Natera agrees to a $8.5M settlement to end class action

Update: Natera agrees to a $8.5M settlement to end class action

• Natera Inc. has agreed to an $8.25 million settlement to resolve a proposed class action alleging the company failed to disclose its noninvasive prenatal tests (NIPTs) could produce false positives for rare genetic conditions.
• The plaintiffs claimed the misleading results caused unnecessary mental anguish for parents and led to unnecessary medical testing and expenses, while Natera denied the allegations and maintained its defense.
• Under the Natera false positive settlement, class members can receive up to $30 without proof of purchase or 10% of documented costs if they spent over $300 out of pocket.
• In addition to monetary relief, Natera will update its website with clearer disclaimers about the limitations of the tests, including the need for diagnostic confirmation.

Natera prenatal test class action lawsuit overview:

• Who: Plaintiff Amanda Davis has filed a class action lawsuit against Natera Inc.
• Why: The Natera noninvasive prenatal tests are allegedly unreliable and show healthy fetuses as having serious disorders.
• Where: The lawsuit was filed in California federal court.

(Feb. 23, 2022)

Natera Inc. is facing a class action lawsuit alleging its noninvasive prenatal tests, or NIPTs, are unreliable and falsely show healthy fetuses as having serious birth defects, according to a class action lawsuit filed Feb. 17 in California federal court.

Prenatal testing is often used to determine whether a fetus has a chromosomal disorder that may be linked to shortened lifespans, intellectual disabilities or other serious complications. Based on the results of these tests, expectant mothers may choose to make potentially life-altering decisions, including deciding whether to terminate the pregnancy.

Diagnostic testing such as amniocentesis is highly invasive, whereas NIPTs require only a blood sample and can be conducted much earlier during a pregnancy.

Plaintiff Amanda Davis alleges Natera has known for years that its NIPT tests are prone to false positives but continues to market the tests as a reliable detector of rare chromosomal abnormalities.

Specifically, Natera markets its Panorama NIPT as “overall the most accurate NIPT commercially available in the United States,” according to the class action lawsuit. Natera also allegedly touts that its NIPT test produces fewer false positives than other prenatal tests.

The Natera NIPT tests are generally effective at screening for Down syndrome, according to the lawsuit. However, a January 2022 investigation by the New York Times allegedly found that positive test results for some rare genetic conditions are incorrect more than 85% of the time. 

Natera false positives may lead parents to make life-altering decisions

False positives on prenatal tests can have significant consequences for expecting parents, the Natera class action lawsuit says. Not only do they cause stress and anxiety about the health of their baby, but the pregnant woman will also likely be subjected to invasive diagnostic testing, genetic counseling and consultations regarding high-risk pregnancies.

Because NIPT testing is often completed early in the pregnancy, diagnostic testing is not always available immediately to confirm the results. In some cases, diagnostic testing may not be an option until after the period in which a pregnancy may be legally terminated. In these situations, parents may be forced to rely exclusively on the results of the NIPT testing to decide whether or not to proceed with the pregnancy

Unfortunately, the New York Times reports that some women have terminated a viable pregnancy based on a false positive from NIPT testing.

According to the prenatal testing class action lawsuit, Natera tests approximately one in 10 pregnant women in the United States. 

“Each patient is led to believe that they will receive accurate results,” the class action lawsuit says. “Users of Natera’s NIPT test, however, have not received what they paid for given the numerous problems that have come to light and many–including Plaintiff–have been subjected to unnecessary stress and anxiety, and additional medical costs due to false positive indications of rare disorders.”

Davis filed the Natera class action lawsuit on behalf of herself and a proposed class of purchasers of Natera’s NIPT testing services.

What do you think about the claims that Natera prenatal tests are incorrect 85% of the time for some genetic conditions? Join the discussion in the comments below!

Davis is represented by Adam E. Polk, Trevor T. Tan and Nina R. Gliozzo of Girard Sharp LLP.

The Natera Prenatal Defect Test Class Action Lawsuit is Amanda Davis v. Natera Inc., Case No. 3:22-cv-00985-AGT, in the U.S. District Court for the Northern District of California.

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