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 BARRON, Circuit Judge. These consolidated appeals, like

the appeals in United States v. Cadden,

(1st Cir. 2020),

and United States v. Chin,

(1st Cir. 2020), trace back

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

. 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

Many of these patients eventually died,

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

See

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,

.

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.

- 3 - 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

. 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,

,

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

- 4 - 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

(d), conspiracy to defraud the United States, see

§ 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

(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

- 5 - or delivery for introduction into interstate commerce of any . . .

drug . . . that is . . . misbranded."

§ 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,

(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

- 6 - 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

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."

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.

We reversed that ruling on an interlocutory appeal. See

. 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.

at 372

- 7 - (quoting United States v. Savarese,

(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

(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,

. We may reverse her convictions on this basis only

- 8 - 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

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

§ 353(b)(1). See Stepanets,

. 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."

.

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

- 9 - 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.

. 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

1We 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 co- defendants. 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,

.

- 10 - 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

- 11 - 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

- 12 - 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

- 13 - 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,

; see also Cadden,

(relying on sufficient circumstantial evidence to support an

inference); United States v. Ridolfi,

(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

- 14 - 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,

. 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

(b)(1). See United States v. Ikejiani,

(11th Cir. 2015) (holding in the context of a

(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,

(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,

- 15 -

(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,

(1st Cir. 2015).

Here, too, however, we are not persuaded.

In Tart v. Massachusetts,

(1st Cir. 1991),

we considered the constitutionality under the Fifth Amendment's

Due Process Clause of "legislative enactments proscribing so-

called 'public welfare' offenses" without mens rea terms,

implicitly including

(a) and § 333(a)(1) among

them. Tart,

(relying on United States v.

Dotterweich,

(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

). We explained that, given the nature of such

public welfare offenses, "[t]he elimination of th[e mens rea]

- 16 - element [in them] is . . . not violative of the due process

clause."

at 502 (quoting Holdridge v. United States,

(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,

(1st Cir. 2018), also

fails. Stepanets relies here only on Graham v. Florida,

(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

- 17 - States,

(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."

.

Here, too, our review is de novo, see Silva,

, 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,

-02 (citing Morissette,

-

51); Morissette,

-60 (quoting Dotterweich,

(discussing FDCA provisions

(a), 303

(1938), which are the predecessor versions of

(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,

-- 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,

.

- 18 - 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,

(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,

(1975) (quoting

Dotterweich,

). 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

- 19 - 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,

(D. Mass.

2019); see also Park,

. 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,

(a) and § 333(a)(1), the

Court rejected the defendant's contention that

(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,

-

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

- 20 - in the business process resulting in unlawful distribution."

.

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,

, 669 (quoting

Dotterweich,

). 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

(a)(1)] 'might operate too

harshly by sweeping within its condemnation any person however

remotely entangled in the proscribed shipment.'"

at 669

(quoting Dotterweich,

).

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

- 21 - 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,

(8th Cir. 2016), which reads Park as imposing a negligence standard on misdemeanor offenses under the FDCA, see

(Gruender, J., concurring), because Park explained that the FDCA "punishes 'neglect where the law requires care, or inaction where it imposes a duty,'" Park,

(quoting Morissette,

). But, the passage from Morissette in Park just quoted refers not only to "neglect" but also to "inaction where [the statute] imposes a duty."

(quoting Morissette,

). 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.

And, consistent with this conclusion, Park's immediately preceding quotation of Smith v. California,

(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,

(quoting Smith,

) (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,

.

- 22 - most subject to review for plain error. See Sirois,

.

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,

; McQuoid v. Smith,

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

or obvious" error under the Eighth Amendment, Sirois,

, 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

(c), predicated on twelve acts of mail fraud, see

§ 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

- 23 - 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

(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

(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

§ 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

(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

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

mislead -- an aggravating factor, see

§ 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 stand-

alone 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.

- 25 - 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,

(1st Cir. 2015) (quoting United States v.

Hebshie,

(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,

(1st Cir. 2019).

1.

The government's theory of mail fraud on the Connolly-

related, 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

- 26 - 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

- 27 - 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

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

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.

- 28 - 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,

, encompass "half

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

- 29 - 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]."

.

- 30 - 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,

.

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."

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

- 31 - 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

As Svirskiy points out, the transcript reveals that 4

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.

- 32 - 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,

(1st Cir. 2017) (quoting

), 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

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

.

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.

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

- 33 - their money years later."

at 150 (quoting Loughrin v. United

States,

, 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."

(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.

;

see Berroa,

. 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,

- 34 - 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,

(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

- 35 - 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.

- 36 - 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,

- 37 - these challenges to his racketeering or racketeering conspiracy

convictions lack merit as well.

2.

Svirskiy's next set of challenges to these racketeering-

related 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,"

(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."

§ 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.,

(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

- 38 - each be reversed. Our review is de novo. See Cadden,

.

a.

The showing that the government needed to make to prove

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

Tr. Corp.,

(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.'"

(quoting H.J.,

).

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 Connolly-

based 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

- 39 - the Connolly-related predicate acts and the one non-Connolly-

related 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,

). 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 closed-

ended continuity "by proving a series of related predicates

extending over a substantial period of time." H.J.,

. Alternatively, the government may prove open-ended

continuity by establishing the existence of "past conduct that by

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

.

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,

, 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.,

. 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,"

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.,

(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."

. 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."

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)."

- 41 - Apparel Art Int'l, Inc. v. Jacobson,

(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,

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

, 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,

, or involved

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

(1st Cir. 2015) (quoting González–Morales,

), 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,

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,

). NECC's pattern of

defrauding customers with false representations about the quality

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

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

met. Cf. Schultz,

(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,

)). 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-Connolly-

based 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

- 43 - 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,

. 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

(a)(2)(A), 331(a), 333(a)(2), and it was based on a shipment

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

Our review is de novo. See Tanco-Baez,

.

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."

(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 polymyxin-

bacitracin 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

6Svirskiy 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,

.

- 45 - 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

(a)(2)(A); (2) counts premised on

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

or misleading, see

§ 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.

- 46 - 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

- 47 - 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,

(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,

(1st Cir. 2016),

- 48 - 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.

- 49 - 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

(c), racketeering conspiracy, see

§ 1962(d), six

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

see

(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.

- 50 - 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,

.

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,

. 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

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

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,

; United States v. Burgos-Montes,

(1st Cir. 2015) ("Arguments incorporated into a brief solely by reference to district court filings are deemed waived.").

- 51 - 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]

- 52 - 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

- 53 - 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

(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

- 54 - 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

8Like Svirskiy, Leary does not challenge the jury instructions' definition of "false or fraudulent pretenses [and] representations" under the mail fraud statute,

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

- 55 - 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,

(quoting

United States v. Cheal,

(1st Cir. 2004), and United

States v. O'Brien,

(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. Vizcarrondo-

Casanova,

(1st Cir. 2014) ("[L]ogically

- 56 - 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,

.

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,

.

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

(a).

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

adulterated because it was produced under unsanitary conditions.

- 57 - See

§ 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

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

count is impossible to reconcile with some of its other findings. But, as we have already explained, such inconsistencies are not

- 58 - 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

(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

§ 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,

. 10In 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.

- 59 - review his preserved Confrontation Clause challenge de novo. See

United States v. Veloz,

(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,

-31 (quoting United States v. Figueroa-

Cartagena,

(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,

(1st Cir. 2014) (quoting Michigan v.

- 60 - Bryant,

(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.

11Because 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,

.

- 61 -