United States v. Moshe Milstein

Defendant-Appellant Moshe Milstein (“Milstein”) appeals a judgment of the United States District Court for the Eastern District of New York (Dearie, /.), entered September 5, 2001, convicting him after a jury trial of distributing misbrand-ed drugs in interstate commerce with fraudulent intent, in violation of 21 U.S.C. §§ 331(a) and 333(a)(2) (Count Three); knowingly distributing wholesale prescription drugs in interstate commerce without a required state license, in violation of 21 U.S.C. §§ 331(t), 333(b)(1), and 353(e)(2)(A) (Count Four); knowingly distributing prescription drugs in violation of criminal trademark laws, 18 U.S.C. § 2320(a) (Count Two); distributing wholesale prescription drugs without providing the required history of transactions, in violation of 21 U.S.C. §§ 331(t), 333(a)(2), and 353(e)(1)(A) (Count Five); and conspiracy to commit the first three above-mentioned crimes, in violation of 18 U.S.C. § 371 (Count One). The District Court sentenced Milstein, under the Sentencing Guidelines (“Guidelines”), to 48 months in prison followed by three years of supervised release; fined him $25,000; and imposed a special assessment of $300. The Court also ordered Milstein to pay approximately $3.5 million in restitution to the drug companies that held the trademarks he had infringed.

On appeal, Milstein contends principally that the district court (a) erred in allowing the government to obtain a midtrial superseding indictment, (b) made erroneous evidentiary rulings, and (c) gave erroneous instructions to the jury. He also challenges the constitutionality of the federal statute requiring states to have a federally mandated scheme for licensing wholesale drug distributors engaged in interstate commerce. Finally, he contends that his sentence was impermissibly enhanced based on misinterpretations of the Guidelines and on facts not found by the jury, and that he is entitled to be resentenced in any event because the Guidelines, treated as mandatory, are unconstitutional. For the reasons that follow, we vacate the judgment of conviction on Count Three; we remand for further proceedings with respect to that count and for resentencing; and we affirm the convictions on the other counts.

*59 FACTUAL AND PROCEDURAL BACKGROUND

The evidence at trial, taken in the light most favorable to the government, revealed the following. Through several business entities, Milstein and others bought, repackaged, and sold foreign prescription drugs: Eldepryl, a medication used to treat Parkinson’s disease, and the fertility drugs Pergonal and Metrodin.

The Food and Drug Administration (“the FDA”) regulates the sale of prescription drugs, including Eldepryl, Pergonal, and Metrodin, in the United States. During the period of Milstein’s drug sales, the only FDA-approved distributor of Elde-pryl in the United States was Somerset Pharmaceuticals, Inc., of Tampa, Florida. The only FDA-approved distributor of Pergonal and Metrodin in the United States was Serono Labs USA, a subsidiary of Laboratories Serono, S.A., of Aubonne, Switzerland.

The Eldepryl, Pergonal, and Metrodin distributed in the United States by these companies were manufactured and packaged outside the United States in compliance with FDA standards. The companies also produced these drugs for distribution outside the United States with different packaging, and not necessarily in compliance with FDA standards.

Federal law imposes numerous requirements on the distribution of prescription drugs, of which three are relevant here. First, the law forbids distribution in interstate commerce of drugs that are mis-branded. See 21 U.S.C. §§ 331(a), 333(a)(2), 352(a), (b), (i)(l), (j), 321(n). Second, the law forbids wholesale distribution of prescription drugs in interstate commerce without a state license. See 21 U.S.C. §§ 331(t), 333(b)(1), 353(e)(2)(A). Third, the law forbids wholesale distribution of prescription drugs without providing a history of transactions from the original manufacturer. See 21 U.S.C. §§ 331 (t), 333(a)(2), 353(e)(1)(A). In addition, prescription drugs are subject to the general federal statutory prohibition of trafficking in counterfeit goods. See 18 U.S.C. § 2320.

The Government established at trial that Milstein and others purchased Eldepryl, Pergonal, and Metrodin produced for distribution outside the United States, stripped them of their original factory packaging, repackaged them with forged labels and packaging materials closely resembling those of drugs produced in accordance with FDA requirements for the U.S. market, and then fraudulently sold the drugs in the United States to doctors, pharmacists, and pharmaceutical wholesalers.

The principal witnesses at trial were Albert Silberberg, Alan Weisberger, and Alan Rosenblum, business associates of Milstein, who were not charged with any crimes in connection with this scheme. According to their testimony and other evidence, Milstein began distributing mis-branded and counterfeit Pergonal in late 1991, and thereafter added Metrodin and Eldepryl. Milstein obtained foreign Perg-onal, Metrodin, and Eldepryl from one George Braun at prices lower than commanded by those drugs when prepared for the U.S. market.

Government lab analysis showed that the drugs Milstein distributed were not identical to the drugs prepared by their manufacturers for the U.S. market. The active ingredient in Milstein’s Pergonal and Metrodin did not come from the same batch as the active ingredient in the drugs produced by the European manufacturer, Ares-Serono, for U.S. distribution. Moreover, some of the saline solution in the saline ampules packaged with Milstein’s Pergonal and Metrodin contained quanti *60 ties of bacteria and endotoxins, and therefore were not sterile. Milstein’s Eldepryl also differed from the drug produced for the American market: his tablets were thicker, were off-white instead of white, and had dirt particles embedded in them. The Government alleged that Milstein. was personally involved in repackaging the drugs to make it appear that they were produced for the U.S. market in accordance with FDA standards.

The Government also asserted that Mil-stein took substantial measures to hide his unlawful conduct from the Government. Specifically, the Government claimed that Milstein first sold his drugs through a company called 'WSE Distributors (“WSE”), and later formed a company called Gem Distributors (“Gem”), through which to sell the bulk of his drugs. Mil-stein needed.a prescription drug wholesaler license to show to his customers. Rather than register and obtain a New York license to operate as a. prescription drug wholesaler in New York (as he otherwise would be required to do since Gem did all of its business in New York), Milstein registered WSE and later Gem as prescription drug wholesalers in New Jersey.

Actually, WSE’s wholesaler application was filed in the name of Milstein’s associate, Alan Weisberger. The Government also offered evidence that Milstein filed the wholesaler application for Gem in the name of Irving Goldstein. Milstein signed Goldstein’s name, and five of Milstein’s fingerprints were found on Gem’s wholesaler filings. Milstein set up a fake supplier, Landys Ltd., in Hollywood, Florida, to make it appear that Gem had a legitimate supplier. After Milstein became aware of the investigation into his activities, he gave Silberberg fictitious Landys Ltd. invoices and a business card for Mark Landys, with instructions to show them to the FDA.

When an investigation of Milstein’s activities appeared likely, Milstein transferred more than $400,000 in profits to his bank account in Israel by means of a complicated series of transactions, routed through accounts in Switzerland and Israel. When FDA agents eventually questioned Milstein regarding his drug sales, he falsely identified Goldstein as the owner of Gem, and Landys Ltd. as Gem’s source for drugs. However, Goldstein’s father testified that Goldstein was mentally unstable and not “well enough to be an owner of a chicken coop,” and the Government’s financial analysis showed that Goldstein received no profits from Gem.

In early September 1993, shortly before his interview with FDA agents, Albert Sil-berberg told Milstein he was worried about investigation rumors and wanted to stop distributing Milstein’s drugs. Consequently, Milstein arranged to sell directly to Silberberg’s largest customer, Alan Rosenblum. Milstein’s business associate Menachem Korall, using the name Mark Landys, then contacted Rosenblum, and the Pergonal and Metrodin sales continued.- The continued illegal sales were accomplished through a new fictitious entity, M. Vase & Co., at a non-existent address. Rosenblum received deliveries of Pergonal and Metrodin on September 15, September 29, October 18, and December 6, 1993.

In September 1998, a grand jury returned an indictment charging Milstein, along with co-defendants Ethel Milstein and Menachem Korall, with criminal trademark' infringement, distribution of mis-branded drugs in interstate commerce, wholesale distribution of prescription drugs without the required state license, wholesale distribution of prescription drugs without providing required documentation of transaction history, and conspiracy to commit the first three of those crimes.

*61 On January 26, 2000, a grand jury returned a superseding indictment directed to Milstein and one of his co-defendants, charging the five counts described above and adding a sixth count, alleging the filing of a false tax return. The Government also had recently discovered evidence that some of Milstein’s prescription fertility drugs were contaminated with bacteria, and that evidence also was presented to the grand jury that returned the superseding indictment; but the Government did not have that portion of the indictment amended to reflect the newly-discovered evidence.

The superseding indictment, however, was imperfectly drafted. On March 8, 2000, immediately after the swearing in of the trial jury, Milstein moved for a judgment of acquittal on Count Four (wholesale distribution of prescription drugs without a state license) for failure to allege the jurisdictional element, ie., that the transactions took place in interstate commerce. In response, the Government sought leave to return to the grand jury to add an allegation of interstate commerce to the indictment. Meanwhile, the presentation of evidence at trial continued.

The Government received permission on March 17, 2000 to obtain an amendment of Count Four in order to meet the jurisdictional requirement. This task was accomplished in a novel manner. The District Court granted a midtrial “theoretical ... mistrial” on Count Four, prompted by the “manifest necessity” of Milstein’s motion for acquittal based on Count Four’s jurisdictional defect. (Trial Transcript (“Trial Tr.”) at 1490.) The Government returned to the Grand Jury to secure an amendment of Count Four to allege the omitted jurisdictional element. In the meantime, the court allowed the trial to continue uninterrupted on all counts and announced that the evidence presented at the ongoing trial would be deemed presented in connection with the anticipated amended indictment. (See id. at 1491.)

On March 22, 2000, the Grand Jury returned a second superseding indictment, adding the phrase “in interstate commerce” in three places: paragraph 19 in Count Four (wholesale distribution of prescription drugs without a state license); paragraph 12(a) in Count One (charging conspiracy to commit the crime charged in Count Four); and paragraph 8 in the introductory section of the indictment that was incorporated by reference into Counts One through Five. Milstein was arraigned on the second superseding indictment on March 28, 2000, and entered a plea of not guilty without waiving his objection to the procedure. The Court then incorporated all of the prior trial evidence nunc pro tunc into the record of the trial on the second superceding indictment.

A jury convicted Milstein of Counts One through Five, and he entered a conditional guilty plea to the tax count, which had been severed from the counts tried. The District Court sentenced Milstein to 48 months in prison and three years’ supervised release, fined him $25,000, and imposed a special assessment of $300. The District Court also ordered restitution to the victimized drug companies in the amount of approximately $3.5 million. Milstein has been released on bail pending this appeal.

DISCUSSION

I. Criminal Trademark Infringement (Count Two)

Milstein challenges his conviction on Count Two, intentionally trafficking in prescription drugs known to be counterfeit, in violation of criminal trademark laws (“Count Two”), 18 U.S.C. § 2320, asserting two errors: (1) that the District Court *62 improperly instructed the jury as to what constitutes a “counterfeit mark”; and (2) that the District Court erroneously refused to permit the jury to consider a defense of laches.

A. Jury Instruction on “Counterfeit Mark”

A “counterfeit mark” is a “spurious mark ... identical with, or substantively indistinguishable from,” a registered trademark, “the use of which is likely to cause confusion, to cause mistake, or to deceive.” 18 U.S.C. § 2320(e)(1)(A)(i-iii). At trial, Milstein conceded that he bought genuine prescription drugs made for foreign markets and then repackaged them for sale in the United States without.the consent of the drugs’ manufacturers. However, Milstein requested a jury instruction that a “spurious” mark is one used in connection with goods that are not “genuine” or are so altered as to lose their genuine character. The District Court refused, instructing the jury that “[a] counterfeit mark is a spurious mark or a mark that is not genuine,” and “in order for the mark to be genuine, it must be placed there by the legitimate owner of the mark or with the owner’s authorization.” The Court further instructed, “[i]f you find that a good’s production process includes the process of packaging, you may then find that the good does not bear a genuine mark if the good was repackaged using a trademark without authorization.”

On appeal, Milstein contends that selling repackaged genuine goods is not a crime, and that “if the court’s instruction were a correct statement of the law, any repackaging of genuine product would be a criminal trademark counterfeiting offense, even where, as here, there was no allegation that the packaging itself was trademarked.” (Milstein brief on appeal at 62.) Milstein relies primarily on the Fifth Circuit’s opinion in United States v. Hanafy, 302 F.3d 485, 486-89 (5th Cir.2002) (“Hanafy ”), which held that attaching a trademark to repackaged baby formula would not give rise to § 2320 liability. The Fifth Circuit suggested that, in the civil infringement context, Supreme Court precedent would require any repackaged good bearing a trademark to be “marked as having been repackaged.” Id. at 488 (citing Prestonettes, Inc. v. Coty, 264 U.S. 359, 368-69, 44 S.Ct. 350, 68 L.Ed. 731 (1924)); cf. Enesco Corp. v. Price/Costco Inc., 146 F.3d 1083, 1085-86 (9th Cir.1998). The Hanafy court declined to apply such a rule in the criminal context, however, reasoning that “Lanham Act precedent is of little value in a § 2320 case because the Lanham Act deals with civil liability.” Hanafy, 302 F.3d at 489 (citing United States v. Giles, 213 F.3d 1247, 1250 (10th Cir.2000)). But see United States v. Hon, 904 F.2d 803, 805 (2d Cir.1990) (“There is no doubt that Congress wished to incorporate the Lan-ham Act’s confusion requirement into 18 U.S.C. § 2320 and did so.”).

Hanafy is readily distinguishable. The defendant in Hanafy resold cans of baby formula in trays that resembled trays used by manufacturers to sell the same product, bore the trademark holders’ mark, and “contain[ed] no more information than that which [wa]s carried on the cans themselves.” 302 F.3d at 486, 488. By contrast, Milstein “sold Eldepryl, Pergonal and Metrodin in forged packaging bearing false lot numbers.” (Milstein brief on appeal at 9.) While the cans in Hanafy were “merely being repackaged, such that consumers could be sure of the goods’ quality and source,” United States v. Farmer, 370 F.3d 435, 441 n. 1 (4th Cir.2004) (citing Hanafy, 302 F.3d at 486), the drugs here were repackaged so that consumers would believe foreign versions of the drug were in fact domestic, FDA-approved versions (see Milstein brief on appeal at 60).

*63 Milstein admits that the drugs “were repackaged in counterfeit packaging with phony lot numbers designed to resemble the authentic packaging approved by the [FDA].” (Id.) Although § 2820 has been read “effectively [to] exclude[] from the definition [of “counterfeit mark”] parallel imports, gray goods and production overruns,” 4 McCarthy on Trademarks § 25:14 (2004), Milstein did more than resell parallel imports or gray goods. He obscured the fact that the drugs had been repackaged, and, with his package design, fraudulently conveyed that the foreign drugs had been manufactured as FDA-approved products. Moreover, he removed identifying codes from the repackaged goods. Cf. John Paul Mitchell Systems v. Pete-N-Larry’s Inc., 862 F.Supp. 1020, 1026-27 (W.D.N.Y.1994). In all the circumstances, given, inter alia, Milstein’s knowing repackaging of the drugs without the trademark holders’ authorizations, the jury permissibly convicted Milstein of violating § 2320(a).

B. Jury Instruction on Laches Defense

Milstein next contends that the District Court erred in failing to instruct the jury that laches was available as a defense to Count Two. Milstein cites 18 U.S.C. § 2320(c), which provides that “[a]ll defenses, affirmative defenses, and limitations on remedies that would be applicable in an action under the Lanham Act shall be applicable in a prosecution under this section.” “It is well established that the equitable defense of laches may be applied to cases brought under the Lanham Act.” Conopco, Inc. v. Campbell Soup Co., 95 F.3d 187, 193 (2d Cir.1996) (citing 15 U.S.C. § 1069 (“In all inter partes proceedings equitable principles of laches ... where applicable may be considered and applied.”)). Therefore, Milstein argues, the District Court erred in refusing to instruct the jury that the defense of laches, which requires that the defendant prove unreasonable delay resulting in prejudice, see, e.g., King v. Innovation Books, 976 F.2d 824, 832 (2d Cir.1992), was available to him. We disagree.

We begin by noting that, in the criminal context, the relevant statute of limitations, as well as the speedy trial safeguards of the Due Process Clause, see, e.g., United States v. Lovasco, 431 U.S. 783, 789-790, 97 S.Ct. 2044, 52 L.Ed.2d 752 (1977), serve to protect a defendant’s interests against unreasonable delay. Further, it is well established that, as a general rule,

[l]aches is not a defense to an action filed within the applicable statute of limitations, United States v. Mack, 295 U.S. 480, 489, 55 S.Ct. 813, 817, 79 L.Ed. 1559 (1935), nor is it available against the United States, United States v. Summerlin, 310 U.S. 414, 416, 60 S.Ct. 1019, 1020, 84 L.Ed. 1283 (1940).

United States v. RePass, 688 F.2d 154, 158 (2d Cir.1982). We have found no case applying a laches defense in the criminal context.

Of course, Congress could have provided that, in this context, such a defense would be available. Against the backdrop of these well-established principles, however, we decline to interpret the statutory scheme in that way. Section 1069 states that the laches defense may only be applied “where applicable”; thus indicating that it may be applied in the criminal context at most where it would be applicable in an analogous civil context. Because laches may not be asserted against the United States in a civil matter, see United States v. Angell, 292 F.3d 333, 338 (2d Cir.2002) (“laches is not available against the federal government when it undertakes to enforce a public right or protect the public interest”), it seems that it is equally inapplicable against the Government in a criminal prosecution.

*64 Further, the manifest purpose of 15 U.S.C. § 1069 is to encourage trademark holders timely to assert their rights against alleged infringers and to protect to some extent the alleged infringers’ reliance interests. See generally Conopco, Inc. v. Campbell Soup Co., 95 F.3d at 192-93. However, when or whether a trademark holder asserts its right against an alleged infringer is irrelevant to the Government’s decision to begin a prosecution for criminal trademark infringement; criminal liability irrevocably attaches at the time of the willful infringement irrespective of the subsequent behavior of either the infringer or the trademark holder. Unlike other defenses to infringement, those contained in § 1069 do not go to the question of the alleged infringer’s substantive liability, and therefore are not incorporated by § 2320(c).

Lastly, we note that construing the defense of laches to apply to prosecutions under § 2320 would lead to absurd results. The equitable doctrine of “unclean hands,” it seems, would prevent its application in every prosecution under that section. As the Supreme Court has explained, “[t]he equitable powers of this court can never be exerted in behalf of one who has acted fraudulently, or who by deceit or any unfair means has gained an advantage.” Bein v. Heath, 47 U.S. (6 How.) 228, 246-47, 12 L.Ed. 416 (1848). Because “willful infringement” necessarily involves fraudulent acts, anyone convicted of it would be unable as a matter of law to benefit from a laches defense. Therefore we conclude that § 2320(c) does not evince a congressional intent to extend the equitable defense of laches to criminal prosecutions.

II. Misbranding (Count Three): Constructive Amendment

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 “[fjorgery 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.”

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 “misbrand-ed” 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.

Nonetheless, at trial, the Government was allowed to present evidence of the contamination; and the court subsequently instructed the jury that it could find Mil-stein 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 ster *65 ile ... 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 misbrand-ed because they were labeled as if they were sterile when in fact they were not.

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).

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), 35200, 352(i)). 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:

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 *66 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.

Stirone, 361 U.S. at 218-19, 80 S.Ct. 270.

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).

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.

III. Failure To Obtain a State License (Count Four)

A. Midtrial Superseding Indictment

For two of the substantive counts against Milstein, (ie., Count Three alleging misbranding, and Count Four alleging the failure to have a state license), distribution in interstate commerce was an essential element of the offense. The indictment alleged such distribution in Count Three (see Superseding Indictment ■ ¶ 17 (alleging that Milstein, with intent to defraud, “introduce[d] and delivered] for introduction into interstate commerce drugs that were misbranded” (emphasis added))); but Count Four contained no similar allegation. When this omission was brought to the attention of the Government and the court shortly after the commencement of trial, the Government obtained a superseding indictment that added the phrase “in interstate commerce” to the licensing count.

In order to facilitate that addition, the District Court employed a somewhat unprecedented procedure. The Court declared a “theoretical ... mistrial” prompted by the “manifest necessity” of Milstein’s motion for a judgment of acquittal because the count was jurisdictionally defective. The Government returned to the Grand Jury to secure an amendment of the aforementioned count to allege the omitted jurisdictional element. And then the District Court incorporated all the prior trial evidence nunc pro tunc. The trial continued, with but a brief interruption for Mil-stein’s arraignment on the new indictment. Milstein claims that this procedure violated his rights under-the Double Jeopardy Clause and the statute of limitations. We are not persuaded.

1. Double Jeopardy

After jeopardy has attached, but before a verdict has been reached, the Double Jeopardy Clause of the Fifth Amendment does not prevent retrial where a mistrial “was required by ‘manifest necessity.’ ” Illinois v. Somerville, 410 U.S. 458, 467-68, 93 S.Ct. 1066, 35 L.Ed.2d 425 (1973). The need to correct a jurisdictionally defective indictment presents one situation in which a mistrial is manifestly necessary. See id. at 468-69, 93 S.Ct. 1066. Therefore, at least where there is only minimal delay resulting from the mistrial and the Government is not thereby given the opportunity to strengthen its case, the Double Jeopardy Clause does not prevent retrial in such cases. See id. at 469, 93 S.Ct. 1066.

Milstein nevertheless contends that the Double Jeopardy Clause prohibits the procedure employed by the District Court in *67 this case. However, given that the Government could have proceeded before a new jury on a new indictment, we cannot agree that allowing his trial to continue before the same jury violated the Double Jeopardy Clause. Indeed, doing so prevented a waste of all parties’ “time, energy, and money,” minimized almost completely any delay or potential prejudice to Milstein, and preserved his “right to have his trial completed by a particular tribunal” — the very values underlying the Double Jeopardy Clause. See id. at 468-70, 93 S.Ct. 1066 (emphasis omitted). Therefore, allowing the prosecution to continue upon the midtrial return of a superseding indictment was appropriate in this case.

Milstein argues that this Court’s decision in United States v. Dhinsa, 243 F.3d 635 (2d Cir.2001), is to the contrary. In that case, however, the indictment was amended after the close of the Government’s case, thus depriving the defense of the opportunity to cross-examine the Government’s witnesses, thereby “increasing] the burden on [the defendant’s defense.” Id. at 668; see also id. at 664 (noting that its holding was “limited to the narrow circumstances” of that case). Here, by contrast, the new indictment was returned well before the close of the Government’s case, the defense was on notice that the indictment would be superseded even earlier, and no change in defense strategy was required by the addition of the jurisdictional element to Count Four, especially given that distribution in interstate commerce was alleged as an element of Count Three. Therefore, United States v. Dhinsa is inapposite, as Milstein was in no way prejudiced by the substitution of the superseding indictment.

2. Statute of Limitations

Milstein also contends that the midtrial superseding indictment violated the statute of limitations, relying on United States v. Gillespie, 666 F.Supp. 1137 (N.D.Ill.1987). However, Gillespie is not the law of this Circuit. See United States v. Grady, 544 F.2d 598 (2d Cir.1976) (“Grady ”); United States v. Drucker, 453 F.Supp. 741 (S.D.N.Y.1978). “Once an indictment is brought, the statute of limitations is tolled as to the charges contained in that indictment.” Grady, 544 F.2d at 601. Further,

[w]henever an indictment ... is dismissed for any reason after the period prescribed by the applicable statute of limitations has expired, a new indictment may be returned in the appropriate jurisdiction within six calendar months of the date of the dismissal of the indictment ..., which new indictment shall not be barred by any statute of limitations.

18 U.S.C. § 3288. Thus, “a superseding indictment brought at any time