A recent New York Times article has shown that up to 85% of the positive results on prenatal tests are false for some of the rarer chromosomal abnormalities, causing emotional and physical anguish for many expecting parents. There is a prenatal test lawsuit being filed; continue reading to see if you qualify.
The medical industry has used prenatal blood tests to provide parents with more information on their growing fetus. Chromosomal abnormality screenings and other methods of monitoring (e.g., ultrasounds) have been developed and used since the 1960s. Recently, there has been an upsurge of companies that are providing less invasive screenings that allow for both doctors and parents early access to genetic information. The only issue is that for every 15 times they correctly find a problem, they are wrong 85 times (false positives).
Originally used to detect Down syndrome early in pregnancy, blood draw tests are still reliable and accurate for detecting that condition. However, as companies have expanded their screenings to include rarer genetic issues that occur in 1 in 4,000 to 1 in 100,000 pregnancies, false positives are becoming more common. After receiving news of a positive result for these rarer genetic conditions, parents often receive little counseling or follow-up. To obtain conclusive results, many have to spend weeks or even months getting multiple blood draws or undergoing the invasive procedure of amniocentesis, which carries a risk to the fetus. About one in three pregnant women undergo these prenatal screenings each year, which totals around 2 million women. Many of those who receive false positives use the information to make decisions about whether to terminate the pregnancy or not.
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Prenatal Tests and their Manufacturers are not FDA-Regulated
Companies that produce genetic test screenings are not regulated by the FDA. This means there is no oversight into how the tests are made or how effective they are, nor is there verification of the data supporting their claims. Neither the government, genetic scientists, nor doctors review the accuracy of these manufacturers’ claims. These manufacturers advertise their findings as "reliable" and "highly accurate," offering "total confidence" and "peace of mind" for patients who want to know as much as possible.
However, as reported by the New York Times in a well-researched and illuminating article, these claims may be exaggerated. For some of the rarer chromosomal abnormalities, possibly 85% of the positive results are false. Some companies offer tests without publishing any data on how well they perform. When information is published, results are found to be selective, promoting the best screenings and leaving out weaker ones.
Do You Have a Claim?
If you or a loved one used a prenatal test after 2010 that resulted in a false positive or emotional and physical anguish, you may have a claim. If you received information from one of these extended tests that you relied on to either terminate or continue your pregnancy, get in contact with one of our attorneys. Find out today if you are eligible to be a part of the prenatal test lawsuit. If your result was inaccurate or unknown if accurate because the pregnancy was terminated, and you would like to file a claim against prenatal manufacturers, contact us today.