United States v. Loran Medical Systems, Inc.
United States District Court for the Central District of California
25 F. Supp. 2d 1082 (1997)
Facts
The United States District Court for the Central District of California granted a temporary restraining order for the Food and Drug Administration (FDA) (plaintiff) against Loran Medical Systems, Inc. and two others (Loran) (defendants) from importing neonatal rabbit and human cells that comprised their cell product that was used to treat human diabetes. After finding that the FDA had demonstrated a reasonable probability of success on the merits of its claim that it had regulatory authority over the cell product under the Public Service Act (PSA) and its drug regulations in the Federal Food, Drug, and Cosmetic Act (FDCA), the district court entered a preliminary injunction enjoining Loran from importing and using the cell product. The parties cross-moved for summary judgment. The FDA argued that it had regulatory authority over the cell product; Loran argued that its cell product falls outside the FDA’s regulatory authority.
Rule of Law
Issue
Holding and Reasoning (Wilson, J.)
What to do next…
Here's why 707,000 law students have relied on our case briefs:
- Written by law professors and practitioners, not other law students. 44,500 briefs, keyed to 983 casebooks. Top-notch customer support.
- The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
- Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
- Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.
