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Date: 10-15-2021
Case Style:
United States of America v. KATHY S. CHIN
United States of America v. MICHELLE L. THOMAS
Case Number: 20-1050
20-1051
Judge: Marc Barron
Court: United States Court of Appeals
For the First Circuit
Plaintiff's Attorney: Randall E. Kromm, Assistant United States Attorney, with whom
Andrew E. Lelling, United States Attorney
Defendant's Attorney:
Description:
Boston, MA - Criminal defense lawyer represented defendant with alleged violations of the Federal Food, Drug, and Cosmetic Act ("FDCA") charges.
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.
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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." Id. § 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 18 U.S.C. § 3559(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, 965 F.3d at 6-7.
- 5 -
is carried out with the intent to defraud or mislead is a felony.
21 U.S.C. § 333(a)(2); see also 18 U.S.C. § 3559(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), 879 F.3d 367, 371 (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. Id. at 374 (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
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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
- 7 -
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
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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, 849
F.3d 477, 487 (1st Cir. 2017).
In undertaking that review, we must consider the
evidence in the record in the light most favorable to the verdict.
Cadden, 965 F.3d at 10. 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, 989 F.3d at 95; see also United States v.
3 We note at the outset that, although Chin and Thomas
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.
- 9 -
Tanco-Baez, 942 F.3d 7, 15 (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 989 F.3d at
95. We nonetheless explained that, even if we assumed otherwise,
the evidence in the record sufficed to uphold the convictions.
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Id. at 95-96. 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, 879
F.3d at 374, 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
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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
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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, 885 F.3d 27, 37 (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, 421
U.S. 658, 673 (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,
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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.
- 14 -
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, 849 F.3d 1, 6 (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,
961 F.3d 1, 13 (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 21 U.S.C. § 333(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, 895 F.2d 1, 17 (1st Cir. 1990) ("[I]ssues adverted to
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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.
21 U.S.C. § 333(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. Id. § 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.
- 16 -
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 879 F.3d at 374. 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
5 Chin also argues that there was insufficient evidence
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.
- 17 -
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, 895 F.2d at 17. 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
- 18 -
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.
- 19 -
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, 577
U.S. 237, 243 (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,
- 20 -
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, 895 F.2d at 17; Dominguez v. United States, 799 F.3d
151, 154 (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, 758 F.3d 40, 45 n.6 (1st
Cir. 2014) (same). In consequence, our review of that contention
is only for plain error. United States v. Luciano, 414 F.3d 174,
177 (1st Cir. 2005) (quoting United States v. Duarte, 246 F.3d 56,
60 (1st Cir. 2001)). We find none. See Rivera-Morales, 961 F.3d
at 13. 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, 989 F.3d at 97 ("Nothing in the statute supports
the notion that only those who deliver misbranded drugs directly
to patients -- without any intermediaries -- 'dispense' such drugs
under 21 U.S.C. § 353(b)(1)."); Penobscot Poultry Co. v. United
States, 244 F.2d 94, 97 (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.").
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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
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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, 511 F.3d 7, 16 (1st Cir. 2007) ("Courts may look to
surrounding circumstances to supply inferences of knowledge which
adequately prove [fraudulent] intent."); United States v. Rosen,
130 F.3d 5, 9 (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
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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, 984 F.3d 127, 140 (1st Cir. 2020) (inferring
that a defendant had intent to participate in a conspiracy based
on his knowledge and continued participation).
- 24 -
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, 711 F.3d 1, 15 (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, 561 U.S. 1, 18-19
(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.'" Id. at 13 (quoting FCC v. Fox Television Stations, Inc.,
567 U.S. 239, 253 (2012)). Our review is de novo. United States
v. Lachman, 387 F.3d 42, 50 (1st Cir. 2004).
Chin trains her focus on the words "dispensing" and
"dispensed" in 21 U.S.C. § 353(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
- 25 -
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,
387 F.3d at 56 ("The mere fact that a statute or regulation
requires interpretation does not render it unconstitutionally
vague."); In re Bithoney, 486 F.2d 319, 324 (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 21 U.S.C.
§ 353(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
- 26 -
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, 879 F.3d at 374, she fails to develop what that notice
problem might be. See Zannino, 895 F.2d at 17.
We close our consideration of Chin's and Thomas' voidfor-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." 879 F.3d at 374.
In fact, "courts have repeatedly upheld the constitutionality of
the [FDCA's] misbranding provisions . . . in the face of vagueness
challenges." Id. at 374 n.7 (quoting United States v. Girod, No.
5:15-87-S-DCR, 2017 WL 760742, 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,
- 27 -
No. 13-273 (SRN/JJK), 2016 WL 11396496, 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, 948 F.3d 418, 437 (1st Cir. 2020) (quoting United States
v. Tull-Abreu, 921 F.3d 294, 301-02 (1st Cir. 2019)). Any
substantial errors of law constitute such an abuse. See United
States v. Munoz, 605 F.3d 359, 373 (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, 948 F.3d at 437.
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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,
948 F.3d at 437, we see no basis for finding reversible error.
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Because we afford a district court "wide latitude" in
making the judgment call that Rule 403 concerns, United States v.
Merritt, 945 F.3d 578, 586 (1st Cir. 2019) (quoting United
States v. Mehanna, 735 F.3d 32, 59 (1st Cir. 2013)), we will
overturn that call only in exceptional circumstances, Freeman v.
Package Mach. Co., 865 F.2d 1331, 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, 874 F.3d 46, 50-51 (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, 617 F.3d 233, 247 (3d Cir. 2010))).
Chin advances a nearly identical challenge, which
accordingly fails. We do note, though, that although she asserts
- 30 -
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, 948 F.3d at 437. 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.
- 31 -
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
- 32 -
that he was testifying as such. We may assume for present purposes
that, given United States v. Vega, 813 F.3d 386, 393 (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,
- 33 -
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.
Outcome: The convictions are affirmed.
Plaintiff's Experts:
Defendant's Experts:
Comments: