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The Food and Drug Administration (FDA) has planned an internal meeting today to discuss the strategic direction of the agency’s medical device center, adding fuel to concerns that the government agency carelessly approved medical devices and as a result put patients’ health and safety at risk, according to the American Association for Justice (AAJ).
Ron Albrecht lives in fear – fear that one day he will learn that the defibrillator implanted in his chest is defective and will cause him excruciating pain when it fails, like his previous one did two years ago. That device turned out to be among the defective heart defibrillators that were recalled by the device’s manufacturer, Medtronic. Albrecht’s device had to be replaced, and while his new one appears to be operating fine, he still worries.
People with Medtronic cardiac defibrillators implanted in their chests converged on Washington, D.C., this week to lobby for the passage of the Medical Device Safety Act. The act will allow consumers who have been hurt by defective medical devices to sue the device’s maker even if the devices have been approved by the Food and Drug Administration (FDA).
A group of FDA scientists recently sent a six-page letter to Barack Obama’s transition team venting consternation over their agency’s corruption and mismanagement. It’s not the first time FDA scientists have sought the help of Washington, pleading for a shakeup, but the number of complaints and the overall tone of the latest letter indicate agency insiders are eager to grab some of the new President’s much promised change.
