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129.

Sample United States' Memorandum in Opposition to Defendants' Motion to Strike Surplusage From Indictment

Defendants have moved under Fed. R. Crim. P. 7(d) to strike Paragraphs 1 through 5 of the Indictment.[FN1] Those paragraphs are incorporated in all counts of the Indictment. In sum, the challenged paragraphs allege that the United States Food and Drug Administration (FDA) was charged with ensuring compliance with portions of the Federal Food, Drug, and Cosmetic Act and "good manufacturing practice" requirements that are described in those paragraphs and are at the core of the conspiracy and substantive counts. These allegations are legally relevant to the charges and neither inflammatory nor prejudicial. Accordingly, defendants cannot meet the exacting standards governing motions to strike, and their motion should be denied.

FN1. The motion was filed by Defendants Animal Drug Laboratories, Inc., and XXXXXXXX XXXXXXXX. Defendant XXXXX XXXXXXXX has joined in the motion [NOTE: names changed from original].
A. BACKGROUND

All defendants are charged with a conspiracy to commit offenses against the United States by manufacturing and distributing adulterated and misbranded drugs, and by taking steps to prevent FDA from learning of their illegal activities. They are also charged with 18 substantive Federal Food, Drug, and Cosmetic Act (FFDCA) violations. Two of the defendants, Animal Drug Laboratories, Inc., (Animal Drug) and XXXXXXXXX XXXXXXXX, are charged with two counts of making false statements violating 18 U.S.C. { 1001.

Counts 2-19 allege that defendants acted with "intent to defraud or mislead." Among others, defendants intended to defraud FDA. Defendants defrauded FDA by denying to that agency the ability to regulate Animal Drug in the manner required by the FFDCA.[FN2] The false statements counts (20 and 21) allege that defendants, in a matter within the jurisdiction of the FDA, made and used documents containing materially false entries.

FN2. See United States v. Bradshaw, 840 F.2d 871, 874 (11th Cir.), cert. denied, 488 U.S. 924 (1988).
Therefore, proof of the substantive counts will establish the manner in which FDA regulates Animal Drug, the diverse ways Animal Drug circumvented FDA, and the materiality of various documents to matters within FDA's jurisdiction. Because the conspiracy was to violate the FFDCA, these matters are equally relevant to the conspiracy count. The allegations of paragraphs 1-5 of the Indictment, which are incorporated in all counts, are highly relevant to these offenses. Indeed, without them the Indictment would be difficult to understand, and the fraud and materiality elements would be plead in a vacuum.

B. THE ALLEGATIONS OF THE INDICTMENT ARE PROPER, AND DEFENDANTS CANNOT CARRY THE HEAVY BURDEN OF SHOWING OTHERWISE

Under Fed. R. Crim. P. 7(d), "[a]llegations will be stricken as surplusage only if 'it is clear that the allegations are not relevant to the charge and are inflammatory and prejudicial.'" United States v. Bucey, 691 F. Supp. 1077, 1081 (N.D. Ill. 1988), (quoting Wright & Miller, Federal Practice and Procedure, { 127 (1982)), aff'd in part, rev'd in part on other grounds, 876 F.2d 1297 (7th Cir.), cert. denied, 110 S. Ct. 565 (1989). "Simply put, legally relevant information is not surplusage. Consequently, due to the exacting standard, motions to strike information as surplusage are rarely granted." Bucey, 691 F. Supp. at 1081 (citation to authority omitted).[FN3]

FN3. The same standard governs motions to strike "legal" rather than factual allegations. See cases cited at p. 8, infra.
Other cases frequently cited for these propositions include United States v. Climatemp, Inc., 482 F. Supp. 376, 391 (N.D. Ill. 1979) (indictment language the government hopes to prove at trial cannot be considered surplusage no matter how prejudicial it may be, if it is legally relevant), aff'd mem., 705 F.2d 461 (7th Cir.), cert. denied sub nom., Fakter v. United States, 462 U.S. 1134 (1983), and United States v. Richter, 610 F. Supp. 480, 496 (N.D. Ill. 1985) (only "irrelevant, inflammatory and prejudicial allegations" can be struck, however, legally relevant information is not surplusage), aff'd mem. sub nom., United States v. Mangovski, 785 F.2d 312 (7th Cir.), aff'd mem. sub nom., United States v. Konstantinov, 793 F.2d 1296 (7th Cir.), cert. denied, 479 U.S. 855 (1986). Accord United States v. Lov-It Creamery, Inc., 704 F. Supp. 1532, 1550-51 (E.D. Wis. 1989).[FN4]

FN4. The Seventh Circuit has not squarely stated grounds for striking indictment language as surplus. The view of other circuits is the same as the courts cited in the text, i.e., that to strike information from an indictment, the language must be inflammatory, unnecessary, irrelevant, and immaterial. E.g., United States v. Thomas, 875 F.2d 559, 562 n.2 (6th Cir. 1989); United States v. Poore, 594 F.2d 39, 41 (4th Cir. 1979).
Because they are relevant to the charges and not prejudicial, the paragraphs of the Indictment at issue should not be struck. They properly set forth the background for the offenses charged, and are directly related to the intent and materiality elements of the substantive offenses, as set forth above. "An indictment may properly set forth background information relevant to a defendant's motive and intent." United States v. Persico, 621 F. Supp. 842, 860 (S.D.N.Y. 1985). Similarly, Climatemp upheld language in an antitrust indictment which gave "background about the sheet metal industry in general and in Chicago in particular" because the language was not prejudicial, and was "relevant to forming an understanding about the nature of this action." 482 F. Supp. at 391-92. Accord United States v. Wecker, 620 F. Supp. 1002, 1006 (D. Del. 1985) (refusing to strike allegations that "while not essential to the charges, are certainly in a general sense relevant to the overall scheme . . . charged"); United States v. Poindexter, 725 F. Supp. 13, 37 (D. D.C. 1989) (indictment allegations describing relationship between United States and Iran proper because necessary to understanding allegedly false statements); United States v. Chaverra-Cardona, 667 F. Supp. 609, 611 (N.D. Ill. 1987) (portions of indictment properly gave background information concerning defendant's incarceration for narcotics offenses to prevent parts of the indictment from being "unintelligible to a jury").[FN5]

FN5. Courts have generally refused to strike even emotionally charged language in indictments if the allegations were relevant to the offenses alleged. See United States v. Napolitano, 552 F. Supp. 465, 480 (S.D.N.Y. 1982) (reference to "the Bonanno Family of La Cosa Nostra" proper because explanatory of structure of criminal association); Persico, 621 F. Supp. at 860, (references to "organized crime," "anti-bugging" equipment, and the use of such aliases as "the Beast" and "the Snake"); Bucey, 691 F. Supp. at 1081-82 (allegations of drug trafficking and narcotics transactions in a mail fraud indictment); Richter, 610 F. Supp. at 496, n.25-26 (references to "laundering" which the indictment defined as "illegally secreting" cash); Chaverra-Cardona, 667 F. Supp. at 610-11 (references to defendant being an inmate awaiting trial for narcotics offenses).
In the instant case, the challenged paragraphs are well within the bounds of proper allegation. Not only do they provide essential background information required to make sense of the substantive offenses, but they also provide a context for motive and intent. Moreover, there is nothing about the challenged language that is inflammatory or prejudicial.

C. DEFENDANTS' MOTION SETS FORTH NO ADEQUATE JUSTIFICATION FOR THE REQUESTED RELIEF

Defendants' motion to strike is based upon the assertion that the paragraphs at issue are "statements of law which deviate entirely from the statutes the defendants are accused of violating and are of only arguable validity." (Motion, ¶ 1.) Defendants also argue that these paragraphs are statements of law that should only be read as jury instructions (id., ¶ 2), and that reading statements of law to the jury at the outset of the case is unnecessary, cumulative, and potentially prejudicial (id., ¶ 3).

Defendants' assertion that paragraphs 1-5 "deviate" from the statutes they are charged with violating cannot be answered in detail, for defendants have not specified any alleged deviations. There are no mis-statements of law in those paragraphs. To the extent the language does not precisely follow the statute, the differences are neither significant nor prejudicial.[FN6]

FN6. Paragraph 1 merely identifies FDA. The government will offer testimonial proof at trial as to paragraph 5 of the Indictment, which describes certain "good manufacturing practice" requirements. Paragraphs 2-4 are based on provisions of the FFDCA. Paragraph 2 follows from 21 U.S.C. {{ 352(b) and (f)(1), which define certain conditions that result in a drug being misbranded, and 21 U.S.C. {{ 331(a) and (k), which prohibit interstate shipment of misbranded drugs, and acts which cause a substance that has moved in interstate commerce to be misbranded. Paragraph 3 reflects the plain meaning of 21 U.S.C. { 321(g)(1)(B) and (C). Paragraph 4 reflects the requirements of 21 U.S.C. { 360b(a)(1)(A) (new animal drugs are "unsafe" unless there is an FDA approval in effect for them), 21 U.S.C. { 351(a)(5) ("unsafe" new animal drugs are adulterated), and 21 U.S.C. {{ 331(a) and (k), which prohibit interstate shipment of adulterated drugs, and acts which cause a substance that has moved in interstate commerce to be adulterated.
In any event, the law is settled that the truth of an indictment's allegations are to be tested at trial, not through pretrial motion. United States v. Knox, 396 U.S. 77, 83 (1969).

Nevertheless, we hasten to emphasize that these paragraphs contain substantive factual allegations. For example, to prove that defendants deviated from "good manufacturing practice," the government will introduce expert testimony on the requirements of good manufacturing practice. Therefore, there will be testimony concerning the allegations of paragraph 5 of the Indictment. Similarly, witnesses will attest to FDA's responsibility to enforce the FFDCA, as set forth in paragraph 1.

Defendants' other assertions, that these paragraphs should only be read as jury instructions, and that reading the paragraphs at the outset of the trial would be prejudicial, are incorrect and premature.[FN7] The government's research for this memorandum revealed no case holding that material should be struck from an indictment because it related to potential matter for jury instruction. Rather, the cases judge statutory discussion in indictments using the same factors used to judge factual assertions.

FN7. Any issue regarding the reading of the indictment, or portions of it, to the jury, can be addressed by the Court at trial. Compare United States v. Wheaton, 463 F. Supp. 1073, 1076 (S.D.N.Y.) (allegations not struck from indictment, subject to proof at trial--indictment would not be furnished to jury before the close of evidence), aff'd mem., United States v. Williams, 614 F.2d 1293 (2d Cir. 1979); United States v. Chaverra-Cardona, 667 F. Supp. 609, 611 (N.D. Ill. 1987) (portions of indictment properly giving background information concerning defendant's incarceration for narcotics offenses proper--cautionary instructions would prevent any prejudice).
Thus, courts dealing with such "legal" allegations of an indictment have struck them only where they are irrelevant, prejudicial, and confusing. In United States v. Walters, 711 F. Supp. 1435 (N.D. Ill. 1989), the defendant moved to strike a portion of the indictment which described and summarized various United States laws, including the mail and wire fraud statutes. The defendant's argument was similar to Animal Drug's. The court denied the motion because the statutes were relevant to the charges and the defendant failed to articulate a plausible prejudice argument. Id. at 1450. See also United States v. Poindexter, 725 F. Supp. 13, 36 (D. D.C. 1989) (references to the Boland Amendment which governed United States aid to Nicaraguan Contras appropriate in indictment relating to "Iran-Contra" affair); United States v. Turoff, 652 F. Supp. 707, 713 (E.D.N.Y. 1987) (references to New York state law not struck because relevant to charges even though not describing elements of the offense charged).[FN8] Thus, a motion to strike a portion of an indictment referring to a law, like any other motion to strike, should be denied absent a showing of irrelevance, prejudice, and potential for confusion. Defendants' assertion that a portion of the indictment contains references to law provides no basis for their motion to strike.

FN8. In United States v. Mandel, 415 F. Supp. 997, 1009 (D. Md. 1976), aff'd, 602 F.2d 653 (4th Cir. 1979), cert. denied, 445 U.S. 961 (1980), on the other hand, the court struck a reference to the Maryland Code of Ethics that was irrelevant, prejudicial, and confusing to the jury.
CONCLUSION

Defendants' Motion to Strike paragraphs 1-5 of the Indictment should be denied.

Dated: March 13, 1991

Respectfully submitted,

GRANT C. JOHNSON United States Attorney OF COUNSEL: ________________________ Kenneth L. Jost

Eric M. Blumberg Office of Consumer Litigation Associate Chief Counsel for U.S. Department of Justice Enforcement Room 6104 Todd Building United States Food and Drug 550 11th Street, N.W. Administration Washington, D.C. 20004 5600 Fishers Lane (202) 307-0048 Rockville, Maryland 20857 (301) 443-43800