Going Through IVF Is An Emotional Spin.

PGT-A Tests Shouldn’t Make It Worse.

If you paid for PGT-A testing during your IVF process, please contact us.

PGT-A Lawsuit

Does PGT-A Work as Advertised?

After years of being unable to have a baby, you decide that it is time to save your money, take on a second job, and/or borrow money so that you can try to have a baby using in vitro fertilization (IVF). Your emotions are ping-ponging as you begin the process in hopes of having your miracle baby as soon as possible when you learn of an add-on to the IVF process called PGT-A, or preimplantation genetic testing for aneuploidy.

You are informed that PGT-A is highly advantageous and has a very high degree of accuracy, and that you should purchase the test to determine whether your embryos are genetically “normal” or “abnormal”. You also are told that PGT-A increases the chance of pregnancy, decreases the chance of miscarriage, and increases the success of IVF, among other benefits. With promises like that, you decide that PGT-A is worth the additional cost of around $5,000, even if your insurance company will not pay for it.

But is it?

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We’re changing the narrative about lawsuits.^™

“PGT-A tests have been prematurely incorporated into fertility medicine.”

– Josephine Johnston, bioethicist and director of research at Hastings Center.

Are You Affected By Class Action Lawsuits Against Genetic Testing Companies That Have Been Filed Alleging That Consumers and Patients Have Been Misled About PGT-A Testing During IVF Treatment?

Class action lawsuits have been filed against:

CooperGenomics, Inc., CooperSurgical, Inc., The Cooper Companies, Inc.
Reproductive Genetic Innovations, LLC.
Progenesis, Inc.
Natera, Inc.

These cases allege consumer fraud, breach of warranty, and related claims arising out of the defendants’ advertising and sale of a genetic test called preimplantation genetic testing for aneuploidy (PGT-A), which is used during the IVF process.

The nationwide class action lawsuits filed so far include:

Weinberg, et al. v. CooperGenomics, Inc., et al. (pending in the District of New Jersey)
Donamaria v. Reproductive Genetic Innovations, LLC. (pending in the Northern District of Illinois)
Cruz, et al. v. Progenesis, Inc. (pending in the Southern District of California)
Petersen, et al. v. Natera, Inc. (pending in the Northern District of California)

In addition, it is expected that similar lawsuits against other genetic testing industry participants such as Ovation Fertility and Igenomix will be prosecuted soon.

What Is PGT-A Testing?

IVF is a process of fertilization in which an egg is combined with sperm in vitro (“in glass”) to create embryos. Once embryos reach the blastocyst stage, PGT-A testing is performed by extracting a few cells from the blastocyst’s trophectoderm and shipping these cells, called the biopsy, to a lab for testing. The biopsy is then analyzed by the lab, purportedly to determine if the biopsy contains a “normal” or “abnormal” number of chromosomes.

Based upon its analysis of the biopsy of just a few cells, the lab represents whether the entire embryo, including the inner cell mass, is “euploid,” “mosaic” or “aneuploid.” “Euploid” embryos are considered “normal” and generally suitable for transfer, “aneuploid” embryos are considered “abnormal” and generally not suitable for transfer, and “mosaic” indicates a middle ground that is not exactly clear, such that the embryo may or may not be suitable for transfer.

The procedure: A very small number of cells, typically five to ten cells, are taken from the outer cell, which ultimately becomes the placenta, to predict the genetic makeup of the entire embryo.

“Labs only test five cells from around 150 that make up the fertilized egg,” said Dr. Hugh Taylor, chairman of the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine. “We’re fooling ourselves if we think we have full information on an embryo based on those few cells.”¹

Are PGT-A Tests As Advertised?

PGT-A is advertised by the genetic testing companies as a genetic test that purports to analyze the chromosomal makeup of fertilized human embryos by screening for chromosomal abnormalities. Consumers undergoing IVF are frequently sold PGT-A as an add-on test costing thousands of dollars and not typically covered by insurance. The complaints that have been filed in federal courts allege misrepresentations by the defendants regarding PGT-A, including that it increases the success of IVF, increases the chance of a healthy IVF pregnancy, decreases the chance of miscarriage, reduces the time to pregnancy, and increases live birth rates, all while failing to disclose its limitations, or that PGT-A is unproven and not established by science. The lawsuits also allege that the defendants make certain assertions concerning the accuracy of their respective tests that leave out other important information such that the assertions are misleading.²

The plaintiffs in the lawsuits seek to recover their out-of-pocket costs spent on PGT-A as well as statutory and other damages resulting from the defendants’ allegedly false and misleading promotion of PGT-A.

It is alleged that since preimplantation genetic testing was first introduced, its efficacy and usage in IVF has been called into question since as early as 2005. Researchers have repeatedly determined that preimplantation genetic testing has no benefit over standard IVF and that its benefits are unsupported by scientific evidence.³

For example, The New England Journal of Medicine has published the results of a randomized controlled trial in which they determined that conventional IVF treatment was noninferior to PGT-A and that “the results of trophectoderm biopsy may not totally represent the genetic composition of the inner cell mass of the blastocyst.”⁴ A similar finding occurred in 2023 when researchers determined that there is no clear improvement to cumulative live birth rates with PGT-A and there is a reduction in live birth rates among the youngest IVF patients.⁵

The American Society for Reproductive Medicine (“ASRM”) and the Society for Assisted Reproductive Technology (“SART”) have also issued opinions stating that the “value of preimplantation genetic testing for aneuploidy (PGT-A) as a universal screening test for all patients undergoing in vitro fertilization (IVF) has not been established.”⁶

Despite this scientific research and many other studies, it is alleged that PGT-A continues to be marketed and sold as an add-on to IVF in a way that is deceptive and misleading to consumers.

Companies storing and working on embryos created during the IVF process have already experienced backlash when storage tanks have broken, thus destroying embryos. Additionally, separate lawsuits have been filed against CooperSurgical for allegedly selling a defective embryo culture media designed to support the growth of embryos created using IVF that instead damaged or destroyed the embryos.⁷

So Why Is PGT-A So Popular? (Hint: Follow the Money.)

Despite the growing consensus of scientific research showing a lack of efficacy and benefit to PGT-A testing, its use has spiked significantly in recent years due to marketing and advertising efforts. For example, it has been alleged that from 2014 to 2021, the use of PGT-A testing increased from being utilized in 13% of IVF cycles to approximately 40% of IVF cycles.

Due to its increasing use, the PGT-A testing industry now generates hundreds of millions of dollars per year.⁸

“Some patients may have paid for this expensive treatment, and in doing so, may have reduced their chances of having a baby through IVF,” said Jack Wilkinson, a research fellow at the University of Manchester in the U.K. who analyzes reproductive medicine data.⁹

Can I Find Out About Filing a Potential Lawsuit for PGT-A Testing?

Yes. The class action lawsuits that have been filed allege:

PGT-A testing results in economic losses for those that pay for it.
PGT-A testing can result in the unnecessary loss of embryos.
PGT-A testing can result in embryos that could result in live births not being transferred.
PGT-A testing can result in embryos that could result in live births being discarded.
PGT-A testing can result in additional egg retrievals.
PGT-A testing can provide false positives and false negatives.
PGT-A testing can result in important decisions being made during IVF based upon inaccurate information.
PGT-A testing can result in embryos being unable to be transferred.
Inaccurate PGT-A testing can result in healthy babies being born from embryos deemed “abnormal” and “unsuitable for transfer”.

If you had PGT-A testing performed on your embryos, you have legal options.

Please reach out to learn more about current class action lawsuits as well as other lawsuits being prepared based upon PGT-A testing.

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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 allegations that are set forth in the complaints that have been filed in court, and the alleged misrepresentation of information that women have relied and depended on to make the most informed decisions possible for their families.

If you’re going through IVF and have questions about PGT-A testing that you have experienced, 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. A Case for Women is working with Constable Law, Justice Law Collaborative, and Berger Montague PC, the law firms that have been retained and that are prosecuting the class action lawsuits that have been filed.

Sources

Jacquelynn Kerubo, “After Genetic Testing, I Took a Chance on an ‘Imperfect’ Pregnancy,” New York Times, April 7, 2021.
Paulson, R. “Hidden in plain sight: the overstated benefits and underestimated losses of potential implantations associated with advertised PGT-A success rates,” National Library of Medicine/PubMed: Human Reproduction, Vol. 35, Issue 3, p. 490-493, (March 2020).
Munne, S., et al. “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,” ScienceDirect: Fertility and Sterility, Vol. 112, No. 6, December 2019.
Junhao Yan, MD, PhD, et al. “Live Birth with or without Preimplantation Genetic Testing for Aneuploidy,” New England Journal of Medicine (NEJM), Vol. 385, No. 22, November 24, 2021.
Doody, K. “Live Birth Rate Following PGT Results in Lower Live Birth Rate Compared to Untested Embryos Transferred at Day 5/6.” Fertility and Sterility. Vol. 114, Issue 3, Supplement E419 (September 2020).
Kucherov, A. et al. “PGT-A is associated with reduced cumulative live birth rate in first reported IVF stimulation cycles age ≤ 40; an analysis of 133,494 autologous cycles reported by SART CORS.” National Library of Medicine/PubMed: Journal of Assisted Reproduction and Genetics (2023) 40:137-149.
Sarah Kliff and Azeen Ghorayshi, “Botched I.V.F. Liquid Destroyed Embryos, Lawsuits Claim,” New York Times, February 15, 2024.
Isabella Cueto, “New research casts fresh doubt on a common procedure that promises to increase the odds of IVF,” STAT News, November 26, 2021.
Practice Committee of the American Society for Reproductive Medicine and the Genetic Counseling Professional Group. “Clinical management of mosaic results from preimplantation genetic testing for aneuploidy of blastocysts: a committee opinion,” National Library of Medicine/PubMed: Fertil Steril. Vol. 120, No. 5. November 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.