The Monash IVF Class Action is a significant and complex legal case that has attracted attention, particularly for Kelly Ross-Howard, a member of the Keystone Team, due to its implications for clinical trials and industry regulation. The case revolves around claims for compensation for financial loss and psychiatric injury stemming from the use of a specific service by Monash IVF Pty Ltd, Adelaide Fertility Centre Pty Ltd (trading as Repromed), Monash IVF Group Limited, and its subsidiaries and related companies. The service at the centre of the controversy involved the use of cell-free non-invasive pre-implantation genetic testing (niPGT-A) of embryos, performed between May 2019 until its suspension in October 2020.
Details on the Class Action
The plaintiffs allege that instead of only utilizing the more established biopsy testing to identify embryos with an abnormal number of chromosomes (aneuploidy), the defendants also offered niPGT-A testing. This newer method was allegedly associated with an increased risk of false-positive results at a rate that was not disclosed to patients. Consequently, it was alleged that some viable embryos may have been wrongly classified as abnormal and discarded or withheld from transfer, causing emotional distress and financial harm to the affected individuals.
The claim alleges that niPGT-A testing should not have been provided by the defendants as the sole means of determining an embryo’s ploidy status because there was a risk, not disclosed to patients, that the niPGT-A testing might produce false positive results and therefore an erroneous determination that an embryo was aneuploidy and not suitable for transfer. In or about October 2020, affected patients received notification from the defendants that the niPGT-A testing of embryos by or on behalf of the defendants has been suspended. The claim alleges that the group members suffered financial loss and psychiatric injury as a result of the niPGT-A testing. These accusations raise critical questions about regulatory oversight and ethical practices in the fertility industry.
Legal Proceedings and Industry Impact
Monash IVF has maintained its non-admission of any liability as part of a proposed $56 million settlement, which still requires approval from the Supreme Court. The class action involves around 700 individuals and is likely to draw further scrutiny from reproductive technology providers. However, there is debate over whether this case will have a long-term impact on the IVF industry as a whole.
Expert Insights
Debbie Kaminskas, a Partner at Collins Biggers & Paisley with expertise in insurance litigation and who jointly led the defence of the Monash IVF class action, provided a general explanation of the pleading documents filed with the Supreme Court of Victoria. Her explanation offers a valuable learning opportunity to understand the complexities of the case.
What’s Next?
With the pending approval of the settlement, the case continues to unfold. Reproductive technology providers may come under increased scrutiny, but the long-term effects on the IVF industry remain uncertain. The Keystone Team is ready to assist with any insurance questions or contractual queries related to life science risks that may arise from this case.
For any questions or concerns regarding Life Science risks, please get in touch with us. We’re here to support you.