Ivy Sports Medicine, LLC v. Sebelius
United States District Court for the District of Columbia
2013 WL 1455271 (2013)
- Written by Alex Ruskell, JD
Facts
The Food and Drug Administration (FDA) found that a surgical mesh manufactured by Ivy Sports Medicine, LLC (plaintiff) was not substantially equivalent to already-approved surgical meshes. Consequently, the FDA did not approve Ivy’s mesh. In response, both New Jersey United States senators and two New Jersey United States congressmen wrote to the FDA. The FDA then met with Ivy without the FDA’s review team present, Ivy sent in a new application, and the FDA approved Ivy’s surgical mesh. Shortly before Ivy began distribution of its mesh, the mesh’s approval process became public and other United States senators contacted the FDA in protest. The FDA then told Ivy that the FDA planned on rescinding its approval, which would make Ivy’s mesh impossible to market in the United States. Ivy sued, arguing that the FDA could not rescind the approval of an already-approved drug. The FDA moved for summary judgment, claiming that the FDA could do so under the circumstances.
Rule of Law
Issue
Holding and Reasoning (Wilkins, J.)
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