Case Overview: A class action lawsuit has been filed against Ovation Fertility, alleging that the company misled consumers about the accuracy and efficacy of preimplantation genetic testing for aneuploidy (PGT-A), leading them to spend thousands of dollars on a test that may be unproven and unreliable.
Consumers Affected: Hopeful parents who purchased PGT-A services from Ovation Fertility between 2020 and 2023.
Court: U.S. District Court for the District of Delaware
Ovation Fertility tricks consumers through unproven claims into getting preimplantation genetic testing for aneuploidy (PGT-A), a new lawsuit alleges.
Parents in the lawsuit allege that Ovation promoted the PGT-A test as a reliable way to boost the chances of a successful pregnancy by screening embryos for chromosomal abnormalities.
However, they argue that Ovation misrepresented the accuracy and efficacy of PGT-A, leading them and many others to pay thousands of dollars for a test they argue is unproven and unreliable, and at worst puts precious embryos at risk.
Rachel Klosowski, Adam Klosowski, Michelle Schafer, Laura Mendoza, Dori Shick, Soupharack Vannasing, Lauren Teverbaugh, Janine Carlin, and Jonathan Carlin filed the class action lawsuit against Ovation Fertility and a number of its associated companies accusing them of violating state trade and business practices, fraud, unjust enrichment, and more.
The hopeful parents all purchased PGT-A services from Ovation between 2020 and 2023, describing relying on the company’s claims that the test would improve their odds of a healthy pregnancy and reduce the risk of miscarriage.
According to the lawsuit, Ovation marketed the PGT-A test as more than 98% accurate and as an effective means of identifying embryos best suited for implantation. Based on these claims, the plaintiffs collectively spent thousands on PGT-A testing, which is often not covered by insurance.
One couple, Rachel and Adam Klosowski, spent roughly $7,500 on PGT-A testing, believing it would increase their likelihood of success in IVF, they say. Like the other plaintiffs, they argue they would not have paid for the test had they known about the limitations of PGT-A’s accuracy and reliability.
PGT-A, or preimplantation genetic testing for aneuploidy, is a test offered as an optional part of in vitro fertilization (IVF) that screens embryos for chromosomal abnormalities. Chromosome irregularities, known as aneuploidy, can affect an embryo’s viability and are often associated with a lower chance of a successful pregnancy.
Through PGT-A, IVF clinics send a small biopsy from each embryo to a laboratory for analysis, determining whether an embryo is “euploid” (normal) or “aneuploid” (abnormal). The goal is to identify embryos most likely to lead to a successful pregnancy.
Ovation has promoted PGT-A as a method to improve pregnancy outcomes, reduce the time to pregnancy, and avoid miscarriages. However, studies referenced in the lawsuit suggest that PGT-A may not offer these advantages, with findings indicating no significant difference in success rates between IVF cycles that use PGT-A and those that do not.
Health insurance companies such as United Healthcare and Aetna also consider PGT-A to be “experimental” or “unproven,” which often leaves the cost as an additional out-of-pocket expense for IVF patients.
The use of genetic testing in IVF has surged, driven by companies that offer prospective parents the opportunity to screen embryos. From 2014 to 2021, the use of PGT-A rose from 13% to about 40% of all IVF cycles, creating an industry valued at approximately $300 to $400 million annually, the lawsuit explains.
Despite this growth, critics caution that these tests may lack the scientific validation required to justify their costs and claims of effectiveness. Concerns also exist about potential ethical issues, as some tests could lead to the discarding of embryos based on incomplete or inaccurate information.
Experts in reproductive health have voiced concerns that companies may be overselling genetic tests like PGT-A without adequate evidence to support their effectiveness, warning that the marketing of such tests can exploit the emotional and financial investments IVF patients make in their fertility journey.
The legal action isn’t the first Ovation Fertility has faced. Several couples in California sued the company claiming that lab errors resulted in unusable embryos, leading to failed IVF attempts. The couples accuse Ovation of poisoning the embryos, with a lab employee wrongly using hydrogen peroxide instead of a sterile solution in an incubator, and still implanting them anyway.
Meanwhile, Aspire Houston Fertility Institute faces a similar class action lawsuit, with patients alleging the clinic knowingly implanted nonviable embryos.
The IVF industry is also seeing legal battles over issues beyond medical errors. In Alabama, a ruling by the state Supreme Court that recognizes frozen embryos as human beings has sparked concerns about legal responsibilities for IVF providers. Additionally, a male couple in New York recently sued the city’s health insurance plan, alleging discrimination in IVF coverage policies that currently only benefit women.
In the current lawsuit against Ovation, the plaintiffs want to represent hopeful parents from across the country, and are alleging violations of a range of state trade and business practices, breach of warranty, fraud, unjust enrichment, and more.
They are seeking damages, an order requiring Ovation to adequately provide notice of and disclose the true nature of PGT-A testing, disgorgement, fees, costs, expenses, and interest.
Case Details
Plaintiffs' Attorneys
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