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Food and Drug Administration: Misclassified patient deaths

People suffering from chronic conditions may be excited to learn of a new product that offers relief. After hearing that the medical device has been approved by the U.S. Food and Drug Administration, they may feel confident that the product is safe. However, each year consumers in Ohio hear reports of FDA approved medical products that have caused deaths. Even more disturbing is that sometimes thousands of people become victims of these defective devices before changes are made.

One reason for the delay in removing products from the market may be the way product manufacturers report patient deaths associated with their devices. While each incident must be reported to the FDA, the administration allows manufacturers to determine if the death is related to the use of their product. Additionally, manufacturers may report a patient’s death as a “malfunction” or an “injury.” These classifications reduce the severity of the incident and may delay the time when the report is reviewed by the FDA.

A former FDA employee has compiled data about safety reports submitted by medical product manufacturers. His research shows that, for the past four years, over 4,000 patient deaths have been misclassified. One investigation showed that only 10 percent of reports labeled “malfunction” are read by FDA analysts. The practice of misclassification may leave consumers uninformed and ill-prepared to make vital decisions about their health.

When products go through rigorous Food and Drug Administration approval, they are protected by federal law from some litigation. However, this does not apply if the product manufacturer has violated the conditions of the product’s approval. People in Ohio who have suffered needlessly because of defective medical devices often speak with a lawyer who is familiar with pharmaceutical litigation. Many people have received fair compensation for their pain and loss despite the limits placed on product liability suits.

Source: CNBC, “Health companies label thousands of patient deaths as ‘injuries’“, Chris Glorioso, Jennifer Schlesinger & Evan Stulberger, Aug. 19, 2016

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