Kaiser Health Blows the Whistle on FDA and Medical Device Fraud

Last year (2018) Netflix produced a documentary about corruption in the medical device industry, which is a 300 BILLION dollar a year industry worldwide. Industry insiders boast that the medical device industry has more power than Big Pharma, and is more powerful than most governments around the world. Earlier this month (March, 2019), Kaiser Health News published an investigation into the FDA and their public database that tracks medical device failures. Their investigation found that the FDA maintains a hidden database that records malfunctions of medical devices that is not available to the public. Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up. Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences. Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski.