FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
MASSACHUSETTS [Hon. Richard G. Stearns, U.S. District Judge]
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,
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
M. Griffin for appellee Chin.
Torruella, Thompson, and Kayatta, Circuit Judges.
THOMPSON, Circuit Judge.
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.
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 or mislead"
commits a crime punishable with up to three years in prison.
See id. § 333(a)(2).
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.
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." 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
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
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 ...