HI-TECH PHARMACEUTICALS, INC. v. CRAWFORD

Civil Action Nos. 1:05-cv-02083-GET, 1:06-cv-00406-GET.

505 F.Supp.2d 1341 (2007)

HI-TECH PHARMACEUTICALS, INC., Plaintiff, v. Lester M. CRAWFORD, D.V.M., PhD, as Commissioner of the United States Food and Drug Administration, United States Food and Drug Administration, Michael O. Leavitt, as Secretary of the Department of Health and Human Services, United States Department of Health and Human Services, Acting Commissioner Andrew C. Von Eschenbach, M.D., Defendants. United States of America, Plaintiff, v. 18 Cases, More or Less, Of An Article Of Food, Each Case Containing 120/100 Tablet Bottles, Labeled In Part Lipodrene Dietary Supplement 100 ct. Sida Cordifolia (leaves) (25mg ephedrine group alkaloids) Lot 05121004 Manufactured for Hi-Tech Pharmaceuticals, Inc. Norcross, GA, 174 Cases, More or Less, Of An Article Of Food, Each Case Containing 12/90 (OR 144/20) Tablet Bottles, Labeled In Part Stimerex-ES (Extra Strength with Ephedra) Dietary Supplement 90 (or 20) Tablets (Sida Cordifolia Extract) (leaves) (25mg ephedrine group alkaloids) Lot 0517502 Manufactured for Hi-Tech Pharmaceuticals, Inc. Norcross, GA, 20 Cases, More or Less, Of An Article Of Food, Each Case Containing 120/100 Tablet Bottles, Labeled In Part Betadrene Dietary Supplement 100 Ct. Sida Cordifolia Extract (leaves) (supplying 25mg Ephedrine Group Alkaloids) Lot 02122635 Manufactured for United Metabolic Research Group, Inc. Birmingham, AL 2 Previously Opened Cardboard Drums Of An Article Of Food, Bulk Dietary Supplement Ingredient, Labeled In Part Mahuang Extract 6% net Weight 25kgs Product of P.R. China Lot 20021119 (or 20021123), All Other Quantities Of The Aforesaid Articles Of Food, With Any Lot Number And In Any Size Or Type Container, That Are Labeled Or Otherwise Identified As Being Or Containing Ma Huang, Ephedra, Or Eph, Including Finished Products, In-Process Materials, and Raw Materials Used in the Manufacture of Such Finished Products by Hi-Tech Pharmaceuticals, Inc., 6015 and 6020 Unity Drive, Norcross, Georgia, Defendants. Hi-Tech Pharmaceuticals, Inc., Claimant & Third-party plaintiff, v. United States of America, Third-party Defendant.

United States District Court, N.D. Georgia, Atlanta Division.

August 15, 2007.


Attorney(s) appearing for the Case

Edmund J. Novotny, Baker, Donelson, Bearman, Caldwell & Berkowitz, P.C., Atlanta, GA, Joseph Paul Schilleci, Jr., Timothy Melvin Fulmer, Natter & Fulmer, P.C., Birmingham, AL, for Hi-Tech Pharmaceuticals, Inc.

Stephen H. McClain, U.S. Attorney's Office, Atlanta, GA, for Lester M. Crawford D.V.M., Ph.D, as Commissioner of the United States Food and Drug Administration, United States Food and Drug Administration, Michael O. Leavitt as Secretary of the Department of Health and Human Services, United States Department of Health and Human Services, Acting Commissioner Andrew C. Von Eschenbach, M.D., United States of America.

Dahil Dueno Goss, Office of United States Attorney, Atlanta, GA, for United States of America.


ORDER

G. ERNEST TIDWELL, District Judge.

The above-styled matter is presently before the court on:

1) defendants Andrew C. von Eschenbach, M.D., United States Food and Drug Administration ("FDA"), Michael 0. Leavitt, and the Department of Health and Human Services's (collectively "the FDA defendants") motion to dismiss [docket no. 8 in case 1:05-cv-02083-GET];

2) the FDA defendants' motion for summary judgment [docket no. 22 in case...

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