Alabama IVF Clinics: Potential Implications of the LePage Case

On February 16, 2024, the Alabama Supreme Court issued a significant and controversial ruling that gave personhood status to unimplanted human embryos—a decision with considerable implications for in vitro fertilization (“IVF”) clinics in Alabama. In LePage v. Center for Reproductive Medicine, the court held that “extrauterine embryos” are considered children for purposes of Alabama's Wrongful Death of a Minor Act¹, which affords parents of a deceased child to recover punitive damages for the death of that child. This is a first-of-its-kind ruling from a state high court in the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.

Determining whether embryos are considered property, children, or something in between is a complex analysis that varies based on state laws, as we covered in detail in our previous post, Taking Security Interests in Human Reproductive Tissue: Clarifying Lender Options under Federal and State Law. Fetal personhood laws, like the one just established by the LePage case, are not “new,” as we discussed in Implications of Abortion Laws for Fertility Services, and these types of laws are underpinned by each state’s abortion restrictions, stemming from the religious belief that life starts at fertilization.²

Background

LePage was brought by three couples who had received IVF treatment in Mobile, Alabama at The Center for Reproductive Medicine P.C. (the “Center”). Their treatment resulted in the creation of several embryos—some were successfully implanted, and the couples contracted to have the remaining embryos maintained in the Center’s cryogenic storage. In 2020, however, their frozen embryos were destroyed when a patient at an adjacent hospital wandered into the Center’s tissue bank through an unsecured entrance, removed the frozen embryos without protective equipment, and dropped them when the patient’s hand was freeze-burned. The couples sued the hospital and the IVF clinic alleging common-law claims and wrongful death under Alabama's Wrongful Death of a Minor Act, an 1872 statute that creates a civil cause of action “[w]hen the death of a minor child is caused by the wrongful act, omission, or negligence of any person, persons, or corporation.” The Alabama trial court dismissed the plaintiffs’ wrongful-death claims, holding the embryos did not meet the definition of a “child” under the Wrongful Death of a Minor Act.³

On appeal, the Alabama Supreme Court disagreed. Citing two prior Alabama Supreme Court decisions (from 2011 and 2012) and a variety of dictionaries, the court said that the statutory term “child” in the Wrongful Death of a Minor Act includes “an unborn child,” and it held that nothing in the Act creates an exception for “unborn children who are not physically located ‘in utero’ … at the time they are killed.” The court reversed and remanded for further litigation consistent with the court’s opinion, noting that the defendants had asserted contractual and equitable defenses that the trial court remained free to consider in the first instance.

The opinion raises several concerns applicable to fertility providers that may have a chilling effect on the services that IVF clinics provide in Alabama, as discussed below.

Could IVF clinics and their staff be held liable for destruction of embryos in Alabama?

In light of the LePage case, there is now the strong potential for other IVF clinics, like the Center, to be held civilly liable for the wrongful death of a minor for the intentional, negligent, or unintentional destruction of “extrauterine embryos” (i.e., embryos created via IVF outside of the uterus, in a petri dish) – at least in Alabama. The Alabama Supreme Court’s decision is also likely to encourage similar litigation to be brought in other states by plaintiffs hopeful for a capacious interpretation of state laws addressing the death of a “child,” particularly because the court’s interpretation of the Alabama statute hinged not on any technical terminology unique to Alabama law, but rather on the proposition that the plain and “ordinary meaning of ‘child’ includes children who have not yet been born.”

Historically, IVF clinics and their staff, like other health care providers, are held to standards of care and may be liable for malpractice, negligence, or other tort claims to the extent that these standards of care may not be met. Clinics and their staff, however, would only be held liable in a wrongful death claim with respect to the death as a result of negligence or wrongdoing to their patient. Claims related to accidental, negligent, or intentional destruction of extrauterine embryos have generally been limited to contract or tort claims (treating the destruction as a breach of contract or negligent act and the embryos like property), even in Alabama.⁴ In fact, the National Library of Medicine published the following in September 2020:

Legal strategies that avoid alleging embryo personhood in tort cases are informed by the universal rejection of these claims in prior lawsuits. To-date, every court that has considered the wrongful death of an in vitro fertilization (IVF) embryo has rejected that claim on the ground that the term “person” or “human being” does not apply to frozen embryos under the meaning of state law (see, e.g., Gentry v. Gilmore, 613 So.2d 1241, 1244 [Ala. 1993]); Jeter v. Mayo Clinic Ariz., 121 P.3d 1256, 1261–62 [Ariz. Ct. App. 2005]; McClain v. Univ. of Mich. Bd. of Regents, 665 N.W.2d 484, 486 [Mich. Ct. App. 2003]; Miccolis v. Amica Mut. Ins. Co., 587 A.2d 67, 71 [R.I. 1991]).

Contrary to the general historical interpretation of state laws and the numerous court decisions cited above, the Alabama Supreme Court in LePage said unequivocally that “an unborn child is a genetically unique human being whose life begins at fertilization and ends at death” and that “an unborn child usually qualifies as a ‘human life,’ ‘human being,’ or ‘person,’ as those words are used in ordinary conversation and in the text of Alabama’s wrongful-death statutes … throughout all stages of an unborn child’s development, regardless of viability.”

Damages under Alabama’s Wrongful Death of a Minor Act include “such damages as the jury may assess in a court”⁵  and the standard of proof is “proof by substantial evidence”⁶ – a low standard of proof for potentially limitless damages, as Alabama has no cap on wrongful death damages.

Potential Considerations to Address LePage

In light of LePage, IVF clinics with tissue and organ banks could be the subject of additional scrutiny from Alabama state regulators, including the potential that regulators will leverage their full audit and investigative authorities, inquire into the security of their tissue and organ bank storage facilities, their internal protocols, security measures, and storage standards as well as inquiries about any potential security breaches that may jeopardize the integrity of cryopreservation equipment.

In addition to considering whether to continue operations of tissue banks in Alabama or to locate tissue and organ storage facilities elsewhere, IVF clinics may consider additional compliance measures:

• Review facility safety and security protocols, including building access and embryo handling and storage protocols;
• Assess their current general liability insurance coverage with their brokers and consider whether increasing coverage is sufficient;
• Review protocols – and training – regarding steps to be taken in the event that there is any type of physical security breach at the facility or if there is an accidental embryo destruction, including how to respond to the incident;
• Review protocols for how to respond to a state audit, investigation, or other request for information and how to address on-site inspections to ensure that the protocols are sufficient; and
• Consider assessing whether patient liability waiver terms in their patient agreements with respect to wrongful death claims of an extrauterine embryo are sufficient.

IVF clinics with locations in Alabama should also be prepared for additional scrutiny as they enter new business arrangements, including investment arrangements, corporate transactions or acquisitions, joint ventures and partnerships, or payor relationships. Potential business partners may want to understand how the IVF clinic is responding to the LePage decision, whether enhanced security measures are in place, or whether the clinic has been the subject of additional state scrutiny.

Does LePage Alter the Licensing Landscape for IVF Clinics in Alabama?

One potentially unique consequence of the LePage decision relates to the court’s multiple references to the Center’s tissue bank as a “cryogenic nursery” – invoking the concept of childcare. Under the laws of most states – including Alabama, at least pre-LePage – extrauterine embryos are generally considered “tissue” or “organs” and cryopreservation facilities require a tissue bank license or certification for storage of such items. In fact, Alabama’s code defines organs as follows: “Any human organ, human bone or human tissue, or any other part or portions of the human body, retrieved in Alabama except that the term ‘organ’ shall not include blood, blood products, or eyes or corneas of the eye for the purposes established by this article.”⁷ Pre-LePage, embryos would meet this definition and, accordingly, Alabama would require a certification to operate a tissue/organ bank.⁸

Under the “cryogenic nursery” view of IVF clinic facilities and what the Alabama Supreme Court understood to be the “ordinary meaning” of the term “child,” however, unborn extrauterine embryos are considered children in Alabama, which suggests that IVF clinics’ tissue/organ banks do not house tissue and organs (with respect to embryos) but rather children. If so, it would seem to follow that IVF clinics’ tissue/organ banks could potentially be considered some form of daycare or childcare center, which all states (including Alabama) regulate and generally require a license or an exemption to operate (not to mention requisite staff requirements).⁹ Despite the facial absurdity of this proposition, the logical implications of the Alabama Supreme Court’s decision should not be lightly ignored, particularly given the significant, novel, and well-funded litigation activity in the reproductive-rights space in just the 20 months since the U.S. Supreme Court’s Dobbs decision. Thus, whether LePage has some implications for licensing and permitting remains to be seen.

Conclusion

It is an uncertain time in the fertility treatment space in Alabama, as the fetal personhood movement seems to be gaining traction, and IVF clinics are cautioned to tread carefully. The LePage litigation will continue in the trial court; however, we understand the University of Alabama Birmingham Division of Reproductive Endocrinology and Infertility, and two others (including the Center), have paused treatments in Alabama as they evaluate the LePage decision. With respect to the potential criminal prosecution of patients and healthcare providers as a result of this decision, on February 23, 2024, Kathrine Robertson, chief counsel to the Alabama Attorney General Steve Marshall, released the following statement: “Attorney General Marshall has no intention of using the recent Alabama Supreme Court decision as a basis for prosecuting IVF families or providers.”

Although for now the LePage case appears to be limited to IVF clinics operating in Alabama, other states with fetal personhood laws that recognize embryos or fetuses as persons, like Louisiana and Georgia; those with current fetal personhood ballot initiatives, like Florida; and others with abortion bans predicated on the idea that life starts at fertilization may follow suit. According to Bloomberg Law, 14 other states currently “allow a cause of action for the wrongful death of an unborn child at any stage of development.” Notably, ten or so years ago, fetal personhood ballot initiatives failed in Colorado, Mississippi, and North Dakota; however, in light of the recent restrictive abortion bans in Mississippi and North Dakota, the fetal personhood movement may again gain traction in those states.

We will continue to monitor the LePage matter and any similar litigation in other states as it arises.

 

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^[1] Ala. Code § 6-5-391.
^[2]  For additional information on these states’ abortion bans, visit: https://states.guttmacher.org/policies.
^[3] The trial court also dismissed the plaintiffs’ alternative state-law tort claims but did not dismiss the contract and bailment claims asserted by one set of plaintiffs. After the trial court’s decision, however, the trial court certified its dismissal order as a final judgment under Alabama Rule of Civil Procedure 54(b), which permitted all three sets of plaintiffs to appeal.
^[4] Gentry v. Gilmore, 613 So.2d 1241, 1244 [Ala. 1993].
^[5] Ala. Code § 6-5-410(a).
^[6] Ala. Code § 6-5-549.
^[7] Ala. Code § 22-19-121(4).
^[8] Ala. Code § 22-19-122(b).
^[9] Ala. Code § 38-7-1 et. seq. 

 

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