Class action lawsuits against genetic testing companies over PGT-A
Former IVF patients in the USA have filed class action lawsuits against several companies for misleading them about the efficacy of PGT-A.
Class action lawsuits have been filed against CooperGenomics, CooperSurgical, The Cooper Companies, Reproductive Genetic Innovations, Progenesis, and Natera by former patients to recuperate funds spent on preimplantation genetic testing for aneuploidy (PGT-A). The lawsuits allege that these companies engaged in consumer fraud and breach of warranty by selling PGT-A to IVF patients, without disclaiming that this test is unproven, experimental, and entails risks of both misdiagnosis and embryo damage during the biopsy. The plaintiffs and class action members claim they would not have purchased testing if given accurate information about its efficacy.
“Our clients have been forced to make consequential decisions based on PGT-A testing that was falsely marketed as having unproven benefits... we seek justice on their behalf.”
PGT-A is conducted to analyse the chromosomal makeup of embryos. The aim is to improve chances of a live birth by avoiding transfer of embryos containing aneuploid cells. However, there is limited evidence that PGT-A improves IVF outcomes, and testing may unnecessarily reduce the number of embryos available for transfer (see BioNews 1097 and 1123). In the USA, this 'add-on' testing can cost thousands of dollars per IVF cycle, and is not usually covered by insurance.
The lawsuits allege that the companies 'misled patients with false and deceptive marketing and advertising' regarding the efficacy of PGT-A testing for financial gain. They argue that the companies made several unsubstantiated claims, including claims that PGT-A is 99 percent accurate and that testing increases IVF success rates, decreases chances of miscarriage and improves pregnancy rates (including for older women). Former patients are seeking to recover the out-of-pocket costs they spent on PGT-A, along with associated damages.
Allison Freeman, managing partner of Constable Law and IVF attorney, states: 'We have filed these class action lawsuits to seek accountability in an industry that seems to be increasingly guided by financial gain.' She added that IVF patients 'should not be taken advantage of with misleading and deceptive assurances when they are at their most vulnerable state and are entitled to damages under consumer fraud statutes'.
Use of PGT has increased in the USA, from 13 percent of IVF cycles involving PGT in 2014 to more than a third of IVF cycles involving PGT in 2021 (see BioNews 1124). The question of how to regulate IVF add-ons including PGT-A has been a vexed issue elsewhere, including in the UK and Canada (see BioNews 1237). In the UK, the Human Fertilisation and Embryology Authority (HFEA) introduced a traffic-light rating system for IVF add-ons to help inform patients (see BioNews 1212 and 1226). PGT-A currently has a range of ratings under this system, depending on the context.
Source: BioNews/PGT