Tuesday, June 6, 2023 | Back issues
Courthouse News Service Courthouse News Service

Class action over prenatal tests with false positives gets trimmed by court

The judge ruled that plaintiffs suing over allegedly unreliable prenatal tests have to do better in spelling out what misleading information they relied on.

(CN) — A putative class action lawsuit over prenatal tests that can produce a high percentage of false positives for rare genetic conditions was significantly trimmed by a federal judge who said the plaintiffs must be more precise if they want to base their claims on fraudulent conduct.

U.S. District Judge Jon Tigar in Oakland on Tuesday dismissed a number of claims brought against Natera Inc., the maker of Panorama tests that screen for an array of fetal chromosomal and genetic conditions. Specifically, the judge agreed with Natera that claims that "sound in fraud," in so far as they relied on Natera’s allegedly fraudulent omissions regarding Panorama’s accuracy and reliability as a prenatal screening product, need to be pleaded with more detail.

"To plead their partial misrepresentation claims with particularity, Plaintiffs must identify the allegedly misleading representations that each of them saw and relied upon in deciding to purchase Panorama," the Obama appointee said. "Plaintiffs have not done so."

Of the six plaintiffs who claimed they reviewed the brochure for Panorama before they bought it, none claimed to have relied on any of the allegedly misleading statements in the brochure in choosing to purchase Panorama, according to ruling.

The lawsuit against Natera, and a similar one against Myriad Genetics, followed a New York Times report last year that prenatal tests that screen for genetic disorders such as Down syndrome early in a pregnancy can produce a high percentage of false positives for exceedingly rare conditions. In the Natera lawsuit, the plaintiffs accused the company of violating numerous California, Florida, Illinois, Maryland, and New Jersey consumer protection laws.

The judge allowed the plaintiffs to revise their lawsuit to meet the legal requirements for their claims that are based on allegedly fraudulent conduct. At the same, he denied Natera's request to also dismiss the claims that are based on violations of warranty statutes.

As such, the judge rejected Natera's argument that the women who relied on the tests didn't sufficiently argue that Panorama wasn't merchantable, or fit to be sold.

"Plaintiffs plausibly allege that the basic function of a test which screens for a specified set of genetic conditions is to accurately detect the risk of such conditions, and that Panorama was unfit to do so," Tigar said. "The Court finds that Plaintiffs have adequately pleaded the product’s unmerchantability."

When ruling on a motion to dismiss, a judge looks at whether a lawsuit meets the basic requirements to proceed, assuming that everything the plaintiffs allege is true, and doesn't address the merits of their claims.

Lawyers for the plaintiffs and Natera did not immediately respond to requests for comment on the ruling.

Categories: Consumers Health National

Read the Top 8

Sign up for the Top 8, a roundup of the day's top stories delivered directly to your inbox Monday through Friday.