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United States v. Stepanets

United States Court of Appeals, First Circuit

January 12, 2018

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]

          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.

          Before Torruella, Thompson, and Kayatta, Circuit Judges.

          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 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."

          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 ...


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