A federal class-action lawsuit filed on February 17, 2022 in the United States District Court Northern District of California against Natera, Inc. alleges that Natera “markets and sells NIPT tests [noninvasive prenatal testing] for pregnant women that screen for various chromosomal and genetic conditions affecting a baby’s health. Natera markets its NIPT tests as the most reliable non-invasive method of screening for genetic conditions. Although NIPT testing is generally effective at screening for Down syndrome, an investigation by the New York Times has revealed that positive test results for some rare genetic conditions are incorrect 85 percent of the time or more—up to 98 percent.”
“During a pregnancy, prenatal testing is used to determine whether chromosomal disorders are present in the fetus. These disorders include Down syndrome, as well as other serious conditions that can result in intellectual disability, a shortened lifespan, and other serious complications. Expectant mothers and their doctors rely on the results of prenatal testing to make potentially life-altering decisions, such as whether to continue with the pregnancy. In the past decade, advances in noninvasive prenatal testing or NIPT have allowed companies to offer tests that can detect developmental deficiencies earlier in the pregnancy by testing a sample of the expectant mother’s blood.”
“A false positive on a prenatal test can have severe consequences for expecting parents. Besides unnecessarily enduring anxiety, stress, and anguish about the health of their child, pregnant women are subjected to invasive and expensive further diagnostic testing and the additional expense of genetic counseling and consulting with doctors specializing in high-risk pregnancies. In addition, because NIPT testing is generally performed relatively early in the pregnancy, diagnostic testing is not immediately available to confirm the test results. In some states, diagnostic testing may not become available until after the period when a pregnancy may be legally terminated, meaning some expectant parents must rely entirely on the results of the NIPT testing to make an extremely difficult decision on whether to proceed with the pregnancy. And even if it is available, follow-up testing is highly invasive and carries the risk of causing a miscarriage. According to the New York Times investigation, some expectant mothers have even terminated a viable pregnancy based on a false positive from NIPT testing.”
“Some of Natera’s Panorama tests for the rarest conditions have a positive predictive value as low as 2-5%, meaning positive test results will be wrong as much as 98% of the time. Despite these low accuracy rates—and the significant impact the test may have on a parent’s decision whether to continue with a pregnancy—Natera advertises Panorama as reliable overall, with much emphasis on the accuracy rates of the tests for more common conditions like Down Syndrome that Panorama can reasonably detect.”
“Natera has known for years that its NIPT tests are susceptible to false positives, yet it continues to promote its NIPT test as a reliable detector of rare abnormalities. It also claims that its NIPT test produces fewer false positives than competing tests without revealing the extent to which pregnant women and their doctors may be induced to make health decisions based on inaccurate test results.”
“Natera processes more than 400,000 NIPT tests each year, meaning that it tests about one in ten pregnant women in the United States. Each patient is led to believe that they will receive accurate results. 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 a false positive indications of rare disorders.”
Davis v. Natera, Inc., Case 3:22-cv-00985.
If you or a loved one have suffered serious harm as a result of defective prenatal testing or defective genetic testing in the United States, you should promptly find a medical malpractice attorney in your state who may investigate your defective medical test claim for you and represent you or your loved one in a defective medical test case, if appropriate.
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