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DeVITO v. HEM, INC.

Civ. A. No. 88-1712.

705 F.Supp. 1076 (1988)

Daniel J. DeVITO, Plaintiff, v. HEM, INC.; Du Pont, Inc.; Hahnemann University; and the Food and Drug Administration, Defendants.

United States District Court, M.D. Pennsylvania.

As Amended March 6, 1989.

Attorney(s) appearing for the Case

Daniel J. Devito, Hershey, Pa., pro se.

Bruce Cooper, Harrisburg, Pa., for plaintiff.

Gerald Kell, U.S. Dept. of Justice, Washington, D.C., Barbara L. Kosik, Asst. U.S. Atty., Scranton, Pa., for Food and Drug Admin.

Fred Magaziner, David S. Thalheimer, Dechert, Price & Rhodes, Philadelphia, Pa., for HEM, Inc.

Thomas B. Schmidt, III, Harrisburg, Pa., for Hahneman University.

Ross Schmucki, E.I. DuPont DeNemours & Co., Legal Dept., Wilmington, Del., for DuPont.

MEMORANDUM

RAMBO, District Judge.

Background

Defendants HEM, Inc. (HEM), and Du Pont, Inc. (Du Pont) are the "sponsors" of "clinical investigations" of an "investigational new drug" called Ampligen. See 21 C.F.R. § 312.3(b) (1988). The clinical investigations were conducted at defendant Hahnemann University's (Hahnemann) facilities. Defendant Food and Drug Administration (FDA) approved the clinical investigations of Ampligen...

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