Death due to defective product often mislabeled in FDA report

Manufacturers of medical devices are required to send reports to the U.S. Food and Drug Administration if patients’ deaths are related to the use of the devices. The FDA leaves it up to the manufacturer to decide if a death was connected to the product. However, recent investigations show that sometimes a manufacturer will misclassify a death to lower the priority of the report. When this happens, patients in Texas may not have enough information to protect themselves from a defective product.

A patient died few hours after receiving a damaged cardiac stent implant. The stent manufacturer reported the death as a malfunction. Another patient died of a septic infection which developed after the patient received a knee injection. The company that made the injection product labeled the death as an injury. By reporting deaths as “malfunctions” or “injuries,” the makers of potentially defective devices lower the priority of the report in the FDA’s review system.

Reports labeled as “deaths” receive top priority, and incidents with other classifications may take the FDA months to read. In fact, one investigation showed that only 10 percent of reports classified as malfunctions are ever reviewed by the FDA. Some suspect that manufacturers misclassify deaths related to their products because negative attention may result in financial loss. Data reveals that in the past four years, over 4,000 patient deaths were reported with lower priority classifications.

Patients in Texas and across the country have the right to know if medical devices are safe to use. Some people who lose loved ones due to a defective product contact an attorney to discuss filing a claim against the manufacturer. In addition to seeking compensation for their loss, many desire to use their claim to make the public aware of a potentially dangerous device.

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