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.”
Another patient developed a fatal, septic infection after receiving a knee injection. The maker of the injection product labeled the death an “injury.”
In a third 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.”
These are just three of the thousands of cases where 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.
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AUGUST 22, 2016 | NBC NEW YORK | CHRIS GLORIOSO, JENNIFER SCHLESINGER, & EVAN STULBERGER