United States Court of Appeals For the First Circuit No. 20-1050

UNITED STATES OF AMERICA,

Appellee,

v.

KATHY S. CHIN,

Defendant, Appellant.

No. 20-1051

UNITED STATES OF AMERICA,

Appellee,

v.

MICHELLE L. THOMAS,

Defendant, Appellant.

APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Richard G. Stearns, U.S. District Judge]

Before

Howard, Chief Judge, Lynch and Barron, Circuit Judges.

Joan M. Griffin for appellant Kathy S. Chin. Michael Bourbeau, with whom Bourbeau & Bonilla, LLP, was on brief, for appellant Michelle L. Thomas. Randall E. Kromm, Assistant United States Attorney, with whom Andrew E. Lelling, United States Attorney, was on brief, for appellee.

October 6, 2021 BARRON, Circuit Judge. These consolidated appeals, like

other appeals that we have recently resolved, arise out of the

federal criminal investigation into the New England Compounding

Center ("NECC"). See United States v. Carter, Nos. 19-1644 and

19-1645 (1st Cir. Sep. 27, 2021); United States v. Stepanets

(Stepanets II),

(1st Cir. 2021), United States v.

Cadden,

(1st Cir. 2020), United States v. Chin,

(1st Cir. 2020). NECC was a compounding pharmacy located

in Framingham, Massachusetts. The federal criminal investigation

into its practices ensued in 2013, after the company distributed

a contaminated medication that led to illnesses and deaths of

patients across the country. See Cadden,

.

The defendants before us are Kathy Chin and Michelle

Thomas, each of whom worked at NECC. Neither is charged with

playing any role in compounding the contaminated medication that

led to the tragedy. But, each was tried and convicted of multiple

counts of introducing through their work at NECC "misbranded" drugs

into interstate commerce with the intent to defraud or mislead.

See

(a), 333(a)(2), 353(b)(1). They now appeal

the convictions. We affirm.

I.

The following facts are not in dispute. Chin and Thomas

were licensed pharmacists who worked in the packing area at NECC.

Chin worked there from about November 2010 until October 2012.

- 3 - Thomas replaced Chin during Chin's parental leave and worked there

between March and August 2012.

Chin and Thomas were among fourteen individuals

-- including Barry Cadden, NECC's founder and president; Glenn

Chin,1 NECC's supervising pharmacist; and ten others affiliated

with NECC -- who were charged in December 2014 in a 131-count

indictment in the District of Massachusetts.2 The charges against

Chin and Thomas were brought for their alleged violations of the

Federal Food, Drug, and Cosmetic Act ("FDCA").

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

introduction or delivery for introduction into interstate commerce

of any . . . drug . . . that is . . . misbranded."

§ 331(a).

It further provides that "[t]he act of dispensing" certain drugs

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).

A violation of § 331 is a misdemeanor. Id. § 333(a)(1);

see also

(a)(6). A violation of that section that

1 This opinion uses "Chin" to refer only to Kathy Chin, Glenn Chin's spouse. 2 For a more detailed recitation of facts surrounding the investigation of the nationwide outbreak and of NECC's operations, we refer the reader to our opinion in Cadden. See Cadden,

.

- 4 - is carried out with the intent to defraud or mislead is a felony.

(a)(2); see also

(a)(5).

The indictment charged Chin with four counts, and Thomas

with two, of introducing "misbranded" drugs into interstate

commerce "with the intent to defraud and mislead" in violation of

§§ 331(a) and 353(b)(1). Chin and Thomas filed a joint motion --

along with another defendant, Alla Stepanets, who also had worked

at NECC and was charged with the same "misbranding" offense -- to

dismiss the counts regarding that offense that each faced. See

United States v. Stepanets (Stepanets I),

(1st

Cir. 2018).

The motion argued, among other things, that the

indictment alleged that the defendants had merely "worked in the

packing area" of NECC "checking orders" prior to shipment of the

drugs at issue.

(quotation marks omitted). The motion

argued that, in consequence, the indictment alleged at most that

the defendants were "mere shipping clerks" and thus failed to

allege that the defendants were responsible for the introduction

into interstate commerce of any drugs that qualified as

"misbranded" under § 353(b)(1). Id.

The District Court agreed. Id. at 371. Relying on a

medical dictionary's definition of the word "dispense," it

determined that "a pharmacist dispenses a drug when she acts in

her role as a licensed professional to fill (put together) a

- 5 - medical prescription for delivery to a patient." Id. It then

concluded that the indictment alleged that the defendants charged

in the counts at issue had engaged in conduct that, given its

clerical nature, was at most "incidental" to the "dispensing" of

the drugs at issue. Id. Accordingly, the District Court granted

the joint motion to dismiss the charges. See id. The District

Court then also denied the government's motion to reconsider. See

id.

The government appealed from the District Court's

dismissal of the charges. See id. at 376. We reversed. Id. We

explained that "the allegations in the indictment [were]

sufficient to apprise the defendant[s] of the charged offense."

Id. at 372. We reasoned that:

the indictment says that each of them (1) was 'a pharmacist licensed . . . to dispense drugs pursuant to a valid prescription from a valid medical practitioner,' (2) 'was employed as a pharmacist at NECC,' and (3) had caused misbranded drugs to be delivered into interstate commerce -- allegations that hardly suggest that they labored at NECC as mere shipping clerks.

Id. (alteration in original).

We further explained that, although the defendants

insisted that the government did not dispute that their "role

checking orders in the shipping department was limited to

confirming that the correct drugs were being sent to the correct

facility and did not include checking the prescriptions or patient

- 6 - names or any other aspect of the dispensing process," the

government in fact did dispute that the defendants' roles were so

limited. Id. at 374. The government argued, we explained, that

the allegations in the indictment -- when viewed "in context and

with common sense -- connote the kind of checking that pharmacists

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

legit prescriptions triggered the drug shipments." Id.

Accordingly, we held that the issue of whether the "dispensing"

element of the offense that had been charged could be established

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

pretrial motions to dismiss," id., and thus that the District

Court's order dismissing the charges had to be reversed, id. at

376.

On remand, the District Court severed Chin's and

Thomas's counts from those of any of the other defendants to

prevent "the prejudicial spillover of hearsay evidence." Chin and

Thomas were then tried jointly on the charges that each faced.

The trial commenced in in April 2019. It lasted four

days. The jury found Chin and Thomas guilty of the counts that

each faced.

Chin and Thomas each then moved under Rule 29 of the

Federal Rules of Criminal Procedure for a judgment of acquittal

or, in the alternative, for a new trial under Rule 33, on each of

the counts for which each had been found guilty. The District

- 7 - Court denied the motions and entered judgments of convictions for

those counts.

The District Court sentenced Chin to two years of

probation and Thomas to one year of probation. Chin and Thomas

then filed these timely appeals, which were then consolidated.3

II.

We begin with Chin's and Thomas's contentions that each

of their respective convictions must be reversed, because none is

supported by sufficient evidence. We review preserved sufficiency

challenges de novo. See United States v. Celaya-Valenzuela,

(1st Cir. 2017).

In undertaking that review, we must consider the

evidence in the record in the light most favorable to the verdict.

Cadden,

. We may reverse convictions on sufficiency

grounds "only if we conclude that, reading the record as a whole

in that light, no rational jury could have found that the

government proved" the elements of the offense beyond a reasonable

doubt. Stepanets II,

; see also United States v.

We note at the outset that, although Chin and Thomas 3

each filed her own briefs on appeal, each also purported in them to incorporate the arguments of the other, at least to the extent that such arguments are applicable. For ease of exposition, however, we describe each argument that we address below as if it were made solely by the defendant who asserted it in her own briefs. We emphasize, though, that in rejecting those arguments, we reject them as to each defendant insofar as each may be understood to have advanced it.

- 8 - Tanco-Baez,

(1st Cir. 2019). As we will explain,

we see no basis for reversing the convictions that are at issue

here on the ground that they are not supported by sufficient

evidence.

A.

Chin and Thomas each contends, chiefly, that her

convictions must be reversed because no reasonable juror could

have found beyond a reasonable doubt that she violated §§ 331 and

353(b)(1). Chin and Thomas each set forth a number of distinct

grounds for so concluding. None of these grounds has merit.

1.

Chin contends that she can be convicted of violating §§

331 and 353(b)(1) only if the evidence suffices to show that "she

herself . . . had a duty to check the prescriptions, caused the

drugs to be dispensed without prescriptions and w[as] negligent in

failing to stop the[ir] delivery into interstate commerce." She

then contends that it does not.

We faced a very similar contention in Stepanets II.

There, a defendant was similarly charged with violating §§ 331 and

353(b)(1). We explained that, given the text of those two FDCA

provisions, it was hardly clear that the government had to prove

as much as the defendant contended that it did. See

. We nonetheless explained that, even if we assumed otherwise,

the evidence in the record sufficed to uphold the convictions.

- 9 -

. We follow that same approach here, given what the

record reveals.

As Chin describes the record, it shows at most that she

performed the role of a shipping clerk who was responsible merely

for matching drugs in shipments to the addresses of their intended

destinations. To bolster this argument, she highlights evidence

in the record that she contends shows both that NECC "split up"

the "process of filling an order" between departments within the

company and that her department was not responsible for checking

patient names. She further contends that so long as those working

at NECC in a department other than her own were responsible for

performing that "checking" function, rather than the more clerical

one that she contends is the only one that the record supportably

shows that she was responsible for performing, she cannot have

committed the charged offense.

In pressing this argument, however, Chin does not

dispute that the FDCA required NECC to ensure that "legit

prescriptions triggered the drug shipments," Stepanets I,

, that are referenced in her counts. Nor does she

dispute that the evidence suffices to show:

(1) that she was a licensed pharmacist while working in

the packing area at NECC during the time period at issue;

(2) that she filled out a "Pharmacist's Rx Order

Verification Sheet" (a "Verification Sheet") for each shipment

- 10 - that corresponds to one of the four counts for which she was

convicted;

(3) that the Verification Sheet required a signature by

a licensed pharmacist and that she provided that signature;

(4) that, as a licensed pharmacist, she was legally

obliged under Massachusetts law to ensure that NECC was complying

with all laws insofar as she was acting there as a pharmacist;

(5) that the shipments for which she completed the

Verification Sheets -- including the ones that gave rise to the

counts with which she was charged -- were accompanied by order

forms that listed names of obviously fictitious patients, such as

those referenced in the indictment; and

(6) that order forms containing those fake names were

attached to the Verification Sheets.

Thus, given the evidence just recounted, at least when

considered as a whole, a rational juror could reasonably conclude

that NECC assigned Chin the task of filling out the Verification

Sheet to ensure that she would sign off on there being legitimate

prescriptions for each drug shipped. Why else, such a juror could

reasonably conclude, would NECC have made sure to assign that role

to a licensed pharmacist, given that a licensed pharmacist is a

type of professional specially authorized to perform that very

function. Indeed, the reasonableness of that conclusion is

reinforced by both the fact that the Verification Sheet that Chin

- 11 - concedes that she was responsible for filling out expressly

provided that it had to be filled out by a licensed pharmacist and

the fact that "patient" names were on a form attached to that very

same sheet. See United States v. Sabean,

(1st

Cir. 2018) ("[A] jury had the right to infer motive or absence of

mistake based on common-sense inferences drawn from evidence of

the attendant circumstances.").

Chin does separately contend that, given the role that

she was assigned at NECC, she was "powerless to prevent or correct

the violation" of the FDCA and thus that she may not be found

guilty of the charged offense under United States v. Park,

(1975) (internal quotation marks omitted). This

contention fails for the reasons that we have just given, however,

insofar as it depends on our accepting the argument, which we have

just rejected, that no reasonable juror could conclude on this

record that Chin was anything more than a shipping clerk.

To the extent that this Park-based argument does not

rest on that mistaken premise, we still cannot accept it. Chin

concedes that Park poses no bar to her convictions if the evidence

suffices to show that she not only carried out the "checking"

function that she asserts that only others performed but also that

she did so at least "negligently." Yet, the evidence supportably

shows just that. There is no evidence of valid prescriptions for

any of the drugs in any of the shipments at issue in her counts,

- 12 - and there is ample evidence that Chin signed off on the shipments

nonetheless.

Chin argues in the alternative that there was no legal

requirement for there to be valid prescriptions for any of the

drugs contained in any of the shipments at issue. But, we are not

persuaded by this contention either.

Chin bases this argument in part on a contention that

she made to the District Court in support of the Rule 29 motion:

that neither of the states to which the drugs at issue were shipped

(Georgia and Nebraska) required under its law that the drugs be

dispensed pursuant to valid prescriptions. But, as the government

points out, nothing in the provisions of the FDCA that set forth

the underlying offense indicates that a valid prescription is

required to trigger a shipment of drugs only if a corresponding

state law so requires. Nor does she develop any argument in

support of such a conclusion.

Chin does elaborate on this contention on appeal. She

argues in her briefing to us that the FDCA did not require there

to be valid prescriptions for the drugs at issue while she was

working at NECC because the company was engaged in a practice known

as anticipatory compounding that the U.S. Food and Drug

Administration ("FDA") had, as of that time, recognized to be

lawful.

- 13 - Chin did not raise this contention in her Rule 29 motion

to the District Court, however. That means that it is subject to

review on appeal only for plain error. See United States v.

Delgado-Sánchez,

(1st Cir. 2017) ("Ordinarily, a

party who fails to . . . raise an argument below is deemed to have

forfeited the argument and faces plain error review."). We find

none, as Chin fails to explain how it is clear or obvious that,

during the relevant time period, any such anticipatory-compounding

exception was applicable to the shipments involved in the counts

for which she was convicted. See United States v. Rivera-Morales,

(1st Cir. 2020) ("[A] criminal defendant generally

cannot show that a legal error is clear or obvious in the absence

of controlling precedent resolving the disputed issue in his

favor.").

Finally, Chin argues that her convictions must be

reversed pursuant to

(c). That provision precludes

a conviction for a misbranding offense of a defendant who, in

certain specified circumstances, acted in "good faith" in

introducing the misbranded drug into interstate commerce.

Chin does not identify, however, which, if any, of those

specified circumstances encompasses her case. She thus fails to

develop any argument as to how any of them do. See United States

v. Zannino,

(1st Cir. 1990) ("[I]ssues adverted to

- 14 - in a perfunctory manner, unaccompanied by some effort at developed

argumentation, are deemed waived.").4

In addition, we have explained that a rational juror

supportably could find on this record that Chin was responsible

for checking to ensure that a legitimate prescription triggered

each shipment of drugs referenced in the counts that she faced. A

rational juror who could so find also supportably could find that

Chin failed to perform that checking function in good faith, given

the transparently fake "patient" names that the record amply shows

4 The second and third exceptions expressly apply to violations of § 331(a), but both are limited in ways that make them inapt here. The second exception provides that no person shall be guilty of violating § 331(a) if: [H]e establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the article, to the effect, in case of an alleged violation of section 331(a) of this title, that such article is not adulterated or misbranded.

(c)(2). Chin has not shown that any such guaranty or undertaking exists. The third exception is exculpatory "where the violation exists because the article is adulterated by reason of containing a color additive not from a batch certified in accordance with regulations promulgated by the" FDA Commissioner and certain other conditions apply.

§ 333(c)(3). Chin does not argue that a faulty color additive was involved in this case. The first exception, which applies to those accused of "having received in interstate commerce any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith," id. § 333(c)(1), appears more applicable to Chin's situation but is ultimately unhelpful, for the reasons set forth above regarding what the record shows about her conduct.

- 15 - were the only ones used at NECC during the relevant time period

for the shipments referenced in her counts.5

2.

Like Chin, Thomas also appears to be arguing that her

convictions for violating §§ 331 and 353(b)(1) must be reversed

because the record precludes a rational juror from finding beyond

a reasonable doubt that she performed the type of "checking" that

we held in Stepanets I could satisfy the "dispensing" element.

See

. But, in pressing this contention, Thomas

does not dispute that the FDCA required that legitimate

prescriptions triggered the drug shipments referenced in her

counts. Nor does she dispute that the record supportably shows

both that she worked in the packing area at NECC and that she was

a licensed pharmacist at the time. She also does not dispute that,

for the shipments giving rise to the two counts of which she was

convicted, the record supportably shows that she filled out a

"Pharmacist's Rx Order Verification Sheet" that required a

signature by a licensed pharmacist, and that the shipments were

accompanied by order forms that listed names of obviously

Chin also argues that there was insufficient evidence 5

to show that she intentionally aided and abetted Barry Cadden in violating the FDCA because the government did not show that she possessed the requisite intent. We need not address that argument because we find that there was sufficient evidence for a reasonable juror to find Chin liable for committing the underlying offense as a principal.

- 16 - fictitious patients. Thus, for the same reasons that we rejected

the similar challenge that Chin raised, we reject Thomas's version

of it as well.

The remainder of Thomas's sufficiency challenge to her

convictions under §§ 331 and 353(b)(1) is somewhat difficult to

parse. It appears to be a contention that she acted in good faith

within the meaning of § 333(c) in performing her tasks at NECC.

Like Chin, Thomas does not develop an argument as to why

any of the circumstances set forth in § 333(c) are like those that

are involved here. Zannino,

. In any event, her

argument based on § 333(c) fails for much the same reasons that

Chin's similar argument did. For, insofar as the argument depends

on our accepting Thomas's contention that the record supportably

shows at most that she performed merely the role of a shipping

clerk, the record refutes that premise for the reasons that we

have already explained.

Thomas does also point to the evidence in the record

that shows that she brought concerns about the use of fake patient

names at the company to the attention of a supervisor. But, the

record supportably shows that she performed the problematic

checking function (and thus signed off on shipments of drugs

associated with fake patients as if they were associated with real

ones) despite harboring those concerns. For that reason, a juror

reasonably could find on this record that Thomas was not acting in

- 17 - good faith, notwithstanding that she had raised concerns about the

use of the fake patient names.6

3.

Chin and Thomas each also argue in their supplemental

briefing that the evidence fails to suffice to support their

convictions under §§ 331 and 353(b)(1) for an additional

reason -- namely, that the evidence fails to show that any of the

drugs at issue ever were dispensed to a patient at all. Chin and

Thomas point out in this regard that the District Court instructed

the jury that "a pharmacist dispenses a drug when she acts in her

role as a licensed professional authorized to fill a medical

prescription and then delivers the drug to the end-user." Chin

and Thomas further contend that "end-user" must refer to the

patient who ultimately takes a drug for medical purposes. They

thus argue that, because the government did not introduce evidence

showing that the drugs were given to and used by even a single

patient, there is insufficient evidence to convict them.

The government does not dispute in its supplemental

briefing that "end-user" in the instruction must be referring to

a patient and not merely to a customer of NECC (such as a hospital

or a medical facility) that then would dispense the drugs that it

6 Thomas also argues that there is insufficient evidence for the jury to find that she aided and abetted Cadden in his commission of the charged offense. We reject this argument for the same reason that we rejected Chin's similar contention.

- 18 - received to a patient. But, the government goes on to contend,

there is no requirement in the relevant FDCA provisions that the

government prove that the drugs at issue were dispensed to a

patient, which means that the offense was complete when the drugs

were shipped from NECC to its customers even though the customers

were intermediaries (hospitals and medical facilities) rather than

patients in their own right. Thus, the government argues, the

fact that the District Court's instructions to the jury required

a finding beyond a reasonable doubt that the drugs at issue had

been "dispensed" to "patients" -- via the reference in the jury

instructions to "end-users" -- provides no support for Chin's and

Thomas's sufficiency challenges. Rather, the government contends,

the jury instructions merely erroneously added an extra element to

the offense, such that the evidence suffices to support the

convictions at issue so long as the evidence is otherwise

sufficient to support them. See Musacchio v. United States,

(2016) (explaining that "when a jury instruction

sets forth all the elements of the charged crime but incorrectly

adds one more element, a sufficiency challenge should be assessed

against the elements of the charged crime, not against the

erroneously heightened command in the jury instruction").

We agree with the government that, in consequence of

Musacchio, Chin and Thomas's contentions regarding the import of

the reference to "end-users" in the jury instructions depend,

- 19 - necessarily, on their being able to make the case that the FDCA

itself required proof beyond a reasonable doubt that the drugs at

issue were in fact dispensed to patients. It is thus significant

that neither Chin nor Thomas developed any such argument about

what the FDCA required in that regard in their Rule 29 motions.

See Zannino,

; Dominguez v. United States,

(1st Cir. 2015) (requiring fully developed arguments to

have specificity so that they are not merely "peripheral" to the

main argument); United States v. Arnott,

, 45 n.6 (1st

Cir. 2014) (same). In consequence, our review of that contention

is only for plain error. United States v. Luciano,

(1st Cir. 2005) (quoting United States v. Duarte,

(1st Cir. 2001)). We find none. See Rivera-Morales,

. We note that in so concluding, we do not mean to suggest

that there would be force to the contention if it were preserved.

Cf. Stepanets II,

("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)."); Penobscot Poultry Co. v. United

States,

(1st Cir. 1957) ("[T]he words of

§ 331(a) . . . look to a present state . . . at the time of

'introduction of delivery for introduction into interstate

commerce,' and not to a future condition that might be reasonably

expected to arise after such introduction.").

- 20 - B.

To this point, we have addressed the sufficiency

arguments that Chin and Thomas make that take aim at their

convictions without regard to what the record shows about whether

the evidence supportably shows that each violated §§ 331 and

353(b)(1) with an intent to defraud or mislead, as it must for

them to be convicted of the felony variant of the crime at issue,

§ 333(a)(2). But, Chin and Thomas do each also take aim at the

sufficiency of the evidence on that score. Here, as well, though,

we are not persuaded.

Starting with Thomas, the evidence supportably shows

that supervisors at NECC used the fake patient names not as mere

internal placeholders to help organize the company's shipping

process but instead to give "logical[] expl[anations] to a

regulator" who might inquire about whether legitimate

prescriptions triggered the company's drug shipments to the

hospitals and medical facilities. There is also direct evidence

in the record that Thomas knew about the company's practice of

using the fake names and that she was sufficiently concerned about

it that she raised that concern to one of her supervisors, Alla

Stepanets. There is further evidence that, after she did so, she

continued to sign off on Verification Sheets, including for

shipments associated with fake patient names, even though there is

nothing in the record to indicate that she was told that there was

- 21 - a legitimate, non-misleading basis for deploying the practice that

caused her concern. In fact, the record contains a note on an

order form by Thomas indicating that she "will notify rep re pt

names."

In other words, the record supportably shows that Thomas

not only had been assigned the kind of checking function described

in Stepanets I but also that she performed that checking function

by signing off on shipments of drugs while knowing that the only

patient names associated with those shipments were fake. Thus, a

rational juror could infer from her willingness to take such action

as a licensed pharmacist that she must have been aware of the

overall misleading use of the fake patient names at the company

and been willing to assist in such use. Given that a finding of

intent may be proved both circumstantially and based on an

inference from the defendant's knowledge, see United States v.

Mousli,

(1st Cir. 2007) ("Courts may look to

surrounding circumstances to supply inferences of knowledge which

adequately prove [fraudulent] intent."); United States v. Rosen,

(1st Cir. 1997), no more was needed here.

There is no similarly direct evidence of Chin's

knowledge of the company's practice of using the fake names. But,

there is sufficient evidence, as we have explained, to show that

supervisors at NECC deployed such a practice to mislead regulators

about the nature of the company's operations. There is also

- 22 - sufficient evidence in the record for a juror to conclude that

Chin performed her "checking" function as to the drugs contained

in the shipments described in the counts at issue while knowing

that the only "patients" associated with them were fake.

As we have already explained, the record supportably

shows that those fake names were attached to the Verification Sheet

that she was charged with filling out as a licensed pharmacist,

and the record contains evidence that the use of fake names was so

common and integral to NECC's operations that employees even joked

about it. Thus, considering the evidence as a whole, we conclude

that a juror reasonably could infer that Chin, as a licensed

professional charged with ensuring that "legit prescriptions"

triggered the shipments referenced in the counts at issue who

performed this role for a longer period of time than Thomas did,

must have known of the company's practice of using the fake names

to mislead. The fact that she continued to sign off on the

shipments despite knowing that the only patient names associated

with them were shams allowed a juror to further reasonably infer

that Chin intended to assist in that practice. Cf. United States

v. Raymundí-Hernández,

, 140 (1st Cir. 2020) (inferring

that a defendant had intent to participate in a conspiracy based

on his knowledge and continued participation).

- 23 - III.

Chin and Thomas separately advance another ground for

reversing their convictions under §§ 331 and 353(b)(1) -- that the

statute that sets forth the underlying offense is void for

vagueness as applied to each of them. See United States v. Zhen

Zhou Wu,

(1st Cir. 2013) ("Outside the First

Amendment context, we consider 'whether a statute is vague as

applied to the particular facts at issue.'" (emphasis omitted)

(quoting Holder v. Humanitarian Law Project,

(2010))). "The 'void for vagueness doctrine' addresses at least

two discrete due process concerns: 'first, . . . regulated parties

should know what is required of them so they may act accordingly;

second, precision and guidance are necessary so that those

enforcing the law do not act in an arbitrary or discriminatory

way.'"

at 13 (quoting FCC v. Fox Television Stations, Inc.,

(2012)). Our review is de novo. United States

v. Lachman,

(1st Cir. 2004).

Chin trains her focus on the words "dispensing" and

"dispensed" in

(b)(1)(B), which she contends are

unconstitutionally vague insofar as they are read to encompass the

conduct of acting merely as a "shipping clerk." Indeed, that is

the premise on which all of her void-for-vagueness challenges to

her convictions rest. But, she develops no argument that the words

"dispensed" and "dispensing" are unconstitutionally vague insofar

- 24 - as they encompass the conduct of performing the kind of "checking"

function that we have explained the record suffices to show that

she was responsible for performing -- namely, the kind of checking

that a licensed pharmacist often performs in filling a

prescription. Thus, these arguments necessarily fail. We note,

however, that we do not see how Chin could have successfully

developed any such argument had she attempted to do so. Lachman,

("The mere fact that a statute or regulation

requires interpretation does not render it unconstitutionally

vague."); In re Bithoney,

(1st Cir. 1973) (noting

that indefinite terms may "take on definiteness and clarity" if

they are "placed in context, as part of a rule directed to a

discrete professional group").

Thomas, for her part, argues that her void-for-vagueness

challenge has merit because she could not "reasonably know that

[her] conduct in working in the shipping department of a large

compounding pharmacy simply inspecting drugs for shipment to

medical facilities was prohibited 'misbranding' under

(b)(1) and § 331(a)." She contends that whether a

prescription was even required for drugs contained in such a

shipment -- or whether the "prescriptions were identity specific"

-- was "an issue for the head pharmacist, Barry Cadden, the sales

force and/or managers of NECC and not within the oversight of these

- 25 - two pharmacists who were involved in making sure the right

medication was shipped to the right facility."

Thomas' contention rests on a premise about the record

that we have already rejected: that the evidence supportably shows

at most that she merely performed the shipping clerk function and

that she was not responsible for performing the kind of function

that would constitute checking of a sort regularly done by a

licensed pharmacist. Moreover, insofar as Thomas means to suggest

that there is a notice problem with the statute under which she

was convicted even if she could reasonably have been found to have

been responsible for doing the kind of checking described in

Stepanets I,

, she fails to develop what that notice

problem might be. See Zannino,

.

We close our consideration of Chin's and Thomas' void-

for-vagueness challenges with one final observation. As in

Stepanets I, "no one cites a case -- and we know of none -- holding

any key [FDCA] provision void for vagueness."

.

In fact, "courts have repeatedly upheld the constitutionality of

the [FDCA's] misbranding provisions . . . in the face of vagueness

challenges."

at 374 n.7 (quoting United States v. Girod, No.

5:15-87-S-DCR,

, at *1 (E.D. Ky. Feb. 27, 2017).

This includes challenges to the sections giving rise to the counts

with which Chin and Thomas were charged. See United States v. Oz,

- 26 - No. 13-273 (SRN/JJK),

, at *9-11 (D. Minn. Feb. 1,

2016) and cited cases.

IV.

We now come to Chin's and Thomas's arguments as to why

each of their convictions must be vacated rather than reversed.

Here, their target is the District Court's denial of their motions

for a new trial pursuant to Rule 33 of the Federal Rules of Criminal

Procedure.

"We review a 'denial of a Rule 33 motion for manifest

abuse of discretion with respect due to the presider's sense of

the ebb and flow of the recently concluded trial.'" United States

v. Veloz,

(1st Cir. 2020) (quoting United States

v. Tull-Abreu,

(1st Cir. 2019)). Any

substantial errors of law constitute such an abuse. See United

States v. Munoz,

(6th Cir. 2010).

Among Chin's and Thomas's arguments for overturning

the District Court's denial of their Rule 33 motions is the

contention that each makes that a new trial was merited because

the verdicts finding them guilty were contrary to the weight of

the evidence. We cannot say that the District Court abused its

discretion in ruling otherwise, however, given what, as we have

explained, the record shows with respect to Chin's and Thomas's

conduct. See Veloz,

.

- 27 - Thus, in what follows, we focus on the other grounds

that Chin and Thomas each develops in arguing that the District

Court erred in rejecting her Rule 33 motion. Those grounds concern

an alleged abuse of discretion by the District Court in making

certain evidentiary rulings. As we will explain, however, none of

these grounds for overturning the District Court's Rule 33 rulings

has merit.

A.

Thomas first directs our attention to the District

Court's asserted abuse of its discretion -- apparently under

Federal Rule of Evidence 403 -- in permitting the government to

introduce evidence regarding NECC's schemes to mislead or defraud

regulators that went beyond the "mere background" necessary for

the jury to understand the case. Rule 403 requires a district

court to "exclude relevant evidence if its probative value is

substantially outweighed by a danger of . . . unfair prejudice."

Fed. R. Evid. 403.

Thomas's argument focuses on several exhibits and the

testimony of one witness who provided details regarding the scheme

to use fake names. The government responds that the objection to

the admission of that evidence was not preserved and thus that our

review is at most for plain error. But, even assuming otherwise,

and thus that our review is for abuse of discretion, see Veloz,

, we see no basis for finding reversible error.

- 28 - Because we afford a district court "wide latitude" in

making the judgment call that Rule 403 concerns, United States v.

Merritt,

(1st Cir. 2019) (quoting United

States v. Mehanna,

(1st Cir. 2013)), we will

overturn that call only in exceptional circumstances, Freeman v.

Package Mach. Co.,

, 1340 (1st Cir. 1988). We see no

basis for doing so here.

The government put forth a great deal of circumstantial

evidence to demonstrate that the effort to defraud or mislead

regulators at NECC through the use of fake patient names was so

pervasive that the defendants must have acted in performing their

checking function not only with knowledge of the fake names but

also the requisite intent to defraud or mislead to bring them with

the scope of § 333(a)(2). The determination as to how much

circumstantial evidence of the company's plan to trick regulators

by using fake names was too much to serve that function in this

case without creating undue prejudice was a line-drawing exercise

that was within the ken of the District Court. See United States

v. Robles-Alvarez,

(1st Cir. 2017) (approving

of the admission of evidence to help "the jury to understand the

circumstances surrounding the charged crime" (quoting United

States v. Green,

(3d Cir. 2010))).

Chin advances a nearly identical challenge, which

accordingly fails. We do note, though, that although she asserts

- 29 - that the jury was "overwhelmed by the gruesome and graphic

highlights" of the conspiracy, the only evidence that she points

to in that regard concerns the company's use of fake names. None

of that evidence exposed the jury to graphic details about the

effects on patients nationwide of the contaminated drugs that NECC

had produced. This additional argument thus provides no basis for

reaching a different conclusion from the one that we reached in

addressing Thomas's challenge to the admission of the evidence of

the separately charged NECC conspiracy.

Thomas also challenges the District Court's decision to

admit testimony by an NECC pharmacist, Scott Connolly, regarding

his work in the company's cardioplegia lab. Here, too, we

understand the contention to be predicated on Rule 403, and we

proceed on the understanding that the objection was preserved.

Accordingly, our review is once again for abuse of discretion.

See Veloz,

. We find none.

Thomas contends that this testimony gave the jury the

"inaccurate and highly prejudicial" impression that Thomas "placed

patients with open heart surgery at risk." Connolly's testimony,

however, was plainly probative. It concerned the operations of

the shipping department at NECC. It thus provided background

information that was relevant to determining the role that Chin

and Thomas would have played while working there.

- 30 - To be sure, Connolly did testify about his own work in

the NECC clean room -- where neither Chin nor Thomas worked. But,

that testimony, by supplying background information regarding his

work at NECC, provided a basis for the jury to understand why he

would have had knowledge of the shipping department's operations.

Moreover, Connolly's testimony lasted less than half a

day and conformed to the strictures set forth by the District Court

for admitting it. Those strictures included the exclusion of any

discussion of "Connolly's licens[ure] status and inappropriate

behavior by personnel in the clean rooms." In such circumstances,

we cannot say that the District Court abused its discretion in

admitting the testimony.

B.

The last challenge before us is raised by Thomas. It

concerns the District Court's admission of testimony by Sam Penta,

an investigator with the Massachusetts Board of Pharmacy (the

"Board").

The District Court allowed Penta to testify to the

meaning of professional pharmacist regulations and the

responsibilities of shipping pharmacists. Thomas contends that

the District Court erred in doing so because Thomas had not been

qualified as an expert.

The government responds that it was not necessary to

qualify Penta as an expert because there was sufficient notice

- 31 - that he was testifying as such. We may assume for present purposes

that, given United States v. Vega,

(1st Cir.

2016), that is not so, because, even if it is not, Thomas still

must show that the admission of Penta's testimony was prejudicial,

and she has not.

Thomas does argue that the District Court erred in

allowing Penta "to testify as an investigator, and not an expert,

as to the meaning of professional pharmacist regulations . . . and

to who was 'responsible' for 'verifying' and 'dispensing' in a

compounding pharmacy." She specifically cites Penta's statements

"that every pharmacist in a compounding pharmacy 'has to verify

and okay every prescription that leaves the pharmacy,'" that "a

drug cannot be dispensed without a pharmacist checking it," and

his statement that "a pharmacist who . . . signs their name on a

drug order verifying that the order can ship [is] . . .

'responsible' for the order."

The problem for Thomas with this contention relates to

the theory of her defense. That theory took no issue with the

proposition that a licensed pharmacist who has been assigned the

function of verifying -- in her role as a licensed pharmacist --

that a prescription for a patient has triggered a shipment of drugs

is "responsible" for the drug being "dispensed." Moreover, Penta

did not testify that Thomas played the role of a verifying

pharmacist. He testified merely that, if she did play that role,

- 32 - then she would be "responsible" for verifying that the drugs being

delivered by the company to its customers were associated with

valid prescriptions for patients.

Thus, while Thomas contends that Penta prejudiced her by

"invad[ing] on the province of the jury to decide [a] fundamental

issue," we do not see how the statements that she identifies in

his testimony infringed on the jury's role in determining whether

Thomas played the role of a verifying pharmacist or otherwise

prejudiced her. Nor, we should add, does Thomas assert that Penta

mischaracterized the law in a manner that prejudiced her, even

accepting that, in characterizing the law at all during the course

of his testimony, he exceeded the bounds of permissible lay

testimony. Accordingly, Thomas's challenge based on Penta's

testimony fails due to her failure to show prejudice.

V.

The convictions are affirmed.

- 33 -