FDA case studies reveal diagnostic risks of laboratory

A report from the FDA suggests that laboratory-developed diagnostic tests, which currently aren’t well-regulated, may put patients at risk for misdiagnosis.

The medical diagnostic process is incredibly complex, and as a result, errors aren't uncommon during this process. It is difficult to trace the number of these mistakes that occur in Chicago and other parts of Illinois each year, since many go uncaught for months or longer. Shockingly, though, U.S. News states that the Institute of Medicine has estimated that literally every patient in the U.S. will suffer a misdiagnosis at some point, some with devastating consequences.

Some cases of delayed or incorrect diagnosis may be virtually unavoidable. However, these errors frequently may arise based on flawed medical tests, faulty reasoning or simple oversight. A recent report from the U.S. Food and Drug Administration suggests that laboratory-developed diagnostic tests may contribute significantly to this problem.

Inaccurate, unvalidated tests

LDTs are tests that are produced and analyzed by the same laboratory, according to The Wall Street Journal. The FDA has generally chosen not to regulate these tests as closely as it does other diagnostic tests. As these tests have grown more complex and started reaching more patients, this lack of oversight has become a serious issue.

In its report, the FDA summarized 20 case studies of LDTs that produced inaccurate and potentially harmful results. The following tests were just a few of the alarming examples cited in the report:

  • An ovarian cancer detection test that checks for a genetic marker that hasn't been conclusively tied to ovarian cancer. This test may yield false positives and cause woman to undergo unnecessary ovary removal procedures.
  • Breast cancer and Human Papillomavirus tests that have poor sensitivity and the potential to produce false negatives. These tests may delay appropriate treatment and allow breast or cervical cancer to progress to dangerous stages.
  • A cardiovascular disease test that has never been scientifically proven to predict whether a patient will experience heart problems. This test may result in the over-treatment of some individuals with statins and the under-treatment of others.

The FDA concluded that these unvalidated or unreliable tests have caused harm to countless patients. Per The Wall Street Journal, the FDA is now seeking to increase its oversight of these tests. However, since opponents have argued that this could harm patients by impeding innovation, the outcome of this initiative remains to be seen.

Recourse for diagnostic mistakes

Legal remedies may be available to patients who suffer harm due to misdiagnoses that arise in part from flawed medical tests. However, patients must prove that the responsible physician departed from an acceptable medical standard of care. For example, if a physician diagnoses a patient based on a questionable LDT while disregarding signs that point to a different diagnosis, the error might represent medical negligence or malpractice.

Unfortunately, proving that a misdiagnosis represents medical malpractice can be challenging, since the diagnostic process is relatively subjective. To improve the likelihood of a favorable resolution, victims may benefit from seeking the assistance of an attorney who has experience in these difficult cases.