Some patients in Oregon and throughout the United States may at some point have been subject to faulty diagnostic tests. This is a issue that may be more common than many people realize.
One problem is that many tests are unregulated by the Food and Drug Administration. Tests used by multiple labs must be regulated by the FDA, but tests that are manufactured by only one lab are not. In the past, only a handful of tests fell into this category, and they were simple tests that were either unlikely to be inaccurate or unlikely to be harmful to a patient if they were wrong. However, now more than 3,000 tests are of this “waived test” variety, and they test for conditions that include heart disease, fetal abnormalities and ovarian cancer.
Because they are waived tests, there is no obligation to report injuries or deaths as a result of the tests to the FDA. In October, the Milwaukee Journal Sentinel did a report on these waived tests and found that over 50 percent of the time the tests are conducted improperly or labs are not authorized to perform the tests. They also found that fewer than 1 percent of the labs were inspected. Patients may be making decisions about surgery and other procedures based on faulty results from these tests.
Patients may suffer delayed treatment, the wrong treatment or no treatment altogether due to these unregulated tests. It may significantly affect that patient’s prognosis. A patient who discovers that this has been the case may wish to speak to an attorney about filing a lawsuit against the laboratory and the manufacturers. Compensation may come from a civil lawsuit or an out-of-court settlement.