RESEARCH ALERT: Multiple U.S. Class Action Lawsuits Allege Consumers were Misled About PGT-A Testing During IVF Treatments – How We Got Here and Where It Will Lead IVF
By Norbert Gleicher, MD, Medical Director and Chief Scientist at The Center for Human Reproduction in New York City. He can be contacted through The Reproductive Times or directly at either ngleicher@thechr.com or ngleicher@rockefeller.edu.
On Wednesday, October 16, 2024, at 09:45 AM, a consortium of law firms announced the filing of several nationwide class action lawsuits accusing genetic testing companies of misleading consumers about preimplantation genetic testing for aneuploidy (PGT-A) testing during in vitro fertilization (IVF) treatments. The lawsuits as of this point are only directed at a small group of leading commercial laboratories offering PGT-A testing. Other defendants can be expected to be added. Whatever the outcomes of these lawsuits will ultimately be years down the road, the IVF field has changed overnight with this filing. How far-reaching these changes will be is difficult to predict. Only so much is clear: they will be substantial, and will not only involve the clinical practice of IVF. They will affect the complete economic structure of the IVF field as it has evolved over the last two decades.
A brief introduction
PGT-A is the most recent name attached to the idea that chromosomal evaluations of embryos prior to potential transfer into the uterus will allow for reliable selection of euploid embryos for transfer and, therefore, improve pregnancy and live birth chances, while reducing failures of embryo to implant and reducing miscarriages due to aneuploid embryos. The concept was initially proposed in the late 1990 as a promising way of improving IVF cycle outcomes and has since only grown in popularity, first under the name preimplantation genetic screening (PGS) and later renamed PGT-A. This rise in popularity remarkably occurred despite the test’s repeated failures to live up to its many promises of improving IVF cycle outcomes.
For those truly interested in finding out the clinical value of PGT-A (to this day a majority of IVF clinics, for reasons discussed below, appear really disinterested, unfortunately), it became increasingly apparent that, for several rather obvious biological and statistical reasons, PGT-A was—with very few exceptions—unable to improve IVF cycle outcomes and, in at least some subgroups of patients, actually significantly harmed chances for a successful IVF pregnancy.
In many developed countries—the U.S. included—clinical utilization of PGT-A has, however, despite significant negative clinical implications, paradoxically continued to increase. Why this has been the case appears to be multifactorial and will be one of the main subjects to be addressed by the courts in response to the recently announced class action lawsuits regarding PGT-A utilization in IVF brought by a consortium of law firms in several states (1). At this point, the defendants are only several leading commercial genetic laboratories (with likely more to come), accused of fraud in misleading consumers about the value of PGS/PGT-A testing. Whether only patients are considered “consumers” or whether this definition also includes IVF clinics appears as of this moment unclear but, very obviously, has considerable legal significance, considering that genetic laboratories and IVF clinics from the beginning have been splitting the income from every PGS/PGT-A cycle, with the clinic charging for performing the embryo biopsies and the laboratory charging roughly for performing the genetic analysis of the embryo biopsy. Genetic laboratories and IVF clinics, therefore, have practically identical financial incentives to perform PGS/PGT-A.
Though IVF clinics have so-far not be named as defendants in the recently filed class action suits (unless corporate entities owned genetic testing laboratories as well as IVF clinics), many appear—for several reasons—potentially vulnerable. As already noted, they receive basically identical fees from patients undergoing IVF cycles involving PGT-A and this fact has actually increased in importance for clinics in recent years, for two reasons. First, clinics receive payments for PGT-A from patients out of pocket in cash, undiscounted and in advance of cycle start and, therefore, without billing costs. This is the case because third-party insurers in the U.S. to this day generally do not cover PGT-A, even if they cover IVF. The reason is that they (rightly) consider PGT-A still an experimental procedure (to the best of our knowledge only one exclusive insurer for the infertility field currently also offers coverage including PGS/PGT-A).
A second reason has been declining average cycle revenue at many IVF clinics because rapidly expanding coverage for at least limited IVF cycle numbers under general medical insurance plans and insurance-covered cycles usually being greatly discounted, average cycle reimbursement rates, especially in markets with considerable insurance coverage have plummeted. In such geographic areas, payments for PGS/PGT-A biopsies, therefore, significantly increased proportional importance.
A Wall Street analyst, indeed, suggested to me in 2022 that for a rapidly growing number of IVF clinics PGT-A revenue, already then, represented the clinic’s profit margin. In other words, how often PGT-A clinics applied PGT-A to their patients IVF cycles often was the difference between being in the green or red with their budgets. Somewhat unsurprisingly, therefore, (one, of course, would hope that such financial incentives did not drive clinical utilization decisions), more U.S. IVF clinics, therefore, have been practically mandating PGT-A for most of their patients.
That the recently announced class action suits will reduce the country’s PGT-A utilization must be expected. While here addressed suits are the first in the U.S., they are not the first in the world (see further details below) and, likely, also not the last ones in the U.S. since other law firms outside of the consortium that filed here-discussed suits also already announced interest in the subject.
Declining revenue for PGT-A cycles, therefore, will undoubtedly affect the profitability of fertility clinics and, therefore, will diminish the commercial interest and the value of IVF clinics, a highly relevant subject for discussion, considering that private equity in recent years has been guzzling up private physician-owned fertility clinics.
And if clinic valuations drop, this in turn will put earlier private equity investments under water, as they no longer will be able to expect profitable exits in the usual five-to-seven-year time spans. In short, the fertility field over the coming years may see unprecedented changes arising out of these legal filings. They, indeed, may represent the most consequential occurrence in the fertility field since birth of Louise Brown on July 25, 1978, the first successful IVF pregnancy in the world.
A short history of PGS/PGT-A
The hypothesis that testing embryos for chromosomal abnormalities before transfer and that exclusion from transfer of aneuploid (chromosomal-abnormal) embryos would improve pregnancy chances for remaining euploid (chromosomal-norma) embryos was first proposed in the late 1990s by Yuri Verlinski, PhD, a brilliant geneticist colleague and friend with strong clinical interest in IVF. In full disclosure, he several years later ended up purchasing my Chicago fertility center, which allowed me to move full-time back to New York City.
His assumption that this kind of embryo deselection prior to transfer would improve IVF outcomes was built on three premises, all on their own correct but in unison, as was later learned, mistaken: (i) It was known that a large percentage (in those days believed to be over 50%) of miscarriages occurred because they demonstrated aneuploidies. (ii) Since only a small number of specific chromosomes were found to be abnormal in miscarriages, one could conclude that abnormalities of other chromosomes simply never implanted. (iii) It, therefore, at the time appeared correct to deduce that deselecting chromosomal abnormal embryos from transfers, should increase pregnancy and live birth chances per transfer for remaining euploid embryos.
In addition, this (at the time PGS) hypothesis was, however, based on an even older hypothesis which to this day has remained a dogma in IVF practice: the so-called concept of embryo selection. The basis for this hypothesis—probably first formulated in the literature in the early 1980s by Jacques Cohen, PhD, at the time working in NYC—was the belief that in a complete cycle cohort of embryos, there must be embryos with significantly better and poorer pregnancy chances. The function of embryo selection, therefore, was to find the “best” embryo(s), once again with the purpose of improving pregnancy rates and time to pregnancy. After embryo morphology (the anatomy of embryos, how they look under the microscope), testing embryos for chromosomal abnormalities, therefore, basically became the second-most-utilized embryo selection method. Though both these hypotheses from the earliest days of IVF on, and to these days, by many colleagues still are considered dogmas, they both—as so often happens in medicine—proved to be mostly mistaken.
At the time, representative of a still very small first generation of IVF experts—like many other colleagues—I found myself severely disappointed when Belgian investigators in three small early clinical trials of what then was called PGS were unable to demonstrate outcome benefits from PGS. When my colleague at The Center for Human Reproduction (CHR) in NYC, David Barad MD, MS, and I were trying to find faults with the Belgian studies, recalculating their data statistically, we not only confirmed their conclusion that PGS did not improve IVF outcome; we, indeed, discovered in those data preliminary evidence that PGS may reduce pregnancy chances in older women in IVF cycles.
Alan DeCherney, MD
Though this experience already in 2007-2008 led us from being enthusiastic about PGS to becoming skeptics, it took many more years of research at our fertility center, in collaboration with colleagues at other institutions, and in following the work of colleagues in The Netherlands, to not only fully convince ourselves of the shortcomings of PGS, but also to try convince others through a long list of publications in peer-reviewed medical journals. Because everybody besides us and a handful of colleagues from all over the world, at that time was still absolutely convinced of the PGS-hypothesis, our first paper on the subject in 2007, recalculating data derived from above-noted Belgian studies, was outright rejected by every decent fertility journal and practically all good general medical journals. It indeed for over a year remained unpublished in a drawer until The New England Journal of Medicine published a prospectively randomized trial of PGS by Dutch colleagues which, indeed, demonstrated declining pregnancy rates in older women as a consequence of PGS (2). Only then did Alan DeCherney, MD (see figure), at the time editor-in-chief of Fertility and Sterility, recall and publish our paper (3).
Why skeptics of the rapidly expanding utilization of PGS/PGT-A initially failed to convince their colleagues
Ever since our first paper on the subject, our center and a very small group of colleagues from other countries fought what can only be described as a valiant battle against an overwhelming majority of colleagues in the IVF field, who increasingly presented themselves as “the experts” in the field and—as experts are supposed to do—quickly formed their own society: the Preimplantation Genetic Diagnosis International Society (PGDIS), which suddenly also considered itself qualified to issue professional guidelines regarding the utilization of PGS and later PGT-A. This society of alleged “experts” indeed became the official spokesperson for the field and—with it—the principal organization responsible for the misdirections of PGS/PGT-A practice.
But it was not alone because a core constituency of the society’s membership were representatives of the rapidly expanding PGS/PGT-A testing industry, which, of course, aggressively supported growing utilization of PGS/PGT-A by fertility clinics and—flush from rapidly increasing revenue—was able to exert influence on other important opinion leaders, including the medical publishing industry and even professional societies.
As is customary, medical publishing, of course, used those perceived as leading “experts” on PGS/PGT-A as peer reviewers of submitted manuscripts. With few exception, they, of course, were (or at least pretended to be) geneticists, professionally biased and economically often obviously conflicted in favor of the PGS-hypothesis, as several among them were owners or co-owners of some of the leading PGS/PGT-A laboratories. Unsurprisingly, the medical literature became favorably biased toward PGS/PGT-A and unfavorably biased against opponents of the procedure who found it increasingly difficult to get their papers published (and, yes, we were among the latter group).
Though still unable to prove outcome improvements from PGS, “experts” however, because of all of this help, had, nevertheless, absolutely no difficulties in explaining away critical studies. They, indeed, often even prevented them from being published. But fortunately, in science, the truth is difficult to suppress in the long run. But this is when the “expert” community (under the guidance of the PGDIS) for the second time misused its standing in the field by fabricating yet another false excuse for the failures of PGS/PGT-A. Once again, it was not the fault of the PGS/PGT-A hypothesis; the PGDIS, indeed, reaffirmed it in a formally published opinion in a medical journal (where the opinion did not even undergo peer review). Once again, the fault was mechanistic; the available technology to test embryos chromosomally was simply still not good enough to correctly diagnose aneuploidy in embryos.
In other words, instead of finally starting at least to consider the possibility that the basic hypothesis behind chromosomal testing of embryos may be flawed (hypotheses in medicine, of course, very frequently turn out to be flawed), the new “expert” claim (or should we call it “excuse”) why PGS/PGT-A to that point had remained unsuccessful—publicly declared in a guidance document by the PGDIS without even the slightest evidence—was that the available technology used was still insufficient.
And this is when the PGDIS declared the need for another round of major changes how PGS/PGT-A should be technically pursued, what we and others have come to call PGS/PGT-A 2.0: Not only the most frequently affected, but all 46 chromosomes should be tested and the only acceptable methodology to be used (at that time) was to be next generation sequencing (NGS). Instead of biopsying embryos on day-3 after fertilization (cleavage-stage) by removing 1-2 out of 6-8 blastomeres, embryo biopsy would be simply moved to blastocyst-stage (days 5-6 after fertilization) and trophectoderm biopsy should replace blastomere biopsy with the removing of on average 5-6 cells. The rational for the latter was, in principle, that this change would improve accuracy of testing because it would produce a larger amount of testable DNA.
As has happened repeatedly in recent years with the introduction of many add-ons to IVF, changes in in procedure may not show immediately, but may become visible downstream only later. For example, that many infertile women demonstrate diminished ability to grow embryos in vitro to blastocyst-stage (a very important point we will return to) was obviously not considered when embryo biopsy was moved from cleavage to blastocyst-stage but, of course, automatically will, in at least some patients, affect cycle outcomes. Failure to recognize this fact, unsurprisingly, has, therefore, become the reason of considerable false outcome reporting with PGS/PGT-A.
We at the time coined the term PGS 2.0 for this new approach to PGS, which the IVF field—short of a very small number of skeptics—welcomed with open arms, once again convinced by “experts” that this, indeed much more accurate form of embryo testing for aneuploidy, would finally result in promised outcome improvements in pregnancy and live birth rates in association with IVF. But all improvements in techniques and technologies will, of course, remain ineffective if the underlying biological hypothesis is false.
Why – paradoxically – opponents of PGS/PGT-A rather than proponents were called upon to prove their point
A widely accepted clinical, ethical, and practical rule in medicine has been since modern medicine evolved that the burden of proof lies with proponents of new treatments. Yet, when it came to PGS/PGT-A, this longstanding principle was put on its head: after also being unable to verify IVF outcome benefits for PGS/PGT-A with PGS 2.0, “experts” suddenly started arguing that it was upon skeptics to disprove the experts’ representations. In other words, the burden of proof was no longer on proponents of PGS/PGT-A, but on the skeptics, even though in the meantime significant such evidence had been published.
Our group in collaboration with colleagues from Rockefeller University’s physics department, for example, demonstrated beyond reasonable mathematical doubt that a 5-6-cell trophectoderm biopsy could never be representative of a blastocyst-stage human embryo. Even under biologically unrealistic best assumption of even distribution of aneuploid cells in mitotic aneuploidies, a valuable test would require a biopsy of over 25 cells, obviously a totally unrealistic expectation (4). But indisputable biological facts were apparently not enough and, indeed, were widely ignored.
In 2014, our fertility center, therefore, reached the conclusion that, with traditional scientific arguments failing to make an impact, only one “ultimate” study might have a chance of impressing the field: Building on the widely accepted fact that monosomic embryos practically never implanted (miscarriages never demonstrated monosomic aneuploidies), our center, in collaboration with two other NYC-based fertility centers, under an experimental protocol offered infertile women who had undergone PGS but had no embryos reported to be euploid, the opportunity to transfer “aneuploid” embryos with reported monosomies (PGS laboratories at that point still reported embryos only binary as either “euploid” or “aneuploid”). The hypothesis of the study was that, should these embryos produce chromosomal-normal euploid pregnancies, this would represent the ultimate proof that embryo biopsies in PGS produced significant false-positive results.
In October of 2015, I presented at the annual ASRM Conference, in that year in Baltimore, on the last day in front of a packed house the first four chromosomal-normal embryos following transfers of embryos which—as of that point—every IVF clinic in the world would have discarded as untransferrable (5). Several weeks later, Italian colleagues reported six normal pregnancies following such transfers in a research letter in The New England Journal of Medicine (6). But—almost shockingly—not much changed; the utilization of PGS by IVF clinics continued at even accelerate pace!
A new name for the procedure and further confusion by introduction of a third potential embryo biopsy diagnosis: “Mosaicism.”
But, considering this news—and especially since our report within a few weeks was confirmed by Italian colleagues—absolutely no response was not an option for our “expert” colleagues and the solution was, once again, not a reevaluation of the underlying PGS-hypothesis but the claim that, once again, the testing procedure had been incorrect. Again publicized in an alleged guidance document, the PGDIS “experts” conclusion was that the “abnormal” embryos transferred that resulted in euploid pregnancies could not really have been “aneuploid,” but must have been “mosaic.” The seemingly logical conclusion, therefore, was that the mechanics of the procedure must again be “improved” by starting to report embryo biopsy results no longer binary as euploid and aneuploid but trinary as “euploid,” “mosaic,” and “aneuploid.” And in order to reemphasize the importance of this change and the expectancy that this change will, indeed, finally fully validate the procedure, the process also was renamed from PGS to PGT-A. We gave it the acronym PGS 3.0.
How problematic all of these decisions were from the beginning is best reflected in the biological ignorance about preimplantation-stage embryology these two changes demonstrated: The “experts” in this case represented by another guideline document of the (PGDIS – defined “mosaicism” as evidence of a second (or more aneuploid) cell lineage in the 5-6-cell trophectoderm biopsy, a categorically incorrect biological definition of mosaicism. The correct diagnosis of mosaicism is, of course, presence of a second (or more) aneuploid cell lineage in a complete organism (arising from a single cell), in this case the complete blastocyst-stage embryo. And the difference between these two definitions is, of course, substantial and the mix-up is inexcusable.
This error is not only inexcusable on biological grounds because it is so obvious, as previously noted mathematical model established beyond reasonable doubt that 5-6, but also because more than one cell lineage in such a biopsy can do only one thing, defining the embryo with certainty as mosaic and with equal certainty as neither euploid or aneuploid.
The same, however, cannot be said about the resulting diagnoses of “euploidy” and “aneuploidy” because here the “experts” picked definitions out of hot air: “Euploidy” was originally defined as <20% aneuploid DNA in the biopsy (by correct definition any aneuploid, strictly speaking, even a single aneuploid cell, renders an embryo mosaic) and is by now defined by various PGT-A laboratories as <40% and, by some, even as less than 50% aneuploid DNA. In other words, a significant portion of currently as “euploid” reported embryos in reality are mosaic embryos. And similarly, “aneuploidy” without any data in support, was arbitrarily defined as >80% aneuploid DNA, again suggesting that at least a minority of such cases may in reality also be mosaic embryos.
While it initially was unclear how the PGDIS concluded that mosaicism should be defined by 20-80% of a second (or more) cell lineage, Santiago Munné, PhD, probably the historically most important “expert” on PGS/PGT-A in the world, currently according to the PGDIS website the Scientific Director of the Center of Reproductive Medicine of the Maastricht University Medical Center in The Netherlands, in a paper in Reproductive Biomedicine Online offered a rather astonishing explanation. It went something like this: Since a trophectoderm biopsy on average involves 5 cells, “mosaicism” (under the unique definition of PGS/PGT-A “experts”) would have to mean that between 2-4 of these 5 cells had to be aneuploid. In other words, between 20% to 80% of aneuploid DNA, therefore, would reflect a “mosaic” biopsy. Why a biopsy between, for example, 0.1% and 19% would still be considered a “euploid” result, was basically left unexplained; but the 80% to 100% range was explained as, simply, meaning all 5 cells of the biopsy were aneuploid.
Santiago Munné, PhD
That this was the explanation for the “guidance” released by the PGDIS in 2016 on how – going forward – PGT-A results should be reported to IVF clinics is, of course, almost unbelievable in its biological naiveté. What, however, can only be described as definitely inexcusable is that the IVF field accepted these definitions, obviously once again trusting in the expertise of the “experts” in the field.
That this enormous mislabeling of large embryo numbers after PGT-A has had – and to this day still has -highly significant clinical consequences is undeniable (more on that below). The degree of misdirection induced by the 2016 PGDIS “guidance” document is, however, best demonstrated by the fact, by now, most “experts” acknowledge that (at least some) mosaic embryos can be safely transferred, indeed producing similar pregnancy and live birth rates as PGT-A untested embryos. Indeed, even the ASRM acknowledged this fact (7).
The introduction of mosaicism as a diagnosis for embryos for all of these reasons, therefore, to significant degrees only further confused patients and the IVF provider community. Many IVF clinics, therefore, requested that genetic testing laboratories go back to binary “euploid” and “aneuploid” reporting. That many – if not most – truly mosaic embryos still have excellent pregnancy and live birth rates and can be safely transferred, however, raises serious clinical as well as ethical questions about such binary reporting because it, very obviously, leads to non-use and/or disposal of many embryos with potential pregnancy and live birth chances.
And where we end up today
Summarizing the current status of PGT-A in the U.S. is, unfortunately, not a very satisfying experience. The very obvious main reason for this judgment is the fact that the utilization of PGT-A in IVF cycles is still continuing to grow, with increasing numbers of IVF clinics practically mandating the procedure to their IVF patients. It remains to be seen whether the very recent ASRM and SART Practice Committees’ opinion which finally (better late than never), formally concluded that PGT-A in general populations offers no outcome benefits whatsoever (7), will have an impact. In the absence of changes in how “the business of infertility” has evolved over the last two decades, we frankly doubt it. IVF clinics owned by private equity, for example, have become the highest utilizers of PGT-A in the U.S. (Patrizio P. et al.; personal communication and unpublished data). They now also are responsible for more than half of all U.S. IVF cycles.
Considering the huge number of human embryos with pregnancy potential which over the last 20 years of PGS and PGT-A utilization have not been used and/or mistakenly discarded one cannot but conclude that PGS/PGT-A must be viewed as one of the most damaging (and maybe the most damaging) fertility treatments ever introduced into practice. Its continuing utilization under current practice criteria, therefore, must be viewed with considerable concern.
And adverse consequences go significantly beyond only missed chances of conception. They also involve large numbers of often still young women who, after several PGT-A cycles which produced only “aneuploid,” non-transferrable embryos were told that their only chances of motherhood were through third-party egg donation or adoption. This was, indeed, a central theme in a prior class action suit regarding PGT-A in Australia. As ABC News recently reported, it settled for – in comparison to the U.S. lawsuits - a paltry $56 million (8). The case involved Monash IVF, one of the largest IVF provider chains in Australia and other countries (mostly in Asia) and was based on only 700 claimants (the number of potential claimants in the U.S. class action suits would, of course be dramatically bigger).
The ABC report quoted one of the lead plaintiffs, Michelle Pedersen and her husband Damien Pedersen, who donated their embryos to research after Monash informed them after PGT-A testing that they were “unviable.” As a consequence, they decided to adopt and only later learned that how their embryos had been assessed by PGT-A “could have been an error.”
In one sense, Monash (which as part of the settlement acknowledged culpability) acted even more irresponsible than most other IVF clinics using PGT-A because the clinic utilized so-called non-invasive PGT-A (niPGT-A) which does not rely on an embryo biopsy but extracts an embryo’s DNA from the culture medium in which the embryo was cultured. This very new technology, in most so-far published studies, however, turned out to be even more inaccurate than traditional PGT-A. Monash, indeed, admitted that this new test gave identical results to the standard biopsy test in only 75-85% of cases.
The use of niPGT-A outside of an openly declared clinical trial with appropriate informed consent is, therefore, not only legally inappropriate but ethically shameful. Yet several U.S. clinics also already offer it in replacement of the standard PGT-A test, a point apparently not even yet addressed in the recently filed class action suits in the U.S..1
What happened in the past is, unfortunately irreversible and – rightly – will enter into the otherwise highly successful history of IVF as a major black eye. The IVF field, however, now has the responsibility to at least minimize future damages. In practical terms this means that our professional organizations must, finally, speak out. It is not enough to recognize that unrestricted PGT-A in IVF was a failure. It must also be stated that the routine practice of PGT-A must be limited, and this must happen now!
It is not acceptable that the field of IVF continues to promote a procedure that offers no outcome benefits, while causing significant harm to so many infertility patients. The field also must learn from this experience and stop the promotion of several other recent add-ons to IVF, which, like PGT-A, have entered routine IVF practice with no evidence of utility. And, finally, we also must acknowledge the power of financial incentives in promulgating useless, and often harmful, procedures in infertility practice.
It is difficult to predict how the recently filed class action lawsuits will fare in the U.S. legal system. As we know, such lawsuits can take many years to resolution by either settlement or judgment. This author and several colleagues from other fertility clinics have in their publications repeatedly warned that, unless the infertility profession self-regulates and intervenes in the unrestricted practice of PGS/PGT-A, either government or the courts will step in.
For very obvious reasons, we in this case wished we had not been so correct in our assessment of PGS/PGT-A since approximately the year 2007. We, however, would like to take this occasion to issue one more warning: Be warned of many of these so-called PGD/PGT-A “experts!”
You will be seeing them resurfacing as a consequence of these recently filed class action lawsuits in return for fat expert-witness honoraria. And in many cases you will be surprised to see on which side of the case they will appear, it will not be in defense of PGS/PGT-A!
How do we know? Because this has been the tactic of PGS/PGT-A “experts” all along: As here described before, all prior shake-ups of PGS/PGT-A (from PGS 1.0, over PGS 2.0, to PGS 3.0) were not voluntary, but occurred – uniformly based on work of skeptics – after prior representations of “experts” were no longer sustainable. Instead of acknowledging their prior mistakes, the “experts” always represented and concomitantly misrepresented themselves to the public as innovators of the next PGS/PGT-A they developed because they had recognized that the old PGS/PGT-A was not working as had been misrepresented to the public.
In full analogy, one, therefore, now can expect to see the resurfacing of some of these prominent PGS/PGT-A “experts” who for over 20 years have represented the foundation of PGS/PGT-A utilization in the U.S. and around the world, though not for the defense but the plaintiffs in those class-action suits. Those “experts,” after all, really have always pointed out the shortcomings of PGS/PGT-A. Didn’t you hear them?
References
1. News release. Accesswire, October 16, 2024. https://www.accesswire.co/929424/constable-law-justice-law-collabor...es-for-misleading-consumers-about-pgt-a-testing-during-ivf-treatment
2. Mastenbroek et al., N Engl J Med 2007; 357(1):9-17
3. Gleicher et al., Fertil Steril 2008; 89(4):780-788
4. Gleicher et al., Reprod Biol Endocrinol 2017;15(10:33
5. Gleicher et al., Fertil Steril 2015;104(suppl 3):e9
6. Greco et al., N Engl J Med 2015;373:2089-2090
7. Practice Committees of ASRM and SART. Fertil Steril 2024;122(3):421434
8. ABC News. August 22, 2024. https://www.abc.net.au/news/2024-08-23/monash-ivf-reproductive-industry-class-action-lawsuit/104259240