United States ex rel. Gilligan v. Medtronic, Inc.
- Case Date: 11/26/2003
- Project Name: Health Care Project
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.
|Victory. Supreme Court denied petition for review on January 9, 2006.|
More Information and Downloads:
11/26/2003: Download the Brief
Litigation Update: Court Bars Qui Tam Suit Alleging Fraud On The FDA
Press Release: Court Urged to Bar Qui Tam Suits Alleging Fraud on the FDA
Litigation Update: Court Agrees to Review Qui Tam Suit Alleging Fraud on the FDA
Press Release: Court Urged To Bar Qui Tam Suits Alleging Fraud On The FDA