Court Opinion

ID: 4228333
Source: CourtListenerOpinion
Date Created: 2017-12-13 17:00:21.216548+00
Date Added: 2024-06-11T13:26:43.518761
License: Public Domain

16-3073-cr
United States v. Scully

                           UNITED STATES COURT OF APPEALS
                                FOR THE SECOND CIRCUIT

                                      August Term, 2017

                     (Argued: August 24, 2017 Decided: December 13, 2017)

                                    Docket No. 16-3073-cr

                                  UNITED STATES OF AMERICA,

                                                        Appellee,

                                           — v. —

                              WILLIAM SCULLY, AKA Liam Scully

                                                        Defendant-Appellant,

                                    SHAHRAD RODI LAMEH,

                                                        Defendant.

B e f o r e:

                 POOLER and LYNCH, Circuit Judges, and COGAN, District Judge.*

*
 Judge Brian M. Cogan, of the United States District Court for the Eastern District
of New York, sitting by designation.
       William Scully appeals from a conviction in the United States District
Court for the Eastern District of New York (Arthur D. Spatt, Judge) for mail and
wire fraud and conspiracy to commit the same; conspiracy to defraud the United
States through the introduction of misbranded drugs into interstate commerce;
introduction of misbranded drugs into interstate commerce; receipt of
misbranded drugs into interstate commerce and delivery thereof for pay;
introduction of unapproved drugs into interstate commerce; and unlicensed
wholesale distribution of prescription drugs. The principal issue on appeal is
whether the district court erred in excluding evidence related to Scully’s advice-
of-counsel defense. Because we find that it was error to exclude that evidence, the
judgment of the district court is VACATED and REMANDED for further
proceedings consistent with this opinion.

                   KENNETH M. ABELL, Assistant United States Attorney (Amy
                   Busa and Charles P. Kelly, Assistant United States Attorneys,
                   on the brief), for Bridget M. Rohde, Acting United States
                   Attorney for the Eastern District of New York, for Appellee.

                   SCOTT A. RESNIK (Michael M. Rosensaft, on the brief), Katten
                   Muchin Rosenman LLP, New York, NY, for Defendant-
                   Appellant.

GERARD E. LYNCH, Circuit Judge:

      William Scully appeals from a judgment of conviction entered following a

five-week jury trial in the United States District Court for the Eastern District of

New York (Arthur D. Spatt, Judge).

      The jury found Scully guilty of mail and wire fraud and conspiracy to

commit the same in violation of 18 U.S.C. §§ 1341, 1343, and 1349; conspiracy to

                                          2
defraud the United States through the introduction of misbranded drugs into

interstate commerce in violation of 18 U.S.C. § 371; introduction of misbranded

drugs into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a)(2);

receipt of misbranded drugs into interstate commerce and delivery thereof for

pay in violation of 21 U.S.C. §§ 331(c) and 333(a)(2); introduction of unapproved

drugs into interstate commerce in violation of 21 U.S.C. §§ 331(d) and 333(a)(2);

and unlicensed wholesale distribution of prescription drugs in violation of 21

U.S.C. §§ 331(t), 333(b)(1)(D), and 355. He was sentenced principally to 60 months

in prison.

      The main issue on appeal is whether the district court properly excluded

evidence relating to Scully’s advice-of-counsel defense. Because we find that the

evidence was admissible and its exclusion was not harmless error, we VACATE

the district court’s judgment and REMAND for further proceedings consistent

with this decision.1

1
  We need not address Scully’s claim that the government’s presentation of two
later-dismissed counts unfairly prejudiced the jury against Scully because a new
trial on remand will not include these counts.

                                         3
                                  BACKGROUND

      The jury found Scully guilty of all charges relevant to this appeal, so we

consider the evidence in the light most favorable to the government. See United

States v. Bouchard, 828 F.3d 116, 120 (2d Cir. 2016).

I.    The Rise and Fall of Pharmalogical

      Scully and Shahrad Rodi Lameh founded Pharmalogical, Inc., in 2002 or

2003 as equal owners, Scully running the company’s day-to-day operations and

Lameh managing payments and providing most of the capital. They initially

planned to acquire pharmaceutical products from manufacturers and sell those

products to retail customers (such as doctors, hospitals, and clinics) as a

wholesale distributor. To that end, Pharmalogical received a license from New

York State authorizing it to act as a wholesale distributor of pharmaceutical

products. Pharmalogical struggled to turn a profit for several years, and

eventually Scully decided to set the company on a new course: parallel

importing. That is, rather than buying prescription drugs and medical devices

approved by the U.S. Food and Drug Administration from the drug

manufacturers, the company would import foreign versions of FDA-approved

products into the United States from European distributors. Pharmalogical could

                                           4
purchase these drugs at reduced prices and then sell them to customers in the

United States for far less than the going rate on the domestic market. Around the

same time, the company also began doing business under the name Medical

Device King or MDK.

      Pharmalogical launched its parallel importing business around 2009 with

purchases of Botox from a Canadian distributor. One of the company’s first

potential customers, Dr. James Avellini, expressed concern that the product

labels did not include a National Drug Code (“NDC”)2 and requested assurances

of the product’s legitimacy before he placed an order. Dr. Avellini’s inquiry

prompted Scully and Lameh to approach an attorney, Richard Gertler, then of

Thaler & Gertler, LLP, to research whether it was legal to resell the imported

products in the United States. Gertler produced an opinion letter dated May 27,

2009, indicating that “Pharmalogical has not received any correspondence or

notification from the FDA advising that Pharmalogical is operating in violation of

any of the provisions of the Federal Food, Drug and Cosmetic Act,” and that

2
 The NDC is a unique number assigned to each drug that allows for easy
identification of the labeler of the product (i.e., manufacturer, repackager, or
distributor); the product’s active ingredients, strength, and dosage form; and the
package size and type. See 21 C.F.R. § 207.33 (2016).

                                         5
“Pharmalogical has no reason to believe that it is not in full compliance with the

FFDCA or any other statute or regulation.” App’x 400. The letter satisfied Dr.

Avellini and others that Pharmalogical was authorized to sell Botox.

      Scully and Lameh soon learned that the Canadian distributor with which

they had been placing Botox orders simply forwarded those orders to a European

distributor, which then shipped the product to Pharmalogical in the United

States. Pharmalogical decided to cut out the Canadian middleman and began to

place orders for Botox and a second product, Mirena intrauterine devices,

directly with the European company. They also began buying Mirena IUDs at an

even lower price from a Turkish company that sold the devices with Finnish- and

Turkish-language labels and packaging. Around that time, the FDA responded to

an inquiry from Scully regarding the sale of the Mirena IUDs, notifying him that

foreign-made versions of FDA-approved drugs were considered unapproved

new drugs. Scully and Lameh asked Gertler to look into the matter and Gertler

once again produced an opinion letter, finding that “the importation of Mirena

. . . from Finland to the United States by Pharmalogical, Inc., for resale to the end

user, would not violate the criminal laws of the United States.” App’x 417.

                                          6
      As had occurred with Botox, when a potential customer for the Mirena

IUDs, Planned Parenthood, requested assurances that the product was lawful to

purchase, Scully and Lameh provided Gertler’s Mirena letter. Planned

Parenthood then placed a small order for Mirena IUDs, but then rejected and

returned the order because the product labels were missing NDCs. Scully and

Lameh nevertheless resolved to continue selling the Mirena IUDs to doctors. As

the company’s sales of Botox and Mirena IUDs increased, Scully and Lameh

further expanded their business into oncology products. Gertler did not issue a

separate legal opinion regarding Pharmalogical’s importation and sale of

oncology drugs.

      The first signs of trouble for Pharmalogical came in May 2012, when FDA

agents executed warrants to search Pharmalogical’s offices. In response, Gertler

and other lawyers, including Peter Tomao for Scully and Geoffrey Kaiser for

Lameh, arranged meetings with prosecutors, and Pharmalogical ceased selling

oncology products. But Scully made at least one shipment of oncology products

after the search through Taranis Medical Corp., a company that he had

incorporated in December 2011 and for which he executed written agreements

authorizing it to use Pharmalogical’s wholesale license to distribute prescription

                                         7
drugs, all without Lameh’s knowledge. Scully did not consult Gertler or Lameh

before making the Taranis shipment.

II.   Indictment and Pre-Trial Motions

      Scully and Lameh were indicted and arrested in April 2014. The indictment

alleged that the two men used Pharmalogical (doing business as Medical Device

King and MDK) and Taranis, to knowingly and willfully import foreign versions

of prescription drugs and medical devices not approved by the FDA for use in

the United States, and that they sold those products to customers under

materially false and fraudulent pretenses. After initially pleading not guilty,

Lameh entered into a cooperation agreement with the government and pled

guilty to conspiracy to commit wire fraud and conspiracy to distribute

misbranded drugs.

      Prior to trial, Scully moved to strike all counts based on violations of FDA

regulations, as well as Count 72, charging fraudulent importation and

transportation of goods, and Count 73, charging trafficking in counterfeit drugs.

The district court denied the motions, but ordered the government to provide a

bill of particulars identifying the specific fraud alleged in each count and the

misbranding alleged in each count. The government provided such a bill, and

                                          8
obtained a superseding 75-count indictment that added two new counts charging

Scully with the introduction of unapproved new drugs into interstate commerce

and the unlicensed wholesale distribution of prescription drugs.

III.   The Trial

       At trial, the government called dozens of witnesses to prove that Scully

purchased prescription drugs and medical devices with labels bearing

instructions in foreign languages and lacking NDCs from foreign distributors,

misrepresented those products to medical professionals as FDA-approved

products with English-language labeling, and continued selling such

pharmaceuticals through Taranis after government officials raided

Pharmalogical. The witnesses included Lameh, who detailed Pharmalogical’s

activities and Scully’s knowledge regarding the legality of the company’s

business model throughout the company’s history; some of the medical

professionals who purchased products from Scully and testified to

representations that Scully made about the products; and pharmaceutical

company representatives and government officials who testified to the

importance of FDA approval and NDCs.

                                         9
        At the close of the government’s case, Scully moved to dismiss all counts of

the superseding indictment for insufficient evidence. The district court denied

that motion except as to Counts 72 and 73, which charged fraudulent importation

and transportation of goods and trafficking in counterfeit drugs, on which the

court reserved decision.

        Scully then advanced an advice-of-counsel defense, contending that he

lacked the requisite intent for all counts alleging fraud due to his good faith

reliance on advice from Gertler and Tomao regarding the legality of his conduct.

The defense called Gertler as its first witness, and both parties questioned him

extensively on the nature of his relationship with Scully. In particular, Gertler

testified to his legal experience with health care matters, the information that

Scully shared with him about Pharmalogical’s business and products, the advice

he provided to Scully and Pharmalogical, and Tomao’s role on Scully’s legal

team.

        The government’s direct examination of Lameh and cross-examination of

Gertler and Scully effectively undermined Scully’s advice-of-counsel defense as

to Gertler. In particular, the government presented evidence that Scully and

Lameh only approached Gertler for opinion letters after they had purchased

                                         10
products and potential customers raised concerns about the legitimacy of the

products sold by Pharmalogical; that Scully provided Gertler with false

information, including that the products sold by Pharmalogical were FDA-

approved and that Pharmalogical followed all laws and regulations for importing

their products into the United States; that Scully did not inform Gertler that

Pharmalogical would advertise FDA-approved products on its website, but

sometimes provide to customers foreign equivalents of those products that were

not FDA-approved; and that Scully did not inform Gertler that U.S. customs

officials seized, sometimes permanently, some of the prescription drugs

Pharmalogical purchased from abroad because they were misbranded.

      The defense did not call Tomao to testify. Instead, they sought to introduce

evidence of Tomao’s legal advice to Scully through Scully’s own testimony. The

government objected to that course of action after the following exchange during

defense counsel’s direct examination of Scully:

            Q.     Did Mr. Tomao also give you an oral legal
                   opinion as to his conclusions about your business
                   model?

            A.     Yes. We sat down and met at Mr. Gertler’s office.
                   We had a meeting. It was Rodi, myself, Mr.
                   Gertler and Peter Tomao, and Peter had given his
                   approval and said the business was completely
                   legal.

                                         11
App’x 279. The government moved to strike, which the district court sustained as

to “[t]he statement that Peter gave us his approval.” Id. As the court explained:

             When we have the alternative of his state of mind and
             the jury hearing hearsay, very important testimony, the
             answer is no. I will not permit that. . . .

             Bring in Mr. Tomao. . . .

             It is extremely prejudicial to the Government for you to
             allow [Scully] to give that testimony. That overtakes the
             state of mind in my opinion. . . .

             It is not an exception to this hearsay rule which is that
             where you have a major figure, a very important figure
             which you do not bring in, I’m not going to let the
             hearsay come in, state of mind or otherwise.

Id. at 280–81.

      The following day, Scully asked the district court to reconsider that ruling,

noting that the defense offered evidence of Tomao’s advice to Scully not for the

truth of the matters asserted, but to establish Scully’s state of mind as part of the

advice-of-counsel defense. Accordingly, the defense argued, that evidence fell

outside of the hearsay rule. See Fed. R. Evid. 801(c)(2). On further reflection, the

district court agreed that the testimony was not technically hearsay, but ruled

that evidence of Tomao’s advice was nevertheless inadmissible under the

balancing inquiry of Federal Rule of Evidence 403, noting:

                                          12
             This testimony is extremely important to the defense,
             and as the prosecutor said, totally prejudicial to the
             government. Where is Mr. Peter Tomao? We all know
             he is a trial lawyer readily available. Why should I
             permit this totally prejudicial evidence for a state of
             mind where it is outweighed by the danger of unfair
             prejudice? . . . So I rule that the evidence’s probative
             value is substantially outweighed by the danger of
             unfair prejudice.

App’x 302. The court then again pointed out that Tomao was “readily available”

and “in court every day.” Id.

      After both sides rested their cases, the district court dismissed Counts 72

and 73 for lack of sufficient evidence, as well as Counts 6 and 22, charging mail

and wire fraud relating to a Dr. R. Daniel Jacob, on the government’s motion

because Dr. Jacob was unable to testify at trial. Although the court did not

provide printed copies of its proposed charge to the parties, it read to them its

proposed jury charge, including its instructions on the advice-of-counsel defense.

The defense’s only requested changes to the court’s instructions on the advice-of-

counsel defense were to remove the term “affirmative” from descriptions of the

defense and to change references to Scully’s “crimes” to his “acts.” App’x 333–34.

The government raised no objections to those proposed changes, and the court

accepted them both.

                                         13
      Later that day, however, the government filed a letter motion objecting on

various grounds to the court’s proposed charge and verdict sheet on the advice-

of-counsel defense. Scully’s counsel responded by letter arguing that “[t]here is

no reason or basis for the Court to now rewrite the advice-of-counsel instruction

it drafted and discussed to the satisfaction o[f] both parties” and urging the court

to use the charge “as agreed during the Court’s charging conference.” G. App’x

56. The court denied the government’s motion as to the jury charge, and

proceeded to instruct the jury on the 71 remaining counts in the superseding

indictment. Of relevance to this appeal, the court instructed the jury on Scully’s

advice-of-counsel defense as follows:

             Now I am going to instruct you on the defense of
             reliance on the advice of an attorney. . . .

             In this regard, I instruct you that the defendant has the
             burden of producing evidence to support the defense,
             but the burden of proof in this case remains on the
             government.

             I further instruct you that the defendant has to satisfy
             the following three elements to sustain the defense of
             advice of counsel:

             First, that the defendant sought the advice of counsel
             honestly and in good faith prior to committing any of
             these crimes;

                                         14
            Second, that the defendant fully and honestly placed all
            of the facts before his counsel, and;

            Third, that the defendant followed his counsel’s advice
            in good faith and honestly believing it to be correct and
            intending that his actions are lawful.

            Each of these three requirements must be satisfied.

App’x 368–69.

      The court also described to the jury how it was to consider the advice-of-

counsel defense on the verdict form:

            As to each count you will be asked to render your
            verdict and mark the verdict sheet. The verdict sheet
            will list every count. And next to it . . . the words “not
            guilty or guilty.” . . .

            [I]f you find the defendant guilty of that count, then you
            will be asked to determine if the defense of “advice of
            counsel” has been established.

            Next to the question on advice of counsel there will be
            two markings, “established,” if the defense has been
            established and “not established” if the defense has not
            been established. If you find the defendant guilty of the
            crime at issue, but also find that the defense of advice of
            counsel has been established, I advise you that the
            defendant will be acquitted of that count.

App’x 369–70.

                                         15
      The jury deliberated for two days and returned a guilty verdict on all

counts except five counts of wire fraud.

IV.   Post-Trial Developments

      After the jury’s verdict, Scully moved for a judgment of acquittal on all

counts and, in the alternative, a new trial. The district court granted the motion

only as to Counts 45 and 62, which concerned the purchase and sale of Altuzan to

the Hematology and Oncology Center of Iowa. The court then entered judgment

and sentenced Scully to 60 months in prison.3 This appeal followed.

                                  DISCUSSION

      On appeal, Scully does not renew his post-trial challenge to all counts for

lack of sufficient evidence to prove criminal intent.4 Instead, Scully’s main

challenge on appeal focuses on two alleged impediments to the fair presentation

and consideration of his advice-of-counsel defense, his only defense at trial: the

3
 In sentencing Scully, the district court applied two sentencing enhancements:
abuse of a position of trust under U.S.S.G. § 3B1.3 and a leadership role in a
criminal activity under U.S.S.G. § 3B1.1(c). Because we vacate Scully’s conviction
and remand for a new trial, we need not address the propriety of these
enhancements.
4
 Scully does raise legal challenges to his convictions on certain specific counts.
Those arguments are discussed in Part III below.

                                           16
district court’s exclusion of evidence of Tomao’s legal advice and the jury

instructions on the advice-of-counsel defense. We now turn to those issues.

I.    Evidence of Tomao’s Legal Advice

      Scully argues that the district court abused its discretion when it excluded

testimony and evidence relating to the legal advice that Scully received from

Tomao. The abuse of discretion standard is “famously slippery” and “there has

been little consensus over the years as to precisely what the phrase means.”

Zervos v. Verizon New York, Inc., 252 F.3d 163, 168 n.4 (2d Cir. 2001) (Cabranes, J.).

A district court’s evidentiary determinations generally “will not be disturbed

unless they are manifestly erroneous.” Davis v. Velez, 797 F.3d 192, 201 (2d Cir.

2015) (internal quotation marks omitted). “Under Rule 403, so long as the district

court has conscientiously balanced the proffered evidence’s probative value with

the risk for prejudice, its conclusion will be disturbed only if it is arbitrary or

irrational.” United States v. Awadallah, 436 F.3d 125, 131 (2d Cir. 2006). In general,

a district court is said to abuse its discretion “when its decision cannot be located

within the range of permissible decisions or is based on a clearly erroneous

factual finding or an error of law.” United States v. Rigas, 490 F.3d 208, 238 (2d Cir.

2007) (internal quotation marks omitted).

                                           17
      During Scully’s trial, the district court ruled that Scully could not introduce

evidence of Tomao’s legal advice through Scully’s direct examination. The court

initially excluded that evidence on hearsay grounds, basing that decision on its

sense that the importance of Tomao’s advice and the “extremely prejudicial”

nature of that testimony to the government’s case “overt[ook] the state of mind”

exception to the hearsay rule. App’x 281.

      Even after defense counsel demonstrated that the testimony was not

hearsay because it went to Scully’s state of mind and was not offered for the truth

of the matter asserted, the court continued to maintain that the evidence was

unfairly prejudicial to the government and therefore inadmissible under Federal

Rule of Civil Procedure 403. Though the district court changed the legal basis for

its ruling, hearsay concerns permeated the court’s reasoning. For example, the

court noted that Tomao was “readily available” and “in court every day,” and

that “allow[ing] this defendant to testify as to what Peter Tomao told him” is

“extremely important and prejudicial probably to the government.” App’x 302.

The court further explained in its post-trial ruling on Scully’s motion to vacate

the judgment that the proposed evidence did “not shed its fundamental character

as hearsay,” “bore the trappings of unreliable hearsay,” and was “largely

                                         18
cumulative of his testimony regarding Gertler.” United States v. Scully, 170 F.

Supp. 3d 439, 475–76 (E.D.N.Y. 2016).

      We find that the district court erred in its balancing of the probative value

and prejudicial effect of the proposed evidence under Rule 403. As the district

court noted, Scully’s efforts to bolster his only defense at trial with relevant

evidence of the advice of a second attorney was “extremely important to the

defense.” App’x 302. But it is difficult to identify what unfair prejudice that

testimony would have imposed on the government. The district court’s

continued concern with the hearsay character of Scully’s secondhand relaying of

Tomao’s words was misplaced. A statement is only hearsay if it is offered “to

prove the truth of the matter asserted.” Fed. R. Evid. 801(c)(2). “Where, as here,

the statement is offered as circumstantial evidence of [the defendant’s] state of

mind, it does not fall within the definition given by Rule 801(c)[,] because it was

not offered to prove the truth of the matter asserted.” United States v. Detrich, 865

F.2d 17, 21 (2d Cir. 1988). Though “the fact that a statement falls within an

exception to the hearsay rule does not mean that the statement is not to be

classified as hearsay,” United States v. Gupta, 747 F.3d 111, 131 (2d Cir. 2014),

                                          19
Scully’s proposed testimony does not fall within a hearsay exception; it is, by

definition, not hearsay at all.

      Nor was it appropriate to require that Scully call Tomao as a witness in

order to ensure the reliability of Scully’s testimony. There may be reasons to

doubt the credibility and reliability of Scully’s testimony in that regard, and the

government may well be correct that the documents proffered by Scully were

unlikely to sway a jury. But such determinations are the province of the jury

alone. See United States v. Khan, 53 F.3d 507, 514 (2d Cir. 1995). Scully is

competent to testify to the advice he received from counsel, even if his testimony

is one-sided and self-serving; we are now a long way from the common law rule

that “excluded as witnesses . . . persons interested in the result of the trial,”

Wolfson v. United States, 101 F. 430, 435 (5th Cir. 1900).

      It was thus error for the district court, in effect, to consider as an element of

prejudice to the government the increased possibility that Scully’s testimony

about Tomao’s oral advice would be false if uncorroborated by testimony from

Tomao himself. One party to a trial will frequently believe that testimony offered

by the other side is false or misleading. That, however, is not a factor to be

weighed against the receipt of otherwise admissible testimony. The opposing

                                           20
party has ample means to challenge the credibility of a party’s testimony, which

is to be decided by the jury. Here, for example, if Scully had been permitted to

testify to what he claims Tomao told him, the government could have cross-

examined him about that testimony, noted in summation the self-serving nature

of the testimony due to Scully’s interest in the outcome and the conspicuous lack

of corroboration from Tomao himself, challenged the likelihood that a reputable

attorney would have given such a significant opinion orally, or called Tomao as a

rebuttal witness, as it did Lameh’s attorney Geoffrey Kaiser. The government’s

strategic preference not to take those steps does not affect the admissibility of

Scully’s evidence.

      The government’s argument that evidence of Tomao’s advice to Scully

would have been cumulative is also unavailing. Scully’s entire defense rested on

the advice he allegedly received from two lawyers, Gertler and Tomao. The

government effectively cross-examined Gertler, raising questions as to Scully’s

version of the relevant events and Gertler’s level of experience with FDA matters.

Evidence of the legal advice of another attorney, and in particular a former

federal prosecutor with acknowledged experience working on FDA compliance

matters, might well have bolstered Scully’s case in the eyes of the jury. Though

                                         21
the record includes references to Tomao and his role on Scully’s legal team, such

stray bits of testimony do not substitute for Scully’s direct account of the advice

that he claims to have received from Tomao, particularly where the case revolved

around what Scully told his attorneys and what they told him.

      Finally, we conclude that that error was not harmless. In assessing whether

the improper exclusion of defense evidence was harmless, we consider

             (1) the importance of the unrebutted assertions to the
             government’s case; (2) whether the excluded material
             was cumulative; (3) the presence or absence of evidence
             corroborating or contradicting the government's case on
             the factual questions at issue; (4) the extent to which the
             defendant was otherwise permitted to advance the
             defense; and (5) the overall strength of the prosecution’s
             case.

United States v. Oluwanisola, 605 F.3d 124, 134 (2d Cir. 2010). Scully’s defense was

that he relied on the advice of counsel in operating his business and therefore

lacked the requisite fraudulent intent that the government had to prove at trial.

Evidence of Tomao’s advice was necessary to rebut the government’s claim. Of

course, the most persuasive evidence of that advice would have been testimony

from Tomao himself. But Scully was not legally required to call Tomao. He was

fully competent to testify about his own state of mind, and about how Tomao’s

                                         22
advice affected his state of mind. It was for the jury to determine whether that

testimony was credible and raised a reasonable doubt about Scully’s guilt.

      On that basis, Scully is entitled to a new trial.

II.   Advice-of-Counsel Jury Instructions

      Scully also argues that the district court’s jury charge on the advice-of-

counsel defense improperly placed the burden on Scully to establish the defense,

rather than on the government to demonstrate that Scully had the requisite

intent. Scully waived that argument, however, when defense counsel, in response

to the government’s letter motion objecting to the advice-of-counsel jury charge

and verdict sheet, urged that “[t]here is no reason or basis for the Court to now

rewrite the advice-of-counsel instruction it drafted and discussed to the

satisfaction o[f] both parties” and that the charge “should be read to the jury as

agreed during the Court’s charging conference.” G. App’x 56. Such affirmative

endorsement of the district court’s jury instructions waives the right to appellate

review. See United States v. Hertular, 562 F.3d 433, 444 (2d Cir. 2009); cf. United

States v. Crowley, 318 F.3d 401, 414 (2d Cir. 2003). Accordingly, were we not

remanding for a new trial in any event, Scully’s belated appellate objection to the

district court’s jury instructions would not warrant vacating his conviction. But

                                          23
because a new trial is required on other grounds, we take the opportunity to

provide some guidance to the district court on the issue.

      While “the prosecution must prove guilt beyond a reasonable doubt,” “the

long-accepted rule was that it was constitutionally permissible to provide that

various affirmative defenses were to be proved by the defendant.” Patterson v.

New York, 432 U.S. 197, 211 (1977). An affirmative defense is “[a] defendant’s

assertion of facts and arguments that, if true, will defeat the plaintiff’s or

prosecution’s claim, even if all the allegations in the complaint are true.” Black’s

Law Dictionary 451 (8th ed. 2004); see also Saks v. Franklin Covey Co., 316 F.3d 337,

350 (2d Cir. 2003). In a fraud case, however, the advice-of-counsel defense is not

an affirmative defense that defeats liability even if the jury accepts the

government’s allegations as true. Rather, the claimed advice of counsel is

evidence that, if believed, can raise a reasonable doubt in the minds of the jurors

about whether the government has proved the required element of the offense

that the defendant had an “unlawful intent.” United States v. Beech-Nut Nutrition

Corp., 871 F.2d 1181, 1194 (2d Cir. 1989). The government must carry its burden to

prove Scully’s intent to defraud, and that burden does not diminish because

Scully raised an advice-of-counsel defense. Accordingly, the district court must

                                          24
advise the jury in unambiguous terms that the government at all times bears the

burden of proving beyond a reasonable doubt that the defendant had the state of

mind required for conviction on a given charge.

      That said, defendants are entitled to an advice-of-counsel instruction only

if there are sufficient facts in the record to support the defense. United States v.

Evangelista, 122 F.3d 112, 117 (2d Cir. 1997). There must be evidence such that a

reasonable juror could find that the defendant “honestly and in good faith sought

the advice of counsel,” “fully and honestly laid all the facts before his counsel,”

and “in good faith and honestly followed counsel’s advice.” United States v.

Colasuonno, 697 F.3d 164, 181 (2d Cir. 2012) (brackets and internal quotation

marks omitted). Once the evidence meets that threshold, it is for the government

to carry its burden of proving fraudulent intent beyond a reasonable doubt and

for the jury to decide whether that burden was met. It is therefore potentially

confusing to instruct the jury that the defendant “has the burden of producing

evidence to support the defense”5 or must “satisfy” the elements of the defense,

5
 The “burden of producing evidence,” App’x 368, simply means that the issue is
not for the jury’s consideration at all absent some evidence of the required facts.
Whether that burden is met is thus, in the first instance, for the court to decide.
See, e.g., United States v. Bok, 156 F.3d 157, 164 (2d Cir. 1998). It is generally
preferable, in our view, not to use the language of “burden of production” in jury

                                          25
or that it is the jury’s job to determine whether the defense was “established.”

App’x 368–70.

      In drafting a more appropriate instruction on the advice-of-counsel

defense, it may be tempting to turn to the Supreme Court’s century-old

formulation, adopted by this Court in Beech-Nut:

            [I]f a man honestly and in good faith seeks advice of a
            lawyer as to what he may lawfully do . . . , and fully and
            honestly lays all the facts before his counsel, and in
            good faith and honestly follows such advice, relying
            upon it and believing it to be correct, and only intends
            that his acts shall be lawful, he could not be convicted of
            [a] crime which involves willful and unlawful intent[,]
            even if such advice were an inaccurate construction of
            the law. But, on the other hand, no man can willfully
            and knowingly violate the law and excuse himself from
            the consequences thereof by pleading that he followed
            the advice of counsel.

871 F.2d at 1194–95 (alterations in original), quoting Williamson v. United States,

207 U.S. 425, 453 (1908). But that language, like many excerpts from appellate

opinions articulating legal principles for an audience of judges and lawyers, is

unwieldy for a jury instruction.

instructions for fear that it would confuse the jury about the all-important burden
of proof that remains on the prosecution.

                                         26
      More manageable contemporary formulations are available. The treatise on

jury instructions authored by the late Leonard B. Sand, a wise and experienced

trial judge, and his colleagues, offers the following template that translates the

Williamson/Beech-Nut formulation into clearer language:

             You have heard evidence that the defendant received
             advice from a lawyer and you may consider that
             evidence in deciding whether the defendant acted
             willfully and with knowledge.

             The mere fact that the defendant may have received
             legal advice does not, in itself, necessarily constitute a
             complete defense. Instead, you must ask yourselves
             whether the defendant honestly and in good faith
             sought the advice of a competent lawyer as to what he
             may lawfully do; whether he fully and honestly laid all
             the facts before his lawyer; and whether in good faith he
             honestly followed such advice, relying on it and
             believing it to be correct. In short you should consider
             whether, in seeking and obtaining advice from a lawyer,
             the defendant intended that his acts shall be lawful. If
             he did so, it is the law that a defendant cannot be
             convicted of a crime that involves willful and unlawful
             intent, even if such advice were an inaccurate
             construction of the law.

             On the other hand, no man can willfully and knowingly
             violate the law and excuse himself from the
             consequences of his conduct by pleading that he
             followed the advice of his lawyer.

                                         27
              Whether the defendant acted in good faith for the
              purpose of seeking guidance as to the specific acts in
              this case, and whether he made a full and complete
              report to his lawyer, and whether he acted substantially
              in accordance with the advice received, are questions
              for you to determine.

1 Leonard B. Sand, et al., Modern Federal Jury Instructions: Criminal, Instruction

8-4, at 8-19 (2017).

       We also refer district courts to the model instructions drafted by our sister

circuits, particularly the Seventh Circuit’s model, which reads as follows:

              If the defendant relied in good faith on the advice of an
              attorney that his conduct was lawful, then he lacked the
              [intent to defraud; willfulness; etc.] required to prove
              the offense[s] of [identify the offense] charged in
              Count[s] __.

              The defendant relied in good faith on the advice of
              counsel if:

              1. Before taking action, he in good faith sought the
              advice of an attorney whom he considered competent to
              advise him on the matter; and

              2. He consulted this attorney for the purpose of
              securing advice on the lawfulness of his possible future
              conduct; and

              3. He made a full and accurate report to his attorney of
              all material facts that he knew; and

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            4. He then acted strictly in accordance with the advice
            of this attorney.

            [You may consider the reasonableness of the advice
            provided by the attorney when determining whether
            the defendant acted in good faith.]

            The defendant does not have to prove his good faith.
            Rather, the government must prove beyond a
            reasonable doubt that the defendant acted [with intent
            to defraud; willfully; etc.] as charged in Count[s] __.

Seventh Circuit Pattern Criminal Jury Instructions, § 6.12 (2012 ed.).

      Neither of these instructions muddles the question of burden of proof by

injecting the concept of a “burden of production” or asserting that a defendant

must “show” or “establish” or “satisfy” the jury about particular facts. The last

paragraph of the Seventh Circuit instruction, which explicitly informs the jury

that a defendant need not establish her good faith, seems to us a valuable final

reminder of the burden of proof that the prosecution must carry and should be

included in any instruction to the jury on the advice-of-counsel defense.6

6
  For similar reasons, we disapprove of the format of the verdict sheet adopted by
the district court in this case. Where the government must establish a defendant’s
fraudulent intent, the jury should not be instructed to first decide whether a
defendant is “guilty” and then determine separately “if the defense of ‘advice of
counsel’ has been established.” App’x 370. Reliance on the advice of counsel, in
cases where fraudulent intent is a required element for guilt, is a defense that
tends to refute the government’s proof of such intent. If the defendant lacks such
intent, he is not guilty of the offense.

                                         29
III.   Scully’s Challenges to Additional Counts

       In addition to the claims of trial error discussed above, Scully also contests

his guilt on several specific counts of which he was convicted. First, Scully argues

that the district court should have dismissed all counts premised on his

distribution of prescription drugs not bearing English-language labeling because

those requirements are imposed by FDA regulation and therefore cannot serve as

the basis of a criminal charge. Second, Scully claims that there was insufficient

evidence to convict him of the two remaining counts relating to Dr. Jacob because

Dr. Jacob did not testify at trial. We find no merit to these arguments.

       Scully claims that he was erroneously convicted of counts based on the sale

of prescription drugs with labels in languages other than English. His argument

misunderstands both the bases for his conviction and the law. A drug is

misbranded if its labeling lacks “adequate directions for use,” 21 U.S.C. § 352(f),

or “if at any time prior to dispensing the label of the drug fails to bear, at a

minimum, the symbol ‘Rx only,’” 21 U.S.C. § 353(b)(4)(A). In the bill of

particulars filed by the government at court order, the government alleged that

each of the drugs that Scully sold “failed to bear the phrase ‘Rx only.’” G. App’x

13–18. Scully did not claim otherwise at trial or on appeal. Accordingly, the

                                          30
evidence of guilt was sufficient without regard to the foreign-language label. But

in any event, we find no legal flaw in the government’s alternative theory based

on the absence of English-language labels. Prescription drugs affixed with

foreign-language labels do not provide adequate directions for use as required by

the statute, and not merely by FDA regulations. It requires no administrative

regulation to reach the common-sense conclusion that medical products bearing

labels in languages other than the prevailing language in the relevant

marketplace—here, English—are, in effect, not labeled at all.

      Scully also argues that the record lacked sufficient evidence to support his

conviction on Counts 40 and 57, charging introduction of Botox into interstate

commerce and receipt of Botox in interstate commerce and delivery thereof to Dr.

R. Daniel Jacob for pay with the intent to defraud or mislead. Because Dr. Jacob

was unable to testify at trial due to illness, Scully argues that the government

failed to prove that Dr. Jacob relied on Scully’s representations when purchasing

the misbranded Botox, thereby defeating any finding of fraudulent intent. But

reliance by a victim is not an element of felony introduction of misbranded drugs

into interstate commerce nor of felony receipt of misbranded drugs in interstate

commerce and delivery thereof for pay, which are complete when the defendant

                                         31
formulates a fraudulent scheme and introduces or receives and sells misbranded

drugs through interstate commerce. Moreover, “direct proof of defendant's

fraudulent intent is not necessary.” United States v. Guadagna, 183 F.3d 122, 129

(2d Cir. 1999). “[A] jury may bring to its analysis of intent on individual counts

all the circumstantial evidence it has received on the scheme and the purpose of

the scheme in which the defendant allegedly participated.” Id. at 130. There is

substantial evidence in the record from which a jury could find that Scully was

engaged in a scheme to defraud doctors, clinics, and hospitals; the whole

corporate enterprise was built on Scully’s assurances that the drugs sold in the

name of Pharmalogical, Medical Device King, and Taranis were appropriate for

sale in the United States. The government need not present testimony from each

victim of Scully’s fraudulent scheme to prove intent as to that victim.

                                  CONCLUSION

      For the reasons stated above, the judgment of the district court is

VACATED and REMANDED for further proceedings in accordance with this

opinion.

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