Why a faulty genetic test is at heart of class action

When Monash IVF Group launched a new genetic test it unlocked hope for hundreds of Australians wanting a family — but after investing time, money and their dreams, they were left devastated. Now they want answers.

**This story was first published on August 2, 2024**

In its 2019 annual report Monash IVF Group boasted it had launched its Non Invasive Preimplantation Genetic Screening technology known as niPGT-A.

It would have been a big deal if the test lived up to the hype as the world’s first to safely and accurately screen for chromosomal abnormalities in precious IVF embryos without the need to biopsy.

But it didn’t and before it was suspended in 2020 about 1300 Australians had invested time, money and their dreams into the expensive “add-on”.

Add-ons are additional procedures or medications many IVF clinics offer on top of standard cycles at an extra fee. The suggestion is they may help improve the chances of a successful pregnancy.

“It was the first time I had done IVF,” Fiona Seath said. “When I was recommended this test I wanted to give myself the best chance.”

The marketing director said that’s how the test was sold to her and partner Matt Kirkham.

“I think the imperative was that the test is less likely to damage the embryo being non-invasive and, more likely to give a reliable result.

“And when you’ve already invested so much money, you’re like, OK, well, what’s an extra whatever?”

Seath is one of about 750 registered members in a multimillion-dollar class action filed at the Supreme Court of Victoria on their behalf by Margalit Injury Lawyers.

The defendants to the claim are Monash IVF Group Limited, Repromed and other related entities. The claim is against the corporate entity and not individual doctors.

A Monash IVF spokesman said it was aware of the allegations contained in the Third Further Amended Statement of Claim.

“Monash IVF filed a detailed defence on 27 October 2023. Monash IVF and the other defendants to the Group Proceeding will be taking the opportunity given by the court to provide some amendments to that defence.

“It is important to note that no claim is made in the Group Proceeding against any named individual. Our people are among the most highly qualified and experienced in their fields and as an organisation Monash IVF continues to strive to provide best-in-class reproductive care to assist our patients to build their families.

“Monash IVF otherwise considers it inappropriate to comment further given that the matter remains part of an active proceeding.”

At the heart of the case are allegations of a cover-up by the IVF giant over its faulty niPGT-A test and in its wake shattered and heartbroken people who say they felt “duped” and robbed of a baby of their own.

For medical law expert Janine McIlwraith, it also raises the question of deficiencies in the regulation of the billion-dollar IVF industry in Australia.

She is part of the Margalit team and has listened to hundreds of stories shared by vulnerable women and men affected by the test, which by Monash IVF Group’s own admission was “faulty”.

McIlwraith says while there are mandatory reporting requirements for medical practitioners and health professionals through the Australian Health Practitioner Regulation Agency, there doesn’t seem to be a similar scheme for laboratory scientists.

In an amended Statement of Claim lodged in the Supreme Court in August 2023, it is alleged that a Monash IVF Group scientist burnt documents fearing possible criminal consequences arising from her conduct during the research underpinning the breakthrough IVF test.

The Herald Sun reported the Statement of Claim also alleges staff removed and destroyed data the day after a senior doctor died to avoid potential criminal charges relating to its faulty embryo genetic screening program.

There were also suspicions alleged over patient signatures on consent forms used in the clinical trial and that these signatures attributed to different patients appeared to be written in the same hand.

The Statement of Claim, amended from an earlier filing, also alleged scientists used patients’ embryos for scientific purposes when patients had instructed them to discard those embryos.

Monash IVF Group told patients and shareholders that niPGT-A could accurately screen for chromosome abnormalities by taking samples from a liquid culture around the embryo rather than the standard biopsy where a few cells are removed from the embryo’s outer shell.

The new test held the promise of a holy grail in fertility treatment: one that posed little risk to an embryo but could determine if it was healthy or what is known as aneuploidy, which can cause early miscarriages and failed IVF cycles due to implantation failure and chromosomal birth defects.

The test was offered to its patients from May 2019 but suspended in October 2020 when the IVF giant said a review had identified a “fault” with the test.

At the time of suspension of niPGT-A, patients were told in a letter that there was a “marginally higher abnormality rate” in the test results.

According to the Statement of Claim, Monash IVF did an internal review of the data used to support the introduction of the testing.

This internal review found the test had a 35 per cent false positive rate. A false positive is where a normal embryo is incorrectly deemed to be abnormal. The Statement of Claim goes on to say that Monash IVF Group in their approval application to the National Association of Testing Authorities (NATA) had represented the false positive rate as approximately 2 per cent.

The Statement of Claim also alleges that Monash IVF Group opted not to disclose such a false positive rate on the basis that to do so, in the words of their chief marketing officer, would be “suicidal”.

Margalit Injury Lawyers managing principal Michel Margalit says the allegations are shocking.

It wasn’t until June 2021 that some patients who had pinned their hopes on science would also learn that the embryos they were told were aneuploidy may not only have been healthy, but were still frozen in the defendants’ clinics across the country.

By then many patients had already undergone new rounds of IVF, offered to them by Monash IVF Group at no out-of-pocket cost to replace the embryos tested by niPGT-A.

The action alleges that Monash IVF Group did not tell the patients at the time that some of their embryos may have been viable before they were offered these additional cycles. Potentially, the further treatment wasn’t needed at all.

For some patients their niPGT-A tested embryos had been destroyed and it is alleged they will never know whether those embryos were in fact normal and could have resulted in a child.

It wasn’t until she met partner Matt Kirkham that Seath says she was ready to bring her own child into the world.

“It was the first time in my life that it felt right,” she says. “It felt like this is it and I think I’ve surprised myself by how maternal I’ve become.”

Then in her early 40s, Seath was also realistic.

“At my age, we were not going to mess about,” she said. “We met late and made the call early in our relationship because of my age and his, to be fair.”

Seath’s GP referred her to a fertility specialist at Monash IVF Group and their journey started out with promise.

On their first IVF cycle the couple created four embryos. One was used in a fresh transfer and three were set aside to be tested and frozen for future use.

She says her IVF specialist told them there were two ways of testing the embryos and recommended the new niPGT-A test as being better for the embryo.

“It was more expensive than the previous way of testing, but the way it was sold (to us) was it was a superior way of testing.”

The couple was delighted to learn they were pregnant from that first transfer and everything looked rosy for a brief, glorious moment.

“Then I had a miscarriage,” Seath said.

After grieving their loss, in 2021 they prepared to try a frozen embryo transfer.

Seath’s remaining three embryos were tested using niPGT-A and they were devastated to be told all had come back as aneuploidy.

She would learn much later that two embryos were in fact viable for a potential pregnancy and could have given her a chance at motherhood.

“We were told we would be refunded any out-of-pocket expenses until those three embryos were replaced (with new embryos),” Seath said.

She clearly remembers asking for the three embryos to be retested first with the original method, just to be sure.

“We were just told no as all three had come back aneuploidy and I guess you take that on face value and you accept that because the scientists are the experts.”

When abnormalities were identified using the test before it was suspended, patients were given the choice of keeping the embryos, donating them to science or destroying them.

Seath says she assumed her embryos had been destroyed.

“IVF is a complicated process, it’s an emotional process. It’s a physically enduring process. I don’t remember signing a form to say they’re destroyed. I don’t remember having a conversation about what actually would happen to them.”

Following the news their embryos were aneuploidy the couple steeled themselves for another few rounds of IVF using Seath’s eggs, which sadly were unsuccessful, and then they did two rounds using donor eggs. These also failed to deliver a longed-for pregnancy.

“Our first run at using donor eggs was our last hurrah,” Seath said “This was going to be it. No more.”

But when the donor eggs failed to fertilise, they were offered another set of donor eggs at no cost.

“So we had our last hurrah twice,” Seath said.

This also failed to produce an embryo and Seath says she received a cold and clinical call from the laboratory.

“It was devoid of any understanding that she had just told me I am never going to be a mother,” she said.

“We were devastated. You think you have hit rock bottom, and then somebody moves the bottom.”

Out of the blue in 2023 she said they received a call from Monash IVF Group.

“The caller was very cheery and said ‘we’ve got three of your embryos here, we just want to know if you want to retest them’.”

Seath said she couldn’t believe her ears. Shell-shocked that the three frozen embryos she had created in her first IVF round had not been destroyed and could be retested using the traditional biopsy method came with mixed emotions.

While it gave her hope, she was now 46.

The retesting confirmed that two of the embryos were viable.

“We had to try,” she said. “These could be our children sitting in a little test tube somewhere and I can’t not go through with it. So we did and we got pregnant and that pregnancy failed.”

Both embryos were transferred and while blood tests confirmed an early pregnancy, scans could not find a baby. It was an ectopic pregnancy of unknown location which had to be ended as it was life threatening for Seath.

“My issue is I know now they started retesting these embryos long before I got a phone call,” Seath said.

“I believe it was around the time I did my first donor round. I feel if I’d been given the opportunity to transfer those eggs when I’d only been through one round of IVF, when I was mentally healthier, I was physically healthier and I was younger, the odds must’ve been better for that child to have made it.”

The Herald Sun was the first to reveal in October 2020 that the publicly listed Monash IVF Group may have destroyed healthy embryos as a result of niPGT-A.

Margalit remembers reading that story as she was breastfeeding her then one-year-old son.

With partner Luke O’Grady she now has two sons, Jonathan and Harry, both born as a result of their long and hard battle with IVF.

That night her phone started pinging with messages from family and friends urging her to do “something” to help those impacted.

“This case is personal, not only because it’s my hope, it’s my aim that we better IVF services into the future, but it’s also personal because my own IVF journey was so fresh,” she said.

“And to back them has not just meant showing up every day and fighting the case for them, but backing this case has also meant personally backing this case financially. It’s certainly been a family affair and we’ve come together to ensure that the case is properly funded.”

She describes the action as a standout case in her career.

“What is consistent is people are left with this nagging question of ‘what if’ and that will never be answered,” Margalit says.

“Whether it’s a matter of wondering what if I could have had my own genetically-related child for those who turned to donor treatment. For others, it’s what if I could have actually had a child full stop, and that nagging question of should I have given up my pursuit of a child?”

Margalit says IVF, in many circumstances, has moved away from a patient-centred care model.

“What we’re seeing is that so many people who are desperate to have a family and will do anything that it takes will simply do what they’re told by these corporations.

“It also, in a reductive sense, raises questions of how we, as women, are treated in this world.”

When the pioneers of IVF in Australia opened the doors to Monash IVF more than 50 years ago the motivation was to help infertile people fulfil their dreams of a baby.

Desire was driven by demand triggered by two events: the availability in Australia of the contraceptive pill and the introduction of the Supporting Mother’s Benefit legislation in 1973 by the Whitlam government that gave women the means to raise a child solo.

It resulted in fewer babies for adoption which forced infertile couples to look to science for a solution.

Back then IVF was not big business. It was frustrating and hard work that struggled for funding and battled with governments and church to prove it was morally, ethically and legally the solution for infertile couples.

Then it would take years to achieve that first pregnancy – which Monash IVF did in 1973 – and a further five years for the first successful live birth – the UK’s Louise Brown thanks to the work of Dr Patrick Steptoe and Sir Robert Edwards.

Edwards would be awarded the Nobel prize for Medicine in 2010 for his role in the development of IVF.

Despite the frustrations, once science got it right, IVF delivered a baby boom and today the technique of fertilising an egg with sperm in-vitro or “outside” is responsible for one in 18 births in Australia.

McIlwraith says two things stand out for her about this case.

“You have people who’ve lost their chance forever to have a family because these embryos have been taken away.

“Then there are those who made other decisions based on the fact that those embryos were said to be abnormal, so people who used donor gametes and have even got children conceived from donor embryos when their own embryos might have been able to be used.”

McIlwraith, who worked as a medical professional for a decade before moving to law, said the group who used donor embryos and had a child were impacted beyond just having that child.

“If you want to add to your family, what do you do? Do you use your own genetic embryos or do you try and have a child with the same genetics as your first child?

“And then even for people who actually managed to go on and have a baby with IVF, there’s still an ongoing impact of whether it’s from the additional cycles they’ve had to have, whether it’s that they had to have a bunch of investigations that probably weren’t needed because their original embryos were OK, or if it’s things more like a complete loss of trust in the health care system or components of that system and how they work.”

She has spoken with hundreds of people impacted and said many had a real anxiety about making decisions and trusting their gut instinct. “Because they felt that they were doing the right thing in this instance for something so important to them.”

McIlwraith said they told her it was because something so important to them had been taken away.

“It was because the decision they made to have the testing and based on the information that was given, obviously, and then to find out that they shouldn’t have had the testing essentially has really destroyed their own self-confidence.”

For almost four years personal injury specialist Margalit and her team has spoken daily with those impacted.

“It’s certainly been an exhausting process, but one that is so worthwhile,” she says.

“Everybody’s story should be heard.”

The class action alleging problems with the genetic test is set to go to trial in Victoria in October.

IVF AT A GLANCE

• The Fertility Society of Australia says one in six Australian couples face fertility issues

• Market analysis by IBISWorld says nationally the fertility clinics industry is projected to climb to $856m over the next five years

• Its says much of this will be driven by older women, new technologies and more frozen embryo use

• Victoria, New South Wales and Queensland have the highest number of IVF clinics