U.S. v. Undetermined Quant. of Clear Plastic Bags
| Decision Date | 31 March 1997 |
| Docket Number | No. C-2-94-0725.,C-2-94-0725. |
| Citation | 963 F.Supp. 641 |
| Parties | UNITED STATES of America, Plaintiff, v. UNDETERMINED QUANTITIES OF CLEAR PLASTIC BAGS OF AN ARTICLE OF DRUG FOR VETERINARY USE ... WRM-RID Dog Wormer ... Defendant. |
| Court | U.S. District Court — Southern District of Ohio |
Marcia Jane Harris, United States Attorney's Office, Columbus, Robert F. Church, United States Attorney, Food and Drug Administration, Rockville, MD, for Plaintiff.
Douglas Stuart Roberts, Clark, Perdue & Roberts Company, Columbus, OH, for Bingman Laboratories, Inc.
This matter is before the Court on the Plaintiff's motion for summary judgment. This civil in rem action was brought by the government under the Food, Drug and Cosmetic Act (the "Act") to request that this Court enter an order of condemnation and destruction against a seized article. The Court GRANTS the government's motion.
Bingman Laboratories, Inc. ("Bingman") has manufactured and marketed "WRM-RID Dog Wormer" ("WRM-RID") since 1952. WRM-RID is an animal drug promoted as a treatment for worms in dogs and cats. The formula for WRM-RID has remained the same since 1955. The drug has two active ingredients: piperazine phosphate and arecoline hydrobromide.
Prior to marketing WRM-Bingman contacted the Food and Drug Administration ("FDA") to determine the requirements for marketing drug products. Bingman followed the agency's suggestions. Between 1955 and 1991, the FDA inspected Bingman's plant and took no exception to Bingman's marketing of WRM-RID.
On April 9, 1991, however, the FDA informed Bingman that WRM-RID was adulterated and misbranded in violation of the Food, Drug and Cosmetic Act. Bingman and the FDA engaged in a dialogue regarding the alleged violation. Nevertheless, the FDA filed a complaint alleging that WRM-RID is an "adulterated," "unsafe" "new animal drug" under the Act. Therefore, according to the FDA, WRM-RID is subject to forfeiture and condemnation under the Act. The FDA requests a warrant in rem directing the U.S. Marshall to retain and hold an undetermined amount of WRM-RID and to notify any interested individuals. The FDA also requests an order of forfeiture and condemnation of the seized WRM-RID.
On August 4, 1994, a warrant was issued and, on September 12, 1994, an undetermined amount of WRM-RID was seized. The government gave notice to all interested parties including Bingman. The FDA now seeks summary judgment on its request for an order of forfeiture and condemnation.
Bingman opposes the FDA's motion on several grounds. First, Bingman suggests that it is inappropriate to establish the status of a drug on summary judgment. Second, Bingman argues that WRM-RID is grandfathered out of the Act's requirements. Third, Bingman argues that the FDA has failed to produce any evidence that WRM-RID is not safe and effective and therefore WRM-RID is not a "new" drug subject to forfeiture and condemnation. Fourth, Bingman asserts that WRM-RID was not in interstate commerce and so does not satisfy a jurisdictional prerequisite of the Act. Fifth, Bingman claims that the FDA's seizure of WRM-RID violated Bingman's constitutional right to due process. Finally, Bingman suggests that the FDA's failure to prosecute Bingman for marketing WRM-RID in the past bars the current action.
Rule 56(c) of the Federal Rules of Civil Procedure provides as follows:
[summary judgment] ... shall be rendered forthwith if the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.
Summary judgment is appropriate where, based on the documentary evidence, there is no genuine issue of material fact to be tried. Lashlee v. Sumner, 570 F.2d 107, 111 (6th Cir.1978). The party moving for summary judgment bears the burden of establishing the absence of a genuine issue of material fact. Adickes v. S.H. Kress & Co., 398 U.S. 144, 157, 90 S.Ct. 1598, 1608, 26 L.Ed.2d 142 (1970). In considering whether to grant a motion for summary judgment, a court must believe all of the non-moving party's evidence and draw all reasonable inferences from the evidence in her favor. Russo v. City of Cincinnati, 953 F.2d 1036, 1042 (6th Cir. 1992).
Bingman asserts that "[s]ummary judgment motions by the FDA to establish a disputed product status are generally disfavored by the courts." (Doc. # 9 at p. 4 (citing United States v. Article of Food Consisting of 345-50 Pound Bags, 622 F.2d 768 (5th Cir.1980)).) The Court disagrees. See, e.g., United States v. An Article of Drug Consisting of 4,680 Pails, 725 F.2d 976, 985 (5th Cir.1984) ().
The Act prohibits "[t]he introduction ... into interstate commerce of any ... drug ... that is adulterated." 21 U.S.C. § 331(a). Thus, to carry its burden on summary judgment under the Act, the government must show that there is no genuine issue of material fact that WRM-RID is a drug which is adulterated and which was held for sale after shipment in interstate commerce. The Court addresses the following two issues: (1) whether WRM-RID is an adulterated drug and (2) whether it has shipped in interstate commerce.
The central issue in dispute is whether WRM-RID is adulterated. There is no dispute that WRM-RID is an animal drug within the meaning of the Act. 21 U.S.C. § 321(g)(1)(B). Therefore, the main issue is whether WRM-RID is adulterated. An adulterated drug is a "new" drug that is not the subject of either an approved application with the FDA or an effective investigational exception. 21 U.S.C. §§ 351(a)(5), 360b(a)(1). WRM-RID is neither the subject of an approved new animal drug application nor the subject of an effective investigational exception. Therefore, the question is whether WRM-RID is a "new" drug. The Court finds that WRM-RID is a new drug.
An animal drug is "new" under the Act if the drug is not "generally recognized as safe and effective" for use as recommended in its labeling. If the drug is a combination of drugs then the combination must be generally recognized as safe and effective even if each component part is generally recognized as safe and effective. 21 U.S.C. § 321(p)(1); 21 C.F.R. § 510.3(i)(2). International Nutrition v. United States Department of Health, 676 F.2d 338, 341 (8th Cir.1982).
The sponsor of a drug has the burden of coming forward with substantial evidence that the drug is generally recognized as safe and effective.1 Ubiotica Corp. v. Food and Drug Administration, 427 F.2d 376, 378 (6th Cir.1970). This requires evidence of an "adequate and well controlled investigation supporting" the safety and effectiveness of the drug. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 630, 93 S.Ct. 2469, 2483, 37 L.Ed.2d 207 (1972). "Clinical impressions of practicing physicians and poorly controlled experiments" do not constitute substantial evidence. Id. at 630, 93 S.Ct. at 2483. Similarly, "[i]solated case reports, random experience and reports lacking the details which permit scientific evaluation will not be considered.'" Id. at 630, 93 S.Ct. at 2483 (quoting 21 C.F.R. § 130.12(a)(5)(ii)(c)).
Bingman has failed to come forward with substantial evidence that WRM-RID, a combination drug, is generally recognized as safe and effective. The sponsor of a combination drug cannot show that the drug is safe and effective merely by showing that each component part is generally recognized as safe and effective; instead, the sponsor must show that the combination is safe and effective. United States v. An Article of Drug, 513 F.2d 1127, 1129-30 (9th Cir.1975). Where a drug sponsor cannot produce evidence of research concerning the safety and effectiveness of a drug combination, then judgment should be rendered against that party. Id. at 1129. Bingman has produced evidence that tends to establish that each of the component parts of WRM-RID — arecoline hydrobromide and piperazine phosphate — is generally recognized as safe and effective. (See Doc. # 9 at pp. 8-14 and referenced exhibits.) The great majority of Bingman's evidence, however, fails to address the safety and effectiveness of these chemicals in combination. (Id.) The only evidence that Bingman introduces that relates to WRM-RID as a combination drug is its 43 year "track record." (See Doc. # 9 at pp. 10, 13.) This evidence is not sufficient to satisfy the "substantial evidence" test. The track record is not a well-controlled investigation and it does not contain the detail necessary to permit scientific evaluation. Therefore, this evidence does not constitute "substantial evidence."
Because there is no evidence in the record showing that WRM-RID is generally recognized as safe and effective, WRM-RID is a "new" drug. According to the foregoing evidence, therefore, WRM-RID is adulterated.
The FDA may bring a condemnation proceeding against an animal drug only if the drug "is adulterated ... when introduced into or while in interstate commerce or while held for sale ... after shipment in interstate commerce." 21 U.S.C. § 334(a)(1). This standard is satisfied if any component of the animal drug has been shipped in interstate commerce. See, e.g., Palmer v. United States, 340 F.2d 48, 49 (5th Cir.1964) (); see also 21 U.S.C. § 321(g)(1)(D) ().
The FDA introduced documentary evidence establishing that both of the...
To continue reading
Request your trial