Opinion ID: 2803231
Heading Depth: 2
Heading Rank: 2

Heading: Darji

Text: In his appeal, Darji argues that: (1) the rule of lenity should apply to reverse his conviction under the CSA; (2) the CSA is unconstitutionally vague as applied to him; (3) the district court should not have instructed the jury on willful ignorance; (4) the district court - 17 - Case Nos. 13-3240/3525, United States v. Darji, et al. abused its discretion by excluding certain evidence from his trial; and (5) the district court abused its discretion by denying his motion for a new trial. 1. The Rule of Lenity Is Not Applicable in Darji’s Case Darji argues both that the CSA is unconstitutionally vague as applied to him and that, even if the law could be interpreted to apply to him, the rule of lenity should resolve the law’s ambiguity in his favor. Under Skilling v. United States, 561 U.S. 358, 405-06 (2010), federal courts must first consider limiting constructions such as the rule of lenity before addressing a vagueness challenge. See United States v. Tobin, 676 F.3d 1264, 1273 (11th Cir. 2012), abrogated on other grounds as recognized in United States v. Castro, 736 F.3d 1308, 1313 (11th Cir. 2013). Accordingly, we first address Darji’s lenity argument. We review statutory-interpretation questions de novo, starting with the language of the statute itself to determine the presence or absence of any ambiguity. United States v. Moore, 567 F.3d 187, 190 (6th Cir. 2009). If the statutory language is clear and unambiguous, “the Court will usually proceed no further.” United States v. Bailey, 228 F.3d 637, 638 (6th Cir. 2000). “In evaluating whether a statute is ambiguous for rule-of-lenity purposes, it is not enough for the plain language to be unclear; only when the plain language, structure, and legislative history provide no guidance will we apply the rule of lenity.” United States v. Wagner, 382 F.3d 598, 611 (6th Cir. 2004). The rule of lenity applies “only if, after using the usual tools of statutory construction, we are left with a ‘grievous ambiguity or uncertainty in the statute.’” Robers v. United States, 134 S. Ct. 1854, 1859 (2014) (quoting Miscarello v. United States, 524 U.S. 125, 139 (1998)). No such ambiguity pervades the CSA’s proscription of distribution of controlled substances such as hydrocodone. Under 21 U.S.C. § 841(a)(1), “it shall be unlawful for any - 18 - Case Nos. 13-3240/3525, United States v. Darji, et al. person knowingly or intentionally . . . to distribute[ ] or dispense . . . a controlled substance.” Under § 829, however, “practitioner[s]” may dispense Schedule III and Schedule IV substances with a “prescription.” Id. § 829(b). Specifically, a prescription “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). Darji argues that § 1306.04(a) is ambiguous because numerous licensed physicians involved in the conspiracy “embraced the technological advancements of the telephone and internet,” suggesting that “the practice of prescriptions based upon a review of medical records and a telephone consultation were within the usual course of professional medical practice.” He further contends that because Congress did not prohibit the distribution of controlled substances over the internet without face-to-face consultations until 2008, see the Ryan Haight Online Pharmacy Consumer Protection Act (the “Ryan Haight Act”), Pub. L. No. 110-425, 122 Stat. 4820 (2008),4 the law regarding distribution of prescriptions online at the time of his conduct was ambiguous. These arguments fail. As an initial matter, this Court long ago held that “the language in § 841(a)(1) and 21 C.F.R. § 1306.04(a) clearly defines the pharmacist’s responsibilities that give rise to conduct that constitutes an unlawful distribution of a prescription drug.” United States v. DeBoer, 966 F.2d 1066, 1068-69 (6th Cir. 1992). Therefore, because the standard applicable to the writing of prescriptions for controlled substances is not ambiguous, the rule of lenity has no application in Darji’s case. Moreover, that the doctors involved in the conspiracy willingly participated in the dispensation of controlled substances based on cursory consultations and review of medical records on an internet platform is not compelling evidence of the statute’s 4 The Ryan Haight Act amended the CSA to prohibit the distribution of controlled substances over the internet. See 21 U.S.C. §§ 829(e)(1), 841(h). The Act also defined “valid prescription” as “a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by . . . a practitioner who has conducted at least 1 in-person medical evaluation of the patient.” Id. § 829(e)(2)(A)(i). - 19 - Case Nos. 13-3240/3525, United States v. Darji, et al. ambiguity. See Tobin, 676 F.3d at 1275 (“Congress’s decision to amend the CSA in 2008 is best understood as confirming that under the CSA, it is unlawful to distribute controlled substances without a valid prescription, regardless of whether the prescription is made in person, by mail, by phone, or through the Internet.” (emphasis added)); see also Moskal v. United States, 498 U.S. 103, 108 (1990) (“[W]e have declined to deem a statute ‘ambiguous’ for purposes of lenity merely because it was possible to articulate a construction more narrow than that urged by the Government.”). In support of his contention that the statute is ambiguous, Darji also cites the Supreme Court’s opinion in Gonzales v. Oregon, in which the Court described “the statutory phrase ‘legitimate medical purpose’ [as] a generality, susceptible to more precise definition and open to varying constructions.” 546 U.S. 243, 258 (2006). But the Court made this statement in the context of determining whether an Attorney General Interpretive Rule regarding doctor-assisted suicide deserved deference, not in the context of determining the constitutionality of the CSA itself. Id. To the contrary, the Supreme Court has upheld and applied the standards set forth in the statute to uphold the conviction of a physician who prescribed methadone outside of the bounds of professional practice based on “inadequate physical examinations or none at all.” United States v. Moore, 423 U.S. 122, 142-43 (1975); see also id. at 145 (declining to apply the rule of lenity to § 841(a)(1)). Ultimately, the plain language of the CSA as it existed prior to the Ryan Haight Act “makes it clear that the channel through which controlled substances are distributed is of no consequence.” Tobin, 676 F.3d at 1277; see also United States v. Birbragher, 603 F.3d 478, 487 (8th Cir. 2010) (“Birbragher was not indicted because his business . . . utilized the internet to distribute controlled substances. Rather, he was prosecuted for conspiring with doctors and - 20 - Case Nos. 13-3240/3525, United States v. Darji, et al. pharmacists to distribute controlled substances in a manner which the government alleges is outside the usual course of professional practice.”).5 A pharmacist with Darji’s experience cannot be characterized as “the unwitting victim of a law he didn’t understand.”6 United States v. Lovern, 590 F.3d 1095, 1103 (10th Cir. 2009). Because well-established law in this Circuit dictates that § 841(a)(1) and § 1306.04(a) are not ambiguous, we decline to employ the rule of lenity to reverse Darji’s convictions. 2. The CSA Is Not Unconstitutionally Vague as Applied to Darji Darji next argues that § 841(a)(1) is unconstitutionally vague as applied to him because it was impossible for him to know the legal standard governing his conduct prior to the passage of the Ryan Haight Act. He argues that no reasonable person in his position could have known that his business model was illegal. Based on the rule-of-lenity analysis set forth above, Darji’s argument must fail. As previously noted, this Court has rejected the claim that § 841 and § 1306.04(a) are void for vagueness. DeBoer, 966 F.2d at 1068-69. Moreover, Darji mischaracterizes the government’s case as “based primarily on the assertion of a per se rule that a prescription is invalid, no matter how thoroughly vetted, if there was no face to face consultation.” Darji was not indicted—and the jury was not instructed—under the Ryan Haight Act, but rather under the 5 To the extent Darji insists his conviction was based on the failure to conduct face-to-face evaluations with patients as required by the Ryan Haight Act in violation of the Ex Post Facto Clause, U.S. Const. art. I, sec. 10, cl. 1, the argument fails for the reasons articulated by the Eighth Circuit in Birbragher. See 603 F.3d at 487. Conspiring to distribute controlled substances in the manner alleged in the indictment would violate § 841(a)(1) regardless of the means used to carry out the distribution—in this case, the internet. Id. Moreover, the district court’s instructions to the jury regarding the elements of the charged offenses did not mention the face-to-face requirement of the Ryan Haight Act; rather, the instructions closely tracked the requirements of § 841(a)(1) and § 1306.04(a) as they existed prior to the Act’s passage. 6 The district court indicated at Darji’s sentencing that the face-to-face argument was a “red herring,” and that the real issue in the case was the writing and filling of “prescriptions without regard to what was happening to the people who were placing those prescriptions.” - 21 - Case Nos. 13-3240/3525, United States v. Darji, et al. more general standards applicable to prescription of controlled substances outside the bounds of professional practice, which courts have recognized for decades. See Moore, 423 U.S. at 142-43. Moreover, in rejecting Darji’s void-for-vagueness argument, we join a considerable weight of precedent rejecting virtually identical claims in the context of internet pharmacies. See, e.g., Tobin, 676 F.3d at 1278 (holding that the CSA had “sufficient definiteness”); United States v. Bansal, 663 F.3d 634, 656-57 (3d Cir. 2011) (“Strictly speaking, [the defendants] were not charged with distributing controlled substances via the internet; they were charged with distributing controlled substances, period.”); Birbragher, 603 F.3d at 488-89 (“Birbragher had adequate notice that the distribution of controlled substances outside the course of professional practice violated the CSA regardless of the means of distribution.”); Lovern, 590 F.3d at 1103; United States v. Quinones, 536 F. Supp. 2d 267, 271 (E.D.N.Y. 2008) (“That the moving defendants allegedly carried out their activities through the Internet is of no consequence. . . . If the means [used to distribute controlled substances] are within the usual scope of professional practice, they are legal; if they are outside that scope, they are illegal.”). Ultimately, Darji is analogous to the defendant as described in the Tenth Circuit’s opinion in Lovern: Mr. Lovern was a pharmacist with decades of experience. According to his own testimony, Mr. Lovern understood that he had a legal duty to ensure he filled only those prescriptions issued in the usual course of medical practice. He understood as well that a patient-physician relationship, including a physical examination, usually precedes a prescription in contemporary medical practice. And he knew that the prescriptions he filled at [the defendant pharmacy] were issued after a customer filled in an online questionnaire with no follow-up physical examination or consultation with a physician. A reasonable jury could find that Mr. Lovern knowingly filled prescriptions outside the usual course of medical practice, something Mr. Lovern admitted he could not do lawfully. On this record, we cannot say that Mr. Lovern was the unwitting victim of a law he didn’t understand. - 22 - Case Nos. 13-3240/3525, United States v. Darji, et al. 590 F.3d at 1103. Similarly here, a reasonable jury could have found that Darji knowingly filled prescriptions outside the usual course of medical practice through the USMeds and Delta Health organizations. We do not find 21 U.S.C. § 841(a)(1) or 21 C.F.R. § 1306.04(a) unconstitutionally vague as applied to Darji. 3. The District Court Did Not Err by Instructing the Jury on Willful Ignorance Darji also argues that the district court should not have instructed the jury regarding willful ignorance because the evidence demonstrated that he verified that all physicians with whom he conducted business had valid licenses and that his technicians checked underlying medical records. The government contends that the evidence was rife with “red flags” that should have alerted Darji to the illegality of the conspiracy’s operation, thereby validating the court’s delivery of the willful-ignorance instruction. The government’s argument prevails. We review challenges to a jury instruction for abuse of discretion. United States v. Mitchell, 681 F.3d 867, 876 (6th Cir. 2012). The district court “does not abuse its discretion unless the jury charge fails accurately to reflect the law.” Id. (quoting United States v. Geisen, 612 F.3d 471, 485 (6th Cir. 2010)) (internal quotation marks omitted). “An improper instruction requires reversal of the judgment ‘only if the instructions, viewed as a whole, were confusing, misleading, or prejudicial.’” Id. (quoting United States v. Kuehne, 547 F.3d 667, 679 (6th Cir. 2008)). The willful-ignorance instruction is appropriate where “(1) the defendant claims a lack of guilty knowledge; and (2) the facts and evidence support an inference of deliberate ignorance”—i.e., where “there is evidence to support an inference ‘that the defendant acted with reckless disregard of [the high probability of illegality] or with a conscious purpose to avoid learning the truth.’” Id. (alteration in original) (quoting United States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980)). While the instruction “should be used sparingly because of the heightened - 23 - Case Nos. 13-3240/3525, United States v. Darji, et al. risk of a conviction based on mere negligence, carelessness, or ignorance,” Geisen, 612 F.3d at 486, we have “approved the giving of this instruction to show a conspirator’s knowledge of the unlawful aims of a conspiracy.” Mitchell, 681 F.3d at 879 (quoting United States v. Williams, 612 F.3d 500, 508 (6th Cir. 2010)) (internal quotation marks omitted). Initially, we note that the district court’s willful-ignorance instruction exactly mirrored Sixth Circuit Pattern Jury Instruction 2.09. We repeatedly have held that Instruction 2.09 is an accurate statement of the law. See, e.g., United States v. Reichert, 747 F.3d 445, 451 (6th Cir. 2014). “[E]ven when it is unsupported by evidence, a deliberate ignorance instruction that properly states the law is harmless error.” United States v. Rayborn, 491 F.3d 513, 520 (6th Cir. 2007). Therefore, any error attributable to the district court’s willful-ignorance instruction is harmless. However, there was no error because substantial evidence supported the district court’s decision to give the instruction. The distribution of hydrocodone from Darji’s pharmacies far outstripped state and national averages, and Darji often shipped multiple high-strength dosages to the same address under different names. Moreover, Darji received highly inflated dispensing fees for controlled substances versus non-controlled substances. Intercepted phone calls also indicated that Darji intentionally ordered lower ratios of controlled versus non-controlled medication and shifted prescriptions among his three pharmacies in order to avoid DEA scrutiny regarding the amount of hydrocodone coming into his pharmacies. At the very least, this evidence indicates that Darji may intentionally have ignored numerous “red flags” regarding the illegality of the conspiracy. Cf. Mitchell, 681 F.3d at 878-79. Accordingly, the district court did not abuse its discretion by instructing the jury on willful ignorance. - 24 - Case Nos. 13-3240/3525, United States v. Darji, et al. 4. The District Court Did Not Abuse Its Discretion by Excluding Certain Evidence from Darji’s Trial Darji argues that the district court erred by excluding two key pieces of evidence from his trial: (1) a May 2005 letter written by attorney Max Kravitz to the DEA; and (2) the testimony of former DEA Diversion Investigator John Mudri, who conducted an on-site inspection of the Medicom pharmacy on January 30, 2006. Darji argues that he offered the letter to show his state of mind rather than to demonstrate the truth or legal accuracy of Kravitz’s opinion. Darji further argues that Mudri reviewed a website analogous to USMeds and prepared a report in which he did not advise Darji that filling online prescriptions would violate the CSA, thereby demonstrating Darji’s lack of intent to violate the law. The government responds that the district court properly excluded the letter—an advocacy document addressed to investigators at the DEA—because it was premised on untrue factual predicates regarding the workings of the conspiracy and did not properly support an advice-of-counsel defense. And in any event, the government argues, any error from the letter’s exclusion was harmless because Darji effectively read the letter into evidence during his testimony. The government further argues that the district court properly excluded Mudri’s testimony because it regarded “observations”—i.e., improper expert opinion testimony—about a website completely unrelated to USMeds. We find the government’s arguments more persuasive. We review a district court’s evidentiary decisions for an abuse of discretion, which occurs only when the district court’s determination was based “‘on clearly erroneous findings of fact, improperly applie[d] the law, or employ[ed] an erroneous legal standard,’ or when we are ‘firmly convinced that a mistake has been made, i.e., when we are left with a definite and firm conviction that the trial court committed a clear error of judgment.” United States v. Miner, 774 F.3d 336, 348 (6th Cir. 2014) (citation omitted) (quoting Griffin v. Finkbeiner, 689 F.3d 584, - 25 - Case Nos. 13-3240/3525, United States v. Darji, et al. 592 (6th Cir. 2012); United States v. Heavrin, 330 F.3d 723, 727 (6th Cir. 2003)). Even erroneous evidentiary rulings require reversal only if they “affected the outcome of the trial.” Id. (quoting Cummins v. BIC USA, Inc., 727 F.3d 506, 510 (6th Cir. 2013)) (internal quotation marks omitted). The district court ruled the Kravitz letter inadmissible under Rule 403 of the Federal Rules of Evidence, which provides that a “court may exclude relevant evidence if its probative value is substantially outweighed by a danger of one or more of the following: unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.” This was not an abuse of discretion. When reviewing Rule 403 balancing determinations, we “must maximize the probative value of the challenged evidence and minimize its potential for unfair prejudice.” United States v. Adams, 722 F.3d 788, 812 (6th Cir. 2013) (quoting United States v. Lloyd, 462 F.3d 510, 516 (6th Cir. 2006)) (internal quotation marks omitted). The basis of the district court’s exclusion of the letter was that it was not a communication between Kravitz and Darji, rendering it improper for use in an advice-of-counsel defense. See United States v. Geiger, 303 F. App’x 327, 330 (6th Cir. 2008) (“The prima facie elements of an advice-of-counsel defense are (1) full disclosure of all pertinent facts and (2) good faith reliance on the advice of counsel.”). Further, the district court emphasized that the letter contained numerous questionable factual assumptions regarding the mechanics of the conspiracy. For example, the letter set forth Kravitz’s understanding that, prior to issuing a prescription, doctors involved in the conspiracy required “each patient [to] have undergone a relatively recent (approximately one-year old or less) face-to-face physical examination by a physician leading to a diagnosis supporting a prescription to treat the diagnosis.” The letter had - 26 - Case Nos. 13-3240/3525, United States v. Darji, et al. little to no probative value regarding advice of counsel because it was not addressed from an attorney to Darji. Moreover, the risk of prejudicing the government or confusing the jury was considerable in light of the unsupported factual postulates on which the letter rested. Given the district court’s “broad discretion in balancing probative value against potential prejudicial impact,” United States v. Layne, 192 F.3d 556, 573 (6th Cir. 1999), we see no reason to disturb the court’s Rule 403 determination. This is especially true in light of the fact that any error resulting from the exclusion of the letter was harmless. The district court explicitly allowed Darji to testify regarding whether “he had certain views of the law and if he relied upon certain things, such as what the lawyer told him or represented to him.” Moreover, during Darji’s direct examination, Darji’s attorney read the portions of Kravitz’s letter he deemed relevant out loud, asking Darji about them. Therefore, it is unlikely that the exclusion of the letter itself materially affected the verdict, rendering any putative error harmless. Lloyd, 462 F.3d at 516. Regarding Mudri’s testimony, the district court refused “to take a person who’s opened up a business as a consultant based on his experience, background, and expertise in an agency, and then to treat him as a layperson at trial, and allow [him] to not only testify to what people told [him], but about what [his] opinions are.” The court viewed Mudri’s anticipated testimony as “an expert opinion as to what’s legal, what’s not legal.” This was not an abuse of discretion. Under Federal Rule of Evidence 701(c), “[i]f a witness is not testifying as an expert, testimony in the form of an opinion is limited to one that is . . . not based on scientific, technical, or other specialized knowledge within the scope of Rule 702.” See also Fed. R. Evid. 702 (requiring expert witnesses to be “qualified . . . by knowledge, skill, experience, training, or education”). - 27 - Case Nos. 13-3240/3525, United States v. Darji, et al. As Darji admitted in his response to the government’s motion to exclude Mudri’s testimony, the testimony would be based on Mudri’s “almost 30 years as a DEA Diversion Investigator and DEA manager.” His observations regarding the legality of Darji’s Medicom pharmacy would therefore be well outside the ken of an ordinary layperson.7 Rule 701(c) is intended to preclude a party from surreptitiously circumventing “the reliability requirements set forth in Rule 702 . . . through the simple expedient of proffering an expert in lay witness clothing” and to “ensure[ ] that a party will not evade the expert witness disclosure requirements set forth in . . . Fed. R. Crim. P. 168 by simply calling an expert witness in the guise of a layperson.” United States v. White, 492 F.3d 380, 400-01 (6th Cir. 2007) (alteration in original) (quoting Fed. R. Evid. 701 advisory committee notes (2000 Amendments)). The district court appropriately rejected the defense’s attempt to “bootstrap” Mudri’s expert testimony in as lay witness testimony. This determination was not an abuse of discretion. 5. The District Court Did Not Abuse Its Discretion by Denying Darji’s Motion for a New Trial Finally, Darji argues that the district court should have granted his motion for a new trial under Federal Rule of Criminal Procedure 33.9 Darji argues that he relied on advice from his attorney and DEA guidance documents to reach his understanding that the law did not require face-to-face meetings between prescribing physicians and patients. He argues that every prescription he filled was written by a licensed physician and that he conducted routine inquiries to verify the prescriptions, credentials, and practices of every physician whose prescriptions he 7 Darji attempted to analogize Mudri to the laypersons the court allowed to testify in United States v. Whaley, 860 F. Supp. 2d 584 (E.D. Tenn. 2012), because their testimony was not based upon specialized knowledge within the scope of Rule 702, but rather “upon their own ‘particularized knowledge,’ i.e., their familiarity with the underwriting process and lending policies at their banks, that they have due to their employment at their respective banks.” Id. at 596. Here, as noted by the district court, Mudri’s testimony would not be based upon his experience with Medicom’s processes gained through employment there, but rather upon his experience with the DEA. Accordingly, Whaley is not on all fours. 8 Federal Rule of Criminal Procedure 16(b)(1)(C) requires the defendant to provide the government with a written summary of any expert-witness testimony that “describe[s] the witness’s opinions, the bases and reasons for those opinions, and the witness’s qualifications.” Darji’s counsel did not provide the government with such a summary or designate Mudri as an expert witness in this case. - 28 - Case Nos. 13-3240/3525, United States v. Darji, et al. filled. He suggests that this demonstrates that the jury’s verdict was against the manifest weight of the evidence. The government responds that overwhelming evidence—including the inflated fill fees and prices of hydrocodone and the abnormally high volume of hydrocodone prescriptions written by participating doctors for customers across the country—supported the district court’s decision to deny the motion for a new trial. The government’s argument prevails. Jury verdicts are presumed valid; “the burden is on the defendant to demonstrate that a new trial ought to be granted.” 3 Charles Alan Wright & Sarah N. Welling, Federal Practice and Procedure, § 581, at 437 (4th ed. 2011). “The paradigmatic use of a Rule 33 motion is to seek a new trial on the ground that ‘the [jury’s] verdict was against the manifest weight of the evidence.’” United States v. Munoz, 605 F.3d 359, 373 (6th Cir. 2010) (alteration in original) (quoting United States v. Crumb, 187 F. App’x 532, 536 (6th Cir. 2006)). Such a motion should be granted “only in the extraordinary circumstance where the evidence preponderates heavily against the verdict.” United States v. Hughes, 505 F.3d 578, 592-93 (6th Cir. 2007) (internal quotation marks omitted). “[A] district court judge, who had a ring-side seat at the trial, may appropriately act as a thirteenth juror, assessing the credibility of the witnesses and the weight of the evidence. Yet appellate court judges, who have only a transcript to work with, have no such authority.” Dimora, 750 F.3d at 627-28 (citation omitted) (quoting Hughes, 505 F.3d at 593) (internal quotation marks omitted). The district court’s denial of Darji’s motion for a new trial was not an abuse of discretion because ample evidence supported the jury’s verdict. The district court cited evidence in the record that customers pre-selected the medication to be prescribed, that USMeds did not accept health insurance, and that USMeds customers paid a price substantially higher than the retail 9 This rule provides that “the court may vacate any judgment and grant a new trial if the interest of justice so requires.” Fed. R. Crim. P. 33(a). - 29 - Case Nos. 13-3240/3525, United States v. Darji, et al. price for hydrocodone. The court also noted that Darji received highly inflated dispensing fees—$20 per order versus the national average of $0.50 to $2.50. Substantial evidence supported the jury’s conclusion that Darji dispensed hydrocodone outside of the usual course of professional practice. Moreover, as noted above, considerable evidence supported a finding that Darji willfully ignored the illegality of the conspiracy. This includes Darji’s own admissions that Dr. Fernandez, a psychiatrist, should not have been seeing patients for chronic pain conditions; that psychiatrists generally do not prescribe hydrocodone; and that, despite these facts, Darji never contacted Dr. Fernandez regarding her thousands of prescriptions. In sum, the evidence did not preponderate heavily against Darji’s convictions. Cf. Dimora, 750 F.3d at 627. On abuse-of-discretion review, we can find no reason in the record to upend either the jury’s verdict or the district court’s denial of Darji’s motion for a new trial.