Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

UNITED STATES v. ARTICLES OF DRUG

March 21, 1983

UNITED STATES of America, Plaintiff,
v.
ARTICLES OF DRUG, consisting of the following: 15 CARTONS, more or less each carton containing 12/2500 tablet bottles, labeled in part: (bottle) "ZENITH * * * HYDRALAZINE HCL, HYDROCHLOROTHIAZIDE AND RESERPINE TABLETS * * * 2500 Tablets * * * Zenith Laboratories, Inc., Northvale, New Jersey 07647 * * * Control No. 2335-58 * * *" and 1/1000 tablet bottles, more or less, labeled in part: (bottle) "Zenith * * * Hydralazine HCL, Hydrochlorothiazide and Reserpine tablets * * * 1000 tablets * * * Zenith Laboratories, Inc., Northvale, New Jersey 07647 Control No. 2338-58 * * *" 160 cartons, more or less, each carton containing 12/1000 tablet bottles labeled in part: (bottle) "Zenith * * * Hydralazine HCL, Hydrochlorothiazide and Reserpine tablets * * * 1000 tablets * * * Zenith Laboratories, Inc., Northvale, New Jersey 07647 * * * Control No. 2335-62R * * *"



The opinion of the court was delivered by: SAROKIN

 In December, 1981, during an inspection of Zenith Laboratories, Northvale, New Jersey (Zenith or Claimant), Investigator Elaine M. Hall of the United States Food and Drug Administration (FDA) collected samples of two articles of drug which had been manufactured by Zenith; that is, Lots 2335-58 and 2335-62R of Zenith's Hydralazine HCL, Hydrochlorothiazide and Reserpine Tablets. These samples were analyzed and tested by FDA's National Center for Drug Analysis. The samples failed to meet the prescribed standards for content uniformity for one of the articles' components, reserpine.

 On April 13, 1982, Plaintiff filed a complaint for forfeiture, alleging that Lots 2335-58 and 2335-62R are adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C. Section 351(b), in that they purport to be a drug, but their strength differs from, and their quality falls below, the standard set forth in the United States Pharmacopeia (USP). The complaint alleges that the drugs fail to meet the standard for content uniformity set forth in the USP. Pursuant to Warrant for Arrest issued by this court, the United States Marshal for this District seized said articles on August 12, 1982. On August 20 Zenith filed a Claim to the articles. On September 7 Zenith filed an Answer.

 Zenith has filed a motion to dismiss the complaint for lack of jurisdiction over the subject matter alleging that the seized articles are not "held for sale" after shipment in interstate commerce as required by 21 U.S.C. Section 334(a). Zenith concedes that the articles of drug involved were placed in the stream of interstate commerce before Zenith was advised of the deficiency in the product. Zenith claims that prior to release of the drugs they were tested, with methods at variance with the method set forth in the USP, and found to be acceptable. Zenith argues that the articles were not being "held for sale" either at the time of seizure or at the time of filing of the complaint, because Zenith voluntarily withheld them from sale. Zenith points to an inter office memorandum dated December 22, 1981, directing that Lot number 2335-62R "shall be held pending FDA and Zenith outside laboratory testing results."*Zenith claims that the articles of drug were withheld from sale in the expectation that the Zenith method of testing would be approved in the USP, or that reformation of the drugs would bring them into compliance with FDA standards.

 The court has jurisdiction over the subject matter of this suit if the requirements of 21 U.S.C. Section 334(a)(1) are met:

 
Any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce, or which may not, under the provisions of section 344 or 355 of this title, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States or United States court of a Territory within the jurisdiction of which the article is found. . ..

 The term "held for sale" in the statute has been broadly construed. "An article is 'held for sale' if it is used for any purpose other than personal consumption." United States v. Articles of Animal Drug Containing Deithylstilbestrol, 528 F. Supp. 202, 205 (D.Neb.1981) (drugs were held for sale despite the claimant's representation that, at the time of seizure, the drugs were being held for return to the manufacturer for refund of the purchase price.) This is consistent with the broad purpose of the statutory scheme. "The Act was designed to safeguard the consumer from the time the article is introduced into the stream of interstate commerce all the way to the moment of delivery to the ultimate consumer." Id. at 206, citing United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 92, 84 S. Ct. 559, 563, 11 L. Ed. 2d 536 (1964). The articles of drug seized were not being held for personal consumption by Zenith, so they were being "held for sale" within the meaning of the statute both at the time of seizure and at the time of the filing of the complaint.

 The fact that Zenith may have intended in the future to cure any adulteration of these drugs does not alter the conclusion that they were being held for sale.

 In United States v. 52 Drums Maple Syrup, 110 F.2d 914 (2d Cir.1940), the trial court had allowed claimant to introduce evidence in support of its argument that the statute did not apply to seizures of maple syrup alleged to contain a poisonous substance, lead, because Claimant would have removed the offending lead before it sold or otherwise disposed of the syrup. The Second Circuit reversed, stating, that this "was a wholly false issue. The intended use to which adulterated food is to be put after it has been shipped in interstate commerce is immaterial on the question of the government's right to forfeit because of such shipment." Id. at 915.

 The statute provides that an adulterated drug "shall be liable to be proceeded against while in interstate commerce, or at any time thereafter . . .." Zenith argues that this language does not allow seizure when the drug has traveled up the stream of interstate commerce, back to the manufacturer. This construction of the statute is plainly incorrect. "In plain, direct and unambiguous language, 21 U.S.C.A. Section 334(a)(1) provides that any adulterated article of drug which is held for sale after shipment in interstate commerce is subject to seizure and condemnation." Articles of Animal Drug, 528 F. Supp. at 206.

 
The government may condemn a device even though not inherently dangerous and not presently in interstate commerce . . . (citations omitted). Once an article is misbranded, it has violated the law and is subject to seizure at any time thereafter and no subsequent action can purge it from the violation.

 United States v. Device Labeled "Cameron Spitler, Amblyo-Syntonizer," 261 F. Supp. 243, 246 (D.Neb.1966). See also Articles of Animal Drug, 528 F. Supp. at 205.

 These articles are alleged to have been adulterated while in interstate commerce and were clearly subject to ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.