FDA warns of risk of misdiagnosis from inaccurate medical tests

Questionable medical tests may lead to missed or false diagnoses, which can cause patients serious harm and may in some cases represent malpractice.

For most medical professionals in Newton, medical tests provide a valuable tool during the diagnostic process. Not surprisingly, many patients take the accuracy of these tests for granted. Unfortunately, according to a new report from the U.S. Food and Drug Administration, many widely used medical tests have been shown to yield inaccurate results or rely on assumptions that haven't been scientifically validated. These tests may expose patients to missed, delayed or false diagnoses, along with unnecessary and harmful health outcomes.

Reliability of tests questioned

The Boston Globe states that the recent FDA report included 20 case studies that highlighted the issues associated with some modern medical tests. In many of the case studies, flaws in the reviewed tests caused serious harm to patients, as in the following three examples:

  • Women who took a certain blood test to diagnose treatable cancer of the ovaries may have received false positive diagnoses. This test was never established as an accurate means of identifying ovarian cancer, yet in some cases it provided grounds for invasive procedures, including surgery to remove the ovaries.
  • Over 150,000 patients were given tests that used the presence of a specific genetic abnormality as an indicator of heart disease. Problematically, a link between this abnormality and heart disease has never conclusively been proven. Many patients may have received inadequate or unnecessary treatment as a result.
  • Pregnant women who took other medical tests may have had abortions based on flawed results. These tests, which were designed to detect fetal abnormalities, may have indicated abnormalities when none were actually present.

Unreliable medical tests such as these can put patients at risk for missed or incorrect diagnoses, along with false positives. The former can result in delays of necessary treatment, while the latter can cause patients to undergo inappropriate and potentially risky procedures.

Inadequate regulation of these tests may be a significant factor in this problem. The FDA closely reviews the accuracy of diagnostic test kits that are marketed and sold to multiple laboratories. However, the FDA typically does not exercise the same level of oversight if a kit is produced and utilized within one laboratory. Now, lawmakers are considering more closely regulating these kits, which could help reduce the risk of harmful outcomes for patients.

Misdiagnosis as malpractice

Medical tests are just one of many tools available to doctors as they attempt to make a diagnosis. If a doctor relies solely on a questionable test or ignores signs that point to another diagnosis, the misdiagnosis may be considered preventable. If another competent medical professional in the same field would not have made the same diagnostic error, the mistake might even be considered medical malpractice.

People who have suffered injuries due to medical malpractice may be able to seek compensation for their losses, but the process can be complex in Massachusetts. Under state law, victims must make their legal claims within three years of the date of the misdiagnosis. Furthermore, a tribunal consisting of a justice, properly qualified physician and attorney must evaluate the merits of a person's claim before it can proceed further.

Given these requirements and the challenges inherent to proving that a diagnostic error should not have occurred, people who have suffered harm from these errors may benefit from consulting with an attorney. An attorney may be able to assess the strength of a person's case and, if the person chooses to make a legal claim, provide additional guidance during this process.