FDA Proposes Changes for Error Prone Medical Tests

By Blume Forte Fried Zerres & Molinari on August 5, 2014

An individual has a better chance at fighting a serious disease, such as cancer, if they receive a diagnosis and proper treatment early on in the disease process. For many, receiving an accurate and timely diagnosis is the key to survival. To improve efficacy of testing for diseases such as cancer, bacterial infections, and heart disease, the Food and Drug Administration (FDA) has proposed a new regulatory plan. The FDA plans to oversee the timing and frequency of various types of tests performed, and what types of treatments should be performed based on the results of those tests.

According to a report in The Wall Street Journal, the FDA is aware that faulty lab-developed tests have led to unneeded antibiotic use and incorrect treatment or therapy for cancer patients and those suffering from heart disease. The Journal article also points to recent scrutiny regarding the way tests are conducted for autism, Lyme disease, and whooping cough. The FDA does not plan on regulating low-risk tests, but high-risk diagnostic tests will have to be approved by the FDA once this proposal goes through.

According to recent statistics reported by the National Center for Policy Analysis, between 10 to 20 percent of cases are misdiagnosed, and about 28 percent of diagnostic mistakes are life threatening. The majority of diagnostic errors are preventable.

Misdiagnosis or delayed diagnosis amounts to medical negligence or medical malpractice. If errors were made during diagnosis or treatment, affected victims and their families may be able to seek financial compensation. Damages which may be pursued include compensation for lost earnings, pain and suffering, and expenses related to medical, surgical and other treatment for complications or worsened prognosis arising from the malpractice.

If you or a loved one is a victim of cancer or any other type of misdiagnosis, the experienced New Jersey medical malpractice lawyers at Blume Forte can help you. We are available to discuss your potential claim at no cost. Please call (973) 635-5400.

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