United States v. Loran Medical Systems, Inc.

AMENDED ORDER GRANTING PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT

TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:

I. Background

On June 20, 1996, this court granted a temporary restraining order enjoining Defendants Loran Medical Systems, Inc., Bent Formby and Ernest Thomas, M.D. (“Defendants”) from importing neonatal rabbit and human fetal cells (the “Cell Product”) from Russia for use in the treatment of human diabetes. Defendants claim that injection of the Cell Product into diabetic patients can stimulate the body’s production of insulin.

On July 1, 1996, the court entered a preliminary injunction against Defendants importation and use of the Cell Product on the grounds that the government had demonstrated a reasonable probability of success on the merits of its claim — that the Cell Product fell within the Food and Drug Administration’s (“FDA”) regulatory authority pursuant to the federal Public Health Service Act (the “PHS Act”), 42 U.S.C. § 201 , et seq. and the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.

Now before the court are the parties cross motions for summary judgment. Plaintiff seeks a permanent injunction against the unregulated use of the Cell Product,…