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February 2023  Volume 4Issue 2
Health Law Connections

Early Career Professionals—The Continued Need for Federal Guidance Addressing Assisted Reproductive Technology, Post-Dobbs

  • February 01, 2023
  • Abigail Saldana , Smith Hulsey & Busey

Fertility clinics have been in legal limbo from the start, and the Dobbs decision last year did everything but clarify any pressing assisted reproductive technology (ART) issues.

On June 24, 2022, the U. S. Supreme Court issued its decision in Dobbs, State Health Officer of the Mississippi Department of Health v. Jackson Women’s Health Organization.1 Although the Dobbs majority opinion, authored by Justice Alito, did not mention ART or in vitro fertilization (IVF), the Court acknowledged that “potential life” and “unborn human life” are unique and uniquely deserving of protection.2 This discussion and the balancing of “potential life” against the privacy rights of a mother are nothing new. The same balancing was performed by both the Roe3 and Casey4 Courts. The Roe Court in 1973 avoided resolving the “difficult question of when life begins.”5 Forty-nine years later, and long after the first live birth from a thawed frozen embryo,6 the Dobbs Court skirted the same question: “[o]ur opinion is not based on any view about if and when prenatal life is entitled to any of the rights enjoyed after birth,” and returned the regulation of abortion and reproductive health, and by implication, ART, directly to the states.7

But state legislatures have had decades to legislate on various aspects of IVF, including the legal status of embryos and standards for their storage and disposition, and yet, few states have enacted any form of legislation. What legislation does exist is inconsistent, nebulous, and lacks key definitions applicable to fertility clinics, embryo and gamete storage facilities, and patients. A few states, such as Louisiana, define an in vitro fertilized embryo as a “juridical person” that may not be destroyed.8 Similarly, New Mexico has a statute that “implicitly vests frozen embryos with personhood status by prohibiting their destruction.”9 States such as Florida treat embryos as something more than property but less than a person with cognizable rights and fail to address any ART/IVF issues, in terms of personhood, head-on.10 Surprisingly, it wasn’t until 2021 that New Jersey became the first state to enact a statute that required the licensing and regulation of embryo storage facilities, including fertility clinics, with the department of health.11

Of major concern to fertility clinics, storage facilities, and other reproductive health practitioners post-Dobbs is the fate of embryos that are “leftover” or, unfortunately, abandoned after IVF procedures. It is estimated that there are upwards of 900,000 to 1,000,000 embryos currently sitting in storage in the United States, storage that will soon reach maximum capacity.12 The federal government has a relatively minimal role in regulating preservation technology, such as cryopreservation.13 Most fertility clinics have implemented stringent, detailed policies and agreements governing the disposition of embryos in the absence of oversight. However, will such agreements have any legal effect post-Dobbs? Can biological donors preemptively consent to the eventual destruction of an embryo formed from their genetic material? Would a fertility clinic be responsible for murder if it runs out of storage space and has no option but to dispose of abandoned genetic materials in accordance with policy? Is it even humane to cryofreeze an embryo? If so, what is the most humane, or ethical, amount of time to keep an embryo in cryostorage? Moreover, how can any similar, pressing questions be determined outside of the viability framework Dobbs abandoned

Such questions will likely not be answered by any form of legislative direction. The Supreme Court has, at least since Roe in 1973, refused to provide any guidance. Where does this leave reproductive health and fertility providers? The legal and ethical quandaries left in light of the Dobbs decision are many and require direct action and bright-line guidance. Ethical guidance and best practices are readily available from professional organizations, such as the American Society for Reproductive Medicine (ASRM); however, their applicability may fall short in light of the various legislative gaps. ART, including IVF, is continually growing, and further issues are bound to arise.14 This limbo is likely to persist in the absence of federal legislation setting strategic frameworks defining the status and future of embryos.

Abigail Saldana is an associate at Smith Hulsey & Busey in Jacksonville, FL. As a member of the firm’s health care practice team, Abigail represents a wide range of entities in the health care industry, including physicians and hospital systems, with compliance, mergers and acquisitions, operational matters and in complex medical malpractice matters. Abigail holds a JD from the University of Tennessee College of Law and has experience in intellectual property law, bankruptcy, real property and personal injury litigation.

*Any opinions expressed in this article are solely those of the author and do not represent those of the individuals, institutions or organizations that the author may or may not be associated with in professional or personal capacity, unless explicitly stated.

1 Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022).

2 The Dobbs dissent briefly raised concerns over “the application of abortion regulations to medical care most people view as quite different from abortion,” including IVF. Id. at 2337.

3 Roe v. Wade, 410 U.S. 113 (1973), overruled by Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022), and holding modified by Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833 (1992).

4 Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833 (1992), overruled by Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022)

5 Roe, 410 U.S. at 159 (“We need not resolve the difficult question of when life begins.”).

6 Zeilmaker GH, Alberda AT, van Gent I, Rijkmans CM, Drogendijk AC, Two pregnancies following transfer of intact frozen-thawed embryos, Fertility and Sterility 1984; 42:293-6.

7 Dobbs, 142 S. Ct. 2228, 2261 (2022).

8 See La. Stat. Ann. §§ 9:123, 129-30.

9 Marlene A. Pontrelli & J. Shoshanna Ehrlich, Family Law in Focus 636 (2017); see N.M. Stat. Ann. § 24-9A-1(D).

10 See Fla. Stat. § 873.05 (providing that a person “may not knowingly advertise or offer to purchase or sell, or purchase, sell, or otherwise transfer, a human embryo for valuable consideration.”); Fla. Stat. § 817.56555 (the Florida DNA Sample Handling & Processing Act, which makes it a felony in the third degree to willfully sell or transfer a person’s “DNA sample” or the result of a DNA analysis to a third party without express consent); Fla. Stat. § 742.17 (covering written agreements providing for the disposition of specimens in the event of divorce, death of a spouse, or other unforeseen circumstances).

11 N.J. Stat. § 26:2A-25.

12 Rinehart LA, Storage, transport, and disposition of gametes and embryos: legal issues and practical considerations, American Society for Reproductive Medicine, Fertility and Sterility 2021; 115:2, P274-81.

13 Blake VK, McGowan ML, Levine AD, Conflicts of interest and effective oversight of assisted reproduction using donated oocytes, J. L. Med Ethics 2015; 43:410-24.

14 Christianson MS, Stern JE, Sun F, Zhang H, Styer AK, Vitek W, et al, Embryo cryopreservation and utilization in the United States from 2004-2013, F&S Rep 2020; 1:71-7.