United States v. Western Serum Co., Inc.

• Decision Date: 10 October 1980
• Docket Number: Civ. No. 77-925. Phx. WPC.
• Citation: 498 F. Supp. 863
• Parties: UNITED STATES of America, Plaintiff, v. WESTERN SERUM COMPANY, INC., Chemalytics, Inc., Iatric Corporation, corporations, and Wallace F. Schmidt, Edward J. Prochaska, William T. Northey, and Rickie M. Adams, individuals, Defendants.
• Court: U.S. District Court — District of Arizona

498 F. Supp. 863

UNITED STATES of America, Plaintiff, v. WESTERN SERUM COMPANY, INC., Chemalytics, Inc., Iatric Corporation, corporations, and Wallace F. Schmidt, Edward J. Prochaska, William T. Northey, and Rickie M. Adams, individuals, Defendants.

Civ. No. 77-925. Phx. WPC.

United States District Court, D. Arizona.

October 10, 1980.

James P. Loss, Asst. U. S. Atty., Phoenix, Ariz., Richard E. Geyer, Associate Chief Counsel for Veterinary Medicine, Food and Drug Admin., Rockville, Md., for plaintiff.

Steven A. Cohen, of Levenbaum, Cohen & Reed, Phoenix, Ariz., for defendants.

MEMORANDUM AND ORDER

COPPLE, District Judge.

In this enforcement action instituted by the United States under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-392 (1976) the "Act", the government seeks to enjoin the Western Serum Company and its principal officers from marketing "adulterated" drugs as prohibited by § 301(a) of the Act, 21 U.S.C. § 331(a). Section 302(a), 21 U.S.C. § 332(a), authorizes this Court to issue an injunction to prevent violations of § 301.

The government alleges that the defendants' drugs are adulterated because under § 501(a)(2)(B), 21 U.S.C. § 351(a)(2)(B), they have not been manufactured in accordance with Current Good Manufacturing Practice (CGMP). Moreover, eleven of defendants' drugs¹ are alleged to be unapproved new animal drugs. Under § 501(a)(5), 21 U.S.C. § 351(a)(5), a drug is adulterated if it is a new animal drug which is unsafe within the meaning of § 512, 21 U.S.C. § 360b. Under § 512, a new animal drug is deemed to be unsafe unless there is in effect a new drug application approval with respect to the drug's intended use. A new animal drug is defined by § 201(w), 21 U.S.C. § 321(w), to mean any drug intended for use in animals other than man, "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and expertise to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions described, recommended, or suggested in the labeling ..."

The United States has moved for summary judgment on both the CGMP and new animal drug issues.² Defendants have moved to dismiss on the basis that this Court lacks subject matter jurisdiction to determine the new animal drug issue.

This Court will address the defendants' motion first. Defendants argue that this Court is without jurisdiction to make the determination of new drug status. Rather, it is contended that this determination must be made in the first instance by the Food and Drug Administration (FDA) after a formal administrative hearing. To support this contention, defendants rely mainly on a trilogy of Supreme Court cases that interpreted the 1962 amendments to the Act. Weinberger v. Hynson, Wescott and Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973); Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973); Ciba Corp. v. Weinberger, 412 U.S. 640, 93 S.Ct. 2495, 37 L.Ed.2d 230 (1973). Since the determination of new drug status involves a resolution of scientific and technical issues, these cases held that primary jurisdiction over new drug status determinations rests with the FDA. Defendants then cite numerous cases to the effect that the district court is without jurisdiction to make this kind of a determination.

None of the cases in the 1973 trilogy involved an FDA enforcement action. Rather, the determination of a new drug status was sought in an action brought by the drug manufacturer. To be sure, there is dicta in Bentex and Ciba that, in an enforcement action, the district court might appropriately await administrative determination of this issue. Bentex, 412 U.S. at 654, 93 S.Ct. at 2494; Ciba, 412 U.S. at 644, 93 S.Ct. at 2498. Nevertheless, these cases neither held that the FDA's jurisdiction was exclusive nor that a district court must decline jurisdiction until such time as a formal administrative determination can be made.

In the context of an enforcement action, three distinct approaches have emerged regarding the extent to which a district court may resolve the new drug issue. In United States v. Mosinee Research Corp., 583 F.2d 930, 931-32 (7th Cir. 1978), the district court was held to have properly exercised jurisdiction in determining new drug status for the purpose of issuing a preliminary injunction. Taking an opposite view, the district court in United States v. Alcon Laboratories, Inc., Civil No. 78-2378 (D.P.R. April 8, 1980), remanded the issue to the FDA so that the agency could hold a formal hearing pursuant to 5 U.S.C. § 554. A third approach is evident in United States v. X-OTAG Plus Tablets, 441 F.Supp. 105 (D.Colo.1977), aff'd, 602 F.2d 1387 (10th Cir. 1979). In X-OTAG, the court limited its determination of the new drug issue to the extent necessary to decide whether an injunction should be issued: whether the FDA had probable cause to believe that the drug in question was a new drug. Id. at 109.

This Court is of the opinion that the X-OTAG approach is the most appropriate under the circumstances. To require the FDA to conduct a full administrative hearing before it could bring an enforcement action would severely hinder the FDA in expediting the removal of drugs potentially dangerous to public health and safety. On the other hand, due to its lack of expertise in scientific and technical matters, the district court should refrain from making a dispositive decision on the new drug issue. Rather, the court should limit its determination to whether the government has met its burden to demonstrate sufficient probable cause to believe the drug in question is a new drug. If the government meets its burden, an injunction will issue and the manufacturer is left in the position of complying with § 505, 21 U.S.C. § 355.³

Under § 201(w), 21 U.S.C. § 321(w), an animal drug may attain "not new drug" status if the drug is generally recognized by qualified experts as being both safe and effective for its labeled uses. This standard of recognition requires a consensus within the community of experts founded upon "substantial evidence" as defined by § 505(d), 21 U.S.C. § 355(d). Hynson, 412 U.S. at 632, 93 S.Ct. at 2484. Thus, general recognition of safety and effectiveness is dependent upon the "expert knowledge and experience of scientists based on controlled clinical experimentation and backed by substantial support in scientific literature." Bentex, 412 U.S. at 652, 93 S.Ct. at 2493; see United States v. An Article of Drug ... Entrol-C Medicated, 513 F.2d 1127, 1128-29 (9th Cir. 1975). Though a determination under § 505(d) and § 201(w) requires the same kind of evidentiary showing, the questions to be resolved are distinct. Whereas § 505(d) requires a finding of actual safety and effectiveness, a determination under § 201(w) relates only to whether there exists a general recognition of safety and effectiveness. Premo Pharmaceutical Laboratories, Inc. v. United States, 629 F.2d 795 (2d Cir. 1980) (citing cases).

Thus, the inquiry of this Court is limited to ascertaining whether there exists a general recognition among qualified experts as to the safety and effectiveness of the drugs at issue. To prevail, the government must demonstrate only that a genuine dispute exists within the scientific community regarding the safety and effectiveness of the drug for use as labeled. Conversely, the burden of the defendant is to demonstrate that there is a lack of a genuine dispute, even if there exists no universal agreement. See United States v. X-OTAG, 441 F.Supp. at 110.

Plaintiff has certainly established a prima facie case. In his affidavit, Dr. Tennant has testified that he is of the opinion that the eleven drugs are not safe and effective for their intended uses and that he is not aware of any scientific literature that evaluates any of the eleven drugs to determine whether they are safe and effective as to their labeled uses.

Since the test is one of general recognition of safety and effectiveness as opposed to actual safety and effectiveness, defendants cannot escape summary judgment merely by questioning the credibility of Dr. Tennant. At issue is not whether Dr. Tennant holds a correct opinion, but whether Dr. Tennant's opinion is that of an extreme minority, as demonstrated either by expert testimony to this effect or by scientific literature evaluating the drugs as safe and effective as to their labeled uses.

Except as for Therahist, defendants' opposition consists simply of an attack upon Dr. Tennant's credibility and a declaration to the effect that defendants intend to defend use in non-equine species, neither of which sufficiently rebuts the government's contention that general recognition does not exist. The fact that Dr. Tennant's objections may be limited to the drugs' labeling can hardly be said to be minor. An examination of § 201(w) reveals that safety and effectiveness are to be judged in regard to the uses for which the drug is prescribed, recommended, or suggested in the labeling. Thus the labeled uses must be considered the focus for the determination of safety and effectiveness. A declaration that defendants intend to defend use in non-equine species is insufficient to raise a question of material fact as to whether there exists a general recognition of safety and effectiveness for use in such species. Defendants have submitted no scientific literature or affidavits to address this issue.

As for Therahist, Dr. Loomis, defendants' expert, has testified that the drug is generally recognized as safe and effective as an antihistamine. Dr. Loomis' testimony, however, does not address all of Therahist's labeled uses, and is therefore insufficient to raise a question of fact as to the general recognition of safety and effectiveness for its uses as labeled.

Defendants' final argument with regard to the new drug issue is that the government...