United States v. Lane Labs-USA, Inc.
- Case Date: 1/31/2005
- Project Name: Health Care Project
On October 21, 2005, the U.S. Court of Appeals for the Third Circuit declined an opportunity to prevent FDA from exercising enforcement powers that the evidence suggests were never delegated to it by Congress. The decision to uphold a massive restitution award against a dietary supplement manufacturer was a setback for WLF, which had filed a brief urging the court to overturn the award. WLF argued that FDA has no power to seek financial restitution from manufacturers alleged to have violated the federal drug laws. WLF argued that Congress has spelled out precisely what enforcement powers it has given to FDA, and that restitution is not among them. WLF noted that FDA, throughout most of its history, never asserted a right to seek restitution. The Third Circuit nonetheless upheld FDA's authority to seek restitution on the grounds that the Food, Drug, and Cosmetic Act's grant of authority to "restrain" violations of the Act should be read broadly to include all forms of equitable relief.
More Information and Downloads:
1/31/2005: Download the Brief
Litigation Update: Court Declines To Rein In FDA's Enforcement Powers
Press Release: Court Urged To Rein In FDA's Enforcement Powers