Prenatal screening tests are an important optional tool to help would-be parents determine the health and risks to their baby. Parents approach these tests for a number of reasons—concern about their own family history, a desire to do the right thing, fear of the unknown, or gentle pressure from a well-meaning doctor.
Indeed, prenatal tests can do much to provide parents with choices and knowledge. Some parents will use the information in the tests to determine whether a pregnancy should be lawfully terminated. A child with serious medical conditions like holoprosencephaly, (a brain that does not properly divide), cystic fibrosis (serious lung problems) or trisomy-13 may face a shortened life expectancy and a lifetime of serious medical problems.
For others, knowledge of the baby’s medical status will allow the parents and doctors to better plan for and prepare for the baby’s arrival. Regardless of the parents’ intent or the choices made afterward, a diagnosis of any serious genetic condition is certainly devastating.
Screening, Not Diagnosis
Most parents, and surprisingly, many doctors, do not understand the limits of several common screening tests which are performed by simple blood test. Though the risk of missing dangerous medical conditions appears to be at least anecdotally significant, even more concerning is the number of false positives. The sales and marketing of these tests does little to reveal that they should not be relied on to diagnose an unborn child’s medical condition. The marketing does not reveal that there are significant risks of “false positives,” that is, a finding that a child has a genetic condition when, in fact, the child has no such problem.
One article reported by the Boston Globe, Oversold prenatal tests spur some to choose abortions, reports that several tests like the MaterniT21 PLUS, have hit the market at a record pace in the past few years since human genome sequencing was accomplished. However, these tests have serious problems.
First, they are currently unregulated by the FDA. That means that, unlike pharmaceuticals and medical devices, the companies selling these tests have relatively few restrictions on their claims. They do not need to be independently tested, and their claims may amount to mere puffery. There are proposed regulations pending, but nothing has been finalized, yet.
Second, these tests are sold to doctors through salespeople. Doctors often get a very biased and one-sided view of what the tests can accomplish. Even though doctors are trained in science, they may not realize (and salespeople may not tell them) of the risk of false positives.
The most important thing to remember? Many of these tests merely help parents to narrow down the relative risks to their child of certain medical conditions. If the blood test reveals a positive finding, the parent should not act rashly by terminating the pregnancy, but should then move to a more accurate level of testing, likely amniocentesis. Many women won’t have an amniocentesis early on because it is invasive or because of the risk of miscarriage, but in the face of a possible genetic defect, the risk might be worth it to some. The accuracy of amniocentesis is about 99.4%.
If your prenatal testing wrongfully identified a genetic defect, or erroneously revealed that your child was healthy, contact our medical malpractice attorneys at (440) 252-4399 or online. We can help you to understand your legal options in your state.