Hi-Tech Pharmaceuticals, Inc. v. Crawford
| Decision Date | 15 August 2007 |
| Docket Number | Civil Action No. 1:05-cv-02083-GET.,Civil Action No. 1:06-cv-00406-GET. |
| Citation | 505 F.Supp.2d 1341 |
| Parties | 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. |
| Court | U.S. District Court — Northern District of Georgia |
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.
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 1:05cv-02083-GE T];
3) plaintiff Hi-Tech Pharmaceuticals, Inc.'s ("Hi-Tech") motion for summary judgment [docket no. 32 in case 1:05-cv-02083-GE T];
4) plaintiff United States of America's ("the government") motion for summary judgment [docket no. 27 in case 1:06-cv-00406-GE T]; and
5) claimant and third-party plaintiff Hi-Tech's motion for summary judgment [docket no. 38 in case 1:06-cv-00406-GET].
Hi-Tech filed one of the instant actions, case 1:05-cv-02083-GET, on August 10, 2005, seeking relief from an FDA Final Rule declaring dietary supplements containing ephedrine alkaloids to be adulterated (the "Final Rule"). Hi-Tech manufactures, markets, distributes, and sells Lipodrene, a dietary supplement containing ephedrine alkaloids. Specifically, Hi-Tech seeks declaratory judgment that the Final Rule and defendants' actions are unlawful and in violation of Dietary Supplement Health and Education Act of 1994 and the Administrative Procedures Act and an order setting aside the Final Rule as void and granting injunctive relief prohibiting the enforcement of the Final Rule. On January 23, 2006, the FDA defendants filed a motion to dismiss in case 1:05-cv-02083-GET.
On February 22, 2006, the government filed a complaint for forfeiture of dietary supplement products and ingredients containing ephedrine alkaloids. The government contends that the products are liable to seizure and condemnation because they are adulterated within the meaning of the Federal Food, Drug and Cosmetic Act ("FDCA") 21 U.S.C. 342(f)(1)(A), by presenting a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling or, if the labeling does not discuss it, under ordinary conditions of use. On February 23, 2006, United States Marshals entered Hi-Tech's premises and seized the products.
On February 27, 2006, Hi-Tech filed a statement of interest in the forfeiture action as the sole owner and one of the persons entitled to the seized property. On the same date, Hi-Tech filed a third-party complaint in case 1:06-cv-00406-GET seeking declaratory judgment against the FDA, the Department of Health and Human Services ("HHS"), Andrew C. von Eschenbach, M.D., Acting Commissioner of FDA, and Michael O'Leavitt, Secretary of HHS. Hi-Tech alleges that the FDA Final Rule banning the sale of dietary supplements containing ephedrine alkaloids violates the FDA's statutory authority from the FDCA, as amended by the DSHEA and the APA, Section 706(2)(a)(c). Further, Hi-Tech alleges that the Final Rule is arbitrary and capricious under the APA, and that the third-party defendants violated Hi-Tech's due process rights. On February 27, 2006, Hi-Tech also filed a motion for preliminary injunction in case 1:06-cv-00406-GET seeking the return of the products seized on February 23, 2006. On March 13, 2006, the court denied Hi-Tech's motion for preliminary injunction.
Pursuant to an oral order on May 18, 2006, the court ordered the parties to file their motions for summary judgment within thirty days. The order also consolidated the two cases and stayed both cases and held in abeyance any pending motions until further order of the court. The order further directed the parties to notify the court when the Tenth Circuit Court of Appeals issued a ruling in Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033 (10th Cir.2006), cert. denied, ___ U.S. ___, 127 S.Ct. 2295, 167 L.Ed.2d 1089 (2007).
The FDA defendants and the government filed their motion for summary judgment on July 10, 2006. Hi-Tech filed its motion for summary judgment on September 5, 2006. The parties jointly filed a notice of the outcome of the appeal to the Tenth Circuit Court of Appeals in Nutraceutical, 459 F.3d 1033.
Courts should grant summary judgment when "there is no genuine issue as to any material fact ... and the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). The moving party must "always bear the initial responsibility of informing the district court of the basis of its motion, and identifying those portions of `the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, if any' which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 324, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). That burden is "discharged by `showing' — that is, pointing out to the district court — that there is an absence of evidence to support the nonmoving party's case." Id. at 325, 106 S.Ct. 2548; see also U.S. v. Four Parcels of Real Property, 941 F.2d 1428, 1437 (11th Cir.1991).
Once the movant has met this burden, the opposing party must then present evidence establishing that there is a genuine issue of material fact. Celotex, 477 U.S. at 325, 106 S.Ct. 2548. The nonmoving party must go beyond the pleadings and submit evidence such as affidavits, depositions and admissions that are sufficient to demonstrate that if allowed to proceed to trial, a jury might return a verdict in his favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 257, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). If he does so, there is a genuine issue of fact that requires a trial. In making a determination of whether there is a material issue of fact, the evidence of the non-movant is to be believed and all justifiable inferences are to be drawn in his favor. Id. at 255, 106 S.Ct. 2505; Rollins v. TechSouth, Inc., 833 F.2d 1525, 1529 (11th Cir.1987). However, an issue is not genuine if it is unsupported by evidence or if it is created by evidence that is "merely colorable" or is "not significantly probative." Anderson, 477 U.S. at 249-50, 106 S.Ct. 2505. Similarly, a fact is not material unless it is identified by the controlling substantive law as an essential element of the nonmoving party's case. Id. at 248, 106 S.Ct. 2505. Thus, to create a genuine issue of material fact for trial, the party opposing the summary judgment must come forward with specific evidence of every element essential to his case with respect to which (1) he has the burden of proof, and (2) the summary judgment movant has made a plausible showing of the absence of evidence of the necessary element. Celotex, 477 U.S. at 323, 106 S.Ct. 2548.
In light, of the foregoing standard, the court finds the following facts solely for the purpose of resolving these motions for summary judgment. On February 11, 2004,...
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