ARTICLE | Politics, Policy & Law
The secret suit
FDA reviewers sought financial reward from secret suit against device makers
July 23, 2012 7:00 AM UTC
While FDA reviewers were publicly working to persuade the agency to withdraw approval of computer-aided detection (CAD) mammography and CT colonoscopy devices, they also were secretly pursuing a lawsuit against the products' manufacturers. The suit included a request that a substantial share of any financial awards go directly to the plaintiffs.
On Dec. 14, 2009, the law firm Kohn, Kohn & Colapinto LLP filed a suit on behalf of current and former FDA reviewers in the U.S. District Court for the District of Colorado. The suit claimed 15 medical device manufacturers, including the GE Healthcare unit of General Electric Co. and Hologic Inc., had violated the False Claims Act...