Monash IVF class action ends with largest settlement of its kind
Monash IVF Group has agreed to pay $56m to settle the largest class action for negligence by an IVF provider in what’s been described as “a wake-up call” to the industry worldwide.
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Monash IVF Group has agreed to pay $56m to settle what is believed to be the largest class action for negligence by an IVF provider.
The multimillion-dollar payout is inclusive of costs and Monash IVF has made no admission of liability as part of the settlement, which is subject to Supreme Court approval.
There were more than 700 registered members in the multimillion-dollar class action filed at the Supreme Court of Victoria on their behalf by Margalit Injury Lawyers in December 2020.
The defendants to the claim were Monash IVF Group Limited, Repromed and other related entities and the claim was against the corporate entity and not individual doctors.
At the time lead plaintiffs Danielle Bopping and Michelle Pedersen said they felt “duped”, having believed they were getting gold standard medical treatment.
That treatment was an expensive “add-on” described as a non-invasive preimplantation genetic screening test known as niPGT-A.
Margalit Injury Lawyers managing principal Michel Margalit said no compensation would ever heal the harm suffered by women and men by the faulty niPGT-A test.
“However, it is significant recognition of tangible harm caused to patients who so desperately wanted to have a family,” Ms Margalit said.
“This ought to be a wake-up call for the IVF industry worldwide. Patients undergoing IVF treatment are undergoing serious medical procedures that cannot only harm their physical condition but their mindset and their mental health at a time when they are vulnerable.
“Sub-standard IVF care will not be tolerated and there will be real consequences where IVF providers do not put the interests of patients at the forefront of their framework.”
At the heart of the case were 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.
Monash IVF Group claimed it had developed the world’s first screening technology to test for chromosomal abnormalities in precious IVF embryos without the need to biopsy.
Launched in May 2019, niPGT-A held the promise of a holy grail in fertility treatment: little risk to an embryo but one that could determine if it was healthy or what is known as aneuploidy. This can cause early miscarriages and failed IVF cycles due to implantation failure and chromosomal birth defects.
Patients were told 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.
It was offered to its patients from May 2019 as an expensive “add-on” treatment but suspended in October 2020 when the IVF giant said a review had identified a “fault” with the test.
In August 2023 an amended Statement of Claim lodged in the Supreme Court 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. It claimed:
• 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;
• Suspicions existed over patient signatures on consent forms used in the clinical trial;
• Signatures attributed to different patients appeared to be written in the same hand; and
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.
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 went 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.
Ms Margalit said a class action sought aggravated and exemplary damages on top of damages for financial loss and psychiatric pain and suffering.
She said as a result of this testing some patients had their embryos classified as abnormal and unsuitable for transfer and feared they may have lost their chance to ever have biological children.
The class action claims the test had not been peer-reviewed and patients were lied to when they were told it was almost 95 per cent accurate.
Medical law expert Janine McIlwraith was 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”.
“It has been an absolute privilege to act on behalf of the lead plaintiffs and group members in this matter,” she told the Herald Sun on Thursday.
“The proposed settlement is recognition of the real harm suffered by the group members as a result of undertaking the testing Monash IVF marketed and provided.
“I hope today can mark the start of a new chapter for the group members and that knowing the Monash IVF Group have been held accountable will allow them to begin to heal and move forward with their lives in the best way possible.”
In a statement Monash IVF Group confirmed it had reached a settlement with the plaintiffs in the group proceedings over the now suspended non-invasive pre-implantation testing (NiPGT) of embryos. The settlement is subject to Court approval.
A spokesman said in reaching an agreement through mediation, Monash IVF Group has made no admission of liability.
“While we have defended the claim, we believe it is in the best interests of our patients and people to resolve the matter rather than go to trial.
“We acknowledge this case has been challenging for many people and we regret any distress or hurt that may have been experienced.
“Achieving the best possible outcomes for our patients has always been and continues to be our absolute focus and mission.
“We will be making no further comment while we await formal approval of the settlement by the Supreme Court of Victoria.”
Lead plaintiffs react
First lead plaintiff Danielle Bopping said in a statement:
“It was always our intention in pursuing this class action to seek justice for the women and families whose lives were irrevocably changed by the commercially driven practices of Monash IVF and to hold Monash IVF accountable for their actions.
“We also hope that this case helps to draw attention to the fact that IVF in Australia has become a multimillion-dollar industry, which does not always put the best interests of its
patients first.
“In particular, regarding the work that is performed by various technicians in the laboratories, which is not regulated. We hope that the outcome brings a sense of closure and healing to all the families impacted.”
Michelle Pedersen, the Second Lead Plaintiff stated:
“Whilst the settlement won’t change the outcomes or remove the heartbreak for those impacted, the settlement provides some acknowledgement of Monash IVF’s failures and brings some closure for those involved.
“We should be able to trust medical and science professionals. The inherent nature of IVF process means that patients are often at their most vulnerable. The lack of transparency in the actual accuracy rates of the niPGT-A testing meant that people were unable to make informed decisions about their fertility. there is need for additional regulation in the fertility industry.
“The impacts of Monash IVF’s actions have not been resolved through this settlement. Class members have had hopes, dreams and ambitions that have been shattered. Our goal was to hold Monash IVF to account and give the 700+ class members a sense of justice, we hope we have achieved this.”
The class action members come from the Victoria, New South Wales, ACT, Northern Territory, Tasmania, Queensland and South Australia.
‘Hope they have some regret’
A member of the class action, marketing director Fiona Seath, says she hopes those involved feel some remorse and regret.
“There’s a little bit of me who would have liked to have seen them have their day in court and have to publicly face up to what they did,” she said.
“But I am also an optimist so I’d like to think those involved do have some sort of regret and remorse over what happened.”
With partner Matt Kirkham, Ms Seath started her IVF journey with Monash IVF Group with hope.
On their first IVF cycle the couple created four embryos and had one transferred, which sadly ended in miscarriage, and three frozen for future use.
They were recommended the faulty niPGT-A test to test the three remaining embryos.
The couple was devastated to be told all had come back as aneuploidy, which can cause early miscarriages and failed IVF cycles due to implantation failure and chromosomal birth defects.
Ms Seath would learn much later that two of these embryos were in fact viable for a potential pregnancy and could have given her a chance at motherhood. But by then they had undergone further rounds of unsuccessful IVF, including donor egg cycles and she was older.
Ms Seath told the Herald Sun in an interview on 2 August that she received a call out of the blue to say the embryos created in her first IVF round had not been destroyed, as she had believed, and could be retested using the traditional biopsy method.
“It came with mixed emotions,” Ms Seath said, as she was now 46.
“We had to try. 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.
“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.”
Ms Seath said she would be forever grateful that the lead plaintiffs, Danielle Bopping and Michelle Pedersen, stepped up and said something needed to be done.
“So I’d like to thank them for doing it. It took bravery and courage and energy at a time when they were probably not feeling great.”
Originally published as Monash IVF class action ends with largest settlement of its kind
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