Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca4-23-04587/USCOURTS-ca4-23-04587-0/pdf.json

Parties Involved:
Anita Louise Jackson
Appellant
Physicians Against Abuse, Inc.
Amicus Supporting Appellant
United States of America
Appellee

Document Text:

PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 23-4467

UNITED STATES OF AMERICA,

 Plaintiff – Appellee,

v.

ANITA LOUISE JACKSON,

 Defendant – Appellant.

------------------------------

PHYSICIANS AGAINST ABUSE, INC.,

 Amicus Supporting Appellant.

No. 23-4587

UNITED STATES OF AMERICA,

 Plaintiff – Appellee,

v.

ANITA LOUISE JACKSON,

 Defendant – Appellant.

------------------------------

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PHYSICIANS AGAINST ABUSE, INC.,

 Amicus Supporting Appellant.

Appeal from the United States District Court for the Eastern District of North Carolina, at

Raleigh. James C. Dever, III, District Judge. (5:21-cr-00259-D-1)

Argued: November 1, 2024 Decided: January 21, 2025 

Before DIAZ, Chief Judge, AGEE, and BENJAMIN, Circuit Judges.

Affirmed by published opinion. Judge Agee wrote the opinion in which Chief Judge Diaz 

and Judge Benjamin joined.

ARGUED: Elliot Sol Abrams, CHESHIRE PARKER SCHNEIDER, PLLC, Raleigh, 

North Carolina, for Appellant. Katherine Twomey Allen, UNITED STATES 

DEPARTMENT OF JUSTICE, Washington, D.C., for Appellee. ON BRIEF: Ripley E. 

Rand, WOMBLE BOND DICKINSON (US) LLP, Raleigh, North Carolina, for Appellant. 

Nicole M. Argentieri, Principal Deputy Assistant Attorney General, Lisa H. Miller, 

Criminal Division, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C.; 

Michael F. Easley, Jr., United States Attorney, David A. Bragdon, Assistant United States 

Attorney, Appellate Chief, OFFICE OF THE UNITED STATES ATTORNEY, Raleigh, 

North Carolina, for Appellee. Eric O. Husby, HUSBY LAW, Land O Lakes, Florida, for 

Amicus Curiae.

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AGEE, Circuit Judge:

Dr. Anita Jackson appeals her convictions for various offenses arising from the 

operation of her private medical practice in North Carolina. She raises multiple arguments 

challenging her conviction for violating the Food, Drug, and Cosmetics Act (“FDCA”) by 

holding for re-sale adulterated medical devices, in violation of 21 U.S.C. § 331(k). Flowing 

from her challenge to the FDCA conviction, she also asserts that the prejudicial spillover 

effect of evidence introduced to support that count requires vacatur of her other 

convictions. And, assuming her case is remanded for a new trial, she submits that the Court 

should reassign the case to a different district judge. Separately, Jackson challenges her 

convictions for two counts of aggravated identity theft, in violation of 18 U.S.C. 

§§ 1028A(a)(1) and 2. 

Finding no reversible error as to any of the challenged convictions, we affirm.

I.

Jackson is a board-certified otolaryngologist, commonly referred to as an ear, nose, 

and throat physician. During the relevant timeframe, she ran a multi-location private 

practice in Lumberton and Rockingham, North Carolina.1

1 We recount the facts established at trial in the light most favorable to the 

Government, as the prevailing party. United States v. Torrez, 869 F.3d 291, 295 (4th Cir. 

2017).

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At one time, Jackson was the leading Medicare biller in the nation for a procedure 

known as balloon sinuplasty surgery, which treats chronic sinusitis.2 The procedure 

consists of the doctor inserting a device through the patient’s nose into one or more of the

sinuses and inflating a small balloon to widen the cavity. The device Jackson used for this 

procedure during the relevant timeframe was an Entellus XprESS Multi-Sinus Dilation 

Tool (“Entellus” or “the device”). The insertable part of this device has a small tip, an 

inflatable balloon, and a thin hollow metal tube. The balloon slides up and down the tube 

and is inflated after it is placed in the patient’s sinus cavity. The rest of the Entellus remains 

outside the patient’s body and consists of the slide mechanism for the balloon, a suction 

port, and a light fiber that runs through the hollow tube to allow the physician to see into

the sinus during the procedure. The device also has small retractable parts that often come 

into contact with and trap bodily fluids and hair from the patient during the procedure. 

These parts are fragile and may break easily, particularly if the Entellus is reused. The 

device was, accordingly, designed for single use and is labeled by the Food and Drug 

Administration as being approved only for single use. 

Physicians who perform sinuplasty surgeries can be reimbursed by Medicare. In 

fact, this particular procedure does not require preapproval to submit a claim. Medicare 

reimbursement levels for sinuplasty and other procedures factor in “three main parts: The 

amount of time and effort it takes to provide service, the costs associated with that service 

2 Medicare is a federal health insurance program for individuals aged 65 or older as 

well as for certain people with qualifying disabilities. 42 U.S.C. § 1395c. Physicians can 

be reimbursed for services provided to Medicare beneficiaries by applying for a national 

provider identifier and enrolling with the program to obtain billing privileges.

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that the doctor will incur, and the costs that the[] doctor incurs for malpractice.” J.A. 1402. 

This formula, which takes into account the cost of the equipment needed to perform the 

procedure, was used to calculate Medicare’s reimbursement amounts for a sinuplasty using 

the Entellus. 

Becoming the nation’s leading Medicare biller for sinuplasty surgery was far from 

happenstance, as Jackson’s employees recounted how she incentivized recruiting Medicare 

patients to agree to the procedure. For her employees, Jackson tied work hours to surgerymarketing efforts, set surgery quotas for her offices, and paid bonuses related to how many 

sinuplasty procedures were performed. She encouraged employees to recruit patients 

throughout the community, targeting rural localities and seeking out individuals likely to 

have Medicare because it did not require preapproval for the procedure. Employees 

testified, for example, that they were told to pitch balloon sinuplasty to potential patients 

at locations like Wal-Mart parking lots, churches, barbershops, and doctor’s offices. In 

addition, Jackson offered some potential patients financial enticements such as not 

requiring any front payment or limiting fees to a $50 copayment rather than the higher 

Medicare-directed copayment amounts. By agreeing to have the sinuplasty procedure,

patients could also receive free transportation to Jackson’s office and gift cards to local 

stores. 

In conjunction with these efforts to drum up new sinuplasty patients, Jackson 

streamlined the process she followed before deeming a patient eligible for the procedure. 

Early on, Jackson ordered diagnostic scans and considered alternative treatments before 

performing the procedure. Later, Jackson would simply perform the procedure on a 

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patient’s first visit, implementing what Jackson’s employees termed an “assembly line” to 

“get to ‘yes’” for the sinuplasty to be performed, thereby skipping a bona fide assessment 

of the patients’ medical condition, alternative treatments, or even determining whether the 

procedure was medically appropriate. J.A. 1766, 1953–55. 

In many cases, Jackson’s recruitment efforts left patients without understanding that 

the proposed procedure was actually a surgery. Instead, it was described to them as a “sinus 

spa” or “rinse.” J.A. 1749–50, 2045. Many patients were also unaware that the procedure 

worked by having the balloon micro-fracture bones. And they were similarly unaware that 

Jackson elected to perform the procedure using the same device on more than one patient. 

Instead, patients were informed that a “small sterile balloon” would be used during the 

procedure. S.J.A. 172.

When investigators searched Jackson’s offices, they discovered that aged, used 

devices were being stored loose in drawers. Those conditions were typical. Employees 

reported that many Entelluses used on patients were rusted and the retractable parts no 

longer operated smoothly. After use, Jackson’s employees would wash the device using a 

variety of cleaning methods because they were not given clear instructions for how to do 

so. They lacked appropriate tools to assist in cleaning the devices’ hollow and delicate 

parts, and they could not see many areas of an Entellus to ensure that it was clean, much 

less sterile. Usually, employees would wash the device with tap water and soap while 

gently scrubbing it so as not to break any of its parts. They would then place it in two 

chemical solutions for around thirty minutes (well below the solutions’ recommended 

cleaning times), rinse with tap water, and then leave the device to dry on top of a pad on 

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the counters of exam rooms. Once dry, the Entelluses were put in drawers where they were

interspersed with other supplies. This process created a significant likelihood that some 

reused devices still contained prior patients’ bodily fluids.

Jackson’s billing practices related to sinuplasty surgeries drew the attention of 

federal investigators, and she was audited four times between 2016 and 2018. After a 2016 

audit, Jackson was forced to repay over $30,000 in Medicare reimbursements because of 

noncompliant (incomplete) recordkeeping. The 2016 audit did not cause Jackson to 

implement better recordkeeping measures; instead, she and her employees began falsifying

documents to support her billing practices. The record shows that each time Jackson was 

informed of an audit and asked to produce complete copies of her medical records 

supporting various claims, she submitted altered records.3 Specifically, Jackson created 

entirely new records, omitted incomplete records, and changed other records. In response 

to one of the 2018 audits (the “2018 Palmetto audit”), Jackson submitted declarations 

purporting to be from sinuplasty patients. The declarations represented that the patients had 

chronic sinusitis and had been unsuccessfully treated with antibiotics before Jackson 

performed the sinuplasty surgery. The declarations contained a statement representing the 

truth and correctness of the contents, under penalty of perjury. Some of the declarations, 

including those belonging to patients with the initials of L.J. and W.F., contained false 

notarizations and forged signatures.

3 The opinion describes certain acts as Jackson’s own conduct, even when the record 

sometimes shows that the acts were performed at Jackson’s direction by those under her 

supervision. Given the way Jackson was charged and the applicable law, these distinctions 

are not meaningful in providing an overview of the offense conduct. 

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As a result of the audits and related investigations into Jackson’s practice, a grand 

jury returned an indictment charging Jackson with an array of federal crimes. The twentycount superseding indictment alleged the following offenses: 

• Count 1: violating 21 U.S.C. § 331(k) by holding for resale adulterated medical 

devices, namely, the Entellus with which Jackson performed the sinuplasty 

surgeries;

• Counts 2–11: violating the federal anti-kickback statute, 42 U.S.C. § 1320a-7b, 

by billing Medicare for procedures without advising patients of their copayment 

responsibilities and without collecting copayments from patients, as required by 

federal law; 

• Counts 12–14: making materially false statements, in violation of 18 U.S.C. 

§§ 1035(a)(2) and 2, during the course of the three 2017 to 2018 Medicare 

audits;

• Counts 15–16: committing aggravated identity theft, in violation of 18 U.S.C. 

§§ 1028A(a)(1) and 2, by submitting forged and fabricated documents 

purportedly from patients L.J. and W.F. as part of Jackson’s response to the 2018 

Palmetto audit described in Count 14;

• Counts 17–19: committing mail fraud, in violation of 18 U.S.C. §§ 1341, 1349, 

and 2, relating to mailing falsified documents responding to the audits described 

in Counts 12 to 14; and

• Count 20: conspiring to commit the federal offenses described in the prior 

counts, in violation of 18 U.S.C. § 371.

During the multi-week trial that ensued, the jury heard evidence from multiple 

witnesses, including Jackson’s employees and patients, as well as the designer of the 

Entellus. In addition, Jackson testified in her defense. After the presentation of evidence, 

the jury convicted Jackson on all charges, specifically finding that she acted with the intent 

to defraud or mislead as to the FDCA violation (Count 1) and that she had obtained 

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$4,794,039.31 as “gross proceeds traceable to the commission of the federal health care 

offenses.” J.A. 3657.4

Jackson moved for a judgment of acquittal as to Counts 2 through 19 (but, notably, 

not Count 1) and included a blanket cross-reference to “the entirety of her preserved 

objections, submissions, legal arguments, motions, denials of said motions, requests, and 

rights preserved in the trial record . . . as grounds for [a] motion for new trial.” J.A. 3674. 

The district court denied these motions.

Jackson was sentenced to a below-Guidelines sentence of twenty-five years’ 

imprisonment and ordered to pay $5,726,218.26 in restitution. 

Jackson noted a timely appeal, and the Court has jurisdiction under 28 U.S.C. 

§ 1291.

II.

In this appeal, Jackson does not directly challenge seventeen of her convictions.5 As 

to the FDCA conviction (Count 1) and aggravated identity theft convictions (Counts 15 

and 16), she raises multiple arguments. Although Jackson also broadly contends that she is 

4 Violating 21 U.S.C. § 331(k) ordinarily carries a maximum sentence exposure of 

not more than one year’s imprisonment or a $1,000 fine, or both. 21 U.S.C. § 333(a)(1). 

But if a person commits such a violation “with the intent to defraud or mislead,” then the 

statutory maximum increases to not more than three years’ imprisonment or a $10,000 fine, 

or both. Id. § 333(a)(2). 

5

In that regard, she does not raise any arguments specifically challenging the 

evidence related to her ten convictions for violating the federal anti-kickback statute 

(Counts 2–11), three convictions for making material false statements (Counts 12–14), 

three convictions for mail fraud (Counts 17–19), or one count of conspiracy to commit the 

other offenses (Count 20).

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entitled to vacatur and remand for a new trial as to all of her convictions, those arguments 

all flow solely from errors that she claims occurred as to Count 1, which she contends 

prejudicially infected the rest of the trial. 

We begin by considering Jackson’s challenge to Count 1, in which she was charged 

with violating the FDCA. Two elements of the offense are undisputed—that the conduct at 

issue involves a “device” as that term is defined in the FDCA, and that the devices had 

been shipped in interstate commerce. The remaining elements are, in relevant part, that the 

defendant (1) engaged in prohibited conduct with respect to the device, (2) while the device 

was “held for sale (whether or not the first sale),” and (3) the prohibited conduct resulted 

in the device “being adulterated.” § 331(k).

6 The prohibited conduct set out above 

encompasses “two distinct offenses,” the first relating to the label itself and potential 

misbranding and the second—the conduct at issue here—relating to adulteration, which “is 

concerned solely with deterioration or contamination of the commodity itself.” United 

States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 89–90 (1964). The FDCA states that a 

“device shall be deemed to be adulterated” “if it has been prepared, packed, or held under 

insanitary conditions whereby it may have been contaminated with filth, or whereby it may 

have been rendered injurious to health.” 21 U.S.C. § 351(a)(2)(A). 

6 The statutory text prohibits the act of or causing of “[t]he alteration, mutilation, 

destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing 

of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such 

act is done while such article is held for sale (whether or not the first sale) after shipment 

in interstate commerce and results in such article being adulterated or misbranded.” 

§ 331(k).

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Jackson raises several arguments aimed at undermining her conviction on Count 1, 

asserting alternatively that problems with the indictment require dismissal of the charge 

outright or that trial errors require vacatur of the conviction and remand for a new trial. As 

reflected in the analysis that follows, most of Jackson’s arguments are raised here for the 

first time on appeal. The fact that she failed to preserve those issues affects our standard of 

review, as outlined below. 

In broad terms, Jackson presses the following arguments: (1) the Entellus devices 

were not “held for sale,” as required to violate § 331(k); (2) her actions were protected 

under 21 U.S.C. § 396, which she claims insulates certain physician conduct that would 

otherwise violate § 331(k) so long as it occurs within a legitimate doctor-patient 

relationship; (3) the Government relied on a defective theory of per se adulteration arising 

from re-use of a device labeled for single use; (4) she should have been permitted to 

demonstrate her cleaning and sanitation process as part of her defense; (5) she should have 

been permitted to introduce documentary evidence about the prevalence of re-using singleuse devices and proper sanitization as part of her defense; (6) the jury should not have been 

instructed that it was “irrelevant” that none of her patients were harmed or that she believed 

the device was clean; and (7) the Government made an improper “Golden Rule” argument 

during closing argument. We address each of these contentions in turn.7

7 We further note that we have considered Jackson’s brief in full even though it 

lodges a number of arguments that we do not directly engage. We reject those arguments 

without further discussion, primarily because they plainly lack merit on their face or are 

subsumed within discussed arguments.

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A.

Jackson posits that the indictment was deficient, the jury instructions erroneous, and 

the evidence insufficient to support the verdict. She argues that each of these alleged errors

permitted the element of § 331(k) requiring that the device be “held for sale” to be satisfied 

by conduct falling outside the scope of that statutory language. In sum, Jackson asserts that,

at most, she held the Entelluses for use during sinuplasty surgeries and that they were not

“held for sale” to her patients. Her rationale is that she did not hold the devices for sale

because ownership of or title to an Entellus never transferred to the patient as a part of the 

procedure. In her view, because “re-use” falls outside the scope of holding the device “for 

sale,” the indictment should have been dismissed because it did not charge her with conduct 

that the statute prohibits. She further asserts that this mismatch between the statutory 

language and her conduct carried forward to the jury instructions, which stated that “[t]he 

phrase ‘held for sale’ includes a single-use device that a doctor used in the course of treating 

a Medicare patient. A device is ’held for sale’ at the time the holder of the device, including 

a doctor, intends it to be sold or used in the course of treating a Medicare patient.”

J.A. 3515. For the same reasons, she asserts the trial record is insufficient to support her 

conviction.

Because Jackson makes each of these arguments centered on the Entellus being 

“held for sale” for the first time on appeal, we apply plain-error review. See Puckett v. 

United States, 556 U.S. 129, 134–35 (2009) (stating that appellate courts review 

“unpreserved claim[s] of trial error” for plain error). Before proceeding with that review, 

however, we briefly discuss our basis for concluding that she failed to preserve any 

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argument with respect to whether the Entellus was “held for sale.” Jackson first maintains 

that she preserved her argument related to the indictment by moving to dismiss Count 1 for 

failure to state an offense. Reviewing Jackson’s arguments in support of that motion reveals 

that she asserted three reasons why Count 1 should be dismissed. First, she claimed that 

§ 331(k) was “[u]nconstitutionally [v]oid for [v]agueness,” J.A. 138, because it failed to 

adequately notify individuals when a device is left in sufficiently unsanitary conditions so 

as to be deemed “adulterated.” Second, she argued the indictment did not sufficiently allege 

her intent to defraud or mislead her patients. Third, she claimed that the indictment did not 

allege that she failed to engage in a permitted off-label use of the Entellus. None of these 

arguments challenges any aspect of the “held for sale” element of § 331(k), let alone 

reflects some variant of the specific grounds she raises on appeal about this element. We 

therefore reject her contention that her motion to dismiss the indictment was sufficient to 

preserve the issue she now brings before the Court.8 As for the jury instructions on this 

8

Jackson also points out that the district court mentioned United States v. Kaplan, 

836 F.3d 1199 (9th Cir. 2016), during its bench ruling denying her motion as to Count 1, 

asserting that because Kaplan addressed the “held for sale” argument, the district court’s 

reference to that decision shows that the issue is preserved. While it’s true that the district 

court mentioned Kaplan, Jackson’s argument is unpersuasive when considering the actual 

bench ruling and Kaplan decision in context. 

In that ruling, the district court noted in passing that “[o]ne case that wasn’t cited in 

the papers,” but which had been “informative to [it] in connection with this entire topic is 

[Kaplan because] the Court there did address some of the same issues.” J.A. 626. But at no 

time during its ruling did the district court specifically mention—in the context of 

referencing Kaplan or otherwise—the element of a device being “held for sale.” 

Kaplan discusses several issues relating to § 331(k), including two issues that were

raised in her motion to dismiss the indictment, namely, a physician’s off-label use of a 

single-use device and the sufficiency of an indictment’s allegations about intent to defraud 

and mislead. See Kaplan, 836 F.3d at 1210–12.

(Continued)

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matter, Jackson did not object to them and instead expressed that she was “satisfied with” 

the instructions to which she did not object. J.A. 3401. So that part of her argument likewise 

was never brought before the district court. Lastly, Jackson did not move for judgment of 

acquittal on a basis remotely related to whether the Entellus was “held for sale,” so she also 

failed to preserve that component of her argument.

The Supreme Court set out the standard for plain-error review in United States v. 

Olano, 507 U.S. 725 (1993). First, there must be an error. Id. at 732–33. Second, the error 

“must be clear or obvious, rather than subject to reasonable dispute.” Puckett, 556 U.S. at 

135 (citing Olano, 507 U.S. at 734). “Third, the error must have affected the appellant’s 

substantial rights, which in the ordinary case means he must demonstrate that it ‘affected 

the outcome of the district court proceedings.’” Id. (quoting Olano, 507 U.S. at 734). 

Fourth, even when “the above three prongs are satisfied, the court of appeals has the 

discretion to remedy the error—discretion which ought to be exercised only if the error 

seriously affect[s] the fairness, integrity or public reputation of the judicial proceedings.” 

Id. (cleaned up) (emphasis in original). 

Notably, only one circuit court has confronted the merits of this particular “held for 

sale” issue in a directly analogous context, and it has rejected Jackson’s argument. In 

United States v. Kaplan, 836 F.3d 1199 (9th Cir. 2016), the Ninth Circuit rejected the 

argument that a physician merely held for “use” (and not for “sale”) single-use devices 

Based on the above, we decline Jackson’s invitation to infer from the district court’s 

invocation of Kaplan that it was doing so to reject an argument the court did not mention 

and Jackson never made.

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used during biopsy exams. Id. at 1208. The Ninth Circuit held that § 331(k)’s requirement 

that the allegedly adulterated device be “‘held for sale’ included a physician’s use of a 

device in treating patients.” Id. In doing so, it relied on the statutory text and the purpose 

of the FDCA, noting that the statute “is to be interpreted broadly in order to protect public 

health.” Id. It also recounted the reasoning of other courts that had interpreted this phrase, 

recognizing that it “extends to physicians using both drugs and devices in the treatment of 

patients” given the commercial nature of a physician’s treatment of patients. Id. at 1209. 

Agreeing with this reasoning, the Ninth Circuit described the doctor–patient relationship 

as setting up a “sale” of services, with the device being part and parcel of those services. 

Id. at 1210 (a “physician [is] engaged in the business of providing medical services in 

exchange for payment: a commercial actor in a commercial setting, using a commercial 

product”). The Ninth Circuit also placed particular significance on the “single-use nature” 

of the device at issue in that case, observing that such devices are “meant to be ‘consumed’ 

in the course of treating a patient—just like a drug.” Id. It then elaborated:

Once the single-use device is used or consumed there is nothing left to be 

done with the device. It no longer possesses a functional purpose in the 

medical practice and, rather than giving the used device to the patient, the 

doctor disposes of it. Therefore, when a physician uses a disposable device 

on a patient, the device is “held for sale” within the meaning of the FDCA 

provided that there is a commercial relationship between the doctor and the 

patient and that the device is one that is meant to be ‘consumed’ in the 

process.

Id.

While acknowledging the common-sense persuasiveness of the Ninth Circuit’s 

reasoning and the body of caselaw from other courts on which it rests, we do not ultimately 

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need to determine whether we would hold the same. Even were we to assume that Kaplan 

was wrongly decided and that Jackson can demonstrate error, her argument fails at the 

second prong of plain-error review—she cannot show a clear or obvious, i.e., a “plain,” 

error. See Olano, 507 U.S. at 734 (“‘Plain’ is synonymous with ‘clear’ or, equivalently, 

‘obvious.’”). In discussing this prong, the Supreme Court has recognized that, “[a]t a 

minimum, court[s] of appeals cannot correct [unpreserved] error pursuant to Rule 52(b) 

unless the error is clear under current law.” Id. Thus, we have previously recognized that 

“[a]n error is plain ‘if the settled law of the Supreme Court or this circuit establishes that 

an error has occurred.’” United States v. Carthorne, 726 F.3d 503, 516 (4th Cir. 2013) 

(quoting United States v. Maxwell, 285 F.3d 336, 342 (4th Cir. 2002) (citation omitted)).

Applying this understanding of what constitutes “plain” error to this case, we 

observe that it’s not “obvious” that Jackson’s conduct falls outside the meaning of “held 

for sale” as it is used in § 331(k). Neither the Supreme Court nor we have taken a position 

on this issue, placing it outside the ordinary circumstances in which we would conclude 

error is “plain.” And we have previously recognized that a “district court does not commit 

plain error by following the reasoning of another circuit” “where we have yet to speak 

directly on a legal issue and other circuits are split.” United States v. Strieper, 666 F.3d 

288, 295 (4th Cir. 2012) (citing United States v. Rouse, 362 F.3d 256, 263–64 (4th Cir. 

2004)); cf. United States v. Alli-Balogun, 72 F.3d 9, 12 (2d Cir. 1995) (per curiam) (stating, 

“we do not see how an error can be plain error when the Supreme Court and this court have 

not spoken on the subject, and the authority in other circuit courts is split”). If a position in 

line with one side of an existing sister-circuit split cannot cause error to be plain, a fortiori, 

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a position in line with the sole circuit court to address an issue cannot be obviously wrong.

In short, where the only circuit court to address the issue goes against the defendant, as 

does a substantial body of case law across courts addressing underlying points that the 

circuit court relied on, any error by the district court in this case was not “plain.” Accord 

United States v. Green, 996 F.3d 176, 185 (4th Cir. 2021) (recognizing that an error is 

“clear” or “obvious” when, even though there is no binding precedent from the Supreme 

Court or the Fourth Circuit, circuit courts of appeals “have uniformly taken a position” 

contrary to the district court’s).

We therefore reject Jackson’s assertion that the conduct relied on to support the 

indictment and her conviction falls outside the scope of § 331(k) because it does not involve 

the device being “held for sale.”

B.

Jackson next argues that the district court erred by failing to recognize that 21 U.S.C. 

§ 396 protects physicians from being prosecuted under § 331(k) for off-label use of 

medical devices that occur within a doctor–patient relationship. That central premise forms 

the basis of another multi-faceted assertion of error: (1) that the district court should have 

dismissed the indictment for failure to allege that the relied-on conduct occurred outside a 

doctor–patient relationship, (2) that the court abused its discretion by rejecting her 

proposed jury instruction that “[i]n order to find [her] guilty of the [FDCA] offense . . . [it] 

must find that the defendant was not acting within the scope of . . . a legitimate doctorpatient relationship when she re-used the medical device at issue in this case,” J.A. 238; 

and (3) that the court should have entered a judgment of acquittal because insufficient 

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evidence existed to prove that Jackson acted outside of a legitimate doctor–patient 

relationship.

9

All three facets of this argument rest on a fundamental misunderstanding of the 

relationship between §§ 396 and 331(k). Moreover, adopting Jackson’s position would 

thwart congressional intent and create a huge loophole in the FDCA. See United States v. 

Regenerative Sciences, LLC, 741 F.3d 1314, 1320 (D.C. Cir. 2014) (observing that 

“classifying [acts prohibited by other provisions of the FDCA] as the practice of medicine” 

for purposes of § 396 would “create an enormous gap in the FDCA’s coverage”). The mere 

fact that the individual charged is a physician cannot be sufficient to prohibit prosecution 

under § 331(k). On its face, § 331(k) prohibits certain conduct, regardless of the individual 

who engages in that conduct. So, nothing in § 331(k) itself suggests that it would not apply 

to a physician who engaged in the proscribed conduct.

Although § 396 protects a doctor’s ability to practice medicine by limiting how the 

FDCA is to be applied to them, the statute does not apply to the circumstances presented 

here. In that regard, the statute provides:

Nothing in [the FDCA] shall be construed to limit or interfere with the 

authority of a health care practitioner to prescribe or administer any legally 

marketed device to a patient for any condition or disease within a legitimate 

health care practitioner-patient relationship. This section shall not limit any 

existing authority of the Secretary to establish and enforce restrictions on the 

sale or distribution, or in the labeling, of a device that are part of a 

determination of substantial equivalence, established as a condition of 

approval, or promulgated through regulations. Further, this section shall not 

9 Our standards of review for this issue vary based on whether Jackson has preserved 

the precise challenge, but we need not delve into that because we conclude under any 

standard of review that there is no error of the sort she alleges.

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change any existing prohibition on the promotion of unapproved uses of 

legally marketed devices.

§ 396. In discussing this provision, the Supreme Court has recognized that it protects “offlabel” usage of medical devices, which it understood to mean “use of a device for some 

purpose other than that for which it has been approved by the FDA.” Buckman Co. v. 

Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001). 

The principal problem with Jackson’s argument is that she equates the sort of offlabel usage that § 396 is designed to protect with the holding for sale of an adulterated 

device, an action not protected by the statute. Section 396 protects only physicians who 

“prescribe or administer any legally marketed device” (emphasis added). The FDCA bars 

adulterated devices from the stream of commerce entirely, so they cannot be lawfully sold.

21 U.S.C. § 331(a), (c). They therefore are not legally marketed devices within the meaning 

of § 396. Judge Rotenberg Educ. Ctr., Inc. v. U.S. FDA, 3 F.4th 390, 397 (D.C. Cir. 2021).

And while off-label use is “an accepted and necessary corollary of the FDA’s mission to 

regulate in this area without directly interfering with the practice of medicine,” Buckman 

Co., 531 U.S. at 350, holding adulterated devices for sale is not. 

Once again, the Ninth Circuit’s decision in Kaplan addressed and rejected the view 

Jackson espouses of how §§ 331(k) and 396 operate. And on this point, we expressly agree 

with its conclusion that “[w]hile a physician may exercise professional judgment in the offlabel use of unadulterated products, nothing in the FDCA or caselaw suggests that the use 

of adulterated products is ever permissible.” 836 F.3d at 1211; accord United States v. Cal. 

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Stem Cell Treatment Ctr., Inc., 117 F.4th 1213, 1220 (9th Cir. 2024).10 Section 396 simply 

does not cover the type of conduct at issue in the charged violation of § 331(k) proven at 

trial here. We therefore reject Jackson’s argument to the contrary.

C.

Allied with her defective § 396 theory, Jackson also argues that her § 331(k) 

conviction cannot stand because it is grounded in a faulty theory that re-use of a device 

labeled for single use constitutes per se adulteration. In her view, “FDA-mandated labels 

do not have the force of law as to doctors’ use of devices” and “it cannot be a per se

violation of the FDCA for a doctor to use a device in a manner different from the way its 

manufacturer intended as provided on the label—including reusing a device labeled as a 

‘single use’ device.” Opening Br. 45, 47. She contends that because the indictment, jury 

instructions, and evidence were directed to show that she was liable based on this flawed 

theory, the Court should vacate her conviction and dismiss the charges.11

We reject Jackson’s argument because it misunderstands the basis for her 

conviction. In short, her conviction followed statutory requirements and is not based on the 

theory she claims as the Government’s basis for her prosecution. To the contrary, the theory 

10 As was true in Kaplan, we note that the record before us contains no evidence that 

Jackson “used professional judgment for some legitimate off-label purpose” when deciding 

to engage in the conduct at issue in Count 1. Kaplan, 836 F.3d at 1211. While this bolsters 

our conclusion that the district court did not err in deeming § 396 irrelevant to Jackson’s 

culpability under § 331(k), it is not essential to our holding.

11 The only part of this argument Jackson preserved relates to the district court’s 

acceptance and rejection of jury instructions, which we review for abuse of discretion. See 

United States v. Campbell, 963 F.3d 309, 315 (4th Cir. 2020). We review the unpreserved 

parts of the argument for plain error. Puckett, 556 U.S. at 134–35.

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for holding Jackson liable was that she “held for sale” an adulterated device—exactly as 

§ 331(k) envisions. That fact is borne out in both the superseding indictment and the jury 

instructions, as well as how the Government prosecuted the case.

For example, the superseding indictment repeatedly cited and quoted § 331(k) and 

§ 351(a)(2)(A)’s statutory language about when a violation occurs and when a medical 

device is adulterated. In connecting that statutory language to Jackson’s alleged violation, 

the indictment described why the Entellus could not be cleaned effectively or sterilized. It 

also described the conditions in Jackson’s practice that caused the device to be adulterated. 

This language does not suggest that mere off-label use such as re-use of a device labeled 

for single use was a per se basis for charging Jackson with violating § 331(k).

The jury instructions similarly tracked the statutory language for what constitutes a 

§ 331(k) violation and adulteration. At no time was the jury instructed that it could convict 

Jackson solely based on her re-use of a device labeled for single use. Indeed, the only time 

the instructions mentioned that the device was labeled for “single-use” is in the context of 

finding Jackson’s intent to defraud—an add-on finding to the threshold determination that 

Jackson had violated § 331(k). That instruction provided the example that “if [the jury] 

f[ou]nd beyond a reasonable doubt that [Jackson] did not disclose to a patient that she was 

reusing a single-use . . . device that she had used on a different patient and that one of her 

reasons for doing so was to enrich herself, then the Government has proven an intent to 

defraud and mislead.” J.A. 3516. This finding about Jackson’s intent became relevant only 

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after the jury’s initial determination that the device was adulterated and that Jackson had 

violated § 331(k).12

To be sure, that the Entellus was labeled for single use came up at trial. And rightly 

so, as it was relevant background information. But the testimony at trial centered on why

the device had been labeled for single use, not on the fact that it was labeled so. Parallel 

with evidence about the Entelluses’ labeling, the Government developed a thorough case 

about what happened to the device after its first use and the risks associated with attempting 

to clean a used device and then reusing it. And the totality of that evidence was directly 

relevant to the issue before the jury—whether Jackson had “do[ne] any other act with 

respect to” the device while it was being “held for sale” that “result[ed] in such [device] 

being adulterated.” § 331(k). In addition, evidence about the Entellus’s single-use label 

was relevant to establishing how Medicare reimbursed doctors for performing a sinuplasty 

procedure on patients, and it supported the Government’s theory about Jackson’s profit 

12 The district court rejected Jackson’s proposed instruction that “the re-use by a 

licensed physician of a . . . medical device labeled by the manufacturer as a single-use 

device is not, in and of itself, unlawful.” J.A. 241. A district court abuses its discretion in 

rejecting a proposed instruction only if the proffered instruction was “(1) A correct 

statement of the law; (2) Not substantially covered by the instructions given by the district 

court; and (3) Involved some point so important that the failure to give the instruction 

seriously impaired the defendant’s defense.” Campbell, 963 F.3d at 315. The instructions 

the district court gave properly counseled the jury on the elements of § 331(k), thereby 

ensuring that the jury’s verdict was properly focused on whether the Entelluses were

adulterated and “held for sale” along with the other elements of the offense. As discussed 

elsewhere in this opinion, Jackson’s proposed instruction did not target the elements of 

§ 331(k), nor did it tread necessary new ground relevant to that determination. As such, 

applying the above test, we conclude the district court did not abuse its discretion in 

declining to give the proposed instruction. 

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motive for engaging in the prohibited conduct. But again, it was not the single-use labeling 

that formed the basis for finding that the Entelluses were adulterated.

In sum, Jackson’s argument ignores large swaths of the Government’s case and 

myopically focuses on and takes out of context one component of admitted evidence to 

argue that a theory of per se adulteration from re-use led to her conviction. Based on the 

totality of the record, including the language of the superseding indictment and the jury 

instructions, we reject this argument. 

D.

Jackson also argues that the district court improperly curtailed her ability to present 

her defense when it prohibited her from introducing a video she recorded in which she 

demonstrated how she cleaned the Entellus. She maintains that the district court mistakenly 

believed that she wanted to testify as an expert witness when her purpose was to offer lay 

testimony about “how she cleaned and sanitized the device[],” so that the jury would hear 

her side of the story. Opening Br. 54.

The record presents a different picture of why the district court disallowed this 

evidence. The night after Jackson began to testify at trial, her attorneys disclosed for the 

first time their intent to introduce a video recording the following day when Jackson 

resumed her testimony. The video would depict Jackson demonstrating her cleaning 

methods, taking culture samples from the device, and then handing over the samples for 

testing. Initially, Jackson explained to the court that she wanted to introduce the video as 

background evidence for introducing her testimony both about her cleaning methods and 

about the results of the culture tests. The Government objected, and the district court agreed 

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with the Government, observing that this request was a “blatant violation of Rule 16 and 

[the court’s] scheduling order,” J.A. 3078, and was “an effort to have [Jackson] testify as 

an expert” without following the pre-trial process, J.A. 3079. Jackson then shifted gears, 

asking the court if it would permit a silent version of the video recording to play while 

Jackson testified about it as “an example of how she washes [the device].” J.A. 3080. The 

district court denied that request too, observing “there’s a process of reviewing information 

or videos like this in a timely fashion. And to produce it the night before—in the middle of 

testimony . . . . No lawyer has tried to do this, and it’s because it’s patently improper.” 

J.A. 3080.

Jackson’s arguments on appeal fail to grapple with the fundamental ground of

untimeliness that the district court relied on when denying admission of the video, 

regardless of whether it was classified as expert testimony or not. Because Jackson 

requested discovery from the Government, Federal Rule of Criminal Procedure 

16(b)(1)(A)(ii) required Jackson to allow inspection of any evidence she wished to use in 

her “case-in-chief at trial.” The district court’s scheduling order required Jackson to make 

her Rule 16(b) disclosures by July 2022—six months before Jackson did so. S.A. 2.

District courts have broad discretion “in all rulings related to the admission and 

exclusion of evidence, and this Court will not reverse the decision to exclude such evidence 

absent abuse of that discretion.” United States v. Holmes, 670 F.3d 586, 598 (4th Cir. 

2012). We see no abuse of discretion in the district court’s refusal to reward Jackson for 

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her disregard of the court’s scheduling order. We reject Jackson’s evidentiary challenge 

to the exclusion of her video evidence.13

E.

Jackson’s second evidentiary argument relates to the district court’s exclusion of 

certain documents about disinfection and sterilization from the Centers for Disease Control 

and Prevention (“CDC”). Though their specifics vary, the documents generally discuss 

sterilization techniques for medical equipment. One such document, titled “Reuse of 

Single-Use Medical Devices,” recounts that “[a]pproximately 20 to 30% of U.S. hospitals 

reported that they reuse at least one type of single-use device.” J.A. 3638. When ruling on 

their admissibility, the district court excluded them as hearsay and rejected Jackson’s 

argument that they were nonetheless admissible to show their effect on her and thereby had 

the potential to negate a finding that she intended to defraud her patients.

13 Jackson contends the district court’s conduct rose beyond an improper evidentiary 

ruling and amounted to a constitutional violation by infringing her ability to present a 

“complete defense.” See United States v. Smith, 451 F.3d 209, 221 (4th Cir. 2006) 

(recognizing that the Fifth and Sixth Amendments guarantee an accused “a meaningful 

opportunity to present a complete defense”). But we have never held that this right entitles 

a criminal defendant to introduce whatever evidence she wants in her defense. And 

unfavorable evidentiary rulings rarely take on constitutional dimensions. See, e.g., United 

States v. Perkins, 937 F.2d 1397, 1401 (4th Cir. 1991) (“[The defendant] cannot transform 

the exclusion of . . . evidence into constitutional error by arguing that he was deprived of 

his right to present a defense. The right to present a defense is clearly fundamental, but in 

the exercise of this right, the accused, as is required of the [Government], must comply 

with established rules of procedure and evidence designed to assure both fairness and 

reliability in the ascertainment of guilt and innocence.” (cleaned up)). 

Here, we observe that nothing specific about the video calls into question Jackson’s 

ability to present a “complete defense.” At trial, Jackson was able to describe at some 

length her cleaning practices, as were her employees. She was also able to make related 

arguments to the jury. As such, we also reject the constitutional component of this 

argument.

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On appeal, Jackson again asserts that these documents were admissible for a purpose 

other than for their truth, i.e., for their effect on her. She contends that had this evidence 

been admitted, the jury “may well have had a reasonable doubt as to whether [she] had a 

reason to cover up her re-use of devices, and thus may have acquitted her of the adulteration 

offense[.]” Opening Br. 55. 

Assuming, without deciding, that the evidence was admissible, we conclude that 

any purported error was harmless. To prove nonconstitutional error harmless, “the 

Government must demonstrate that the error did not have a ‘substantial and injurious effect 

or influence in determining the jury’s verdict.’” United States v. Curbelo, 343 F.3d 273, 

278 (4th Cir. 2003) (quoting Kotteakos v. United States, 328 U.S. 750, 776 (1946)). “An 

appellate court does not inquire into whether absent the error sufficient evidence existed to 

convict, but rather whether we believe it highly probable that the error did not affect the 

judgment.” United States v. Ibisevic, 675 F.3d 342, 350 (4th Cir. 2012) (internal quotation 

marks and citation omitted). So, to affirm, we “must be able to ‘say, with fair assurance, 

after pondering all that happened without stripping the erroneous action from the whole, 

that the judgment was not substantially swayed by the error.’” Id. (citation omitted). We 

have the requisite “fair assurance” here. The CDC documents provide scant support for the 

propositions Jackson uses them to advance. None of them address the disinfection or 

sterilization of the Entellus or a similar device. And the document about re-use of singleuse devices likewise does not mention this device as one that is reused by other medical 

providers. At bottom, the documents do not show that this device could be sterilized 

effectively or that Jackson was justified in believing that they could be. For this reason, we 

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conclude it is “highly probable that [their exclusion] did not affect the judgment.” Ibisevic, 

675 F.3d at 350 (quotation marks and citation omitted).

F.

Next, Jackson asserts the district court prejudiced her case by instructing the jury 

that it was “irrelevant” that no patient was harmed.14 The instructions she challenges were 

given in response to objected-to questioning during her testimony (i.e., not immediately 

before deliberations). Though the specific instructions vary, in each instance, the district 

court returned the jury’s attention to the Government’s burden with respect to the § 331(k) 

violation, cautioning them, for example, that evidence that no patients were harmed as a 

result of Jackson’s methods “is irrelevant. . . . The United States does not have to prove in 

Count 1 that a single patient got sick because of the defendant’s process.” J.A. 3167. 

Jackson contends these instructions erroneously prohibited her “from showing that the 

devices were not adulterated,” “that she had no motive to—and thus did not—adulterate 

the devices . . . or otherwise scheme to cover up the fact that she was using dirty devices,” 

and that they “misinformed the jury about how they should consider evidence related to 

adulteration.” Opening Br. 60.

Jackson’s argument misapprehends what § 331(k) required of the Government. As 

the statutory definition makes clear, the district court was correct when it instructed that 

14 Alongside this argument, Jackson asserts that the district court abused its 

discretion by instructing the jury that it was “irrelevant” that “Jackson believed the devices 

were clean.” Opening Br. 58. But none of her cited examples contained such an instruction. 

Instead, the context of each statement shows that the Government’s objection and the 

district court’s instructions centered on whether Count 1 requires proof of actual harm to a 

patient.

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§ 331(k) did not require proof of actual harm to patients for a jury to find that the Entellus

had been adulterated. Section 351(a)(2)(A) states that a device “shall be deemed to be 

adulterated” if it is “held under insanitary conditions whereby it may have been

contaminated by filth, or whereby it may have been rendered injurious to health.” 

(Emphases added). A device can satisfy this definition without causing someone actual 

harm; it is sufficient that the potential for contamination or injury exist. Thus, the district 

court was well within its discretion to instruct the jury to that effect. 

G.

Jackson’s final challenge to this count contends that reversible error occurred during 

the Government’s closing argument as a result of an impermissible “Golden Rule” 

argument. An invitation “urg[ing] jurors to identify individually with the victim” is an 

improper “Golden Rule” closing argument. United States v. Huskey, 90 F.4th 651, 671 (4th 

Cir. 2024) (quoting United States v. Al-Maliki, 787 F.3d 784, 795 (6th Cir. 2015)); accord 

United States v. Moreno, 947 F.2d 7, 8 (1st Cir. 1991) (observing that improper “golden 

rule” arguments “encourage[] the jury to depart from neutrality and to decide the case on 

the basis of personal interest and bias rather than on the evidence”). “A golden-rule 

objection typically arises when a lawyer asks jurors to place themselves in the plaintiff’s 

position with respect to the calculation of damages,” with “[t]he rationale for prohibiting 

such an argument [being] that the jury’s sympathy will be unfairly aroused, resulting in a 

disproportionate award of damages.” Ermini v. Scott, 937 F.3d 1329, 1340 (11th Cir. 2019) 

(quoting Burrage v. Harrell, 537 F.2d 837, 839 (5th Cir. 1976)). 

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Jackson asserts that two portions of the Government’s closing argument violated 

this precept. In suggesting that every patient would prefer a sterile device to an adulterated 

one, the Government asked, “Which one would you want? . . . . If you could have a device 

that had been here fully coated and contaminated with another person’s blood and mucous, 

or you could have that perfectly pristine device, which one would you want? Which one 

would you choose?” J.A. 3418. The Government then “add[ed] another factor to [the 

juror’s] choice,” observing that the unused device was “completely sterile” and posed “zero 

risk that another human’s bodily fluids would get inside your body . . . . Would that impact 

your decision?” J.A. 3418. 

Assuming, without deciding, that these statements constitute an impermissible 

“Golden Rule” argument, we conclude that they were not prejudicial in context and 

therefore do not require reversal. We will reverse a conviction based on an improper 

closing argument only when the impropriety “so prejudicially impacted the defendant’s 

substantial rights as to deprive him of a fair trial.” United States v. Webb, 965 F.3d 262, 

267 (4th Cir. 2020) (quotations and citation omitted). And here our review is further 

constrained by the plain-error standard because Jackson neither lodged a contemporaneous 

objection nor moved for judgment of acquittal on this ground in the district court.15 See id.

15 Jackson argues that she did not need to object to preserve her Golden Rule 

argument. But our decisions say only that parties need not object contemporaneously—

raising the issue at the end of closing statements will do. Werner v. Upjohn Co., 628 F.2d 

848, 854 (4th Cir. 1980); Leathers v. Gen. Motors Corp., 546 F.2d 1083, 1085–86 (4th Cir. 

1976). We do not read our decisions in Werner and Leathers to free Jackson from any 

obligation to present the Golden Rule issue to the district court.

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Jackson has not met her burden. The allegedly improper argument consists of three 

lines in a closing argument that spans some thirteen pages devoted just to Count 1. Quite

apart from these brief references, the jury had overwhelming evidence supporting 

Jackson’s culpability. Indeed, Jackson admitted to reusing Entelluses, and it’s undisputed 

that she did not inform her patients that she did so. Other evidence supported the jury’s 

conclusion that Jackson’s re-use and cleaning methods nonetheless “adulterated” the 

device. And still more evidence supported the jury’s finding that by reusing the devices, 

Jackson profited by billing Medicare in full for the sinuplasty procedure that factored in 

the full price of a new device. Jackson profited handsomely from her approach. On this 

record, we cannot discern that Jackson’s substantial rights were impacted and, absent that

showing of prejudice, reversal is not warranted. See Huskey, 90 F.4th at 671.

* * * *

Having rejected each of Jackson’s arguments as to Count I, we affirm her conviction 

for violating 21 U.S.C. § 331(k).16

III.

Jackson next challenges her convictions for aggravated identity theft, in violation of 

18 U.S.C. §§ 1028A(a)(1) and 2, which formed Counts 15 and 16 of the superseding 

indictment. This offense imposes a mandatory consecutive two-year term of imprisonment 

if an individual has been convicted of other qualifying offenses and, during or in relation 

16 Because we affirm this conviction, we reject Jackson’s argument that errors 

relating to Count 1 require vacatur of her other convictions.

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to those offenses, the defendant “knowingly transfers, possesses, or uses, without lawful 

authority, a means of identification of another person.” § 1028A(a)(1), (b)(2); see United 

States v. Abdelshafi, 592 F.3d 602, 607 (4th Cir. 2010) (recounting the four elements of 

this offense). 

The superseding indictment charged that Jackson aided and abetted in aggravated 

identity theft by manufacturing backdated declarations purporting to be from two patients, 

using their names and, most importantly, their forged signatures. Jackson then submitted

those declarations as part of her responses to the 2018 Palmetto audit.

After the jury convicted Jackson, the Supreme Court decided Dubin v. United States, 

599 U.S. 110 (2023), which clarified what it meant to “use” an individual’s identity “in 

relation to” another qualifying offense. Arguing that Dubin invalidated her convictions,

Jackson moved for a judgment of acquittal or a new trial as to Counts 15 and 16. The 

district court denied her motion. It concluded that the concerns present in Dubin about 

when a defendant’s “use” of another’s identifying information is sufficiently close to the 

qualifying offense to be deemed “in relation to” to it were not at issue in this case. In the 

court’s view, the requisite hook between the identity theft and qualifying other offense 

existed here because Jackson had forged the patients’ signatures on declarations purporting 

to be from those patients and then submitted them as part of the false statements that 

constituted the qualifying other offense (making false statements relating to health care 

matters). 

On appeal, Jackson does not challenge the denial of her motion for judgment of 

acquittal. Instead, she relies on Dubin to make two different arguments: that Dubin

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rendered the superseding indictment and the jury instructions deficient because it requires

a specific finding—by the grand jury and the petit jury, respectively—that the alleged 

misuse of the victim’s identity was what made the qualifying offense criminal. Because the 

grand jury did not so find as part of Counts 15 or 16, she contends the Court should vacate 

those convictions and remand for the district court to dismiss those charges. Alternatively, 

because the jury instructions did not require the jury to make this finding before convicting 

her, she asserts the Court should vacate those convictions and remand to permit a new trial. 

Because Jackson did not raise either of these challenges in the district court, we 

review for plain error. See Greer v. United States, 593 U.S. 503, 507–08 (2021).

17 Jackson 

has not met her burden of showing any error, let alone an obvious one.

In Dubin, the Supreme Court “clarified the scope of the statute prohibiting 

aggravated identity theft” by resolving a circuit split (which we were not part of) about 

17 Jackson acknowledges that she did not preserve a challenge to the relevant jury 

instructions, but she maintains that her general pretrial challenge to the sufficiency of the 

indictment preserved her challenge to the indictment. We disagree. 

When Jackson moved to dismiss Counts 15 and 16 of the indictment, she asserted

that the charges were unconstitutionally vague. Her only argument in support of that 

conclusion challenged the allegations addressing the element of the offense that the identity 

theft occurred without the lawful authority of the person whose identity was used. Simply 

put, her argument challenging these charges in the district court did not bear even passing 

resemblance to the challenge she now raises. And even though Jackson did not have the 

benefit of Dubin’s precise language at the time she moved to dismiss the indictment, the 

arguments she made in her pretrial motion are far removed from the sorts of concerns 

addressed in that decision, which concern different elements of the offense. Moreover, once 

Dubin was decided, Jackson filed a post-judgment motion that did not raise the types of 

arguments she now raises concerning the indictment. Under these circumstances, we 

readily conclude that Jackson did not preserve the challenge to the indictment that she 

brings before us, so plain-error review is appropriate.

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when a defendant “uses” another’s identifying information “in relation to” another 

qualifying offense. United States v. O’Lear, 90 F.4th 519, 532–33 (6th Cir. 2024). The 

defendant in Dubin conducted certain psychological tests on a patient and then submitted 

claims to Medicaid for reimbursement. Dubin, 599 U.S. at 114. That paperwork referred 

to the patient by name and described the procedures performed, but fraudulently inflated 

the amount to be reimbursed by misrepresenting the qualifications of the person performing 

the procedures. Id. Unlike this case, the patient’s signature did not appear on the 

paperwork. And while the patient’s name appeared on the provider-submitted paperwork, 

services had been performed on that named patient. Id. The provider’s “fraud” thus related 

to identifying the type and dates of services identified for reimbursement, not the identity 

or existence of any particular patient.

The Government charged the Dubin defendant with aggravated identity theft based 

on the submitted paperwork bearing the name of the patient. Id. at 114–15. But the Supreme 

Court held that § 1028A(a)(1) does not cover such conduct, observing identity theft 

offenses occur “when the defendant’s misuse of another person’s means of identification 

is at the crux of what makes the conduct criminal,” i.e., when the means of identification 

is “used in a manner that is fraudulent or deceptive . . ., [which] can often be succinctly 

summarized as [deception about] ‘who’ is involved.” Id. at 113, 132. The “use” in Dubin 

was not in “relation to” the healthcare fraud because the “crux” of the defendant’s 

qualifying offense was that the “fraud was in misrepresenting how and when services were 

provided to a patient, not who received the services.” Id. at 132 (emphasis in original). The 

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Fifth Circuit has since helpfully summarized the disconnect between the underlying fraud 

and the identity theft that motivated the Supreme Court’s holding—

In Dubin, the Supreme Court identified a mismatch between the ‘crux’ of the 

predicate felony—overbilling Medicaid by misrepresenting Person A’s 

qualifications—and the § 1028A conviction that the government argued the 

predicate felony supported—the incidental use of Person B’s name and 

Medicaid ID on the billing statement. Because the billing statement was 

rendered fraudulent by the misrepresentation about Person A, and not by the 

misrepresentation about Person B, Person B’s means of identification was 

not used ‘in relation to’—that is, central to, the predicate offense of fraud.

United States v. Croft, 87 F.4th 644, 648 (5th Cir. 2023).

At the outset, then, we note that Dubin did not alter our understanding of the

elements of the aggravated identity theft offense or require additional factual findings in 

each prosecution. Instead, it clarified the scope of the “use” and “in relation to” elements 

in cases, requiring a narrower reading than the Fifth Circuit had previously permitted. We 

therefore reject Jackson’s contention that the indictment and jury instructions were 

inherently defective because Dubin requires a specific factual finding in every case that the

use of the means of identification was “the crux” of what made the qualifying offense 

criminal. 

Nor do we discern any reason to believe that Dubin undercuts the factual basis on 

which Jackson was charged or convicted. The “crux” of Jackson’s fraud was in submitting 

falsified paperwork as part of a Medicaid audit. But crucially, for § 1028A purposes, that 

falsified paperwork contained the two declarations that then formed the basis of the 

aggravated identity theft counts. And “who” created and signed those declarations was 

essential to the qualifying offense’s fraud—Jackson submitted them claiming that they 

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were declarations signed by her patients supporting what they represented and thus 

supporting her responses to the audit. Instead, the declarations were not the patients’ 

representations at all, nor did they bear the patients’ real signatures. Rather, it was Jackson

(or those under her direction) who both crafted the declarations purporting to be from her 

patients and attested to those representations by forging the patients’ signatures.

Thus, unlike the circumstances in Dubin, the circumstances here present a classic 

case of identity theft, falling cleanly within the aggravated identity theft statute’s scope. At 

bottom, the facts in Dubin differ significantly from this case, and the concerns the Supreme 

Court targeted there are not implicated here. See, e.g., United States v. Gladden, 78 F.4th 

1232, 1245 (11th Cir. 2023) (concluding that no Dubin-like mismatch existed where the 

defendant used others’ identities “to continue refilling prescriptions in their names,” 

making that forgery “the heart of” the fraudulent practice of billing for medically 

unnecessary prescriptions). We reject Jackson’s contention that the indictment or 

instructions were deficient in view of Dubin’s clarifying language about the scope of the 

offense. Discerning no error—plain or otherwise—with Jackson’s convictions for 

aggravated identity theft (Counts 15 and 16), we affirm them.

IV.

For the reasons set forth above, we affirm all of Jackson’s convictions.

AFFIRMED

USCA4 Appeal: 23-4587 Doc: 79 Filed: 01/21/2025 Pg: 35 of 35