United States v. 7 CARTONS, MORE OR LESS, ETC., P-2853.

• Decision Date: 16 December 1968
• Docket Number: No. P-2853.,P-2853.
• Parties: UNITED STATES of America v. 7 CARTONS, MORE OR LESS * * * Labeled in part * * * "FERRO-LAC SWINE FORMULA CONCENTRATE (MEDICATED)".
• Court: U.S. District Court — Southern District of Illinois

293 F. Supp. 660

UNITED STATES of America v. 7 CARTONS, MORE OR LESS * * * Labeled in part * * * "FERRO-LAC SWINE FORMULA CONCENTRATE (MEDICATED)".

No. P-2853.

United States District Court S. D. Illinois, N. D.

December 16, 1968.

Richard E. Eagleton, U. S. Atty., Peoria, Ill., for libelant.

O. J. Taylor, Neale, Newman, Bradshaw, Freeman & Neale, Springfield, Mo., Richard E. Quinn, Cassidy, Cassidy, Quinn & Lindholm, Peoria, Ill., for claimant.

MEMORANDUM DECISION ON MOTION FOR PARTIAL SUMMARY JUDGMENT

ROBERT D. MORGAN, District Judge.

This is a civil action in rem arising under the provisions of the Federal Food, Drug and Cosmetic Act. 21 U.S. C. § 301 ff.

This cause is now before the court upon the motion of the United States for partial summary judgment.

On or about March 22, 1966, claimant, Naremco, Inc., shipped 7 Cartons, each containing 12 bags, of a product labeled "Ferro-Lac Swine Formula Concentrate (Medicated)" in interstate commerce from Springfield, Missouri, to Atkinson, Illinois. This libel is directed against those 7 Cartons of Ferro-Lac.

The libel alleges that there were three violations of the Act in the shipment of the product in interstate commerce.

First, it alleges that Ferro-Lac is a new drug, within the meaning of 21 U.S.C. § 321(p), which was unlawfully introduced into interstate commerce without an approved "new-drug" application in effect with respect to the product in violation of 21 U.S.C. § 355(a).

Second, it alleges that Ferro-Lac is a food within the meaning of 21 U.S.C. § 321(f), and that the article is adulterated as a food within the meaning of 21 U.S.C. § 342(a) (2) (C), in that it contains a combination of food additives which are unsafe within the meaning of 21 U.S.C. § 348, because the use and intended use of the combination of additives are not in conformity with any regulation or exemption promulgated pursuant to 21 U.S.C. § 348.

Third, it alleges that the commodity is misbranded as a drug within the meaning of 21 U.S.C. § 352(a).

The government's motion for partial summary judgment is directed to the "new drug" and adulterated food issues.

The active ingredients of the product, labeled and sold by claimant for use as an additive to food for swine for the prevention and treatment of infectious nonspecific diarrhea and bacterial interitis, are sodium propionate, sodium phthalysulfacetamide and methylrosaniline chloride.

The parties have stipulated that the product is a drug within the meaning of 21 U.S.C. § 321(g) and that no new drug application is in effect with respect thereto. They further stipulate that the product is a food within the meaning of 21 U.S.C. § 321(f).

The test whether a drug is a "new drug" within the meaning of the statute is whether its composition is such that it "is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use" as prescribed by the labeling. 21 U.S.C. § 321(p). A like test of general recognition by qualified experts applies to the question whether any given product is an unsafe food additive. 21 U.S.C. §§ 321(s), 342(a) (2) (C), 348.

In addition to the pleadings and the answers of the parties to interrogatories, there are before the court on this motion for summary judgment affidavits submitted by the government in support of the motion, and by the claimant in opposition thereto.

To a degree, there is some conflict between the affidavits submitted by the government and those submitted by the claimant.

The government contends that any conflict between the affidavits of experts related to the question of general recognition proves the want of general recognition of the statutory factors. Three district court cases are cited by the government which do tend to lend support to that theory. Merritt Corp. v. Folsom, D.D.C., 165 F.Supp. 418, 421 (1958); United States v. 354 Bulk Cartons, etc., D.N.J., 178 F.Supp. 847, 853 (1959); United States v. Article of Drug, etc., N.D.Ga.1968, 294 F.Supp. 1307.

Actually only two of those cases arose in the summary judgment context, and neither contains any well-reasoned basis for the conclusion that a conflict of relevant expert opinion is proof of a want of general recognition as a matter of law. In the Merritt case, that principle is stated as a conclusion of law, without any opinion or analysis. In 354 Bulk Cartons, the court cited Merritt, without analytic discussion, to support its statement of the principle.

In the 204 Boxes case, decided this year, the court quoted the statement of principle from those earlier cases in stating its conclusion that the principle was clearly established. It also appears very questionable that this case can have any relevance upon the issue here involved. The opinion indicates that the decision followed a bench trial, and that the court was evaluating the diametrically opposed testimony of expert witnesses after subjection to cross-examination. In that context, the existence of conflict in expert opinion might well prove the fact of the lack of general recognition of the safety and effectiveness of a drug. It seems to this court quite something else to conclude, as a matter of law, that conflict between affidavits upon a motion for summary judgment disposes of that issue of fact.

A Court of Appeals has recently disavowed expression as to the validity of the principle in AMP, Inc. v. Gardner, 2 Cir., 389 F.2d 825, 831 (1968), saying:

"While we would not necessarily accept the defendants' position that whenever a court in a case such as this one is presented with a genuine difference of opinion among experts as to a drug's safety and effectiveness, that case is ripe for summary judgment, we agree that on the affidavits presented here there remained no genuine issue of material fact to be tried."

So stating, that court then characterized the affidavits presented by AMP as being limited to the statement of personal or professional opinions of the respective affiants, and not addressed to the fact of general recognition or lack thereof.

This court is convinced that the government's contention cannot be accepted as a sound principle of procedural law for application to this statute. The statute provides a test of general recognition. The rule stated in Merritt and subsequent cases would equate the statutory language, "generally recognized," to "unanimously recognized." There is no justification for such equation. There is nothing in the statute to indicate that Congress intended "generally recognized" in other than its commonly understood meaning. The adverb, "generally," is defined, inter alia, to mean, "In general; extensively, though not universally; most frequently, but not without exception; * * *" Webster's New Twentieth Century Dictionary, Unabridged, 2nd Ed.

The statute relates to drugs. The question of the safety and effectiveness of a drug encompasses the realms of physiology, biology, pathology, pharmacology, toxicology, organic chemistry, among other sciences. It could be expected that genuinely honest differences in expert opinion on the safety and effectiveness might exist with reference to most drug compounds.

When such genuine differences of expert opinion addressed to the relevant factual question are expressed in opposed affidavits, the case is not a proper case for summary judgment. That conflict of opinion seems to present a genuine issue of fact for trial.

The government argues that the rule stated in Merritt and subsequent cases is compelled by the statute's purpose of protection of the public health. This court does not agree. The statutory purpose is served by an orderly judicial procedure. It cannot justify the decision of factual issues by summary judgment.

Where, as here, each party has submitted affidavits in support of its position, the court must examine those affidavits to determine whether a genuine difference of expert opinion is presented. If such difference of opinion appears, decision must abide the results of a trial of the issues. If, on the other hand, no genuine difference of expert opinion as to the fact of general recognition is shown to exist, summary judgment is proper.

On the new drug issue, the government has submitted the affidavit of Harold E. Amstutz, D. V. M., a Professor of Veterinary Medicine and the Head of the Department of Veterinary Science and Medicine at Purdue University.

Doctor Amstutz specializes in the clinical study of the nature, causes and treatment of diseases in horses, cattle and swine, and acts as a consultant for the swine industry in his specialty.

It is his opinion that Ferro-Lac is not now, and has never been, generally recognized among qualified and informed clinical veterinarians as safe and effective for the treatment or prevention of bacterial enteritis and infectious, nonspecific diarrhea in swine.

That opinion was formulated upon the basis of the following facts stated in his affidavit: that he keeps himself currently informed of developments in his specialty by studying the veterinary medical literature, attending professional meetings, and consultation with his colleagues in the field of clinical veterinary medicine; that, in his specialty, he would normally have knowledge of any product which was recognized as effective in the prevention and treatment of...