Going Through IVF Is An Emotional Spin.

Fraudulent PGT-A Tests Shouldn’t Make It Worse.

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PGT-A Lawsuit

Are Your IVF Embryos In Danger?

So you put a lien on your house and started carpooling with your partner to save the $20,000-$35,000 to try for a baby with IVF (in vitro fertilization) technology. Your emotions are ping-ponging when your Ob/Gyn urges a standard add-on test for your first round: it’s called PGT-A, short for preimplantation genetic testing for aneuploidy (chromosomal abnormality).

The doctor sells you on the test’s popularity and “high accuracy” in assessing whether your embryos are genetically sound or prone to developing any one of hundreds of unsustainable genetic abnormalities. Okay, you rationalize, another $6,000-$12,000¹ we didn’t count on, but the doctor thinks it’s ‘do not pass go’ and the baby’s health is what matters. We’ve come this far.

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We’re changing the narrative about lawsuits.^™

“It’s a little like running mammograms on kids. The chance of breast cancer is so low, so why are you doing it? I think it’s purely a marketing thing.”

– Mary Norton, obstetrician and geneticist at the University of California, San Francisco.²

What Is a PGT-A Test?

PGT-A testing is a screening performed on cryopreserved (frozen-thawed) IVF embryos biopsied to analyze chromosomes prior to transfer to the uterus. It’s pricey on top of an already expensive and emotionally fraught IVF procedure that isn’t guaranteed to work in any given attempt. If a cycle is unsuccessful, it’s back to square one.

The test is not usually covered by health insurance unless it’s medically necessary.

Aneuploidy refers to an abnormal number of chromosomes, compared to euploidy (46 = normal), or mosaic (partially normal, partially abnormal). According to PGT-A test marketing, when aneuploidy is identified it can accurately predict rare, life-altering genetic abnormalities should the embryo grow into a full-term fetus and come into the world in the current medical climate.

The procedure: A nano-sliver of cells is biopsied from each lab-thawed embryo, which is dangerous in itself because exposure to low quality air in the laboratory can kill fragile embryos;³ the cells are then shipped to an outside laboratory for analysis and interpretation. The Fertility & Reproductive Center collaborates with several laboratories that perform PGT-A testing.

But a New York Times investigation published April 20, 2022, concluded that PGT-A testing “is better at detecting common disorders like Down Syndrome and much worse at detecting rare conditions called microdeletions that are usually caused by a missing piece of chromosome.”⁴ Microdeletions present in many ways, from learning disabilities and heart defects to shortened life span and high infant mortality rate.

What Do You Mean PGT-A Tests Are a Scam?

In February 2024, the National Institutes of Health published a new study with this headline: “Preimplantation Genetic Testing for Aneuploidy Could Not Improve Cumulative Live Birth Rate Among 705 Couples with Unexplained Recurrent Implantation Failure.”⁵

A study by Oxford Academic in 2022 found that only 15 in 100 PGT-A tests were correct, meaning that 85 out of 100 viable embryos were unused or discarded by labs based on AI (artificial intelligence, not even human) error.⁶ PGT-A examines fertilized eggs grown to 5- to 6-day-old blastocysts, optimal for implantation, yet such preliminary results are treated as gravely definitive.

In October 2019, a large study published in Fertility and Sterility by Santiago Munné found that a single abnormal cell does not doom an embryo and that “PGT-A testing made no difference to rates of live births.”⁷

To support that finding, Dr. Albert Gutierrez, former head of the FDA department overseeing medical tests, called the tests “meaningless.”

More unsettling, patients who decided not to transfer embryos based on the test’s premature science rejected tens of thousands of viable childlings – a term coined by Australian geneticists to try and avoid political and religious quicksand. Said another way, they could have resulted in healthy births.⁸

Turns out the tests are nowhere close to being as accurate as manufacturers and their marketing hype have claimed; companies are dependent on physicians who take kickbacks to push them.

Meanwhile, “viable embryos are currently being disregarded, leaving many women to believe they have no other options to achieve a pregnancy.”

What Is PGT-A Testing Looking For?

No major advancements in IVF protocol have evolved over the past 45 years (except the equipment) since the first successful procedure in 1978. But as competition and profits have escalated in the last 20 years, additional and rarer disorders have been included in what PGT-A claims it can pinpoint. Here’s a partial list:

Jacobsen Syndrome – delayed motor skills and cognitive (speech) development, sagging facial structure on one side, bleeding disorders, serious heart problems: occurs in 1 in 100,000 newborns.
Edwards syndrome – clenched fists with overlapping fingers, abnormal facial features, e.g., small head (microcephaly), small jaw, low-set ears: occurs in 1 in 5,000 newborns.
Patau syndrome – cleft lip and/or palate, small head, small lower jaw, low-set ears, defects in the iris: occurs in 1 in 10,000-20,000 newborns.
Triploidy – severe fetal growth problems, usually ending in miscarriage: occurs in 1 in 10,000 newborns.
Prader Willi syndrome – floppy muscle tone, weak cry, weak sucking reflex, small genital organs: occurs in 1 in 10,000-30,000 newborns.

“I’ve never seen a case of that [Jacobsen Syndrome] in my 20-plus years of practicing genetics,” said Dr. Diana Bianchi who runs a National Institutes of Health laboratory studying prenatal blood screenings.

So Why Do PGT-A Tests Exist? (Hint: Money.)

PGT-A supposedly protects prospective embryos from a dismal future + hopeful mothers against a higher risk of failed implantation and miscarriage; however, evidence has proven these claims are invalid.

Also, massive differences exist in results from one fertility clinic to the next, not just in terms of results but data and a host of other variables: Each clinic’s method of freezing & thawing embryos, platforms & algorithms, interpretation, personnel skill, and most importantly thoughtful counsel for hopeful parents is like day and night.¹⁰

That last point – sensitive counseling to explain how the tests are not standard, not required, and not all that accurate (understatement) – is typically skipped.

Another point of contention: Hardly any clinics/labs use original data, instead citing data from other reference labs, which means “these clinics and labs themselves do not know if their euploid, mosaic, or aneuploid diagnosis is any good.”

Theoretically, if PGT-A tests were reliable, similar clinics treating similar patients would see similar rates of euploidy or aneuploidy. However, that’s not the case, as evidenced by the different results of two clinics located less than 100 miles away from each other.¹¹

Can I File a PGT-A Lawsuit?

Yes, if you’re caught in this situation, you have legal options. And yes, there are lawsuits.

A class action PGT-A lawsuit for financial recompense was filed in March 2023 in California against several makers including Ovation, Panorama, Myriad Genetics, and Natera, after their PGT-A tests and marketing claims were found to be wildly inaccurate, leading to the reckless abandonment of unnumbered IVF embryos.

US District Judge Jon Tigar (Oakland) allowed plaintiffs to revise their lawsuit to meet the legal requirements for allegations of fraudulent conduct; they had to better define how false marketing influenced their decision to have the PGT-A screen. Tigar could have thrown the case out, but he allowed it and denied Natera’s request to invalidate the plaintiffs’ claims.¹²

There is still time for you to join this class action and also new lawsuits that are predicted in light of recent evidence.

We Have Been Here for Women Since the Beginning.

A Case for Women was founded in 2017 by women, for women. Among our growing team of 75 team members across the country are women who have had all their children via IVF and not necessarily on the first try. We are women who’ve had miscarriages, healthy & unhealthy births. We’ve tried and pretty successfully juggled career, relationship, and children – a near impossible juggling act, if you ask us.

The PGT-A case is of particular importance to us. We are outraged by the culture of corporate greed leading to the misrepresentation of sensitive data that women have relied and depended upon in order to make the most informed decisions possible for their families.

If you’re going through IVF and confused about this scam, wow, please contact us 24/7/365 so we can help. There is strength in numbers and, you know, it takes a village. We might know something you’ve not been informed about or vice versa. If you’ve been affected by PGT-A testing, you may have legal grounds to sue the company that made & marketed your test or the clinic that forgot to say it wasn’t really required and could do more harm than good.

Sources

Pamela Mahoney Tsigdinos, “The Big IVF Add-On Racket,” New York Times, December 12, 2019.
Sarah Kliff and Aatish Bhatia, “When They Warn of Rare Disorders, These Tests Are Usually Wrong,” New York Times, January 1, 2022.
Romualdo Scorio, Erica Rapalini, and Sandro C. Esteves, “Air quality in the clinical embryology laboratory: a mini-review,” National Library of Medicine/PubMed, February 11, 2021.
Ibid. Pamela Mahoney Tsigdinos, New York Times, December 12, 2019.
Yang Liu, Xianxin Lan, Juanjuan Lu, Qien Zhang, Tingting Zhou, Tianxiang Ni, and Junhao Yan, “Preimplantation Genetic Testing for Aneuploidy Could Not Improve Cumulative Live Birth Rate Among 705 Couples with Unexplained Recurrent Implantation Failure,”National Library of Medicine/PubMed, February 1, 2024.
Azeen Ghorayshi, “Study Raises Questions about Popular Genetic Test for ‘Abnormal’ Embryos,” New York Times, April 20, 2022.
Santiago Munné, PhD, Brian Kaplan, MD, John L. Fratterelli, MD, Sharon Stock-Myer, PhD, and Susan Willman, MD, “Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial,” Fertility and Sterility, September 21, 2019.
Pamela Mahoney Tsigdinos, “Alabama lawsuit reveals what happens when IVF industry wants it both ways, Boston Globe, February 26, 2024.
Dr. Eve Feinberg, Dr. Caroline McCaffrey, and Dr. Brian Levine, “PTG-A Genetic Screening: Criticisms of PGT-A,” FertilityIQ, 2024.
Ibid.
Edvard Pettersson, “Class action over prenatal tests with false positives gets trimmed by court,” Courthouse News, March 28, 2023.

WE WEAR THIS BADGE PROUDLY. Because, in a time when legal services are still dominated by men, only a Women Owned Business can bring the woman’s perspective to issues that disproportionately affect women.

We are the ones, far more than men, who are injured by sexual assault, financial scams, the gender pay gap, toxic chemicals, and the misguided practices of powerful pharmaceutical companies.