United States v. 25 cases, More or Less, of an Article of Device … “Sensor Pad for Breast Self-Examination”
United States Court of Appeals for the Seventh Circuit
942 F.2d 1179 (1991)
- Written by Alex Ruskell, JD
Facts
The United States (plaintiff) sued Sensor Pad (defendant) to seize 25 cases, more or less, of Sensor Pads, believing the Sensor Pads were adulterated devices under the Federal Food, Drug, and Cosmetic Act. Sensor Pad argued that Sensor Pads were not devices under the act because the pads were intended to be used to help women feel bumps in their breasts that might turn out to be cancerous. Sensor Pad argued that the act defined devices as instruments that diagnosed disease and that diagnosing a disease meant determining the nature of already diseased conditions. In Sensor Pad’s view, its pads were only used for screening and did not determine the nature of an already diseased breast. The district court granted the government’s motion for summary judgment, and Sensor Pad appealed.
Rule of Law
Issue
Holding and Reasoning (Cudahy, J.)
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