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Potential Product Liability Concerns Dismissed by Fed Inspectors

Food and Drug Administration scientists who allege they were pressured by their managers to approve medical devices believed to deliver an overdose of radiation have had their harassment claim dismissed. Along with the dismissal of the scientists' claim against their managers are the concerns of possible product liability issues for new CT scanners.

Food and Drug Administration scientists have been at issue with CT scanners that use radiation to detect diseases and other medical devices that use radiation to treat diseases. The new medical devices have a higher risk of radiation exposure than older technology like X-ray machines. Over the last year, imaging devices including CT scanners have been attributed to hundreds of cases of radiation overdoses.

Since 2008, nine FDA scientists who conduct medical device reviews have tried to blow the whistle on the approval of the new medical devices. The scientists alleged in their suit that managers at the Food and Drug Administration wrongly overruled their decisions to not approve the devices. FDA managers also attempted to harass the scientists when they went public with their concerns. The recent suit addressed the alleged improper overrulings and harassment.

Believing there was not a potential product liability concern, the Food and Drug Administration concluded today that the CT scanners are safe when properly used and attribute the overdoses to improper use by imaging technicians. The FDA scientists who voiced concern and brought the claim say managers often overruled their decisions without providing proper documentation for the decision. Three scientists left the Food and Drug Administration explaining their contracts were terminated after they sent complaint letters to the FDA, Congress and outside groups.

Source: The Associated Press, "Feds Dismiss Misconduct Claims at FDA Device Unit," 11/9/10

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