United States v. ARTICLE OF DRUG..." MYKOCERT"

• Decision Date: 19 May 1972
• Docket Number: No. 71 C 235.,71 C 235.
• Citation: 345 F. Supp. 571
• Parties: UNITED STATES of America, Plaintiff, v. An ARTICLE OF DRUG . . . "MYKOCERT.", Defendant.
• Court: U.S. District Court — Northern District of Illinois

345 F. Supp. 571

UNITED STATES of America, Plaintiff, v. An ARTICLE OF DRUG . . . "MYKOCERT.", Defendant.

No. 71 C 235.

United States District Court, N. D. Illinois, Eastern Division.

May 19, 1972.

William Bauer, U. S. Atty., Robert B. Schaefer, Asst. U. S. Atty., for plaintiff.

Kirkpatrick W. Dilling, Dilling & Dilling, Chicago, Ill., for claimant Beutlich Pharmaceutical Co.

MEMORANDUM OPINION

MAROVITZ, District Judge.

On January 29, 1971, subsequent to the filing of a Complaint For Forfeiture, the Plaintiff seized a quantity of the prescription drug, Mykocert medicated vaginal tampons pursuant to the provisions of 21 U.S.C. § 301 et seq. and now seeks a decree of condemnation in regard to the drug seized.

The Complaint alleges that the seized article of drug was misbranded while held for sale after shipment in interstate commerce within the meaning of the Act, 21 U.S.C. as follows:

§ 352(a) in that its labeling, namely, the box label, contains statements which represent and suggest that the article is adequate and effective as a treatment of most vaginal infections caused by Gram-positive and Gram-negative organisms, which statements are false and misleading, since the article is not adequate and effective for such conditions; and

352(f) (1) in that it is a drug and its labeling fails to bear adequate directions for use and it is not exempt from such requirement, under the regulations, 21 CFR 1.106(g), since the article is a new drug subject to the provisions of 21 U. S.C. § 355, and no approval of an application filed pursuant to 21 U.S.C. § 355(b) is effective with respect to such drug, and no notice of claimed investigational exemption under 21 U.S.C. § 355 (i) and regulations 21 CFR 130.3 is on file for such drug.

Beutlich, Inc., the pharmaceutical company which manufactures Mykocert, filed a claim for the seized articles and interrogatories were subsequently served and answered by both sides. Plaintiff has filed a motion for summary judgment and claimant has filed a cross-motion for summary judgment, both motions appended by a voluminous amount of affidavits, expert's opinions and substantiating material. Both Plaintiff and claimant were granted leave for oral argument on their respective motions and all parties entered into the very important stipulation that should the Court decide that it cannot or does not wish to dispose of the case within the limitations of the summary judgment rule that it may proceed to decide on the merits taking into consideration the affidavits, depositions, interrogatories and other information now on file as refined and distilled by oral argument. We are now prepared to render that decision.

The seeming complexity of this action diminishes, once the critical issue around which the entire case revolves is isolated. The drug here in question consists of a tampon impregnated with 14 mgs. of the chemical ingredient 9-aminoacridine hydrochloride and a "binder" of 14 mgs. of polyvinylpyrrolidone which Beutlich markets as a prescription drug for the alleviation of various vaginal infections. The tampon is inserted in the conventional manner and its intended purpose is to slowly release the medication onto the infected area. The Government in its 21 U.S.C. § 352(a) argument contends that purpose falls short of accomplishment and that the labeling statements in regard to its adequacy and effectiveness are therefore false and misleading in violation of the statute. Though not in any way conceding any part of these allegations the Government's briefs concentrated on the second part of its argument in regard to the 21 U.S.C. § 352(f) (1) violations.

There are five conceivable defenses that claimant could have raised to the Government's § 352(f) (1) grounds for forfeiture. It could have claimed that Mykocert indeed bore adequate instructions for lay use as required by § 352 (f) (1) and 21 CFR 1.106(a) but was foreclosed from doing so since Mykocert is a prescription drug and by its very nature cannot bear such instructions. It could have claimed exemption from the adequate directions requirement as provided by 21 CFR 1.106(g) for new drugs but no approval of an application pursuant to 21 U.S.C. § 355(b) was effective for Mykocert and no notice of claimed investigational exemption under 21 U.S. C. § 355(i) and 21 CFR 130.3 has been filed with the United States Food and Drug Administration which would have allowed for such an exemption. Mykocert could have qualified for the prescription drug exemption provided for by 21 CFR 1.106(b) by bearing labeling authorized by an approved new drug application but claimant has not filed a new drug application. The fifth and final avenue and the one chosen by claimant is that Mykocert is not a "new" drug as defined in 21 U.S.C. § 321 and 21 CFR § 130.1 and that even though § 352 (f) (1) is inapplicable because of the drug's prescriptive nature the non-newness of the drug exempts it from any of the requirements of the previously mentioned alternatives such as application or filing with the Federal Drug Administration. Thus the entire crux of the case is dependent on the one critical decisive issue as whether Mykocert is or is not a new drug.

The criteria for determining whether or not a drug is "new" appears in various statutes and regulations and is further delineated by numerous cases.

The essential starting point in a definitional survey of a "new drug" is 21 U.S. C. § 321 which states:

(p) The term "new drug" means—

(1) Any drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof . . . .

The regulations in 21 CFR § 130.1(h) further indicate the various conceivable manifestations of "newness":

(h) The newness of a drug may arise by reason (among other reasons) of:

(1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component.

(2) The newness for drug use of a combination of two or more substances, none of which is a new drug.

(3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug.

(4) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body.

(5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.

The words "generally recognized" as they appear in 21 U.S.C. § 321(p) are terms of art and their interpretation as in the context of drug usage poses various problems that have led to the case law development of certain objective indications of recognition and non-recognition.

One indication that a drug is not generally recognized among qualified experts as safe and effective for its intended use, that some Courts have accepted, is the absence of any published medical or scientific literature relating to the usage of the drug since the lack of documented sources of information perforce curtails the widespread knowledge of the drug's effectiveness or safety. This test by itself has been recognized as determinative of "newness" by several cases especially in this district. United States v. An Article of Drug . . . Xerac 70 C 106 (N.D.Ill. April 29, 1971); United States v. Aspersleep, 70 C 196 (N.D.Ill. September 15, 1971). See also United States v. 41 Cases . . . Myconox, 420 F.2d 1126 (5th Cir. 1970); United States v. Article of Drug (Norwich Pharmacal), 415 F.2d 390 (5th Cir. 1969); United States v. Article of Drug . . . Furestol Vaginal Suppositories, 294 F.Supp. 1307 (N.D.Ga.1968).

Other Courts have searched for proof of general recognition in different, other directions and have required a higher degree of proof to establish non-recognition. The most common procedure is the disposition of the cause in drug cases of this nature on cross-motions for summary judgment which are accompanied by various affidavits attesting to the non-recognition or general recognition of the drug as the case may be. These affidavits must be directed not at the "safe and effective" portion of 21 U.S.C. § 321 (p) but at the "generally recognized" portion and actual safety and effectiveness is not at issue under this test. Thus actual safety proven by a small sampling short of general recognition is not sufficient to cure violations of the regulations applying to new drugs. AMP v. Gardner, 389 F.2d 825 (2nd Cir.1968); United States v. 41 Cases . . . Naremco, Inc., 420 F.2d 1126 (5th Cir. 1970); Tyler Pharmacal Dist., Inc. v. HEW, 408 F.2d 95 (7th Cir. 1969); United States v. Article of Drug . . . Furestol Vaginal Suppositories, supra.

Some difficulty has been encountered by the Courts in determining precisely what degree of recognition both in quantity and quality constitutes "general recognition" under the statute and that task is rendered all the more difficult when it must be accomplished within the strict confines of the summary judgment rule on the basis of conflicting affidavits which all claim...