In the wake of a Central Florida couple suing a Longwood fertility clinic for implanting the wrong embryo, legal experts say Florida’s outdated laws on the subject do little to prevent such “heartbreaking” mixups from occurring, or help handle them when they do.
“There’s not a lot of Florida law for you all to reach a resolution,” Circuit Judge Margaret Schreiber told the couple and lawyers at the end of a court hearing last month.
There were more than 95,000 in vitro fertilization births in the United States in 2023, according to the most recent data provided by the American Society for Reproductive Medicine, or ASRM. In vitro fertilizations accounted for nearly 3% of all births in the United States that year.
But experts said fertility clinics are not held to the same standards and regulations as other areas of medicine. Many still rely on manual oversight, rather than high-tech systems.
“[They’re] looking at it with human eyes,” said Ponte Vedra Beach attorney Robert Travieso, who specializes in medical malpractice cases, regarding the fertilization of eggs and storing the embryos before implant. “You’re just exposing it to more risks of human error occurring. A lot of this comes down to the clinic not wanting to invest in the technology.”
The Longwood clinic implanted Tiffany Score with an embryo she and Steven Mills believed was one of three it had produced and frozen in early 2020 using her eggs and Mills’ sperm, according to the lawsuit filed last month.
But soon after their daughter was born, the Caucasian couple realized the baby was not of the same race. Genetic tests ordered by the couple revealed the girl was not their biological child.
The Brevard County couple decided to file a lawsuit against Dr. Milton McNichol and IVF Life Inc. after repeatedly contacting the clinic but getting no response.
Lawyers for the couple say Score and Mills love their daughter and are raising her as if she’s their own. Even so, they demand the clinic, which does business as the Fertility Center of Orlando, answer as to what happened to their other embryos and whether one may have been wrongly implanted into another woman.
They also want the clinic to pay for the genetic testing of any child born under the clinic’s care in the past five years.
As of Friday, Schreiber had not yet reached a decision on a settlement agreement.
“This heartbreaking circumstance is gravely aggravated by the knowledge that some other couple may be parenting — or about to be parenting — [Score’s and Mills’] child,” said Jack Scarola, one of the couple’s attorneys, in a Jan. 5 letter to Dr. McNichol. “Moreover, in the absence of the racial disparity that alerted [the couple] to your inexcusable error, the fact and results of the error might be concealed for years or left or undiscovered indefinitely.”
IVF mix-ups are extremely rare. But they are deeply troubling for everyone involved.
Last year, a Georgia woman sued a fertility clinic after she gave birth to a boy conceived through IVF who turned out not to be genetically hers. She ended up losing custody of him to his biological parents after months of bonding with him.
Unfortunately, laws and regulations at all levels have not kept up with the growing use of the procedure since it was first done successfully in 1978, according to Mary Ziegler, a law professor at the University of California in Davis and an expert on the politics of reproduction, abortion and IVF.
“There is very little federal law,” Ziegler said this week regarding IVF. “And the law isn’t very clear. … And so it comes [down] to professional organizations. But they are not as helpful with what happens in these cases and how to prevent mix-ups.”
Florida law also isn’t very clear — and is rather old-fashioned when it comes to modern relationships.
It states that “any child born within wedlock who has been conceived by the means of artificial or in vitro insemination is irrebuttably presumed to be child of the husband and wife.” In other words, no one can show up, demonstrate they are the child’s biological parent, and take it away from the couple who bore it.
The law also provides an exception for cases of gestational surrogacy agreed to by “both husband and wife.”
But it’s not clear who has what rights when a couple is not married.
While the laws themselves may be outdated, assisted reproductive technology (ART) — which includes IVF, the most common procedure — “is one of the most highly regulated of all medical practices in the U.S.,” according to ASRM’s website. It cites, for example, that fertility clinics must follow state requirements for medical licensing and medical education. Physicans also can disciplined for physician misconduct by state boards.
Federal regulations include that clinics must report IVF cycle data to the Centers for Disease Control and Food and Drug Administration. An IVF cycle is the period from the stimulation of the ovaries and collection of the eggs to the implantation of the embryo in a woman’s uterus.
“Additionally, the medical profession exercises significant self-regulation to assure the continuing competence of practicing physicians,” according to the ASRM’s website. It adds that ASRM, as a professional society, develops ethical and practice guidelines for its member fertility clinics.
The organization also points out that the percentage of single-child births from IVF cycles, as opposed to twins, triplets and other multiple births, remains consistently at nearly 97%.
Representatives for the organization only provided links to its websites in response to emailed questions from the Orlando Sentinel.
But Ziegler and Travieso said simply reporting the number of IVF procedures to the federal government is not enough.
Travieso says “more robust protections” should be put in place for a procedure that can cost tens of thousands of dollars.
“It’s unspeakably catastrophic for these families,” Travieso said in regard to embryo mix-ups.
He advocates requiring fertility clinics use Electronic Witnessing Systems (EWS), such as radio frequency identification (RFID) tags and digital barcodes, to track every dish and tube in a lab. If a dish does not sync with a patient, an alarm or lockout is triggered.
Travieso recommends couples wanting to undergo IVF to look for a clinic using EWS and “feel free to ask questions: ‘What kind of policies and procedures are in place to prevent this from happening.’”
Ziegler said more regulations are not enacted because of politics, despite IVF having bipartisan appeal. President Donald Trump pledged during his campaign to make IVF free and signed an executive order last year to make the procedure more accessible and less expensive. But that effort has stalled in Congress, despite both chambers being controlled by Trump’s Republican Party.
The reason for the difficulty: Some pro-life advocates argue that fertilized embryos are human beings and are conflicted on whether it is ethical to freeze or discard embryos. Many couples decide to freeze their embryos as a way to store and preserve them for years before they decide to implant them.
That argument substantially complicates the policy and procedures surrounding IVF.
“A lot of pro-life groups are worried about IVF,” Ziegler said. “That’s made it very hard for legislators in Republican states, like Florida. So it’s easier for legislators not to do anything and leave it to the market to regulate.”
State Sen. Jason Brodeur and State Rep. Rachel Plakon — Republicans who represent the area where the clinic is located in Seminole County — did not respond to emailed questions regarding IVF and regulations.
