When is a death ... not a death? In thousands of cases, medical device manufacturers have been allowed to classify patient fatalities as less serious injuries, because the U.S. Food and Drug Administration allows companies to make their own determinations on causality.
One patient died a few hours after being implanted with a cardiac stent that was "damaged and stretched." The stent maker called it a "malfunction."
In another instance, a patient developed a fatal, septic infection after receiving a knee injection. The maker of the injection product labeled the death an "injury."
In another case, a patient died on the floor after falling out of a hospital safety bed. Hospital staff said the bed's alert system failed, but the bed manufacturer labeled the incident a "malfunction" instead of a "death."
Even though those patient fatalities happened in close proximity to medical device malfunctions and problems, Angela Stark, an FDA spokeswoman, said, "The reports were likely classified correctly."
How could a patient's death be correctly classified as an injury?
It is a question perplexing to family of Oklahoma's Shelly Wilhite.