IVF Embryo Lawsuit Alleges Ovation Fertility PGT-A Testing Error Caused Loss

Lawsuit claims testing company overstated the accuracy and benefits of its genetic screening.

A Virginia woman has filed a lawsuit alleging an error during preimplantation genetic testing disrupted her IVF treatment, forcing her remaining embryos to undergo additional procedures that exposed them to unnecessary risks.

The complaint (PDF) was brought by a woman identified as Jane Doe in the U.S. District Court for the Middle District of North Carolina on September 10. It names FPG Labs LLC, doing business as Ovation Fertility, as well as several entities associated with the Atrium Health Wake Forest Baptist Center for Fertility and Reproductive Surgery.

Doe alleges Ovation Fertility made misleading claims about the accuracy and benefits of preimplantation genetic testing for aneuploidy, or PGT-A, then mishandled biopsy samples taken from three of her embryos.

According to the lawsuit, the samples could not be used, requiring the embryos to be thawed and biopsied again so new samples could be collected. One of the three embryos allegedly did not survive the additional procedure.

PGT-A Testing Concerns

IVF is a common fertility treatment that involves fertilizing eggs outside the body and transferring selected embryos into the uterus in an effort to achieve pregnancy.

PGT-A is an optional screening test that may be performed during IVF to identify potential chromosomal abnormalities in embryos. After an embryo reaches the blastocyst stage, a small number of cells are removed and analyzed, with the findings used to help guide decisions about which embryos should be considered for transfer.

Prior PGT-A genetic testing lawsuits have challenged claims about the accuracy and benefits of the screening, alleging companies promote the tests as nearly 100% accurate and suggest they can increase implantation and IVF success rates, lower miscarriage risks and shorten the time needed to become pregnant.

However, plaintiffs argue those representations exaggerate the reliability and clinical benefits of PGT-A while downplaying its limitations, which may lead patients to reject potentially viable embryos and suffer significant financial and emotional losses.

PGT-A Testing Error Allegations

According to the complaint, Doe first sought fertility treatment in 2017 due to diminished ovarian reserve, with the clinic ultimately freezing 14 eggs for future use. She returned in June 2023 for IVF, resulting in three embryos that underwent biopsies for PGT-A testing by Ovation.

Doe alleges Ovation promoted its testing as highly accurate and capable of improving pregnancy outcomes. However, after the three biopsies were analyzed using Ovation’s LifeView platform in September 2023, all returned no result due to an amplification failure.

The lawsuit indicates an Ovation representative later attributed the failed testing to human error and recommended that Doe’s embryos be thawed and biopsied again using a different testing platform. Doe claims she was told the procedure would not harm the embryos, but neither Ovation nor the IVF clinic adequately warned her about the risks of another thawing and biopsy cycle.

Doe followed their recommendations, but one embryo did not survive the thaw. The two remaining embryos were rebiopsied and tested using Ovation’s NextGen platform, with one classified as low-level mosaic and the other as abnormal. Based on recommendations from Ovation and the IVF clinic, neither was transferred.

Ovation allegedly failed to disclose before Doe’s initial testing that another available platform carried a lower risk of the type of amplification failure she experienced. In addition, she challenges representations that PGT-A was more than 98% accurate and could improve pregnancy and IVF success rates while reducing miscarriage risks.

The lawsuit claims Ovation failed to adequately train and supervise employees or implement sufficient safeguards against testing errors, with a fluid-transfer error identified as a potential cause of the failed amplification. Doe also alleges the IVF clinic failed to adequately disclose the risks of rebiopsy or obtain informed consent.

Doe says the testing error and subsequent procedures cost her months of fertility treatment, caused additional expenses and prevented the transfer of embryos that may have been suitable, resulting in emotional distress and lost reproductive opportunities.

“Neither Ovation nor the IVF Clinic adequately informed Plaintiff that subjecting her previously biopsied and cryopreserved embryos to an additional warming and biopsy cycle carried incremental risks, including the risk of damage to or loss of an embryo and potential adverse effects on IVF outcomes.”

— Jane Doe v. FPG Labs LLC et al.

The complaint raises allegations of negligent misrepresentation, negligence, professional negligence, negligent hiring and supervision of employees, breach of contract, breach of fiduciary duty, fraudulent misrepresentation and concealment, negligent infliction of emotional distress, unjust enrichment and violation of North Carolina’s Unfair Deceptive Trade Practices Act. It seeks compensatory, statutory, restitution and punitive damages.

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