.2024.1366530

[4] Hurst DJ, Rodger D, Padilla LA, Ovalle F. Attitudes toward pig islet xenotransplantation for type 1 diabetes: a scoping review. J Endocrinol Invest. 2025;48(10):2249-2260. doi:10.1007/s40618-025-02626-0; Padilla LA, Hurst DJ, Zink A, Parent B, Kimberly LL. Public attitudes to xenotransplantation: A national survey in the United States. Am J Transplant. 2024;24(11):2066-2079. doi:10.1016/j.ajt.2024.07.018; Al-Haboubi M, Boadu P, Pacho A, Cronin AJ, Mays N. Public views on xenotransplantation from the first representative sample survey in the UK. Lancet. 2025;406(10508):1083-1085. doi:10.1016/S0140-6736(25)01195-X

[5] Padilla et al., 2024; Hurst et al., 2025

[6] There was an anonymous peer review process. The study was approved by the Virtua Health Group IRB #G25061

Envisioning Originalism Applied to Bioethics Cases

Robert Swidler — 2026-03-15

Photo ID 123697425 © Alexandersikov | Dreamstime.com

Abstract

Originalism is an increasingly prevalent method for interpreting provisions of the US Constitution. It requires strict adherence to the root meanings of constitutional terms, irrespective of drastically different contexts and without regard to consequences. This article offers a brief description of Originalism and summarizes key criticisms of Originalism in principle and in practice. It then examines a mix of past and pending legal cases that implicate bioethical principles and require interpretation of the Constitution, and it envisions an originalist approach to deciding them.

Introduction

Originalism and bioethics are distinct approaches to shaping public policy and private conduct. Originalism, an increasingly prevalent method for interpreting provisions of the US Constitution, requires strict adherence to the meaning of constitutional terms as understood at the time the provision was enacted, irrespective of drastically different contexts and without regard to consequences. Proponents suggest that it removes the policy preferences of judges from decision making and provides neutrality and objectivity. Critics regard it as an unreliable tool, used selectively by conservative justices to reach their desired legal conclusions.

Bioethics emerged in large part as a multidisciplinary effort to examine issues raised by advances in medicine and biotechnology, from late-20th-century developments like the ventilator, in vitro fertilization, and organ transplantation to today’s use of ECMO, CRISPR, and artificial intelligence. Bioethicists strive to identify the competing ethical values at stake, weigh them, and propose ethical bedside and policy answers to them.

Originalism matters to bioethicists because courts have and will continue to invoke the theory to resolve constitutional questions concerning such advances, including questions the Framers could not have envisioned.

This article offers a brief description of originalism and the rationale for it and summarizes key criticisms of originalism in principle and in practice. It then examines a mix of past and pending constitutional law cases relevant to bioethics and envisions an originalist approach to deciding them.

Since there is no single bioethics position on the issues presented in these cases, it is not possible to state whether an originalist approach would align or conflict with a bioethical position. Even so, the exercise is illuminating: it alerts bioethicists, with their diverse views, to the possible impact of originalism in bioethical matters.

Originalism

Originalism claims to offer an objective interpretation of constitutional provisions, free from judicial preference, politics, and policy.^[1] Essentially, it calls upon judges to examine historical documents to reveal the original understanding of the provision and adhere to it. Originalism differs from textualism, a related doctrine that calls upon judges not to stray from the text of a constitutional provision or statute. To a strict textualist, the First Amendment, which states that “Congress shall make no law abridging the freedom of speech,” has no exceptions. An originalist, however, would point to laws from that period against libel, fraud, obscenity and more, and conclude that the original meaning of the Free Speech clause included such exceptions.

A key recent example of an originalist opinion is NYS Rifle & Pistol Assn, Inc. v. Bruen.^[2] Plaintiffs claimed that New York’s handgun licensing law violated the Second Amendment, which states that “a well-regulated Militia, being necessary to the security of a free State, the right of the people to keep and bear Arms, shall not be infringed.” Years earlier, the Supreme Court ruled that the right to bear arms did not depend upon service in a militia, and that the term “arms” is not limited to arms in existence in the 18th century.^[3] The sole issue in Bruen was whether the handgun licensing law infringed the right “to keep and bear arms.”

In an opinion written by Justice Thomas, the majority approached the question as follows: it stated that the plain text of the Second Amendment protects the plaintiff’s right to possess arms, which would include a handgun. The Court dismissed as irrelevant New York’s argument, based on precedent, that it had a compelling interest in its gun licensing law and had narrowly tailored the law to address that interest. Rather, the Court held that New York must prove that in the era in which the Second Amendment was passed there were similar licensing laws. It regarded the original understanding of the clause as determinative. The Court then reviewed historical sources produced by the litigants and concluded that there was no analogous licensing law in the history of the colonies or the early Republic. As a result, the Court invalidated New York’s handgun licensing statute.

The next day, the Court issued an opinion by Justice Alito that employed a similar originalist methodology, this time to strike down the constitutional right to abortion. In Dobbs v. Jackson Women's Health Organization,^[4] the issue was whether a Mississippi law restricting abortion violated the 14th Amendment due process clause, a result seemingly compelled by the precedent Roe v. Wade^[5] and its progeny. The Court again started with the text and found that the Constitution “makes no mention of abortion.”^[6] It acknowledged that its prior decisions accepted the "theory" that the due process clause protects some unspecified substantive liberty interests, but only those "deeply rooted in [our] history and tradition.”^[7]

The Court then engaged in an examination of the historical evidence presented by the parties and concluded that abortion rights were not deeply rooted in American history and tradition, nor were they part of the mid-to-late 19th century understanding of the meaning of the due process clause. Accordingly, the Court found that abortion rights are not constitutionally protected. Of interest to bioethicists, the Court noted that its originalist analysis was similar to the analysis it had employed to uphold state laws against “assisted suicide.”^[8]

Since Bruen and Dobbs, the Court and lower courts have increasingly used originalism to rule on the constitutionality of other acts of Congress, agency regulations, or state statutes.^[9] As one legal author put it, “Originalism is ascendent on the Supreme Court.”^[10]

Criticisms of Originalism

When applied in good faith, originalism seeks to address the most fundamental challenge in judicial philosophy: how to interpret the law objectively, without regard to personal policy preferences or bias. In theory, originalism promises almost automated decision making: once a judge feeds the relevant clause and the historical record into the analysis, the ruling is inexorable and unassailable. Arguably, the approach avoids the subjectivity of competing judicial philosophies, primarily activism or “living constitutionalism,” that invite judges to interpret constitutional provisions in light of the social and political problems of the day. Put differently, originalism is designed to ensure that judges strictly apply the law and not act like legislators. However laudable its purpose, originalism is subject to a long list of formidable criticisms in principle and as practiced.^[11]

Criticisms of Originalism Theory

Critics have questioned whether it is appropriate for courts to research and evaluate centuries-old historical records and, indeed, whether they are qualified to do so. One legal scholar and historian wrote that most historians regard the Court’s attempts to identify history and tradition “with detached disdain, puzzled wonderment, and even dismissive bemusement – as in: ‘Surely, they can't be serious.’”^[12]

There is also the question of whether it is desirable or even morally defensible to resolve today’s issues based on textual interpretations of the Framers and early legislative bodies, given their composition.^[13] Invariably, they consisted exclusively of male, white, wealthy landowners, including slaveholders. Consider this comment by Osagie K. Obasogie:

[T]he precise historical moments sought to serve as moral and interpretive reference points—a period of slavery, genocidal eradication of Native Americans, conquest and illegitimate land capture, patriarchy and deep gender bias, and other discriminatory attitudes—were so doggedly inequitable that it becomes hard to justify transporting eighteenth-century legal mores into the present as anything other than an attempt to maintain white male privilege."^[14]

To be sure, not all Framers shared the same morals or views. But the different perspectives among them further erode the argument for an originalist approach. It is doubtful that all the Framers understood key clauses the same way, so there may be no single original understanding of a clause.^[15]

An even more fundamental attack on originalism is that the original understanding of a clause was based on the circumstances of that day, not the circumstances of today. The historical record cannot reliably answer whether the Framers would have supported a right to bear arms if the arms included today’s high-powered weapons. Similarly, their views on extending free speech to unlimited corporate election spending are impossible to know. Nor did the Framers claim to be resolving future issues: as the Supreme Court observed, the Founders “knew they were writing a document designed to apply to ever-changing circumstances over centuries.”^[16]

Next, at least some originalist justices exhibit a striking disregard for stare decisis – the legal doctrine of respect for precedent.^[17] Both Bruen and Dobbs gave scant regard to the longstanding and largely settled caselaw. In fact, it is fair to ask why longstanding precedents such as Roe v. Wade do not now demonstrate our history and tradition, entitling them to as much, or greater, deference than historical records from the founding period. As one writer put it, “Does tradition afterward count?”^[18]

An especially sharp criticism of originalism is its disregard of justice, of consequences to people. Originalist judges consider this dispassionate adjudication a feature, not a flaw. If the historical record does not support handgun licensing, so be it; the potential for mayhem is not a relevant consideration. (Although, in some cases, the originalist approach would lead to results too intolerable for at least some originalists to bear. For example, in a case in which a violent spouse abuser challenged a court order restricting his access to weapons, all but one of the Bruen originalists relaxed their analysis to uphold the restriction.^[19] Justice Thomas, dissenting, would have allowed the violent abuser to have his weapons, explaining that “[n]ot a single historical regulation justifies the statute at issue.”)

Criticisms of Originalism in Practice

A key criticism of originalism in practice is that it is applied selectively.^[20] The conservative majority on the Supreme Court employed originalism in cases where, in its view, the historical record disfavored a right to medical aid-in-dying, disfavored a right to abortion, and favored a right to carry unlicensed firearms. However, the Court chose not to employ an originalist analysis in deciding whether corporations have the right to make unlimited campaign contributions^[21] or whether the president of the United States has broad immunity from prosecution for federal criminal laws.^[22]

Furthermore, originalists are charged with cherry-picking historical evidence in support of their political or ideological aims. For example, the dissenters in Dobbs accused Justice Alito of choosing items from the historical record that supported the decision he favored, while disregarding the contrary historical evidence. Whether true in that case or not, in practice originalism is not structurally guaranteed to be an objective methodology; judges can use history selectively to reach the desired result.

Originalism Applied to Bioethics Cases

This section reviews past and pending bioethics-related cases and considers both how originalism would affect the outcome and how bioethicists might view such outcomes.^[23]

Past Bioethics-Related Cases

I. The 14th Amendment Due Process Clause and the Right to Refuse Life-Sustaining Treatment

In the 1990 Supreme Court case, Cruzan v. Director, Missouri Department of Health,^[24] the parents of a permanently unconscious patient sought a court order directing the hospital to discontinue the patient’s feeding tube. In a decision authored by Chief Justice Rehnquist, the Court held that (1) a competent person has a liberty interest under the due process clause in refusing unwanted medical treatment, but that (2) in the case of an incompetent patient, Missouri may constitutionally require clear and convincing evidence of the patient’s wishes to exercise that right.

An originalist analysis would likely overrule the first part of this precedent. It would first find that the text of the Constitution does not include a right to refuse unwanted medical treatment. The analysis would entail a review of the record from the latter half of the 19th century (the 14th Amendment was passed in 1866 and ratified in 1868) to see whether the original understanding encompassed such rights. In the absence of such evidence, it would reject the first holding in Cruzan; it would find that there is no 14th Amendment due process right to refuse unwanted medical treatment.

In fact, Justice Scalia, in a concurring opinion, followed this precise originalist formula in contending that there is no constitutional right to refuse treatment. He wrote:

It is at least true that no “substantive due process” claim can be maintained unless the claimant demonstrates that the State has deprived him of a right historically and traditionally protected against state interference. . . ^[25]

To raise up a constitutional right here we would have to create [it] out of nothing (for it exists neither in text nor tradition) . . . ^[26]

Interestingly, an originalist decision overruling the constitutional right to refuse unwanted medical treatment would not appear to have a great practical impact on decisions regarding life-sustaining treatment. Both red and blue states have laws or state court decisions that allow patients to forgo life-sustaining treatment, either directly or through advance directives, most of which predate Cruzan. Most states also allow surrogate decision-making. Respect for the right to forgo life-sustaining treatment is a rare area of consensus in a time of culture war.

In fact, overruling Cruzan's constitutional right to refuse unwanted medical treatment may prove a greater barrier to persons claiming a right to refuse vaccination or other pandemic-related treatments. Many of the challenges by vaccination opponents rely upon Cruzan as among the constitutional bases for their asserted right.^[27]

As noted at the outset, there is no single bioethics position on the ethical issues raised by medicine and biomedical technology. However, a pervasive theme in bioethical literature is respect for autonomy and specifically respect for capable adult patients’ decision to accept or decline recommended treatment.^[28] The option of declining treatment necessarily follows from the fundamental ethical obligation to secure a patient’s informed consent to treatment. The constitutional right to forgo life-sustaining treatment recognized in Cruzan aligns with the mainstream bioethics perspective. An originalist rejection of such a constitutional right would conflict with the predominant bioethical perspective.^[29]

As an aside, while there is no Supreme Court decision on point, originalism likely would not support a constitutional right to informed consent, a key bioethical value. The roots of informed consent do not run deep enough to satisfy originalists.^[30] Like the right to forgo unwanted treatment, the principle of informed consent more recently became enshrined in common law, statutes, and regulations, and well as in nationwide professional standards.

Cruzan is just one example of how originalism might impact cases that construe the 14^th Amendment due process clause in the sphere of bioethics. Over the past 75 years, the clause was invoked as a basis for a constitutional right to contraceptives^[31] and abortion.^[32] Due process also provides a basis for constitutional protections, procedures, and limitations to protect people from unjustified involuntary mental health commitment.^[33] among other rights. The federal right to abortion is already a casualty of originalism;^[34] the others would be at risk from a challenge based on the 19^th-century legislators’ original understanding of due process.^[35]

II. The First Amendment Free Speech Clause and Countering Misinformation about Vaccines in a Pandemic

Murthy v. Missouri (2024)^[36] addressed an issue highly relevant to bioethics: whether and to what extent the federal or state government can suppress views that it believes endanger public health.

During the Covid-19 pandemic, officials in the Biden administration publicly and privately urged social media platforms like Facebook not to allow misinformation about the pandemic and the Covid-19 vaccine on their websites. Two states and five individual social media users sued, claiming that the Biden administration’s actions constituted censorship in violation of the First Amendment’s free speech clause. The Biden administration contended that it was merely calling the platforms’ attention to harmful misinformation and encouraging them to guard against it. But the District Court found that the government engaged in unconstitutional censorship and issued an injunction. The Fifth Circuit affirmed that decision.^[37]

The Supreme Court dismissed the complaint on the grounds that the plaintiffs lacked "standing", i.e., a sufficient personal stake in the lawsuit to meet the requirement that the court may only hear a case or controversy. Justice Alito dissented, declaring that “this is one of the most important free speech cases to reach the court in years.”^[38] He contended that the record showed egregious coercion and suppression of disfavored anti-vaccination speech. He argued that the Court should have recognized the plaintiffs’ standing and reached the merits.

Assessing the merits under a traditional (not originalist) analysis, a court would first determine whether the government in fact suppressed speech. Having determined that it did so, the court would consider whether the restriction of speech fell within an exception, such as the government’s ability to block speech “directed to inciting or producing imminent lawless action and … likely to incite or produce such action.”^[39] In this case, the Biden administration made no such claim. Accordingly, under a traditional analysis, if not for the standing defect, the Court likely would have found that the government violated the free speech clause.

Now, turning to a hypothetical originalist analysis, the most restrictive view is that espoused by Robert Bork, the conservative legal scholar and a founder of originalism. He contended, based on his reading of the history of the First Amendment, that it protects only “speech that is explicitly political.”^[40] Under that view, the federal government could suppress disfavored views about vaccines and every other nonpolitical topic.

Most originalists would not go that far. They would engage in a narrower historical inquiry, such as whether the public understood the First Amendment to bar the government from pressuring the media of their day to not publish content that the government believed posed a threat to public health.

There may well be historical evidence that could answer that question. Epidemics and governmental efforts to contain them occurred intermittently throughout US history.^[41] Perhaps early lawmakers expected the free speech clause to apply to such measures, perhaps not. But significantly, Justice Alito’s lengthy dissent did not address that question. He opted to forgo an originalist analysis of the case.

Government censorship of or opposition to disfavored views has arisen with even greater force during the second Trump administration. The current administration has punished or threatened universities,^[42] law firms,^[43] and other institutions^[44] with the loss of millions of dollars of funding for expressing, or allowing their community members to express, disfavored views about diversity, equity, and inclusion (DEI), the war in Gaza, and other issues. Of direct interest to bioethics, it is punishing hospitals and physicians for supporting gender reassignment procedures.^[45] It will be interesting to see if the Court or dissenters condemn censorship here as well, or whether it applies an originalist analysis and perhaps finds historical support for the government’s conduct.

III. The 14th Amendment Equal Protection Clause and a State Prohibition of Gender Reassignment Treatments for Minors

This example is based on United States v. Skrmetti (2025).^[46] Plaintiffs challenged a Tennessee statute that restricted sex transition procedures for minors, claiming it employed sex-based classifications in violation of the equal protection clause. That clause provides that a State shall not “deny to any person within its jurisdiction the equal protection of the laws.”

The Court employed a traditional (not originalist) equal protection analysis, which involved querying whether the statute injured either a suspect class or a fundamental right – in which case it would be subject to heightened scrutiny. It found that the statute did neither; rather, it used classifications based on age and medical conditions, which are subject only to rational review. It then found that the state law had a rational relationship to a legitimate government interest, satisfying rational basis review.

An originalist analysis would likely reach the same result, but through a different path. First, originalists like Professor Bork and Justice Alito contended that the equal protection clause was originally understood to protect only the legal treatment of black citizens post-slavery.^[47] Accordingly, in his view, the clause does not guarantee equal protection for women, people with disabilities, LGBTQ people, noncitizens, or other groups.^[48]

A less radical originalist approach would be to examine the history to answer the narrower question presented in Skrmetti: would mid-19^th-century lawmakers or the public have understood the equal protection clause to protect transgender persons? Laws from that period that discriminated against or punished conduct by transgender persons would weigh against the argument that the original understanding of equal protection included protection of this class. It seems doubtful that these plaintiffs could have established their historical right to equal protection.

The Skrmetti example illustrates how fundamentally conservative originalism is: the doctrine requires that whatever groups were subjected to injustices and prejudices considered acceptable at the time the Constitutional provision was adopted must remain unprotected by the provision.

In Obergefell v. Hodges, which held that the due process and equal protection clauses require states to recognize same sex marriage, Justice Kennedy wrote:

The nature of injustice is that we may not always see it in our own times. The generations that wrote and ratified the Bill of Rights and the Fourteenth Amendment did not presume to know the extent of freedom in all of its dimensions, and so they entrusted to future generations a charter protecting the right of all persons to enjoy liberty as we learn its meaning.^[49]

Originalism emphatically rejects that view. It would require judges to continue historical injustices because they are historical. To the originalist, the equal protection clause should not have been construed to prohibit laws against same-sex marriage because such laws were publicly accepted at the time the clause was adopted.

In any event, this is another instance in which the Court inexplicably chose not to follow originalist methodology in favor of a traditional, less controversial equal protection analysis that was sufficient to reach the same result.

Pending Bioethics-Related Cases

I. The 1st Amendment Free Exercise Clause and the Right to a Religious Exemption from Mandatory School Immunizations

This example is based on a pending lawsuit, Miller v. McDonald.^[50] The plaintiffs in Miller claim that New York’s mandatory vaccination law for school children infringes their free exercise rights under the First Amendment by failing to allow religious exemptions. The federal Court of Appeals upheld the statute as a law of general applicability that the legislature deemed necessary to protect child health. However, the Supreme Court remanded the case to the Court of Appeals to reconsider its decision in light of Mahmoud v. Taylor, its most recent free exercise ruling.

In Mahmoud, the Court held that a school must allow parents to excuse their children from having to read LGBTQ+ related stories that they found objectionable on religious grounds. The Court found that the mandate imposed an undue burden on the parents’ free exercise rights. For present purposes, what is notable about Mahmoud and other recent pro-religious exemption decisions^[51] or dissents^[52] is that they do not employ originalist analyses. Indeed, the cases mentioned do not address the historical understanding of the free exercise clause at all.

An originalist analysis of the religious exemption claim would review the historical record regarding exemptions to mandatory vaccination. The Supreme Court addressed that record in its 1905 decision, Jacobson v. Massachusetts.^[53] In response to a smallpox outbreak, the city of Cambridge, Massachusetts, passed a regulation requiring its inhabitants to be vaccinated. A resident objected to the regulation on constitutional (though not specifically religious) grounds. The Court per Justice Harlan essentially applied an originalist analysis: it provided extensive historical support for authority of a state to enact quarantine laws and “health laws of every description.”^[54] It also noted the practice of compelling persons to be drafted in war time, “without regard to his personal wishes or his pecuniary interests, or even his religious or political convictions.”^[55]

Arguably, Jacobson’s originalist approach supports mandatory vaccination without exemption only in the case of a public health emergency, as opposed to mandatory routine preventive vaccinations. And there might well be historical support from the constitutional era for religious exemptions. But significantly, the Miller Court chose not to raise the historical question at all. That failure illustrates the key criticism mentioned earlier: the subjective choice to employ the originalist approach only when it will lead to politically desired outcomes undermines the claim that originalism ensures neutrality and objectivity. Put differently, the Court could have, but chose not to, review or remand the case in light of Bruen and Dobbs.

Bioethicists disagree among themselves about the ethics of offering a religious exemption to a vaccination mandate. Some focus on the fundamental importance of individual autonomy, including respect for religious belief; others focus on the principle of justice, including obligations to the community. But the point here is that the bioethical debate would turn on competing ethical values, not on whether there was an original understanding that religious objectors would be exempt from mandatory vaccinations.

II. The Article II Vesting Clause and the Prohibition of Gender Reassignment Treatment for Minors

At least three major lawsuits^[56] are challenging an executive order of President Trump that aims to eliminate gender reassignment treatment to persons under age nineteen by directing the US Department of Health and Human Services (HHS) and other agencies to eliminate research and educational grants and taking other regulatory action against providers and institution that offer such treatment.^[57] A key claim in the legal challenges is that the executive order in question is beyond the constitutional authority of the president under Article II of the Constitution and usurps the legislative function. In legal jargon, the executive order is ultra vires.

An originalist analysis would start with the text of the Article II vesting clause, which states that "The Executive Power shall be vested in a President of the United States of America.” It must be read in conjunction with Article I, which states that “All legislative powers granted by the Constitution are given to Congress....” In short, the Constitution gives Congress the exclusive power to legislate and the executive branch the exclusive power to execute the laws.

The originalist analysis would then research the historical record to discern whether the Framers and the public at the time would have regarded an executive order restricting a disfavored medical procedure as more akin to legislating or to executing federal law. It would be an interesting analysis: on one hand, a core purpose of the American Revolution was to achieve independence from a tyrannical king; yet the early experiment of the Articles of Confederation demonstrated the need for an executive with significant authority, albeit within the bounds of law.

Ultimately, a historical analysis would likely show that the Framers viewed the president’s authority as far narrower than the view prevalent today. Turning then to an executive order against gender reassignment treatments, an originalist analysis would likely view this as a legislative action, rather than an execution of existing laws.

This raises a broader point: an originalist approach to interpreting the Article II vesting clause would likely restrict presidential authority to a degree far greater than that which recent presidents routinely exercise. If applied uniformly, it would restrain presidential initiatives that many bioethicists might support, as well as others that many would oppose.

Conclusion

This exercise offers only a few examples of how originalism might be applied to cases in bioethics. Originalism is extremely conservative in the literal sense – it compels the resolution of today’s novel legal issues by mining the views of lawmakers from long ago. Advances in medicine and biotechnology have often “outpaced” the law.^[58] When that happens, originalism stands guard in the doorway, defiantly barring constitutional law from catching up. It is an especially firm bulwark against the recognition of rights that are not specified in the Constitution, including those highly relevant to bioethics, such as privacy, contraception, abortion, and medical-aid-in dying.

While originalism is inherently conservative, the examples studied in this article reveal some surprises: in some cases, it yields results that would not be regarded as conservative by today's standards. For example, an originalist analysis would likely support a law mandating vaccination without a religious exemption. And it might disfavor an executive order, issued without legislative support, that restricts gender reassignment treatments. Or the denial of funding to suppress speech.

Accordingly, originalism can be politically fickle; it might in some cases point to an arguably progressive result.^[59] Perhaps for that reason, the doctrine seems to be used selectively by the Court. But that selectivity undermines its rationale as an objective judicial philosophy, in contrast to judicial legislating.

In constitutional cases involving modern bioethical issues, while originalism can lead to outcomes across the political spectrum, ultimately, the public is ill-served by the Supreme Court's demand for evidence of the inapposite views of our ancestors.

[1] Antonin Scalia, “Originalism: The Lesser Evil,” University of Cincinnati Law Review 57 (1989): 849. https://teachingamericanhistory.org/document/originalism-the-lesser-evil/

[2] 597 U.S. 1 (2022). https://www.oyez.org/cases/2021/20-843

[3] District of Columbia v. Heller, 554 U.S. 570 (2008). https://supreme.justia.com/cases/federal/us/554/570/

[4] 597 U.S. 215 (2022). https://supreme.justia.com/cases/federal/us/597/19-1392/

[5] 410 U.S. 113 (1973). https://supreme.justia.com/cases/federal/us/410/113/

[6] Dobbs, 597 U.S. at 225. https://supreme.justia.com/cases/federal/us/597/19-1392/

[7] Ibid., 597 U.S. at 231.

[8] Ibid., 597 U.S. at 239, referring to Washington v. Glucksberg, 521 U.S. 702 (1997).

[9] E.g., Moore v. Harper, 143 S.Ct. 2065(2023). https://supreme.justia.com/cases/federal/us/600/21-1271/#tab-opinion-4757256 (federal court review of state election laws); Trump v. Anderson, 144 S.Ct. 662 (2024). https://supreme.justia.com/cases/federal/us/601/23-719/ (meaning of insurrection clause); Kennedy v. Bremerton Sch. Dist., 142 S. Ct. 2407 (2022). https://supreme.justia.com/cases/federal/us/597/21-418/ (prayer on school football field does not violate establishment clause).

[10] Ian Bartrum, “Structural Originalism: A Second Amendment Case Study,” University of Pennsylvania Journal of Constitutional Law 27 (2025): 846. https://doi.org/10.58112/jcl.27-4.3

[11] Bruen, 83 - 133 (Breyer, dissenting). See also, Erwin Chemerinsky, Worse than Nothing (Yale University Press, 2022); Thomas Wolf, Seth Breidbart, and Chika Isozaki, Countering Originalism: A Guide for Litigators (New York: Brennan Center for Justice at New York University, December 2025), https://www.brennancenter.org/media/14809/download/bcj-166-countering-Originalism.pdf.

[12] William J. Novak, “Some Realism about Originalism,” Michigan Law Review 123 (2025): 1185–1190. https://doi.org/10.36644/mlr.123.6.some; Saul Cornell, “Learning to Read Like an Eighteenth-Century Lawyer: The Historical Critique of Originalism Revisited,” William & Mary Bill of Rights Journal 33 (2024): 439. https://scholarship.law.wm.edu/cgi/viewcontent.cgi?article=2104&context=wmborj

[13] Chemerinsky. The Abhorrence Problem. In Erwin Chemerinsky, Worse Than Nothing: The Dangerous Fallacy of Originalism (Yale University Press, 2022),

[14] Osagie K. Obasogie, “Can Originalism Save Bioethics?” in Critical Approaches to Science and Religion, chap. 4 (New York: Columbia University Press, 2023), 97.

[15] Chemerinsky. The Epistemological Problem. In Erwin Chemerinsky, Worse Than Nothing: The Dangerous Fallacy of Originalism (Yale University Press, 2022).

[16] NLRB v. Noel Canning, 573 U.S. 513, 533–34 (2014). https://supreme.justia.com/cases/federal/us/573/513/

[17] J. Bernstein, "Originalism's Precedent Problem," 45 Northern Illinois University Law Review 172. https://huskiecommons.lib.niu.edu/niulr/vol45/iss2/6/

[18] "Conservative Caution v. Progressive Originalism: How Justices Barrett and Jackson Are Paving Their Own Paths on the Court," symposium, 31 Cardozo Journal of Equal Rights and Social Justice 607 (2025) at 636. https://larc.cardozo.yu.edu/cgi/viewcontent.cgi?article=1029&context=cardozoersj

[19] United States v. Rahimi, 602 U.S. 680 (2024). https://supreme.justia.com/cases/federal/us/602/22-915/

[20] Chemerinsky. The Hypocrisy Problem. In Erwin Chemerinsky, Worse Than Nothing: The Dangerous Fallacy of Originalism (Yale University Press, 2022).

[21] Citizens United v. Federal Election Commission, 558 U.S. 310 (2010). https://supreme.justia.com/cases/federal/us/558/310/

[22] Trump v. United States, 603 U.S. 593 (2024). https://supreme.justia.com/cases/federal/us/603/23-939/

[23] Obasogie, “Can Originalism Save Bioethics”,” 97. Obasogie, addressing a related but separate topic, observes that "Germline engineering, embryo screening, and similar techniques give rise to the ability of science and medicine to enhance or eliminate populations in ways that would make nineteenth-century eugenicists utterly giddy." He then calls for bioethicists to employ Originalism, to "reorient itself away from principalism and back toward its original founding value: anti-eugenics."

[24] 497 U.S. 261 (1990). https://supreme.justia.com/cases/federal/us/497/261/

[25] Ibid. At 294.

[26] Ibid. at 300.

[27] E.g., Health Freedom Defense Fund, Inc. v. Carvalho, 148 F.4th 1020 (9th Cir. 2025). https://cdn.ca9.uscourts.gov/datastore/opinions/2025/07/30/22-55908.pdf; Johnson v. Kotek, NO. 22-35624, 2024 WL 747022 (9th Cir. 2024). https://www.supremecourt.gov/DocketPDF/24/24-173/322395/20240813193006226_Johnson%20v%20Kotek%20Petition.pdf; Children's Health Defense, Inc. v. Rutgers, the State University of New Jersey, 93 F.4th 66 (3rd Cir. 2024). https://law.justia.com/cases/federal/appellate-courts/ca3/22-2970/22-2970-2024-02-15.html; We The Patriots USA, Inc. v. Connecticut Office of Early Childhood Development 76 F.4th 130 (2nd Cir. 2023). https://law.justia.com/cases/federal/appellate-courts/ca2/22-249/22-249-2023-08-04.html

[28] Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 8th ed. (New York: Oxford University Press, 2019).

[29] A bioethicist might respect a patient’s decision to forgo treatment as an ethical matter but not support it as constitutional right. While principled arguments could be made for holding those separate positions, the positions are not “aligned” in whether they support the patient’s decision.

[30] Ruth R. Faden and Tom L. Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

[31] Carey v. Population Services International, 431 U.S. 678 (1977). https://supreme.justia.com/cases/federal/us/431/678/ (An earlier right-to-contraceptives decision. Griswold v. Connecticut, 381 U.S.479 (1965), relied upon a combination of constitutional provisions, but principally the First Amendment).

[32] Roe v. Wade, 410 U.S. 113 (1973). https://supreme.justia.com/cases/federal/us/410/113/

[33] O’Connor v. Donaldson, 422 U.S. 563 (1975); Parham v. J.R., 442 U.S. 584 (1979). https://supreme.justia.com/cases/federal/us/422/563/

[34] Dobbs v. Jackson Women’s Health Organization (2022).

[35] See e.g. Erwin Chemerinsky, “The Future of Substantive Due Process: What are the Stakes?,” 76 SMU Law Review 427 Summer 2023); Parker Wilkson, “The Danger of Dobbs: Substantive Due Process, Fundamental Rights, And a Critique of the Theory of Historical Tradition.” 35 U. Fla. J.L. & Pub. Pol'y 197 (Spring 2025).

[36] Murthy v. Missouri, 603 U.S. 43 (2024). https://supreme.justia.com/cases/federal/us/603/23-411/

[37] Missouri v. Biden, 83 F.4th 350 (5th Cir. 2023). https://law.justia.com/cases/federal/appellate-courts/ca5/23-30445/23-30445-2023-09-08.html

[38] Murthy v. Missouri, 603 U.S. at 77 (Alito,J., dissenting).

[39] Brandenburg v. Ohio, 395 U.S. 444, 447 (1969). https://supreme.justia.com/cases/federal/us/395/444/

[40] Robert Bork, “Neutral Principles and Some First Amendment Problems,” 47 Indiana Law Review (1971):1, 20. https://www.repository.law.indiana.edu/cgi/viewcontent.cgi?article=2720&context=ilj

[41] See Polly Price, Plagues in the Nation: How Epidemics Shaped America (Beacon)(2022).

[42] E.g., “Columbia Agrees to Trump’s Demand After Federal Funds Are Stripped,” New York Times, March 21, 2025. https://www.nytimes.com/2025/03/21/nyregion/columbia-response-trump-demands.html

[43] “Trump Expands Attacks on Law Firms, Singling Out Paul, Weiss,” New York Times, March 28, 2025. https://www.nytimes.com/2025/03/14/us/politics/trump-law-firm.html

[44] “When It Comes to D.E.I. and ICE, Trump Is Using Federal Grants as Leverage,” New York Times, April 7, 2025. https://www.nytimes.com/2025/04/07/us/politics/trump-homeland-security-ice-dei-grants.html

[45] President Donald J. Trump, Exec. Order No. 14,187, “Protecting Children from Chemical and Surgical Mutilation,” n.33 supra. https://www.federalregister.gov/documents/2025/02/03/2025-02194/protecting-children-from-chemical-and-surgical-mutilation

[46] United States v. Skrmetti, 605 U.S. 495 (2025). https://www.justice.gov/crt/media/1404486/dl?inline

[47] United States v. Virginia, 518 U.S. 515, 568-69 (1996)(Scalia, J. dissenting). https://supreme.justia.com/cases/federal/us/518/515/

[48] Chereminsky, ibid., Chapters 4 and 5.

[49] Obergefell v. Hodges, 576 U.S. 644, 664 (2015). https://supreme.justia.com/cases/federal/us/576/644/

[50] Order 25-133 (December 8, 2025) https://www.supremecourt.gov/orders/courtorders/120825zor_i4ek.pdf

[51] Fulton v. City of Philadelphia, Pennsylvania, 593 U.S. 522 (2021). https://supreme.justia.com/cases/federal/us/593/19-123/; Roman Catholic Diocese of Brooklyn v. Cuomo, 592 U.S. 14 (2020). https://www.oyez.org/cases/2020/20A87

[52] Dr. A. v. Hochul, 142 S.Ct. 552 (2021). https://www.supremecourt.gov/opinions/21pdf/21a145_gfbi.pdf (Gorsuch, dissenting)

[53] Jacobson v. Massachusetts, 197 U.S. 11 (1905). https://supreme.justia.com/cases/federal/us/197/11/

[54] Id. at 25.

[55] Id. at 29.

[56] PFLAG, Inc. v. Trump, 8:25-cv-00337 https://storage.courtlistener.com/recap/gov.uscourts.mdd.575616/gov.uscourts.mdd.575616.1.0_3.pdf; Commonwealth of Massachusetts v. Trump, 25 CV- 12162, at p 2. https://storage.courtlistener.com/recap/gov.uscourts.mad.287522/gov.uscourts.mad.287522.1.0.pdf; San Francisco Aids Foundation v. Trump, 3:25-cv-1824 https://storage.courtlistener.com/recap/gov.uscourts.cand.444946/gov.uscourts.cand.444946.1.0.pdf (challenging several executive orders)

[57] President Donald J. Trump, Exec. Order No. 14,187, “Protecting Children from Chemical and Surgical Mutilation,” January 28, 2025, https://www.govinfo.gov/content/pkg/DCPD-202500192/pdf/DCPD-202500192.pdf.

[58] E.g., Susan M. Wolf et al., “Anticipating Biopreservation Technologies That Pause Biological Time: Building Governance & Coordination Across Applications,” Journal of Law, Medicine & Ethics 52 (2024): 534–552. https://doi.org/10.1017/jme.2024.129; Susan L. Crockin, Alta L. Charo, and M. Edmonds, “The History and Future Trends of Art, Medicine and Law,” Family Court Review 59, no. 1 (January 2021): 22–45, https://doi.org/10.1111/fcre.12550.

[59] Novak at 1190 (discussing "Dreams of a Progressive Originalism"). https://repository.law.umich.edu/cgi/viewcontent.cgi?params=/context/mlr/article/14175/&path_info=

Specimens and Data, Not Evidence

Melissa Jones — 2026-03-12

Photo ID 26405281© Anyaivanova | Dreamstime.com

Introduction

Clinical laboratories are built on trust, with patients expecting their specimens and associated data for diagnosis or treatment to remain confined to clinical purposes. However, notable cases demonstrate how easily clinical samples and related medical records can be repurposed for criminal investigations.^[1] For instance, police used DNA from a routine pap smear in the Blind Torture Kill (BTK) case; authorities in New Jersey accessed decades-old newborn blood spots in the Brian Avis case; and investigators used relatives’ genetic data from a genealogy database in the Golden State Killer case.^[2] These incidents highlight a growing tension between medical care and law enforcement, underscoring critical ethical concerns about patient autonomy, confidentiality, and the limits of clinical sample use.

Law enforcement’s growing interest in clinical laboratory data raises pressing questions about whether patient specimens are being treated as investigatory evidence rather than components of healthcare. While the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments (CLIA) regulate privacy and laboratory standards, both have broad exceptions for law enforcement and do not address specimen retention or secondary use.^[3] Since these laws offer limited protections, constitutional safeguards become central. This paper argues that existing legal and regulatory frameworks inadequately safeguard clinical specimens and medical records from investigatory repurposing. After outlining the ethical principles that protect patients, the analysis turns to constitutional doctrines affecting law enforcement access, variations across states, and real-world examples illustrating the impacts of these gaps. The paper concludes by proposing reforms to enhance transparency, autonomy, and public trust in the clinical laboratory.

Ethical Frameworks: Principles Guiding Patient Protection

Deontological ethics holds that specific actions are impermissible regardless of their outcomes. In the clinical laboratory, deontological ethics includes respecting autonomy, maintaining confidentiality, and honoring fidelity. Using specimens collected for clinical care in criminal investigations without explicit, voluntary consent violates these duties, even when HIPAA permits it under its law-enforcement exceptions.^[4]

Utilitarian arguments for using clinical laboratory specimens and related data often emphasize the benefits of solving crimes, but this perspective risks treating patients as means to an end and ignoring broader harms. Evidence shows that concerns about genetic privacy decrease participation in newborn screening, biobanking, and other public health efforts.^[5] Therefore, a utilitarian approach must consider long-term effects, such as reduced trust and lower engagement with healthcare systems. Ethical frameworks delineate clear boundaries: clinical specimens are collected for care, not surveillance. Despite these ethical imperatives, the legal system provides uneven protection, particularly where constitutional doctrines intersect with law enforcement interests. This tension becomes most apparent in the Fourth Amendment context.

Constitutional Limitations

Regardless of the regulatory structure governing clinical laboratories, the constitutional landscape ultimately determines the extent to which law enforcement may access patient specimens and data. Because statutory protections are limited, courts have become the primary arbiters of what constitutes a permissible intrusion.^[6]

The Special Needs Doctrine: Lessons from Skinner

In Skinner v. Railway Labor Executives’ Association (1989), the Supreme Court upheld warrantless drug and alcohol testing of railway employees. The Court reasoned that the government’s interest in public safety constituted a “special need” beyond ordinary law enforcement. This decision established the modern Special Needs Doctrine, which permits warrantless searches, including the collection of specimens, when the primary purpose is considered administrative. ^[7] Although Skinner arose in the context of transportation safety, the Court’s reasoning has been extended to other settings, weakening Fourth Amendment protections for clinical specimens.

The Third-Party Doctrine

Under the Third-Party Doctrine, individuals forfeit constitutional privacy protections for information they voluntarily shared with third parties, including hospitals and laboratories. In the clinical laboratory context, this doctrine treats disclosures made for medical care as equivalent to disclosures made for non-medical purposes, a conflation that undermines patient autonomy and confidentiality. ^[8]

Fourth Amendment Case Law

Courts have long debated the extent of bodily intrusion allowed under the Fourth Amendment when law enforcement seeks biological evidence. In Schmerber v. California, the Court upheld a warrantless blood draw under limited exigent circumstances. ^[9] However, subsequent rulings have narrowed that reasoning. In Missouri v. McNeely (2013), the Court rejected a categorical rule that the natural dissipation of alcohol in the bloodstream alone creates exigency and instead required a case-by-case evaluation.^[10] In Birchfield v. North Dakota (2016), the Court distinguished breath tests, which can be performed without a warrant, from blood tests, which generally require a warrant.^[11]

Courts have also condemned more invasive procedures. In Winston v. Lee, the Court ruled that forced surgical removal of a bullet violated the Fourth Amendment, and in United States v. Fowlkes (2015), the Ninth Circuit found forced catheterization to obtain urine to be an unreasonable search.^[12] These cases demonstrate that the level of bodily intrusion is a key constitutional issue and that the use of medical procedures for law enforcement raise serious Fourth Amendment concerns.

State-Level Variation

Although the Fourth Amendment sets a federal constitutional baseline, states vary significantly in how they interpret and apply bodily‑intrusion case law. Some states adopt broad implied‑consent statutes that authorize blood or urine testing following arrest, while others limit implied consent to breath tests or require warrants for all invasive procedures. For example, Nevada’s statute permits expansive implied‑consent testing and authorizes chemical testing under a wide range of circumstances.^[13] By contrast, California limits implied consent to situations following a lawful arrest and requires warrants for blood draws absent exigency.^[14] Utah protects healthcare workers who refuse warrantless blood draws, emphasizing clinician autonomy and liability.^[15] Historically, Pennsylvania required healthcare workers to comply with police requests for blood samples, reflecting a more law-enforcement approach.^[16] States also differ in their treatment of forced catheterization, the collection and retention of clinical laboratory specimens and data, and other invasive procedures as means of evidence collection, with some courts viewing them as categorically unreasonable and others permitting them under narrow circumstances.^[17]

Ultimately, the degree of protection afforded to patients depends heavily on state-level choices regarding consent, clinician authority, the permissibility of invasive procedures, and law enforcement access.

Toward Ethical Integrity: Policy Reform Proposals

The interplay of statutory gaps, including the exception to HIPAA’s privacy rule, constitutional limitations, and divergent state practices demonstrates that current frameworks inadequately protect clinical specimens from investigatory use. This landscape highlights the need for reforms that reinforce ethical and legal safeguards.

Reform 1: Require Voluntary, Explicit Consent

Law enforcement access to specimens or metadata should require explicit, voluntary consent. In the clinical laboratory, presumed consent — where agreement is inferred from silence, unconsciousness, or routine clinical encounters — is ethically indefensible. It treats patients as passive subjects of investigation rather than autonomous individuals. Although some contend that explicit consent may delay investigations, deontological ethics holds that convenience cannot override autonomy. Utilitarian reasoning likewise supports explicit consent, considering the long-term harms of eroding trust.^[18]

Reform 2: Prohibit Conditioned Consent

Healthcare access must never depend on investigatory cooperation. Conditioning medical care on a patient’s willingness to provide specimens or information for law enforcement purposes undermines autonomy and erodes trust in the clinical relationship. Evidence shows that coercive consent reduces willingness to share sensitive information and discourages engagement with healthcare systems, ultimately harming individual care and public health.^[19]

Reform 3: Protect Specimens and Metadata Equally

Metadata can be reidentified through linkage with other datasets.^[20] Treating metadata as less sensitive creates exploitable loopholes. Policies must extend protection to both specimens and associated data.

Reform 4: Mandate Independent Oversight and Transparency

Oversight bodies should evaluate investigatory requests and issue transparency reports. Rather than adding bureaucratic burden, oversight enhances accountability and clarifies the separation between clinical care and criminal investigations. However, most jurisdictions lack an independent entity to monitor how often patient records are accessed for law enforcement or how metadata is queried, linked, or reused.^[21] Without such oversight, patients and clinicians lack visibility into the frequency and scope of investigative access, and policymakers lack the data needed to evaluate whether current practices align with ethical and constitutional norms.

Reform 5: Update Newborn Screening Policies

Newborn screening programs should adopt opt-in consent for secondary uses and establish clear limits on the retention of residual blood spots. Research consistently shows parental opposition to non-consensual secondary use and highlights trust as essential to program participation.^[22]

Conclusion

Unrestricted law enforcement access to clinical specimens risks transforming clinical encounters into a surveillance pathway. Deontological ethics demands the protection of patient rights regardless of investigatory outcomes, while utilitarian analysis warns against systemic harms caused by privacy erosion. Legally, HIPAA and CLIA offer insufficient safeguards, particularly regarding specimen retention and metadata use. Reform must begin with explicit, revocable consent, independent oversight, and a clear separation between clinical care and criminal investigation.

The clinical laboratory is not a forensic repository. It is a space of healing, trust, and ethical responsibility. Policymakers, administrators, and clinicians must act now to establish statutory reforms that prevent investigatory misuse, mandate transparency, and restore public trust.

[1] Ram, N., Guerrini, C. J., & McGuire, A. L., “Genealogy Databases and the Future of Criminal Investigation,” Annual Review of Genomics and Human Genetics 22 (2021): 467–489; Hazel, J. W., & Clayton, E. W., “The Law and Ethics of Using DNA from Clinical Samples for Criminal Investigations,” Journal of Law, Medicine & Ethics 49, no. 2 (2021): 235–244: Ram, Guerrini, & McGuire AL, “Genealogy Databases,” 467–489.

[2] State of Kansas v. Radar, No. 05 CR 2101(2005). The criminal case is for murder, but the ethically relevant detail is how investigators used clinical samples from a relative to identify and apprehend Rader; State of New Jersey v. Brian Lee Avis (2021) (case number unavailable). In this case, the formal criminal charges were for sexual assault. This case is ethically significant because law enforcement allegedly obtained DNA from a child’s Guthrie card to implicate Avis.

[3] Abraha, H., “HIPAA and CLIA: Gaps in Regulating Specimen Retention and Metadata Use,” Journal of Health Law & Policy 14, no. 2 (2021): 201–220.

[4] Beauchamp, T. L. and Childress, J.F., Principles of Biomedical Ethics, 5th ed. (Oxford: Oxford University Press, 2003); Mandal, J., Ponnambath, D. K., and Parija, S. C., “Utilitarian and Deontological Ethics in Medicine,” Tropical Parasitology 6, no. 1 (2016): 5–7.

[5] Mandal, Ponnambath, and Parija; Tuazon, J., Smith, A., and Patel, R., “Utilitarian Perspectives on Forensic Use of Clinical Specimens,” Journal of Forensic Ethics 12, no. 2 (2024): 101–118; Ruhl, D. S., et al., “Public Attitudes Toward Genetic Privacy and Law Enforcement Access,” Genetics in Medicine 22, no. 1 (2020): 145–152; Tuazon, J., A. Smith, and R. Patel, “Utilitarian Perspectives on Forensic Use of Clinical Specimens,” Journal of Forensic Ethics 12, no. 2 (2024): 101–118.

[6] Abraha, “HIPAA and CLIA,” 201–220.

[7] Skinner v. Railway Labor Executives’ Association, 489 U.S. 602 (1989). In Skinner, the Supreme Court upheld federal regulations authorizing warrantless drug and alcohol testing of railway employees following accidents or safety violations. The Court reasoned that the government’s interest in preventing catastrophic harm in the transportation sector constituted a “special need” beyond ordinary law enforcement, allowing searches without individualized suspicion or a warrant.

[8] Kerr, O. S., “The Case for the Third‑Party Doctrine,” Michigan Law Review 107, no. 4 (2009): 561–601; Slobogin, C., Privacy at Risk (Chicago: University of Chicago Press, 2018).

[9] Schmerber v. California, 384 U.S. 757 (1966).

[10] Missouri v. McNeely, 569 U.S. 141 (2013).

[11] Birchfield v. North Dakota, 579 U.S. 438 (2016).

[12] Winston v. Lee, 470 U.S. 753 (1985). In this case, the Court ruled that extreme bodily intrusion violated the Fourth Amendment and the individual’s right to bodily integrity; United States v. Fowlkes, 804 F.3d 954 (9th Cir. 2015). The Ninth Circuit held that forced catheterization to obtain urine was an unreasonable search, noting the significant physical intrusion and the availability of less invasive alternatives.

[13] Nevada Legislature, NRS 484C.160–484C.180 (2024). Nevada’s implied‑consent framework authorizes chemical testing of blood, breath, or urine following arrest for driving‑related offenses and permits testing under certain circumstances even without express consent. https://www.leg.state.nv.us/NRS/NRS-484C.html.

[14] California Vehicle Code § 23612 (2024). California’s statute limits implied consent to breath tests following lawful arrest and requires warrants for blood draws unless exigent circumstances exist. https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=23612&lawCode=VEH

[15] Utah Code Ann. § 26‑1‑30 (2024). Utah law protects clinicians who refuse warrantless blood draws and require warrants or patient consent except in narrow circumstances. https://le.utah.gov/xcode/historical.html?date=1/16/2024&oc=/xcode/Title58/Chapter67/C58-67-S305_2022050420220504.html

[16] Commonwealth v. Shaw, 770 A.2d 295 (Pa. 2001); 75 Pa. Cons. Stat. § 1547 (2024). Pennsylvania courts historically interpreted implied‑consent statutes to require compliance with police requests for blood samples.

[17] State v. Thompson, 886 N.W.2d 224 (Iowa 2016) (holding forced catheterization unconstitutional); contrast with State v. Trahan, 886 N.W.2d 216 (Minn. 2016) (evaluating catheterization under a totality‑of‑the‑circumstances analysis). These cases illustrate divergent state approaches to invasive evidence‑collection procedures.

[18] Beauchamp, Principles of Biomedical Ethics; Grady, C., “Enduring and Emerging Challenges of Informed Consent,” New England Journal of Medicine 372, no. 9 (2015): 855–862. DOI: 10.1056/NEJMra1411250

[19] American Medical Association. “Informed Consent.” AMA Code of Medical Ethics, Opinion 2.1.1. https://code-medical-ethics.ama-assn.org/ethics-opinions/informed-consent

[20] Hazel, J. W., and Slobogin, C. “Reidentification Risks in Genomic Data.” Journal of Law and the Biosciences 10, no. 1 (2023): lsad001

[21] Ram, N., C. J. Guerrini, and A. L. McGuire, “Genealogy Databases and the Future of Criminal Investigation,” Annual Review of Genomics and Human Genetics 22 (2021): 467–489.

[22] Yin, X., et al., “Parental Awareness and Perspectives on Newborn Screening in China,” BMC Medical Ethics 25 (2024): 140; Armstrong, B., et al., “Parental Attitudes Toward Standard Newborn Screening and Newborn Genomic Sequencing,” Frontiers in Genetics 13 (2022): 867371.

Silencing Sorrow

Katherine Shiells — 2026-03-03

Introduction

In a world where every emotion seems to require a diagnosis, grief has become medicine’s most misdiagnosed form of suffering, not ignored but absorbed into clinical categories like depression that obscure its meaning. This paper applies a historical lens to evaluate how diagnoses function as both medical conditions and cultural constructs. The analysis examines how grief-related suffering, particularly chronic sorrow, is still routinely misclassified as clinical depression despite the DSM-5 TR’s 2022 addition of prolonged grief disorder (PGD) as a distinct diagnosis,^[1] and its role in society and culture. While the DSM-5-TR (2022) now recognizes prolonged grief disorder as distinct from major depressive disorder, this paper argues that a broader category of grief-related suffering—chronic sorrow—remains unaddressed by either diagnosis and continues to be mislabeled as depression in clinical practice.^[2] Drawing on the concept of diagnostic logic, the reflex to read all suffering as a symptom, what is often identified as depression in social and clinical contexts, can be better defined as chronic sorrow, a subtype of grief. Chronic sorrow comes from losses that continue to affect a person over time and can be clinically recognized without being framed as a disorder. This paper does not argue that grief should be excluded from diagnostic frameworks, nor that it should be universally pathologized; rather, it argues that clinicians need narrative competence^[3] to interpret grief-based suffering contextually rather than defaulting to pharmaceutical intervention.

Diagnostic Systems and Power

Economic, institutional, and cultural powers shape modern psychiatry’s diagnostic system, medicalizing depression while excluding grief, unless it is prolonged.^[4] The DSM-5-TR’s inclusion of prolonged grief disorder in 2022 was a significant development, classifying it under trauma- and stressor-related disorders rather than depressive disorders.^[5] Yet PGD applies only to grief following death that persists beyond twelve months; it does not address chronic sorrow arising from ongoing, nonfinite losses such as disability or caregiving.^[6] Insurance systems and pharmaceutical development impact diagnostic symptom checklists. Scientific clarity does not solely determine diagnosis.^[7] The “sick role” is granted to individuals who suffer from depression through exemptions and expectations of recovery.^[8]

Chronic Sorrow Versus Clinical Depression

Clinical depression is a mood disorder characterized by ongoing low energy, lack of interest, and difficulties in functioning.^[9] Its symptoms are broad and may persist beyond any specific precipitating event, even when a clear cause is present. In contrast, chronic sorrow arises from ongoing loss, causing exhaustion from repeatedly coping with it.^[10] The feelings are directly linked to the loss and typically do not improve with medication.^[11] Chronic sorrow often arises in the context of illness, disability, or other enduring conditions that repeatedly reopen emotional wounds for patients or caregivers. Loss may take the form of identity, independence, social role, status, or imagined futures.^[12] Mislabeling chronic sorrow as depression risks trapping patients in cycles of misunderstanding and ineffective treatment.

Scholars have linked symptoms of depression, including nervousness and exhaustion, to modern urbanization, capitalism, and alienation, with depression often described as a “disease of civilization.”^[13] Grief, however, is frequently overlooked within this framework and treated as depression despite its capacity to build community through rituals, religion, and shared meaning. While the global expansion of depression diagnoses has helped many sufferers, it has also displaced cultural grief practices.^[14] Unlike depression, grief and mourning often affirm love, loyalty, and meaning through social recognition rather than medication.

Grief and Medicalization

Grief itself is a natural response^[15], and when society frames it as pathological, ethical concerns arise. Such distress can be psychological, physical, and psychosomatic,^[16] yet the experience remains nonfinite and evolving, affecting individuals and those around them.^[17] Although grief may resemble illness in its social effects, it does not comfortably fit within a biomedical disease model. It should be resistant to medicalization. However, bureaucratic and pharmaceutical forces influence what is formally recognized as a disease.

Disenfranchised Grief and Institutional Failure

At a systems level, the failure to distinguish between chronic sorrow and clinical depression, a distinction the DSM-5-TR addresses for prolonged grief but not for ongoing nonfinite losses, reflects the problem of disenfranchised grief in medicine, where grief is acknowledged not through diagnosis, but through appropriate clinical support and referral.^[18] When grief is overlooked or misdiagnosed, patients’ rights to appropriate support are undermined,^[19] leading institutions to rely on medication rather than adaptive, relational forms of care.^[20]

Narrative Competence and Ethical Diagnosis

Critiques of diagnostic logic emphasize the need for greater attention to contextual meaning in clinical practice.^[21] In this paper, I am critiquing diagnostic logic rather than arguing that sorrow should be diagnosed as a disorder by default. Through training in narrative competence, clinicians can read patient stories holistically rather than as symptom lists, incorporating cultural variation and moral reflection before assigning psychiatric diagnoses.^[22] With this framework, clinicians can better recognize grief-based suffering without reducing it to pathology, and support patients by referring them to social supports when diagnosis is not the best fit. This approach encourages ethical awareness in the use of diagnosis and treatment.^[23]

Counterargument: Access to Care

A common counterargument is that diagnosing grief as depression facilitates access to existing medical and insurance systems. While access concerns are significant, diagnostic inaccuracy risks inappropriate treatment^[24] and further marginalization of grief. Ethical care requires institutional reform that expands support without reducing grief to pathology.

Medicine often treats depression pharmaceutically at the individual level, while chronic sorrow reflects a systems-level condition rooted in ongoing relational and social loss. Improved screening and training can help clinicians recognize this distinction and avoid unnecessary medication, supporting patients in ways that promote autonomy, beneficence, and justice.

[1] American Psychiatric Association. (2022). Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) (5^th ed.).

[2] Eakes, G. G., Burke, M. L., & Hainsworth, M. A. (1998). Middle-range theory of chronic sorrow. Image--the journal of nursing scholarship, 30(2), 179–184. https://doi.org/10.1111/j.1547-5069.1998.tb01276.x; Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/

[3] Charon, R. (2001). Narrative medicine: A model for empathy, reflection, profession, and trust. JAMA, 286(15), 1897–1902.

[4] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[5] Szuhany, K. L., et al. (2021). Prolonged grief disorder: Course, diagnosis, assessment, and treatment. Focus, 19(2), 161–172.

[6] Lindgren, C. L., et al. (1992). Chronic sorrow: A lifespan concept. Scholarly Inquiry for Nursing Practice, 6(1), 27–40.

[7] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[8] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[9] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[10] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[11] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.; Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/

[12] Breen, L. J., & Fernandez, M. E. (2019). Grief and mental illness. In Harris, D. L. (Eds.), Non-Death loss and grief, pp. 227–236. Routledge. https://doi.org/10.4324/9780429446054-22.

[13] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[14] Sadowsky, J. (2020). The empire of depression: A new history. Cambridge: Polity Press.

[15] Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/

[16] Breen, L. J., & Fernandez, M. E. (2019). Grief and mental illness. In Harris, D. L. (Eds.), Non-Death loss and grief, pp. 227–236. Routledge. https://doi.org/10.4324/9780429446054-22.

[17] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[18] Thompson, N., & Doka, K. J. (2017). Disenfranchised grief. In N. Thompson & G. R. Cox (Eds.), Handbook of the sociology of death, grief, and bereavement: A guide to theory and practice (pp. 177–189). Routledge. https://doi.org/10.4324/9781315453859-15.

[19] Thompson, N., & Doka, K. J. (2017). Disenfranchised grief. In N. Thompson & G. R. Cox (Eds.), Handbook of the sociology of death, grief, and bereavement: A guide to theory and practice (pp. 177–189). Routledge. https://doi.org/10.4324/9781315453859-15.

[20] Grubbs, L. (2023). Diagnostic logic and forensic reading: The case of Wieland. American Literary History, 35(3), 1132–1157. https://doi.org/10.1093/alh/ajad075

[21] Harris, D. L., & Winokuer, H. R. (2019). Living losses: Nonfinite loss, ambiguous loss, and chronic sorrow. In Principles and practice of grief counseling (3rd ed., pp. 121–137). https://doi.org/10.1891/9780826173331.0008.

[22] Harris, D. L., & Winokuer, H. R. (2019). Living losses: Nonfinite loss, ambiguous loss, and chronic sorrow. In Principles and practice of grief counseling (3rd ed., pp. 121–137). https://doi.org/10.1891/9780826173331.0008.

[23] Harris, D. L., & Winokuer, H. R. (2019). Living losses: Nonfinite loss, ambiguous loss, and chronic sorrow. In Principles and practice of grief counseling (3rd ed., pp. 121–137). https://doi.org/10.1891/9780826173331.0008.

[24] Schoo, C., Azhar, Y., Mughal, S., & Rout, P. (2025). Grief and prolonged grief disorder. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK507832/