US v. Seven Cardboard Cases of an Article of Drug, 88-1398C(3).

• Decision Date: 10 July 1989
• Docket Number: No. 88-1398C(3).,88-1398C(3).
• Citation: 716 F. Supp. 1221
• Parties: UNITED STATES of America, Plaintiff, v. SEVEN CARDBOARD CASES, MORE OR LESS, OF AN ARTICLE OF DRUG ... "100 CAPSULES NDC * * * ESGIC * * * WITH CODEINE CAPSULES, etc., Defendant, and Forest Pharmaceuticals, Inc., Claimant-Defendant.
• Court: U.S. District Court — Eastern District of Missouri

716 F. Supp. 1221

UNITED STATES of America, Plaintiff, v. SEVEN CARDBOARD CASES, MORE OR LESS, OF AN ARTICLE OF DRUG ... "100 CAPSULES NDC * * * ESGIC * * * WITH CODEINE CAPSULES, etc., Defendant and Forest Pharmaceuticals, Inc., Claimant-Defendant.

No. 88-1398C(3).

United States District Court, E.D. Missouri, E.D.

July 10, 1989.

Henry J. Fredericks, Asst. U.S. Atty., St. Louis, Mo., for U.S.

Greensfelder, Hemker, Wiese, Gale & Chappelow, Edward A. Chod and John W. Moticka, St. Louis, Mo., Jacqueline H. Eagle, Office of Consumer Litigation, U.S. Dept. of Justice, Washington, D.C., Clayton H. Paterson, Food and Drug Admin., Rockville, Md., for claimant-defendant Forest Pharmaceuticals.

ORDER

HUNGATE, District Judge.

On June 21, 1989, in open Court, the parties argued plaintiff's motion for summary judgment and Forest Pharmaceuticals, Inc.'s motion to strike Mr. Hamilton's declaration. The defendants, a prescription analgesic drug product, Esgic with Codeine,¹ and its distributor, Forest Pharmaceuticals, Inc., oppose the motion.

Plaintiff filed this action under the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 334, seeking the condemnation and destruction of the drug product, Esgic with Codeine, because the product is a "new drug" within the meaning of 21 U.S.C. § 321(p) that may not, without violating 21 U.S.C. § 355(a), be introduced into interstate commerce. Section 355(a) prohibits the interstate distribution of any "new drug" unless that drug is the subject of an application approved by the Food and Drug Administration ("FDA") confirming the drug's safety and effectiveness. There is no such FDA-approved application in effect for Esgic with Codeine. In addition, plaintiff seeks to permanently enjoin the drug's distributor, Forest Pharmaceuticals, Inc. ("Forest"), pursuant to 21 U.S.C. § 332, from the continued unlawful interstate distribution of the drug.

Forest admits that Esgic with Codeine is a drug and that it was shipped in interstate commerce. Forest also admits that there is no FDA approval of an application filed pursuant to 21 U.S.C. § 355 in effect for the drug, and that it has been, and still is, distributing Esgic with Codeine in interstate commerce, despite the lack of FDA approval of the drug's safety and effectiveness. In light of these admissions, there is only one issue before the Court: whether, based upon the undisputed facts, Esgic with Codeine is a "new drug" within the meaning of 21 U.S.C. § 321(p). If it is a "new drug," which Forest denies,² the amount of the drug under seizure should be condemned pursuant to 21 U.S.C. § 334 because the FDA has not approved an application for it under 21 U.S.C. § 355. In addition, Forest's continued distribution of the drug should be enjoined, pursuant to 21 U.S.C. § 332, because the continued distribution of a "new drug" not subject to an FDA-approved application violates 21 U.S.C. §§ 355 and 331(d).

To protect the public from drugs that are not safe and effective, Congress has created a scheme that strictly limits the drugs which may be distributed in interstate commerce without first being subjected to premarket review and approval by the FDA. Congress has not, however, conferred plenary power on the FDA to require such premarket approval of all drugs. Drugs that are not "new drugs" may be marketed without being subjected to any premarketing review by the FDA. Drugs that are "new drugs," however, may not be legally marketed until a new drug application, that establishes that the drug is safe and effective, has been submitted to and approved by the FDA. The crux of this case, therefore, is whether Forest may legally market Esgic with Codeine without submitting any data whatever to the FDA to establish that the drug is safe and effective for the conditions for which it is marketed.

The Act defines a "new drug," in relevant part, as:

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.

21 U.S.C. § 321(p) (emphasis added). Therefore, "new drug" does not mean simply a drug that is new on the market, and "the mere fact that a drug product has been marketed for an extended period does not preclude a finding of `new drug' status." United States v. Articles of Drug ... Hormonin, 498 F.Supp. 424, 432 (D.N. J.1980), aff'd without opinion, 672 F.2d 904 (3d Cir.1981). Rather, it is any drug, regardless of how old, about which insufficient data exists upon which qualified experts can reach a consensus that the drug is safe and effective. In Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 629-30, 93 S.Ct. 2469, 2483, 37 L.Ed.2d 207 (1973), the Supreme Court stated that general recognition by experts must be based upon at least the same quality and quantity of evidence that is necessary to obtain approval of an application for the product in the first instance under 21 U.S.C. § 355.<sup>3</sup> In a companion case, Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653, 93 S.Ct. 2488, 2494, 37 L.Ed.2d 235 (1973), the Supreme Court stated that "the reach of scientific inquiry under both § 505(d) 21 U.S.C. § 355(d) and § 201(p) 21 U.S.C. § 321(p) is precisely the same," and went on to state that "whether a particular drug is a `new drug,' depends in part on the expert knowledge and experience of scientists based on controlled clinical experimentation and backed by substantial support in scientific literature." Id. at 652, 93 S.Ct. at 2493.

In order for a drug product to be generally recognized, therefore, the following elements must be shown:

(1) there must be a consensus of expert opinion that the drug product is safe and effective for its labeled indications (2) that expert consensus must be based upon adequate and well-controlled clinical investigations conducted on the drug product in issue; and

(3) the studies conducted on the drug in issue must be published in the medical literature and available to experts generally.

A drug product that fails to meet any one of the three conditions is a new drug. See United States v. Articles of Drug * * * Promise Toothpaste, supra, 826 F.2d at 569; United States v. An Art. of Drug Con. of 4,680 Pails, supra, 725 F.2d at 985; United States v. 118/100 Tablet Bottles, 662 F.Supp. 511, 513 (W.D.La. 1987).

Summary judgment is proper only "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 a judgment as a matter of law." Fed.R. Civ.P. 56(c). The movant is not required to "support its motion with affidavits or other similar materials negating the opponent's claim." Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986) (emphasis in original). Rather, the moving party must identify the portions of the record and any affidavits that demonstrate the absence of a genuine issue of material fact. Id. Once movant has made a proper showing, the nonmoving party must "go beyond the pleadings and by its own affidavits, or by the `depositions, answers to interrogatories, and admissions on file,' designate `specific facts showing that there is a genuine issue for trial.'" Id. at 324, 106 S.Ct. at 2553. To preclude entry of summary judgment based on a proper motion, the nonmovant must make a sufficient showing on every essential element of its case on which it has the burden of proof at trial. Id. at 322-23, 106 S.Ct. at 2552-53. For "a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial." Id. at 323, 106 S.Ct. at 2552.

The only issue in dispute in this case is whether Esgic with Codeine is, by virtue of its lack of general recognition, a new drug. The government may prove lack of general recognition by proving an absence of material fact as to any of the three elements set out above. United States v. Articles of Drug * * * Promise Toothpaste, supra, 826 F.2d at 569; United States v. An Art. of Drug Con. of 4,680 Pails, supra, 725 F.2d at 985; United States v. 118/100 Tablet Bottles, supra, 662 F.Supp. at 513.

The government in this case filed the declaration of an FDA consumer safety officer which declaration established that, based upon a computer search of the medical and scientific literature, there are no published studies involving Esgic with Codeine or even of any product that contains the same active ingredients as Esgic with Codeine. Thus, there is no literature available to experts generally upon which experts can form an opinion that Esgic with Codeine is generally recognized as safe and effective for its labeled indications.

In opposition, Forest has filed the affidavits of two experts who state they believe Esgic with Codeine to be generally recognized; and Forest has asserted that because the government has filed no such expert affidavits, summary judgment is not appropriate. However, Forest has failed to cite any cases in support of its assertion that, absent countering expert affidavits, summary judgment cannot be entered. Further, Forest has failed to supply any evidence that the government's showing that there are no published studies on Esgic with Codeine is incorrect, and has failed to supply any evidence of any such studies. In fact, Forest's own experts fail to cite any such studies, relying instead on published studies involving products that contain active ingredients other than those contained in Esgic with Codeine, and asserting in general that an opinion concerning Esgic with Codeine can be formed on the basis of extrapolation from studies of other products.

Where there are no published studies, there can be no general...