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FDA finds unreliable, potentially harmful medical tests are widely used


According to a recent FDA report, many patients may be at risk for missed diagnoses, false positives and other errors from inaccurate medical tests.

As many people in Kansas City know, the medical diagnostic process can be highly complex, and errors in diagnosis are not uncommon. Many patients assume that diagnostic tests represent one of the few objective and invariably accurate tools that are available to healthcare providers during this difficult process. Unfortunately, though, a new report from the Food and Drug Administration reveals that many commonly used medical tests may be unreliable.

Poorly Regulated Tests

The Kansas City Star explains that the FDA carefully reviews and regulates most commercial medical tests. However, if a test is produced and analyzed in the same laboratory, it is not subjected to the same strict oversight. As a result, these tests, which might be utilized by healthcare providers throughout the country, may not always meet reasonable standards of accuracy.

The FDA recently published a report that describes 20 case studies of these unreliable diagnostic tests. The report found that many of these tests rely on questionable assumptions or simply haven’t been proven effective. However, the tests are still frequently used, and the results may even be presented to patients as conclusive.

Grave Outcomes

Sadly, patients may suffer various harmful ramifications when they are inaccurately diagnosed based on questionable medical tests. These potential outcomes include:

  • Going without appropriate treatment due to failure to diagnose or misdiagnosis
  • Undergoing unnecessary medical interventions, such as surgery, when a medical condition is incorrectly diagnosed
  • Experiencing needless emotional distress due to a false positive result

The FDA cites several examples of these outcomes in its report. One test for heart disease may have led to thousands of patients needlessly taking statins or going without these cholesterol-lowering drugs. Another test for ovarian cancer may have caused women to unnecessarily consent to ovary removal surgery. In all of these cases, patients may have faced harmful complications, further mistakes during medical treatment, unnecessary expenses and significant emotional suffering.

Liability for Misdiagnoses

Medical professionals who make diagnostic errors based largely on questionable tests may be partly liable for the subsequent harm that patients suffer. For example, if a doctor ignores clear evidence that points to a different diagnosis, the error might be considered malpractice. Similarly, the knowing use of a questionable medical test as the basis for a diagnosis might be considered a professional lapse.

In Missouri, victims of medical malpractice may be able to recover various forms of compensation if they can prove a healthcare provider was negligent. However, they must make legal claims within two years of the date of the error. Injury victims also must provide an affidavit of merit stating that a qualified medical professional has assessed the claim and found it valid. For help handling these tasks and other parts of the claim process, victims may benefit from seeking the assistance of an attorney.