Opinion ID: 799257
Heading Depth: 1
Heading Rank: 3

Heading: Facilitating the Sale of Illegally Imported HGH and Conspiracy to Facilitate the Sale of Illegally Imported HGH

Text: 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, 1214 (10th Cir.2003) (Our conclusion that [defendant's] convictions on counts 2 through 5 must be reversed does not, however, preclude retrial of [defendant] on these counts....); cf. Level 3 Commc'ns v. Liebert Corp., 535 F.3d 1146, 1150 (10th Cir.2008) (vacating the jury's verdict and remanding for a new trial where the court erroneously instructed the jury). 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. [11] None of these arguments has merit. (i) Importation of Illegally Manufactured API or Finished Drug Product Lacking NDA Approval 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. [12] Specifically, the government produced sufficient evidence upon which a reasonable jury could have concluded that the HGH that Mr. Bader imported was a finished drugprimarily through detailed witness testimony explaining how the imported Genescience HGH remained essentially unaltered prior to distribution. Much of this testimony pertained to the specific, step-by-step protocol that College Pharmacy employees followed in preparing the imported Chinese HGH for distribution. Stacy Griffin, one of those employees, read portions of College Pharmacy's Somatropin prepackaged protocol aloud from the stand as she testified. Aplee. App., Vol. I, Tr. at 131 (Test. of Stacy Griffin). That protocol was remarkably simple, requiring College Pharmacy employees to simply gather and sterilize 5 cc 20-millimeter vials, clean the requisite measuring materials, calibrate the scales used to weigh out the appropriate doses, then [p]lace [an] empty sterile vial on the balance and begin to weigh powder into it. Id. at 132-34 (internal quotation marks omitted). Ms. Griffin verified that this was essentially the process that was followed when College Pharmacy took the Somatropin from the large bottles and put it into small vials, id. at 134, and confirmed that College Pharmacy got Somatropin from Genescience, id. at 131. 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. Id. at 170. On the basis of testimony from the man who actually imported and dealt directly with Genescience, it would have been entirely reasonable for a jury to conclude that Genescience's HGH, to which nothing was being added or taken out, was essentially (in substance) identical to the smaller Somatropin doses that College Pharmacy later marketedparticularly in light of Mr. Blum's testimony that he was able to personally use (as well as distribute to his friends) the finished HGH that he received directly from Genescience. See id. at 172, 182. 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. (ii) Mens Rea 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 Chris Strong, College Pharmacy's managing pharmacist at the time that Mr. Bader began importing the Chinese HGH. Mr. Strong testified that he had expressed his concerns about the importation of Chinese HGH to Mr. Bader and other College Pharmacy pharmacists at a meeting in 2004. He explained that the meeting had centered upon whether or not College Pharmacy was going to operate the pharmacy with the compliance policy guidelines of the FDA, and he recalled that Mr. Bader's opinion [had been] that [the FDA's policy] was a guideline not a rule or a regulation that College Pharmacy was obligated to follow. Aplee. App., Vol. I, Tr. at 113 (Test. of Chris Strong); see also id., Vol. II, Tr. at 293-94 ([T]he FDA wanted in, and [Mr. Bader] wanted them out.... [T]hey were known as Big Pharma. They were the big enemy, and we were the good guys.). Mr. Strong further testified that he and Mr. Bader had quarreled over appropriate College Pharmacy protocol, usually in relation to Mr. Bader's continuous attempts to increase College Pharmacy's profit. Not long after Mr. Strong attempted to institute a new policy at College Pharmacypursuant to which pharmacists would be asked to verify that any new physician who sought to fill a prescription with College Pharmacy was adequately certifiedhe was fired from his position at the pharmacy. 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.