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UNITED STATES v. TORIGIAN LABS.

January 18, 1984

UNITED STATES of America, Plaintiff,
v.
TORIGIAN LABORATORIES, INC., and Puzant C. Torigian, Defendants



The opinion of the court was delivered by: BARTELS

MEMORANDUM-DECISION AND ORDER

 BARTELS, Senior District Judge.

 This criminal prosecution under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 331(a), (k), resulted in a verdict by Magistrate Caden that the defendants, Torigian Laboratories, Inc., and Puzant C. Torigian, were guilty of all eighteen counts of the information with which they were charged.

 In or about October, 1976, the defendants received intraocular lenses from Copeland Intra Lenses, Inc. for the purposes of sterilization, individual packaging in vials and labeling. After performing the work, the defendants sent the lenses back to Copeland.

 It was determined below that three lots of intraocular lenses, which were packaged in sealed containers and marked as "sterile", were in actuality contaminated with pseudomonas and other micro-organisms. The defendants were found by the Magistrate to be guilty of causing the lenses in these three lots to be adulterated (counts 1 through 3) and misbranded (counts 4 through 6), and of causing the delivery for introduction into interstate commerce of six shipments of intraocular lenses that were adulterated (counts 7 through 12) and misbranded (counts 13 through 18).

 The defendants appeal on four grounds: 1) the information should have been dismissed for vagueness; 2) the information should have been dismissed for being multiplicious; 3) the defendant Puzant C. Torigian should not have been held to be personally responsible; and 4) the government did not prove beyond a reasonable doubt that the lenses were adulterated by Torigian Laboratories.

 After having carefully examined the briefs as well as the decision of Magistrate Caden, and based upon the oral argument, this court concludes that the Magistrate's decision thoroughly and correctly analyzed the issues raised in this appeal and that it is supported by substantial evidence in the record. Accordingly, this court affirms the Magistrate's decision in all respects and adopts his well considered opinion.

 SO ORDERED.

 -- APPENDIX --

 MEMORANDUM OF DECISION

 CADEN, United States Magistrate.

 This is a criminal prosecution under the Federal Food, Drug and Cosmetic Act (the "Act"), 21 U.S.C. § 321 et seq. [§ 301 et seq.]. The eighteen count information charges the defendants, Torigian Laboratories, Inc. and Dr. Puzant C. Torigian, with four kinds of criminal violations. *fn1" They are charged with violating 21 U.S.C. § 331(k) by causing intraocular lenses, "devices" within the meaning of 21 U.S.C. § 321(h), to be processed while being held for sale after their shipment in interstate commerce, resulting in the lenses being adulterated (counts 1 through 3) and misbranded (counts 4 through 6). They are further charged with violating 21 U.S.C. § 331(a) by causing the delivery for introduction into interstate commerce of intraocular lenses that were adulterated (counts 7 through 12) and misbranded (counts 13 through 18).

 All of the counts result from defendants alleged processing and shipping, in or about October, 1976, of three lots of intraocular lenses, numbered 76285, 76289 and 76296, which were packaged in sealed containers marked "sterile" but which were contaminated with pseudomonas and other micro-organisms. Counts 1 through 3 and 7 through 12 charge that the lenses were adulterated within the meaning of 21 U.S.C. § 351(c) because their purity was less than they were represented to possess. Counts 4 through 6 and 13 through 18 charge that the lenses were misbranded within the meaning of 21 U.S.C. § 352(a) and (j) because their labeling was false or misleading and because they were dangerous to health when used in the manner suggested in their labeling.

 On the first day of trial, defendants surprised the government and the court with the filing of a motion to dismiss the information upon the affidavit of defendants' counsel, Howard F. Cerny (Tr. I, pp. 1-26). *fn2" The affidavit contained various allegations and legal arguments. Mr. Cerny argued that: (1) the information contained duplicitous counts which must be stricken; (2) the use of the term "sterile" in the information, unaccompanied by specific reference to a particular contaminant, namely pseudomonas, was so vague as to render the charges unconstitutional; (3) the statements made by Dr. Torigian during Food and Drug Administration ("FDA") inspections of Torigian Laboratories should be suppressed because the defendant was "in custody"; (4) the government was precluded from bringing the criminal action because the government had previously elected a civil remedy; and (5) defendants were prejudiced due to the unavailability of a potential witness at trial.

 In view of the surprise occasioned by the motion, the court reserved decision with respect to grounds (1), (2), (4) and (5) until after the government had put in its evidence, and permission was granted for defense counsel to renew the motion at that time (Tr. I, pp. 1-26). The court ruled that ground (3) would be addressed at an appropriate time during the trial (Tr. I, pp. 20-21).

 Grounds (1), (2), (4) and (5) were renewed. Subsequently, defendants, in their Post Trial Memorandum, charged that the information was multiplicious. Whether this constituted a new ground for the motion to dismiss the information or merely a modification of ground (1) above (charging that the information was duplicitous) was not made clear.

 A. Defendants' Motion to Dismiss the Information

 Defendants' motion to dismiss the information was formally denied at trial (Tr. IV, pp. 190-192). The denial stands.

 1. The Information Was Neither Duplicitous Nor Multiplicious

 "Duplicity" means the charging of more than one offense in a single count. 8 Moore's Federal Practice, § 8.03 (1981).

 Counts 1 through 3 allege that defendants adulterated three lots, or batches, of lenses while holding the same after their shipment in interstate commerce. Counts 7 through 12, on the other hand, allege that defendants caused 13 specific adulterated lenses to be delivered for introduction into interstate commerce. Likewise, counts 4 through 6 charge the misbranding of three lots, or batches, of lenses while the same were held for shipment in interstate commerce, while counts 13 through 18 charge that defendants caused the delivery of 13 specific misbranded lenses for introduction into interstate commerce.

 None of the counts are duplicitous. Defendants apparently mean to argue that the counts were multiplicious.

 The counts are not multiplicious. The test for multiplicity was enunciated by the Supreme Court in Blockburger v. United States, 284 U.S. [299], 304 [284 U.S. 299, 52 S. Ct. 180, 182, 76 L. Ed. 306] (1932), as follows:

 
The test to be applied . . . is whether each [violation] requires proof of an additional fact which the other does not.

 Defendants argue that, because the requirement of interstate commerce is merely jurisdictional, United States v. Eisenberg, 596 F.2d 522, 526 (2d Cir.1979), no distinction can be drawn between counts 1 through 3 and 7 through 12, all of which concern adulteration of lenses, and, similarly, no distinction can be drawn between counts 4 through 6 and 13 through 18, all of which concern misbranding of lenses. Defendants are mistaken.

 For counts 1 through 3, the government was required to prove that defendants caused lenses to be adulterated while the same were held for sale after their shipment in interstate commerce. 21 U.S.C. § 331(k). For counts 7 through 12, the government was required to prove that, after the adulteration, defendants took the next step of delivering 13 adulterated devices for shipment in interstate commerce. 21 U.S.C. § 331(a). The Act defines two separate actions as distinct violations -- first, the adulteration of the device and, second, causing the delivery of the adulterated device for introduction into the channels of interstate commerce. The same distinction exists for the counts alleging misbranding: for counts 4 through 6, the government must prove that defendants caused the misbranding, while, for counts 13 through 18, the government must prove that defendants caused the misbranded lenses to be delivered for introduction into interstate commerce.

 2. The Information is Not Unconstitutionally Vague

 The information charged in all counts that defendants had represented certain lenses, or batches of lenses, to be sterile when they were not sterile (Counts 1-3 and 7-12), or that they had labeled certain lenses, or batches of lenses, as sterile when they were not sterile (Counts 4-6 and 13-18). Testimony at trial established that "sterile" is a word of common usage, meaning the absence of microbial contamination (Tr. II, p. 45; Tr. IV, pp. 30, 108-109). Dr. Torigian himself expressed no confusion when asked about the sterility of the lenses (See, e.g., Tr. V, p. 92, "Q: And you knew that intraocular lenses needed to be sterile didn't you? A: Absolutely"). Documents obtained from the defendants and introduced into evidence demonstrate that, at the time of the occurrences charged in the information, defendants fully understood the meaning of "sterile" and "sterility" (See, e.g., Exhibits 3, 22-25, 30). Furthermore, the Government has assured the court that defendants were offered the opportunity in May 1982, to inspect all documents relating to the case, including the work sheets of the FDA analysts and copies of the FDA inspector's report on Torigian Laboratories, which information reveals the FDA's finding of contamination of pseudomonas (Tr. IV, pp. 191-192; Government's Response to Defendant's Post Trial Memorandum, at 2). Thus, defendants knew or reasonably should have known well ahead of trial that the contamination found on each lense was pseudomonas. I note also that defendants filed no motion for additional discovery.

 In any event, the gravamen of the offenses charged is not that the lenses were contaminated with pseudomonas, but that the lenses were not sterile when so represented and labeled. That the contaminating organism was pseudomonas was merely evidence. There is no requirement that an information plead evidence. Van [Liew] v. United States, 321 F.2d 664, 670 (5th Cir. 1963).

 The information fairly apprised defendants of the nature of the accusations against them: it specified lot numbers, lens numbers, date, and the representation or labeling that was false or misleading. The facts were "set forth with reasonable particularity of time, place and circumstances." United States v. Cruikshank, 92 U.S. 542, 558 [23 L. Ed. 588] (1875); Russell v. United States, 369 U.S. 749, 765 [82 S. Ct. 1038, 1048, 8 L. Ed. 2d 240] (1962).

 3. Testimony Concerning Statements Made By Dr. Torigian Was Properly Admitted

 Defendants objected to the admission of testimony by Mr. Stewart Mueller concerning statements made by Dr. Torigian during the course of the FDA inspection based on the failure to give Dr. Torigian his Miranda warnings. Based on the evidence presented at trial, the court ruled that defendants were not in the custody of the FDA at any time, citing Miranda v. Arizona, 384 U.S. 436 [86 S. Ct. 1602, 16 L. Ed. 2d 694] (1966) (Tr. III, p. 60). The court additionally ruled that the inspections were proper, regulatory inspections done under statutory authority, that no criminal search warrant was required, and that the records provided by defendants were given voluntarily (Tr. II, p. 84). See also United States v. Jamieson-McKames Pharmaceuticals, Inc., 651 F.2d 532, 536-40 (8th Cir. 1981), cert. denied, 455 U.S. 1016, 102 S. Ct. 1709 [72 L. Ed. 2d 133] (1982); United States v. New England Grocers Supply Co., 488 F. Supp. 230, 237-39 (D. Mass. 1980).

 4. The Government's Pursuit Of A Civil Remedy Did Not Foreclose Criminal Prosecution

 Defendants argue that it was unconscionable for the government to prosecute defendants some years after obtaining injunctive relief based upon the same misconduct. Defendants cite no authority for this proposition. The Act specifically provides for both civil penalties, such as injunctions (21 U.S.C. § 332) and seizures (21 U.S.C. § 334), and criminal penalties (21 U.S.C. § 333). The government may use one, two or all three types of relief; it need not choose among them. See United States v. Kordel, 397 U.S. 1, 11 [90 S. Ct. 763, 769, 25 L. Ed. 2d 1] (1970).

 5. Defendants Have Failed To Demonstrate Actual Prejudice By The Delay In The Criminal Action

 Defendants argue that the government is estopped from bringing a criminal proceeding because at the time of trial a potential witness, Ms. Jay Shree Lala, was unavailable to testify.

 The decisions by the Supreme Court in United States v. Lovasco, 431 U.S. 783 [97 S. Ct. 2044, 52 L. Ed. 2d 752] (1977), and United States v. Marion, 404 U.S. 307 [92 S. Ct. 455, 30 L. Ed. 2d 468] (1971), are dispositive on the issue of whether pre-indictment delay warrants dismissal of an indictment. The Court in Lovasco emphasized that the defendants' primary protection against pre-indictment delay is statutory rather than constitutional in nature:

 
. . . Statutes of limitation, which provide predictable, legislatively enacted limits on prosecutorial delay, provide "the primary guarantee against bringing overly stale criminal charges."

 431 U.S. at 789 [97 S. Ct. at 2048] (quoting United States v. Marion, 404 U.S. at 322 [92 S. Ct. at 464] and United States v. Ewell, 383 U.S. 116, 122 [86 S. Ct. 773, 777, 15 L. Ed. 2d 627] (1966)). The defendants concede that the instant case is not barred by the statute of limitations.

 Accordingly, when a case is brought within that statutory period, the Fifth Amendment's Due Process Clause has only "a limited role to play." United States v. Lovasco, 431 U.S. at 789 [97 S. Ct. at 2048]. To invoke that role, the Court mandated a showing by the defendant that the delay resulted in ...


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