FDA Study Suggests Flawed Medical Tests Cause Countless Misdiagnoses

A new FDA analysis shows that many medical tests may use faulty assumptions or deliver inaccurate results, leading to incorrect diagnoses.

Diagnostic errors are a prevalent risk for patients in the U.S. In September 2015, the Institute of Medicine published a report indicating that about one in 20 people who receive outpatient care are diagnosed incorrectly each year, according to The Oregonian. Furthermore, according to the same report, literally every person is statistically likely to receive an inaccurate diagnosis at some point in his or her life.

The factors that contribute to these incorrect or missed diagnoses are often varied and complex. However, a set of recent case studies from the U.S. Food and Drug Administration suggests that flawed medical tests may contribute to many mistaken and potentially harmful diagnoses.

Questionable tests and results

The FDA identified and reviewed 20 laboratory-developed tests that may have caused thousands of people harm by providing inaccurate diagnostic results. These tests were vulnerable to various types of errors, according to the official report, including the following:

• False positives – certain tests used to detect Lyme disease and ovarian cancer weren’t proven reliable or were known to cause a high rate of false positive results. This could have led patients to undergo unnecessary treatments and potentially risky interventions, such as surgery.

• False negatives – the FDA found that multiple tests to identify certain cancers failed to detect the presence of those cancers due to sensitivity issues. This may have resulted in delayed treatment and worse prognoses for patients.

• Inaccuracy – one test to detect fetal abnormalities was found to produce a mix of false positives and negatives. This could have led parents to make important medical decisions based on false results.

Furthermore, some of the tests relied on assumptions that lacked scientific support. For example, the tests for fibromyalgia and heart disease that the FDA reviewed searched for biomarkers that have not been conclusively linked to either condition.

The FDA noted that greater oversight of tests developed and used in a single lab, which typically don’t receive strict review now, could help address this issue. More effective premarket test assessments, reporting of adverse events and transparency regarding the effectiveness of each test could also help lower the risk of missed diagnoses. Unfortunately, until such measures are undertaken, people in Oregon may face a significant risk of inaccurate diagnoses based on questionable lab tests.

Holding medical professionals accountable

Some diagnostic mistakes aren’t reasonably avoidable, given the limited information that may be available to medical professionals when a diagnosis is made. However, if a professional makes an inaccurate diagnosis based on a test with known flaws or another questionable method, the error might be considered a lapse in professional medical standards. In these cases, victims may be able to seek recourse through a medical malpractice lawsuit.

Unfortunately, given the complexity of the diagnostic process, showing that a misdiagnosis constitutes medical malpractice can be challenging. Consequently, Oregon residents who have been harmed due to these medical errors may benefit from consulting with an attorney. An attorney may be able to offer advice on assessing the cost of a misdiagnosis and navigating the legal claim process.