United States v. Laerdal Manufacturing Corp.
United States Court of Appeals for the Ninth Circuit
73 F.3d 852 (1995)
- Written by Alex Ruskell, JD
Facts
The government sued Laerdal Manufacturing Corp. (defendant) for a permanent injunction to stop it from failing to furnish information in accordance with Medical Device Reporting (MDR) regulations within the Food, Drug, and Cosmetic Act. The court granted the permanent injunction, finding that Laerdal had violated the MDR by not filing a report after a death was linked to one of Laerdal’s defibrillators. Laerdal appealed, arguing that there was no cognizable danger that Laerdal would violate the MDR in the future. Specifically, Laerdal argued that it was justified in not filing the report because the death was an isolated incident, the Food and Drug Administration suffered from a backlog of filing its reports, and Laerdal’s reputation and financial interests would be harmed if it filed a report based on that one incident.
Rule of Law
Issue
Holding and Reasoning (Nelson, J.)
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