United States Court of Appeals

For the First Circuit

No. 19-1471

UNITED STATES OF AMERICA,

Appellee,

v.

ALLA V. STEPANETS,

Defendant, Appellant.

No. 19-1595

UNITED STATES OF AMERICA,

Appellee,

v. 

GENE SVIRSKIY,

Defendant, Appellant.

No. 19-1600

UNITED STATES OF AMERICA,

Appellee,

v. 

CHRISTOPHER M. LEARY,

Defendant, Appellant.

APPEALS FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Richard G. Stearns, U.S. District Judge]

Before

Thompson, Selya, and Barron,

Circuit Judges. 

John H. Cunha, Jr., with whom Helen Holcomb, Charles Allan 

Hope, and Cunha & Holcomb, P.C. were on brief, for appellant Alla 

V. Stepanets. 

Christopher M. Iaquinto, with whom Jeremy M. Sternberg, 

Zachary D. Reisch, and Holland & Knight LLP were on brief, for 

appellant Gene Svirskiy. 

Paul V. Kelly, with whom Sarah W. Walsh and Jackson Lewis, 

P.C. were on brief, for appellant Christopher M. Leary. 

Ross B. Goldman, Criminal Division, Appellate Section, United 

States Department of Justice, with whom Andrew E. Lelling, United 

States Attorney, Amanda P.M. Strachan, Assistant United States 

Attorney, Donald C. Lockhart, Assistant United States Attorney, 

Brian A. Benczkowski, Assistant Attorney General, and John P. 

Cronan, Deputy Assistant Attorney General, were on brief, for 

appellee. 

February 26, 2021
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BARRON, Circuit Judge. These consolidated appeals, like 

the appeals in United States v. Cadden, 965 F.3d 1 (1st Cir. 2020), 

and United States v. Chin, 965 F.3d 41 (1st Cir. 2020), trace back 

to tragic events that occurred in the fall of 2012. See Cadden, 

965 F.3d at 6-7. Around that time, patients across the country 

began falling seriously ill after having been injected with a 

contaminated medication compounded by the New England Compounding 

Center ("NECC"), a pharmacy that operated out of Framingham, 

Massachusetts. See id. Many of these patients eventually died, 

and a federal investigation, including a criminal one, ensued. 

See id.

The defendants here -- Alla Stepanets, Gene Svirskiy, 

and Christopher Leary -- are, like the defendants in Cadden and 

Chin, former NECC employees. However, unlike the defendants in 

those cases, these three defendants are not accused of playing any 

role in compounding the medication alleged to have caused the 

patient illnesses and deaths. Cf. Cadden, 965 F.3d at 6-7. 

Rather, they each were tried and convicted for a number of federal 

offenses that relate to other aspects of NECC's operations but 

that were identified in the course of the federal criminal 

investigation spurred by the nationwide outbreak that was 

ultimately attributed to NECC's medication. The defendants now 

appeal each of those convictions and, in Stepanets's case, her 

sentence as well. We affirm.
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I.

For a more detailed recitation of the background to the 

federal criminal investigation into the nationwide outbreak itself

and to NECC's operations, we refer the reader to our opinion in 

Cadden. See id. at 6-7. For present purposes, we focus initially 

on the travel of these three appeals, reserving a more detailed 

recounting of the facts that are relevant to each of them to our 

consideration of the specific challenges raised by each appellant.

Suffice it to say for now that NECC was a compounding 

pharmacy, which combined drugs with other substances to create 

specialized medications for patient use, see Chin, 965 F.3d at 45, 

and that Stepanets, Svirskiy, and Leary were NECC pharmacists who 

were each engaged in different parts of the company's operations. 

In December of 2014, a grand jury in the District of Massachusetts 

returned a 131-count indictment that charged each of them -- as 

well as Barry Cadden, NECC's founder and president; Glenn Chin, 

NECC's supervising pharmacist; and nine others affiliated with 

NECC -- with committing a range of federal offenses.

The trials of Cadden, Chin, and several other defendants 

were severed, and a number of the other defendants pleaded guilty. 

The three appellants, however, went to trial in October of 2018 

along with three of their co-defendants.

The trial lasted ten-and-a-half weeks. The jury found 

Stepanets, Svirskiy, and Leary each guilty of committing multiple 
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federal crimes. They each now appeal their convictions and, in 

the case of Stepanets, with whose challenges we begin, her sentence 

as well.

II.

Stepanets was charged in the indictment with the 

following federal crimes: racketeering conspiracy, see 18 U.S.C. 

§ 1962(d), conspiracy to defraud the United States, see id. § 371, 

and seven counts in connection with the introduction of 

"misbranded" drugs into interstate commerce with the intent to 

defraud and mislead in violation of the Federal Food, Drug, and 

Cosmetic Act ("FDCA"), see 21 U.S.C. §§ 353(b)(1), 331(a), 

333(a)(2). The jury found Stepanets not guilty of the racketeering 

conspiracy and conspiracy to defraud counts. She was convicted, 

however, on six of the seven FDCA counts. Her appeal focuses on 

those six convictions. 

We begin by describing the counts that underlie those 

convictions more fully, as well as the relevant procedural 

background to Stepanets's challenges to those convictions. We 

then consider each of her challenges to her convictions on those 

six counts, as well as her challenge to the sentence that she 

received.

A.

The FDCA criminalizes, among other things, "[t]he 

following acts and the causing thereof . . . : The introduction 
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or delivery for introduction into interstate commerce of any . . . 

drug . . . that is . . . misbranded." Id. § 331. Various 

provisions of the FDCA then describe the ways in which a drug can 

be deemed "misbranded." 

The drugs at issue in Stepanets's convictions were 

alleged to be "misbranded" under § 353(b)(1). That subsection 

provides that "[t]he act of dispensing a drug" meeting certain 

criteria without a written or oral prescription by a licensed 

practitioner "shall be deemed to be an act which results in the 

drug being misbranded while held for sale." Id. § 353(b)(1).

Thus, the government's theory as to why the medications 

in the shipments at issue in the six counts were "misbranded"

within the meaning of the FDCA was that they were "dispensed" for 

patient use without a valid prescription. See id. In support of 

that charge, the indictment alleged that the medications at issue 

were dispensed for patient use pursuant to fictional 

prescriptions, given the evidence linking the medications to 

prescriptions for patients like "Wonder Woman" and "Bud Weiser." 

In the fall of 2015, Stepanets and two other defendants 

filed motions to dismiss the FDCA counts in the indictment. See

United States v. Stepanets, 879 F.3d 367, 371 (1st Cir. 2018). 

They argued in those motions, among other things, that the 

indictment did not fairly allege the "dispensing" element of the 

misbranding offense. See id. 
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In seeking the counts' dismissal, the motions argued

that the dispensing element required the government to have alleged 

in the indictment that the defendants had engaged in conduct that 

amounted to them personally having dispensed the drugs at issue, 

even though there was no valid prescription for those drugs. The 

motions contended that the indictment included no such allegation,

because it merely alleged that the defendants "worked in the 

packing area [of NECC] checking orders prior to shipment," which, 

if true, the motions further asserted, would make them "shipping 

clerk[s]" and not dispensers. 

The District Court granted the motions to dismiss. See

id. In explaining why, the District Court relied on a dictionary 

definition of the word "dispensing" according to which "a 

pharmacist dispenses a drug when she acts in her role as a licensed 

professional authorized to fill (put together) a medical 

prescription for delivery to a patient." Id. The District Court

then concluded that the indictment alleged that the defendants had 

engaged in conduct that was at most "incidental" to the

"dispensing" of the drugs at issue. Id.

We reversed that ruling on an interlocutory appeal. See

id. at 376. We explained that "the allegations in the indictment 

[were] sufficient to apprise the defendant[s] of the charged 

offense[,]" because the allegations specified and connected the 

relevant statutory provisions, elements, and facts. Id. at 372 
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(quoting United States v. Savarese, 686 F.3d 1, 7 (1st Cir. 2012)). 

We further explained that, contrary to the defendants' contention,

nothing in the indictment committed the government to the view 

that the defendants could be convicted of the offense even if they 

were mere shipping clerks. See id. at 374. We thus explained 

that the issue of whether the dispensing element ultimately could 

be met was a question of fact to "be resolved at trial rather than 

on pretrial motions to dismiss." Id.

The case then proceeded to trial, at which the jury found 

Stepanets guilty of the six FDCA counts at issue here. The jury 

did not find that Stepanets acted with an intent to defraud or 

mislead on any of these counts, which is a finding that, had it 

been made, would have increased her maximum sentence beyond the 

one-year term of imprisonment. See 21 U.S.C. § 333(a)(2). The 

District Court sentenced Stepanets to twelve months' probation on 

each of the counts of conviction, to be served concurrently with 

one another.

B.

1.

Stepanets's lead challenge to her convictions takes aim 

at what she contends was a lack of sufficient evidence concerning 

the dispensing element. Our review is de novo, and we construe

the evidence in the light most favorable to the verdict. Cadden, 

965 F.3d at 10. We may reverse her convictions on this basis only 
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if we conclude that, reading the record as a whole in that light, 

no rational jury could have found that the government proved the 

dispensing element beyond a reasonable doubt. See id.

The statute does not define "dispensing," as used in 

§ 353(b)(1). See Stepanets, 879 F.3d at 369. But, according to 

Stepanets, we held in the interlocutory appeal from the District 

Court's dismissal of these counts in the indictment that 

"dispensing" involves "the kind of checking that pharmacists 

regularly do when filling prescriptions, i.e., confirming that 

legit prescriptions triggered the drug shipments." Id. at 374. 

She then contends that, under that definition of "dispensing," the 

evidence does not suffice to show that she, personally, "dispensed" 

any of the purportedly misbranded medications. Accordingly, she 

contends, her convictions must be reversed for lack of sufficient 

evidence.

A necessary premise of this challenge is that the

government needed to prove not only that the drugs at issue had 

been dispensed by someone before Stepanets caused them to be 

introduced or delivered into interstate commerce but also that she 

personally was the one who dispensed them. It is not clear to us, 

however, that this premise is right. 

The FDCA provides by its plain terms that to prove that 

this type of misbranding-based offense has been committed by the 

defendant, the government needs to show only that the drugs at 
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issue had been "dispensed" -- such that they qualified as

"misbranded" -- and that the defendant then undertook the 

prohibited acts of "causing . . . [t]he introduction or delivery 

for introduction into interstate commerce of any" such drug. 21 

U.S.C. § 331. That text is not naturally read to equate the 

introduction or delivery of misbranded drugs into interstate 

commerce -- or the causing of their introduction or delivery into 

such commerce -- with their dispensing, because "dispensing" is a 

predicate for deeming a drug to be "misbranded."1

1 We note that the District Court instructed the jury 

that the government needed to "prove[] . . . beyond a reasonable 

doubt" that Stepanets "caused the introduction of drugs or caused 

the delivery of them for introduction into interstate commerce" 

and "that the drugs were dispensed without a valid prescription." 

The District Court did not in doing so instruct the jury that it 

needed to find that Stepanets had dispensed the drugs herself to 

find her guilty of the offense, although the District Court did 

later tell the jury to proceed to a determination of Stepanets's 

intent, if it were to find her "guilty of dispensing a drug in 

interstate commerce," in the course of distinguishing the counts 

on which Stepanets had been charged from those of her codefendants. We note, too, that the indictment charges Stepanets 

with the "Introduction of Misbranded Drugs into Interstate 

Commerce," and alleges that Stepanets "caused" "the drugs" "to be 

dispensed" rather than that she dispensed them herself. In 

addition, in our earlier opinion reversing the dismissal of her 

indictment, we focused on whether the indictment adequately 

alleged "that each defendant-pharmacist performed NECC-assigned 

tasks that caused misbranded drugs to be introduced into interstate 

commerce," not whether it adequately alleged that each of them 

personally dispensed those drugs herself. Stepanets, 879 F.3d at

375.
- 11 -

But, we need not question that premise here. The 

government does not challenge it and, even if we accept it, 

Stepanets's sufficiency challenge fails.

Stepanets does not dispute that the evidence suffices to 

show that she was what she refers to as a "checker" of the orders

for the drugs at issue in each of the six counts. But, she 

contends, the evidence suffices to show only that, in that 

capacity, she was responsible merely for verifying that each 

package contained the correct medication and bore the correct 

address. She contends that the evidence does not suffice to show 

that she also was responsible for ensuring that the drugs at issue 

were to be provided for patient use pursuant to a valid 

prescription.

Stepanets points in support of this contention to the 

fact that the evidence supportably shows that she filled out a 

"Pharmacist's Rx Order Verification Sheet" ("Verification Sheet") 

for each shipment and not a "Prescription Order Form." She 

contends that this point is significant because the Verification 

Sheet required that she, by her checkmarks and signature, verify 

only the customer facility's name and address, as well as the 

medication, vial size, number of units, lot number, and -- where 

applicable -- the enclosed lab report. Stepanets stresses that 

nothing on the Verification Sheet required her to look at NECC's

Prescription Order Form, which, unlike the Verification Sheet, did 
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contain the fictitious patient names referenced in the indictment. 

Instead, the Verification Sheet referenced information that was

printed on the invoice and label attached to the package containing 

each shipment.

Thus, Stepanets argues, the record does not suffice to 

permit a rational trier of fact to find that she was responsible 

for carrying out the distinct task of verifying the prescription 

and patient names. She contends that the record makes clear that 

this task was exclusively the responsibility of those NECC 

employees who, unlike herself, were responsible for what she refers 

to as "confirming" the orders for the drugs in the six shipments, 

as they alone were responsible for completing the Prescription 

Order Forms.

We agree with Stepanets that there is no evidence in the 

record that she was responsible for completing a Prescription Order 

Form rather than a Verification Sheet for the six shipments at 

issue. Nor does the government contend otherwise to us. But, 

that does not mean that a reasonable jury could not find on this 

record that, as certainly would befit a licensed pharmacist, the 

parameters of her role as to the shipments at issue encompassed 

the task of ensuring that the drugs were associated with a valid 

prescription for a real patient. 

William Frisch, an employee of the Massachusetts Board 

of Registration of Pharmacy, testified that the "final pharmacist 
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verification check also required to check that the drug is based 

on a prescription," (emphasis added), and the evidence in the 

record supportably shows that Stepanets did have at least access 

to the Prescription Order Forms that NECC collected in customer 

folders. There is also testimony about Stepanets's role from two 

NECC employees responsible for sales, Mario Giamei and Kenneth 

Boneau. They testified that Stepanets was among the employees who 

followed up about requests from customers for shipments in which 

the requests had "issues with patient names" and who instructed

Giamei and Boneau "to get a real name" or "more patient names" 

from their customers in placing orders for those shipments. Giamei

and Boneau at no point indicated that Stepanets took on that role

only as to requests for shipments for which she had not been asked 

to fill out a Verification Sheet.

True, none of this evidence expressly concerns one of 

the six shipments at issue. But, significantly, the record does 

contain evidence of an email chain from May 12, 2011, in which 

Stepanets alerted salesperson John Notarianni of "patient name 

issues" with respect to shipments requested by Hill Country Sports 

Medicine in San Marcos, Texas. That email chain further shows 

that Stepanets brought two names to Notarianni's attention --

"Donald Trump" and "Jennifer Lopez." And, the record supportably 

shows, those two distinctive names were the names on the 

Prescription Order Form for the shipment on May 3, 2011, which is 
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the shipment underlying the sixth count of which the jury convicted 

Stepanets and for which the evidence shows that she filled out 

only the Verification Sheet.

Thus, in light of this evidence, circumstantial though 

it is, a reasonable juror could have found that Stepanets's role 

at NECC went beyond that of a mere shipping clerk as to the drugs 

at issue, even if she filled out only the Verification Sheet for 

each of those shipments. Such a juror could have found that her 

role encompassed with respect to all six shipments "the kind of 

checking that pharmacists regularly do when filling prescriptions, 

i.e., confirming that legit prescriptions triggered the drug 

shipments." Stepanets, 879 F.3d at 374; see also Cadden, 965 F.3d 

at 11 (relying on sufficient circumstantial evidence to support an 

inference); United States v. Ridolfi, 768 F.3d 57, 61 (1st Cir. 

2014) (noting that a juror may make "reasonable, common sense 

inferences drawn from the evidence"). For that reason, this aspect 

of Stepanets's sufficiency challenge fails.

2.

Stepanets also mounts a closely related sufficiency 

challenge. She contends that, regardless of what the record shows 

about her particular role vis-à-vis ensuring that the drugs at 

issue were associated with prescriptions for real patients, the 

evidence does not suffice to show that the drugs at issue were 

dispensed at all -- that is, by anyone at NECC and not just by her 
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personally. According to Stepanets, "dispensing" requires 

delivering the drugs to patients. Yet, she contends, the six 

orders at issue were sent to medical facilities rather than to the 

patients themselves. Again, our review is de novo. See Cadden, 

965 F.3d at 10. Again, we find no merit to the challenge. 

Nothing in the statute supports the notion that only 

those who deliver misbranded drugs directly to patients -- without 

any intermediaries -- "dispense" such drugs under 21 U.S.C. 

§ 353(b)(1). See United States v. Ikejiani, 630 F. App'x 933, 937 

(11th Cir. 2015) (holding in the context of a 21 U.S.C. § 331(k) 

prosecution that "the term 'dispensing,' as used in § 353(b)(1), 

applies to all sales, including wholesale sales, and not merely to 

sales to end users"); De Freese v. United States, 270 F.2d 730, 

736 (5th Cir. 1959) (rejecting, again in the context of a § 331(k) 

prosecution, the argument that "dispensing" under § 353(b)(1) 

should be interpreted "to connote retail selling only" because 

"[s]uch an interpretation would not be consistent with the commonly 

accepted meaning of the term and would be carving out an 

unwarranted exception to the statute"). Nor does Stepanets develop 

any argument that the fictious names were used within NECC merely 

as placeholders for tracking orders from medical facilities, so 

that the facilities could then receive those drugs in bulk for 

office use and dispense them pursuant to valid individual 

prescriptions using real patient names. United States v. Zannino, 
- 16 -

895 F.2d 1, 17 (1st Cir. 1990). We thus reject this challenge to 

her six convictions as well. 

3.

We turn, then, to Stepanets's separate contention 

that -- even setting aside what the record shows in relation to 

the dispensing element -- her convictions must be reversed under 

the Fifth Amendment to the United States Constitution because the 

underlying offense contained no mens rea element. Stepanets 

preserved this contention below, and thus we review it de novo.

See United States v. Silva, 794 F.3d 173, 177 (1st Cir. 2015).

Here, too, however, we are not persuaded.

In Tart v. Massachusetts, 949 F.2d 490 (1st Cir. 1991), 

we considered the constitutionality under the Fifth Amendment's 

Due Process Clause of "legislative enactments proscribing socalled 'public welfare' offenses" without mens rea terms, 

implicitly including 21 U.S.C. § 331(a) and § 333(a)(1) among 

them. Tart, 949 F.2d at 502 (relying on United States v. 

Dotterweich, 320 U.S. 277 (1943), which characterized predecessor 

versions of these provisions as "a now familiar type of legislation 

whereby penalties serve as effective means of regulation" and 

explained that "[s]uch legislation dispenses with the conventional 

requirement for criminal conduct -- awareness of some wrongdoing," 

see id. at 280-81). We explained that, given the nature of such 

public welfare offenses, "[t]he elimination of th[e mens rea] 
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element [in them] is . . . not violative of the due process 

clause." Id. at 502 (quoting Holdridge v. United States, 282 F.2d 

302, 310 (8th Cir. 1960)).

Thus, Tart refutes the notion that due process requires 

there to be a mens rea element in an offense as a categorical 

matter. Accordingly, Tart necessarily refutes Stepanets's due 

process challenge to her convictions insofar as it is premised on 

that categorical notion.

For similar reasons, her Eighth Amendment-based variant 

of this categorical challenge to mens rea-less crimes, which was 

not preserved and so is subject only to plain error review, see

United States v. Sirois, 898 F.3d 134, 136 (1st Cir. 2018), also

fails. Stepanets relies here only on Graham v. Florida, 560 U.S. 

48, 71 (2010). But, the Supreme Court did not address in that 

case whether the Eighth Amendment requires an offense -- as a 

categorical matter -- to include a mens rea element, even if the 

Fifth and Fourteenth Amendments do not. Nor are we aware of any 

authority that would support such a categorical position. 

Stepanets does make the additional argument that, 

despite Tart, the penalty she faced under the FDCA -- imprisonment 

of up to one year -- and the prospect of her losing her state 

pharmacist license precluded this offense from omitting a mens rea 

element and comporting with the Fifth Amendment's Due Process

Clause. She relies for this contention on Morissette v. United 
- 18 -

States, 342 U.S. 246 (1952), which states that public welfare 

offenses that lack a mens rea element commonly impose "penalties

[that] are relatively small, and [for which] conviction does no 

grave damage to an offender's reputation." Id. at 256.

Here, too, our review is de novo, see Silva, 794 F.3d at 

177, and here, too, Tart appears to stand in Stepanets's way. Tart

relied on Morissette to describe the universe of public welfare 

offenses that could permissibly omit a mens rea element, yet 

Morissette expressly included in that universe the predecessor 

FDCA offenses to those at issue here, which themselves lacked a 

mens rea element and imposed a maximum prison sentence of one year. 

See Tart, 949 F.2d at 501-02 (citing Morissette, 342 U.S. at 250-

51); Morissette, 342 U.S. at 259-60 (quoting Dotterweich, 320 U.S. 

at 280-81 (discussing FDCA provisions 21 U.S.C. §§ 301(a), 303 

(1938), which are the predecessor versions of 21 U.S.C. §§ 331(a), 

333(a) at issue here)). 

Moreover, insofar as Stepanets means to suggest that 

Tart does not decide the question -- perhaps because the actual 

offense at issue there was for landing raw fish without a permit,

see Tart, 949 F.2d at 502 -- her argument still fails. And that 

is because Morissette itself does not support it. 

Morissette addressed how a court should determine 

whether a statute impliedly contains a mens rea element that it 

does not expressly set forth. Morissette, 342 U.S. at 252. 
- 19 -

Morissette did not purport to hold that all convictions for

offenses that both lack a mens rea element and impose a maximum 

punishment of imprisonment for one year violate due process. 

Indeed, Dotterweich, which predates Morissette, explained that an 

earlier version of the misbranding offense at issue here, which

carried the same penalty, was a public welfare offense and 

therefore properly construed not to include a mens rea element. 

See Dotterweich, 320 U.S. at 281 (explaining that the provision 

"dispenses with the conventional requirement for criminal 

conduct -- awareness of some wrongdoing"). Thus, we reject this 

variant of her due process challenge as well.

4.

Stepanets's final challenge to her convictions asserts 

that, even if the misbranding offense at issue here permissibly 

omits a mens rea element, it still must be construed to require 

the government to prove that she at least had "a responsible share 

in the furtherance of the transaction which the statute outlaws."

United States v. Park, 421 U.S. 658, 669 (1975) (quoting

Dotterweich, 320 U.S. at 284). Yet, she contends, the evidence 

did not suffice to show that she had such a share with respect to 

the shipments of the misbranded medications that are at issue.

The District Court rejected this contention, because it 

held that the two cases on which Stepanets chiefly relies for 

it -- Dotterweich and Park -- make clear that the government need 
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prove that a defendant had a responsible share only if the 

defendant did not personally engage in the proscribed criminal 

conduct and instead merely oversaw the operations of the company 

that produced and distributed the drugs at issue, as, for example, 

a chief executive officer of a large pharmaceutical company might. 

See United States v. Stepanets, 362 F. Supp. 3d 22, 24 (D. Mass. 

2019); see also Park, 421 U.S. at 670-71. Arguably, however,

Dotterweich and Park do accord with Stepanets's contention that 

the responsible share requirement is not limited to the class of 

cases identified by the District Court. 

For example, in Dotterweich, which upheld the conviction 

of a corporate officer under earlier versions of the FDCA 

provisions at issue here, 21 U.S.C. § 331(a) and § 333(a)(1), the 

Court rejected the defendant's contention that 21 U.S.C. 

§ 333(a)(1)'s reference to "any person" encompasses only the 

corporation that produces or distributes the adulterated or 

misbranded drugs or to the sole proprietor of such a business and 

not to the individual employees of such a corporation, insofar as 

it is not a sole proprietorship. Dotterweich, 320 U.S. at 281-

82. And, in doing so, the Court explained in seemingly 

encompassing terms that "any person" punishable for such conduct 

refers not only to the corporation itself but also to "the 

individual agents of the corporation" who "share[] responsibility 
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in the business process resulting in unlawful distribution." Id.

at 282, 284. 

Moreover, in Park, the Court stated that in the corporate 

context "individuals other than proprietors are [also] subject to 

the criminal provisions of the [FDCA]" as long as they "'have . . . 

a responsible share in the furtherance of the transaction which 

the statute outlaws.'" Park, 421 U.S. at 668, 669 (quoting 

Dotterweich, 320 U.S. at 284). And the Court then elaborated on 

that conclusion by observing -- again, in seemingly encompassing 

terms -- that this limitation on the reach of the offense addressed 

the due process-based concern that "literal enforcement [against 

'any person' as per 21 U.S.C. § 333(a)(1)] 'might operate too 

harshly by sweeping within its condemnation any person however 

remotely entangled in the proscribed shipment.'" Id. at 669 

(quoting Dotterweich, 320 U.S. at 284).

But, in any event, Stepanets does not dispute that the 

responsible share requirement -- which she equates with a 

proximate rather than merely but-for cause requirement -- is met

here if the evidence suffices to show that she personally dispensed 

the medications in the shipments at issue. Thus, because, for the 

reasons that we have already given, we reject her contention that 
- 22 -

the evidence does not suffice in that regard, we reject this aspect 

of her challenge as well.2

C.

All that remains of Stepanets's challenges on appeal, 

then, is her apparent challenge to her twelve-month probationary 

sentence on the ground that, because the underlying offense 

contained no mens rea element, it violates the Eighth Amendment. 

But, Stepanets did not raise this challenge below, and so it is at 

2 Stepanets develops no argument that, even if the 

offense omitted a mens rea requirement, the government still needed 

to show that she acted negligently in causing the misbranded drugs 

to be introduced or delivered into interstate commerce and that 

the evidence did not suffice to allow a reasonable juror to find 

such negligence, though she does cite at one point to the 

concurring opinion in the Eighth Circuit case United States v. 

DeCoster, 828 F.3d 626 (8th Cir. 2016), which reads Park as 

imposing a negligence standard on misdemeanor offenses under the 

FDCA, see id. at 637 (Gruender, J., concurring), because Park

explained that the FDCA "punishes 'neglect where the law requires 

care, or inaction where it imposes a duty,'" Park, 421 U.S. at 671 

(quoting Morissette, 342 U.S. at 255). But, the passage from 

Morissette in Park just quoted refers not only to "neglect" but 

also to "inaction where [the statute] imposes a duty." Id.

(quoting Morissette, 342 U.S. at 255). That quotation therefore 

indicates that there is criminal liability for failing to fulfill 

the statutorily required duty even in the absence of a showing of 

negligence. Id. And, consistent with this conclusion, Park's 

immediately preceding quotation of Smith v. California, 361 U.S. 

147 (1959), is that "the public interest in the purity of its food 

is so great as to warrant the imposition of the highest standard 

of care on distributors." Park, 421 U.S. at 671 (quoting Smith, 

361 U.S. at 152) (emphasis added). Smith makes clear that the 

"highest standard of care" to which Park refers is "strict or 

absolute criminal responsibility" rather than negligence. Smith, 

361 U.S. at 150. 
- 23 -

most subject to review for plain error. See Sirois, 898 F.3d at

136. 

We conclude that Stepanets has failed to meet that 

demanding standard in pressing this challenge. Her probationary 

sentence is less severe than the prison sentences for strict 

liability crimes that we have held were not cruel and unusual.

See Tart, 949 F.2d at 503-04; McQuoid v. Smith, 556 F.2d 595, 597

(1st Cir. 1977). For that reason, we cannot say that it was "clear 

or obvious" error under the Eighth Amendment, Sirois, 898 F.3d at 

138, for the District Court to impose the sentence that she 

received. 

III.

We next consider the appeal that Gene Svirskiy, an NECC 

pharmacist in charge of one of NECC's clean rooms, brings. He was 

indicted for a substantive racketeering offense, see 18 U.S.C. 

§ 1962(c), predicated on twelve acts of mail fraud, see id. § 1341, 

which is a racketeering activity, see id. § 1961(1)(B). Of those 

twelve acts of racketeering activity, ten were based on NECC's use 

of Scott Connolly, a pharmacist technician who lacked a 

registration that was required by Massachusetts law for those 

performing such work, in the clean room that Svirskiy oversaw. 

The remaining two predicate acts of mail fraud were based on 

shipments of medications that NECC sent to customers that either 

were untested or contained expired ingredients in violation of 
- 24 -

Chapter 797 of the United States Pharmacopeia, which is a set of 

specifications for the compounding of sterile medications that 

Massachusetts requires pharmacists to follow. See 247 Mass. Code 

Regs. 9.01(3); United States Pharmacopeia, General Chapter <797> 

Pharmaceutical Compounding -- Sterile Preparations (2008) 

[hereinafter "USP-797"].

In addition to the substantive racketeering offense just 

described, Svirskiy was charged with a racketeering conspiracy 

offense, see 18 U.S.C. § 1962(d). The racketeering conspiracy 

offense was predicated on unspecified acts of mail fraud.

Separately, Svirskiy was charged with twelve stand-alone 

mail fraud counts. See id. § 1341. Each count corresponded to 

one of the twelve predicate acts of mail fraud on which the 

substantive racketeering charge rested.

Finally, the indictment charged Svirskiy with committing 

a pair of FDCA violations. One count was for introducing 

adulterated drugs into interstate commerce, and one count was for 

introducing misbranded drugs into interstate commerce. See 21 

U.S.C. §§ 351(a)(2)(A), 352(a), 331(a), 333(a)(2).

Svirskiy's case went to trial, and the jury convicted 

him of the following crimes: racketeering; racketeering 

conspiracy; ten of the twelve counts of stand-alone mail fraud, 

based on nine of the ten Connolly-related counts and one additional 

count for shipping expired drugs; and two FDCA violations, both of 
- 25 -

which, the jury found, he committed with an intent to defraud or 

mislead -- an aggravating factor, see id. § 333(a)(2). The special 

verdict form revealed that the jury found, as to the substantive 

racketeering offense, that the government proved the same ten 

racketeering acts of mail fraud that corresponded to the ten standalone mail fraud counts for which Svirskiy was found guilty. The 

District Court sentenced Svirskiy to a prison term of thirty months 

and one year of supervised release.

On appeal, Svirskiy raises various challenges to his 

convictions, most of which focus on whether the evidence sufficed 

to support his convictions. We begin by focusing on his 

sufficiency challenges to his stand-alone mail fraud convictions, 

which, he contends, also require the reversal of his racketeering 

convictions, given their dependence on the same allegations of 

mail fraud as the stand-alone mail fraud convictions. We then 

turn to his sufficiency challenges to his racketeering-related 

convictions that do not pertain to whether the evidence of mail 

fraud sufficed to support them. Next, we address his sufficiency 

challenges to his FDCA convictions. Finally, we address his 

challenge to one of the instructions that the District Court gave 

the jury on the FDCA counts. We find no merit to any of these 

challenges.
- 26 -

A.

To prove mail fraud, the government needed to show three 

elements: "(1) a scheme to defraud based on false pretenses; (2) 

[Svirskiy's] knowing and willing participation in the scheme with 

the intent to defraud; and (3) the use of interstate mail . . .

communications in furtherance of that scheme." United States v. 

Soto, 799 F.3d 68, 92 (1st Cir. 2015) (quoting United States v. 

Hebshie, 549 F.3d 30, 35 (1st Cir. 2008)). Svirskiy first contends 

that the evidence did not suffice to permit a reasonable juror to 

find beyond a reasonable doubt that he committed mail fraud on the 

nine counts for which he was convicted that related to shipments

of medications compounded by Connolly. Our review is de novo, 

though we must assess the evidence in the light most favorable to 

the jury verdict. See United States v. Tanco-Baez, 942 F.3d 7, 15

(1st Cir. 2019).

1.

The government's theory of mail fraud on the Connollyrelated, stand-alone counts of mail fraud was that each of the 

customers who received a shipment of compounded medications that 

Connolly helped to prepare had been informed that NECC would only 

use registered technicians, even though Connolly was not one. 

Svirskiy does not dispute that Connolly was involved in preparing 

the medications at issue or that Connolly lacked a registration 

required by Massachusetts law. Svirskiy also does not dispute 
- 27 -

that, to the extent a mail fraud scheme existed, he was a knowing 

and willing participant in it. Svirskiy contends, however, that 

the evidence did not suffice to establish that false 

representations about NECC's use of registered technicians were 

ever made to the NECC customers who received the shipments of 

medications that Connolly helped to prepare. It is on that basis 

that he contends that the evidence does not suffice to support his 

convictions.

In support of this contention, Svirskiy points out, 

correctly, that none of the NECC customers identified in the 

Connolly-related counts testified that they personally received 

such a representation from NECC. But, there was testimony from 

others that we conclude sufficed to permit a reasonable juror to 

make the requisite finding.

Kenneth Boneau, a salesperson for NECC, testified at the 

trial that NECC's sales strategy emphasized that to ensure the 

quality of its compounding operations the company "had pharmacists 

that were making [its] medications, not technicians." Boneau also 

testified about some of the specific representations NECC made to 

its customers about the qualifications of its technicians, 

including one that was set forth in a document introduced at trial. 

Boneau described that document, which was labeled with the NECC 

logo on the front page and contained the word "Hospital" there as 
- 28 -

well, as "material[] that we would bring with us on our sales calls 

to hospitals" and give to customers.

That document contained a page labeled "Company 

Overview," and it made claims to NECC's customers about its 

"Personnel." Among those claims was that NECC's personnel 

consisted of "Highly Specialized and Extensively Trained 

Compounding Pharmacists and Certified Technicians." (emphasis 

added).

Svirskiy makes no developed argument that Boneau's 

testimony failed to suffice to permit a reasonable juror to infer 

that those marketing materials were provided to each of the 

customers described in each of the nine Connolly-related mail fraud 

counts of which he was convicted. Thus, he makes no developed 

argument that a reasonable juror could not infer that each customer 

identified in those counts received a representation from NECC 

indicating that it would use "Certified Technicians" to compound 

its products.3 Instead, Svirskiy contends only that the evidence 

was insufficient to permit a juror supportably to find that 

Connolly was not a "Certified Technician," as the marketing 

3 For that reason, Svirskiy's arguments that he had no

duty to correct a misleading omission about NECC's use of Connolly 

are beside the point. NECC made affirmative representations to 

its customers about the qualifications of its pharmacy 

technicians, and it is the misleading nature of those 

representations that grounds each of the Connolly-related mail 

fraud convictions. 
- 29 -

materials represented him to be, and thus that the evidence was 

insufficient to permit a reasonable juror to find that the alleged 

false representation pertaining to Connolly being "registered" had 

been made. 

To make that case, Svirskiy points out that, despite 

working without a state-mandated registration during the relevant 

period, the undisputed evidence in the record shows that Connolly 

did in fact possess a "certification" issued by the national 

Pharmacy Technician Certification Board during the period in which 

he helped to produce each of the shipments. Svirskiy further 

asserts, correctly, that, although there is no dispute that 

Massachusetts law requires pharmacy technicians to be "registered 

by the board of pharmacy," the provision of Massachusetts law that 

imposes that requirement does not use the words "certified" or 

"certification." Mass. Gen. Laws ch. 112, § 24E. Thus, he 

contends, the marketing materials that described NECC pharmacist 

"[t]echnicians" as being "[c]ertified" were not a representation 

that they were "registered," as Massachusetts law required them to 

be, thereby precluding them from providing support for finding 

that the alleged false representation to customers had been made.

The jury instructions were clear, however, that the 

"false or fraudulent pretenses [and] representations" prohibited 

by the mail fraud statute, 18 U.S.C. § 1341, encompass "half 

truth[s]" and the "concealment of a material fact" -- something 
- 30 -

that Svirskiy nowhere challenges. And, the language of the 

marketing materials, which refers only to "Certified Technicians," 

gives no indication that the use of the term "Certified" is meant 

only in some technical sense.

The marketing materials fail to specify what 

certification is required or who must do the certifying. Nor does 

Svirskiy point to anything in the record that would suggest that 

either NECC or any of its customers understood "Certified" as used 

in the marketing document in the technical sense that he urges us 

to conclude is the only understanding that a reasonable juror could 

have had of how that word was used. In fact, the record shows 

that at least one pharmacy technician formerly employed by NECC 

referred to her state registration at trial as a "certification." 

And, in an ordinary sense, someone who cannot legally work within 

a given profession at their place of employment because they are 

not "registered" as required by the law is not a "certified" member 

of that profession. See Webster's Third New International 

Dictionary (2002) (defining "certified" as "endorsed 

authoritatively: guaranteed or attested as to quality, 

qualifications, fitness, or validity"). Consistent with that 

usage of the term, Massachusetts law itself presently defines a 

"certified pharmacy technician" as a "pharmacy technician who is," 

among other things, "currently registered by the [Massachusetts] 

Board [of Registration in Pharmacy]." 247 Mass. Code Regs. 2.00.
- 31 -

Thus, although the defendant in Cadden did not advance 

the argument that Svirskiy now makes about why the use of the word 

"Certified" in the marketing document cannot suffice to ground a 

mail fraud conviction predicated on NECC's use of an unregistered 

pharmacist, we reach the same conclusion here as we did there, 

based on Boneau's testimony and the marketing document 

representing that NECC used only "Certified Technicians." For, in 

light of that evidence, on this record as on that one, "a juror 

reasonably could find that there was a sufficient circumstantial 

basis to draw the inference that the allegedly fraudulent 

representations concerning technician licensure had been made in 

each instance for these seven convictions, notwithstanding the 

absence of direct evidence to that effect." Cadden, 965 F.3d at 

11.

Svirskiy next asserts that, even if the evidence did 

suffice to show that each customer received a false representation 

that the medications would be prepared by registered pharmacist 

technicians, the evidence fails to establish that such 

representations were "material" ones. But, as we explained in 

Cadden, to establish materiality, "the government 'need not prove 

that the decisionmaker actually relied on the falsehood,'" so long 

as "the false statement 'had a natural tendency to influence, or 

[was] capable of influencing' its target's decision." Id. at 12 

(alteration in original) (quoting United States v. Prieto, 812 
- 32 -

F.3d 6, 13 (1st Cir. 2016)). And, here, the evidence of 

materiality was strong, just as it was there. 

Ralph McHatton, an employee of North Shore Medical 

Center, which received the shipment underlying one of the Connolly 

counts, testified that compliance with state registration and 

certification requirements was "vital" and that he would not have 

purchased compounded medications from NECC had he known that those 

medications were prepared by a pharmacy technician who lacked a 

required registration. Moreover, Boneau, the NECC salesperson, 

similarly testified that it was important, from a marketing 

perspective, to inform customers that NECC's pharmacy technicians 

were licensed.4 Finally, evidence at trial showed that the 

American Society of Hospital Pharmacists ("ASHP") put out a "tool" 

for hospital pharmacies to use to evaluate outside contractors 

like NECC and that the tool recommended that such pharmacies 

inquire as to whether pharmacy technicians employed by the 

contractor were "licensed or registered in the state where they 

4 As Svirskiy points out, the transcript reveals that 

the government asked Boneau whether it was important "that the 

pharmacists were licensed [and] the physician [sic] technicians 

were licensed," and that it was this question that Boneau responded 

to with a "[y]es." (emphasis added). Of course, Connolly was a 

pharmacy technician, not a "physician technician." But, context 

makes clear that the government and Boneau were both discussing 

the pharmacy technicians employed by NECC, and Svirskiy advances 

no plausible alternative explanation for what Boneau could have 

understood the government to mean when he responded to the 

question. 
- 33 -

are practicing." Thus, as in Cadden, we see no merit to the 

defendant's materiality-focused sufficiency challenges. See 965 

F.3d at 12.

Svirskiy also challenges the sufficiency of the evidence 

to support the nine Connolly-related, stand-alone counts of mail 

fraud on one other ground. Here, he contends that the evidence 

failed supportably to show that he "obtained money or property 'by 

means of' [the] alleged fraud," United States v. Berroa, 856 F.3d 

141, 148 (1st Cir. 2017) (quoting 18 U.S.C. § 1341), and he

contends that Berroa itself supports that contention. But, there 

is no merit to this argument either.

In Berroa, we considered mail fraud convictions of 

defendants who obtained medical licenses through falsified test 

scores and went on to use those licenses to make money off medical 

patients years later. See id. We held that even though the 

defendants' gains from patients could not have been acquired absent 

their fraudulent scheme to obtain medical licenses, those gains 

were not acquired "by means of" that fraud within the meaning of 

18 U.S.C. § 1341. Id. In reaching that conclusion, we held that 

the mail fraud statute imposed not only a but-for causation 

requirement, but also a "natural[] induc[ement]" requirement, akin 

to proximate causation. Id. at 149 & n.4. We went on to hold

that the "fraud in obtaining . . . medical licenses cannot be said 

to have 'naturally induc[ed]' healthcare consumers to part with 
- 34 -

their money years later." Id. at 150 (quoting Loughrin v. United 

States, 573 U.S. 351, 363 (2014)).

But, here, the recipients of NECC's fraudulent 

representations and the entities from whom NECC obtained its 

profits were one and the same: medical providers who were 

customers of NECC. The conclusion that this distinction is fatal 

to Svirskiy's contention draws support from Loughrin.

There, the Supreme Court interpreted the federal bank 

fraud statute, which criminalizes executing a fraudulent scheme to 

acquire the property of a financial institution if done so "by 

means of false or fraudulent pretenses, representations, or 

promises." 18 U.S.C. § 1344(2) (emphasis added). The Court 

interpreted that statute's "by means of" language to impose a 

natural inducement requirement. Loughrin, 573 U.S. at 363. 

Berroa made clear that the "by means of" language that 

Loughrin interpreted in the bank fraud statute carries a similar 

meaning when used in the mail fraud statute. 18 U.S.C. § 1341;

see Berroa, 856 F.3d at 149-51. We thus find it significant that 

the Supreme Court made clear in Loughrin that the natural 

inducement requirement is met "most clearly, when a defendant makes 

a misrepresentation to the bank itself -- say, when he attempts to 

cash, at the teller's window, a forged or altered check."

Loughrin, 573 U.S. at 363. Accordingly the fraudulent scheme 

involved here -- which, unlike the scheme in Berroa itself,
- 35 -

depended on the use of fraudulent representations to the precise 

entities whose property the perpetrators of the fraudulent scheme 

sought to obtain -- relied on the "most clear[]" way for a 

misrepresentation to naturally induce a victim to part with their 

money. 

Svirskiy emphasizes that Berroa expressed concern that, 

absent a natural inducement requirement, "virtually any false 

statement in an application for a medical license could constitute 

[the] federal crime" of mail fraud. 868 F.3d at 150. Berroa thus 

worried that reading the mail fraud statute to cover the conduct 

at issue there might "infringe on the states' 'distinctively 

sovereign authority to impose criminal penalties for violations 

of' licensing schemes, 'including making false statements in a 

license application.'" Id. (quoting Cleveland v. United States, 

531 U.S. 12, 23 (2000)). But, the only fraud in Berroa involved 

the use of misrepresentations to a state agency in order to obtain 

a license from it. The charged fraud here, by contrast, arises 

from misrepresentations to other private parties about whether a 

license from the state exists. Punishing such a misrepresentation 

does not infringe on the ability of states to regulate the 

licensing process itself. After all, there is little difference 

between a misrepresentation about a state licensing regime made to 

one's customers and other types of misrepresentations made to those 
- 36 -

customers about the seller's credentials that the federal mail 

fraud statute undoubtedly does penalize. 

2.

That brings us to Svirskiy's challenge to the last of 

his stand-alone mail fraud convictions, which is the only one for 

a count that is not related to NECC's use of Scott Connolly in its 

compounding operations. This final count alleged that Svirskiy 

had committed mail fraud because NECC sold methotrexate 

injectables to one of its customers, USC University Hospital, after 

making false representations to that customer about the products 

that it would sell them. 

Svirskiy argues that his conviction on this count cannot

stand because the evidence shows that the medications that were 

shipped were both sterile and potent. But, even assuming that is 

so, his opening brief fails to acknowledge, much less engage with, 

the government's theory that the mail fraud was based on the fact 

that NECC claimed to comply with USP-797 yet subsequently sold 

medications to USC University Hospital that contained an expired 

ingredient in violation of USP-797.5 And, indeed, the evidence 

5 Svirskiy's reply brief does make note of witness 

testimony indicating that the FDA allows for the stockpiling of 

certain emergency medications past their expiration date upon 

appropriate testing. But, he fails to develop an argument for why 

the existence of this program -- of which Svirskiy does not contend 

NECC's activities to have been a part -- suggests that NECC's 

conduct adhered to USP-797, which is the critical issue. 
- 37 -

supportably shows that even though NECC represented to USC 

University Hospital that it complied with USP-797, the 

methotrexate injectables at issue were prepared with an expired 

ingredient -- the methotrexate itself, which had expired more than 

four years prior -- in violation of USP-797. Thus, Svirskiy's 

sufficiency challenge to his conviction on this count fails as 

well.

B.

We come, then, to Svirskiy's challenges to his 

racketeering convictions, rather than his convictions for 

committing stand-alone mail fraud offenses. Here, too, though, 

the challenges are without merit.

1.

We first confront Svirskiy's contention that, because 

his convictions for racketeering and racketeering conspiracy were 

premised, at least in part, on acts of mail fraud that mirror the 

mail fraud grounding each of his ten stand-alone mail fraud 

convictions, the evidentiary holes that he identifies in the 

government's theory of mail fraud in challenging his convictions 

on the stand-alone counts of mail fraud also require us to reverse 

his racketeering and racketeering conspiracy convictions due to a 

lack of sufficient evidence. But, as we have just explained, his 

challenges to the sufficiency of the evidence supporting the 

convictions on the stand-alone mail fraud counts lack merit. Thus, 
- 38 -

these challenges to his racketeering or racketeering conspiracy 

convictions lack merit as well. 

2.

Svirskiy's next set of challenges to these racketeeringrelated convictions also takes issue with the sufficiency of the 

evidence supporting them. But, in this set of challenges, Svirskiy 

does not question whether the evidence suffices to support the 

existence of the predicate acts of mail fraud found by the jury. 

Instead, he contends that the evidence did not suffice to show 

that those predicate acts, when viewed as a collective, constitute 

a "pattern of racketeering activity," 18 U.S.C. § 1962(c), even 

assuming the evidence of the existence of each individual predicate 

act of mail fraud sufficed. 

A pattern of racketeering activity must consist of "at 

least two acts of racketeering activity," the most recent of "which 

occurred within ten years . . . after the commission of a prior 

act of racketeering activity." Id. § 1961(5). The Supreme Court 

has made clear that, to establish such a "pattern," the government 

"must show that the racketeering predicates are related, and that 

they amount to or pose a threat of continued criminal activity." 

H.J. Inc. v. Nw. Bell Tel. Co., 492 U.S. 229, 239 (1989). 

Svirskiy argues that the government's evidence of both 

relatedness and continuity was lacking and that his convictions 

for racketeering and conspiring to racketeer for that reason must 
- 39 -

each be reversed. Our review is de novo. See Cadden, 965 F.3d at 

15.

a.

The showing that the government needed to make to prove 

relatedness "is not a cumbersome one." Feinstein v. Resolution 

Tr. Corp., 942 F.2d 34, 44 (1st Cir. 1991). The government needed 

to prove only that "the predicate acts 'have the same or similar 

purposes, results, participants, victims, or methods of 

commission, or otherwise are interrelated by distinguishing 

characteristics and are not isolated events.'" Id. (quoting H.J., 

492 U.S. at 240). 

As we have explained, the jury found that Svirskiy 

committed ten predicate acts of mail fraud: nine Connolly-related 

predicate acts and one predicate act based on a fraudulent 

representation of USP-797 compliance. Svirskiy argues that the

Connolly-based predicate acts and the USP-797-based predicate act

are not related to one another and thus that the relatedness 

requirement is not supported by sufficient evidence. The Connollybased predicate acts, he contends, concerned "one state regulatory 

violation, raise[d] no issues relating to patient harm or 

production practices, and ha[d] no link to . . . deficient drugs 

or improper cleaning and sanitization practices." 

We considered and rejected an identical challenge in 

Cadden. As we explained, despite the evident differences between 
- 40 -

the Connolly-related predicate acts and the one non-Connollyrelated predicate act, the similarities between the two categories 

of acts were numerous:

[A]ll reflect the same crime (mail fraud), the 

same category of victims (medical providers), 

the same purpose (profit), similar fraudulent 

misrepresentations (claims of compliance with 

regulatory schemes), similar methods of 

communicating those representations (NECC 

marketing materials), similar participants 

(employees of NECC), and the same method of 

commission (medication sales through NECC). 

They also all occurred within the same time

frame. Thus, a juror reasonably could find 

that they were related, despite their 

differences.

Cadden, 965 F.3d at 15–16 (citing Feinstein, 942 F.2d at 44). The 

same conclusion follows here.

b.

The next aspect of Svirskiy's challenge to these 

racketeering-related convictions takes aim at the evidence offered 

in support of the requirement that a "pattern of racketeering 

activity" be continuous. The Supreme Court has recognized two 

ways in which the government may satisfy this continuity 

requirement. First, it may establish the existence of closedended continuity "by proving a series of related predicates 

extending over a substantial period of time." H.J., 492 U.S. at

242. Alternatively, the government may prove open-ended 

continuity by establishing the existence of "past conduct that by 
- 41 -

its nature projects into the future with a threat of repetition." 

Id. at 241. 

The jury found ten predicate acts of mail fraud that

were committed over more than twenty-one months and targeted eight 

different customers. Svirskiy contends that the government failed 

to establish that these acts demonstrate either open-ended or 

closed-ended continuity. We conclude, reviewing de novo, see

Cadden, 965 F.3d at 15, that the government has adequately 

established the existence of at least a closed-ended continuity. 

Closed-ended continuity is "centrally a temporal 

concept." H.J., 492 U.S. at 242. While the Supreme Court has 

made clear that it is not enough to show that the acts "extend[ed] 

over a few weeks or months," id., we have previously recognized 

that a twenty-one month period is longer than what the Supreme 

Court has required, see Efron v. Embassy Suites (P.R.), Inc., 223 

F.3d 12, 17 (1st Cir. 2000). Nevertheless, we have also recognized 

that such a period of time is "no[t] so far beyond the minimum 

time period that common sense compels a conclusion of continuity." 

Id. at 18. In particular, we have deemed "highly relevant" the 

fact that "a defendant has been involved in only one scheme with 

a singular objective and a closed group of targeted victims." Id.

As we have explained, a racketeering pattern "does not encompass 

a single criminal event, a single criminal episode, a single

'crime' (in the ordinary, nontechnical sense of that word)." 
- 42 -

Apparel Art Int'l, Inc. v. Jacobson, 967 F.2d 720, 722 (1st Cir. 

1992). Rather, we look for whether "the defendant's conduct 

consists of 'multiple criminal episodes' over long periods of 

time." González–Morales v. Hernández–Arencibia, 221 F.3d 45, 52 

(1st Cir. 2000) (quoting Schultz v. R.I. Hospital Tr. Nat'l Bank, 

94 F.3d 721, 731–32 (1st Cir. 1996)). 

Svirskiy contends that all the predicate racketeering 

acts found by the jury are part of the same criminal effort and 

thus do not establish closed-ended continuity as a matter of law. 

We disagree. 

This is not a case where the multiple predicate acts 

"were aimed at [a] single goal," Efron, 223 F.3d at 18, or involved 

the same "transaction," Home Orthopedics Corp. v. Rodríguez, 781 

F.3d 521, 530 (1st Cir. 2015) (quoting González–Morales, 221 F.3d 

at 52), because each individual predicate act of mail fraud was 

intended to generate its own distinct payment from a customer. 

Nor is this case one where all the predicate acts had the same 

"targeted victim" in common, id., as the ten predicate acts 

involved shipments sent to eight different customers of NECC. 

The racketeering acts here, moreover, "had the potential 

to last indefinitely," id. at 529, and were not merely of a "finite 

nature," id. (quoting Efron, 223 F.3d at 19). NECC's pattern of 

defrauding customers with false representations about the quality 

of its production process, after all, was not the sort of conduct 
- 43 -

that would invariably come to an end once a certain objective was 

met. Cf. Schultz, 94 F.3d at 732 (finding no closed-ended 

continuity where "the alleged racketeering acts . . . 'taken 

together, . . . comprise a single effort' to facilitate a single 

financial endeavor" (quoting Apparel Art, 967 F.2d at 723)). Had 

the operation not come to a halt, NECC's pattern of mail fraud was 

such that it could easily have reproduced its fraudulent conduct 

with new shipments of medications and new targets. 

Svirskiy nevertheless persists in his characterization 

of the illegal activity as consisting only of a single event. In 

doing so, he emphasizes that the Connolly-based predicate acts 

involved a single regulatory violation, namely, Connolly's work 

without a mandatory registration. 

But, even setting aside the fact that the jury found a 

pattern of racketeering activity that included a non-Connollybased act, the Connolly-based acts themselves were distinct. Those 

acts were deemed predicate acts because each one constituted a 

separate instance of mail fraud, not because each was a separate 

violation of Massachusetts law. Each act of mail fraud in turn 

involved a separate fraudulent shipment to an NECC 

customer -- eight customers in total. 

Svirskiy also argues, in an attempt to support his 

characterization of the alleged pattern of racketeering activity 

as constituting a single episode, that "the government did not 
- 44 -

allege and did not offer any evidence that [he] did anything other 

than work alongside" Connolly. But, Svirskiy does not dispute 

that, as the jury necessarily found, the evidence sufficed to show 

that, for each of the mail fraud counts and corresponding predicate 

acts, he did not simply work alongside Connolly but actually 

"cause[d] the use of the mails . . . for the purpose, or in 

furtherance, of executing [a] scheme to defraud." Hebshie, 549 

F.3d at 36. Thus, this aspect of Svirskiy's challenge must fail. 

c.

Svirskiy's brief also could be read to claim that 

insufficient evidence supported his racketeering conspiracy 

conviction, as, he claims, the evidence failed to show that the 

predicate acts he conspired to commit constituted a "pattern of 

racketeering activity." But, to the extent he means to make this 

argument, he simply echoes his challenges to the existence of a 

pattern of racketeering for the purpose of the racketeering count. 

Because those challenges fail, so, too, must his challenges to the 

racketeering conspiracy count. 

C.

Svirskiy has one last evidentiary sufficiency challenge, 

and it takes aim at one of his two FDCA convictions. That

conviction was for introducing adulterated drugs into interstate 

commerce with the intent to defraud or mislead, see 21 U.S.C. 

§§ 351(a)(2)(A), 331(a), 333(a)(2), and it was based on a shipment 
- 45 -

of polymyxin-bacitracin that NECC sold to Glens Falls Hospital. 

Our review is de novo. See Tanco-Baez, 942 F.3d at 15. 

Svirskiy contends that the medication contained in the 

shipment was untested, and, furthermore, that the existing

evidence suggests that the medication was in fact sterile. But, 

even accepting his characterization of the record, the FDCA defines 

a drug as adulterated "if it has been prepared, packed, or held 

under insanitary conditions whereby it may have been contaminated 

with filth, or whereby it may have been rendered injurious to 

health." 21 U.S.C. § 351(a)(2)(A). Svirskiy makes no argument 

that the evidence failed to support the government's contention 

that the conditions in the NECC clean room where the polymyxinbacitracin was compounded were sufficiently unclean or unsafe to 

render medications produced in that clean room "adulterated." 

Thus, he provides no ground for concluding that the conviction 

must be overturned for insufficient evidence.6

D.

Svirskiy's final challenge targets his FDCA conviction 

relating to the shipment of polymyxin-bacitracin sent to Glens 

Falls Hospital. But, unlike in his challenges to his other 

6 Svirskiy also contends that the evidence showed that 

he had no personal interaction with Glens Falls Hospital. But, he 

fails to explain why this fact, even if compelled by the evidence, 

would require reversal of his FDCA conviction, and thus he has 

waived any argument to that effect. See Zannino, 895 F.2d at 17. 
- 46 -

convictions, in this one he asks us only to vacate the conviction, 

as he contends that the District Court erred in instructing the 

jury with respect to the underlying offense. 

The relevant background is the following. Multiple 

defendants charged with multiple FDCA crimes were being tried 

together. Accordingly, the District Court identified three 

distinct sets of charged FDCA offenses for which instructions would 

have to be given: (1) counts premised on drugs alleged to be 

"adulterated" because they had been compounded under unsanitary 

conditions, see 21 U.S.C. § 351(a)(2)(A); (2) counts premised on 

drugs alleged to be "misbranded" because their labels were false 

or misleading, see id. § 352(a); and (3) counts premised on drugs 

alleged to be "misbranded" because they were dispensed without a 

prescription, see id. § 353(b)(1). The District Court proposed 

instructing the jury on the different sets separately. However, 

because all three sets of counts involved allegations that the 

defendants introduced drugs into interstate commerce "with an 

intent to defraud or mislead," id. § 333(a)(2), the District Court 

also proposed defining "intent to defraud or mislead" in the 

portion of the instructions in which it explained the elements of 

the unsanitary conditions counts, and then relying on that 

definition when describing the counts premised on mislabeling or 

dispensing drugs without a prescription. 
- 47 -

Consistent with this proposal, the District Court's 

draft instructions to the jury explained what the government needed 

to show to prove "an intent to defraud or mislead" as follows:

An intent to defraud or mislead signifies 

a departure from fundamental honesty, or fair 

play and candid dealings in the general life 

of the community. To act with "intent to 

defraud" means to act knowingly and with the 

intention or the purpose to deceive or to 

cheat. 

An intent to defraud or mislead may be 

shown by evidence that a defendant took 

actions to conceal or prevent the discovery of 

the truth. The deceit must be about something 

material, that is, something important that 

has a natural tendency to influence, or that 

is capable of influencing, a customer. The 

government does not have to prove that any 

person to whom the deceit was directed was in 

fact influenced, only that a defendant 

intended such a result. 

As with any other offense alleging an 

intent to defraud or mislead, the government 

must prove beyond a reasonable doubt that a 

defendant did not act in good faith for you to 

find on these counts that he acted with an 

intent to defraud or mislead.

The government then proposed revisions to the draft 

instructions, in which it asked for the words "or a government 

regulator" to be inserted after "a customer," to clarify that the 

deceit could target not only customers, but also regulators. In 

the next round of revisions, the District Court adopted the 

government's suggestion on this point. 

At a subsequent charge conference with counsel, 

Svirskiy's attorney took issue with the relevant instruction as it 
- 48 -

had been revised. He argued that, as to the unsanitary conditions 

counts, "[t]here's no evidence of any representations or 

involvement with regulators." The government's counsel, in 

response, pointed out that, in the District Court's instructions, 

the same "definition of an intent to defraud or mislead is used in 

reference in the counts that go to the unsanitary conditions [FDCA 

counts], to the mislabeling [counts], and the no prescriptions 

[counts]," and that, as to "the no prescriptions" counts, 

"[t]here's certainly an allegation" of "an intent to defraud or 

mislead a regulator." The District Court proceeded to instruct 

the jury with the "regulator" phrase included. 

Svirskiy challenges his conviction based on the 

instructions' inclusion of the "regulator" phrase. He does not 

dispute that, in theory, an "intent to defraud or mislead" could 

be based on deceit that targets a government regulator, see United 

States v. Bradshaw, 840 F.2d 871, 872 (11th Cir. 1988), and thus 

we may assume that the District Court's instruction did not 

misstate the law. Yet, he argues that there was "not a scintilla 

of evidence to link Svirskiy's role as checking pharmacist of the 

polymyxin-bacitracin sent to Glens Falls Hospital to" an intent to

"violate or defeat government enforcement of NECC." 

Because Svirskiy does not argue that the instruction in 

question was legally deficient, we review for abuse of discretion,

see United States v. De La Cruz, 835 F.3d 1, 12 (1st Cir. 2016), 
- 49 -

assuming, that is, the challenge to the instruction was preserved. 

We find no such abuse. 

The District Court structured the instructions so that 

the description of the requisite "intent to defraud or mislead" 

applied not just to the FDCA count at issue here but also to 

multiple FDCA counts involving multiple defendants. Svirskiy does 

not dispute that this is so or that, as to some of those FDCA 

counts (albeit ones that did not involve him), the government did 

present evidence that would allow a jury to find an intent to 

defraud or mislead a regulator. Moreover, he acquiesced in the 

District Court's structuring of the instructions at trial and fails

to argue now that the District Court abused its discretion in 

structuring its instructions the way it did, such that the "intent 

to defraud or mislead" explanation first appeared in the 

"unsanitary conditions" section of the instructions on the FDCA 

counts and then was referred to in the other portions of the 

District Court's FDCA instructions. Instead, his only argument to 

the District Court was that the instructions should not have 

referenced government regulators at all. Given that he concedes 

that the instruction was legally accurate and applicable to at 

least some of the FDCA counts to which it applied, this argument 

provides no basis for concluding that the District Court abused 

its discretion. Thus, we reject his instructional-error 

challenge.
- 50 -

IV.

The last of the three former NECC pharmacists who 

challenge their convictions in these consolidated appeals is 

Christopher Leary. Leary worked in NECC's clean rooms and was 

sometimes responsible for signing off on medications before they 

left a clean room for shipment. 

The indictment charged him with racketeering, see 18 

U.S.C. § 1962(c), racketeering conspiracy, see id. § 1962(d), six 

counts of mail fraud, see id. § 1341, and three FDCA violations, 

see 21 U.S.C. §§ 331(a), 333(a). One mail fraud count was 

dismissed before the verdict. 

The case went to trial, and the jury convicted Leary of 

three mail fraud counts and three FDCA counts -- one with an intent 

to defraud or mislead -- but acquitted him of the racketeering

count, the racketeering conspiracy count, and the other mail fraud 

counts. Based on those convictions, the District Court sentenced 

him to two years' probation with eight months of home confinement

and one hundred hours of community service. 

Leary appeals each of his mail fraud convictions on 

sufficiency-of-the-evidence grounds. He does the same for his 

FDCA convictions. He also raises a Confrontation Clause challenge. 

We review each argument in turn.
- 51 -

A.

Leary first contends that the evidence does not suffice 

to establish his guilt as to each of the three mail fraud counts. 

Our review is de novo. See Tanco-Baez, 942 F.3d at 15. 

For each of the charged shipments, the government's 

theory was, at least in part, that Leary participated in a mail 

fraud scheme that involved informing customers of NECC's 

compliance with USP-797 and then selling them medications that 

were not tested in the manner that USP-797 required prior to 

shipment. Leary does not dispute that he caused each of the 

shipments of medications identified in each mail fraud count to be 

sent in the mail. See Hebshie, 549 F.3d at 35-36. He also does 

not dispute that NECC represented to the customers identified in 

each of the shipments that it complied with USP-797. Nor does he 

meaningfully dispute the government's contention that, despite 

those representations of compliance, each of the charged shipments 

was sent to a customer without having gone through the testing 

that USP-797 requires.7 Instead, Leary focuses on the requirement 

7 Leary does suggest that the lack of testing for two of 

these shipments may not have violated USP-797. But, as he concedes 

in his brief, he does "not go into detail on the technicalities 

for required testing under the USP guidelines," and instead only 

refers back to his District Court filings for a more developed 

argument. Thus, we treat this aspect of his argument as waived 

for lack of development. See Zannino, 895 F.2d at 17; United 

States v. Burgos-Montes, 786 F.3d 92, 111 (1st Cir. 2015)

("Arguments incorporated into a brief solely by reference to 

district court filings are deemed waived.").
- 52 -

that he was a "knowing and willing participa[nt]" in "a scheme to 

defraud." Id. at 35. 

Leary primarily contends that the evidence did not 

suffice to show that, for each of the charged shipments, he was 

aware that the medication was prepared in violation of USP-797. 

He also contends, in support of this argument about his lack of 

knowledge, that other employees of NECC were responsible for 

conducting tests in accordance with USP-797 and reviewing the 

results of such tests. 

But, as the government points out, and Leary does not 

contest, the evidence clearly establishes that Leary was aware of 

NECC's frequent practice of sending out untested lots of medication 

and that he personally approved of the production of such lots 

without the mandated testing on a number of occasions. Leary also 

fails to identify any relevant differences between the untested 

shipments underlying the counts for which he was convicted and 

untested shipments of which the evidence showed Leary to have been 

generally aware. Moreover, Leary concedes that, for each of the 

counts of conviction, he was responsible for filling out a logged 

formula worksheet, a step that William Frisch, the Massachusetts 

Board of Pharmacy witness, testified was the "final quality control 

of the compounded mixture" and signified that the pharmacist had 

"check[ed] that [the] formulation is correct, [and] that there 

[were] proper ingredients, proper weights, . . . [and that the] 
- 53 -

expiration dates of components" had not passed. Thus, 

notwithstanding that Leary would not have been personally 

responsible for testing the medications, given his important role 

in approving the medications to leave the clean room for shipment 

and the strong evidence that he was generally aware of NECC's 

practice of shipping untested medications, we do not see how a 

juror would be precluded from drawing the reasonable inference 

that Leary would have been aware of the untested nature of each of 

the medications underlying each of the counts of conviction. 

Leary also argues that he was unaware of various other 

substandard aspects of the medications contained in the shipments 

in question. For instance, he contends that, as to one of the 

counts, he was unaware that the medication was made using 

contaminated stock solution, and that, as to another, he was 

unaware that it was improperly prepared. But, because we find the 

evidence that Leary was aware of the untested nature of the 

medications to be sufficient to establish mail fraud, we need not 

consider whether Leary had knowledge of other facts about the 

compounded medications that would conflict with representations 

that NECC had made to its customers about the quality of its 

products. For similar reasons, the arguments Leary makes that 

customers were satisfied with NECC's medications are beside the 

point, as they fail to show that Leary did not participate in a 
- 54 -

mail fraud scheme aimed at misleading customers about NECC's 

compliance with the testing requirements of USP-797.

Leary further contends that, even if he did know that 

the medications he was verifying had been prepared in violation of 

USP-797, he nevertheless could not have been a participant in a 

mail fraud scheme, because he was unaware that NECC had made any 

misrepresentations to customers about that standard. Leary points 

out, furthermore, that the evidence did not show any interaction 

between him and NECC's customers or NECC's marketing staff. 

But, as a pharmacist working in Massachusetts, Leary was 

legally obligated to follow USP-797, see 247 Mass. Code Regs. 

9.01(3), and a juror could easily infer that Leary would not have 

been ignorant of that obligation. Likewise, a juror could easily 

infer that Leary would have been aware of the importance of NECC's 

compliance with this obligation to customers. 

Boneau, the NECC salesperson, testified that "U.S. 

Pharmacopeia was like the Bible for all pharmacies" and that as a 

compounding pharmacy "you need[ed] to show that you're . . . 

exceeding those guidelines so that [customers] felt more 

comfortable outsourcing." After all, the testing and sterility 

guidelines of USP-797 that the government introduced into evidence 

were explicitly aimed at "prevent[ing] harm, including death, to 

patients that could [otherwise] result." USP-797 at 1. Thus, a 

reasonable juror could conclude that Leary knew that NECC's 
- 55 -

customers were relying on its compliance with USP-797 and that 

their orders despite NECC's lack of compliance were indicative of 

misrepresentations by NECC -- at the very least in the sense that 

they were indicative of concealment.8

Leary does contend that, in any event, the evidence was 

insufficient to conclude that those misrepresentations were 

material and also to show that he possessed the requisite intent 

to defraud or mislead. But, here, too, we are not persuaded.

Leary does not challenge the District Court's jury 

instructions on the elements of materiality and intent, which 

defined "a fact or matter [a]s material if it has a natural 

tendency to influence or is capable of influencing the 

decisionmaker involved" and explained that "[t]o act with intent 

to defraud means to act willfully and with the specific intent to 

deceive or cheat for the purpose of either causing some financial 

loss to another or to bring about some financial gain to oneself." 

Because of the importance of USP-797 for the safety of NECC's 

medications, as we have just explained, the jury had sufficient 

evidence to find that the government had proven beyond a reasonable 

8 Like Svirskiy, Leary does not challenge the jury 

instructions' definition of "false or fraudulent pretenses [and] 

representations" under the mail fraud statute, 18 U.S.C. § 1341, 

as encompassing "half truth[s]" and the "concealment of a material 

fact." 
- 56 -

doubt that the misrepresentations concerned "a material fact or 

matter." 

Moreover, a reasonable juror could supportably find that 

NECC's sales were premised on USP-797 compliance and, hence, that 

its misrepresentations about that fact were aimed at "bring[ing] 

about some financial gain" to NECC. Combining this aim with 

Leary's "knowing and willing participation" in "a scheme to 

defraud," and "taking all reasonable inferences in [the 

government's] favor," we see no reason that a reasonable juror 

could not also have inferred that Leary participated in that scheme 

"with the intent to defraud." Hebshie, 549 F.3d at 35 (quoting 

United States v. Cheal, 389 F.3d 35, 41 (1st Cir. 2004), and United 

States v. O'Brien, 14 F.3d 703, 706 (1st Cir. 1994)). Nor does 

Leary provide such a reason.

Separately, Leary argues that the jury's findings that 

he committed mail fraud are impossible to square with its 

acquittals of Leary and some of his co-defendants on other counts 

involving related conduct. But, even assuming we were to agree 

with him that the jury's verdict could not be reconciled with 

itself in these respects (a matter on which we take no view), he 

concedes that it would not provide an independent reason to upset 

the jury's findings of guilt. See United States v. VizcarrondoCasanova, 763 F.3d 89, 104 (1st Cir. 2014) ("[L]ogically 
- 57 -

inconsistent jury verdicts on multiple counts are not grounds for 

reversing a conviction."). 

That leaves Leary's assertions that, because he 

personally did not represent to customers that NECC was complying 

with USP-797 and because he personally was not responsible for 

NECC's failure to test the medications, he could not have committed 

mail fraud. But, as we have explained, the government presented 

sufficient evidence for a jury to conclude that NECC was engaged 

in a mail fraud scheme, that Leary was a knowing and willing 

participant in that scheme, and that, as to each count, Leary 

caused a shipment of medication to be sent through the mail in 

furtherance of that scheme. No more was needed to show his guilt. 

See Hebshie, 549 F.3d at 35-36. 

B.

There remain Leary's challenges to the evidentiary 

sufficiency for each of his three FDCA convictions. Because Leary 

already raised these challenges in his Rule 29 motion, we apply de 

novo review. See Tanco-Baez, 942 F.3d at 15. 

1.

Leary first takes issue with his one FDCA conviction in 

which the government alleged that he introduced an adulterated 

drug into interstate commerce in violation of 21 U.S.C. § 331(a). 

The government's theory was that the medication in question was 

adulterated because it was produced under unsanitary conditions. 
- 58 -

See id. § 351(a)(2)(A). As to this conviction, the jury found 

that he engaged in this conduct with an "intent to defraud or 

mislead," an aggravating factor. Id. § 333(a)(2). Leary disputes 

that he possessed such an intent. 

The District Court's instructions to the jury specified 

that the jury may find an intent to defraud or mislead if there is 

evidence of "deceit . . . about something material" and a failure 

to act in "good faith." Leary does not argue that these 

instructions in any way misstated the law. Instead, he contends 

that he acted in good faith and without deceit about something 

material. But his contention does not grapple with the relevant 

evidence. 

The shipment at issue in this FDCA count was identical 

to a shipment that also grounded one of Leary's mail fraud 

convictions: a shipment of polymyxin-bacitracin irrigation bags 

to Glen Falls Hospital in New York. As we explained for that 

conviction, a jury could find that Leary knew that the medication 

was not tested in accordance with USP-797, despite NECC's 

representations to the contrary, and that Leary nevertheless 

approved the medication for shipment without notifying the 

customer about the inconsistency.9 Leary fails to explain why this 

9 Leary again contends that the jury's verdict on this 

count is impossible to reconcile with some of its other findings. 

But, as we have already explained, such inconsistencies are not 
- 59 -

conduct did not constitute a failure to act in good faith or why 

the deceit involved in this conduct was not material.

2.

Leary's remaining two FDCA convictions were each 

premised on shipments of methotrexate injectables that were 

alleged to have been misbranded due to false and misleading 

labeling. See 21 U.S.C. § 352(a). Leary's contention is that the 

evidence did not suffice to demonstrate that he acted with an 

intent to defraud. But, the jury did not find that Leary acted 

with an intent to defraud or mislead, see id. § 333(a)(2); it 

convicted Leary on these counts only of misdemeanor strict 

liability FDCA violations, see id. § 333(a)(1). Thus, Leary's 

challenge to these convictions lacks merit.10

C.

In Leary's last challenge, he contends that we should 

reverse all of his convictions because a government exhibit was 

improperly introduced into evidence in violation of his rights 

under the Confrontation Clause of the federal Constitution. We 

grounds for reversing a conviction. See Vizcarrondo-Casanova, 763 

F.3d at 104.

10 In a short footnote, Leary asserts that his 

convictions on all three FDCA counts should also be vacated because 

their underlying strict-liability provisions -- like "any statute 

that does not require a mens rea" -- "violate his constitutional 

rights afforded to him by due process." We find this assertion 

unpersuasive for the same reasons that led us to reject Stepanets's 

due process challenge above.
- 60 -

review his preserved Confrontation Clause challenge de novo. See

United States v. Veloz, 948 F.3d 418, 430 (1st Cir. 2020). 

The exhibit in question relates to the testimony of a 

witness, Owen Finnegan, who was a pharmacy technician at NECC. 

During Finnegan's testimony, Leary's lawyers tried to show that 

Finnegan harbored a personal dislike of Leary. In furtherance of 

that objective, they introduced into evidence an email chain 

involving Finnegan and Leary that, they claimed, showed the 

animosity between them. After Finnegan's testimony concluded,

though, the government attempted to introduce other parts of that 

same email exchange that could be read to show that what Leary 

characterized as hostility was just the two men joking around. 

Leary argues that the introduction of the email exchange 

between him and Finnegan after Finnegan's testimony concluded 

violated his rights under the Confrontation Clause. But, the 

"threshold question in every [Confrontation Clause] case is 

whether the challenged statement is testimonial," and "the 

Confrontation Clause has no application" if the answer is no. 

Veloz, 948 F.3d at 430-31 (quoting United States v. FigueroaCartagena, 612 F.3d 69, 85 (1st Cir. 2010)). The emails Finnegan 

sent to his co-worker were in no sense testimonial, as we cannot 

see how they were "produced with a 'primary purpose of creating an 

out-of-court substitute for trial testimony,'" United States v. 

Lyons, 740 F.3d 702, 719 (1st Cir. 2014) (quoting Michigan v. 
- 61 -

Bryant, 562 U.S. 344, 358 (2011)), and Leary mounts no argument to 

the contrary.11 Thus, we find no merit to this final challenge. 

V.

We affirm Stepanets's convictions and sentence, and we 

affirm Svirskiy's and Leary's convictions.

11 Because we conclude that the Confrontation Clause has 

no application to the exhibit in question, we need not reach 

Leary's further assertion that its introduction "was unfair and 

caused significant prejudice to [him]." To the extent that Leary 

means to raise an independent "unfair prejudice" argument against 

the exhibit's admission based on Rule 403 of the Federal Rules of 

Evidence, he did not preserve this argument below, nor does he 

adequately develop it now, and so it is waived. See Zannino, 895 

F.2d at 17.