A patient died after having a damaged cardiac stent implanted. However, the company that makes the stents labeled the incident a “malfunction.” Another patient received a knee injection and developed a fatal septic infection. The company that produced the knee injection called the death an “injury.” In another incident, a patient fell out of a hospital bed. When the bed’s sensor alert system failed and the patient died, the company that manufactures the bed called the incident a “malfunction” instead of a death.
These are just a few out of thousands of incidents where medical device manufacturers misclassify patient fatalities caused by defective medical devices as injuries. According to the Food and Drug Administration (FDA), these reports are classified correctly. This begs the question: How can a death be correctly classified as an injury or a malfunction?
The FDA is supposed to protect public health by determining whether drugs, food, cosmetics and medical devices are safe to use. That said, how these types of incidents are labeled is extremely important because it gives the FDA accurate information to help determine how safe those products are and whether they should be made available to the public.
By law, medical device manufacturers are required to report any incident that “reasonably suggests a device may have caused or contributed to a death or serious injury,” according to an FDA consultant. When deaths caused by defective products are reported as injuries or malfunctions, this delays a review of the product’s issue and could put patients in danger in the meantime.
The FDA is making improvements to how it tracks issues with medical devices by implementing new software. However, analysts receive approximately 10 percent of their reports from this software. In the meantime, defective products are slipping through the FDA’s fingers due to the mislabeling of patient deaths.
Koonz, McKenney, Johnson, DePaolis & Lightfoot, LLP is a personal injury law firm that helps injured workers in Washington, D.C., Virginia and Maryland. We help those injured due to defective products, including medical devices. Call us today to speak to one of our attorneys.