In my previous post on this subject, I wrote of how new products in prenatal testing have caused several false testing reports, causing many expectant couples to elect abortions, out of fear that the fetus would be born with severe birth defects.
The tests, which can be conducted as early as nine weeks of pregnancy, detect placental DNA in the mother’s blood and test it for chromosomal abnormalities, as well as gender. The tests were originally designed for older women and women at high risk of pregnancy difficulties, but many of these tests are now marketed to all pregnant women. Industry analysts estimate that between 450,000 to 800,000 of these tests have been performed in the United States since 2011. Several companies are racing to corner what some analysts predict could be a $3.6 billion global industry by the year 2019.
Many of these test screens have indicated that fetuses might carry serious genetic defects, when that wasn’t the case. Legally, this falls under the area of law known as Product Liability or Defective Products – specifically, defective medical Products. As a Boston defective medical products attorney, I’ve seen a lot of defective medical products that never should have been brought to market, but still were. The victims of cases of medical product liability are not numbers and statistics. They’re real people, just like you and me. Exhibit “A” in this particular story is Stacie Chapman. She took one of these prenatal screening tests, and was later told by her doctor that her fetus had tested positive for a disease called Edwards Syndrome, which is a gravely serious genetic abnormality. Chapman was told that if she carried her baby to term, his life would be extremely short (as in weeks.) Relying on marketing & advertising claims from the product’s sales reps, her doctor informed her that the test — MaterniT21 PLUS — boasted a 99 percent detection rate.
Tragically, what neither Chapman nor her doctor knew, was that there was a high chance that her prenatal test result was wrong. The reality is that there is a crucial difference between a prenatal test that can detect a potential problem, and a test that is accurate enough to confirm that a life-threatening birth defect exists, for certain. In fact, recent studies show that prenatal test results can sound a false alarm as much as 50% of the time. Prenatal testing companies don’t communicate clearly to both patients and doctors that the results of their tests are not accurate enough to make a certain diagnosis. Result: A high number of women have terminating their pregnancies based on the results of these prenatal screening tests, alone.
Dr. Michael Greene, director of obstetrics at Massachusetts General Hospital and a professor at Harvard Medical School, has commented, “The companies have done a very poor job of education [and] advertising this new technology, failing to make clear that it is screening testing with very good but inevitably not perfect test performance . . . and that doctors are recommending, offering, ordering a test they do not fully understand.” Industry groups and companies such as Natera’s claim that companies don’t oversell the tests, but the data so far indicate otherwise.
How does something like this happen on this large a scale? Largely, two reasons: 1) Prenatal screening tests are not subject to testing and approval by the Food and Drug Administration (FDA.) Due to a regulatory loophole, these companies operate free of FDA oversight and the type of independent analysis that would could validate their accuracy claims. There’s a second reason that defective medical products like this can make it to market, endangering people’s lives. And that is: 2) Corporate greed; it never ends. Trust me; I’ve spent my professional life battling the harm that unbridled corporate greed can cause.
If you or someone you know has encountered a problem with prenatal screening tests make sure that you seek out the legal counsel of an attorney or law firm that specializes in defective medical products litigation. This type of litigation is very complex, and requires special legal expertise.