Natera IVF Genetic Testing Class Action Lawsuit Claims PGT-A Results Were Misleading

Lawsuit claims Natera falsely marketed its PGT-A genetic testing as 99% accurate, causing prospective parents to discard potentially viable embryos while incurring substantial financial and emotional costs.

A new class action lawsuit alleges Natera deceptively marketed its preimplantation genetic testing for aneuploidy (PGT-A) as an accurate and effective tool for improving in vitro fertilization (IVF) outcomes, despite scientific evidence showing the testing may not increase pregnancy or live birth rates.

The complaint (PDF) was filed on June 2 in the U.S. District Court for the Northern District of California by Melissa Klein of New York and Valerie Griffeth of Illinois, who seek to represent a nationwide class of consumers who paid for Natera’s Spectrum PGT-A testing. It names Natera Inc. as the sole defendant.

Klein and Griffeth allege patients spent thousands of dollars on the testing based on false claims that it was highly accurate and could reduce miscarriage risks, increase implantation rates and improve the chances of delivering a healthy baby.

PGT-A Testing Concerns

IVF is a common fertility treatment that involves fertilizing eggs in a laboratory before transferring selected embryos into the uterus.

PGT-A testing is offered as an add-on during many IVF treatments. After embryos reach the blastocyst stage, a small number of cells are removed and sent to a laboratory for genetic analysis. The results are then used to determine which embryos are considered suitable for transfer and which are labeled abnormal.

According to the lawsuit, Natera promoted its testing as being 99% accurate and capable of increasing implantation rates, reducing miscarriages, shortening the time to pregnancy and improving IVF success rates, particularly for women over age 35. However, Klein and Griffeth claim those representations were false and omitted key information about the limitations of the testing, which may have led prospective parents to discard viable embryos and suffer significant financial and emotional strain.

PGT-A Accuracy Allegations

The complaint alleges there is no reliable scientific evidence showing that PGT-A improves pregnancy outcomes when compared to IVF cycles that do not use the testing. Klein and Griffeth point to positions taken by major insurers, including United Healthcare and Aetna, which allegedly classify PGT-A as unproven, investigational or lacking sufficient evidence of effectiveness.

The lawsuit further claims PGT-A results can produce false positives and false negatives, leading patients to discard or decline transfer of embryos that may have resulted in healthy births. According to the complaint, inaccurate testing can influence critical treatment decisions, trigger additional egg retrieval procedures and result in the unnecessary loss of embryos.

Klein and Griffeth cite a number of published studies that allegedly found substantial discrepancies when embryos labeled abnormal were retested. In one study referenced in the complaint, researchers found that more than half of embryos initially classified as abnormal were later determined to be normal or potentially viable upon reevaluation. The lawsuit alleges these findings undermine claims that PGT-A can reliably determine embryo viability.

The complaint also alleges that despite growing scientific criticism, the use of PGT-A genetic testing increased from approximately 13% of IVF cycles in 2014 to about 40% by 2021, creating a market that generates hundreds of millions of dollars annually. Plaintiffs claim Natera continued promoting the testing despite knowing it lacked evidence supporting many of the benefits highlighted in its marketing materials.

“Plaintiff Klein relied upon Defendant’s false and misleading misrepresentations and omissions and paid approximately $2,850.00 plus additional costs for her PGT-A testing which she would not have purchased absent Defendant’s false and misleading misrepresentations and omissions.”

— Melissa Klein et al. v. Natera Inc.

The complaint raises allegations of violations of consumer protection laws in New York and Illinois, as well as fraud, fraudulent concealment and unjust enrichment. It seeks class action certification, monetary damages, restitution and other relief for consumers nationwide who paid for Natera’s PGT-A testing based on the company’s alleged misrepresentations.

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