United States v. Stepanets

United States Court of Appeals
For the First Circuit
Nos. 16-2402
16-2403
16-2404
UNITED STATES OF AMERICA,
Appellant,
v.
ALLA V. STEPANETS; KATHY S. CHIN; MICHELLE L. THOMAS,
Defendants, Appellees.
APPEALS FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Richard G. Stearns, U.S. District Judge]
Before
Torruella, Thompson, and Kayatta,
Circuit Judges.
Daniel Tenny, Attorney, Appellate Staff, Civil Division, U.S.
Department of Justice, with whom Chad A. Readler, Acting Assistant
Attorney General, William D. Weinreb, Acting United States
Attorney, Amanda P.M. Strachan, Assistant United States Attorney,
George P. Varghese, Assistant United States Attorney, Douglas N.
Letter, Attorney, Appellate Staff, and Scott R. McIntosh,
Attorney, Appellate Staff, were on brief, for appellant.
John H. Cunha Jr., with whom Cunha & Holcomb, P.C. was on
brief, for appellee Stepanets. Michael C. Bourbeau, with whom
Bourbeau & Bonilla, LLP was on brief, for appellee Thomas.
Joan M. Griffin for appellee Chin.
January 12, 2018
THOMPSON, Circuit Judge.
Preface
The government appeals from orders dismissing counts in
an indictment that charged Alla Stepanets, Kathy Chin, and Michelle
Thomas with "dispens[ing]" misbranded drugs in violation of the
Federal Food, Drug, and Cosmetic Act, see 21 U.S.C. §§ 353(b)(1),
331(a), and 333(a)(2) — a statute that often goes by the
unpronounceable initialism "FFDCA." Reviewing the matter de novo,
see United States v. Guerrier, 669 F.3d 1, 3 (1st Cir. 2011), we
think dismissal was not called for. And so we reverse and remand
for further proceedings.
FFDCA Primer
Here is what you need to know about the FFDCA (we
simplify a bit). Enacted many decades ago "to protect consumers
from dangerous products," see United States v. Sullivan, 332 U.S.
689, 696 (1948), the FFDCA bans "[t]he introduction or delivery
for introduction into interstate commerce of any . . . misbranded"
prescription drug, see 21 U.S.C. § 331(a). A prescription drug is
"misbranded" if it is "dispensed" without "a written prescription
of a practitioner licensed by law to administer such drug." Id.
§ 353(b)(1). "Dispensed" is an undefined FFDCA term, however.
Anyhow, anyone who violates this law "with the intent to defraud
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or mislead" commits a crime punishable with up to three years in
prison. See id. § 333(a)(2).
Case Background
Shifting from the general to the specific, we believe a
simple sketch of the key events suffices to put things in
perspective. A quick heads up, though: because the judge
dismissed the charges before trial, we describe the facts as though
the government had proved what the indictment alleged, see United
States v. Councilman, 418 F.3d 67, 71-72 (1st Cir. 2005) (en banc)
— which of course is not the case.
The Defendants
Stepanets, Chin, and Thomas were Massachusetts-licensed
pharmacists. That meant they could (among other things) dispense
drugs, but only through "valid prescriptions from a medical
practitioner."1 The trio worked as pharmacists for New England
Compounding Center ("NECC" for short), a now-defunct
Massachusetts-licensed pharmacy that specialized in "high-risk
compounding" — a process that involves "using non-sterile
ingredients to create sterile drugs." Assigned to NECC's "packing
area," they "check[ed]" drug "orders" before "shipment to NECC's
customers."
1 All quotations in this section come from the indictment
unless otherwise noted.
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The Indictment
Eventually, Stepanets, Chin, and Thomas got swept up in
a 131-count indictment that included 11 other persons with NECC
ties. The gargantuan document catalogs an array of felonious
conduct — for example, it alleges that NECC failed to follow proper
sterilization procedures, opted to use expired or expiring
ingredients, and neglected to run proper tests. As relevant for
our purposes, the indictment alleges that our defendants dispensed
drugs in violation of the FFDCA, specifically by causing misbranded
drugs to be introduced into interstate commerce with the intent to
defraud or mislead. And the indictment charges them both as
principals and as aiders and abettors. See 18 U.S.C. § 2 (making
aiders and abettors punishable as principals for the offenses they
aided and abetted).
The indictment is quite detailed — as a for-instance,
the indictment identifies particular drug shipments to particular
places on particular dates based on prescriptions for fake
patients, and it specifies the laws the defendants allegedly broke.
By way of illustration, just consider the following allegations
pulled from the indictment:
 on February 18, 2010, Stepanets caused 60 vials of
"betamethasone repository" to be delivered to Lincoln,
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Nebraska, based on prescriptions for "Wonder Woman" and "Fat
Albert," among others;2
 similarly, on March 8, 2012, Chin caused 60 vials of
"betamethasone repository" to be delivered to Lincoln,
Nebraska, based on prescriptions for "Flash Gordon," "Tony
Tiger," and "Chester Cheeto," among others;
 and on March 20, 2012, Thomas and Stepanets caused 12 vials
of "betamethasone repository" to be delivered to Elkhart,
Indiana, based on prescriptions for "L.L. Bean," "Coco Puff,"
and "Filet O'fish," among others.3
2 Betamethasone is a steroid medication "with anti-
inflammatory and immunosuppressive properties." See Baldwin v.
White, No. 3:12CV210, 2013 WL 3893997, at *5 n.17 (E.D. Va. July
26, 2013).
3For anyone not up on pop culture: Wonder Woman is a made-
up superhero of comic book, television, and movie fame. Wonder
Woman, Wikipedia, https://en.wikipedia.org/wiki/Wonder_Woman
(last visited Jan. 3, 2018). So is Flash Gordon. Flash Gordon,
https://en.wikipedia.org/wiki/Flash_Gordon (last visited Jan. 3,
2018). Fat Albert is a cartoon character created by Bill Cosby.
Fat Albert and the Cosby Kids,
https://en.wikipedia.org/wiki/Fat_Albert_and_the_Cosby_Kids (last
visited Jan. 3, 2018). Tony Tiger — a/k/a "Tony the Tiger" — is
a cartoon spokesperson for Kellogg's Frosted Flakes cereal. Tony
the Tiger, https://en.wikipedia.org/wiki/Tony_the_Tiger (last
visited Jan. 3, 2018). Chester Cheeto — a/k/a "Chester Cheetah"
— is a cartoon spokesperson for Frito Lay's Cheetos snacks.
Chester Cheeto, https://en.wikipedia.org/wiki/Chester_Cheetah
(last visited Jan. 3, 2018). L.L. Bean is a Maine-based outdoor
clothing and equipment retailer. L.L. Bean,
https://en.wikipedia.org/wiki/L.L.Bean (last visited Jan. 3,
2018). Coco Puff — a variant spelling of "Cocoa Puffs" — is a
chocolate-flavored cereal made by General Mills. Cocoa Puffs,
https://en.wikipedia.org/wiki/Cocoa_Puffs (last visited Jan. 3,
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Also, the indictment notes the statutory bases for the charges —
21 U.S.C. §§ 353(b)(1), 331(a), and 333(a)(2), and 18 U.S.C. § 2
— and mimics their language in key respects.
The Dismissal Battles
Responding to the indictment, Stepanets, Chin, and
Thomas moved to dismiss the FFDCA charges against them — Stepanets
filed her own motion, and Chin and Thomas filed a joint motion.
Stepanets argued that she was not sufficiently involved in NECC's
process to have "dispensed" the drugs and that the pertinent FFDCA
provisions are unconstitutionally vague as applied to her. Chin
and Thomas argued that the FFDCA does not require prescriptions to
be "valid" for licensed pharmacists to fill them; that as a factual
matter they were not personally responsible for taking the steps
they deemed necessary for them to have "dispensed" the drugs; and
that the parts of the FFDCA covering their conduct are
impermissibly vague as applied to them. The government responded
that the FFDCA does not allow licensed pharmacists to fill
obviously fraudulent prescriptions; that the indictment's
allegations — which must be taken as true — support the charges;
2018). And Filet O'fish — a variant spelling of "Filet-O-Fish" —
is a fish sandwich sold by McDonald's, a fast-food restaurant
chain. Filet-O-Fish, https://en.wikipedia.org/wiki/Filet-O-Fish
(last visited Jan. 3, 2018).
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and that the FFDCA is sufficiently clear to withstand the
defendants' vagueness challenges.
Acting on the parties' submissions, the judge dismissed
the FFDCA counts against the defendants. Stripped to essentials,
the judge's reasoning went something like this: The indictment's
allegations, the judge wrote, show that the defendants "knew or
should have known that at least some of the shipping labels were
made out in the names of fictitious patients." But, the judge
added, that conclusion helped the government only so much. Relying
on a medical dictionary's definition of "dispense," the judge ruled
that "a pharmacist dispenses a drug when she acts in her role as
a licensed professional to fill (put together) a medical
prescription for delivery to a patient." From there, the judge
said that the FFDCA "as written clearly punishes pharmacists who
fill or take part in the filling of invalid prescriptions placed
into interstate commerce with the intent to defraud or mislead the
government." But he still thought the indictment did not provide
"fair notice." Explaining why, the judge wrote that "conduct
incidental to the distribution of prescribed drugs" — like
"checking a package" — falls outside the FFDCA's reach, and he
expressed his concern that "a reasonable pharmacist" would not
know "from the indictment that by matching orders to packages prior
to their being shipped, she was criminally liable for participating
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in the filling of a prescription that she had never approved (or
is even alleged to have seen)."
Sticking to his views, the judge later denied the
government's motion to reconsider. Two things about that ruling
stand out. First, the judge read the indictment as simply accusing
our defendants of committing a "clerical task" — a task, the judge
added, that does not rise to the level of dispensing under the
FFDCA. Second, responding to the government's argument that his
earlier order did not address aiding-and-abetting liability, the
judge said the indictment's allegations portrayed each defendant
as "mere[ly] presen[t]" at the scene of the crime — and mere
presence does not an aider and abettor make, the judge wrote, "even
when coupled with knowledge that a crime is being committed by
others."
The Appeal Taken
That brings us to today, with the government trying to
torpedo the judge's rulings and the defendants trying to save them.
Our jurisdiction secure thanks to 18 U.S.C. § 3731, we now offer
our de novo take on the case.
Analysis
Guiding Legal Principles
We begin with a few basics. The Constitution says that
a criminal defendant cannot "be held to answer for a capital, or
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otherwise infamous crime, unless on a presentment or indictment of
a Grand Jury," U.S. Const. amend. V, and that she has "the right
. . . to be informed of the nature and cause of the accusation,"
U.S. Const. amend. VI. Consistent with these commands, Federal
Rule of Criminal Procedure 7(c)(1) says that an indictment must
contain "a plain, concise, and definite written statement of the
essential facts constituting the offense charged" — though an
indictment's "count[s] may allege that the means by which the
defendant committed the offense are unknown." An indictment need
not say much to satisfy these requirements — it need only outline
"the elements of the crime and the nature of the charge so that
the defendant can prepare a defense and plead double jeopardy in
any future prosecution for the same offense." See Guerrier, 669
F.3d at 3. This means that an indictment that tracks a statute's
terms is legally sufficient if the indictment itself gives the
defendant adequate notice of the charges she must meet. See, e.g.,
Hamling v. United States, 418 U.S. 87, 117 (1974); United States
v. Savarese, 686 F.3d 1, 6 (1st Cir. 2012); United States v. Troy,
618 F.3d 27, 34 (1st Cir. 2010).
As you read on, keep in mind as well that "[t]he
government need not recite all of its evidence in the indictment."
See United States v. Innamorati, 996 F.2d 456, 477 (1st Cir. 1993).
Also keep in mind that courts must not inquire into the sufficiency
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of the evidence underlying the indictment — for when "a defendant
seeks dismissal of the indictment, the question is not whether the
government has presented enough evidence to support the charge,
but solely whether the allegations in the indictment are sufficient
to apprise the defendant of the charged offense." See Savarese,
686 F.3d at 7; see also Guerrier, 669 F.3d at 4 (noting that courts
"routinely rebuff efforts to use a motion to dismiss as a way to
test the sufficiency of the evidence behind an indictment's
allegations"). Keep in mind too that in seeing whether an
indictment is up to snuff, a court must reject arguments that
embrace technical niceties at the expense of common sense. See
United States v. Mubayyid, 658 F.3d 35, 69-70 (1st Cir. 2011); 1
Charles Alan Wright & Andrew D. Leipold, Federal Practice and
Procedure § 123 at 522-23 (4th ed. 2008). And definitely keep in
mind that a court must deny a motion to dismiss if the motion
relies on disputed facts. See, e.g., United States v. Covington,
395 U.S. 57, 60 (1969) (holding that a court can resolve a pretrial
motion to dismiss the indictment only when "trial of the facts
surrounding the commission of the alleged offense would be of no
assistance in determining the validity of the defense"); Fed. R.
Crim. P. 12(b)(3) (noting that a motion to dismiss for failure to
state a crime "must be raised by pretrial motion if the basis for
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the motion is then reasonably available and the motion can be
determined without a trial on the merits" (emphasis added)).
A Sufficient Indictment
Measured against these modest standards, the indictment
here easily passes muster — just as the government argues. After
all, and again: The indictment notes the statutory bases for the
counts, listing the crimes' key elements. The indictment also
provides the relevant factual backdrop, alleging for example that
each defendant-pharmacist approved specified drug shipments, on
specified dates, to specified locations, based on obviously
invalid prescriptions for specified fake patients (e.g., "Wonder
Woman" and "Coco Puff"). And the indictment connects the elements
and the facts. So the indictment gives the defendants enough info
to prepare a defense and to invoke double-jeopardy protections to
forestall a later trial on the same charges. The law requires no
more.4 See, e.g., Savarese, 686 F.3d at 6; Troy, 618 F.3d at 35.
4 The defendants scold the government for "[f]inding comfort
in [the indictment's] tracking the language of the [FFDCA]." But
we see nothing wrong with the government's approach, particularly
since we have long held that "the statutory language may be used
in the indictment to describe the offense," provided the indictment
lets the defendant know the "general factual scenario on which the
charges rest," see Troy, 618 F.3d at 34, 35 — a standard this
indictment meets, for reasons already explained.
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No Persuasive Counterarguments
The reason why the judge's analysis veered off-track is
because he made some out-of-place fact-assumptions — assumptions
that devastate his conclusion about how the indictment
insufficiently charges principal or aider-and-abettor liability.
Unfazed, the defendants invite us to follow the judge's lead,
advancing a number of counterarguments aimed at defending the
judge's rulings. We decline the invitation — though before
explaining why, we must first recap some things we said earlier.
Recall that after focusing on the word "dispense" in the
FFDCA, the judge ruled that the statute "punishes pharmacists who
fill or take part in the filling of invalid prescriptions placed
in interstate commerce."5 Moving on, the judge then read the
5
We take a quick timeout to straighten something out. Taking
their cue from the judge below, the defendants say that
Commonwealth v. Brown, 925 N.E.2d 845 (Mass. 2010), is — to quote
their brief — "instructive in how to define 'dispense'" under the
FFDCA. Dealing with Massachusetts's controlled-substances act —
not with the FFDCA — Brown noted that the term "dispense" in the
state statute is defined and limited to "deliver[y]" to the
"ultimate user," and "ultimate user" is defined as someone who
"lawfully possesses a controlled substance for his own use or the
use of a member of his household." Id. at 855 (emphasis removed)
(quoting Mass. Gen. Laws ch. 94C, § 1). So according to Brown, a
drug is not "dispensed" under that statute if a person receives it
because of "an invalid prescription" — though in that situation,
because she "has devolved into a 'pusher,'" the physician can be
prosecuted for "the crime of 'distribution.'" Id. at 857-58.
Importantly for us, the FFDCA provisions in play here have no
lawful-possession requirement. And given this big-time difference
between the two statutes, there is no need to rely on Brown.
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indictment as alleging that the defendants simply performed a
"clerical task," like checking the address on a drug package's
mailing label. And having done this, the judge concluded that the
defendants could not have understood from the indictment that their
conduct — helping fill prescriptions they never approved, much
less saw — infracted the FFDCA. More, the judge also read the
indictment as alleging that the defendants were merely present
when the crimes occurred, which as he saw it sinks any aiding-and-
abetting theory.
Recall too that the defendants — echoing the judge's
analysis — claim as a factual matter that they acted not as NECC
pharmacists but as NECC shipping clerks, performing "rotely
clerical" tasks, like checking addresses on packages. They also
insist that they did not "understand" from the FFDCA's language
that they could be criminally liable for helping fill prescriptions
they never signed off on, let alone caught sight of. And last but
not least, they too assert that the indictment's allegations show
only their mere presence at a crime scene, which in their telling
means the document inadequately alleges aiding-and-abetting
liability.
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Taking first things first, we consider the indictment's
allegations that the defendants participated as principals in the
FFDCA crimes:
We agree with the government that the major flaw in the
judge's and the defendants' analyses is that the indictment says
nothing — zippo — about the defendants' having simply checked
addresses or worked as clerks. Rather, the indictments 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. Nor does the indictment say anything
about how a non-pharmacist could do the jobs each defendant-
pharmacist did at NECC.
Undaunted, the defendants note that the indictment
alleges that each of them worked "in the packing area checking
orders." And they insist — emphasis theirs — that "[i]t is
undisputed 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 names or any other aspect of the
dispensing process." But the government does dispute that
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contention, arguing for example that the "worked in the packing
area checking orders" allegations — 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. Anyway, the
defendants cite nothing in the indictment to support their theory
that they did not check patient names or prescriptions.6 So at
best for the defendants, we have disputes of fact — disputes that
must be resolved at trial rather than on pretrial motions to
dismiss. See Covington, 395 U.S. at 60; Guerrier, 669 F.3d at 3-
4.
And what we have just said undermines the judge's and
the defendants' no-fair-notice analyses as well. Even putting to
6 Interestingly, the defendants later admit that they did do
more than check addresses, conceding in a footnote that NECC
"use[d] a pharmacist . . . to check that the name and dosage of
the drug on the shipping label [was] the same as the name and
dosage on the order form." No big deal, they say, because NECC's
use of a pharmacist was "a surfeit" and "hardly means that a non-
pharmacist could not easily have performed the task." To their
minds, "a pharmacist would only be required" — again, emphasis
theirs — "if some sort of testing was performed," which "was not
done, or alleged." This line of argument is full of holes, the
most notable ones being: The defendants do not explain why they
think NECC's use of a pharmacist was a surfeit (surfeit is
basically a fancy word for excessive) — perhaps because the
indictment does not allege non-pharmacists could have done what
the defendants did. Also and critically, the indictment nowhere
says that NECC needed pharmacists only when "some sort of testing"
was required.
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the side that no one cites a case — and we know of none — holding
any key FFDCA provision void for vagueness,7 the no-fair-notice
thesis depends on fact-assumptions about how the defendants did
not know that they could be on the hook criminally for taking part
in filling prescriptions they neither approved nor saw. But as
the government notes, the indictment says nothing about the
defendants' not approving or seeing the prescriptions. Properly
understood then, the no-fair-notice theory depends on contested
"facts surrounding the commission of the alleged offense" — facts
no court may consider before trial. See Covington, 395 U.S. at
60; see also Guerrier, 669 F.3d at 3.
Turning then to the indictment's allegations that the
defendants acted as aiders and abettors in the FFDCA crimes:8
Generally speaking, an aider and abettor is one who
knowingly helps another commit a crime. See United States v.
Urciuoli, 513 F.3d 290, 299 (1st Cir. 2008) (explaining that an
7See generally United States v. Girod, No. 5:15-87-S-DCR,
2017 WL 760742, at *1 (E.D. Ky. Feb 2, 2017) (stressing that "the
courts have repeatedly upheld the constitutionality of the
[FFDCA's] misbranding provisions . . . in the face of vagueness
challenges").
8We should first say that the defendants imply that the
government cannot go the aiding-and-abetting route because it
debuted that theory in a motion for reconsideration. But the judge
did not reject the issue on lateness grounds, opting instead to
address the issue head-on. So we consider the issue preserved for
appellate review. See Trenkler v. United States, 536 F.3d 85, 96
(1st Cir. 2008).
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aider and abettor is one who "associate[s] himself with the
venture, . . . participate[s] in it as in something that he wishes
to bring about," and "seek[s] by his action to make it succeed"
(quoting United States v. Peoni, 100 F.2d 401, 402 (2d Cir.
1938))). In outlawing "aiding and abetting, Congress used language
that 'comprehends all assistance rendered by words, acts,
encouragement, support, or presence.'" Rosemond v. United States,
134 S. Ct. 1240, 1246 (2014) (quoting Reves v. Ernst & Young, 507
U.S. 170, 178 (1993)).
As the government notes, the indictment specifically
cites to the aiding-and-abetting statute, even though such a cite
is not automatically required for the government to proceed on an
aiding-and-abetting theory. See United States v. Sanchez, 917
F.2d 607, 611 (1st Cir. 1990) (holding that "the government may
rely on an 'aiding and abetting' theory, although the indictment
neither alleges nor adverts to it, except on a showing of unfair
surprise"). And despite what the judge thought and the defendants
think, we believe a common-sense reading of the indictment's
allegations suggests that each defendant-pharmacist performed
NECC-assigned tasks that caused misbranded drugs to be introduced
into interstate commerce — allegations that indicate that the
defendants were not merely present, but were culpably present.
See Urciuoli, 513 F.3d at 299. So once again, the defendants,
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tracking the judge's line of reasoning, rely here on disputed facts
that they want found in their favor — a situation that calls for
a trial, not a dismissal on pretrial motions.9 See Covington, 395
U.S. at 60; Guerrier, 669 F.3d at 3-4.
Wrap Up
Our work over, we reverse the judge's dismissal of the
FFDCA charges against the defendants.
9 Two loose ends dangle. Focusing on the scienter element
for aiding-and-abetting liability, the defendants suggest that the
indictment does not allege that they knew the names on the
prescriptions were phony. Even the judge below did not buy that
argument, as he accepted for purposes of deciding the dismissal
motions that the defendants had the requisite knowledge. And the
defendants offer no persuasive basis for second-guessing the
judge's reasoning.
Without citing any authority, the defendants also suggest
that we should affirm the judge's aiding-and-abetting ruling
because the indictment (in their minds) fails to specifically
identify who the principals were (if not these defendants, that
is) — a ground not relied on by the judge. The suggestion is
waived, however — they neglected to make it below; and if that
were not enough, they neglected to adequately brief it here. See,
e.g., Ayala-Sepúlveda v. Municipality of San Germán, 671 F.3d 24,
30 n.4 (1st Cir. 2012); Muñiz v. Rovira, 373 F.3d 1, 8 (1st Cir.
2004).
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