United States v. Stepanets, 362 F. Supp. 3d 22

Defendant Alla Stepanets was convicted by a jury of six misdemeanor violations of the Food, Drug, and Cosmetic Act (FDCA) after a ten-and-a-half week trial; she was acquitted on related felony counts.
Stepanets moved under Rule 29 for judgment of acquittal and alternatively for a new trial under Rule 33 on the convicted counts. The court considered both motions together.
Her principal arguments: (1) strict-liability misdemeanors under the FDCA violate due process; (2) she lacked managerial responsibility or power to prevent the offenses; and (3) the evidence did not show she "dispensed" drugs as the statute requires.
The court declined to overrule Supreme Court precedents permitting FDCA strict-liability prosecutions and explained it lacked power to do so.
The court noted binding First Circuit precedent defining "dispense" to include pharmacists' routine checking that can trigger drug shipments, and applied the law-of-the-case/mandate principles from the First Circuit.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Constitutionality of FDCA strict-liability misdemeanors	FDCA misdemeanors that lack mens rea violate due process	Supreme Court precedent permits such strict-liability enforcement under FDCA	Denied; court bound by Supreme Court precedents (Dotterweich, Park) allowing strict liability
Corporate/officer liability standard	Stepanets lacked managerial authority/responsibility to be held liable	Government: liability charged is for defendant's own acts, not solely officer delegation	Denied; Dotterweich/Park language on officer liability not controlling because case involves personal-act prong
Meaning of "dispense" under FDCA	"Dispense" should be read to require pharmacist act of filling and delivering prescriptions	Government and First Circuit: "dispense" can include pharmacists' routine checking that triggers shipments	Denied; bound by First Circuit's definitional ruling that "dispense" may include confirming prescriptions
Sufficiency of evidence re: knowledge of invalid prescriptions	No evidence she knew prescriptions used false patient names	Government: record supports inference she knew; court previously rejected contrary legal claim	Denied; court found sufficient evidence and noted prior rulings rejecting defendant's contention

Morissette v. United States, 342 U.S. 246 (1952) (discusses role of mens rea in criminal law)
United States v. Dotterweich, 320 U.S. 277 (1943) (upholds strict-liability officer liability under FDCA)
United States v. Park, 421 U.S. 658 (1975) (extends corporate/officer liability under FDCA for public-health risks)
United States v. Olbres, 61 F.3d 967 (1st Cir. 1995) (standard for reviewing sufficiency of the evidence post-verdict)
United States v. Taylor, 54 F.3d 967 (1st Cir. 1995) (evidentiary-sufficiency principles)
United States v. Ortiz, 966 F.2d 707 (1st Cir. 1992) (‘‘viewpoint principle’’ on considering evidence as a whole)
United States v. Rothrock, 806 F.2d 318 (1st Cir. 1986) (Rule 33 new-trial standard allowing assessment of weight and credibility)
United States v. Andrade, 94 F.3d 9 (1st Cir. 1996) (new trial warranted only to avoid miscarriage of justice)
United States v. Indelicato, 611 F.2d 376 (1st Cir. 1979) (new-trial standard discussion)
United States v. Stepanets, 879 F.3d 367 (1st Cir. 2018) (First Circuit definition of "dispense" binding on remand)
United States v. Matthews, 643 F.3d 9 (1st Cir. 2011) (law-of-the-case exceptions)
Conley v. United States, 323 F.3d 7 (1st Cir. 2003) (mandate rule requires compliance with appellate remand instructions)
Diaz v. Jiten Hotel Mgmt., Inc., 741 F.3d 170 (1st Cir. 2013) (mandate-rule principles reaffirmed)