Health Law

Contracting Babies: The Dark Side of Surrogacy and the European Union’s Recent Condemnation of the Practice

February 23, 2026
EU Law, Health Law, Reproductive Health

Rachel King, MJLST Staffer

Introduction

In January 2026, Meghan Trainor (Trainor) took to Instagram to reveal the birth of her third child, Mikey Moon Trainor, a baby born via surrogate.[1] Surrogacy is the process in which someone (the “surrogate”) carries and delivers a child for a couple or an individual (the intended parent(s), or “IPs”).[2] This process occurs through in vitro fertilization (IVF), an assisted reproductive technology where doctors create and implant an embryo into a surrogate.[3]

Almost immediately, Trainor was met with intense criticism about the ethics of her choice, with some calling her baby “her most recent purchase,” and others commenting on Reddit: “surprise: meghan trainer [sic] is a piece of shit.”[4] Although surprising to some, this is only the most recent public uproar against the practice of surrogacy. Lily Collins, Anderson Cooper, and Kim Kardashian are other celebrities who have similarly sparked online debate about the ethics of surrogacy.[5]

History of Surrogacy

Since the practice of modern surrogacy began in the 1970s, there has been extensive debate about whether surrogacy is an ethical practice that should be condoned in any circumstance.[6] Many of these debates highlight the autonomy of the surrogates, the enforceability of surrogacy contracts, whether the benefits of surrogacy outweigh the inherent risks, and whether those risks are evenly distributed between the surrogate and the IPs.[7] These debates highlight that while surrogacy can be an incredibly positive thing for IPs, there is some discomfort in placing monetary value on the ability of a surrogate to have a healthy child. Given that the European Union (EU) recently passed a resolution condemning surrogacy, it is unlikely these debates will end any time soon.[8]

The EU Condemns Surrogacy

In November 2025, the European Parliament convened to discuss the moral and ethical implications of surrogacy following the EU’s complete condemnation of the practice earlier that month.[9] The EU’s condemnation of surrogacy was in response to a UN report which discussed the human rights violations happening as a result of the global surrogacy market. Specifically, the report highlights increased instances of human trafficking, as women across the world are lured into surrogacy agencies that keep them in confinement, confiscate passports, and force reproductive labor.[10] The report likens these practices to slavery, as these agencies exercise ownership over the surrogates’ bodies and severely limit their freedom of movement and autonomy.[11]

Surrogacy Contracts

The UN report further highlighted the issues with surrogacy contracts, which can require the surrogates to waive their right to make medical decisions about their own bodies, entitle IPs to constant surveillance over the surrogate’s life and movements, and often involve unequal bargaining power; even in the best situations.[12]

These issues are well exemplified in a story reported on by Wired about a surrogate contracted in the United States whose baby died in utero.[13] Believing the surrogate mother responsible for the baby’s passing, the IPs sued the surrogate, launched a public smear campaign against her, disclosed her private health information online, and are refusing to pay for the medical treatments she received while pregnant, causing the surrogate severe financial strain.[14] Additionally, the surrogate faces ongoing and intense trauma from her health complications and the passing of the child.

This story speaks to the fundamental imbalances in surrogacy contracts:

When a surrogate breaks contract, her IPs can stop paying her and stop paying the medical bills for her pregnancy. But if an IP breaks contract—say, by sharing their [surrogate’s] private information online or withholding compensation—a [surrogate] typically has to hire a lawyer. No matter what, IPs get the baby at the end.[15]

Although it could be debated whether these exploitative practices are present in all surrogacy arrangements, the UN report claims that no legislation nor international human rights treaties could effectively address the exploitation involved in surrogacy, arguing for a full eradication of the practice.[16]

Conclusion

It seems unlikely that the United States will follow suit in condemning the practice of surrogacy, especially since Michigan, Massachusetts, and New York have all legalized the practice within the past five years.[17] But it remains important to keep the dangers of surrogacy in mind when family planning. And although Meghan Trainor’s experience with surrogacy was clearly positive, there’s still a long way to go before it’s a safe practice for everyone.[18]

 

Notes

[1] Leyla Mohammed, After Her Third Child Announcement Sparked a Load of Discourse, Meghan Trainor has Explained Why She and Her Husband Opted for Surrogacy, BuzzFeed (Jan. 22, 2026), https://www.buzzfeed.com/leylamohammed/meghan-trainor-explains-why-she-chose-surrogacy.

[2] Surrogacy, Yale Med., https://www.yalemedicine.org/conditions/gestational-surrogacy.

z Id.; In Vitro Fertilization (IVF), Mayo Clinic, https://www.mayoclinic.org/tests-procedures/in-vitro-fertilization/about/pac-20384716 (last visited Feb. 20, 2026).

[4] (@Timely_Guitar_881), Reddit (Jan. 23, 2025), https://www.reddit.com/r/popculture/comments/1qkmb4i/meghan_trainors_picture_lays_bare_the_cruelty_of/; Victoria Smith, Meghan Trainor’s Picture Lays Bare the Cruelty of Surrogacy, Telegraph (Jan. 23, 2026, 7:00), https://www.telegraph.co.uk/news/2026/01/23/meghan-trainor-picture-lays-bare-the-cruelty-of-surrogacy/.

[5] Martha Gill, Sorry, Lily Collins, but When People Outsource Childbirth, Their Motives Really Count, Guardian (Feb. 8, 2025, 14:30), https://www.theguardian.com/commentisfree/2025/feb/08/sorry-lily-collins-but-when-people-outsource-childbirth-their-motives-really-count; Youha Kim, Consent, Commodification, and Anderson Cooper’s Surrogacy Case, Prindle Post (June 18, 2020), https://www.prindleinstitute.org/2020/06/consent-commodification-and-anderson-coopers-surrogacy-case/;

Ali Rosen, Surrogacy is Misunderstood and Unfairly Maligned. We Need to Change the Narrative, Washington Post (Jan. 24, 2020), https://www.washingtonpost.com/lifestyle/2020/01/24/surrogacy-is-misunderstood-unfairly-maligned-we-need-change-narrative/.

[6] Worldwide Surrogacy Specialists, The History of Surrogacy: A Legal Timeline, Worldwide Surrogacy Specialists LLC (Jan. 8, 2026), https://www.worldwidesurrogacy.org/blog/the-history-of-surrogacy-a-legal-timeline.

[7] See generally, Francoise Shenfield, et al., Ethical Considerations on Surrogacy, 40 Hum. Reprod. 420 (2025).

[8] European Parliament Resolution of 13 November 2025 on the Gender Equality Strategy 2025, Eur. Parl. Doc. 2024/2125 (INI).

[9] Experts Convene at European Parliament to Address Harms of Surrogacy, Following EU Resolution Condemning Practice, ADF Int’l (Nov. 19, 2025), https://adfinternational.org/news/experts-convene-at-european-parliament-to-address-harms-of-surrogacy#:~:text=Experts%20convene%20at%20European%20Parliament,%7C%20November%2019%2C%202025.

[10] U.N. Secretary-General, Violence Against Women and Girls, Its Causes and Consequences, U.N. Doc. A/80/158 (July 14, 2025), [hereinafter “The Report”]; Sarah A Topol, They Answered an Ad for Surrogates, and Found Themselves in a Nightmare, N.Y. Times (Dec. 14, 2025), https://www.nytimes.com/2025/12/14/magazine/fertility-surrogates-trafficking.html.

[11] The Report at 13–14.

[12] Id. at 11.

[13] Emi Nietfeld, The Baby Died. Whose Fault Is It?, Wired (Sept. 3, 2025, 6:00), https://www.wired.com/story/the-baby-died-whose-fault-is-it-surrogate-pregnancy/.

[14] Id.

[15] Nietfeld, supra note 13.

[16] The Report at 17–20, 22.

[17] The Best U.S. States for Surrogacy in 2026, Hatch Fertility (May 6, 2025), https://www.hatch.us/en/blog/best-states-for-surrogacy.

[18] Mohammed, supra note 1.

Beyond the Business Case for Lawyer Well-Being: Tracking Individual Health Metrics

September 30, 2025
Health Law, Law Firms, Social Welfare

Noah Leinen, MJLST Staffer

Introduction and Context

“[T]he commodification of the legal profession is an ‘unambiguous contributor’ to the pervasiveness of lawyer distress.”[1] In other words, associates suffer for each dollar a firm earns. Historically, lawyers were more likely to be anxious, interpersonally insensitive, isolated, obsessive-compulsive, and hostile.[2] And, at least as of the 1990s, we were more likely to suffer from depression, phobic anxiety, and paranoid ideation as well.[3] Although language has changed, lawyers today are more suicidal, more likely to be problem drinkers, depressed, and stressed.[4] And yes, we are still anxious.[5] So, we are unhappy and unhealthy (and undoubtedly still unethical).[6]

Who cares? Young professionals, like me, for one. But firm executives ought to as well because of the increase in well-being initiatives.[7] If these initiatives don’t actually help associates, firms are simply burning cash.

Generally speaking, promoting wellness is a good investment as it reduces attrition.[8]  Healthy people make a healthy firm, which is more stable and productive, making them more likely to resist drastic market shifts by increasing associate retention over the long run. But not all strategies are equal, and optimizing such initiatives is an ongoing project.

Instead of dumping money into inefficient strategies, like hiring a well-being speaker for a brief Tuesday lunch hour, firms should invest in individual-based well-being strategies. One way to increase individual health is to track it. Thus, personal health metric devices ought to be a standard benefit for new associates. The question, however, is how a firm might improve individual wellness and well-being.

Methods of Measuring Well-Being

Although there is no definition of well-being, the scientific community discusses it as a composite of subparts, including but not limited to economic, emotional, physical, and spiritual dimensions.[9] Another definition might include interpersonal, communal, and occupational wellness as additional elements. Simply put, well-being is not one-dimensional.

Well-being is also difficult—if not downright impossible—to meaningfully measure. One might try a social welfare analysis from microeconomics to capture collective well-being, for example, by summing the total wealth, utility, or capability of a community as a proxy for well-being. This could provide insight into a community’s wellness. As a proxy, this is not useless, but it is unlikely to give a strong measuring stick for comparing the collective well-being of two firms. Alternatively, one might try to record, qualitatively, each individual’s satisfaction of the hierarchy of needs as conceived by Maslow. Besides economic welfare analysis and psychology, human health metrics may also provide meaningful insights. Finally, long-term friendships are really, really good for human longevity and healthspan.[10] Conversely, isolation is clearly detrimental to one’s well-being.[11] Measuring an individual’s significant relationships (their depth, consistency, and length) might therefore also serve as a useful proxy for estimating well-being. Regardless of whether the analysis is economic, psychological, or sociological in nature, well-being is complex. Despite this complexity, firms still try to improve it.

Current Methods and Strategies of Improving Well-Being

From wellness speakers to weeklong celebrations, titled “Well-being Week”, firms have a host of strategies for improving the health of their workers. Some firms have well-being committees consisting of self-selected employees who provide educational wellness opportunities for fellow colleagues.[12] Other firms hire dedicated well-being directors to spearhead internal well-being initiatives, both to provide similar educational opportunities and also destigmatize dialogue regarding mental health issues.[13] Finally, the ABA has published a Well-Being Toolkit, which includes an eight-step action plan for legal employers, along with other lawyer well-being resources, such as book recommendations, public speakers, and consultants.[14] Firms have several methods for improving well-being; however, one uncommon approach is distributing individual health metric devices.

Firm-Wide Distribution of Individual Health Metric Devices

Beyond books, speakers, and dedicated committees of employees, one comparatively simple step that has not been widely adopted is enabling and encouraging individuals to track their health metrics. From a broad meta-survey in 2022, activity trackers were found to generally improve physical activity and health.[15] Such behavioral changes persisted for upwards of six months.[16] Fitness trackers, such as a Whoop Band or Oura Ring, can serve as physical activity trackers.

Health metric monitors often record sleep data as well. Sleep monitoring is correlated with an improved perception of sleep quality and reduced disturbances.[17] Instead of being caused by the health metric monitor, however, this correlation could be caused by an increase in physical activity.[18] The perception of improved sleep may simply have occurred after participants started working out more.[19] So, if the goal is to improve sleep, tracking physical activity data instead of sleep data is a safer investment. Thus, firms should consider explicitly including physical activity tracker devices in benefits packages, with the goal of improving individual physical well-being, which, when aggregated, is likely to improve firm well-being.

Conclusion

Well-being initiatives are a step in the right direction toward improving lawyer well-being. Given that a firm’s number one resource is its workers, improving individual health can improve overall collective firm health. As tracking individual health metrics via personal fitness devices is likely to lead to an increase in individual well-being, then in the name of a more productive and stable firm, personal fitness devices should be provided to every associate.

 

Notes

[1] Jarrod Reich, Capitalizing on Healthy Lawyers, The Practice (Mar. 2020), https://clp.law.harvard.edu/knowledge-hub/magazine/issues/approaching-lawyer-well-being/capitalizing-on-healthy-lawyers/.

[2] Id.

[3] Id.

[4] Id.

[5] Id.

[6] Patrick Schiltz, On Being a Happy, Healthy, and Ethical Member of an Unhappy, Unhealthy, and Unethical Member of an Unhappy, Unhealthy, and Unethical Profession, 52 Vand. L. Rev. 871, 871 (1999).

[7] See e.g. Well-Being Pledge Campaign, ABA, https://www.americanbar.org/groups/lawyer_assistance/well-being-in-the-legal-profession/well-being-pledge-campaign/ (last visited Sept. 22, 2025, 3:05 PM).

[8] Reich, supra note 1.

[9] Tara Bautista, et. al., What is Well-Being? A Scoping Review of the Conceptual and Operational Definitions of Occupational Well-being, 7 J. Clinical & Translational Sci. 1, 1, 8 (2023).

[10] Zara Abrams, The Science of Why Friendships Keep Us Healthy, 54 Monitor on Psych. (4) (June 1, 2023), https://www.apa.org/monitor/2023/06/cover-story-science-friendship.

[11] Id.

[12] Operationalizing Well-Being, The Practice, (Mar. 2020), https://clp.law.harvard.edu/knowledge-hub/magazine/issues/approaching-lawyer-well-being/operationalizing-well-being/ (last visited Sept. 22, 2025, 3:08 PM).

[13] Id.

[14] Anne Brafford, Well-being Toolkit for Lawyers and Legal Employers, ABA, (Aug. 2018), https://www.americanbar.org/groups/lawyer_assistance/well-being-in-the-legal-profession/well-being-pledge-campaign/.

[15] Ty Ferguson et. al., Effect of Wearables on Sleep in Healthy Individuals: A Systematic Review of Systematic Reviews and Meta-analyses, 4 Lancet Digital Health (8), e615 (2022).

[16] Id.

[17] Sarah Berryhill et. al., Effect of Wearables on Sleep in Healthy Individuals: a Randomized Crossover Trial and Validation Study, 16 J. Clinical Sleep Med. 5, 775 (2020).

[18] Id.

[19] Iuliana Hartescu et. al., Increased Physical Activity Improves Sleep and Mood Outcomes in Inactive People with Insomnia: a Randomized Controlled Trial, 24 J. Sleep Rsch. 5, 526 (2015) (discussing a strong correlation between increased physical activity with improved sleep).

Your Property Nightmare Just Got Worse: Assisted Reproductive Technology and the Rule Against Perpetuities

August 7, 2025
Biotechnology, Property Law, Public Health, Reproductive Health

Peyton Soethout, MJLST Web Content Editor

The Rule Against Perpetuities (“Rule”) has been drilled into law students’ brains for decades; “no interest is good unless it must vest, if at all, not later than twenty-one years after some life in being at the creation of the interest.”[1] The Rule can be tough to grasp, so think of this common example: “T leaves Blackacre ‘to my grandchildren who shall reach the age of [twenty-one].’”[2] Under the common law Rule and in general circumstances, this gift is valid.[3] That is, assume T and T’s children all die. But, on T’s child’s last day on Earth, they gave birth to T’s grandchild. That grandchild would turn twenty-one and gain the interest within the Rule’s permissible timeframe. This used to be a simple example of the Rule. However, as assisted reproductive technologies (“ARTs”) continue to develop, the example presents a slew of unanswered questions.

Multiple technologies fall under the umbrella of ARTs, but cryopreservation of reproductive genetic material and in vitro fertilization (“IVF”) are some of the most common. Many ARTs were first successful during the late 1970s and early 1980s.[4] From then on, it became possible for T’s grandchildren to be born multiple years after T’s and T’s children’s deaths. That is, sperm, ovum, and embryo could be cryopreserved—or frozen—after the deaths of the individuals that genetic material was taken from.[5]

Shortly after the initial success of ARTs, legal scholarship attempted to address ARTs’ effect on the Rule.[6] Some scholarship suggests the Rule should follow Barton Leach’s proposal that the Rule should focus on the concept of paternal rights and “that the duration of a male life in being under the Rule should ‘be defined as the period of his reproductive capacity, including any post-mortem period during which his sperm remains fertile.’”[7] Others suggest an outright exclusion of cryopreserved matter when making Rule determinations.[8] Finally, some suggest “a rebuttable presumption that the will contains an implicit provision stating that ‘nothing in this will shall be construed to provide an inheritance for any posthumously born individuals.’”[9] Despite a variety of proposed solutions, it is unclear if any proposal was successful in any jurisdiction.

The lack of clear guidance on the relationship between ARTs and the Rule is especially concerning as the most recent article on the topic was published in 2008.[10] At that point, “[c]ryopreservation of mature, unfertilized eggs [was] not standard clinical practice.”[11] Additionally, the length of time a frozen sperm could remain viable after collection was unknown.[12] In the last two decades, however, the likelihood of fertility technology success and the length of time the cryopreserved matter is viable has grown drastically. Recently, cryopreservation of eggs “went from an experimental procedure to a promising insurance policy.”[13] Cryopreservation of ovarian tissue has only been available for about twenty years and has only been likely successful in the last ten years.[14] With the general rise in ART success, over a hundred countries practice ART.[15]

The likelihood of success of ARTs is especially important when considering the Rule as it relies on the rule of logical possibility or logical proof: “if individuals who affect vesting are alive, then they are assumed to be able to do any act possible for a living person.”[16] Before the late 1970s, having a child after one’s death was illogical and thus not included in the Rule considerations. Now, a post-mortem child is not only logical, it is probable.[17] Moreover, it is now widely accepted that frozen embryos and sperm could remain viable for over twenty-one years after initial cryopreservation.[18] ART success will likely continue its upward trajectory in upcoming years, making it necessary for consistent guidelines—either through judicial precedent or legislation—for applying the Rule to ARTs.[19]

 

Notes

[1] John Chapman Gray, the Rule Against Perpetuities § 201 (4th ed. 1942). There are other approaches to the Rule Against Perpetuities that some jurisdictions use, but this blog only addresses the common law Rule. See Joshua Greenfield, Note, Dad Was Born A Thousand Years Ago? An Examination of Post-Mortem Conception and Inheritance, with a Focus on the Rule Against Perpetuities, 8 Minn. J.L. Sci. & Tech. 277, 577 (2006).

[2] Sharona Hoffman & Andrew P. Morris, Birth After Death: Perpetuities and the New Reproductive Technologies, 38 Ga. L. Rev. 575, 601 (2004).

[3] Id. at 602.

[4] Alan Trounson & Linda Mohr, Human Pregnancy Following Cryopreservation, Thawing and Transfer of an Eight-Cell Embryo, 305 Nature 707, 707 (1983) (“The first pregnancy resulting from a frozen embryo was reported in Australia in 1983.”); Ashley M. Eskew of Developments to Improve in vitro Fertilization, 114 Mo. Med. 156, 156 (May/June 2017) (“[K]nowledge [about IVF] led to the widely acclaimed first live birth of a ‘test tube baby,’ Louise Brown, in England in 1978.”).

[5] Hoffman & Morris, supra note ii, at 593 (“Cryopreservation is the preservation of biological material, such as semen, at very low temperatures.”).

[6] See generally e.g., Laura D. Heard, A Time to Be Born, A Time to Die: Alternative Reproduction and Texas Probate Law, 17 St. Mary’s L.J. 927 (1986); James E. Bailey, An Analytical Framework for Resolving the Issues Raised by the Interaction Between Reproductive Technology and the Law of Inheritance, 47 DePaul L. Rev. 743, 790 (1998); Les A. McCrimmon, Gametes, Embryos and the Life in Being: The Impact of Reproductive Technology on the Rule Against Perpetuities, 34 Real Prop. Prob. & Tr. J. 697 (2000).

[7] Les A. McCrimmon, Gametes, Embryos and the Life in Being: The Impact of Reproductive Technology on the Rule Against Perpetuities, 34 Real Prop. Prob. & Tr. J. 697, 709 (2000); Greenfield, supra note i, at 578.

[8] Hoffman & Morris, supra note ii, at 621 (explaining the Bloom Rule: “By ignoring all cases of posthumously conceived children, the modified Bloom rule protects some interests that should be struck-for example, those where the testator has made a gift with the knowledge that he or she leaves behind stored genetic material and has written a will that violates the Rule”).

[9] Id. at 624–27.

[10] See generally Kathryn Venturatos Lorio, Conceiving the Inconceivable: Legal Recognition of the Posthumously Conceived Child, 34 ACTEC J. 154 (2008).

[11] Hoffman & Morris, supra note ii, at 597.

[12] Id. at 581 (“The maximum length of time that sperm can remain viable is not currently known, but estimates range from twelve years to centuries.”);

[13] Julia Calderone, 10 Years of Fertility Advances, New York Times, https://www.nytimes.com/2020/04/19/parenting/fertility/fertility-advances.html (Apr. 19, 2020).

[14] Id.

[15] G. David Adamson et al., Global Fertility Care with Assisted Reproductive Technology, 120 Fertility & Sterility 473, 473 (2023) (“Since the birth of Louise Brown in 1978, assisted reproductive technology (ART) has brought incredible benefits to millions of people experiencing infertility and wanting to build a family. […] Assisted reproductive technology is now practiced in over a hundred countries globally with an increasing number, from 25 in 1991 to 79 in 2018.”).

[16] Greenfield, supra note i, at 578, 592 (“All forms of the Rule Against Perpetuities depend on the Rule’s traditional common law logical possibility test for at least part of their analysis. Under this approach, any living individual is assumed to be capable of producing children, even at an advanced age. Thus, many of the circumstances that provoke the most criticism of the common law Rule turn on improbable pregnancies among octogenarians and infants.”).

[17] Eskew & Jungheim, supra note iv, at 157–59 (showing ART success rates steadily increasing); Adamson et al., supra note xv, at 474 (discussing current success rates for ART).

[18] Sharona Hoffman & Andrew P. Morris, Currents in Contemporary Ethics, 31 J.L. Med. & Ethics 721, 721 (2003) (“Children have now been conceived with sperm that was frozen for twenty-one years, and with the capability of freezing stem cells of sperm, the possibilities extend perpetually.”); Katheleen R. Guzman, Property, Progeny, Body Part: Assisted Reproduction and the Transfer of Wealth, 31 U. Cal. Davis L. Rev. 193 (1997) (“Continuous technological advances suggest much longer storage periods are possible, thus violating the Rule whenever frozen embryos could be part of a class gift.”).

[19] This is especially true in the aftermath of Dobbs v. Jackson Women’s Health Org., 597 U.S. 215 (2022). Since then, the Alabama Supreme Court recently held that frozen embryos are children, causing some experts to speculate that an embryo itself may be a “life in being.” See Joe Patrice, Alabama Declares Frozen Embryos are Children, Creating Nightmare Rule Against Perpetuities Hypo, Above the Law, https://abovethelaw.com/2024/02/alabama-declares-frozen-embryos-are-children-creating-nightmare-rule-against-perpetuities-hypo/ (Feb. 20, 2024).

I Feel the Rush: Chemsex and Consent Laws

June 17, 2025
Food and Drug Law, Health Law, Psychology

Violet Butler, MJLST Note/Comment Editor

Sex and drugs don’t mix. Or do they? A scroll on the popular LGBTQ+ hookup and dating app Grindr will show many users looking to have a good time (in more ways than one). Chemsex, more commonly known as “Party and Play” in the United States, is the practice of using psychoactive drugs as a part of having sex.[1] Chemsex became more popular amongst queer men in recent years, with over ten percent of queer men in the United States reporting engaging in chemsex in a 2021 study. The same study found it was more popular in the global community.[2] With the surging prevalence of chemsex across the world, is our legal system capable of handling chemsex?

The practice may seem odd—or even dangerous—to some, but there are a variety of reasons why queer men might engage in chemsex. A study out of Kazakhstan found that people commonly engage in chemsex for self-empowerment, sexual liberation, detachment, and as part of social dynamics.[3] Whatever their personal reason for doing so, the men who engage in chemsex acknowledge its risks. The men in the aforementioned Kazakh study described risks associated with mental health, physical health, and the risk of violence.[4] One of the largest risks is how psychoactive substances such as GHB or meth—some of the drugs commonly used in chemsex—renders users mentally incapacitated.[5]

Because the law is not currently set up to handle the voluntary intoxication associated with chemsex, it is helpful to understand how those who choose to participate in chemsex create their own subcultural understanding of consent when they can no longer rely on the law. A gay male from Chicago said that consent in chemsex is often based on the ability to read body language or facial expressions instead of verbal affirmations of consent.[6] This can make ensuring consent in a chemsex encounter more difficult, and he said that “people give somewhat more grace to anyone who initiates unwanted contact” during a chemsex encounter because of these fuzzy lines of consent.[7] Additionally, chemsex participants report that people can change behavior and preferences when under the influence of drugs, which can create feelings of remorse after becoming sober.[8] In order to navigate these messy lines of consent, some chemsex participants give forward-looking consent to “whatever happens … (within reason).”[9] More concerningly, some chemsex participants have reported feeling as if they have “relinquished any version of consent” when drugs become involved.[10] Although many individual chemsex encounters may be perfectly consensual, it seems that chemsex does not have the same clear culture of consent found in other sexual subcultures, such as kink (or BDSM) culture.

But can the law fix this problem? Considering the heavy risks involved in chemsex and a possibly fuzzy culture of consent, this question doesn’t have a clear answer. One possible solution is the use of sexual advance directives. More commonly seen in the healthcare world, advanced directives can either be instructive directives (giving or blocking consent for future actions) or proxy directives (authorizing a third party to give consent in the person’s stead).[11] The use of sexual advanced directives could clear up the issues of fuzzy, “in the moment,” consent that is common in chemsex, providing guardrails for people who are at high risk of sexual exploitation. Instructive sexual advanced directives could provide a list of “dos and don’ts” or “yesses and noes” that all parties sign onto in advance. The primary benefit of these instructive directives is that they would set out clear expectations for all participants, hopefully reducing any crossing of lines. However, using substances such as meth can have a strong impact on one’s behavior and there is no guarantee that the boundaries signed onto while sober will still be respected once the participants start using drugs. Chemsex users have reported violence associated with drug use as a major concern in the chemsex community.[12] If an accusation of consent being crossed arises after the fact, an instructive sexual advanced directive could help clarify what was and was not consented to before drugs got involved.

The use of proxy sexual advanced directives could provide another layer of protection for chemsex encounters. Participants would have one or more, depending on the size of the chemsex encounter, people be their proxies, giving these proxies the power to step in and make consent decisions for them in situations where it might seem like consent has gotten fuzzy.[13] While it may seem awkward for a sober third party to just be sitting and watching someone have sex, the use of consent proxies can prevent a situation from going too far when chemsex participants can no longer advocate for themselves in a situation.

Ultimately, even if legal systems can be set up to protect chemsex participants, it will take both public health campaigns and community buy-in to create a stronger and clearer culture of consent in the chemsex scene. Absent legal guardrails, some steps can be taken to ensure a safer chemsex encounter, such as only participating in it with a trusted partner and being familiar with the drug being used.

 

Notes

[1] Viiv Healthcare, Chemsex: Navigating Pleasure, Safety, and Health, 2021,https://viivhealthcare.com/ending-hiv/stories/community-engagement/chemsex/#:~:text=In%20the%20USA%2C%2010.3%25%20of,in%20the%20past%2012%20months.

[2] Id.

[3] Lunchenkov et al., “A Way to Liberate Myself”: A Qualitative Study of Perceived Benefits and Risks of Chemsex Among Gay, Bisexual, and Other Men Who Have Sex with Men in Almaty, Kazakhstan, Drug & Alcohol Dependence 1, 5–6 (Oct. 10. 2024).

[4] Id. at 7.

[5] Viiv Healthcare, supra note i. See also, Alexander A. Boni-Saenz, Sexuality and Incapacity, 76 Ohio State L.J., 1201, 1212 (2015) (giving intoxication as an example of “temporary transient incapacity”).

[6] Interview with a Gay Man Living in Chicago (Feb. 11, 2025) (on file with author).

[7] Id.

[8] Healy-Cullen et. al., Understanding How Gay Men Construct ‘Good’ Chemsex Participation Using Critical Discursive Psychology,15 Psych. & Sexuality 539, 548 (2024).

[9] Interview with a Gay Man Living in Chicago, supra note viii.

[10] Zachary Zane, It’s Time to Talk About Chemsex and Consent, Advoc., (Sept. 11, 2017 7:00 AM) , https://www.advocate.com/current-issue/2017/9/11/its-time-talk-about-chemsex-and-consent#toggle-gdp.

[11] Alexander A. Boni-Saenz, Sexual Advance Directives, 68 Ala. L. Rev. 1, 11 (2016).

[12] Lunchenkov et al., supra note iii at 7.

[13] It is also possible to have some combination of written instructive and proxies to ensure the most clarity in sexual encounters. See, Alexander A. Boni-Saenz, supra note xii at 12–13 for a brief introduction to hybrid directives.

A Requiem for Fear, Death, and Dying: Law and Medicine’s Perpetually Unfinished Composition

March 31, 2024
Biotechnology, Ethics, Health Law, Healthcare

Audrey Hutchinson, MJLST Staffer

In the 18th and 19th century, the coffins of newly deceased lay six feet below, but were often outfitted with a novel accessory emerging from the freshly turned earth: a bell hung from an inconspicuous stake, its clapper adorned with a rope that disappeared beneath the dirt.[1] Rather than this display serving as a bygone tradition of the mourning process—some symbolic way to emulate connection with the departed—the bell served a more practical purpose: it was an emergency safeguard against premature burial.[2] The design, and all its variously patented 18th and 19th century designs, draws upon a foundational—and by some biopsychological theories, a biologically imperative—quality: fear of death.[3]

In the mid-1700’s, the French author Jacques Benigne Winslow published a book ominously titled The Uncertainty of the Signs of Death and the Danger of Precipitate Interments and Dissections, marking a decisive and public moment in medical history where death was introduced as something nebulous rather than definite to a highly unsettled public.[4] For centuries, medical tests and parameters had existed by which doctors could “affirmatively” conclude a patient had, indeed, passed.[5] While the Victorian newspapers were riddled with adverts for “safety coffins” in a macabre, but unsurprising expression of capitalism in the wake of mounting cholera deaths and the accompanying rate of premature burial reports, efforts to evade the liminal space of “dying” and the finality of “death” can be seen as far back as ancient Hebrew scriptures, wherein resuscitation attempts via chest compressions are described.[6] Perhaps this is unsurprising: psychologist and experimental theorist Robert C. Bolles conceptualized that fear is “a hypothetical cause [motivation] of behavior” and that its main purpose is to keep organisms alive.[7] Perhaps there has always been a subconscious doubt or suspicion about the finality of death, or perhaps it was human desperation and delusion arising from loss that has left behind an ancient record of fear and subsequent acts of defiance in the face of death still germane today.

Contemporarily we see the fruits of this fear of dying, death, or being somewhere in between in the form of advances in medical technology and legal guidelines. Though death is still commonly understood to be a discrete status—a state one enters but cannot exit—medical and legal definitions have, over time, evolved approaching death more gingerly—the former understanding death as a nuanced scale, the latter drawing hard lines on that scale.[8] Today, 43 states have enacted the Uniform Law Commission’s Uniform Determination of Death Act (“UDDA”).[9] The UDDA requires two distinct standards be met for someone to effectively, and legally, be deemed dead:  1) the irreversible cessation of circulatory and respiratory functions, and 2) the irreversible cessation of all functions of the entire brain, including the brainstem.[10] The UDDA’s legal determination of death, in its bright line language, relies in large part on  “generally accepted medical standards” of the medical practice and practitioner discretion. While the loss of respiratory, circulatory, and total brain death of the entire brain are the common parameters of determining death medically, the UDDA is distinctly “silent on acceptable diagnostic tests [and] procedures.” It is argued that the language is purposeful in creating statutory flexibility in an era of constant scientific and medical research, understanding, and innovation.

As it relates to brain death, the medical approach to determining is a scale that contemplates brain injury/activity and somatic survival, a “continuous biological spectrum”[11] that naturally contemplates not only a patient’s current status, but the possibility and likelihood of both degenerative and improved changes in status. But, as a matter of policy and regulation, the UDDA drew a bright line between the two and called it brain-death. Someone in a permanent vegetative state is not considered braindead, but someone with a necrotic “liquified” brain is. As a result, the medical determination of death is arguably subservient to the legal determination, designating a point of no return–not because the medical professionals see no alternate path, but the law has provided a blindfold required from that point forward.

While this may be an efficient way to ensure people are not denied advanced and improved medical practices, it also means that there is ambiguity and variance from state to state as to the nature of governing factual guidelines and standards. There are practical and policy reasons for this, including maximizing efficacy and reach of organ donation systems and generally preventing strain on healthcare resources and systems; nonetheless, the brightline fails to be so bright. While the Commission could have situated the UDDA such that the determination of legal brain death and medical brain death worked in tandem, being triggered at some distinct moment by certain explicit conditions or after certain standardized medical tests, it did not.

Is that because it will not, or because it simply cannot do so? Today, the standards become increasingly muddied by advancements in technology to prolong life that have, in turn, paradoxically, also prolonged the process of dying—expanding the scope of that liminal space. Artificial means of keeping someone alive where they otherwise could not stay so imperatively creates a discrete state of the act of dying. New legal and medical methods of describing these states have become imperative with lively debate ongoing concerning bridging the medical-legal gap concerning death determination[12]—specifically, the distinction between the “permanent” (will not reverse) and “irreversible” (cannot reverse) cessation of cardiac, respiratory, and neurological function relative to the meaning of a determination of death.[13] James Bernat, a neurologist and academic who examines the convergence of ethics, philosophy, and neurology, is a contemporary advocate calling for reconciliation between medical practice with the law.[14] Dr. Bernat suggests the UDDA’s irreversibility standard—a function that has stopped and cannot be restarted—be replaced with a permanence standard—a function that has stopped, will not restart on its own, and no intervention will be undertaken to restart it.[15] This distinction, in large part, is attempting to address the incongruence of the UDDA’s language that, by the ULC’s own concession, “sets the general legal standard for determining death, but not the medical criteria for doing so.”[16] In effect, in trying to define and characterize death and dying, we have created a dynamic wherein one could be medically dead, but not legally.[17]

Upon his death bed, composer Frédéric Chopin uttered his last words: “The earth is suffocating …. Swear to make them cut me open, so that I won’t be buried alive.”[18] A century and a half later, yet only time will tell if law and medicine can find a way to reconcile the increasingly ambiguous nature of dying and define death explicitly and discretely—no bells required.

Notes

[1] Steven B. Harris, M.D. The Society for the Recovery of Persons Apparently Dead. Cryonics (Sept. 1990) https://www.cryonicsarchive.org/library/persons-apparently-dead/.

[2] Id.

[3] Id.; Shannon E. Grogans et. al., The nature and neurobiology of fear and anxiety: State of the science and opportunities for accelerating discovery, Neuroscience & Biobehavioral Reviews, Volume 151, 2023, 105237, ISSN 0149-7634, https://doi.org/10.1016/j.neubiorev.2023.105237.

[4] Harris, supra note 1.

[5] Id.

[6] Id.

[7] Grogans et. al., supra note 3.

[8] Robert D. Truog, Lessons from the Case of Jahi McMath. The Hastings Center report vol. 48, Suppl. 4 (2018): S70-S73. doi:10.1002/hast.961.

[9] Unif. Determination of death act § 1 (Nat’l Conf. of Comm’n on Unif. L Comm’n. 1981).

[10] Id.

[11] Truog supra at S72.

[12] James L. Bernat, “Conceptual Issues in DCDD Donor Death Determination.” The Hastings Center report vol. 48 Suppl 4 (2018): S26-S28. doi:10.1002/hast.948.

[13] James Bernat, (2010). How the Distinction between ‘Irreversible’ and ‘Permanent’ Illuminates Circulatory-Respiratory Death Determination. The Journal of Medicine and Philosophy. 35. 242-55. 10.1093/jmp/jhq018.

[14] Faculty Database: James L. Bernat, M.D. Dartmouth Geisel School of Medicine https://geiselmed.dartmouth.edu/faculty/facultydb/view.php/?uid=353 (last accessed Oct. 23, 2023).

[15] JD and Angela Turi, Death’s Troubled Relationship With the Law Brendan Parent, AMA J Ethics. 2020;22(12):E1055-1061. doi: 10.1001/amajethics.2020.1055; See also, Bernat JL. Point: are donors after circulatory death really dead, and does it matter? Yes and yes. Chest. 2010;138(1):13-16.

[16] Thaddeus Pope, Brain Death and the Law: Hard Cases and Legal Challenges. The Hastings Center report vol. 48 Suppl. 4 (2018): S46-S48. doi:10.1002/hast.954.

[17] Id.

[18] Death: The Last Taboo – Safety Coffins, Australian Museum (Oct. 20, 2020) https://australian.museum/about/history/exhibitions/death-the-last-taboo/safety-coffins/ (last accessed Oct. 23, 2023).

Regulating the Revolution: A Legal Roadmap to Optimizing AI in Healthcare

January 21, 2024
Artificial Intelligence, Health Law, Healthcare

Fazal Khan, MD-JD: Nexbridge AI

In the field of healthcare, the integration of artificial intelligence (AI) presents a profound opportunity to revolutionize care delivery, making it more accessible, cost-effective, and personalized. Burgeoning demographic shifts, such as aging populations, are exerting unprecedented pressure on our healthcare systems, exacerbating disparities in care and already-soaring costs. Concurrently, the prevalence of medical errors remains a stubborn challenge. AI stands as a beacon of hope in this landscape, capable of augmenting healthcare capacity and access, streamlining costs by automating processes, and refining the quality and customization of care.

Yet, the journey to harness AI’s full potential is fraught with challenges, most notably the risks of algorithmic bias and the diminution of human interaction. AI systems, if fed with biased data, can become vehicles of silent discrimination against underprivileged groups. It is essential to implement ongoing bias surveillance, promote the inclusion of diverse data sets, and foster community involvement to avert such injustices. Healthcare institutions bear the responsibility of ensuring that AI applications are in strict adherence to anti-discrimination statutes and medical ethical standards.

Moreover, it is crucial to safeguard the essence of human touch and empathy in healthcare. AI’s prowess in automating administrative functions cannot replace the human art inherent in the practice of medicine—be it in complex diagnostic processes, critical decision-making, or nurturing the therapeutic bond between healthcare providers and patients. Policy frameworks must judiciously navigate the fine line between fostering innovation and exercising appropriate control, ensuring that technological advancements do not overshadow fundamental human values.

The quintessential paradigm would be one where human acumen and AI’s analytical capabilities coalesce seamlessly. While humans should steward the realms requiring nuanced judgment and empathic interaction, AI should be relegated to the execution of repetitive tasks and the extrapolation of data-driven insights. Placing patients at the epicenter, this symbiotic union between human clinicians and AI can broaden access to healthcare, reduce expenditures, and enhance service quality, all the while maintaining trust through unyielding transparency. Nonetheless, the realization of such a model mandates proactive risk management and the encouragement of innovation through sagacious governance. By developing governmental and institutional policies that are both cautious and compassionate by design, AI can indeed be the catalyst for a transformative leap in healthcare, enriching the dynamics between medical professionals and the populations they serve.

The Double-Helix Dilemma: Navigating Privacy Pitfalls in Direct-to-Consumer Genetic Testing

November 7, 2023
Administrative Law, Biotechnology, Data, Ethics, Food and Drug Law, Health Law, Healthcare, Privacy

Ethan Wold, MJLST Staffer

Introduction

On October 22, direct-to-consumer genetic testing (DTC-GT) company 23andME sent emails to a number of its customers informing them of a data breach into the company’s “DNA Relatives” feature that allows customers to compare ancestry information with other users worldwide.[1] While 23andMe and other similar DTC-GT companies offer a number of positive benefits to consumers, such as testing for health predispositions and carrier statuses of certain genes, this latest data breach is a reminder that before choosing to opt into these sorts of services one should be aware of the potential risks that they present.

Background

DTC-GT companies such as 23andMe and Ancestry.com have proliferated and blossomed in recent years. It is estimated over 100 million people have utilized some form of direct-to-consumer genetic testing.[2] Using biospecimens submitted by consumers, these companies sequence and analyze an individual’s genetic information to provide a range of services pertaining to one’s health and ancestry.[3] The October 22 data breach specifically pertained to 23andMe’s “DNA Relatives” feature.[4] The DNA Relatives feature can identify relatives on any branch of one’s family tree by taking advantage of the autosomal chromosomes, the 22 chromosomes that are passed down from your ancestors on both sides of your family, and one’s X chromosome(s).[5] Relatives are identified by comparing the customer’s submitted DNA with the DNA of other 23andMe members who are participating in the DNA Relatives feature.[6] When two people are found to have an identical DNA segment, it is likely they share a recent common ancestor.[7] The DNA Relatives feature even uses the length and number of these identical segments to attempt to predict the relationship between genetic relatives.[8] Given the sensitive nature of sharing genetic information, there are often privacy concerns regarding practices such as the DNA Relatives feature. Yet despite this, the legislation and regulations surrounding DTC-GT is somewhat limited.

Legislation

The Health Insurance Portability and Accountability Act (HIPAA) provides the baseline privacy and data security rules for the healthcare industry.[9] HIPAA’s Privacy Rule regulates the use and disclosure of a person’s “protected health information” by a “covered entity.[10] Under the Act, the type of genetic information collected by 23andMe and other DTC-GT companies does constitute “protected health information.”[11] However, because HIPAA defines a “covered entity” as a health plan, healthcare clearinghouse, or health-care provider, DTC-GT companies do not constitute covered entities and therefore are not under the umbrella of HIPAA’s Privacy Rule.[12]

Thus, the primary source of regulation for DTC-GT companies appears to be the Genetic Information Nondiscrimination Act (GINA). GINA was enacted in 2008 for the purpose of protecting the public from genetic discrimination and alleviating concerns about such discrimination and thereby encouraging individuals to take advantage of genetic testing, technologies, research, and new therapies.[13] GINA defines genetic information as information from genetic tests of an individual or family members and includes information from genetic services or genetic research.[14] Therefore, DTC-GT companies fall under GINA’s jurisdiction. However, GINA only applies to the employment and health insurance industries and thus neglects many other potential arenas where privacy concerns may present.[15] This is especially relevant for 23andMe customers, as signing up for the service serves as consent for the company to use and share your genetic information with their associated third-party providers.[16] As a case in point, in 2018 the pharmaceutical giant GlaxoSmithKline purchased a $300 million stake in 23andMe for the purpose of gaining access to the company’s trove of genetic information for use in their drug development trials.[17]

Executive Regulation

In addition to the legislation above, three different federal administrative agencies primarily regulate the DTC-GT industry: the Food and Drug Administration (FDA), the Centers of Medicare and Medicaid services (CMS), and the Federal Trade Commission (FTC). The FDA has jurisdiction over DTC-GT companies due to the genetic tests they use being labeled as “medical devices”[18] and in 2013 exercised this authority over 23andMe by sending a letter to the company resulting in the suspending of one of its health-related genetic tests.[19] However, the FDA only has jurisdiction over diagnostic tests and therefore does not regulate any of the DTC-GT services related to genealogy such as 23andMe’s DNA Relatives feature.[20] Moreover, the FDA does not have jurisdiction to regulate the other aspects of DTC-GT companies’ activities or data practices.[21] CMS has the ability to regulate DTC-GT companies through enforcement of the Clinical Laboratory Improvements Act (CLIA), which requires that genetic testing laboratories ensure the accuracy, precision, and analytical validity of their tests.[22] But, like the FDA, CMS only has jurisdiction over tests that diagnose a disease or assess health.[23]

Lastly, the FTC has broad authority to regulate unfair or deceptive business practices under the Federal Trade Commission Act (FTCA) and has levied this authority against DTC-GT companies in the past. For example, in 2014 the agency brought an action against two DTC-GT companies who were using genetic tests to match consumers to their nutritional supplements and skincare products.[24] The FTC alleged that the companies’ practices related to data security were unfair and deceptive because they failed to implement reasonable policies and procedures to protect consumers’ personal information and created unnecessary risks to the personal information of nearly 30,000 consumers.[25] This resulted in the companies entering into an agreement with the FTC whereby they agreed to establish and maintain comprehensive data security programs and submit to yearly security audits by independent auditors.[26]

Potential Harms

As the above passages illustrate, the federal government appears to recognize and has at least attempted to mitigate privacy concerns associated with DTC-GT. Additionally, a number of states have passed their own laws that limit DTC-GT in certain aspects.[27] Nevertheless, given the potential magnitude and severity of harm associated with DTC-GT it makes one question if it is enough. Data breaches involving health-related data are growing in frequency and now account for 40% of all reported data breaches.[28] These data breaches result in unauthorized access to DTC-GT consumer-submitted data and can result in a violation of an individual’s genetic privacy. Though GINA aims to prevent it, genetic discrimination in the form of increasing health insurance premiums or denial of coverage by insurance companies due to genetic predispositions remains one of the leading concerns associated with these violations. What’s more, by obtaining genetic information from DTC-GT databases, it is possible for someone to recover a consumer’s surname and combine that with other metadata such as age and state to identify the specific consumer.[29] This may in turn lead to identity theft in the form of opening accounts, taking out loans, or making purchases in your name, potentially damaging your financial well-being and credit score. Dealing with the aftermath of a genetic data breach can also be expensive. You may incur legal fees, credit monitoring costs, or other financial burdens in an attempt to mitigate the damage.

Conclusion

As it sits now, genetic information submitted to DTC-GT companies already contains a significant volume of consequential information. As technology continues to develop and research presses forward, the volume and utility of this information will only grow over time. Thus, it is crucially important to be aware of risks associated with DTC-GT services.

This discussion is not intended to discourage individuals from participating in DTC-GT. These companies and the services they offer provide a host of benefits, such as allowing consumers to access genetic testing without the healthcare system acting as a gatekeeper, thus providing more autonomy and often at a lower price.[30] Furthermore, the information provided can empower consumers to mitigate the risks of certain diseases, allow for more informed family planning, or gain a better understanding of their heritage.[31] DTC-GT has revolutionized the way individuals access and understand their genetic information. However, this accessibility and convenience comes with a host of advantages and disadvantages that must be carefully considered.

Notes

[1] https://www.reuters.com/world/us/23andme-notifies-customers-data-breach-into-its-dna-relatives-feature-2023-10-24/#:~:text=%22There%20was%20unauthorized%20access%20to,exposed%20to%20the%20threat%20actor.%22

[2] https://www.ama-assn.org/delivering-care/patient-support-advocacy/protect-sensitive-individual-data-risk-dtc-genetic-tests#:~:text=Use%20of%20direct%2Dto%2Dconsumer,November%202021%20AMA%20Special%20Meeting

[3] https://go-gale-com.ezp3.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[4] https://www.reuters.com/world/us/23andme-notifies-customers-data-breach-into-its-dna-relatives-feature-2023-10-24/#:~:text=%22There%20was%20unauthorized%20access%20to,exposed%20to%20the%20threat%20actor.%22

[5] https://customercare.23andme.com/hc/en-us/articles/115004659068-DNA-Relatives-The-Genetic-Relative-Basics

[6] Id.

[7] Id.

[8] Id.

[9] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[10] https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/combined/hipaa-simplification-201303.pdf

[11] Id.

[12] Id; https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[13] https://www.eeoc.gov/statutes/genetic-information-nondiscrimination-act-2008

[14] Id.

[15] https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC3035561&blobtype=pdf

[16] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[17] https://news.yahoo.com/news/major-drug-company-now-access-194758309.html

[18] https://uscode.house.gov/view.xhtml?req=(title:21%20section:321%20edition:prelim)

[19] https://core.ac.uk/download/pdf/33135586.pdf

[20] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[21] Id.

[22] https://www.law.cornell.edu/cfr/text/42/493.1253

[23] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[24] https://www.ftc.gov/system/files/documents/cases/140512genelinkcmpt.pdf

[25] Id.

[26] Id.

[27] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[28] Id.

[29] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[30] Id.

[31] Id.

NC Gives Medicaid Expansion a Foothold in the Southeast While Giving Many North Carolinians a Helping Hand

October 27, 2023
Health Law, Healthcare

Matt Buechner, MJLST Staffer

North Carolina is set to take a step to address structural racism in communities across the state when it begins Medicaid expansion implementation on December 1. Governor Roy Cooper championed expansion in his state and signed a bipartisan Medicaid expansion bill in March. This signaled the state’s intention to expand the government-sponsored health insurance program for low-income people to roughly 600,000 additional North Carolinians.[1] However, the bill required the legislature to pass a separate state budget law to appropriate funds and implement the plan.[2] The Republican-controlled state legislature passed a delayed two-year budget deal on September 22, which went into effect October 3 after Cooper declined to veto the bill.[3]

Implementation of Medicaid expansion should help North Carolina see the reduction of uninsurance rates that other expansion states have seen since passage of the ACA.[4] A recent study found that while Medicaid expansion helps populations across a state, the eligibility expansion disproportionately helps residents of formerly redlined[5] neighborhoods gain access to coverage.[6] Coverage is essential, as greater access to health insurance leads to medical care, including preventive care and management of chronic illness.[7]

Meanwhile, recent analyses of health disparities and access to health insurance have shown that health disparities in the United States may be less tied to race itself, but rather to structural racism levied against non-white Americans.[8] One recent study showed that states with policies that reflect and reinforce structural racism also see significantly higher rates of premature death among their populations.[9] While these findings may not be surprising, policymakers and advocates can use this evidence to target investments and interventions, while working to disentangle the tapestry of discrimination at the state level.

Accessing Medicaid for Newly Eligible North Carolinians

The Medicaid program currently covers about 2.9 million North Carolinians.[10] But like most states that have yet to expand their Medicaid program, the maximum income requirements for North Carolina Medicaid eligibility for adults is quite low.[11] Adult caregivers of children or adult family members may earn a household modified adjusted gross income (MAGI)[12] up to 37 percent of the federal poverty level (FPL) to maintain North Carolina Medicaid eligibility, while non-caregiver adults do not qualify for Medicaid at all.[13] Medicaid expansion will increase the maximum household MAGI threshold to 138 percent[14] FPL to qualify for Medicaid coverage, regardless of whether an adult cares for an additional family member.[15]

North Carolina currently provides reproductive health care benefits for residents who earn up to 195 percent FPL through their Medicaid Family Planning Program (BE SMART).[16] Nearly half of the expected 600,000 new Medicaid-eligible North Carolinians are currently enrolled in BE SMART and have a qualifying-income under the new 138 percent FPL Medicaid eligibility threshold. These people will automatically be enrolled in full Medicaid coverage.[17] Newly qualifying individuals who do not take part in the BE SMART program must apply (online, in person, by telephone, or by mail) and await determination, which is set to take up to 45 days.[18]

Making Sense of the Federal Dollars at Play

State Medicaid programs are traditionally paid for through a partnership with the federal government. While the state administers the program, the federal government provides the state matching funding, without limit.[19] Matching funds are provided based on an algorithm that measures a state’s ability to pay for the program using the state’s per capita income compared to the per capita income of the nation. This rate is called the Federal Medical Assistance Percentage (FMAP).[20] A state’s FMAP is set by statute to be at least 50 percent, but not more than 83 percent.[21] Using FMAP allows a state with a theoretically lower tax base (relative to the size of their state population) to receive additional federal funding to offset the burden of providing for its residents.

To help states with the burden of paying for an increase in their Medicaid population after expansion, Congress established an enhanced FMAP calculation for a state’s Medicaid expansion population. Beginning with the implementation of expansion in 2014, the federal government provided states with a 100 percent FMAP for the expansion population, followed by a phased down approach.[22] The current FMAP for the expansion population is 90 percent.[23]

To help encourage remaining states to expand their Medicaid program, Congress included a 5 percent FMAP bump for two years post-expansion in the American Rescue Plan—not for the expansion population, but for the traditional Medicaid population.[24] This is particularly enticing for states, because this includes all Medicaid recipients, including children, seniors, people with disabilities, and all other non-expansion groups. On average, these populations account for nearly 80 percent of all Medicaid costs in expansion states, making this benefit likely more lucrative than a 100 percent FMAP rate for expansion populations.[25]

Looking at Health Equity Beyond Expansion

While North Carolina looks to expand its Medicaid population in the coming months, states across the country are purging Medicaid beneficiaries from their programs following the expiration of a federal disenrollment prohibition to qualify for a Covid-era enhanced FMAP.[26] Recent reports estimate that nearly 9 million people across the country have been disenrolled from Medicaid so far, including more than 120,000 North Carolinians–more than 20 percent of North Carolina’s current Medicaid population.[27]

While North Carolina has one of the lowest rates of churn among states across the nation, 87 percent of disenrolled North Carolinians lost coverage for procedural concerns–not eligibility concerns.[28] This means that North Carolina Medicaid beneficiaries are losing their health insurance coverage largely because they did not fill out a form properly or the state had an incorrect address on file.

Few states publicly report the racial and ethnic demographics of their Medicaid disenrollees. For those that do, most seem to be disenrolling Medicaid recipients at even rates based on race and ethnicity.[29] As disenrollment continues and North Carolina moves into expansion of their Medicaid program, policymakers, advocates, and observers will keep a keen eye on the state as it navigates its population’s fluctuating access to Medicaid. This expansion is but one step to ensure that people have equitable access to essential coverage and care.

Notes

[1] Gary D. Robertson, Medicaid Expansion to Begin Soon in North Carolina as Governor Decides to Let Budget Bill Become Law, Associated Press, Sept. 22, 2023, https://apnews.com/article/north-carolina-medicaid-expansion-governor-legislature-330ea1adef37a323b31a9cfe0d470a58.

[2] Id.

[3] In some states, inaction by a governor can lead to a pocket veto, however in others, inaction by a governor leads to passage of the bill. In North Carolina, a bill can become a law following inaction by a governor for ten days. Aimee Wall, The Governor’s Role in the Legislative Process, Coates’ Canons NC Gov’t Law (Jan. 11, 2017), https://canons.sog.unc.edu/2017/01/governors-role-legislative-process/.; Governor Roy Cooper, a Democrat, allowed the two-year budget bill to become law without action. See House Bill 259 / SL 2023-134, N.C. General Assembly, https://www.ncleg.gov/BillLookup/2023/H259 (last visited Oct. 15, 2023).

[4] The Far-Reaching Benefits of the Affordable Care Act’s Medicaid Expansion, Ctr. on Budget and Pol’y Priorities, https://www.cbpp.org/research/health/chart-book-the-far-reaching-benefits-of-the-affordable-care-acts-medicaid-expansion (last visited Oct. 15, 2023).

[5] Redlining occurred, beginning in the 1930s, when the federal government’s Home Owners’ Loan Corporation (HOLC) began the process of rating the investment desirability of various neighborhoods. The rating system used neighborhood racial demography to determine the grades, with the lowest grade reserved for neighborhoods that were “infiltrated with undesirable populations such as Jewish, Asian, Mexican, and Black families.” In turn, banks often refused to grant credit to prospective homeowners looking to purchase homes in those communities, or extended credit with excessive interest rates. Redlining was outlawed by the Fair Housing Act in 1968, but the impact on communities is still seen today. See Jason Semprini et al., Medicaid Expansion Lowered Uninsurance Rates Among Nonelderly Adults in the Most Heavily Redlined Areas, 42 Health Aff. 1439 (2023).

[6] Id.

[7] The Far-Reaching Benefits of the Affordable Care Act’s Medicaid Expansion, Ctr. on Budget and Pol’y Priorities, https://www.cbpp.org/research/health/chart-book-the-far-reaching-benefits-of-the-affordable-care-acts-medicaid-expansion (last visited Oct. 15, 2023).

[8] See Jason Semprini et al., Medicaid Expansion Lowered Uninsurance Rates Among Nonelderly Adults in the Most Heavily Redlined Areas, 42 Health Aff. 1439 (2023); Jaquelyn L. Jahn et al., Legislating Inequity: Structural Racism in Groups of State Laws and Associations with Premature Mortality Rates, 42 Health Aff. 1325 (2023).

[9] Jaquelyn L. Jahn et al., Legislating Inequity: Structural Racism in Groups of State Laws and Associations with Premature Mortality Rates, 42 Health Aff. 1325 (2023).

[10] Gary D. Robertson, N. Carolina Governor Signs Medicaid Expansion Bill into Law, Associated Press, March 27, 2023, https://apnews.com/article/north-carolina-medicaid-expansion-roy-cooper-legislature-f00242e5883bccf816a679a76584a5f9.

[11] The median maximum income limit for adults with family member caregiving responsibilities is 37 percent FPL in states that have not expanded Medicaid and childless adults remain ineligible in all of these states (except Wisconsin), regardless of income. Robin Rudowitz et al., How Many Uninsured Are in the Coverage Gap and How Many Could be Eligible if All States Adopted the Medicaid Expansion? Henry J. Kaiser Family Foundation. (Mar. 31, 2023), https://www.kff.org/medicaid/issue-brief/how-many-uninsured-are-in-the-coverage-gap-and-how-many-could-be-eligible-if-all-states-adopted-the-medicaid-expansion/.

[12] MAGI, as used to determine health care benefit eligibility, uses a different methodology than MAGI as used for tax purposes. For health benefit purposes, MAGI is adjusted gross income plus untaxed foreign income, non-taxable Social Security Benefits, and tax-exempt interest. Modified Adjusted Gross Income (MAGI), HealthCare.gov,  https://www.healthcare.gov/glossary/modified-adjusted-gross-income-magi/#:~:text=MAGI%20is%20adjusted%20gross%20income,%2C%20and%20tax%2Dexempt%20interest (last visited Oct. 15, 2023).

[13] Medicaid Income Eligibility Limits for Adults as a Percent of the Federal Poverty Level, Henry J. Kaiser Family Foundation. (Jan. 1, 2023), https://www.kff.org/health-reform/state-indicator/medicaid-income-eligibility-limits-for-adults-as-a-percent-of-the-federal-poverty-level/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D.

[14] The Affordable Care Act established a 5 percent income disregard in determining eligibility for Medicaid and CHIP. The percent thresholds used in this blog post include the built-in income disregard used to establish Medicaid eligibility determinations. CMS Answers to Frequently Asked Questions: Telephonic Applications, Medicaid and CHIP Eligibility Policy and 75/25 Federal Matching Rate, Medicaid.gov. (Aug. 9, 2013),  https://www.medicaid.gov/faq/respect-magi-conversion-how-will-5-disregard-be-applied/index.html.

[15] Questions and Answers about Medicaid Expansion, NC Medicaid Div. of Health Benefits. https://medicaid.ncdhhs.gov/questions-and-answers-about-medicaid-expansion#:~:text=Quick%20Facts%20about%20North%20Carolina%27s,%2Fyear)%20may%20be%20eligible (last visited Oct. 15, 2023).

[16] Facts About the Medicaid Family Planning “BE SMART” Program, N.C. Dept. of Health and Human Svcs. Div. of Med. Assistance and Div. of Public Health. (Sept. 16, 2016), https://files.nc.gov/ncdma/BeSmart_Fact_Sheet-Beneficiaries_2016_09_15.pdf.

[17] Questions and Answers about Medicaid Expansion, NC Medicaid Div. of Health Benefits. https://medicaid.ncdhhs.gov/questions-and-answers-about-medicaid-expansion#:~:text=Quick%20Facts%20about%20North%20Carolina%27s,%2Fyear)%20may%20be%20eligible (last visited Oct. 15, 2023).

[18] Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics/.

[19] Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics/.

[20] Id.

[21] The District of Columbia and territories have statutorily set FMAPs and the territories each have a statutorily set per capita Medicaid funding cap. Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics/.

[22] Elizabeth Williams et al., Medicaid Financing: The Basics, Henry J. Kaiser Family Foundation, April 13, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-financing-the-basics.

[23] Id.

[24] Katie Keith, Final Coverage Provisions in the American Rescue Plan and What Comes Next, Health Aff: Forefront (Mar. 11, 2021), https://www.healthaffairs.org/content/forefront/final-coverage-provisions-american-rescue-plan-and-comes-next.

[25] Id.

[26] Jennifer Tolbert & Meghana Ammula, 10 Things to Know About the Unwinding of the Medicaid Continuous Enrollment Provision, Henry J. Kaiser Family Foundation, June 9, 2023, https://www.kff.org/medicaid/issue-brief/10-things-to-know-about-the-unwinding-of-the-medicaid-continuous-enrollment-provision/#one.

[27] Medicaid Enrollment and Unwinding Tracker, Henry J. Kaiser Family Foundation, Oct. 11, 2023, https://www.kff.org/medicaid/issue-brief/medicaid-enrollment-and-unwinding-tracker/.

[28] Id.

[29] Sophia Moreno et al., What Do Medicaid Unwinding Data by Race and Ethnicity Show? Henry J. Kaiser Family Foundation, Sept. 28, 2023, https://www.kff.org/policy-watch/what-do-medicaid-unwinding-data-by-race-and-ethnicity-show/.

Will Moody v. NetChoice, LLC End Social Media?

October 27, 2023
Constitutional Law, COVID-19, Elections, First Amendment, Internet, Social Media

Aidan Vogelson, MJLST Staffer

At first, the concept that social media’s days may be numbered seems outlandish. Billions of people utilize social media every day and, historically, social media companies and other internet services have enjoyed virtually unfettered editorial control over how they manage their services. This freedom stems from 47 U.S.C. § 230.[1] § 230 withholds liability for “any action voluntarily taken in good faith to restrict access to or availability of material that the provider or user considers to be obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable, whether or not such material is constitutionally protected…”[2]  In other words, if someone makes an obscene post on Facebook and Facebook removes the post, Facebook cannot be held liable for any violation of protected speech. § 230 has long allowed social media companies to self-regulate by removing posts that violate their terms of service, but on September 29, the Supreme Court granted a writ of certiorari in Moody v. NetChoice, LLC, a case that may fundamentally change how social media companies operate by allowing the government at the state or federal level to regulate around their § 230 protections.

At issue in Moody is whether the methods social media companies use to moderate their content are permissible under the First Amendment and whether social media companies may be classified as common carriers.[3] Common carriers are services which hold themselves open to the public and transport people or goods.[4] While the term “common carrier” once referred only to public transportation services like railroads and airlines, the definition now encompasses communications services such as radio and telephone companies.[5] Common carriers are subjected to greater regulations, including anti-discrimination regulations, due to their market domination of a necessary public service.[6]  For example, given our reliance on airlines and telephone companies in performing necessary services, common carrier regulations ensure that an airline cannot decline to sell tickets to passengers because of their religious beliefs and a cellular network cannot bar service to customers because it disapproves of the content of their phone conversations. If social media companies are held to be common carriers, the federal government and the state governments could impose regulations on what content those companies restrict.

Moody stems from state efforts to do just that. The Florida legislature passed State Bill 7072 to curtail what it saw as social media censorship of conservative voices.[7] The Florida law allows for significant fines against social media companies that demonstrate “unfair censorship” or “deplatform” political candidates, like X (formerly Twitter) did when it removed former President Trump from its platform for falsely claiming that the 2020 election was stolen.[8] Florida is not the only state to pursue a common carrier designation for social media. Texas passed a similar law in 2021 (which is currently enjoined by NetChoice, LLC  v. Paxton and will be addressed alongside Moody) and the attorney general of Ohio has sued Google, seeking for the court to declare that Google is a common carrier to prevent the company from prioritizing its own products in search results.[9] Ohio v. Google LLC is ongoing, and while the judge partially granted Google’s motion to dismiss, he found that Ohio’s claim that Google is a common carrier is cognizable.[10] Given the increasing propensity with which states are attempting to regulate social media, the Supreme Court’s ruling is necessary to settle this vital issue.

Supporters of classifying social media companies as common carriers argue that social media is simply the most recent advancement in communication and should accordingly be designated a common carrier, just as telephone operators and cellular networks are. They explain that designating social media companies as common carriers is actually consistent with the broad protections of § 230, as regulating speech on a social media site regulates the speech of users, not the speech of the company.[11]

However, they ignore that social media companies rely on First Amendment and § 230 protections when they curate the content on their sites. Without the ability to promote or suppress posts and users, these companies would not be able to provide the personalized content that attracts users, and social media would likely become an even greater hotbed of misinformation and hate speech than it already is. The purpose of § 230 is to encourage the development of a thriving online community, which is why Congress chose to shield internet services from liability for content. Treating social media companies as common carriers would stifle that aim.

It is unclear how the Court will rule. In his concurrence in Biden v. Knight First Amend. Inst., Justice Thomas indicated he may be willing to consider social media companies as common carriers.[12] The other justices have yet to write or comment on this issue, but whatever their decision may be, the ramifications of this case will be significant. The conservative politicians behind the Florida and Texas laws have specifically decried what they argue is partisan censorship of conservative views about the Covid-19 pandemic and the 2020 election, yet these very complaints demonstrate the need for social media companies to exercise editorial control over their content. Covid-19 misinformation unquestionably led to unnecessary deaths from the Covid-19 pandemic.[13] Misinformation about the 2020 election led to a violent attempted overthrow of our government. These threats of violence and dangerous misinformation are the harms that Congress created § 230 to avoid. Without the ability for social media companies to curate content, social media will assuredly contain more racism, misinformation, and calls for violence. Few would argue given the omnipresence of social media in our modern world, our reliance on it for communication, and the misinformation it spreads that social media does not need some form of regulation, but if the Court allows the Florida and Texas laws implicated in Moody and NetChoice to stand, they will be paving the way for a patchwork quilt of laws in every state which may render social media unworkable

Notes

[1] See 47 U.S.C. § 230.

[2] 47 U.S.C. §230(c)(2)(A).

[3] Moody v. Netchoice, LLC, SCOTUSblog, https://www.scotusblog.com/case-files/cases/moody-v-netchoice-llc/.

[4] Alison Frankel, Are Internet Companies ‘Common Carriers’ of Content? Courts Diverge on Key Question, REUTERS, (May 31, 2022, 5:52 PM), https://www.reuters.com/legal/transactional/are-internet-companies-common-carriers-content-courts-diverge-key-question-2022-05-31/.

[5] Id.

[6] Id.

[7] David Savage, Supreme Court Will Decide if Texas and Florida Can Regulate Social Media to Protect ‘Conservative Speech’, LA TIMES (Sept. 29, 2023, 8:33 AM), https://www.msn.com/en-us/news/us/supreme-court-will-decide-if-texas-and-florida-can-regulate-social-media-to-protect-conservative-speech/ar-AA1hrE2s.

[8] Id.

[9] AG Yost Files Landmark Lawsuit to Declare Google a Public Utility, OHIO ATTORNEY GENERAL’S OFFICE (June 8, 2021), https://www.ohioattorneygeneral.gov/Media/News-Releases/June-2021/AG-Yost-Files-Landmark-Lawsuit-to-Declare-Google-a.

[10] Ohio v. Google LLC, No. 21-CV-H-06-0274 (Ohio Misc. 2022), https://fingfx.thomsonreuters.com/gfx/legaldocs/gdpzyeakzvw/frankel-socialmediacommoncarrier–ohioruling.pdf.

[11] John Villasenor, Social Media Companies and Common Carrier Status: A Primer, BROOKINGS INST. (Oct. 27, 2022), https://www.brookings.edu/articles/social-media-companies-and-common-carrier-status-a-primer/.

[12] Biden v. Knight First Amend. Inst., 141 S. Ct. 1220 (2021),  https://www.law.cornell.edu/supremecourt/text/20-197.

[13] Alistair Coleman, ’Hundreds Dead’ Because of Covid-19 Misinformation, BBC (Aug. 12, 2020), https://www.bbc.com/news/world-53755067.

The Inaccessible Cure: the Struggle With Feline Infectious Peritonitis and Thoughts on the Underlying Law

October 10, 2023
Administrative Law, Food and Drug Law, Health Law, Intellectual Property, Patents

Lan Gan, MJLST Staffer

For fellow feline fanatics, you may share some of my traits. I care for my cat’s health as I care for my own. Besides giving her nutritiously balanced meals, I take notes when she’s unwell and schedule annual physicals for her, just like I would for myself. I also browse online discussions posts of cats. Some make me laugh, some give me new understanding of cat behaviors, but the ones about feline infectious peritonitis are always grim.

Feline Infectious Peritonitis, or FIP, is a severe disease that typically develops in young cats when they are infected with feline enteric coronavirus (FeCV) which later mutates into FIPV and causes inflammations.[1] The mutations happen about ten percent of the time, and, until recently, have almost always been deadly.[2]

In 2018, researchers at the School of Veterinary Medicine at UC Davis partnered with Gilead Sciences and published an article about the discovery of GS-441524, which, through their experiments with cats that were infected with FIPV in an in vitro process, “caused a rapid reversal of disease signs and return to normality with as little as two weeks of treatment in 10/10 cats and with no apparent toxicity.”[3] Another paper, published in 2019, also by researchers of the two institutions, revealed that GS-441524 was an effective treatment for cats with naturally occurring FIP.[4]

This gave cat rescuers and cat owners hope. But despite promising experiment results, Niels Pederson, who partook in the studies and was a long-time researcher devoted to FIP, warned that the development was “proof-of-concept,” showing possibility in terms of science but not immediately translating into commercially available products.[5] Subsequently, GS-441524 did not move forward to become an FDA-approved drug to treat cats.[6] Instead, it seemed to be set aside as Gilead prioritized another drug, remdesivir, which is identical to GS-441524 in part of its structural formula and has the same mechanism of inhibiting coronavirus.[7] When Gilead failed to obtain FDA approval to use remdesivir to treat Ebola, they changed course to study its effects on the then-rising Covid-19 pandemic.[8] GS-441524, with its studies on animals halted, was also part of the race and was argued by some scientists to have more efficacy in treating Covid-19 than remdesivir.[9]

The much-needed cure became inaccessible. In as early as 2019, anxious people were turning to the black market for help. GS-441524 that circulated on the black market had murky origins: potential leaks from lab orders for research, personnel that synthesized the compound themselves in overseas locations such as China.[10] The benefits of the drug, while still salient, based on surveys of cat owners who utilized them, were potentially compromised by the disparity in quality of the black market drugs, and lack of veterinary expertise involved.[11]

Pharmaceutical companies are more than incentivized to patent their research products. A search on World Intellectual Property Organization (WIPO)’s database revealed 66 patents applied for by Gilead, from as early as 2009 to as recently as July 2023.[12] The list of patents documented development in Gilead’s GS-441524 research.[13] Gilead patented GS-441524’s treatment for cats in 2018 and 2020[14], but those accounted for only 3 of the 66 patents they obtained; the rest were regarding human use.[15] Patents benefit their owners by giving them a cause of action against future infringement. They are about owning, not sharing. Patents are the culmination of a strenuous journey of scientific research. But this celebratory landmark might not go any further. Many patents do not make their way onto the market; having one is not itself an incentive for doing so.

Next comes the approval process as stipulated in federal law. 21 U.S.C. § 360b governs the approval process of new animal drugs.[16] The statute lays the burden on pharmaceutical companies – referred to as drug sponsors – of contacting the FDA after initial research of the drug, making the decision to pursue approval for the drug, and conducting tests to ensure the effectiveness and safety of the drug.[17] Additionally, the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988 provides an abbreviated process for generic copies of approved new animal drugs;[18] the Minor Use and Minor Species Animal Health Act (the “Mums Act”) of 2004 paves paths for drugs affecting a small population of major species of animals (defined as horses, dogs, cats, cattle, pigs, turkeys and chickens) and minor species (those that are not major species) that have few drugs available to them.[19] In 2018, the Animal Drug and Animal Generic Drug User Fee Amendments expanded the eligibility for conditional approval of non-MUMS drugs intending to treat a serious or life-threatening disease or condition or address an unmet animal or human health need, for which a demonstration of effectiveness would require a complex or particularly difficult study or studies.[20]

How has GS-441524 escaped the statutory provisions when they have been amended to be more inclusive? There may be various reasons. It may not qualify for conditional approval under 21 U.S.C. § 360ccc(a)(1)(ii) because peer-reviewed articles have already demonstrated the drug’s effectiveness. It may be hard to quantify the FIP-affected cat population to meet the “minor use” threshold set out in the Mums Act because of the difficulty of FIP testing. Current testing cannot differentiate between FeCV and the mutated FIPV, and an FIP diagnosis is often assumed for young cats based on their higher infection rate.[21] Lastly, no matter which approval process GS-441524 is eligible to take, the process wouldn’t start unless Gilead decides to contact the FDA and set forth the drug for approval. Current statutes create paths, but no incentives to do so. The market may provide some monetary incentives, as treatment costs via the black market can be up to $10,000 for 12 weeks[22], but this is singularly held back by the decision to prioritize approval for human treatment, and the presumption that the approval process of an animal drug would negatively impact the approval process of a similar drug for humans.[23]

The black market is not a long-term solution for FIP treatment. Though the U.S. has yet to adjudicate the circulation of unlicensed FIP treatment, in July 2023, a woman in China was sentenced to 15 years in prison and fined with more than $5 million in damages for producing and selling fake, substandard products pursuant to China’s criminal law statutes.[24] Gilead also holds the exclusive patents on feline treatments. Facing unclear prospects for legitimate FIP treatment, subsequent statutory amendments need to create actual incentives to spur innovation in animal drugs, in addition to the creation of paths. The law should also create safeguards to promote transparency and fairness in the application review process in order to reduce bias against animal drugs.

Notes

[1] Feline Infectious Peritonitis, Cornell Feline Health Center, https://www.vet.cornell.edu/departments-centers-and-institutes/cornell-feline-health-center/health-information/feline-health-topics/feline-infectious-peritonitis (last visited Oct. 2, 2023).

[2] Id.

[3] B.G. Murphy et al., The Nucleoside Analog GS-441524 Strongly Inhibits Feline Infectious Peritonitis (FIP) Virus in Tissue Culture and Experimental Cat Infection Studies, 219 Veterinary Microbology 226, 226 (2018).

[4] Niels C Pedersen, Efficacy and Safety of the Nucleoside Analog GS-441524 for Treatment of cats with Naturally Occurring Feline Infectious Peritonitis, 21(4) J. of Feline Med. & Surgery 271, 271 (2019).

[5] Human Antiviral ‘GS-441524’ Shows Great Promise Against Infectious Disease in Cats, Science Daily (Feb. 13, 2019), https://www.sciencedaily.com/releases/2019/02/190213100442.htm.

[6] Sarah Zhang, A Much-Hyped COVID-19 Drug Is Almost Identical to a Black-Market Cat Cure, The Atlantic (May 8, 2020), https://www.theatlantic.com/science/archive/2020/05/remdesivir-cats/611341/.

[7] Id.

[8] Kai Kupferschmidt & Jon Cohen, WHO Launches Global Megatrial of the Four Most Promising Coronavirus Treatments, Science (Mar. 22, 2020), https://www.science.org/content/article/who-launches-global-megatrial-four-most-promising-coronavirus-treatments.

[9] E.g., Victoria C. Yan & Florian L. Muller, Advantages of the Parent Nucleoside GS-441524 over Remdesivir for Covid-19 Treatment, 11 ACS Med. Chemistry Letters 1361, 1361 (2020).

[10] See Sarah Zhang, A Much-Hyped COVID-19 Drug Is Almost Identical to a Black-Market Cat Cure, The Atlantic (May 8, 2020), https://www.theatlantic.com/science/archive/2020/05/remdesivir-cats/611341/; see also Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2258 (2021).

[11] Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2264–67 (2021).

[12] CHEM:(BRDWIEOJOWJCLU-LTGWCKQJSA-N), WIPO, https://patentscope.wipo.int/search/en/result.jsf?_vid=P22-LN8EIR-06824 (last visited Oct. 2, 2023).

[13] Id.

[14] See World Patent No. 169,946 (filed Mar. 13, 2018); see also U.S. Patent No. 0,296,584 (filed Mar. 13, 2018); see also U.S. Patent No. 0,376,014 (filed Apr. 17, 2020).

[15] See CHEM:(BRDWIEOJOWJCLU-LTGWCKQJSA-N), WIPO, https://patentscope.wipo.int/search/en/result.jsf?_vid=P22-LN8EIR-06824 (last visited Oct. 2, 2023).

[16] 21 U.S.C. § 360b.

[17] From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process, FDA (Aug. 14, 2020), https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process.

[18] Generic Animal Drug and Patent Term Restoration Act (GADPTRA), FDA (Apr. 24, 2023), https://www.fda.gov/animal-veterinary/guidance-regulations/generic-animal-drug-and-patent-term-restoration-act-gadptra.

[19] Conditional Approval Explained: A Resource for Veterinarians, FDA (Sept. 17, 2020), https://www.fda.gov/animal-veterinary/resources-you/conditional-approval-explained-resource-veterinarians.

[20] 21 U.S.C. § 360ccc (a)(1)(ii).

[21] Feline Infectious Peritonitis, Cornell Feline Health Center, https://www.vet.cornell.edu/departments-centers-and-institutes/cornell-feline-health-center/health-information/feline-health-topics/feline-infectious-peritonitis (last visited Oct. 2, 2023).

[22] Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2264–67 (2021).

[23] Id.

[24] Wu Shubin (吴淑斌), Zhishou Maoyao Yishen Huoxing 15 Nian: Maoquan “Jiumingyao” de Yinmi Shengyi (制售猫药一审获刑15年:猫圈“救命药” 的隐秘生意) [Sentenced at Trial for 15 Years for Manufacturing and Selling Medicine for Cats: The Secret Business of Life-Saving Drugs in Cat-loving Communities], Sanlian Shenghuo Zhoukan (三联生活周刊) [Sanlian Lifeweek] (July 20, 2023), https://mp.weixin.qq.com/s/VKJO_AIVBy3Hm6GhWUOnWA.

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