Ethicon, Inc. v. Food and Drug Administration
United States District Court for the District of Columbia
762 F. Supp. 382 (1991)
- Written by Mary Phelan D'Isa, JD
Facts
Ethicon, Inc. (plaintiff), a manufacturer of generic absorbable surgical sutures, challenged the Food and Drug Administration’s (FDA) (defendant) decision to reclassify a generic class of poly sutures from Class III to Class II. The FDA made its decision to reclassify the sutures after four years of study and after the unanimous recommendation of an independent panel of eminent physicians and researchers. After the FDA denied Ethicon’s challenge, Ethicon sought judicial review and a judgment declaring the reclassification decision null and void. Ethicon argued that the FDA failed to meet the statutory requirements in the Food, Drug, and Cosmetic Act (FDCA) for the reclassification of medical devices because there was not sufficient information on the manufacturing variables for each independently manufactured suture included in the group that may affect the safety and effectiveness of any suture. The FDA argued that the sufficient information required for evaluating a generic device requires there be valid scientific evidence in the record that correlates the control of performance parameters to the safe and effective use of the device.
Rule of Law
Issue
Holding and Reasoning (Green, J.)
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