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Case Detail


United States ex rel. Gilligan v. Medtronic, Inc.
On April 6, 2005, the US Court of Appeals for the Sixth Circuit threw out a lawsuit designed to second-guess a Food and Drug Administration (FDA) decision to authorize the sale of medical devices manufactured by Medtronic, Inc. The decision was a victory for WLF, which filed a brief urging dismissal. The suit alleged that the devices never should have been approved for sale and that Medtronic obtained approval only by providing false and fraudulent evidence to FDA. The suit was based on the False Claims Act (FCA), a federal law that permits individuals to file qui tam suits (i.e., suits in which the plaintiff is acting as a private attorney general on behalf of the US). WLF argued that Congress did not intend to permit private litigants to second-guess an FDA decision to approve the sale of a medical device. The court instead relied on a narrower ground: it held that the FCA claim was barred because the information upon which it was based was publicly known before suit was filed.
Case Status:
Victory. Supreme Court denied petition for review on January 9, 2006.
More Information and Downloads:
11/26/2003: Download the Brief

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