HOLMES, Circuit Judge.
Defendant-Appellant Thomas Bader appeals his convictions of distribution of human growth hormone ("HGH"), conspiracy to knowingly facilitate and knowingly facilitating the sale of HGH brought into the United States contrary to law, and conspiracy to possess with intent to distribute a controlled substance (testosterone cypionate). He asks this court to reverse his convictions or, at a minimum, to grant him a new trial. Mr. Bader also challenges the district court's forfeiture order requiring him to remit the $4.8 million in proceeds that he allegedly derived from his unlawful activity. Exercising jurisdiction pursuant to 28 U.S.C. § 1291, we affirm Mr. Bader's convictions for distribution of HGH and conspiracy to possess with intent to distribute testosterone cypionate, but reverse based upon instructional error his convictions for knowingly facilitating the sale of HGH imported into the United States contrary to law, and conspiring to do so. Further, in light of our reversals, we conclude that the forfeiture judgment cannot rest on its current statutory basis, but we leave to the district court in the first instance the task of determining the precise amount (if any) of the forfeiture judgment authorized by the remaining, upheld convictions. We remand the case to the district court with instructions to vacate the judgment and sentence and for further proceedings consistent with this opinion.
Mr. Bader, a licensed pharmacist in the State of Colorado, owned and operated College Pharmacy, a compounding pharmacy located in Colorado Springs, Colorado. In the context of this case, the precise definition of drug "compounding" remains in dispute. Nevertheless, the parties agree that College Pharmacy is involved in the process of purchasing, labeling, repackaging, and distributing drugs—including HGH—in finished dosages for patient consumption.
In Spring 2004, Mr. Bader instructed Kevin Henry, a College Pharmacy sales representative, to locate an economical source of HGH for purchase and distribution.
Employees of College Pharmacy were then directed to repackage the imported HGH into smaller vials for distribution. Pursuant to College Pharmacy's repackaging protocol, employees copied the relevant HGH drug-instruction guides from a Food and Drug Administration ("FDA")-approved version of HGH known as Saizen and included them with College Pharmacy's own HGH drug, which they labeled and sold as Somatropin. If asked whether Somatropin was FDA-approved, College Pharmacy employees were instructed to explain that the FDA did not have jurisdiction in China, and to reassure customers that the imported HGH was manufactured in an FDA-approved Chinese facility. College Pharmacy also issued several promotional letters and advertisements which implied that Somatropin had been approved by the FDA.
Between 2003 and 2007, Mr. Bader and his employees at College Pharmacy also distributed testosterone cypionate, an anabolic steroid, to individual body-builders and to body-building and "anti-aging" clinics. Among College Pharmacy's top "clients" was Peak Physique, a large anti-aging clinic that purchased HGH and testosterone cypionate via purchase agreements that required no prescription from a licensed physician. College Pharmacy also promoted and sold the steroid, along with Somatropin, at American Academy of Anti-Aging Medicine ("A4M") conferences and trade shows, despite the fact that neither "anti-aging" nor "body-building" is a medically necessary use for these drugs.
On September 9, 2008, the government filed a Second Superseding Indictment in the District of Colorado charging Mr. Bader with a total of forty-three counts involving: (1) conspiracy to knowingly facilitate the sale of merchandise (HGH) brought into the United States contrary to law, in violation of 18 U.S.C. § 371; (2) mail fraud, in violation of 18 U.S.C. § 1341; (3) distribution of HGH, in violation of 21 U.S.C. § 333(e); (4) knowingly facilitating the sale of merchandise (HGH) brought into the United States contrary to law, in violation of 18 U.S.C. § 545; and (5) conspiracy to possess with intent to distribute a controlled substance (testosterone cypionate), in violation of 21 U.S.C. §§ 846 and 841. The indictment also indicated that the government would seek a forfeiture judgment in the amount of $4.8 million—the estimated amount of proceeds obtained by Mr. Bader due to his unlawful conduct—as well as forfeiture of the College Pharmacy building that allegedly had facilitated these crimes. The government subsequently dismissed Mr. Bader's mailfraud charges, and Mr. Bader was tried on the remaining thirty-three counts beginning on January 4, 2010.
On February 2, 2010, a jury convicted Mr. Bader on thirty-two of the thirty-three counts of the indictment, acquitting him on one count of receiving illegally imported goods (Count Sixteen). The jury further found that Mr. Bader had obtained a sum of $4.8 million in proceeds from his illegal activities, and that the College Pharmacy building listed in the indictment had facilitated the crimes charged. The district court entered judgment on Mr. Bader's
Mr. Bader challenges on appeal each of his convictions and attacks the district court's forfeiture order. More specifically, Mr. Bader raises an array of arguments contesting the legal propriety of the jury instructions and the sufficiency of the evidence; alleges prosecutorial misconduct and entrapment by estoppel; and asserts violations of his Sixth Amendment rights and federal evidentiary rules. Mr. Bader asks us to reverse his convictions or, in the alternative, to grant him a new trial. We address below each of his challenges.
Mr. Bader alleges that the district court erroneously instructed the jury in three ways: (1) by including an "alternative prong on uncharged API [active pharmaceutical ingredient] importation" when it issued instructions regarding the charges of knowingly facilitating the sale of HGH imported contrary to law and conspiring to do so, Aplt. Opening Br. at 51; (2) "by telling the jury [that] all [of the] evidence about compounding was irrelevant," id. at 47; and (3) by refusing to instruct the jury on applicable state pharmacy laws and his First Amendment right to advertise. The government contends that any error in the court's "alternative prong" instruction was harmless, that the district court was correct to reject Mr. Bader's compounding definition, and that the court properly refused to instruct the jury regarding state pharmacy dispensing regulations and Mr. Bader's First Amendment rights.
Mr. Bader's first argument pertains to two of his convictions—specifically, his convictions for knowingly facilitating the sale of HGH imported into the United States contrary to law and conspiring to do so (Counts Seventeen and One of the Second Superseding Indictment, respectively). These convictions implicate 18 U.S.C. § 545, which prohibits the smuggling of illegal goods into the United States by providing, in relevant part, that "[w]hoever fraudulently or knowingly imports or brings into the United States, any merchandise contrary to law, or receives ... buys, [or] sells" such merchandise, "knowing the same to have been imported or brought into the United States contrary to law" shall be fined or imprisoned for a maximum of twenty years. 18 U.S.C. § 545.
In the present case, Mr. Bader was charged in Count One with conspiring to knowingly facilitate the sale of HGH after importation "knowing the same to have been imported into the United States" contrary to several identified federal statutes: 21 U.S.C. § 331(a), which prohibits the introduction into interstate commerce of a misbranded drug; 21 U.S.C. § 352(f)(1), which relates to causing the introduction into interstate commerce of a misbranded drug that fails to bear adequate directions for use; 21 U.S.C. § 331(d), which prohibits the introduction into interstate commerce of an article that is in violation of
According to FDA documents, "finished drug products" must be approved through an "effective new drug application" ("NDA") before they can be legally imported.
The government concedes that the district court significantly limited the basis upon which the jury could convict Mr. Bader under § 545, focusing upon the government's primary theory that the HGH that Mr. Bader imported from China was a "finished" drug product subject to FDA oversight and, because Mr. Bader had failed to file an NDA, he had imported HGH "contrary to" 21 U.S.C. § 355's ban on the importation of "new drugs" that lack FDA approval.
As the court later explained in its order partially granting Mr. Bader's motion for judgment of acquittal, its instruction on Count One—outlined in jury instruction number twenty ("Jury Instruction No. 20")—"[d]istilled to its essence, ... directed the jury to resolve the `imported contrary to law' question by first determining whether the HGH being imported was a `finished drug' or an `ingredient.'" Aplee. App., Vol. IV, at 1258 (Op. & Order Granting, in Part, Mot. for J. of Acquittal and Den. Remaining Mots., filed Apr. 29, 2010). The court further instructed that "[t]here is no definition under the law for the term `finished drug'" but that "in determining whether the [HGH] was a finished drug, [the jury could] consider whether it was in
In the event that the jury determined that the Chinese HGH was in finished form, "they were instructed that a `finished drug' must have NDA approval in order to be legally imported, and because it was undisputed at trial that the HGH here did not have such approval, a finding that the HGH was a `finished drug' compelled the conclusion that it was `imported contrary to law.'" Aplee. App., Vol. IV, at 1258-59; see Aplt.App., Vol. VIII, Tr. at 2715-16. However, significantly, the district court further instructed the jury, in the alternative, that if the jury "f[ound] that the [HGH] was not a finished drug but instead an active pharmaceutical ingredient," then it still was authorized to find that the HGH was "imported contrary to federal law if it was manufactured by a foreign entity that was not registered with the FDA." Aplt. Trial Tr.App., Vol. VIII, at 2170 (emphases added).
Importantly, the district court incorporated the legal standards concerning the contrary-to-law component of § 545, articulated in Count One's Jury Instruction 20, into the instructions that would control the jury's finding as to Count Seventeen. Specifically, the court stated: "For purposes of determining whether the human growth hormone was imported into the United States in a manner contrary to federal law, you should use the same standards and instructions I gave you with regard to that issue in Count 1." Id. at 2176. Therefore, to the extent that a ground for reversal could be demonstrated regarding Count One relating to a defect in Jury Instruction 20's contrary-to-law standard, that ground for reversal would also fatally undermine Mr. Bader's conviction as to Count Seventeen because it employed the same standard.
Mr. Bader contends that there is such a ground for reversal, focusing on the final sentence of Jury Instruction 20, relating to API importation. However, Mr. Bader did not specifically object to this portion of Jury Instruction No. 20 at trial—despite the fact that the court afforded him ample opportunity to do so, see id. at 2145 (Jury Trial Tr., dated Jan. 28, 2010) ("Counsel, this is your second opportunity to lodge any objections to the concluding jury instructions reflected in the packet or to the verdict form."). At most, Mr. Bader's counsel made a general "object[ion] to the [c]ourt's instruction"—with no reference to which of the enumerated instructions was put at issue in his objection—and "reurge[d]" the court to adopt the defense's compounding instruction. Id. at 2148. This falls far short of Mr. Bader's obligation to lodge a timely and specific objection. See, e.g., Abuan v. Level 3 Commc'ns, Inc., 353 F.3d 1158, 1172 (10th Cir.2003) ("No party may assign as error... the failure to give an instruction unless that party objects thereto before the jury retires to consider its verdict, stating distinctly the matter objected to and the grounds of the objection." (quoting Fed. R.Civ.P. 51) (internal quotation marks omitted)); Medlock v. Ortho Biotech, Inc., 164 F.3d 545, 553 (10th Cir.1999) ("Because the purpose of [an] objection is to give the court an opportunity to correct any mistake before the jury enters deliberations, an excessively vague or general objection to the propriety of a given instruction is insufficient to preserve the issue for appeal." (citation omitted)).
We therefore review Mr. Bader's objection to Jury Instruction No. 20 for plain error. See, e.g., United States v. Willis, 476 F.3d 1121, 1127 (10th Cir.2007); see also Aplee. App., Vol. IV, at 1261 ("In
In undertaking the threshold error inquiry, we must "determine whether, as a whole, the instructions correctly state the governing law and provide the jury with an ample understanding of the issues and the applicable standards." United States v. Visinaiz, 428 F.3d 1300, 1308 (10th Cir. 2005) (quoting United States v. Smith, 413 F.3d 1253, 1273 (10th Cir.2005)) (internal quotation marks omitted). Regarding the second prong, we have recognized that error is plain if it is "clear or obvious under current law." United States v. Cooper, 654 F.3d 1104, 1117 (10th Cir.2011) (quoting United States v. Goode, 483 F.3d 676, 681 (10th Cir.2007)) (internal quotation marks omitted). As for the third prong of the test, "[i]n the ordinary case," to have the requisite affect on substantial rights, an error must be "prejudicial," which means that "there must be a reasonable probability that the error affected the outcome of the trial." United States v. Marcus, ___ U.S. ___, 130 S.Ct. 2159, 2164, 176 L.Ed.2d 1012 (2010) (internal quotation marks omitted); accord United States v. Thornburgh, 645 F.3d 1197, 1212 (10th Cir.2011); United States v. Fishman, 645 F.3d 1175, 1196 (10th Cir.2011). Lastly, as to the fourth prong, it is notable that there is a relationship between that prong and the third: "[I]n most circumstances, an error that does not affect the jury's verdict [i.e., the third prong] does not significantly impugn the `fairness,' `integrity,' or `public reputation' of the judicial process [i.e., the fourth prong]." Marcus, 130 S.Ct. at 2166 (quoting Johnson v. United States, 520 U.S. 461, 467, 117 S.Ct. 1544, 137 L.Ed.2d 718 (1997)).
We are constrained to conclude that, in propounding Instruction No. 20 to the jury, the district court committed clear or obvious error; that there is a reasonable probability that the error affected the outcome of the trial; and that, under the circumstances presented here, this error significantly impugned the fairness, integrity, and public reputation of the trial. In denying Mr. Bader's post-trial motion for a judgment of acquittal, the district court concluded that the final sentence of Instruction No. 20 was "unnecessary," but that any potential error was harmless.
We also are convinced that there is a reasonable probability that this error affected the outcome—i.e., that there is a reasonable probability that the jury would not have convicted Mr. Bader of the § 545-related counts but for this error. See United States v. Marcus, 628 F.3d 36, 42 (2d Cir.2010) ("[T]he overall effect of the due process [instruction-related] error must have been sufficiently great such that there is a reasonable probability that the jury would not have convicted him absent the error."). The probable prejudicial impact of Instruction No. 20 is evident when we examine it within the context of the entire trial. See Visinaiz, 428 F.3d at 1308. In his closing argument, the prosecutor invited the jury to consider several email exchanges between Mr. Bader, Mr. Henry, and Genescience representatives that "reflect[ed] a concern about whether [the Genescience facilities] [were] even registered facilities." Aplt.App., Vol. IX, Tr. at 2760. In one of those email chains, Mr. Henry asked a Genescience representative whether Genescience was "FDA registered yet," to which the representative responded that Genescience "ha[d]n't got registered in FDA yet." Id. at 2767 (Gov't Ex. 34). In another, Mr. Henry informed Mr. Bader that a representative from Medisca—apparently an API supply company—would be "sending a letter with information on the FDA[-]registered facility that their HGH comes from," explaining that the representative was "totally convinced that Medisca is the only place in the country that is bringing in [HGH] legally." Id. at 2771 (Gov't Ex. 44). In conclusion, Mr. Henry noted, College Pharmacy "need[ed] to ... find out if anybody [was] telling the truth or if they[ were] all doing it `illegally.'" Id.
Dr. Jason Woo, Associate Director for Medical and Scientific Affairs with the Center for Drug Evaluation Research, testified at trial. When questioned about the FDA approval of foreign-produced HGH, Dr. Woo explained that "[t]here are no approved Chinese facilities"—more specifically, there are not "any facilities in China that are approved to make any components of the approved human growth hormone products." Aplee. App., Vol. I, Tr. at 18 (emphasis added). As Dr. Woo explained, those "components"—also known as API—are "basically the precursor to an approved drug. [They are] part of the mix that goes into making the drug." Id.
A reasonable jury presented with this evidence—the emails exchanged by Mr. Bader, Mr. Henry, and the Genescience
This plain-error analysis indicates that because of Jury Instruction No. 20's inclusion of an erroneous theory of liability—viz., a theory that permitted Mr. Bader's conviction for having imported an API, as opposed to a finished drug, so long as that API was "manufactured by a foreign entity that was not registered with the FDA," Aplt. Trial Tr.App., Vol. VIII, at 2170 (Jury Instruction No. 20)—we must reverse and remand. Specifically, we reverse Mr. Bader's conviction on Count Seventeen, for knowingly facilitating the sale of HGH imported into the United States contrary to law, and on Count One, for conspiracy to do so. Both counts rely on the erroneous liability theory set forth in Jury Instruction 20.
Next, Mr. Bader challenges Jury Instruction number twelve ("Jury Instruction No. 12"), pursuant to which the court informed the jury that "evidence concerning whether Mr. Bader's actions constituted compounding under various legal authorities [was] not relevant to the issues" that the jury was to "resolve under [the court's instructions]." Id. at 2164 (Jury Instruction No. 12). Though Mr. Bader represents that he "objected" at trial to the court's instruction, he did not do so on the grounds that he asserts here. See Aplt.
Mr. Bader argues that the court erroneously "told the jury that none of these meticulous and required pharmacy processing standards mattered when, in truth, they controlled the core questions: whether the [HGH] was already finished prior to College's purchase, and whether [Mr.] Bader knew this." Aplt. Opening Br. at 49; see also Aplt. Reply Br. at 12 (noting that "[Mr.] Bader's defense that compounding absolutely had to occur before this [HGH] was in finished form safe and ready for patient dispensing was wholly negated by the court's instruction that all evidence about compounding was irrelevant"). His objection to Instruction No. 12, therefore, relates exclusively to his § 545-related charges. As discussed above, however, we must reverse and vacate Mr. Bader's § 545-related convictions on account of the erroneous "alternative prong" in Instruction No. 20. Consequently, we need not (and do not) consider whether the district court's characterization of compounding law as "irrelevant" obliges us to reverse Mr. Bader's § 545-related convictions; we have already determined that those convictions cannot stand.
Finally, Mr. Bader argues that the district court erred with respect to the jury instructions that it did not give—i.e., in refusing to inform the jury of Colorado's pharmacy-dispensing laws, see Aplt. Opening Br. at 52-54, and in failing to instruct the jury that Mr. Bader "had a Supreme Court-recognized right to advertise" under the First Amendment, id. at 55. We review the district court's refusal to issue these instructions for an abuse of discretion. See United States v. Crockett, 435 F.3d 1305, 1314 (10th Cir.2006). However, in determining "whether the district court exercised its discretion properly, we review the jury instructions de novo to determine whether, as a whole, they accurately state the governing law and provide the jury with an accurate understanding of the relevant legal standards and factual issues in the case." Id.
Applying this standard to the present case, it is patent that the district court appropriately exercised its discretion when it rejected Mr. Bader's proposed instructions. Mr. Bader first contends that the district court erred in refusing to issue several "relevant" state pharmacy instructions regarding: (1) "Colorado requirements that pharmacies maintain adequate drug inventories and provide adequate services," Aplt. Opening Br. at 52; (2) "[s]tate laws governing ordering, dispensing[,] and requirements for valid prescriptions," id. at 53; (3) "[s]tate laws clarifying that pharmacists who prepare, compound, package, repackage, or dispense drug[s] are not drug wholesalers or manufacturers," id.; and (4) a "Colorado law providing that pharmacists may rely on a physician's professional judgment in ordering a drug for a patient," id. at 54. However, Mr. Bader fails to identify to which of the forty-three charged counts these state laws pertain, let alone explain how they are "relevant" to the charges upon which he was convicted. Indeed, it is clear from the record that the district court was more than generous in including "some language [from
Mr. Bader's undeveloped First Amendment claim, which he seeks to assert throughout his opening brief, is even less persuasive. As we discuss infra, the government introduced evidence of College Pharmacy advertisements in order to prove that Mr. Bader purposefully marketed HGH and testosterone cypionate for impermissible purposes. At no point, however, did the government contest, as a general matter, College Pharmacy's right to advertise its products. In other words, Mr. Bader's First Amendment right to advertise was in no way implicated, let alone compromised, by the charges against him. Consequently, an instruction regarding Mr. Bader's First Amendment rights could not possibly have promoted an "accurate understanding of the relevant legal standards and factual issues in the case." See Crockett, 435 F.3d at 1314. We therefore reject Mr. Bader's unsubstantiated assertion that the district court somehow abused its discretion in refusing to issue an (irrelevant) instruction pertaining to his First Amendment right to advertise.
Mr. Bader avers that there was insufficient evidence to support his convictions, renewing many of the unsuccessful arguments that he asserted in his Renewed Motion for Judgment of Acquittal and Alternative Motion for a New Trial that he filed post-trial. We review de novo the sufficiency of the evidence upon which Mr. Bader was convicted, "ask[ing] only whether taking the evidence—both direct and circumstantial, together with the reasonable inferences to be drawn therefrom—in the light most favorable to the government, a reasonable jury could find the defendant guilty beyond a reasonable doubt." United States v. McCane, 573 F.3d 1037, 1046 (10th Cir.2009) (alteration in original) (quoting United States v. Brown, 400 F.3d 1242, 1247 (10th Cir. 2005)) (internal quotation marks omitted). "Rather than examining the evidence in `bits and pieces,' we evaluate the sufficiency of the evidence by `consider[ing] the collective inferences to be drawn from the evidence as a whole.'" United States v. Wilson, 107 F.3d 774, 778 (10th Cir.1997) (alteration in original) (quoting United States v. Hooks, 780 F.2d 1526, 1532 (10th Cir.1986)), abrogated on other grounds as recognized by United States v. King, 632 F.3d 646, 651-52 & n. 5 (10th Cir.2011); accord United States v. McGehee, 672 F.3d 860, 871 (10th Cir.2012). In so doing, "we may not assess the credibility of witnesses or weigh conflicting evidence, as these tasks are exclusively for the jury." United States v. Bowen, 527 F.3d 1065, 1076 (10th Cir.2008).
In order to convict Mr. Bader of unlawful possession with intent to distribute HGH in violation of 21 U.S.C. § 333(e), the government was obligated to prove each of three elements beyond a reasonable doubt: (1) that Mr. Bader knowingly distributed HGH or possessed HGH with the intent to distribute it; (2) that Mr. Bader knew that the HGH that he possessed and intended to distribute was for use in humans; and (3) "[e]ither [that] Mr. Bader knew that
Mr. Bader principally argues that his conviction cannot stand because the government failed to present proof that he knowingly filled a prescription for an unauthorized use—"[i]llegal distribution," he contends, "requires proof of a prescription sale for an unapproved use and that a pharmacist knowingly filled it." Aplt. Opening Br. at 31. This is simply incorrect. Under 21 U.S.C. § 333(e)(1),
21 U.S.C. § 333(e)(1) (emphasis added). Thus, the plain terms of the statute belie Mr. Bader's argument—specifically, his contention that there is only one means to violate the statute involving knowingly filling a prescription for an unauthorized use.
Indeed, Jury Instruction No. 38—the instruction that outlined the elements of the unlawful distribution charge and to which Mr. Bader has offered no objection—was phrased in the disjunctive. According to that instruction, proof of the filling of an improper physician prescription was but one of three ways that the government could satisfy its burden. The government could demonstrate either: (1) that "Mr. Bader knew that the [HGH] was not being distributed for a[] use authorized by the Secretary of Health and Human Services"; "or [ (2) ] that Mr. Bader knew that the [HGH] was not being distributed pursuant to the order of a physician"; "or [ (3) that Mr. Bader knew that the HGH that he possessed] was not being prescribed for a valid medical purpose." Aplt. Trial Tr. App., Vol. VIII, at 2181 (emphases added).
Throughout Mr. Bader's trial, the government introduced a series of exhibits consisting of College Pharmacy advertisements that extolled the anti-aging and muscle-building benefits of HGH, as well as related statements from Mr. Blum and various College Pharmacy employees. Several of the witnesses who testified recalled that Mr. Bader had promoted HGH at A4M trade shows as an anti-aging and body-building drug. And their testimony was corroborated by photographs depicting Mr. Bader and his advertisements at one of these trade shows. Mr. Bader apparently argues that this evidence is insufficient because it merely demonstrates promotion, as opposed to actual distribution, of HGH. However, under the plain language of the statute—as well as Mr. Bader's counts of conviction—proscribed is not only the actual distribution of HGH but also possession with intent to distribute. 21 U.S.C. § 333(e). As it is undisputed
In that regard, the government introduced evidence demonstrating that the FDA had not approved the use of HGH for either anti-aging or body-building purposes through the testimony of Dr. Woo. After establishing that his position as medical director had familiarized him with the process that a pharmaceutical manufacturer must undergo in order to obtain FDA approval for a drug such as HGH, Dr. Woo informed the jury that HGH had yet to be approved for any off-label uses due to congressional safety concerns.
While we must vacate Mr. Bader's 18 U.S.C. § 545-related convictions of facilitating the sale of illegally imported HGH and conspiracy to facilitate that sale due to the aforementioned error in Jury Instruction No. 20, standing alone, this action would not preclude the government from re-prosecuting Mr. Bader on these charges. It is the law of this circuit that the reversal of a defendant's conviction "bars retrial only where the government presents no evidence that could support [his] conviction." United States v. Holly, 488 F.3d 1298, 1311 n. 11 (10th Cir.2007); accord United States v. Pearl, 324 F.3d 1210,
This principle is grounded in the Double Jeopardy Clause. In contrast to a second trial following an acquittal, which would "present an unacceptably high risk that the [g]overnment, with its vastly superior resources, might wear down the defendant so that `even though innocent, he may be found guilty,'" United States v. Scott, 437 U.S. 82, 91, 98 S.Ct. 2187, 57 L.Ed.2d 65 (1978) (quoting Green v. United States, 355 U.S. 184, 188, 78 S.Ct. 221, 2 L.Ed.2d 199 (1957)), the Supreme Court has held that "the successful appeal of a judgment of conviction, on any ground other than the insufficiency of the evidence to support the verdict ... poses no bar to further prosecution on the same charge" because "to require a criminal defendant to stand trial again after he has successfully invoked a statutory right of appeal to upset his first conviction is not an act of governmental oppression of the sort against which the Double Jeopardy Clause was intended to protect," id. at 90-91, 98 S.Ct. 2187.
Accordingly, this circuit has established a distinction between "trial error" deriving from an erroneous jury instruction and "pure insufficiency of evidence" such that, in the former case, a defendant "may be retried without violating double jeopardy." Pearl, 324 F.3d at 1214; accord United States v. Wacker, 72 F.3d 1453, 1465 (10th Cir.1995). Thus, Mr. Bader may be retried following remand to the district court if his case falls within this "trial error" category—in other words, so long as the government presented legally sufficient evidence. See United States v. Nacchio, 519 F.3d 1140, 1157 (10th Cir.2008) ("Although we have concluded that Mr. Nacchio's conviction must be reversed on account of trial error, we cannot leave it at that. He also claims that the government failed to introduce evidence sufficient for him to be convicted. If he is right, he was entitled to a judgment of acquittal and cannot be retried without violating the Double Jeopardy Clause."), vacated in part on other grounds, 555 F.3d 1234, 1236 (10th Cir. 2009).
Perhaps because he is aware of this fact, Mr. Bader devotes a substantial portion of his briefs to challenging the sufficiency of the evidence supporting his § 545-related convictions. Specifically, he avers that: (1) his convictions cannot stand because they were premised upon the importation of an API rather than a finished drug—i.e., that a reasonable jury could not have concluded that the imported HGH was a "finished drug" on the basis of the evidence that the government produced at trial; (2) the record contains no evidence that Mr. Bader possessed the requisite mens rea to be convicted of the importation of HGH contrary to law; and (3) the government failed to prove that Mr. Bader knowingly participated with a specific intent to further the conspiracy to sell contraband HGH. Aplt. Opening Br. at 21-30.
Mr. Bader insists that a reasonable jury could not have convicted him of the § 545-related charges because the government failed to sufficiently demonstrate that the imported HGH was a "finished" drug product rather than an API. Though as noted we find error with the dual avenues that Jury Instruction No. 20 provided for conviction, there was ample evidence upon which a reasonable jury could have convicted Mr. Bader on the proper ground specified in this instruction: that is, the imported HGH was a finished drug that was illegally imported on account of Mr. Bader's failure to garner NDA approval.
John Ruth, a College Pharmacy national sales representative, also told the jury that, at least initially, College Pharmacy did no more than simply "repackag[e]" the imported HGH. Id., Vol. II, Tr. at 296 (Test. of John Ruth). Mr. Ruth explained that College Pharmacy employees were "told via Mr. Bader" to repackage the imported HGH, and that the College Pharmacy sales team, in turn, "told all of [its] clients and prospective clients" the same thing: College Pharmacy was "bringing in a drug, importing it from another country, and ... repackaging [it] into [College Pharmacy's] own package and selling it to them." Id. Then, "in early 2005, after [College Pharmacy] had been selling the Somatropin for several months and had done well, [the sales team was] told ... that [it was] not repackaging [the HGH] because [it] could not get a license to repackage from the ... FDA." Id. The College Pharmacy sales team then simply began to inform customers that the HGH "was compounded; that it was no longer repackaged." Id. Any change in College Pharmacy's Genescience processes—from "repackaging" to "compounding"—was therefore illusory, and was aimed at avoiding FDA oversight rather than actually "compounding" imported ingredients.
The testimony of Ms. Griffin and Mr. Ruth was corroborated by the testimony of Mr. Blum, who stated that he was not aware of "anything being added or taken out of the bottled version [of HGH] that [Genescience] provided [College Pharmacy] [as juxtaposed with] the vials that [College Pharmacy was] putting out." Id., Vol. I, Tr. at 182 (Test. of Brad Blum). Mr. Blum consistently referred to the Genescience HGH product that he sold to Mr. Bader as "Somatropin," and even testified that he "personal[ly] use[d]" Somatropin after purchasing it directly from Genescience. Id. at 168-69. Upon receiving the Genescience shipment from China, Mr. Blum explained, he mixed the imported vial of HGH powder with a vial of water and injected himself with the hormone at his home, noting that HGH enables one to "recover faster from injury" and that he found it to improve his "general well being."
Having learned (1) that the imported Genescience HGH was merely repackaged into smaller vials as "Somatropin," (2) that College Pharmacy employees themselves told clients they were merely repackaging the imported HGH, and (3) that the imported Genescience HGH was—at least in certain significant instances (e.g., the use of Mr. Blum)—patient-ready even prior to College Pharmacy's processing, a reasonable jury could have easily inferred that the imported Genescience HGH was already in its "finished" form when it arrived at College Pharmacy for repackaging and distribution. In sum, Mr. Bader's conviction was supported by a wealth of evidence.
Mr. Bader also argues that the government failed to present sufficient evidence that he possessed the necessary mens rea to be convicted under 18 U.S.C. § 545. See Aplt. Opening Br. at 28. Neither party does a good job of developing this issue. And, in particular, the government's conclusory assertion that "[i]t was uncontroverted that [Mr. Bader] knew the [HGH] in question was not the subject of an approved NDA," Aplee. Br. at 23—with no citations to the record that support this statement—is unhelpful. Our independent review of the record, however, confirms that the government is correct: a reasonable jury could have easily concluded that Mr. Bader knew the illicit nature of his transactions on the basis of the evidence adduced at trial.
Admittedly, our own circuit has offered little in the way of guidance regarding the mens-rea requirement of § 545. Our sister circuits, however, have observed that "the word `knowingly'"—as it appears in § 545—"modifies `imports or brings into the United States, any merchandise contrary to law.'" United States v. Garcia-Paz, 282 F.3d 1212, 1217 (9th Cir.2002) (quoting 18 U.S.C. § 545); accord United States v. Molt, 615 F.2d 141, 146 (3d Cir. 1980) ("An essential element of a section 545 offense is ... a knowing importation of merchandise contrary to law."); see also Roseman v. United States, 364 F.2d 18, 23 (9th Cir.1966) (noting that an appellant's charge under 18 U.S.C. § 545 for the sale of LSD required proof "(1) that the appellants sold the LSD"; "(2) that [the] appellants had knowingly brought this LSD into the United States contrary to law"; "and (3) that the LSD ... was a `new drug' ... for which there was no effective new drug application" (emphasis added)). Under § 545, "[i]t is not a requirement of the offense that the defendant know the type of merchandise he is importing. He need only know that he is importing or bringing in `merchandise contrary to law.'" Garcia-Paz, 282 F.3d at 1217 (quoting 18 U.S.C. § 545). In the present case, therefore, the government could satisfy § 545's mens-rea requirement so long as it could demonstrate that Mr. Bader "knew" that he was importing a drug from Genescience illegally.
As proof that Mr. Bader possessed the requisite mens rea to be convicted of a § 545-related offense, the government first presented the testimony of
Mr. Bader's knowing disregard of the FDA's regulatory scheme was directly confirmed by the testimony of Mr. Blum, who admitted that both he and Mr. Bader had known that the Genescience HGH was not an FDA-approved product and had also known that it was being imported from China. Mr. Ruth also told the jury that Mr. Bader had known that the imported HGH was subject to FDA approval, and recounted how Mr. Bader had directed his sales staff to inform College Pharmacy customers that the pharmacy was "compound[ing]" rather than merely "repackaging" the imported HGH in order to avoid FDA licensing requirements. Id., Vol. II, Tr. at 296.
A reasonable jury certainly could have construed the testimony of Mr. Strong, Mr. Blum, and Mr. Ruth—particularly when viewed collectively—as constituting sufficient evidence that Mr. Bader "knowingly" imported HGH from Genescience and that he knew that he was doing so "contrary to law." See 18 U.S.C. § 545; see Garcia-Paz, 282 F.3d at 1217. As such, the government presented sufficient evidence upon which a reasonable jury could have concluded that the mens rea element of § 545 was satisfied.
Finally, Mr. Bader contends that the government failed to prove that he conspired with Mr. Blum and others to illegally import HGH, alleging that (1) "the [g]overment failed to prove anything other than an equipoise buyer-seller relationship between [Mr.] Blum and the purchasing pharmacies," and (2) that the government failed to prove that he knowingly participated in the alleged conspiracy. Aplt. Opening Br. at 29. The district court here instructed the jury that, in order to convict Mr. Bader of conspiring to violate 18 U.S.C. § 545, the government was obligated to prove, beyond a reasonable doubt, that "(1) Mr. Bader entered into an agreement or understanding with one or more others to import [HGH] into the United States contrary to federal law and thereafter to sell or distribute that [HGH] within the United States"; (2) "[t]here was an interdependence among Mr. Bader and the others involved in [the] agreement"; (3) "Mr. Bader knew that the purpose of the agreement was to import the [HGH] contrary to federal law[,]" to sell it thereafter, and that he
First, on redirect, Mr. Blum clearly and unequivocally testified that he illegally imported and distributed HGH, and that he did so with Mr. Bader's knowledge and assistance. Mr. Blum acknowledged that he had "agree[d] to violate the law" when he "agreed to do business with Tom Bader," and he further admitted that this agreement amounted to a conspiracy involving "importation of [HGH] and delivery to Mr. Bader," that the "essential objective of the conspiracy" was to "distribute [HGH]," and that the "members of that conspiracy" were "[him]self and Tom [Bader]." Aplee. App., Vol. I, Tr. at 252. Mr. Blum also confirmed that Mr. Bader had "knowingly and voluntarily participated in that agreement." Id.; see id. at 189 (agreeing that "Mr. Bader . . . kn[e]w that this was not FDA[-]approved product").
Mr. Blum's statements were corroborated by the testimony of Mr. Strong, who told the jury that Mr. Bader was aware of the fact that his importation of Genescience HGH violated FDA protocol, as well as the testimony of Mr. Ruth, who confirmed that College Pharmacy was purchasing HGH from Mr. Blum and from Genescience in China at the direction of Mr. Bader. On the basis of this testimony, a reasonable jury could have concluded that Mr. Bader "knowingly" entered into an agreement with Mr. Blum to import and distribute HGH in a manner that Mr.
Finally, Mr. Bader challenges the sufficiency of the evidence that the government presented to prove Count Nineteen of the Superseding Indictment—conspiracy to distribute and to possess with the intent to distribute testosterone cypionate (an anabolic steroid), in violation of 21 U.S.C. § 841(a)(1), (b)(1)(D), and 21 U.S.C. § 846. Mr. Bader argues that, of the nearly four thousand doctors that College Pharmacy serviced, only two admitted that they had "secretly" prescribed testosterone through College Pharmacy for unlawful uses. Aplt. Opening Br. at 56. He also avers that he was unaware of these unlawful prescriptions.
As the jury was instructed at trial, the government bore the burden of proving, beyond a reasonable doubt, that: "(1) Mr. Bader entered into an agreement or understanding with one or more others to unlawfully distribute or to possess . . . with the intention of unlawfully distributing a controlled substance; namely, testosterone cypionate, an anabolic steroid"; "(2) Mr. Bader knew that the purpose of the agreement" was to unlawfully distribute or to possess with intent to distribute that testosterone cypionate; and "(3) [t]here was an interdependence among Mr. Bader and the others involved in this agreement or understanding." Aplt. Trial Tr.App., Vol. VIII, at 2178 (Jury Instruction No. 34). Mr. Bader contests the government's proof of the first two of these three elements.
Although Mr. Bader primarily attempts to discredit the government's evidence regarding the two doctors who prescribed testosterone cypionate for unlawful uses through prescriptions filled by College Pharmacy,
Additionally, the government introduced a series of College Pharmacy's advertisements promoting testosterone for anti-aging and body-building purposes.
Indeed, Mr. Ruth confirmed that all of College Pharmacy marketing materials and major decisions were subject to Mr. Bader's approval. His testimony, combined with these College Pharmacy advertisements, provided more than sufficient evidence upon which a reasonable jury could have concluded that Mr. Bader "entered into an agreement" with Mr. Ruth and other members of the sales department to unlawfully distribute testosterone cypionate—in other words, the government
The government also established that "Mr. Bader knew that the purpose of the agreement was to unlawfully distribute" testosterone cypionate. Id. at 2178 (emphasis added). At trial, the jury was instructed that "[w]ith regard to whether any distribution or possession with intent to distribute testosterone cypionate by Mr. Bader was unlawful," it was to consider whether the government had shown "that Mr. Bader either knew that he was distributing or possessing with intent to distribute the testosterone cypionate without a valid prescription by a medical practitioner or knew that the prescription he was filling was issued without a valid medical purpose." Id. at 2178-79. As Mr. Ruth and others testified, Mr. Bader knew that he was distributing testosterone to Peak Physique and other clinics for anti-aging and body-building purposes. Furthermore, particularly in light of Mr. Ruth's concession that he knew that anti-aging was not a "valid medical purpose," id. at 2179, a reasonable jury could have easily inferred that "a reasonable pharmacist acting in good faith," id. at 2173, would have known that these were unlawful uses. Thus, the government also satisfied its burden of proof regarding element two of the testosterone-conspiracy charge. Accordingly, construing the evidence in the light most favorable to the government, a reasonable jury could have convicted Mr. Bader of conspiracy to distribute and to possess with the intent to distribute testosterone cypionate.
Mr. Bader claims that the government committed prosecutorial misconduct when it prosecuted him for importation of HGH contrary to law in spite of the district court's purported pretrial ruling that the imported Genescience HGH was an API as opposed to a finished drug. In so doing, he argues that the prosecution "intentionally misled th[e] jury to convict on an unfounded legal basis"—that is, he was prosecuted on the basis of "no legally cognizable evidence." Aplt. Reply Br. at 15 (emphasis removed); see United States v. Farinella, 558 F.3d 695, 700-01 (7th Cir. 2009) (reversing a defendant's conviction where the prosecutor committed egregious misconduct in failing to present any evidence that the defendant violated any federal law or FDA regulation).
"We use a two-step process when evaluating claims of prosecutorial misconduct. First, we examine whether the conduct was, in fact, improper. If we answer that question in the affirmative, we must then determine whether it warrants reversal." United States v. Oberle, 136 F.3d 1414, 1421 (10th Cir.1998). "When evaluating allegedly inappropriate remarks of counsel for plain error, we must view the remarks in the context of the entire trial." Id. (quoting Sands, 968 F.2d at 1063-64) (internal quotation marks omitted). Thus, "[t]he relevant question is whether the prosecutors' comments `so infected the trial with unfairness as to make the resulting conviction a denial of due process.'" Darden v. Wainwright, 477 U.S. 168, 181, 106 S.Ct. 2464, 91 L.Ed.2d 144 (1986) (quoting Donnelly v. DeChristoforo, 416 U.S. 637, 643, 94 S.Ct. 1868, 40 L.Ed.2d 431 (1974)). Applying these standards to the facts before us here, it is patent that Mr. Bader's allegations fall short.
Mr. Bader's argument fails, in part, because it is premised upon a misreading of the record. Though Mr. Bader insists that the district court concluded pretrial that "the imported [HGH] undisputedly was API," Aplt. Opening Br. at 19, actually the court made no such determination. As discussed above, the government alleged that Mr. Bader had "represented" to FDA officials that the Genescience HGH was an "ingredient" in order to successfully (but unlawfully) smuggle it into the United States. Aplt. App., Vol. VI, Tr. at 1778 (emphasis added). If anything, the government's allegation underscored its position that Mr. Bader had facilitated the unlawful HGH importation through the use of false statements, as charged in Count Sixteen of the Second Superseding Indictment. See Aplee. App., Vol. IV, at 1038. It certainly did not amount to a government concession that the imported HGH was in fact an "API" as opposed to a finished drug. Moreover, at no point did the court conclude that the imported HGH was API; indeed, the API/finished-drug distinction was exclusively reserved for jury determination. Consequently, because neither the court nor the government concluded or represented that the imported HGH was an API, as opposed to a finished drug, the government's argument that it was the latter (i.e., a finished drug) was entirely proper. As such, Mr. Bader cannot satisfy even the first prong of Oberle's two-step analysis with regard to the government's allegedly impermissible statements pertaining to finished HGH. See Oberle, 136 F.3d at 1421. In sum, Mr. Bader has failed to offer any plausible argument that the prosecution's actions were in any way improper.
Though the precise nature of Mr. Bader's claims are unclear, he appears to contend
"The defense of entrapment by estoppel is implicated where an agent of the government affirmatively misleads a party as to the state of the law and that party proceeds to act on the misrepresentation so that criminal prosecution of the actor implicates due process concerns under the Fifth and Fourteenth Amendments." United States v. Nichols, 21 F.3d 1016, 1018 (10th Cir.1994). In order to establish an entrapment-by-estoppel defense, a defendant must prove: (1) that there was an "active misleading by a government agent"; (2) that the defendant actually relied upon the agent's representation, which was "reasonable in light of the identity of the agent, the point of law misrepresented, and the substance of the misrepresentation"; and (3) that the government agent is "one who is responsible for interpreting, administering, or enforcing the law defining the offense." United States v. Apperson, 441 F.3d 1162, 1204-05 (10th Cir.2006) (quoting United States v. Hardridge, 379 F.3d 1188, 1192 (10th Cir. 2004)) (internal quotation marks omitted).
To the extent that Mr. Bader premises his estoppel claim upon federal court decisions, it fails at the outset. While this circuit has yet to explicitly address whether a court's ruling can give rise to a claim of estoppel,
Mr. Bader's remaining estoppel claim against the prosecution fails at step one of the Apperson inquiry. See Apperson, 441 F.3d at 1204. Mr. Bader presents no evidence that any government official made any sort of "active[ly] misleading" statement with regard to the FDAMA; even if he had, his argument would be based upon a faulty premise. As the district court explained in its order denying Mr. Bader's motion to dismiss, the FDAMA is "material to this case only as a defense belonging to Mr. Bader." Aplee. App., Vol. IV, at 1060 (emphasis removed).
Under the FDAMA, 21 U.S.C. § 353a(a), a licensed pharmacist is exempt from federal liability where he compounds a drug product "for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation," provided that certain conditions are met, id. The FDAMA therefore presents an affirmative defense that Mr. Bader might have asserted, not a "charge" that the government impermissibly sought. Thus, if anything, the FDAMA could have worked to Mr. Bader's advantage—an advantage that was precluded by Mr. Bader's repeated averments that the FDAMA had no bearing upon his case. See Aplee. App., Vol. I, Tr. at 1-2. As Mr. Bader offers no evidence of "active misleading"— let alone evidence of such conduct that might have prejudiced him at trial—his entrapment-by-estoppel claim is without merit.
As for Mr. Bader's argument that "due process confusion precluded [his] conviction," Aplt. Opening Br. at 39, although it is not entirely clear, Mr. Bader appears to argue that the confusion rendered in the wake of Western States and Medical Center Pharmacy failed to place him on notice that his "compounding" of HGH was subject to FDA oversight. In this regard, Mr. Bader asserts that "[t]he courts told
With regard to Western States, by its terms, the Court's decision merely invalidated the FDAMA's speech-related provisions as they related to advertising; it did not address the FDAMA's substantive exemptions and accompanying restrictions with respect to compounding. See 535 U.S. at 366, 377, 122 S.Ct. 1497. Therefore, Mr. Bader could not have divined from the text of Western States that his compounding activities were free from substantive FDA regulation.
The district court's decision in Medical Center Pharmacy is also unavailing. In
Moreover, as the district court correctly concluded, Mr. Bader misreads Medical Center Pharmacy's actual holding. In Medical Center Pharmacy, the court found that subsections (a) and (c) of the FDAMA, 21 U.S.C. § 353a, were severable from the remainder of § 353a; consequently, pharmacies were still obligated to comply with subsection (b)'s requirements for "compounded drugs." 451 F.Supp.2d at 863. In other words, the court's decision can be read as concluding that "only drugs compounded in compliance with the restrictions set forth in [the] FDAMA fall outside [of] FDA regulation and the NDA process." Aplt.App., Vol. II, at 559 (emphasis removed).
Furthermore, this "exemption for compounded drugs from the new drug definition [was] limited to compounds which are made in reasonable quantities upon receipt of a valid prescription for an individual patient from a licensed practitioner." 451 F.Supp.2d. at 863 (emphases added). Indeed, the Medical Center Pharmacy court clarified that "[d]rugs that are compounded in large quantities before a prescription is received from a doctor do not fall within [this] narrow exemption." Id. It is clear from the record that Mr. Bader's large-scale HGH compilation method fell outside the protective scope of this exemption.
Specifically, Ms. Griffin's testimony regarding College Pharmacy's "Somatropin prepackaged protocol" indicated that College Pharmacy repackaged massive amounts of HGH as Somatropin long before it received individual prescriptions, and College Pharmacy's numerous advertisements extolling the anti-aging and body-building benefits of HGH—in conjunction with its promotion of the drug at trade shows for those purposes—clearly
Mr. Bader also argues that his Sixth Amendment rights were violated: (1) when the district court purportedly limited his ability to adequately cross-examine the government's "star witness," FDA Agent Catherine Hermsen, in violation of the Confrontation Clause; and (2) by "the [g]overnment's efforts to keep out [evidence of] pharmacy practices," which prompted a ruling by the court that allegedly hindered his ability to raise a plausible mens-rea defense at trial. Aplt. Opening Br. at 43.
Because Mr. Bader neglected to raise a Confrontation Clause objection at trial, we review his first claim for plain error. See United States v. Pablo, 625 F.3d 1285, 1291 (10th Cir.2010). In so doing, the record reveals the absurdity of his argument: the district court permitted Mr. Bader to extensively cross-examine Agent Hermsen; the cross-examination fills approximately 138 pages of transcript. Consequently, Mr. Bader Confrontation Clause argument is wholly without merit and cannot satisfy even the first prong of the plain-error standard.
Mr. Bader's second argument is equally unavailing. Apparently, Mr. Bader challenges the district court's setting of "parameters as to what questions can be asked of witnesses," seemingly in reference to a warning that the court issued to Mr. Bader's attorney: "if witnesses are repeatedly asked questions about the state of the law[,] [the court] w[ill] be compelled to admonish him before the jury." Aplt. App., Vol. VII, Tr. at 2339; see Aplt. Opening Br. at 43. Mr. Bader avers that this "ruling" deprived him of the ability to introduce pertinent information regarding Colorado state pharmacy regulations, consequently hindering his ability to "disprove mens rea," Aplt. Opening Br. at 43, pursuant to Cheek v. United States, 498 U.S. 192, 202, 111 S.Ct. 604, 112 L.Ed.2d 617 (1991). This argument is unpersuasive.
In Cheek, the Supreme Court noted that "forbidding the jury to consider evidence that might negate willfulness would raise a serious question under the Sixth Amendment's jury trial provision." Id. at 203, 111 S.Ct. 604. Cheek, however, was premised upon the district court's error in instructing the jury that it was obligated to completely disregard evidence that the defendant had a good faith misunderstanding of the applicable tax laws. Id. Here, in contrast, the district court merely (and permissibly) limited the scope of defense counsel's questioning on account of counsel's repeated attempts to surreptitiously introduce a legal definition of "compounding" that would favor Mr. Bader. See Aplt. Trial Tr.App., Vol. IV, at 962 ("I'm . . . going to instruct the jury that this witness'[s] understanding of what compounding is[,] is not a legal definition of compounding and therefore they should not understand it as such."). This in no way ran afoul of the Sixth Amendment, nor did it prevent Mr. Bader from otherwise attempting to introduce a defense as to his understanding of the law at the time of the allegedly illegal conduct. Accordingly, we conclude that Cheek is inapposite,
Alternatively, Mr. Bader alleges that he should at least be afforded a new trial on account of various evidentiary objections that the government made and that the district court ruled upon. First, Mr. Bader asserts that the government impermissibly and excessively objected to much of the evidence that the defense offered, particularly that relating to the FDA's approval of the HGH shipments as an API, College Pharmacy employees' understanding of the meaning of "compounding," FDA import alerts distinguishing between API and finished HGH, and test results regarding the HGH that was seized from College Pharmacy. Mr. Bader apparently claims that the government's frequent objections somehow amounted to prosecutorial misconduct. Because he failed to challenge these objections at trial, we review for plain error. Sands, 968 F.2d at 1063.
It is clear that there was nothing "improper" about the government's objections, nor has Mr. Bader fashioned any argument as to how we might construe them as such. See Oberle, 136 F.3d at 1421. Each of the objections that Mr. Bader contests was grounded in the Federal Rules of Evidence, and each was entirely consistent with the government's overarching theory of the case—viz., that the imported HGH was a "finished drug," not an API. In raising these objections, the government merely upheld its obligation to zealously advocate for its position, and the district court certainly did not clearly or obviously err by permitting the objections.
Second, Mr. Bader argues that the district court erred in sustaining the government's objections and in "refus[ing] to allow the defendant the same latitude" as the government with regard to the introduction of evidence. Aplt. Opening Br. at 44. However, Mr. Bader offers absolutely no explanation as to how the district court abused its discretion in ruling on the government's objections, nor does he establish that each of the allegedly impermissible government objections was actually sustained in the first place. See Aplt. Opening Br. at 42-43. Consequently, he has left us with no basis upon which we might discern error with the district court's evidentiary rulings.
Furthermore, Mr. Bader provides no meaningful support for his conclusory assertion that the court "allow[ed] the [g]overnment to offer evidence on critical issues" while depriving him of an opportunity to do the same. Id. at 44. Specifically, Mr. Bader contends that the court allowed the government to "impermissibl[y] use . . . its rejected compounding definition," while rejecting Mr. Bader's
Mr. Bader also appears to argue that the court abused its discretion in refusing to admit the government's pretrial concession that "their case was gutted" with regard to Mr. Bader's HGH claims if the court were to adopt the compounding definition that he proffered.
Finally, Mr. Bader challenges the district court's $4.8 million forfeiture order,
"Forfeiture is an element of the sentence imposed following conviction. . . ." Libretti v. United States, 516 U.S. 29, 38-39, 116 S.Ct. 356, 133 L.Ed.2d 271 (1995) (emphasis removed); see United States v. Wittig, 575 F.3d 1085, 1096 (10th Cir.2009) ("Double jeopardy does not apply to the forfeiture findings because forfeiture is a component of a sentence rather than an offense for which the defendants were tried." (internal quotation marks omitted)). Consequently, we review the district court's forfeiture order as we would any other sentencing determination—that is, we review its legal conclusions de novo and its factual findings for clear error. See, e.g., United States v. Olguin, 643 F.3d 384, 395 (5th Cir.2011) (observing that, in reviewing a district court's forfeiture order, the "court reviews the district court's findings of fact under the clearly erroneous standard of review, and the question of whether those facts constitute legally proper forfeiture de novo."); United States v. Browne, 505 F.3d 1229, 1278 (11th Cir.2007) ("We review de novo the district court's legal conclusions regarding forfeiture and the court's findings of fact for clear error." (quoting United States v. Puche, 350 F.3d 1137, 1153 (11th Cir.2003)) (internal quotation marks omitted)); cf. United States v. McGinty, 610 F.3d 1242, 1245 (10th Cir.2010) (concluding that we apply de novo review to our legal interpretation of federal forfeiture statutes). A forfeiture judgment must be supported by a preponderance of the evidence. See United States v. Dicter, 198 F.3d 1284, 1289 (11th Cir.1999) ("[T]he preponderance standard is most consistent with the notion that section 853(a)(2) forfeiture is a matter of sentencing."); Stefan D. Cassella, Asset Forfeiture Law in the United States § 15-3(d), at 480 (2007) [hereinafter Asset Forfeiture Law] ("Because forfeiture is part of sentencing, the Government's burden is to establish the nexus between the property and the offense by a preponderance of the evidence, not beyond a reasonable doubt.").
Mr. Bader seemingly seeks to reassert here the argument that he set forth in his post-trial motion to set aside the jury's forfeiture verdict—viz., that "the calculation of proceeds based on gross HGH sales, instead of net sales, was improper." Aplee. App., Vol. IV, at 1273; see id. at 1189-1212 (Def.'s Mot. to Set Aside Special Forfeiture Verdict Under Rule 29(C) and Opp'n to Gov't's Mot. for Forfeiture, filed Mar. 5, 2010). In his motion before the district court, Mr. Bader relied primarily upon the Supreme Court's ruling in United States v. Santos, 553 U.S. 507, 128 S.Ct. 2020, 170 L.Ed.2d 912 (2008), where he argued that only the "profits" that he derived from the allegedly illegal conduct, as opposed to the "gross receipts," could be included for purposes of the forfeiture calculation, see Aplee. App., Vol. IV, at 1201-02 (internal quotation
In any event, unlike the present case, Santos involved whether the term "proceeds" meant "profits"—as opposed to gross receipts—under the federal money-laundering statute. See 553 U.S. at 513-14, 128 S.Ct. 2020; see also 18 U.S.C. § 1956(a)(1)(A)(i). As we recently observed, "Santos . . . caused considerable disagreement and confusion among the circuit courts of appeal," Thornburgh, 645 F.3d at 1208, with the result that "the Santos decision has been interpreted by lower courts in many different ways," Fishman, 645 F.3d at 1193. We "therefore confined it to its factual setting, and conclude[d] that `proceeds' means `profits' for the purpose of the money laundering statute only where an illegal gambling operation is involved." Fishman, 645 F.3d at 1193-94. Mr. Bader's reliance on Santos is therefore misplaced, as his convictions pertain neither to the federal money-laundering statute nor to an illegal gambling operation.
Mr. Bader's remaining two claims—that the court erred in failing to exclude the amount of HGH (1) that the government seized and kept, and (2) that was attributable to the counts upon which he was acquitted—are also waived on account of his utter failure to explain or in any way substantiate his allegations, including with citation to legal authority.
There must be a nexus between the property forfeited and an offense of conviction that authorizes forfeiture. See United States v. Bornfield, 145 F.3d 1123,
However, because we reverse Mr. Bader's convictions of conspiring to knowingly facilitate the sale of illegally imported HGH and knowingly facilitating the sale of illegally imported HGH, the forfeiture judgment against Mr. Bader cannot rest on his violation of 18 U.S.C. § 545. See Asset Forfeiture Law, supra, § 15-3(a), at 476 ("[I]f the conviction that supported a forfeiture is reversed on appeal, the forfeiture—along with all other aspects of the defendant's sentence for that offense— must be reversed as well."). Ordinarily, such violations would trigger forfeiture under 18 U.S.C. § 981(a)(1)(C) (noting that "property is subject to forfeiture to the United States" where it "constitutes or is derived from proceeds traceable to a violation of section . . . 545 . . ., or a conspiracy to commit such offense"). Yet, significantly, the district court's analysis focused primarily on this § 545-related path of forfeiture, in particular in rejecting Mr. Bader's contention that "the $4.8 million forfeiture verdict is inconsistent with evidence that reveals a smaller amount is attributable to illegal HGH sales." Aplee. App., Vol. IV, at 1275.
As the court's analysis revealed, there was ample evidence of unlawful HGH sales to support the $4.8 million figure by a preponderance of the evidence. Among other things, the government presented College Pharmacy's own sales records detailing a total of approximately $4.7 million in sales of imported HGH. This sales log was corroborated by Catherine Hermsen, a Special Agent ("SA") with the FDA Office of Criminal Investigations, who testified that the log detailed College Pharmacy's Somatropin sales from September 13, 2004 to March 30, 2007. SA Hermsen also explained that she verified this figure through information retrieved from College Pharmacy's computer server, as well as through her own review of checks that the FDA had subpoenaed. These records revealed that College Pharmacy also had issued additional payments to Bradley Blum, which resulted in a total of $4.8 million estimated proceeds attributable to Mr. Bader's HGH-related crimes. See id., Vol. II, Tr. at 441 ("We came up with $4.8 million."). Additionally, as the district court observed in its disposition of Mr. Bader's motion to set aside the forfeiture order, SA Hermsen explicitly noted that this "$4.8 million figure excluded College Pharmacy's lawful sales of commercially-produced, NDA[-]approved HGH, such as Saizen and Norditropin." Id., Vol. IV, at 1275 (emphasis altered); see id., Vol. II, at 440 (SA Hermsen testifying about a separate log that exclusively recorded the sales of the illegally imported HGH).
To be sure, the district court correctly suggested that the Second Superseding Indictment charged Mr. Bader with violating other statutes that, in appropriate circumstances, may support a forfeiture judgment.
Yet, given the current posture of this case—involving our reversal of the § 545-related HGH counts—we are reluctant to speak definitively regarding the precise amount (if any) of proceeds that properly may be attributed to the other (i.e., non- § 545) counts of the Second Superseding Indictment for purposes of adjudging the forfeiture amount.
And, second, we do not have the benefit of the parties' briefing on the implications of our reversal of the § 545-related counts with regard to the precise amount of the forfeiture judgment that is legally authorized based on the remaining convictions. Of course, that is not surprising because it is only through this opinion that we effectuate our reversals. However, the reversals do raise serious questions. As noted, the district court relied in its forfeiture
Let us assume, however, that Mr. Bader only may be held accountable in monetary forfeiture under the Second Superseding Indictment for all of the unlawful HGH sales identified by the government, because of his § 545-related conspiracy charge, which sweeps broadly enough to encompasses those sales. See, e.g., Capoccia, 503 F.3d at 117-18 ("Where the conviction itself is for executing a scheme, engaging in a conspiracy, or conducting a racketeering enterprise, the government need only establish that the forfeited assets have the `requisite nexus' to that scheme, conspiracy, or enterprise." (emphasis added) (citation omitted) (quoting Fed.R.Crim.P. 32.2(b)(1))); Asset Forfeiture Law, supra, § 15-3(a), at 477 ("[I]f the defendant is convicted of an over-arching conspiracy offense, he may be ordered to forfeit all property involved in the conspiracy, including property involved in substantive conduct that is not charged in the indictment or on which the defendant was acquitted." (emphasis added)). Put another way, let us assume that proceeds from uncharged discrete acts of facilitating the sale of illegally imported HGH may not be considered in determining the total monetary proceeds subject to forfeiture. See Asset Forfeiture Law, supra, § 15-3(b), at 478 ("Because forfeiture is part of the defendant's sentence for committing a given offense, the criminal forfeiture is limited to the property involved in that offense." (emphases added)). In this event, even assuming that some of the remaining counts of conviction (e.g., involving 21 U.S.C. § 333(e) or 21 U.S.C. § 846) would yield forfeitable proceeds, what would be the proper amount of those proceeds? The district court's analysis does not offer an answer, nor have the parties addressed the matter before us.
We are disinclined to answer such complex questions without input from the parties or the district court. The district court is better equipped to entertain the parties' arguments; if necessary, consider additional evidence; and to resolve such questions in the first instance. In sum, given our reversal of Mr. Bader's § 545-related convictions, we think it the prudent course to allow the district court in the first instance to speak to the precise amount (if any) of the forfeiture judgment that is legally authorized in this case.
For the foregoing reasons, we
Id. (alteration in original) (citations omitted) (quoting 21 U.S.C. § 355(b)(1) and 21 C.F.R. § 314.50(d)(5)(viii) (2008)) (internal quotation marks omitted). In order to receive FDA approval, a new drug must be "safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof," there must be "substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof," and the drug's proposed labeling must not be "false or misleading in any particular." 21 U.S.C. § 355(d); see also Aplee. App., Vol. I, Tr. at 17 (Test. of Jason Woo) ("The new drug approval process refers to the requirement that any article that's intended for use in the diagnosis, treatment, prevention, mitigation or cure of a disease for humans or animals has to be presented to the ... FDA[] for review for safety and efficacy before it can be marketed legally.").
As the Supreme Court has explained, "[t]he active ingredients in most prescription drugs constitute less than 10% of the product; inactive `excipients' (such as coatings, binders, and capsules) constitute the rest." United States v. Generix Drug Corp., 460 U.S. 453, 454, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983). A "complete product[]," therefore, consists of "active ingredients and excipients together." Id. at 461, 103 S.Ct. 1298. Thus, the district court was correct when it instructed the jury that a finished drug product—as opposed to an API—is often in "finished dosage form; for example, a tablet, capsule, or solution." Aplt. Trial Tr.App., Vol. VIII, at 2169.
Much of the law concerning the finished-drug versus API distinction is grounded in the recent methamphetamine epidemic. Pursuant to 21 U.S.C. § 971(c)(1), for example, the DEA "may order the suspension of any importation or exportation of a listed chemical... on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance." PDK Labs., Inc. v. DEA, 438 F.3d 1184, 1186 (D.C.Cir.2006) (quoting Pub.L. No. 100-690, tit. VI, § 6053(a), 102 Stat. 4312 (1988)) (internal quotation marks omitted). One of these "listed chemical[s]"—ephedrine—"is an active ingredient in over-the-counter medications for the treatment of asthma and nasal congestion. Ephedrine is also used in the illicit production of methamphetamine, a controlled substance." PDK Labs., Inc. v. DEA, 362 F.3d 786, 789 (D.C.Cir.2004). It has therefore fallen upon the courts to determine whether the DEA can act pursuant to § 971(c)(1) in order to divert a pharmacy's finished drug—as opposed to the raw API that it imports—from the hands of methamphetamine producers who seek to buy (or purchase) the medication from retail stores. In so doing, courts have offered at least a cursory explanation of the production process: pharmacies "purchase[] raw, bulk ephedrine from foreign companies, combine[] the chemical with other active agents, and produce[] a finished product in tablet form, packaged in bottles or blister packs." Id. (emphases added). Thus, at least in the methamphetamine context, an API is a raw product that is combined with other active ingredients to produce a "finished drug product" that is ready for public consumption. In other words, a finished drug is a final, patient-ready drug that consists of one or more APIs and, most likely, one or more "excipients." See Generix, 460 U.S. at 461, 103 S.Ct. 1298.
Indeed, this Court has also weighed in on the API/finished-drug distinction. In Pharmanex v. Shalala, 221 F.3d 1151 (10th Cir.2000), the FDA challenged the district court's decision to enjoin an FDA administrative decision that concluded that Cholestin—a product intended to promote healthy cholesterol levels—was not a "dietary supplement" that was exempt from FDA regulation. "The district court," we explained, "based its decision on the determination that [the relevant statute] refer[ed] unambiguously to finished drug products, rather than their individual constituents." Id. at 1153 (emphases added). On appeal, the FDA argued that the applicable statute was "properly understood to contemplate active ingredients as well as finished drug products." Id. at 1154 (footnotes omitted). Our role, therefore, was to "determine whether Congress unambiguously manifested its intent to exclude only finished drug products (rather than ingredients) from the definition of dietary supplement." Id.
In so doing, we noted that the term "`[a]ctive ingredient' means `any component that is intended to furnish pharmacological activity or other direct effect.'" Id. at 1154 n. 3 (emphasis added) (quoting 21 C.F.R. 210.3(b)(7)), while a "`[d]rug product'"—a term that we analogized to "finished drug product"—"is defined as a `finished dosage form ... that contains a drug substance, generally, but not necessarily, in association with one or more drug ingredients.'" Id. at 1154 n. 4 (emphases added) (quoting 21 C.F.R. 314.3(b)). These definitions—promulgated by the FDA itself—are certainly less than clear. At the very least, however, they provide a rudimentary foundation regarding the interrelation between the two terms: an API is a medicinally active "component" that is associated with additional "drug substance[s]" to form a "finished product" available in individual doses. See id. at 1154 n. 3-4. These definitions, in conjunction with the aforementioned case law, should inform the district court's jury instructions in the event that Mr. Bader is retried.
First, with regard to the government's allegedly inconsistent pretrial position, Mr. Bader misinterprets the government's statements. The government merely asserted pretrial that Mr. Bader had falsely "represented" that the HGH was an "ingredient" in order to import it into the United States, in accordance with its theory that Mr. Bader received smuggled HGH on the basis of false statements, see Aplt.App., Vol. VI, Tr. at 1778 ("That's how it [i.e., HGH] was represented, your Honor, for compounding purposes as an ingredient." (emphasis added)); at no point did the government indicate that the imported HGH was actually an API. Moreover, at no point did the court "note[]," Aplt. Opening Br. at 19, that the imported HGH was an API; on the contrary, the court observed that the Genescience API was released for importation by FDA inspectors on the basis of Mr. Bader's allegedly false representation that the Genescience HGH was an API as opposed to a finished drug, see Aplt.App., Vol. VI, Tr. at 1962. Second, the court's subsequent decision to vacate Mr. Bader's convictions for distribution of HGH to minors hinged upon the government's inability to prove that those HGH prescriptions had been dispensed in the United States for improper purposes; the dismissals had absolutely nothing to do with the importation of that HGH.
Because Mr. Bader cursorily asserts his third argument for the first time in his reply brief, we need not consider it in the first place. See, e.g., Stump v. Gates, 211 F.3d 527, 533 (10th Cir.2000) ("This court does not ordinarily review issues raised for the first time in a reply brief.... It robs the appellee of the opportunity to demonstrate that the record does not support an appellant's ... assertions...."). However, even if we were to do so, we would conclude that it is without merit. Specifically, the jury's decision to acquit Mr. Bader of receiving stolen goods under Count Sixteen of the Second Superseding Indictment had no bearing upon his § 545-related convictions. Count Sixteen primarily turned upon 18 U.S.C. § 542, which relates to the entry of merchandise into the United States by means of false statements. Aplee. App., Vol. IV, at 1038-39; see Aplt. Trial Tr.App., Vol. VIII, at 2173 (Jury Instruction No. 26). A reasonable jury could have found that Mr. Bader was not guilty of having knowingly facilitated the importation of HGH into the United States through false statements to the FDA (i.e., statements indicating that the HGH was an API in order to gain import approval), yet simultaneously concluded that Mr. Bader was nevertheless guilty of knowingly facilitating the sale of an illegally imported finished drug—even if the importation of this finished drug was not facilitated through false representations.
Cooper, 654 F.3d at 1115 (quoting United States v. Bedford, 536 F.3d 1148, 1156 (10th Cir.2008)) (internal quotation marks omitted). We pause, however, to observe that the district court equated the "overt act" element with the accomplishment of a "substantial step" toward the completion of the crime. Yet, as we have noted, an "overt act" and a "substantial step" are distinct concepts in the law and the latter necessarily contemplates a threshold or baseline action of greater magnitude than the former. See United States v. Irving, 665 F.3d 1184, 1198 n. 14 (10th Cir. 2011) ("In conspiracy law, given the existence of an unlawful agreement, `virtually any act will satisfy the overt act requirement.' In other words, the overt act need not necessarily be substantial." (citation omitted) (quoting Wayne R. LaFave, Substantive Criminal Law § 12.2(b), at 627 (4th ed. 2003))). Thus, theoretically, the district court's instruction could be interpreted as having placed a greater burden of proof on the government than mandated by § 371. However, the government did not object to any possible error in this instruction and therefore was bound by it. See, e.g., United States v. Williams, 376 F.3d 1048, 1051 (10th Cir.2004) ("The law of the case is applied to hold the government to the burden of proving each element of a crime as set out in a jury instruction to which it failed to object, even if the unchallenged jury instruction goes beyond the criminal statute's requirements."). In any event, given the nature of Mr. Bader's specific challenges, we have no need to address this matter further.
Id. However, the overarching premise of this policy guidance was that, generally, the FDA had maintained some degree of regulatory authority over pharmacy compounding both before Western States—as ultimately defined and restricted by the FDAMA, cf. Food and Drug, supra, § 13.74, at 194 (noting that "no FDAMA-described safe harbor would have been necessary if the FDA indeed [previously] lacked the power to regulate compounded drugs")—and after Western States. However, following Western States the agency "recognize[d] the need for immediate guidance on what types of compounding might be subject to enforcement action under current law," and it indicated that its principal focus would be on the situation "when the scope and nature of a pharmacy's activities raise the kinds of concerns normally associated with a drug manufacturer." CPG § 460.200 (emphasis added). In that regard, among other things, the FDA would consider whether the pharmacy was involved in "[c]ompounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions." Id. (emphasis added). As the Third Circuit noted:
Wedgewood Vill. Pharmacy, Inc. v. United States, 421 F.3d 263, 274 (3d Cir.2005) (internal quotation marks omitted); accord Food and Drug, supra, § 13:74, at 13-95 (3d ed. 2007). As we further explicate infra, Mr. Bader and College Pharmacy were involved in the large-scale preparation and marketing of dosages of HGH. Consequently, even taking into account the FDA's arguably broad reading of the substantive impact of Western States, Mr. Bader still would have had fair warning—as it related at least to his pharmacy business—of the possibility of FDA regulatory oversight.
Moreover, viewed from another perspective, Mr. Bader has repeatedly discounted the effect of this specific policy provision—CPG § 460.200—noting that it is "nonbinding" and "not law or proper for instruction." Aplt. Opening Br. at 7 n.11; see id. at 38 (noting that "the [compliance policy guidance] CPG admittedly is not law and may not be instructed"). In this regard, he has cited Professionals and Patients for Customized Care v. Shalala, 56 F.3d 592, 597, 602 (5th Cir. 1995) (holding that Compliance Guidance Manual provision relating to whether pharmacies were engaged in drug manufacturing did not establish "binding norms"). As a consequence, Mr. Bader is not well-situated now to contend that this policy guidance had placed a gloss on Western States that muddied the waters concerning the FDA's substantive regulatory authority over compounding. Furthermore, insofar as Mr. Bader's argument focuses on whether the FDAMA's specific substantive provisions related to compounding remained viable after Western States, Mr. Bader would be hard-pressed to claim prejudice resulting from any lack of notice concerning the state of the law because he has expressly declined to avail himself of a statutory FDAMA defense to justify his compounding activities. See, e.g., Aplee. Supp.App., Vol. I, at 1-2. In light of his large-scale preparation and marketing of HGH doses this declination is not entirely surprising. See 21 U.S.C. § 353a(a)(2); Aplee Br. at 40 ("Defendant's waiver [of a FDAMA compounding defense] is consistent with the knowledge that, even if the FDAMA was viable, the evidence did not support its applicability to the instant case.").
