United States v. Loran Medical Systems, Inc.

25 F. Supp. 2d 1082 (1997)

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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.)

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