Explainer: IVF access in Alabama – what comes next? 

Credit: Shutterstock / nevodka

In Vitro Fertilisation (IVF) procedures in the US state of Alabama are set to restart on April 1st following a state supreme court decision that put an immediate and shocking halt on the industry when it ruled that frozen embryos are people, and IVF facility staff can be held liable for destroying them. 

The news came as a shock to the entirety of the US IVF industry, with multiple facilities across the state of Alabama having to immediately cease business following the February 16 ruling. The decision came following the conclusion of the Alabama state supreme court case, LePage v. Mobile Infirmary Clinic Inc., that concluded that “The Wrongful Death of A Minor Act applies on its face to all unborn children, without limitation.” 

The shock change in policy came as a result of local political initiatives to target abortion services across the US, with state legislatures across the US perusing new laws that would seek to make abortion services inaccessible or banned outright. It comes off the heels of the US Supreme Court’s June 2022 case of Dobbs v. Jackson Women’s Health, in which the US Supreme Court overturned the constitutional protection for abortion that had previously been established as a result of the 1973 Roe v. Wade decision. 

The initial court case, elevated to the state supreme court from regional courts, was brought by couples whose frozen embryos were stored at a fertility clinic in Mobile, Alabama, and were destroyed when a patient removed several embryos and inadvertently dropped them on the floor. 

The Wrongful Death of a Minor Act, enacted in 1872, allows for parents of deceased children to seek punitive damages. Under the wording of this law, all unborn children are imbued with personhood and are legally people. As a result, the destruction of embryos in IVF facilities could be considered a wrongful death. 

Responding to the decision, one of Alabama’s largest suppliers of IVF treatment, The University of Alabama at Birmingham, was forced to put all IVF services on an indefinite halt. In a statement, the university hit back against the decision, stating: “We are saddened that this will impact our patients’ attempt to have a baby through IVF, but we must evaluate the potential that our patients and our physicians could be prosecuted criminally or face punitive damages for following the standard of care for IVF treatments.” 

Additionally, two other providers, such as the AlabamaCenter for Reproductive Medicine at Mobile Infirmary, announced that they had also paused IVF treatments. 

Following the shock change in laws, Alabama lawmakers responded on March 6, passing an amendment to the law that would exempt IVF clinics and staff from all criminal and civil prosecution in a seemingly bi-partisan drive to protect the industry. The amendment passed 81-12 in the state’s House and 29-1 in the Alabama Senate. 

Following the decision, Alabama Governor Kay Ivey told Reuters: “Right now, I am confident that this legislation will provide the assurances our IVF clinics need and will lead them to resume services immediately.” 

However, the damage may already have been done, with lawmakers, legal professionals and charity groups across the country scrambling to ensure that an industry, which according to GlobalData’s Healthcare Intelligence Centre reported $3bn in revenue throughout 2023, from US Republican attempts to undermine and ban abortion.

US civil rights groups immediately responded to the announcement, calling it a ‘gross overstep’ of the Alabama court system. In a statement released immediately following the decision, the American Civil Liberties Union (ACLU), described the decision as having ‘terrifying implications.’ 

The ACLU said: “One in six people worldwide are impacted by infertility and need in-vitro fertilization (IVF) as an option. The Alabama Supreme Court has grossly overstepped its role by classifying frozen embryos, single-celled fertilized eggs, as children. Justices have crossed a critical boundary to assign personhood to something created in a lab that exists outside of a human body. This ruling has terrifying implications for people in Alabama who are planning to have children and for the fertility clinics that provide necessary services. 

“This ruling endangers the fertility clinics in Alabama that provide IVF, those that have embryos stored, and the future of family planning in our state. Furthermore, this ruling, along with Alabama’s strict ban on abortions, means for many, it is the state, not the person, who can decide whether they can become pregnant.” 

On March 18, the Federal Branch of the US government decided to respond to the Alabama incident by issuing an executive order aimed at addressing challenges associated with the study of women’s health through the White House Initiative on Women’s Health Research. 

The announcement comes in hopes of ensuring the confidence of investors in women’s health issues in the wake of the Alabama decision, especially as research by GlobalData identified women’s health and women’s health as it relates to fertility specifically, came as one of the top ten indications that will be investigated in clinical trials in 2024. 

The backlash against the Alabama decision has had some ramifications on other Republican-held states that have similarly planned on passing similar wrongful death of a child bills that would similarly have caused a shutdown of IVF facilities. In late February, Florida republican representatives abandoned plans to pass their own “Civil Liability for the Wrongful Death of an Unborn Child” law, in seeming acknowledgement of the mistakes of Alabama’s bill. 

Whilst the main crux of the issue has been addressed for now, the Alabama supreme court decision has similarly sent shockwaves through the medical-legal community, with the concerning nature of the open language used in such bills when defining a child potentially leading to greater ramifications than just IVF treatment. 

Responding to the decision, US-based multinational law firm Sidley Austin, raised concerns the ruling will affect the assisted reproductive technology (ART) industry, possibly resulting in an unprecedented amount of financial damage to companies that research, develop, design, manufacture, sell, and use ART products. 

Despite the issue having been patched over in Alabama for now, the decision has opened a significant number of legal holes that have yet to be addressed by the state legislature which may potentially leave both industries open to prosecution or lawsuits. 

A spokesperson for Sidley, said: “The Alabama Supreme Court did not address the impact on the ART and IVF industry. For example, the decision does not answer whether only clinics may be held liable under the statute or whether individuals may also be held liable for the loss of frozen embryos. 

“The ruling does not address what fertility clinics can do with unused embryos, for example, when a family is complete or when frozen embryos are no longer needed, what fertility clinics can do with discarded embryos. For example, due to chromosomal abnormalities, failure to properly develop, or genetic disorders, or what duties arise when embryos are donated to other families, donated to science, or fail to develop in utero after implant. 

“While this case is limited to Alabama’s interpretation of an Alabama statute and its constitution, the Alabama Supreme Court relied on the U.S. Supreme Court’s 2022 ruling in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade. 

“There is growing concern that courts in other states could issue similar rulings or state lawmakers could pass related legislation, leaving clinics in multiple states potentially vulnerable to lawsuits over frozen embryos and hindering access to fertility treatment. Those in the IVF industry should be prepared for a changing landscape that may extend beyond IVF patients or clinics in Alabama.” The legal firm is advising IVF firms to take several steps to protect themselves from lawsuits or potential prosecution, including going as far as to set up contractual arrangements for losses arising from the use of fertility products in any part of the IVF procedures. 

The paper showcased attempts to make GPT-4 produce data that supported an unscientific conclusion – in this case, that penetrating keratoplasty had worse patient outcomes than deep anterior lamellar keratoplasty for sufferers of keratoconus, a condition that causes the cornea to thin which can impair vision. Once the desired values were given, the LLM dutifully compiled a database that to an untrained eye would appear perfectly plausible.

Taloni explained that, while the data would fall apart under statistical scrutiny, it didn’t even push the limits of what Chat-GPT can do. “We made a simple prompt […] The reality is that if someone was to create a fake data set, it is unlikely that they would use just one prompt. [If] they find an issue with the data set, they could fix it with consecutive prompts and that is a real problem. 

“There is this sort of tug of war between those who will inevitably try to generate fake data and all of our defensive mechanisms, including statistical tests and possibly software trained by AI.”

The issue will only worsen as the technology becomes more widely adopted too. Indeed, a recent GlobalData survey found that while only 16.1% of respondents from its Hospital Management industry website reported that they were actively using the technology, a further 26.8% said either that they had plans to use it or were exploring its potential use.

Nature worked with two researchers, Jack Wilkinson and Zewen Lu, to examine the dataset using techniques that would commonly be used to screen for authenticity. They found a number of errors including a mismatch of names and sexes of ‘patients’ and lack of a link between pre- and post-operative vision capacity. 

In light of this, Wilkinson, senior lecturer in Biostatistics at the University of Manchester, explained in an interview with Medical Device Network that he was less concerned by AI’s potential to increase fraud.

“I started asking people to generate datasets using GPT and having a look at them to see if they could pass my checks,” he said. “So far, every one I’ve looked at has been pretty poor. To be honest [they] would fall down under even modest scrutiny.” 

He acknowledged fears like those raised by Dr. Taloni about future improvements in AI-generated datasets but ultimately noted that most data fraud is currently done by “low-skill fabricators,” and that “if those people don’t have that knowledge, they don’t know how to prompt Chat-GPT to have it either.”

The problem for Wilkinson is how widespread falsification already is, even without generative AI.