United States v. Torigian Laboratories, Inc., 81 Cr. 598.

• Citation: 577 F. Supp. 1514
• Decision Date: 18 January 1984
• Docket Number: No. 81 Cr. 598.,81 Cr. 598.
• Parties: UNITED STATES of America, Plaintiff, v. TORIGIAN LABORATORIES, INC., and Puzant C. Torigian, Defendants.
• Court: U.S. District Court — Eastern District of New York

577 F. Supp. 1514

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

No. 81 Cr. 598.

United States District Court, E.D. New York.

January 18, 1984.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

David G. Adams, Associate Chief Counsel for Enforcement, U.S. Food and Drug Administration, Rockville, Md., Raymond J. Dearie, U.S. Atty. for the Eastern Dist. of N.Y., Brooklyn, N.Y. by Vicki G. Golden, Consumer Affairs Section, Antitrust Div., Dept. of Justice, Washington, D.C., for plaintiff.

Howard F. Cerny, John T. McDonald, New York City, for defendants.

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.¹ 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).² 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 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...