The pause, the unpause, and remaining challenges
The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.
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BY: RON SHINKMAN
The decision from the Alabama Supreme Court giving a just-fertilized ovum the same legal rights as children has upended the IVF business in that state, with at least three of its SART-affiliated fertility clinics pausing such procedures and patients taking their embryos elsewhere.
Alabama’s highest court reversed the prohibition on seeking wrongful death damages late last month, concluding that a human life begins at fertilization. It also concluded that it was up to the state Legislature to make any accommodations regarding that issue.
The decision puts many IVF clinics in a bind because the damages awarded in a wrongful death lawsuit can be much higher than for a breach-of-contract claim, as the latter only focuses on placing a dollar value on the services provided by the clinics and whether they made an earnest attempt to deliver IVF services as promised. Wrongful death litigation focuses more on emotional losses suffered by parents and other family members and could also include punitive damages – additional financial penalties for negligent or deliberate acts.
The state Supreme Court ruling could also lead to criminal prosecutions of clinics that destroyed embryos, although Alabama’s Attorney General promised that would not occur in connection with delivery of IVF services.
Alabama’s four SART-affiliated IVF centers, and what they’re doing
The decision immediately created ripple waves throughout Alabama’s reproductive medicine community, with most pausing procedures. Alabama Fertility Specialists, the University of Alabama at Birmingham health system and the Center for Reproductive Medicine have all placed pauses on IVF procedures. They comprise three of the four providers in Alabama affiliated with the Society of Assisted Reproductive Technology. The fourth clinic, New Leaders in Fertility and Endocrinology, did not immediately respond to a query about the status of its IVF services.
“We are finishing out patients who are in stimulation and we are just trying to see what happens this week,” said Kathleen Miller, who is laboratory director for Alabama Fertility Specialists in Birmingham, specifically referring to a bill crafted by Alabama lawmakers that would exempt fertility clinics from liability under the Supreme Court ruling The clinic previously announced that it is putting on hold any new IVF treatments or cycles.
The University of Alabama at Birmingham – which runs perhaps the biggest IVF program in the state, is also continuing to do some work. “Everything through egg retrieval remains in place,” the provider said in a statement. “Egg fertilization and embryo development is paused.”
A source indicated that the Alabama Center for Reproductive Medicine is continuing to perform IVF procedures, but that could not be independently confirmed. Practice founder Cecil Long, M.D. and practice administrator Emma Williams did not respond to phone and email queries.
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Impact on Non-Clinic Fertility Companies Doing Business in Alabama
Miller noted that the bill currently lacks a safe harbor for ancillary businesses, who she said are apparently balking at sending supplies and equipment to Alabama practices until that issue is addressed by lawmakers.
Meanwhile, there are signs that IVF patients in Alabama are taking steps to move their embryos out of the state. Louis Villalba, chief executive officer for New York City-based TMRW Life Sciences, noted that his company’s offer of one year of free storage to anyone wishing to remove their embryos from Alabama has received a strong response. Typically, the company receives about 50 phone calls a week about moving and storing embryos, Villalba said. That call volume has quadrupled since the offer was made.
Moreover, moving requests are also coming from other nearby states, such as Texas. “It’s coming from all the Red states if you will, and from the Southeast in particular,” Villalba said.
Inception Fertility, which operates 48 clinics in nine states, also confirmed that IVF patients in Alabama have been moving embryos to its facilities in Tennessee and Georgia, according to an email from Chief Marketing Officer Lindsey Rabaut.
Remaining Challenges for IVF in Alabama
Igor Brusil, a former embryologist who now is an attorney in Texas, noted that while the high court’s decision will cause chaos in the short-term, there are feasible workarounds for IVF clinics in Alabama.
“There are things to be done to reduce the number of embryos that the clinic works with, which reduces the risk of any action” that might inadvertently damage them, said Brusil, who added that he is not involved in the Alabama case.
“Clinics can freeze unfertilized oocytes to reduce the number of oocytes that would be inseminated with sperm. This would result in fewer embryos created, thus reducing the number of embryos that potentially could be cryopreserved,” he added. “Alternatively, clinics may have to change stimulation protocols to decrease the number of oocytes collected.”
However, Brusil added that any changes to how the clinics approach the procedure will come at the expense of patients. “They will certainly suffer because whatever decision is made is not going to be the most effective IVF treatment possible,” he said.
The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.
Correction: 2/29/24 The Inside Reproductive Health article ASRM, SART, SRBT Withdraw Proposal to Eliminate Doctoral Requirement for Embryology Lab Directors, stated that ELDs are governed by the Clinical Laboratory Improvement Amendments of 1988, better known as CLIA. The CLIA regulations govern andrology and endocrinology laboratories within a fertility clinic.
Regulations suggested by the Centers for Disease Control and Prevention and endorsed by the American Board of Bioanalysis and the American Society for Reproductive Medicine and its affiliates require that an ELD have a medical or osteopathic degree or an earned doctorate degree from an accredited institution in a chemical, physical, or biological science as the major subject. Alternatively, individuals may serve as ELD directors without a medical or doctoral degree if they were certified prior to July 20, 1999.
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