United States v. Anita Jackson, 126 F.4th 847

Background

Dr. Anita Jackson, an otolaryngologist in North Carolina, was convicted on multiple federal counts related to her private medical practice, including violations of the Food, Drug, and Cosmetics Act (FDCA), aggravated identity theft, anti-kickback, false statements, mail fraud, and conspiracy.
The main FDCA charge stemmed from her systematic reuse of single-use sinuplasty devices (Entellus) on multiple Medicare patients, contrary to FDA labeling and without patient disclosure.
Jackson incentivized staff to recruit Medicare patients for sinuplasty procedures, often bypassing proper medical assessments and enticing patients with transportation and financial incentives.
Investigation revealed improper cleaning and storage of reused devices, falsification of records in response to Medicare audits, and forged patient declarations to support her billing practices.
Following a jury trial, Jackson received a 25-year sentence and appealed her FDCA and aggravated identity theft convictions, arguing several trial errors and legal misinterpretations.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether the FDCA's "held for sale" element applied	Devices were not "held for sale"—used in treatment, not sold to patients	Doctor-patient services involve commercial sale of device as part of procedure	Use in treatment of Medicare patients met the "held for sale" standard
Physician immunity under 21 U.S.C. § 396	Conduct protected if within legitimate doctor-patient relationship/off-label use allowed	§ 396 protection limited to legally marketed, unadulterated devices—not adulterated ones	Immunity did not extend to conduct with adulterated devices
Basis for FDA violation: Per se rule on single-use label	Government impermissibly prosecuted her merely for reusing a single-use device	Prosecution based on holding adulterated devices under insanitary conditions, not just reusing single-use devices	Conviction was for adulteration, not simple reuse; jury instructions adequate
Presentation of cleaning method video	Court wrongfully excluded video demonstration of cleaning process as lay evidence	Exclusion was proper due to untimely, mid-trial disclosure violating scheduling orders and discovery obligations	No abuse of discretion in excluding untimely evidence
Exclusion of CDC documents on device reuse	Exclusion harmed ability to argue intent and industry practice	Documents did not specifically address Entellus or justify her belief in effective sterilization	Any error was harmless; exclusion didn't affect the outcome
Jury instruction re: lack of harm to patients	Court erred by telling jury that patient harm was irrelevant	Statute does not require proof of actual harm—just potential for contamination or injury	Instruction correct; actual harm not required under FDCA
"Golden Rule" closing argument	Government improperly invited jurors to put themselves in patients' shoes	Any reference was brief and not prejudicial in context of overwhelming evidence	No substantial rights affected; no plain error
Aggravated identity theft—application after Dubin	Dubin v. United States required jury to find identity theft was "crux" of underlying offense	Facts here matched classic aggravated identity theft—fraudulent signatures central to underlying false statement	Dubin did not require reversal; convictions stand

Key Cases Cited

United States v. Wiesenfeld Warehouse Co., 376 U.S. 86 (FDA definition of "adulteration" focuses on contamination risk, not actual harm)
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (Section 396 protects legitimate off-label use, not adulteration)
United States v. Kaplan, 836 F.3d 1199 (Use of single-use devices on patients by doctors qualifies as "held for sale" under the FDCA)
United States v. Olano, 507 U.S. 725 (Standard for plain error review on appeal)
Dubin v. United States, 599 U.S. 110 (Defines limits of aggravated identity theft statute—identity misuse must be at crux of offense)