It’s scary to consider what illegal activities a medical device might engage in, it’s perhaps even scarier to actually know. Synthes is a company that developed a bone cement called Norian XR, which turns to bone when injected in the human skeleton. The company was accused of conducting illegal human trials and off-labeling—promoting a product for unapproved uses. Five patients who had the cement injected in their spines—an unapproved use by the Food and Drug Administration—died on the operating table. Four top executives at Synthes each plead guilty to a misdemeanor under the Responsible Corporate Office Doctrine.
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