Opinion ID: 789574
Heading Depth: 2
Heading Rank: 2

Heading: Misbranding (Count Three): Constructive Amendment

Text: 35 Milstein also was convicted of distributing misbranded drugs in interstate commerce with fraudulent intent, in violation of 21 U.S.C. §§ 331(a) and 333(a)(2) (Count Three). The indictment on that count alleged that [f]orgery or falsification of any part of the packaging material, including the instructional inserts, lot numbers or expiration dates, renders the drug misbranded under federal law, and that Milstein and others regularly distributed [the modified drugs] that had been repackaged using forged materials. It further alleged that [t]hey sold these re-packaged drugs as if they were the original product from the licensed manufacturers, thus distributing misbranded drugs. 36 Following Milstein's indictment, the Government claims to have learned that Milstein's drugs also were contaminated with bacteria and endotoxins. The Government contended that its contamination evidence was relevant to Count Three, charging Milstein with selling misbranded drugs, because saline ampules labeled sterile could be considered mislabeled if they were contaminated. On its return to the Grand Jury to obtain the second superseding indictment adding the interstate commerce allegation to other counts, the Government also presented testimony regarding the contamination evidence to the grand jury. The Government did not, however, secure an amendment to Count Three of the indictment to allege that the drugs had been misbranded because they were supposedly sterile when they were not. 37 Nonetheless, at trial, the Government was allowed to present evidence of the contamination; and the court subsequently instructed the jury that it could find Milstein guilty of misbranding as alleged in Count Three if it found that the labeling of the ampules of saline diluent suggested untruthfully that these ampules were sterile ... when in fact they were a danger to health (Trial Tr. 3870). Milstein argues that this instruction, allowing the jury to convict him of misbranding on the basis of the contamination evidence, constructively amended the indictment, leaving it uncertain whether he was convicted of the conduct alleged in the indictment. The Government contends that the generally framed indictment covered the specific theory that the drugs had been misbranded because they were labeled as if they were sterile when in fact they were not. 38 Although the cases dealing with claims of constructive amendment sometimes appear to reach divergent results, see, e.g., Stirone v. United States, 361 U.S. 212, 80 S.Ct. 270, 4 L.Ed.2d 252 (1960); United States v. Zingaro, 858 F.2d 94 (2d Cir.1988); United States v. Salmonese, 352 F.3d 608, 620-22 (2d Cir.2003) ( Salmonese ); United States v. Danielson, 199 F.3d 666, 669-71 (2d Cir.1999); United States v. Patino, 962 F.2d 263, 265-67 (2d Cir.1992), the fundamental principle is clear. When the trial evidence or the jury charge operates to broaden [ ] the possible bases for conviction from that which appeared in the indictment, the indictment has been constructively amended. United States v. Miller, 471 U.S. 130, 138, 105 S.Ct. 1811, 85 L.Ed.2d 99 (1985) (emphasis omitted). Constructive amendment is a per se violation of the Fifth Amendment. United States v. Roshko, 969 F.2d 1, 5-6 (2d Cir.1992). `To prevail on a constructive amendment claim, a defendant must demonstrate that either the proof at trial or the trial court's jury instructions so altered an essential element of the charge that, upon review, it is uncertain whether the defendant was convicted of conduct that was the subject of the grand jury's indictment.' Salmonese, 352 F.3d at 620 (quoting United States v. Frank, 156 F.3d 332, 337 (2d Cir.1998)). There is no constructive amendment where a generally framed indictment encompasses the specific legal theory or evidence used at trial. Salmonese, 352 F.3d at 620 (internal quotation marks omitted). 39 In the instant case, we are persuaded that the indictment, charging Milstein with misbranding due to his repackaging of the drugs, was constructively amended when the Government alleged that the drugs were misbranded because they were not sterile. At the time of Milstein's offenses, there were twenty different methods of misbranding, see 21 U.S.C. § 352(a)-(t) (1994) (describing ways in which one could misbrand drugs), amended by, inter alia, Food and Drug Administrative Modernization Act of 1997, Pub.L. No. 105-115, Title I, §§ 125, 126 (repealing 21 U.S.C. §§ 352(d), 352(k), 352( l )). Alleging, as the Government did in the second superseding indictment, that Milstein was charged with misbranding because he re-packaged drugs as if they were the original product from the licensed manufacturers would not necessarily place Milstein on notice that the Government would also attempt to prove that the drugs were not sterile. The Government seemed to have recognized this when it presented the contamination evidence to the grand jury in the course of obtaining the amendment alleging the jurisdictional element. However, the Government neglected to have Count Three amended to include the contamination allegation. This is precisely the type of activity against which the Supreme Court cautioned in Stirone: 40 The right to have the grand jury make the charge on its own judgment is a substantial right which cannot be taken away with or without court amendment. Here ... we cannot know whether the grand jury would have included in its indictment a charge that commerce in steel from a nonexistent steel mill had been interfered with. Yet because of the court's admission of evidence and under its charge this might have been the basis upon which the trial jury convicted petitioner. If so, he was convicted on a charge the grand jury never made against him. 41 Stirone, 361 U.S. at 218-19, 80 S.Ct. 270. 42 Therefore, we vacate Milstein's conviction on Count Three and remand for a new trial on that count, should the Government wish to pursue the matter, see, e.g., United States v. Wozniak, 126 F.3d 105, 111 (2d Cir.1997); United States v. Mollica, 849 F.2d 723, 731 (2d Cir.1988). 43 We reject, however, Milstein's contention that reversal of Count Three requires reversal of all counts as a result of prejudicial spillover from what he characterizes as the inflammatory evidence of contamination on which the jury was instructed it could base its verdict on Count Three. As discussed in Part V below, the contamination evidence was admissible in connection with Count One, and thus was properly before the jury. 44