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.